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Ceftazidime


Pronunciation: sef-TAZ-i-deem
Generic Name: Ceftazidime
Brand Name: Examples include Fortaz and Tazicef
Ceftazidime is used for:

Treating bacterial infections.

Ceftazidime is a cephalosporin antibiotic. It works by killing sensitive bacteria.

Do NOT use Ceftazidime if: you are allergic to any ingredient in Ceftazidime or to another cephalosporin (eg, cephalexin) you are taking chloramphenicol

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ceftazidime:

Some medical conditions may interact with Ceftazidime. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to a penicillin (eg, amoxicillin) or beta-lactam antibiotic (eg, imipenem) if you have stomach or bowel problems (eg, inflammation), blood clotting problems, kidney or liver problems, myasthenia gravis, or poor nutrition

Some MEDICINES MAY INTERACT with Ceftazidime. Tell your health care provider if you are taking any other medicines, especially any of the following:

Aminoglycosides (eg, gentamicin) or diuretics (eg, furosemide) because risk of kidney side effects may be increased Chloramphenicol because it may decrease Ceftazidime's effectiveness Hormonal birth control (eg, birth control pills) because its effectiveness may be decreased by Ceftazidime

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ceftazidime may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Ceftazidime:

Use Ceftazidime as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ceftazidime is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Ceftazidime at home, carefully follow the injection procedures taught to you by your health care provider. Do not use Ceftazidime if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged. To clear up your infection completely, take Ceftazidime for the full course of treatment. Keep taking it even if you feel better in a few days. Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal. If you miss a dose of Ceftazidime, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ceftazidime.

Important safety information: Ceftazidime may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Ceftazidime with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Ceftazidime only works against bacteria; it does not treat viral infections (eg, the common cold). Be sure to use Ceftazidime for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future. Long-term or repeated use of Ceftazidime may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur during treatment or within several months after treatment with Ceftazidime. Do not treat diarrhea without first checking with your doctor. Ceftazidime may reduce the ability of your blood to clot. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools. Diabetes patients-Ceftazidime may cause the results of some tests for urine glucose to be wrong. Ask your doctor before you change your diet or the dose of your diabetes medicine. Hormonal birth control (eg, birth control pills) may not work as well while you are using Ceftazidime. To prevent pregnancy, use an extra form of birth control (eg, condoms). Ceftazidime may affect certain lab test results. Make sure your doctor and lab personnel know you are using Ceftazidime. Lab tests, including kidney or liver tests or blood cell counts, may be performed while you use Ceftazidime. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Use Ceftazidime with caution in the ELDERLY; they may be more sensitive to its effects. Use Ceftazidime with extreme caution in CHILDREN younger than 10 years old who have diarrhea or an infection of the stomach or bowel. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using this while you are pregnant. Ceftazidime is found in breast milk. If you are or will be breast-feeding while you use Ceftazidime, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Ceftazidime:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; headache; nausea; numbness or tingling of skin; stomach pain; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal muscle movements; bloody stools; decreased urination; fever; hoarseness; pain, redness, or swelling at the injection site; red, swollen, or blistered skin; seizures; severe diarrhea; severe nausea or vomiting; severe stomach pain/cramps; unusual bruising or bleeding; unusual tiredness; vaginal irritation or discharge; vein inflammation; white patches in the mouth; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Ceftazidime side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately. Symptoms may include loss of consciousness; muscle spasms; seizures.

Proper storage of Ceftazidime:

Ceftazidime is usually handled and stored by a health care provider. If you are using Ceftazidime at home, store Ceftazidime as directed by your pharmacist or health care provider. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ceftazidime out of the reach of children and away from pets.

General information: If you have any questions about Ceftazidime, please talk with your doctor, pharmacist, or other health care provider. Ceftazidime is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Ceftazidime. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Ceftazidime resources Ceftazidime Side Effects (in more detail) Ceftazidime Use in Pregnancy & Breastfeeding Ceftazidime Drug Interactions Ceftazidime Support Group 0 Reviews for Ceftazidime - Add your own review/rating Ceftazidime Prescribing Information (FDA) Ceftazidime Professional Patient Advice (Wolters Kluwer) Ceftazidime Monograph (AHFS DI) Fortaz Prescribing Information (FDA) Fortaz Concise Consumer Information (Cerner Multum) Tazicef Prescribing Information (FDA) ceftazidime Injection Advanced Consumer (Micromedex) - Includes Dosage Information Compare Ceftazidime with other medications Bacteremia Bladder Infection Bone infection Endocarditis Endometritis Febrile Neutropenia Intraabdominal Infection Joint Infection Kidney Infections Melioidosis Meningitis Nosocomial Pneumonia Otitis Externa Otitis Media Pelvic Inflammatory Disease Peritonitis Pneumonia Pneumonia with Cystic Fibrosis Sepsis Septicemia Sinusitis Skin and Structure Infection Skin Infection Urinary Tract Infection
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Tobramycin Drops


Pronunciation: toe-bra-MYE-sin
Generic Name: Tobramycin
Brand Name: Examples include AK-Tob and Tobrex
Tobramycin Drops are used for:

Treating eye infections.

Tobramycin Drops are an antibiotic. It works by killing or slowing the growth of certain types of bacteria.

Do NOT use Tobramycin Drops if: you are allergic to any ingredient in Tobramycin Drops or to similar medicines

Contact your doctor or health care provider right away if any of these apply to you.

Before using Tobramycin Drops:

Some medical conditions may interact with Tobramycin Drops. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Tobramycin Drops. Tell your health care provider if you are taking any other medicines, especially any of the following:

Cephalosporins by injection (eg, ceftazidime) because they may decrease Tobramycin Drops's effectiveness Cyclosporine, fludarabine, loop diuretics (eg, furosemide), methoxyflurane, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, indomethacin), nitrosoureas (eg, streptozocin), polypeptide antibiotics (eg, polymyxin B), or vancomycin injection because they may increase the risk of Tobramycin Drops's side effects, including increased risk of kidney or hearing problems Cephalosporins by injection (eg, ceftazidime), nondepolarizing muscle relaxants (eg, pancuronium), or succinylcholine because their side effects may be increased by Tobramycin Drops

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tobramycin Drops may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Tobramycin Drops:

Use Tobramycin Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Remove contact lenses before you use Tobramycin Drops. Do not wear contact lenses while you are using Tobramycin Drops. Take care of your contact lenses as directed by the manufacturer. Check with your doctor before you use them. To use Tobramycin Drops in the eye, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eyelid for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them. To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed. To clear up your infection completely, take/use Tobramycin Drops for the full course of treatment. Keep taking/using it even if you feel better in a few days. Tobramycin Drops works best if it is used at the same time each day. Do not miss any doses. If you miss a dose of Tobramycin Drops, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Ask your health care provider any questions you may have about how to use Tobramycin Drops.

Important safety information: Tobramycin Drops may cause blurred vision. Use Tobramycin Drops with caution. Do not drive or perform other possibly unsafe tasks if you cannot see clearly. If your symptoms do not get better within a few days or if they get worse, check with your doctor. Be sure to use Tobramycin Drops for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future. Long-term or repeated use of Tobramycin Drops may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this. Tobramycin Drops should not be used in CHILDREN younger than 2 months old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tobramycin Drops while you are pregnant. It is not known if Tobramycin Drops are found in breast milk. Do not breast-feed while using Tobramycin Drops. Possible side effects of Tobramycin Drops:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Burning or stinging in the eye.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); eye or eyelid swelling, itching, or redness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; eye pain; eye watering; swelling and itching of the eyelid.

Proper storage of Tobramycin Drops:

Store Tobramycin Drops at room temperature, between 46 and 80 degrees F (8 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tobramycin Drops out of the reach of children and away from pets.

General information: If you have any questions about Tobramycin Drops, please talk with your doctor, pharmacist, or other health care provider. Tobramycin Drops are to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Tobramycin Drops. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Tobramycin resources Tobramycin Use in Pregnancy & BreastfeedingTobramycin Support Group3 Reviews for Tobramycin - Add your own review/rating Compare Tobramycin with other medications Conjunctivitis, Bacterial
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Tazicef


ceftazidime pentahydrate
Dosage Form: for Injection, USP

PHARMACY BULK PACKAGE ?

NOT FOR DIRECT INFUSION

Rx only

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tazicef (ceftazidime) and other antibacterial drugs, Tazicef (ceftazidime) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Tazicef Description

Ceftazidime is a semisynthetic, broad-spectrum, beta-lactam antibiotic for parenteral administration. It is the pentahydrate of pyridinium, 1-[[7-[[(2-amino-4-thiazolyl)[(1-carboxy-1-methyl-ethoxy) imino]acetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabicyclo (4.2.0.)oct-2-en-3-yl] methyl]-,hydroxide, inner salt, [6R-[6?,7?(Z)]]. It has the following structure:

The molecular formula is C22H32N6O12S2, representing a molecular weight of 636.6.

Tazicef (ceftazidime for injection, USP) is a sterile, dry, powdered mixture of ceftazidime pentahydrate and sodium carbonate. The sodium carbonate at a concentration of 118 mg/gram of ceftazidime activity has been admixed to facilitate dissolution. The total sodium content of the mixture is approximately 54 mg (2.3 mEq)/gram of ceftazidime activity. Solutions of Tazicef range in color from light yellow to amber, depending on the diluent and volume used. The pH of freshly reconstituted solutions usually ranges from 5.0 to 7.5.

Tazicef is available in a 6 gram Pharmacy Bulk Package. The contents of this Pharmacy Bulk Package are intended for use by a pharmacy admixture service for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion. FURTHER DILUTION IS REQUIRED BEFORE USE.

Tazicef - Clinical Pharmacology

This drug product can be administered intramuscularly, intraperitoneally or by direct intravenous infusion. HOWEVER THE INTENT OF THIS PHARMACY BULK PACKAGE IS FOR THE PREPARATION OF SOLUTIONS FOR INTRAVENOUS INFUSION ONLY.

After IV administration of 500-mg and 1-gram doses of ceftazidime over 5 minutes to normal adult male volunteers, mean peak serum concentrations of 45 mcg/mL and 90 mcg/mL, respectively, were achieved. After IV infusion of 500-mg, 1-gram and 2-gram doses of ceftazidime over 20 to 30 minutes to normal adult male volunteers, mean peak serum concentrations of 42 mcg/mL, 69 mcg/mL and 170 mcg/mL, respectively, were achieved. The average serum concentrations following IV infusion of 500-mg, 1-gram and 2-gram doses to these volunteers over an 8-hour interval are given in Table 1.

Table 1

Ceftazidime

Serum Concentrations (mcg/mL)

IV Dosage

0.5 hr.

1 hr.

2 hr.

4 hr.

8 hr.

500 mg

42

25

12

6

2

1 gram

60

39

23

11

3

2 grams

129

75

42

13

5

The absorption and elimination of ceftazidime were directly proportional to the size of the dose. The half-life following IV administration was approximately 1.9 hours. Less than 10% of ceftazidime was protein bound. The degree of protein binding was independent of concentration. There was no evidence of accumulation of ceftazidime in the serum in individuals with normal renal function following multiple IV doses of 1 gram and 2 grams every 8 hours for 10 days.

Following IM administration of 500-mg and 1-gram doses of ceftazidime to normal adult volunteers, the mean peak serum concentrations were 17 mcg/mL and 39 mcg/mL, respectively, at approximately 1 hour. Serum concentrations remained above 4 mcg/mL for 6 and 8 hours after the IM administration of 500-mg and 1-gram doses, respectively. The half-life of ceftazidime in these volunteers was approximately 2 hours.

The presence of hepatic dysfunction had no effect on the pharmacokinetics of ceftazidime in individuals administered 2 grams intravenously every 8 hours for 5 days. Therefore, a dosage adjustment from the normal recommended dosage is not required for patients with hepatic dysfunction, provided renal function is not impaired.

Approximately 80% to 90% of an IM or IV dose of ceftazidime is excreted unchanged by the kidneys over a 24-hour period. After the IV administration of single 500-mg or 1-gram doses, approximately 50% of the dose appeared in the urine in the first 2 hours. An additional 20% was excreted between 2 and 4 hours after dosing, and approximately another 12% of the dose appeared in the urine between 4 and 8 hours later. The elimination of ceftazidime by the kidneys resulted in high therapeutic concentrations in the urine.

The mean renal clearance of ceftazidime was approximately 100 mL/min. The calculated plasma clearance of approximately 115 mL/min. indicated nearly complete elimination of ceftazidime by the renal route. Administration of probenecid before dosing had no effect on the elimination kinetics of ceftazidime. This suggested that ceftazidime is eliminated by glomerular filtration and is not actively secreted by renal tubular mechanisms.

Since ceftazidime is eliminated almost solely by the kidneys, its serum half-life is significantly prolonged in patients with impaired renal function. Consequently, dosage adjustments in such patients as described in the DOSAGE AND ADMINISTRATION section are suggested.

Therapeutic concentrations of ceftazidime are achieved in the following body tissues and fluids.

Table 2. Ceftazidime Concentrations in Body Tissues and Fluids

Tissue or

Fluid

Dose/

Route

No.

Patients

Time of

Sample

Post-Dose

Average

Tissue or

Fluid

Level

(mcg/mL or mcg/g)

Urine

500 mg IM

6

0 to 2 hours

2,100.0

2 grams IV

6

0 to 2 hours

12,000.0

Bile

2 grams IV

3

90 min.

36.4

Synovial fluid

2 grams IV

13

2 hours

25.6

Peritoneal fluid

2 grams IV

8

2 hours

48.6

Sputum

1 gram IV

8

1 hour

9.0

Cerebrospinal

fluid (inflamed

2 grams q8h IV

5

120 min.

9.8

meninges)

2 grams q8h IV

6

180 min.

9.4

Aqueous humor

2 grams IV

13

1 to 3 hours

11.0

Blister fluid

1 gram IV

7

2 to 3 hours

19.7

Lymphatic fluid

1 gram IV

7

2 to 3 hours

23.4

Bone

2 grams IV

8

0.67 hour

31.1

Heart muscle

2 grams IV

35

30 to 280 min.

12.7

Skin

2 grams IV

22

30 to 180 min.

6.6

Skeletal muscle

2 grams IV

35

30 to 280 min.

9.4

Myometrium

2 grams IV

31

1 to 2 hours

18.7

Microbiology: Ceftazidime is bactericidal in action, exerting its effect by inhibition of enzymes responsible for cell-wall synthesis. A wide range of gram-negative organisms is susceptible to ceftazidime in vitro , including strains resistant to gentamicin and other aminoglycosides. In addition, ceftazidime has been shown to be active against gram-positive organisms. It is highly stable to most clinically important beta-lactamases, plasmid or chromosomal, which are produced by both gram-negative and gram-positive organisms and, consequently, is active against many strains resistant to ampicillin and other cephalosporins.

Ceftazidime has been shown to be active against the following organisms both in vitro and in clinical infections (see INDICATIONS AND USAGE).

Aerobes, Gram-Negative:Citrobacter spp. (including Citrobacter freundii and Citrobacterdiversus); Enterobacter spp. (including Enterobacter cloacae and Enterobacter aerogenes); Escherichia coli; Haemophilus influenzae, including ampicillin-resistant strains, Klebsiella spp. (including Klebsiella pneumoniae); Neisseria meningitidis; Proteus mirabilis; Proteus vulgaris; Pseudomonas spp. (including Pseudomonas aeruginosa);and Serratia spp.

Aerobes, Gram-Positive:Staphylococcus aureus, including penicillinase- and non-penicillinase-producing strains; Streptococcus agalactiae (group B streptococci); Streptococcus pneumoniae, and Streptococcus pyogenes (group A beta-hemolytic streptococci).

Anaerobes:Bacteroides spp. (NOTE: Many strains of Bacteroides fragilis are resistant).

Ceftazidime has been shown to be active in vitro against most strains of the following organisms; however, the clinical significance of these data is unknown: Acinetobacter spp., Clostridium spp. (not including Clostridium difficile); Haemophilus parainfluenzae; Morganellamorganii (formerly Proteus morganii); Neisseria gonorrhoeae; Peptococcus spp.; Peptostreptococcus spp.; Providencia spp. (including Providencia rettgeri, formerly Proteus rettgeri); Salmonella spp.; Shigella spp.; Staphylococcus epidermidis; and Yersinia enterocolitica.

Ceftazidime and the aminoglycosides have been shown to be synergistic in vitro against Pseudomonas aeruginosa and the enterobacteriaceae. Ceftazidime and carbenicillin have also been shown to be synergistic in vitro against Pseudomonas aeruginosa.

Ceftazidime is not active in vitro against: methicillin-resistant staphylococci, Streptococcus faecalis and many other enterococci, Listeria monocytogenes, Campylobacter spp., or Clostridiumdifficile.

Susceptibility Tests:Diffusion Techniques: Quantitative methods that require measurement of zone diameters give an estimate of antibiotic susceptibility. One such procedure1-3 has been recommended for use with disks to test susceptibility to ceftazidime.

Reports from the laboratory giving results of the standard single-disk susceptibility test with a 30 mcg ceftazidime disk should be interpreted according to the following criteria:

Susceptible organisms produce zones of 18 mm or greater, indicating that the test organism is likely to respond to therapy.

Organisms that produce zones of 15 mm to 17 mm are expected to be susceptible if high dosage is used or if the infection is confined to tissues and fluids (e.g., urine) in which high antibiotic levels are attained.

Resistant organisms produce zones of 14 mm or less, indicating that other therapy should be selected.

Organisms should be tested with the ceftazidime disk, since ceftazidime has been shown by in vitro tests to be active against certain strains found resistant when other beta-lactam disks are used.

Standardized procedures require the use of laboratory control organisms. The 30 mcg ceftazidime disk should give zone diameters between 25 mm and 32 mm for Escherichia coli ATCC 25922. For Pseudomonas aeruginosa ATCC 27853, the zone diameters should be between 22 mm and 29 mm. For Staphylococcus aureus ATCC 25923, the zone diameters should be between 16 mm and 20 mm.

Dilution Techniques: In other susceptibility testing procedures, e.g., ICS agar dilution or the equivalent, a bacterial isolate may be considered susceptible if the minimum inhibitory concentration (MIC) value for ceftazidime is not more than 16 mcg/mL. Organisms are considered resistant to ceftazidime if the MIC is ?64 mcg/mL. Organisms having an MIC value of <64 mcg/mL but >16 mcg/mL are expected to be susceptible if high dosage is used or if the infection is confined to tissues and fluids (e.g., urine) in which high antibiotic levels are attained.

As with standard diffusion methods, dilution procedures require the use of laboratory control organisms. Standard ceftazidime powder should give MIC values in the range of 4 mcg/mL to 16 mcg/mL for Staphylococcus aureus ATCC 25923. For Escherichia coli ATCC 25922, the MIC range should be between 0.125 mcg/mL and 0.5 mcg/mL. For Pseudomonas aeruginosa ATCC 27853, the MIC range should be between 0.5 mcg/mL and 2 mcg/mL.

Indications and Usage for Tazicef

Tazicef (ceftazidime for injection, USP) is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases:

Lower Respiratory Tract Infections, including pneumonia, caused by Pseudomonasaeruginosa and other Pseudomonas spp.; Haemophilus influenzae, including ampicillin-resistant strains; Klebsiella spp.; Enterobacter spp.; Proteus mirabilis; Escherichia coli; Serratia spp.; Citrobacter spp.; Streptococcus pneumoniae; and Staphylococcusaureus (methicillin-susceptible strains).

Skin and Skin-Structure Infectionscaused by Pseudomonas aeruginosa; Klebsiella spp.; Escherichia coli; Proteus spp.; including Proteus mirabilis and indole-positive Proteus ; Enterobacter spp.; Serratia spp.; Staphylococcus aureus (methicillin-susceptible strains); and Streptococcus pyogenes (group A beta-hemolytic streptococci).

Urinary Tract Infections, both complicated and uncomplicated, caused by Pseudomonas aeruginosa ; Enterobacter spp.; Proteus spp., including Proteus mirabilis and indole-positive Proteus; Klebsiella spp.; and Escherichia coli.

Bacterial Septicemia caused by Pseudomonas aeruginosa, Klebsiella spp., Haemophilus influenzae, Escherichia coli, Serratia spp., Streptococcus pneumoniae, and Staphylococcus aureus (methicillin-susceptible strains).

Bone and Joint Infections caused by Pseudomonas aeruginosa; Klebsiella spp.; Enterobacter spp., and Staphylococcus aureus (methicillin-susceptible strains).

Gynecologic Infections, including endometritis, pelvic cellulitis, and other infections of the female genital tract caused by Escherichia coli.

Intra-abdominal Infections, including peritonitis caused by Escherichia coli, Klebsiella spp., and Staphylococcus aureus (methicillin-susceptible strains) and polymicrobial infections caused by aerobic and anaerobic organisms and Bacteroides spp. (many strains of Bacteroides fragilis are resistant).

Central Nervous System Infections, including meningitis, caused by Haemophilus influenzae and Neisseria meningitidis. Ceftazidime has also been used successfully in a limited number of cases of meningitis due to Pseudomonas aeruginosa and Streptococcus pneumoniae.

Specimens for bacterial cultures should be obtained before therapy in order to isolate and identify causative organisms and to determine their susceptibility to ceftazidime. Therapy may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly.

Tazicef (ceftazidime for injection, USP) may be used alone in cases of confirmed or suspected sepsis. Ceftazidime has been used successfully in clinical trials as empiric therapy in cases where various concomitant therapies with other antibiotics have been used.

Tazicef may also be used concomitantly with other antibiotics, such as aminoglycosides, vancomycin and clindamycin, in severe and life-threatening infections and in the immunocompromised patient. When such concomitant treatment is appropriate, prescribing information in the labeling for the other antibiotics should be followed. The dose depends on the severity of the infection and the patient’s condition.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tazicef (ceftazidime) and other antibacterial drugs, Tazicef (ceftazidime) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Contraindications

Tazicef is contraindicated in patients who have shown hypersensitivity to ceftazidime or the cephalosporin group of antibiotics.

Warnings

BEFORE THERAPY WITH Tazicef IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFTAZIDIME, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG BETA-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO Tazicef OCCURS, DISCONTINUE TREATMENT WITH THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, IV FLUIDS, IV ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including ceftazidime, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.

Treatment with antibacterial agents alters the normal flora of the colon and may permit, overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of“antibiotic-associated colitis.”

After the diagnosis of pseudomembranous colitis has been established, appropriate therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an oral antibacterial drug clinically effective against Clostridium difficile colitis.

Elevated levels of ceftazidime in patients with renal insufficiency can lead to seizures, encephalopathy, asterixis and neuromuscular excitability (see PRECAUTIONS).

Precautions General:

Ceftazidime has not been shown to be nephrotoxic; however, high and prolonged serum antibiotic concentrations can occur from usual dosages in patients with transient or persistent reduction of urinary output because of renal insufficiency. The total daily dosage should be reduced when ceftazidime is administered to patients with renal insufficiency (see DOSAGE AND ADMINISTRATION). Elevated levels of ceftazidime in these patients can lead to seizures, encephalopathy, asterixis and neuromuscular excitability. Continued dosage should be determined by degree of renal impairment, severity of infection and susceptibility of the causative organisms.

As with other antibiotics, prolonged use of Tazicef (ceftazidime for injection, USP) may result in overgrowth of nonsusceptible organisms. Repeated evaluation of the patient’s condition is essential. If superinfection occurs during therapy, appropriate measures should be taken.

Inducible type-1 beta-lactamase resistance has been noted with some organisms (e.g., Enterobacter spp., Pseudomonas spp., and Serratia spp.). As with other extended-spectrum beta-lactam antibiotics, resistance can develop during therapy, leading to clinical failure in some cases. When treating infections caused by these organisms, periodic susceptibility testing should be performed when clinically appropriate. If patients fail to respond to monotherapy, an aminoglycoside or similar agent should be considered.

Cephalosporins may be associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy. Prothrombin time should be monitored in patients at risk and exogenous vitamin K administered as indicated.

Tazicef should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Distal necrosis can occur after inadvertent intra-arterial administration of ceftazidime.

Prescribing Tazicef (ceftazidime) in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Drug Interactions:

Nephrotoxicity has been reported following concomitant administration of cephalosporins with aminoglycoside antibiotics or potent diuretics, such as furosemide. Renal function should be carefully monitored, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibiotics. Nephrotoxicity and ototoxicity were not noted when ceftazidime was given alone in clinical trials.

Chloramphenicol has been shown to be antagonistic to beta-lactam antibiotics, including ceftazidime, based on in vitro studies and time kill curves with enteric gram-negative bacilli. Due to the possibility of antagonism in vivo, particularly when bactericidal activity is desired, this drug combination should be avoided.

Drug/Laboratory Test Interactions:

The administration of ceftazidime may result in a false-positive reaction for glucose in the urine when using Clinitest® tablets, Benedict’s solution or Fehling’s solution. It is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix® or Tes-Tape®) be used.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Long-term studies in animals have not been performed to evaluate carcinogenic potential. However, a mouse micronucleus test and an Ames test were both negative for mutagenic effects.

Pregnancy:

Teratogenic Effects: Pregnancy Category B. Reproduction studies have been performed in mice and rats at doses up to 40 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to Tazicef. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers:

Ceftazidime is excreted in human milk in low concentrations. Caution should be exercised when Tazicef is administered to a nursing woman.

Pediatric Use:

(See DOSAGE AND ADMINISTRATION).

Information for Patients:

Patients should be counseled that antibacterial drugs including Tazicef (ceftazidime) should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Tazicef (ceftazidime) is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Tazicef (ceftazidime) or other antibacterial drugs in the future.

Adverse Reactions

Ceftazidime is generally well-tolerated. The incidence of adverse reactions associated with the administration of ceftazidime was low in clinical trials. The most common were local reactions following IV injection and allergic and gastrointestinal reactions. Other adverse reactions were encountered infrequently. No disulfiram-like reactions were reported.

The following adverse effects from clinical trials were considered to be either related to ceftazidime therapy or were of uncertain etiology:

Local Effects, reported in fewer than 2% of patients, were phlebitis and inflammation at the site of injection (1 in 69 patients).

Hypersensitivity Reactions, reported in 2% of patients, were pruritus, rash and fever. Toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme have also been reported with cephalosporin antibiotics, including ceftazidime. Immediate reactions, generally manifested by rash and/or pruritus, occurred in 1 in 285 patients. Angioedema and anaphylaxis (bronchospasm and/or hypotension) have been reported very rarely.

Gastrointestinal Symptoms, reported in fewer than 2% of patients, were diarrhea (1 in 78), nausea (1 in 156), vomiting (1 in 500) and abdominal pain (1 in 416). The onset of pseudomembranous colitis symptoms may occur during or after treatment (see WARNINGS).

Central Nervous System Reactions (fewer than 1%) include headache, dizziness and paresthesia. Seizures have been reported with several cephalosporins, including ceftazidime. In addition, encephalopathy, asterixis and neuromuscular excitabiIity have been reported in renally impaired patients treated with unadjusted dosage regimens of ceftazidime (see PRECAUTIONS: General).

Less Frequent Adverse Events (fewer than 1%) were candidiasis (including oral thrush) and vaginitis.

Hematologic: Rare cases of hemolytic anemia have been reported.

Laboratory Test Changes noted during Tazicef (ceftazidime for injection, USP) clinical trials were transient and included: eosinophilia (1 in 13), positive Coombs’ test without hemolysis (1 in 23), thrombocytosis (1 in 45), and slight elevations in one or more of the hepatic enzymes, aspartate aminotransferase (AST, SGOT) (1 in 16), alanine aminotransferase (ALT, SGPT) (1 in 15), LDH (1 in 18), GGT (1 in 19) and alkaline phosphatase (1 in 23). As with some other cephalosporins, transient elevations of blood urea, blood urea nitrogen and/or serum creatinine were observed occasionally. Transient leukopenia, neutropenia, agranulocytosis, thrombocytopenia and lymphocytosis were seen very rarely.

Observed During Clinical Practice: In addition to the adverse events reported from clinical trials, the following events have been identified during post-approval use of ceftazidime. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to ceftazidime.

General: Anaphylactic or anaphylactoid reactions, which, in rare instances, were severe (e.g., cardiopulmonary arrest), including laryngeal edema, stridor, and urticaria; pain at injection site.

Hepatobiliary Tract and Pancreas: Hyperbilirubinemia.

Renal and Genitourinary: Renal impairment.

Cephalosporin-Class Adverse Reactions: In addition to the adverse reactions listed above that have been observed in patients treated with ceftazidime, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics:

Adverse Reactions: Urticaria, colitis, renal dysfunction, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemorrhage.

Altered Laboratory Tests: Prolonged prothrombin time, false-positive test for urinary glucose, elevated bilirubin, pancytopenia.

Overdosage

Ceftazidime overdosage has occurred in patients with renal failure. Reactions have included seizure activity, encephalopathy, asterixis and neuromuscular excitability. Patients who receive an acute overdosage should be carefully observed and given supportive treatment. In the presence of renal insufficiency, hemodialysis or peritoneal dialysis may aid in the removal of ceftazidime from the body.

Tazicef Dosage and Administration

NOTE: This insert is for a Pharmacy Bulk Package and is intended for preparing IV admixtures only. Dosage recommendations for intramuscular or intravenous injection and intraperitoneal use are for informational purposes only.

Dosage: The usual adult dosage is 1 gram administered intravenously every 8 or 12 hours. The dosage and route should be determined by the susceptibility of the causative organisms, the severity of infection and the condition and renal function of the patient.

The guidelines for dosage of Tazicef (ceftazidime for injection, USP) are listed in Table 3. The following dosage schedule is recommended.

Table 3. Recommended Dosage Schedule

Dose

Frequency

Adults

Usual recommended dose

1 gram IV

q8 or 12h

Uncomplicated urinary tract infections

250 mg IV

q12h

Bone and joint infections

2 grams IV

q12h

Complicated urinary tract infections

500 mg IV

q8 or 12h

Uncomplicated pneumonia; mild skin and

500 mg to 1 gram

q8h

skin structure infections

IV

Serious gynecological and

2 grams IV

q8h

intra-abdominal infections

Meningitis

2 grams IV

q8h

Very severe life-threatening infections,

2 grams IV

q8h

especially in immunocompromised patients

Lung infections caused by Pseudomonas

30 to 50 mg/kg IV

q8h

spp. in patients with cystic fibrosis

to a maximum

with normal renal function*

of 6 grams/day

Neonates (0? 4 weeks)

30 mg/kg IV

q12h

Infants and children

30 to 50 mg/kg IV

q8h

(1 month ? 12 years)

to a maximum

of 6 grams/day†

* Although clinical improvement has been shown, bacteriological cures cannot be expected in patients with chronic respiratory disease and cystic fibrosis.

† The higher dose should be reserved for immunocompromised pediatric patients or pediatric patients with cystic fibrosis or meningitis.

Impaired Hepatic Function: No adjustment in dosage is required for patients with hepatic dysfunction.

Impaired Renal Function: Ceftazidime is excreted by the kidneys, almost exclusively by glomerular filtration. Therefore, in patients with impaired renal function (glomerular filtration rate [GFR]<50 mL/min.), it is recommended that the dosage of ceftazidime be reduced to compensate for its slower excretion. In patients with suspected renal insufficiency, an initial loading dose of 1 gram of ceftazidime may be given. An estimate of GFR should be made to determine the appropriate maintenance dose. The recommended dosage is presented in Table 4.

Table 4. Recommended Maintenance Doses of Tazicef (ceftazidime for injection, USP) in Renal Insufficiency

NOTE: IF THE DOSE RECOMMENDED IN TABLE 3 ABOVE IS LOWER THAN THAT RECOMMENDED FOR PATIENTS WITH RENAL INSUFFICIENCY AS OUTLINED IN TABLE 4, THE LOWER DOSE SHOULD BE USED.

Creatinine

Clearance

(mL/min.)

Recommended

Unit Dose of

Tazicef

Frequency

of Dosing

50 ? 31

1 gram

q12h

30 ? 16

1 gram

q24h

15 ? 6

500 mg

q24h

<5

500 mg

q48h

When only serum creatinine is available, the following formula (Cockcroft’s equation)4 may be used to estimate creatinine clearance. The serum creatinine should represent a steady state of renal function:

Males:

Creatinine clearance (mL/min.) =

[Weight (kg) x (140 - age)] / [72 x serum creatinine (mg/dL)]

Females:

0.85 x male value

In patients with severe infections who would normally receive 6 grams of Tazicef daily were it not for renal insufficiency, the unit dose given in the table above may be increased by 50% or the dosing frequency increased appropriately. Further dosing should be determined by therapeutic monitoring, severity of the infection and susceptibility of the causative organism.

In pediatric patients as for adults, the creatinine clearance should be adjusted for body surface area or lean body mass and the dosing frequency reduced in cases of renal insufficiency.

In patients undergoing hemodialysis, a loading dose of 1 gram is recommended, followed by 1 gram after each hemodialysis period.

Tazicef (ceftazidime for injection, USP) can also be used in patients undergoing intra-peritoneal dialysis and continuous ambulatory peritoneal dialysis. In such patients, a loading dose of 1 gram of Tazicef may be given, followed by 500 mg every 24 hours. In addition to IV use, Tazicef can be incorporated in the dialysis fluid at a concentration of 250 mg for 2 liters of dialysis fluid.

Note: Generally Tazicef should be continued for 2 days after the signs and symptoms of infection have disappeared, but in complicated infections longer therapy may be required.

Administration: See above NOTE concerning the proper use of Pharmacy Bulk Packages.

Intravenous Administration: The IV route is preferable for patients with bacterial septicemia, bacterial meningitis, peritonitis, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure or malignancy, particularly if shock is present or pending.

Intermittent intravenous infusion with a Y-type administration set can be accomplished with compatible solutions. However, during infusion of a solution containing ceftazidime it is desirable to discontinue the other solution.

All vials of Tazicef as supplied are under reduced pressure. When Tazicef is dissolved, carbon dioxide is released and a positive pressure develops. See RECONSTITUTION.

Solutions of Tazicef, like those of most beta-lactam antibiotics, should not be added to solutions of aminoglycoside antibiotics because of potential interaction.

However, if concurrent therapy with Tazicef and an aminoglycoside is indicated, each of these antibiotics can be administered separately to the same patient.

RECONSTITUTION

Directions for Proper Use of Pharmacy Bulk Packages:

Note: The Pharmacy Bulk Package is for use in a pharmacy admixture service only. Using aseptic technique, the closure should be penetrated only 1 time after reconstitution using a sterile dispensing set which allows measured dispensing of the contents. Use of a syringe and needle is not recommended as it may cause leakage. The withdrawal of container contents should be accomplished without delay. THE ENTIRE CONTENTS OF THE VIAL SHOULD BE DISPENSED WITHIN 4 HOURS OF INITIAL ENTRY.

A plastic bail attached to the Pharmacy Bulk Package provides a suitable hanging device while dispensing in the pharmacy.

Reconstitute with Sterile Water for Injection according to the following table.

Table 5

Diluent to

Be Added

Approx. Avail.

Volume

Approx. Avg.

Concentration

26 mL

30 mL

1 gram/5 mL

56 mL

60 mL

1 gram/10 mL

The vacuum may assist entry of the diluent. SHAKE WELL.

Insert a gas relief needle through the vial closure to relieve the internal pressure. Remove the gas relief needle before extracting any solution.

COMPATIBILITY AND STABILITY

IMPORTANT: The following chemical stability information in no way indicates that it would be acceptable practice to use this product well after the preparation time. Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

Intravenous:Tazicef (ceftazidime for injection, USP) when reconstituted as directed with Sterile Water for Injection, maintains satisfactory potency for 24 hours at room temperature or for 7 days under refrigeration (5°C). Solutions in 0.9% Sodium Chloride Injection in Viaflex® small volume containers that are frozen immediately after reconstitution are stable for 3 months when stored at -20°C. Components of the solution may precipitate in the frozen state and will dissolve upon reaching room temperature with little or no agitation. Potency is not affected. Frozen solutions should only be thawed at room temperature. Do not force thaw by immersion in water baths or by microwave irradiation. For larger volumes where it may be necessary to warm the frozen product (to a maximum of 40°C), care should be taken to avoid heating after thawing is complete. Once thawed, solutions should not be refrozen. Thawed solutions may be stored for up to 8 hours at room temperature or for 4 days in a refrigerator (5°C).

Tazicef (ceftazidime for injection, USP) is compatible with the more commonly used IV infusion fluids. Solutions at concentrations between 1 mg/mL and 40 mg/mL in the following infusion fluids may be stored for up to 24 hours at room temperature or 7 days if refrigerated: 0.9% Sodium Chloride Injection; Ringer’s Injection USP; Lactated Ringer’s Injection USP; 5% Dextrose Injection; 5% Dextrose and 0.225% Sodium Chloride Injection; 5% Dextrose and 0.45% Sodium Chloride Injection; 5% Dextrose and 0.9% Sodium Chloride Injection; 10% Dextrose Injection.

Tazicef is less stable in Sodium Bicarbonate Injection than in other IV fluids. It is not recommended as a diluent. Solutions of Tazicef in 5% Dextrose and 0.9% Sodium Chloride Injection are stable for at least 6 hours at room temperature in plastic tubing, drip chambers and volume control devices of common IV infusion sets.

Ceftazidime at a concentration of 20 mg/mL has been found physically compatible for 24 hours at room temperature or 7 days under refrigeration in Sterile Water for Injection when admixed with: cefazolin sodium 330 mg/mL; heparin 1000 units/mL; and cimetidine HCl 150 mg/mL.

Ceftazidime at a concentration of 20 mg/mL has been found physically compatible for 24 hours at room temperature or 7 days under refrigeration in 5% Dextrose Injection when admixed with potassium chloride


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Milkhouse Pre-Post Teat Dip


Generic Name: iodine liquid
Dosage Form: FOR ANIMAL USE ONLY
Pre-Post 1/2%

TEAT DIPPING IN COLD WEATHER:
When the temperature falls below 10 degrees F, or when wind chill is significant,
special precautions should be taken to avoid chapped and frozen teats.
1. Teats should be dry before turning cows out into cold weather.
2. When teats are dipped after milking, allow 30 seconds contact, and blot
    off any excess teat dip with a single service towel.
3. Warm the teat dip to reduce drying time.
4. Provide windbreaks in outside areas for cows.
5. Monitor fresh cows with swollen udders and teats since they are more
    susceptible to chapped and frozen teats.

PRODUCT INFORMATION:  This teat dip is an IODOPHOR (a combination of
iodine and complexing agents), and when properly used, is effective as an
aid in reducing the spread of mastitis causing organisms.  IODOPHORS are
considered relatively non-toxic, but should always be used in accordance
with label directions.  Consult your veterinarian in case of teat irritation.

DO NOT DILUTE.  USE AT FULL STRENGTH.
Important Use Instructions
For Pre-Milking
1.  Wash each individual teat with a sanitizing udder wash.  NOTE: For best results,
     keep hair around teat based clipped.
2.  Hand strip teats to initial let down.
3.  Pre-dip entire teat with PRE-POST 1/2% on all four quarters.  Repeat process on
     next 4 to 6 cows or until first cow prepped has at least 1 minute contact time.
4.  Wipe each individual teat with a clean paper towel.  Utilize a "pulling down" motion
     which removes iodine solution, germs, and sediment from teat skin. Very
     important!
5.  Place machine on cow and repeat wiping process on remaining cows that have
     been predipped.
For Post Milking
DIRECTIONS FOR TEAT DIPPING.  Dip entire teat with undiluted dip solution.  Allow
to air dry and remain on teats for prolonged contact time.  Clean, sanitize and
thoroughly dry each teat prior to next milking.  Replace dip solution when visibly
cloudy or dirty.
PROTECT FROM FREEZING CAUTION
Not for internal use.  Avoid contamination of foods.  Avoid contact with
eyes.
FIRST-AID
EYES: Immediately flush eyes with plenty of cool running water for at
least 15 minutes.
INTERNAL:  If swallowed, drink large quantities of water. DO NOT induce
vomiting.
GET MEDICAL ATTENTION IMMEDIATELY
KEEP OUT OF REACH OF CHILDREN
FOR ASSISTANCE WITH MEDICAL
EMERGENCY CONTACT:
CHEM-TEL, 1-800-255-3924
MILKHOUSE BRAND
Pre-Post 1/2%
A SANITIZING PRE AND POST DIP
An Aid in Reducing the Spread of
Organisms Which May Cause Mastitis
Active Ingredient............................0.5% Available Iodine
Emollient System Contains............5% Glycerin
Minimum pH...................................4.0
CAUTION:
KEEP OUT OF REACH OF CHILDREN
NET CONTENTS:  1 U.S. FL. GALLON (3.78 LITERS)
STEARNS PACKAGING CORPORATION
4200 Sycamore Avenue - Madison, Wisconsin 53714
MILKHOUSE BRAND PRE-POST 
iodine  liquid Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 60282-1106 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IODINE (IODINE) IODINE 0.5 L  in 100 L Inactive Ingredients Ingredient Name Strength GLYCERIN 5 L  in 100 L Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 60282-1106-1 3.78 L In 1 BOTTLE, PLASTIC None 2 60282-1106-2 18.93 L In 1 PAIL None 3 60282-1106-3 56.78 L In 1 DRUM None 4 60282-1106-4 208.2 L In 1 DRUM None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/21/2004
Labeler - Stearns Packaging Corporation (006069256) Registrant - Stearns Packaging Corporation (006069256) Establishment Name Address ID/FEI Operations Stearns Packaging Corporation 006069256 manufacture Revised: 09/2010Stearns Packaging Corporation

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Boots Hayfever Relief Nasal Spray


Boots Hayfever Relief Nasal Spray

(Beclometasone Dipropionate)

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription to treat hayfever. However, you still need to use it carefully to get the best results from it.

Keep this leaflet, you may need to read it again Ask your pharmacist if you need more information or advice You must contact a doctor if your symptoms worsen or do not improve within 10 days What this medicine is for

This medicine contains Beclometasone Dipropionate, which belongs to a group of medicines called corticosteroids, which act to reduce swelling (inflammation) in the nose.

It can be used to treat hayfever.

Before you use this medicine

This medicine can be used by adults aged 18 years and over. However, some people should not use this medicine or should seek the advice of their pharmacist or doctor first.

Do not use: If you are allergic to any of the ingredients If you are pregnant or breastfeeding, unless your doctor tells you to Talk to your pharmacist or doctor: If you think you have a nasal infection as well as hayfever If you have recently had steroid injections or have been taking steroid tablets for a long time If you take other medicines

This medicine is not expected to affect any medicines that you may be taking.

If you are unsure about interactions with any medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.

How to use this medicine Directions for using the spray 1. Shake the bottle gently and remove the dust cap and lock-ring (if fitted). 2. A new spray, or one which has not been used for a few days, may not work the first time. You may need to prime the bottle by pumping the spray a few times until a fine mist is produced. To do this put your forefinger and middle finger on the collar either side of the nozzle and your thumb underneath the bottle. Keeping your thumb still, press down with your fingers to pump the spray. Hold the nozzle pointing away from you while you are doing this. If the spray still doesn’t work and you think it may be blocked, clean it as described further on in the leaflet. Never try to unblock it or enlarge the tiny spray hole with a pin or other sharp object because this will destroy the spray mechanism. 3. Blow your nose gently. To use close one nostril and put the nozzle in the other nostril. Tilt your head forward slightly and keep the bottle upright. Hold the bottle as shown. 4. Start to breathe in slowly through your nose. While you are breathing in squirt a spray of fine mist into your nostril by pressing down firmly on the collar with your fingers. Breathe out through your mouth. Repeat this step to take a second spray in the same nostril. Remove the nozzle from this nostril and breath out through your mouth. 5. Repeat step 3 and 4 for the other nostril.

After using the spray, wipe the nozzle carefully with a clean tissue or handkerchief, and replace the dust cap.

To clean the spray 1. Take the dust cap off. 2. Pull upwards on the white collar to remove the nozzle. 3. Soak the nozzle and dust cap in warm water for a few minutes and then rinse under a running tap. 4. Shake off the excess water and allow to dry in a warm, not hot, place. 5. Re-fit the nozzle. 6. ‘Prime’ the bottle if necessary by pumping the spray a few times until a fine mist is produced.

Your nasal spray should be cleaned at least once a week or more often if it gets blocked.

Adults of 18 years and over: Use two sprays in each nostril, twice a day (morning and evening). Don’t use more than 8 sprays in 24 hours.
Once your symptoms are controlled try to use one spray in each nostril twice a day. If symptoms return, go back to using two sprays in each nostril.

For use in the nose only.

Do not use on children or adolescents under 18 years.

Do not use more than the amount recommended.

Do not use this medicine continuously for more than 3 months, unless your doctor tells you to.

If symptoms do not improve within 10 days talk to your doctor.

If you use too much or if anyone accidentally swallows some of the medicine: Talk to a doctor or pharmacist.

Possible side effects

Most people will not have problems, but some may get some of these:

Dry irritated nose and throat, nose bleeds Unpleasant taste and smell Rarely, perforation of the middle of the nose, raised pressure in the eye (glaucoma) Skin irritation – possibly caused by benzalkonium chloride in this medicine

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

How to store this medicine

Store below 30°C. Do not refrigerate. Protect from light.

Throw away any medicine left 3 months after you open it.

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the end flap of the carton.

What is in this medicine

Each spray for nasal use contains Beclometasone Dipropionate 50 mcg which is the active ingredient.

As well as the active ingredient, the spray also contains dextrose anhydrous, polysorbate 80, dispersible cellulose, benzalkonium chloride, phenylethanol, purified water.

Who makes this medicine Manufactured for The Boots Company PLC Nottingham NG2 3AA by the Marketing Authorisation holder Generics (UK) Ltd Station Close Potters Bar Herts EN6 1TL

Leaflet prepared March 2008

If you would like any further information about this medicine, please contact

The Boots Company PLC Nottingham NG2 3AA

3439eMC


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Selenium Lotion


Pronunciation: se-LEE-nee-um
Generic Name: Selenium
Brand Name: Examples include Dandrex and Selsun Blue
Selenium Lotion is used for:

Treating dandruff and other conditions of the scalp and skin.

Selenium Lotion is a cytostatic agent. It works by reducing skin cell growth and inhibiting growth of organisms associated with chronic flaking and itching.

Do NOT use Selenium Lotion if: you are allergic to any ingredient in Selenium Lotion

Contact your doctor or health care provider right away if any of these apply to you.

Before using Selenium Lotion:

Some medical conditions may interact with Selenium Lotion. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Selenium Lotion. Because little, if any, of Selenium Lotion is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Selenium Lotion may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Selenium Lotion:

Use Selenium Lotion as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Shake well before each use. Remove jewelry before using Selenium Lotion. Do not use on broken or inflamed skin or scalp. To use Selenium Lotion on the scalp - Massage 1 or 2 teaspoonfuls of the medicine on the wet scalp. Leave on the scalp for 2 to 3 minutes. Rinse scalp thoroughly. Wash hands well after treatment. If you are using Selenium Lotion before or after bleaching, tinting, or permanent waving of hair, rinse hair for at least 5 minutes in cool running water. To use Selenium Lotion on the skin - Apply a sufficient amount to cover affected areas of the body. Lather well with a small amount of water. Leave the medicine on the skin for 10 minutes. Rinse thoroughly in the shower. Wash hands well after treatment. If you miss a dose of Selenium Lotion, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once

Ask your health care provider any questions you may have about how to use Selenium Lotion.

Important safety information: If your symptoms do not get better within 1 to 2 weeks or if they get worse, check with your doctor. Do NOT use for longer than prescribed without checking with your doctor. Do not get Selenium Lotion in your eyes, or on the inside of your nose or mouth. Do not use Selenium Lotion on broken or blistered skin. Do not apply Selenium Lotion to the genital area. If you get Selenium Lotion on your genitals, rinse thoroughly with water. Selenium Lotion may damage jewelry. Remove jewelry before using Selenium Lotion. Selenium Lotion should not be used in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Selenium Lotion while you are pregnant. It is not known if Selenium Lotion is found in breast milk. Do not breast-feed while taking Selenium Lotion. Possible side effects of Selenium Lotion:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Hair discoloration (minimized by thorough rinsing); increase in mild hair loss or thinning; oiliness or dryness of hair and scalp.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Selenium side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately. Selenium Lotion may be harmful if swallowed.

Proper storage of Selenium Lotion:

Store Selenium Lotion below 86 degrees F (30 degrees C) in a tightly closed container. Store away from heat and light. Keep Selenium Lotion out of the reach of children and away from pets.

General information: If you have any questions about Selenium Lotion, please talk with your doctor, pharmacist, or other health care provider. Selenium Lotion is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Selenium Lotion. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Selenium resources Selenium Side Effects (in more detail) Selenium Use in Pregnancy & Breastfeeding Selenium Support Group 3 Reviews for Selenium - Add your own review/rating Compare Selenium with other medications Seborrheic Dermatitis Tinea Versicolor
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VIDENE SURGICAL SCRUB (Ecolab)


1. Name Of The Medicinal Product

VIDENE SURGICAL SCRUB

2. Qualitative And Quantitative Composition

Povidone-iodine 7.5% w/w

3. Pharmaceutical Form

Topical solution.

4. Clinical Particulars 4.1 Therapeutic Indications

Videne Surgical Scrub is a broad-spectrum antiseptic for topical use. It is indicated for pre-operative hand disinfection by the surgical team, or for disinfecting the site of incision prior to elective surgery.

4.2 Posology And Method Of Administration

Pre-operative surgical scrub - after first wetting the hands and arms with water, approximately 3.5 ml of Videne Surgical Scrub is applied and rubbed thoroughly on to these areas. A brush may be used to scrub the nails. A little water is added to develop a lather and finally this is rinsed off with running water.

Pre-operative skin preparation - the site of incision should be washed with Videne Surgical Scrub two or three times a day for at least two days prior to the operation. Immediately before surgery the skin should be moistened with water, Videne Surgical Scrub applied and rubbed thoroughly into the area for several minutes. A sterile gauze swab is used to develop a lather which is finally rinsed off with water.

Only water should be used to dilute Videne Surgical Scrub.

There are no special dosage recommendations for children or elderly patients.

4.3 Contraindications

Videne Surgical Scrub must never be administered orally.

4.4 Special Warnings And Precautions For Use

Care should be taken when Videne Surgical Scrub is used on known iodine-sensitive subjects, although such people do not normally react to povidone-iodine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

4.6 Pregnancy And Lactation

Videne Surgical Scrub is not recommended for use during pregnancy because of the possibility of absorption through broken skin and subsequent interference with tests of neonatal thyroid function.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

In very rare instances Videne Surgical Scrub may produce skin reactions in iodine-sensitive subjects. These reactions subside on cessation of treatment.

4.9 Overdose

In cases where Videne Surgical Scrub has been taken orally, gastric lavage with dilute starch mucilage or a 1% solution of sodium thiosulphate must be administered. The electrolyte balance must be corrected and lost fluids replaced.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Povidone-iodine has antiseptic activity and is used mainly for the treatment of contaminated wounds and pre-operative preparation of skin and mucous membranes. It is considered to be less irritant than iodine.

5.2 Pharmacokinetic Properties

Povidone-iodine is slightly absorbed when applied to the skin. Iodides are excreted mainly in the urine, with smaller amounts appearing in the faeces, saliva and sweat.

5.3 Preclinical Safety Data

Povidone-iodine had a low acute toxicity in both dogs and cats following either oral or intraperitoneal administration. Absorption of iodine through intact skin is low following the application of solutions of povidone-iodine although systemic absorption of iodine is greatly increased if the solutions are applied to broken skin, mucous membranes or are introduced into cavities of the body. At subcutaneous dose levels of up to 75mg/Kg/day, povidone-iodine was non-teratogenic in rabbits following administration to pregnant animals during the period of organogenesis.

Some early in vitro studies indicated a possible mutagenic action for povidone-iodine. However, a number of later studies, using in vitro and in vivo test systems, do not indicate a significant level of mutagenic/genotoxic activity for povidone-iodine. Although conflicting data have been published, there is no convincing evidence to suggest that povidone-iodine adversely affects wound healing. Concentration of 0.05 and 0.5% povidone-iodine did not cause significant ocular damage when administered into the vitreous cavities of rabbits' eyes. There is some evidence to suggest that povidone-iodine-containing solutions applied to the round window of the chinchilla ear could result in high frequency hearing loss.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Alkyl Phenol Ether Sulphate (Ammonium Salt)

Polyethylene glycol 400

Cocoamide DEA

Glycerol

PVP K90

Citric acid

Di-sodium phosphate, anhydrous

Purified Water

6.2 Incompatibilities

None stated.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Store below 30°C in a dry place, protected from light.

6.5 Nature And Contents Of Container

Videne Surgical Scrub is packaged in a 500 ml HDPE bottle sealed with a plastic screw cap.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Ecolab Ltd, Lotherton Way, Garforth, Leeds, LS25 2JY.

8. Marketing Authorisation Number(S)

PL 04509/0042

9. Date Of First Authorisation/Renewal Of The Authorisation

1 March 2003

10. Date Of Revision Of The Text

August 2006


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Lorabid


Generic Name: loracarbef (lor a KAR bef)
Brand Names: Lorabid, Lorabid Pulvules

What is Lorabid (loracarbef)?

Loracarbef is an antibiotic that fights bacteria in your body.

Loracarbef is used to treat many different types of infections caused by bacteria.

Loracarbef may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Lorabid (loracarbef)? Do not take this medication if you are allergic to loracarbef, or to similar antibiotics, such as Ceftin, Cefzil, Duricef, Fortaz, Keflex, Omnicef, Spectracef, Suprax, and others.

Before taking this medication, tell your doctor if you are allergic to any drugs (especially penicillin).

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Loracarbef will not treat a viral infection such as the common cold or flu.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

What should I discuss with my healthcare provider before taking Lorabid (loracarbef)? Do not take this medication if you are allergic to loracarbef or to any cephalosporin antibiotic, such as:

cefadroxil (Duricef);

cefdinir (Omnicef);

cefditoren (Spectracef);

cefixime (Suprax);

cefprozil (Cefzil);

ceftazidime (Fortaz);

cefuroxime (Ceftin);

cephalexin (Keflex); and others.

Before taking loracarbef, tell your doctor if you have:

kidney disease;

a history of intestinal problems (especially colitis); or

are allergic to any drugs, especially penicillins.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take loracarbef.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether loracarbef passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

The liquid form of loracarbef may contain sucrose (sugar). Talk to your doctor before using this form of loracarbef if you have diabetes.

How should I take Lorabid (loracarbef)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take this medicine with a full glass of water. Take loracarbef on an empty stomach, at least 1 hour before or 2 hours after a meal. Shake the suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Take loracarbef for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Loracarbef will not treat a viral infection such as the common cold or flu.

Contact your doctor if your infection does not improve or if your symptoms get worse.

Store this medication at room temperature away from moisture and heat.

Throw away any unused liquid medication that is older than 14 days.

What happens if I miss a dose?

Take the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include nausea, vomiting, stomach pain, and diarrhea.

What should I avoid while taking Lorabid (loracarbef)? Avoid using antacids within 1 hour before or after taking loracarbef. Antacids can make it harder for your body to absorb loracarbef.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Lorabid (loracarbef) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

diarrhea that is watery or bloody;

seizure (convulsions);

fever, sore throat, and joint pain with a severe blistering, peeling, and red skin rash;

easy bruising or bleeding, unusual weakness; or

skin rash, bruising, severe tingling, numbness, pain, muscle weakness.

Less serious side effects may include:

mild itching or skin rash;

mild nausea, vomiting, stomach pain, loss of appetite;

warmth, redness, or tingling under your skin;

headache;

dizziness, drowsiness; or

vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

What other drugs will affect Lorabid (loracarbef)?

Before you take loracarbef, tell your doctor if you are also taking:

probenecid (Benemid); or

a diuretic (water pill) such as amiloride (Midamor, Moduretic), furosemide (Lasix), hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Lopressor, Vasoretic, Zestoretic), metolazone (Mykrox, Zarxolyn), spironolactone (Aldactazide, Aldactone), triamterene (Dyrenium, Maxzide, Dyazide), and others.

This list is not complete and there may be other drugs that can interact with loracarbef. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start taking a new medication without telling your doctor.

More Lorabid resources Lorabid Side Effects (in more detail) Lorabid Use in Pregnancy & Breastfeeding Lorabid Drug Interactions Lorabid Support Group 1 Review for Lorabid - Add your own review/rating Lorabid Prescribing Information (FDA) Lorabid Monograph (AHFS DI) Lorabid Advanced Consumer (Micromedex) - Includes Dosage Information Lorabid MedFacts Consumer Leaflet (Wolters Kluwer) Compare Lorabid with other medications Bladder Infection Bronchitis Impetigo Kidney Infections Otitis Media Pneumonia Sinusitis Skin Infection Strep Throat Tonsillitis/Pharyngitis Upper Respiratory Tract Infection Where can I get more information? Your pharmacist can provide more information about loracarbef.

See also: Lorabid side effects (in more detail)


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Lorabid Pulvules


Generic Name: loracarbef (lor a KAR bef)
Brand Names: Lorabid, Lorabid Pulvules

What is Lorabid Pulvules (loracarbef)?

Loracarbef is an antibiotic that fights bacteria in your body.

Loracarbef is used to treat many different types of infections caused by bacteria.

Loracarbef may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Lorabid Pulvules (loracarbef)? Do not take this medication if you are allergic to loracarbef, or to similar antibiotics, such as Ceftin, Cefzil, Duricef, Fortaz, Keflex, Omnicef, Spectracef, Suprax, and others.

Before taking this medication, tell your doctor if you are allergic to any drugs (especially penicillin).

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Loracarbef will not treat a viral infection such as the common cold or flu.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

What should I discuss with my healthcare provider before taking Lorabid Pulvules (loracarbef)? Do not take this medication if you are allergic to loracarbef or to any cephalosporin antibiotic, such as:

cefadroxil (Duricef);

cefdinir (Omnicef);

cefditoren (Spectracef);

cefixime (Suprax);

cefprozil (Cefzil);

ceftazidime (Fortaz);

cefuroxime (Ceftin);

cephalexin (Keflex); and others.

Before taking loracarbef, tell your doctor if you have:

kidney disease;

a history of intestinal problems (especially colitis); or

are allergic to any drugs, especially penicillins.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take loracarbef.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether loracarbef passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

The liquid form of loracarbef may contain sucrose (sugar). Talk to your doctor before using this form of loracarbef if you have diabetes.

How should I take Lorabid Pulvules (loracarbef)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take this medicine with a full glass of water. Take loracarbef on an empty stomach, at least 1 hour before or 2 hours after a meal. Shake the suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Take loracarbef for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Loracarbef will not treat a viral infection such as the common cold or flu.

Contact your doctor if your infection does not improve or if your symptoms get worse.

Store this medication at room temperature away from moisture and heat.

Throw away any unused liquid medication that is older than 14 days.

What happens if I miss a dose?

Take the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include nausea, vomiting, stomach pain, and diarrhea.

What should I avoid while taking Lorabid Pulvules (loracarbef)? Avoid using antacids within 1 hour before or after taking loracarbef. Antacids can make it harder for your body to absorb loracarbef.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Lorabid Pulvules (loracarbef) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

diarrhea that is watery or bloody;

seizure (convulsions);

fever, sore throat, and joint pain with a severe blistering, peeling, and red skin rash;

easy bruising or bleeding, unusual weakness; or

skin rash, bruising, severe tingling, numbness, pain, muscle weakness.

Less serious side effects may include:

mild itching or skin rash;

mild nausea, vomiting, stomach pain, loss of appetite;

warmth, redness, or tingling under your skin;

headache;

dizziness, drowsiness; or

vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

What other drugs will affect Lorabid Pulvules (loracarbef)?

Before you take loracarbef, tell your doctor if you are also taking:

probenecid (Benemid); or

a diuretic (water pill) such as amiloride (Midamor, Moduretic), furosemide (Lasix), hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Lopressor, Vasoretic, Zestoretic), metolazone (Mykrox, Zarxolyn), spironolactone (Aldactazide, Aldactone), triamterene (Dyrenium, Maxzide, Dyazide), and others.

This list is not complete and there may be other drugs that can interact with loracarbef. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start taking a new medication without telling your doctor.

More Lorabid Pulvules resources Lorabid Pulvules Side Effects (in more detail) Lorabid Pulvules Use in Pregnancy & Breastfeeding Drug Images Lorabid Pulvules Drug Interactions Lorabid Pulvules Support Group 0 Reviews for Lorabid Pulvules - Add your own review/rating Lorabid Pulvules Advanced Consumer (Micromedex) - Includes Dosage Information Lorabid Prescribing Information (FDA) Lorabid Monograph (AHFS DI) Lorabid MedFacts Consumer Leaflet (Wolters Kluwer) Compare Lorabid Pulvules with other medications Bladder Infection Bronchitis Impetigo Kidney Infections Otitis Media Pneumonia Sinusitis Skin Infection Strep Throat Tonsillitis/Pharyngitis Upper Respiratory Tract Infection Where can I get more information? Your pharmacist can provide more information about loracarbef.

See also: Lorabid Pulvules side effects (in more detail)


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Panixine


Generic Name: cephalexin (sef a LEX in)
Brand Names: Keflex, Panixine

What is Panixine (cephalexin)?

Cephalexin is in a group of drugs called cephalosporin antibiotics. Cephalexin fights bacteria in the body.

Cephalexin is used to treat infections caused by bacteria, including upper respiratory infections, ear infections, skin infections, and urinary tract infections.

Cephalexin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Panixine (cephalexin)? Do not use this medication if you are allergic to cephalexin, or to similar antibiotics, such as Ceclor, Ceftin, Cefzil, Duricef, Fortaz, Omnicef, Spectracef, Suprax, and others.

Before using cephalexin, tell your doctor if you are allergic to any drugs (especially penicillins), or if you have kidney or liver disease, a stomach or intestinal disorder such as colitis, diabetes, or if you are malnourished.

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Cephalexin will not treat a viral infection such as the common cold or flu. What should I discuss with my healthcare provider before taking Panixine (cephalexin)? Do not use this medication if you are allergic to cephalexin, or to other cephalosporin antibiotics, such as:

cefaclor (Ceclor);

cefadroxil (Duricef);

cefdinir (Omnicef);

cefditoren (Spectracef);

cefixime (Suprax);

cefprozil (Cefzil);

ceftazidime (Fortaz); or

cefuroxime (Ceftin).

Before using cephalexin, tell your doctor if you are allergic to any drugs (especially penicillins), or if you have:

kidney disease;

liver disease;

a stomach or intestinal disorder such as colitis;

diabetes; or

if you are malnourished.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take cephalexin.

The oral suspension (liquid) form of cephalexin may contain sugar. This may affect you if you have diabetes.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Cephalexin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take Panixine (cephalexin)?

Take the medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.

Take cephalexin with a full glass of water.

Dissolve the cephalexin dispersible tablet in a small amount of water, about 2 teaspoonfuls. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away. Do not swallow or chew a dispersible tablet.

Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Take cephalexin for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Cephalexin will not treat a viral infection such as the common cold or flu.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using cephalexin.

Store the tablets and capsules at room temperature away from moisture and heat. Store the liquid medicine in the refrigerator. Throw away any unused medication after 14 days. What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include nausea, vomiting, stomach pain, diarrhea, and blood in your urine.

What should I avoid while taking Panixine (cephalexin)?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Panixine (cephalexin) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

diarrhea that is watery or bloody;

seizure (convulsions);

fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

pale or yellowed skin, dark colored urine, fever, confusion or weakness;

easy bruising or bleeding, unusual weakness;

confusion, agitation, hallucinations (seeing things that are not there); or

urinating less than usual or not at all.

Less serious side effects may include:

mild nausea, vomiting, diarrhea;

dizziness, tired feeling;

joint pain; or

vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Panixine (cephalexin)?

Before using cephalexin, tell your doctor if you are using any of the following drugs:

a blood thinner such as warfarin (Coumadin);

metformin (Fortamet, Glucophage, Riomet, Actoplus, Avandamet, Metaglip); or

probenecid (Benemid).

This list is not complete and there may be other drugs that can interact with cephalexin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Panixine resources Panixine Side Effects (in more detail) Panixine Use in Pregnancy & Breastfeeding Panixine Drug Interactions Panixine Support Group 0 Reviews for Panixine - Add your own review/rating Panixine Prescribing Information (FDA) Cephalexin Prescribing Information (FDA) Cephalexin Professional Patient Advice (Wolters Kluwer) Cephalexin Monograph (AHFS DI) Cephalexin MedFacts Consumer Leaflet (Wolters Kluwer) cephalexin Advanced Consumer (Micromedex) - Includes Dosage Information Keflex Prescribing Information (FDA) Keflex MedFacts Consumer Leaflet (Wolters Kluwer) Keflex Consumer Overview Compare Panixine with other medications Acne Bacterial Endocarditis Prevention Bacterial Infection Bladder Infection Bone infection Kidney Infections Otitis Media Pharyngitis Prostatitis Skin Infection Upper Respiratory Tract Infection Where can I get more information? Your pharmacist can provide more information about cephalexin.

See also: Panixine side effects (in more detail)


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Supartz


Pronunciation: HYE-al-ure-ON-ate SOE-dee-um
Generic Name: Hyaluronate Sodium
Brand Name: Examples include Hyalgan and Supartz
Supartz is used for:

Treating knee pain in patients with osteoarthritis who have not received relief from other treatments.

Supartz is a hyaluronic acid derivative. It works by increasing the effectiveness of the fluid within the knee joint to act as a lubricant and shock absorber.

Do NOT use Supartz if: you are allergic to any ingredient in Supartz you have an infection or skin disease near the joint or injection site

Contact your doctor or health care provider right away if any of these apply to you.

Before using Supartz:

Some medical conditions may interact with Supartz. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you are allergic to birds or bird products (eg, eggs, feathers, poultry)

Some MEDICINES MAY INTERACT with Supartz. Tell your health care provider if you are taking any other medicines, especially any of the following:

Quaternary ammonium salts because side effects may occur

This may not be a complete list of all interactions that may occur. Ask your health care provider if Supartz may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Supartz:

Use Supartz as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Supartz comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Supartz refilled. Supartz is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Supartz at home, a health care provider will teach you how to use it. Be sure you understand how to use Supartz. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions. Supartz is usually given as a series of injections 1 week apart for a total of 3 to 5 injections depending upon the particular product you are using. You may not experience relief until you have received several injections. Do not use Supartz if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged. Do not use disinfectants containing ammonium salts to prepare the skin for injection because side effects may occur. Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal. If you miss a dose of Supartz, contact your doctor to establish a new dosing schedule.

Ask your health care provider any questions you may have about how to use Supartz.

Important safety information: Supartz may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Supartz with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. You may experience a temporary inflammation in your knee after using Supartz. If the inflammation is severe or continues, contact your doctor. Avoid strenuous activity or prolonged (more than 1 hour) weight-bearing activity (eg, running, tennis, heavy lifting) for at least 48 hours after you are injected with Supartz. Supartz should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Supartz, contact your doctor. You will need to discuss the benefits and risks of using Supartz while pregnant. It is not known if Supartz is found in breast milk. If you are or will be breast-feeding while you are using Supartz, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Supartz:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; mild bruising, heat, redness, swelling, or pain at the injection site; temporary achy feeling; temporary knee inflammation.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Supartz side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Supartz:

Supartz is usually handled and stored by a health care provider. If you are using Supartz at home, store Supartz as directed by your pharmacist or health care provider. Keep Supartz out of the reach of children and away from pets.

General information: If you have any questions about Supartz, please talk with your doctor, pharmacist, or other health care provider. Supartz is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Supartz. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Supartz resources Supartz Side Effects (in more detail) Supartz Use in Pregnancy & Breastfeeding Supartz Drug Interactions Supartz Support Group 3 Reviews for Supartz - Add your own review/rating Compare Supartz with other medications Osteoarthritis
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Hyalgan


Pronunciation: HYE-al-ure-ON-ate SOE-dee-um
Generic Name: Hyaluronate Sodium
Brand Name: Examples include Hyalgan and Supartz
Hyalgan is used for:

Treating knee pain in patients with osteoarthritis who have not received relief from other treatments.

Hyalgan is a hyaluronic acid derivative. It works by increasing the effectiveness of the fluid within the knee joint to act as a lubricant and shock absorber.

Do NOT use Hyalgan if: you are allergic to any ingredient in Hyalgan you have an infection or skin disease near the joint or injection site

Contact your doctor or health care provider right away if any of these apply to you.

Before using Hyalgan:

Some medical conditions may interact with Hyalgan. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you are allergic to birds or bird products (eg, eggs, feathers, poultry)

Some MEDICINES MAY INTERACT with Hyalgan. Tell your health care provider if you are taking any other medicines, especially any of the following:

Quaternary ammonium salts because side effects may occur

This may not be a complete list of all interactions that may occur. Ask your health care provider if Hyalgan may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Hyalgan:

Use Hyalgan as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Hyalgan comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Hyalgan refilled. Hyalgan is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Hyalgan at home, a health care provider will teach you how to use it. Be sure you understand how to use Hyalgan. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions. Hyalgan is usually given as a series of injections 1 week apart for a total of 3 to 5 injections depending upon the particular product you are using. You may not experience relief until you have received several injections. Do not use Hyalgan if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged. Do not use disinfectants containing ammonium salts to prepare the skin for injection because side effects may occur. Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal. If you miss a dose of Hyalgan, contact your doctor to establish a new dosing schedule.

Ask your health care provider any questions you may have about how to use Hyalgan.

Important safety information: Hyalgan may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Hyalgan with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. You may experience a temporary inflammation in your knee after using Hyalgan. If the inflammation is severe or continues, contact your doctor. Avoid strenuous activity or prolonged (more than 1 hour) weight-bearing activity (eg, running, tennis, heavy lifting) for at least 48 hours after you are injected with Hyalgan. Hyalgan should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Hyalgan, contact your doctor. You will need to discuss the benefits and risks of using Hyalgan while pregnant. It is not known if Hyalgan is found in breast milk. If you are or will be breast-feeding while you are using Hyalgan, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Hyalgan:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; mild bruising, heat, redness, swelling, or pain at the injection site; temporary achy feeling; temporary knee inflammation.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Hyalgan side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Hyalgan:

Hyalgan is usually handled and stored by a health care provider. If you are using Hyalgan at home, store Hyalgan as directed by your pharmacist or health care provider. Keep Hyalgan out of the reach of children and away from pets.

General information: If you have any questions about Hyalgan, please talk with your doctor, pharmacist, or other health care provider. Hyalgan is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Hyalgan. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Hyalgan resources Hyalgan Side Effects (in more detail) Hyalgan Use in Pregnancy & Breastfeeding Hyalgan Drug Interactions Hyalgan Support Group 0 Reviews for Hyalgan - Add your own review/rating Hyalgan injection Concise Consumer Information (Cerner Multum) Hyalgan Advanced Consumer (Micromedex) - Includes Dosage Information Compare Hyalgan with other medications Osteoarthritis
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Ciprofloxacin Hydrochloride


Class: Quinolones
VA Class: AM900
Chemical Name: 1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7(1-piperazinyl)-3-quinolinecarboxylic acid
CAS Number: 85721-33-1
Brands: Cipro, ProQuin

Fluoroquinolones, including ciprofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all age groups.1 579 715 851 852 This risk is further increased in older adults (usually those >60 years of age), individuals receiving concomitant corticosteroids, and kidney, heart, or lung transplant recipients.1 579 715 851 852 (See Tendinopathy and Tendon Rupture under Cautions.)

REMS:

FDA approved a REMS for ciprofloxacin to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of ciprofloxacin and consists of the following: medication guide. See the FDA REMS page () or the ASHP REMS Resource Center ().

Introduction

Antibacterial; fluoroquinolone.1 181 205 206 479 481 579 715

Uses for Ciprofloxacin Hydrochloride Bone and Joint Infections

Treatment of bone and joint infections (including osteomyelitis)205 296 326 362 365 367 368 369 370 371 375 474 479 535 706 caused by susceptible Pseudomonas aeruginosa,1 205 296 300 326 359 362 368 369 370 371 380 433 474 479 535 579 Enterobacter cloacae,1 362 369 370 375 380 474 579 706 or Serratia marcescens;1 296 362 368 369 370 380 474 579 also has been used in bone and joint infections caused by E. aerogenes†,369 370 706 Escherichia coli†,362 368 369 370 474 535 Klebsiella pneumoniae†,326 368 371 Morganella morganii†,369 370 or Proteus mirabilis†.368 369 371 380 474 706

Has been used for treatment of bone and joint infections caused by susceptible gram-positive bacteria, including Staphylococcus aureus†,296 326 370 474 535 S. epidermidis†,326 474 535 other coagulase-negative staphylococci†,326 370 or Enterococcus faecalis†.370 Other anti-infectives generally preferred for these gram-positive infections,522 538 but ciprofloxacin may be a useful alternative for treatment of infections caused by susceptible oxacillin-resistant (methicillin-resistant) staphylococci.522 538

Endocarditis

Alternative for treatment of native or prosthetic valve endocarditis† caused by fastidious gram-negative bacilli known as the HACEK group (Actinobacillus actinomycetemcomitans, Cardiobacterium hominis, Eikenella corrodens, Haemophilus aphrophilus, H. influenzae, H. parainfluenzae, H. paraphrophilus, Kingella denitrificans, K. kingae).768 AHA and IDSA recommend ceftriaxone or ampicillin-sulbactam as drugs of choice,768 but a fluoroquinolone (ciprofloxacin, levofloxacin, moxifloxacin) may be considered when ?-lactam anti-infectives cannot be used.768 Consultation with an infectious disease specialist is recommended.768

Alternative for treatment of uncomplicated right-sided S. aureus native valve endocarditis†.768 For native valve staphylococcal endocarditis, AHA and IDSA recommend IV nafcillin or oxacillin (with or without gentamicin) as regimen of choice and IV cefazolin (with or without gentamicin) as an alternative; IV vancomycin is recommended when staphylococci are oxacillin-resistant.768 An oral regimen of ciprofloxacin and rifampin can be considered in IV drug abusers who will not comply with a parenteral regimen.768 769

Alternative to gentamicin in regimens used for treatment of coagulase-negative staphylococcal endocarditis in the presence of prosthetic valves or materials†.768 For prosthetic valve staphylococcal endocarditis, AHA and IDSA recommend IV nafcillin or oxacillin with oral or IV rifampin and parenteral gentamicin; IV vancomycin with oral or IV rifampin and parenteral gentamicin is recommended when staphylococci are oxacillin-resistant.768 If causative organism is resistant to aminoglycosides, AHA and IDSA suggest a fluoroquinolone replace gentamicin in these regimens, provided in vitro susceptibility tests indicate the organism is susceptible to the fluoroquinolone.768

Empiric treatment of culture-negative endocarditis†.768 For empiric treatment of native valve culture-negative endocarditis, AHA and IDSA recommend a regimen of ampicillin-sulbactam with gentamicin or a regimen of vancomycin, gentamicin, and ciprofloxacin.768 Selection of the most appropriate anti-infective regimen is difficult and should be guided by epidemiologic features and clinical course of the infection.768 Consultation with an infectious diseases specialist is recommended.768

GI Infections

Treatment of infectious diarrhea caused by susceptible enterotoxigenic E. coli,1 293 297 474 477 Campylobacter fetus subsp. jejuni,1 293 297 350 474 538 Salmonella (see Typhoid Fever and other Salmonella Infections under Uses), Shigella297 477 538 612 flexneri,1 612 S. boydii, S. sonnei,1 474 or S. dysenteriae.1 612 Active in vitro against most pathogens associated with infectious diarrhea; may be a drug of choice for empiric treatment.296 350 378 420 493 522 610 611 Consider increasing emergence of fluoroquinolone-resistant Campylobacter secondary to widespread use of the drugs; use judiciously for treatment and prevention of enteropathogenic diarrhea.588 589

Alternative to co-trimoxazole for treatment of GI infections caused by Cyclospora† or Isospora†.477 533 667

Treatment of GI infections caused by Yersinia enterocolitica† or Y. pseudotuberculosis†.681 These infections usually self-limited, but IDSA, AAP, and others recommend anti-infectives for severe infections or when septicemia or other invasive disease occurs.477 667 681 Some suggest that the role of anti-infectives in management of enterocolitis, pseudoappendicitis syndrome, or mesenteric adenitis caused by Yersinia needs further evaluation.677

Treatment of travelers’ diarrhea†.378 399 420 525 650 651 661 677 679 Generally self-limited and may resolve within 3–4 days without anti-infective treatment;420 525 648 if diarrhea is moderate or severe, persists for >3 days, or is associated with fever or bloody stools, short-term (1–3 days) anti-infective treatment may be indicated.420 525 648 Fluoroquinolones (ciprofloxacin, levofloxacin, norfloxacin, ofloxacin) usually drugs of choice when treatment, including self-treatment, is indicated.420 525 594 611 612 650 648 661 677 679 Azithromycin is a treatment alternative for those who should not receive fluoroquinolones (e.g., children, pregnant women) and may be a drug of choice for travelers in areas with a high prevalence of fluoroquinolone-resistant Campylobacter (e.g., Thailand, India) or those who have not responded after 48 hours of fluoroquinolone treatment.420 525 Rifaximin is another alternative for treatment of travelers’ diarrhea caused by noninvasive E. coli.420 525

Prevention of travelers’ diarrhea† in individuals traveling for relatively short periods to areas where enterotoxigenic E. coli and other causative bacterial pathogens (e.g., Shigella) are known to be susceptible to the drug.420 525 610 611 661 677 679 CDC and others do not recommend anti-infective prophylaxis in most individuals traveling to areas of risk;420 525 661 677 679 the principal preventive measures are prudent dietary practices.525 650 651 661 If anti-infective prophylaxis is used (e.g., in immunocompromised individuals such as those with HIV infection), a fluoroquinolone (ciprofloxacin, levofloxacin, ofloxacin, norfloxacin) is recommended for nonpregnant adults,420 525 661 although the increasing incidence of quinolone resistance in pathogens that cause travelers’ diarrhea (e.g., Campylobacter) should be considered.420 525

Intra-abdominal Infections

Parenteral treatment of complicated intra-abdominal infections caused by E. coli, Ps. aeruginosa, P. mirabilis, K. pneumoniae, or Bacteroides fragilis; used in conjunction with oral metronidazole.1 579

For immunosuppressed patients or those with severe intra-abdominal infections, IDSA recommends an initial empiric regimen with broad spectrum of activity such as meropenem or imipenem; a third or fourth generation cephalosporin (cefepime, cefotaxime, ceftazidime, ceftizoxime, ceftriaxone) in conjunction with metronidazole; ciprofloxacin in conjunction with metronidazole; piperacillin-tazobactam; or aztreonam in conjunction with metronidazole.773 For mild to moderate community-acquired intra-abdominal infections, IDSA recommends an initial empiric regimen with narrower spectrum of activity such as ampicillin-sulbactam; cefazolin or cefuroxime in conjunction with metronidazole; ticarcillin-clavulanate; ertapenem; or a fluoroquinolone (ciprofloxacin, levofloxacin, moxifloxacin) in conjunction with metronidazole.773

Meningitis and CNS Infections

Has been used for treatment of meningitis and other CNS infections† caused by susceptible gram-negative bacteria (e.g., Ps. aeruginosa, Salmonella) either alone or in conjunction with other drugs (e.g., aminoglycoside, ceftriaxone or cefotaxime).360 707 762 763 764 765 818

Safety and efficacy not established for CNS infections;293 481 only low ciprofloxacin concentrations attained in CSF.1 436 707 (See Distribution under Pharmacokinetics.) Fluoroquinolones (including ciprofloxacin) generally considered for treatment of meningitis only when the infection is caused by multidrug-resistant gram-negative bacilli or when the usually recommended anti-infectives cannot be used or have been ineffective.774

Otic Infections

Treatment of malignant otitis externa† caused by Ps. aeruginosa.781 782 783 784 785 816 Treatment of choice usually is ciprofloxacin or an antipseudomonal ?-lactam (e.g., ceftazidime, imipenem).781 782 783 784 Consider the possibility of ciprofloxacin-resistant strains if there is an inadequate response to treatment.783 784 785

Respiratory Tract Infections

Treatment of respiratory tract infections (including bronchiectasis,333 374 474 479 596 bronchitis,205 297 301 333 335 345 346 347 356 374 435 466 474 479 lung abscess,474 596 pneumonia)205 326 333 346 347 356 357 435 466 474 479 491 596 caused by susceptible E. cloacae,1 333 474 579 E. coli,1 333 345 355 474 491 579 Haemophilus influenzae,1 297 301 324 333 346 351 380 427 474 491 596 579 H. parainfluenzae,1 297 474 579 K. pneumoniae,1 297 301 333 345 351 380 474 579 P. mirabilis,1 380 474 579 Ps. aeruginosa,1 300 301 324 333 346 359 374 380 427 433 474 579 or S. pneumoniae;1 324 326 333 345 346 355 356 357 425 427 474 491 also has been used for respiratory tract infections caused by susceptible E. aerogenes†,474 K. oxytoca†,474 or S. aureus†.333 345 380 491

Treatment of acute sinusitis caused by susceptible H. influenzae, M. catarrhalis, or S. pneumoniae.1

Treatment of acute exacerbations of chronic bronchitis caused by susceptible Moraxella catarrhalis.1 324 333 346 356 395 427 474 491 579

Parenteral treatment of nosocomial pneumonia caused by susceptible H. influenzae or K. pneumoniae.579

Most effective in treatment of respiratory tract infections caused by H. influenzae or M. catarrhalis;178 296 298 479 596 treatment failures have occurred when used in infections caused by S. pneumoniae178 324 358 425 427 479 or Ps. aeruginosa.178 324 346 358 427 479 596

Not a drug of first choice for pneumonia caused by S. pneumoniae;1 generally should not be used for empiric treatment of community-acquired pneumonia (CAP) when S. pneumoniae is likely or suspected.5 178 296 356 427 479 522 621 IDSA and ATS state that other fluoroquinolones with enhanced activity against S. pneumoniae (gemifloxacin, levofloxacin, moxifloxacin) are drugs of choice for empiric treatment of CAP in outpatients at risk for infections caused by drug-resistant S. pneumoniae (DRSP) and also are drugs of choice for empiric treatment of CAP in inpatients.605

Treatment of acute exacerbations of bronchopulmonary Ps. aeruginosa infections in cystic fibrosis patients.178 205 296 299 301 302 304 305 307 308 309 310 311 359 424 474 479 As with other anti-infectives, Ps. aeruginosa may be cleared temporarily from the sputum, but a bacteriologic cure rarely is obtained and should not be expected in these patients.205 306 307 309 310 312 424 425 466 474 479

Probably should not be used for treatment of aspiration pneumonia since these infections generally involve anaerobic bacteria.293 296 621

Skin and Skin Structure Infections

Treatment of skin and skin structure infections (e.g., cellulitis, abscesses, folliculitis, furunculosis, pyoderma, postoperative wound infections, infected ulcers, burns, or wounds) caused by susceptible C. freundii,1 372 474 579 E. cloacae,1 362 474 579 E. coli,1 326 372 374 375 376 377 380 474 579 K. oxytoca,474 K. pneumoniae,1 362 372 376 377 380 474 579 M. morganii,1 474 579 P. mirabilis,1 362 364 372 376 377 380 474 579 P. vulgaris,1 372 474 579 P. stuartii,1 374 377 474 579 Ps. aeruginosa,1 280 300 326 359 362 372 374 375 376 377 382 433 474 579 S. marcescens†,362 380 S. aureus (oxacillin-susceptible strains),1 326 362 364 372 373 374 375 376 377 382 466 474 579 S. epidermidis,1 364 372 375 376 377 382 474 579 or S. pyogenes (group A ?-hemolytic streptococci).1 362 373 374 579

Urinary Tract Infections (UTIs) and Prostatitis

Treatment of complicated UTIs and pyelonephritis caused by susceptible E. coli in pediatric patients 1–17 years of age.1 579 Not a drug of first choice in pediatric patients because of increased risk of adverse events (e.g., events related to joints and/or surrounding tissues) in this age group.1 579 (See Musculoskeletal Effects under Cautions.)

Treatment of acute uncomplicated cystitis in adults caused by susceptible E. coli, P. mirabilis, S. saprophyticus, or E. faecalis.715

Treatment of complicated or uncomplicated UTIs in adults caused by susceptible gram-negative bacteria, including Citrobacter diversus,1 474 579 C. freundii,1 339 340 341 375 380 474 579 E. cloacae,1 327 332 380 474 579 E. coli,1 297 326 327 329 332 336 338 339 340 351 352 353 375 380 474 504 579 715 K. pneumoniae,1 297 327 329 336 338 340 341 353 375 474 504 579 715 M. morganii,1 340 341 474 579 P. mirabilis,1 327 332 336 340 352 353 474 504 579 715 Providencia rettgeri,1 474 579 Ps. aeruginosa,1 297 300 326 327 336 338 339 340 341 351 353 359 375 379 380 474 538 579 715 or S. marcescens;1 340 341 353 380 474 504 579 also has been used for UTIs caused by E. aerogenes†,474 Klebsiella oxytoca†,474 or P. stuartii†.326 474

Treatment of UTIs in adults caused by susceptible gram-positive bacteria, including S. aureus†,327 353 380 S. epidermidis,1 327 336 340 474 579 S. saprophyticus,1 332 579 or E. faecalis.1 327 336 339 340 341 353 474 538 579 715

Treatment of acute uncomplicated pyelonephritis in adults caused by E. coli.715

Treatment of recurrent UTIs and chronic prostatitis in adults caused by E. coli or P. mirabilis in men.1 180 294 296 339 343 379 466 579 May be a drug of choice because high concentrations are attained in prostatic tissue.180 293 338 339 343 466 479

Usually reserved for treatment of complicated UTIs, especially those caused by multidrug-resistant bacteria;299 336 379 425 481 551 generally not recommended for uncomplicated UTIs (e.g., acute cystitis) unless more commonly employed urinary anti-infectives are likely to be ineffective or other equally effective, less expensive anti-infectives are contraindicated or not tolerated.293 299 522 551 585

Anthrax

Postexposure prophylaxis to reduce the incidence or progression of disease following suspected or confirmed exposure to aerosolized Bacillus anthracis spores (inhalational anthrax).1 579 663 667 668 670 678 681 682 683 686 Initial drug of choice for such prophylaxis is ciprofloxacin or doxycycline.668 683 696 697 Based on in vitro data, other fluoroquinolones (e.g., moxifloxacin, ofloxacin, levofloxacin) are considered alternatives to ciprofloxacin when needed.668

Treatment of inhalational anthrax.667 668 670 678 683 686 Monotherapy may be effective for anthrax that occurs as the result of natural or endemic exposures, but a multiple-drug parenteral regimen (ciprofloxacin or doxycycline and 1 or 2 other anti-infectives predicted to be effective) is recommended for inhalational anthrax that occurs as the result of exposure to anthrax spores in the context of biologic warfare or bioterrorism.668 686 703 Other drugs suggested as possibilities to augment ciprofloxacin or doxycycline in such multiple-drug regimens include chloramphenicol, clindamycin, rifampin, vancomycin, macrolides (azithromycin, clarithromycin, erythromycin), imipenem, meropenem, penicillin, ampicillin, daptomycin, quinupristin and dalfopristin, linezolid, and aminoglycosides (gentamicin).668 683 686 If meningitis is established or suspected, some clinicians suggest a multiple-drug regimen that includes a fluoroquinolone (e.g., ciprofloxacin) and 1 or 2 additional agents with good CSF penetration (e.g., ampicillin or penicillin, meropenem, rifampin, vancomycin, chloramphenicol).668 683 770

Treatment of cutaneous anthrax†, including that occurring following exposure to B. anthracis spores in the context of biologic warfare or bioterrorism.686 Parenteral multiple-drug regimen recommended for initial treatment when there are signs of systemic involvement, extensive edema, or lesions on the head and neck668 670 686 or when cutaneous anthrax occurs in children <2 years of age.703

Treatment of GI and oropharyngeal anthrax.681 If occurring in the context of biologic warfare or bioterrorism, use parenteral regimens recommended for inhalational anthrax.668 681 686 703

Prophylaxis following ingestion of B. anthracis spores† in contaminated meat.662

Although ciprofloxacin not usually used in children <18 years of age or in pregnant women, CDC and others state ciprofloxacin can be used when necessary in these patients for postexposure prophylaxis or treatment of anthrax since the benefits of ciprofloxacin outweigh the risks.703

Bartonella Infections

Treatment of infections caused by Bartonella henselae† (e.g., cat scratch disease, bacillary angiomatosis, peliosis hepatitis).733

Cat scratch disease generally self-limited in immunocompetent individuals and may resolve spontaneously in 2–4 months; some clinicians suggest that anti-infectives be considered for acutely or severely ill patients with systemic symptoms, particularly those with hepatosplenomegaly or painful lymphadenopathy, and probably is indicated in immunocompromised patients.667 729 730 731 732 Anti-infectives also indicated in patients with B. henselae infections who develop bacillary angiomatosis, neuroretinitis, or Parinaud’s oculoglandular syndrome.730 731 732 Optimum regimens have not been identified; some clinicians recommend azithromycin, ciprofloxacin, erythromycin, doxycycline, rifampin, co-trimoxazole, gentamicin, or third generation cephalosporins.538 667 729 730 731 732 733

Brucellosis

Treatment of brucellosis† caused by Brucella melitensis.538 624 683 771 772 Ciprofloxacin used in conjunction with rifampin is an alternative to a regimen of a tetracycline and rifampin.538 683 771 772

Capnocytophaga Infections

Alternative to penicillin G for treatment of infections caused by Capnocytophaga canimorsus†.538

Chancroid

Treatment of chancroid† (genital ulcers caused by Haemophilus ducreyi).321 462 538 606 631

CDC and others recommend azithromycin, ceftriaxone, ciprofloxacin, or erythromycin as drugs of choice for treatment of chancroid.606 631 HIV-infected patients and uncircumcised patients may not respond to treatment as well as those who are HIV-negative or circumcised.606 631

Crohn’s Disease

Management of Crohn’s disease† as an adjunct to conventional therapies.737 742 743 744 745 746 747 748

Has been used (with737 742 744 745 746 748 or without metronidazole743 747 ) for induction of remission of mildly to moderately active Crohn’s disease.737 742 743 744 745 746 747 748 May be more effective in patients with ileitis than in those with colitis.739 742

Has been used in the management of refractory perianal Crohn’s disease†.737 739 750 751 Relapse usually occurs when the drug is discontinued.739


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Lamisil AT 1% Cream


1. Name Of The Medicinal Product

Lamisil AT ® 1% Cream

2. Qualitative And Quantitative Composition

Terbinafine hydrochloride 1% w/w

3. Pharmaceutical Form

Cream

4. Clinical Particulars 4.1 Therapeutic Indications

The treatment of tinea pedis (athlete's foot) and tinea cruris (dhobie itch/jock itch) caused by Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum) and Epidermophyton floccosum.

4.2 Posology And Method Of Administration

Adults

Lamisil AT 1% Cream is applied once daily.

The affected area should be cleaned and dried thoroughly before application of Lamisil AT 1% Cream. The cream should be applied to the affected skin and surrounding area in a thin layer and rubbed in lightly. In the case of intertriginous infections (interdigital, intergluteal, inguinal) the application may be covered with a gauze strip, especially at night.

Duration of treatment is one week for tinea pedis and tinea cruris. Relief of clinical symptoms usually occurs within a few days. Irregular use or premature discontinuation of treatment carries the risk of recurrence. If there are no signs of improvement after two weeks, the diagnosis should be verified by a physician.

Children

The experience with topical Lamisil AT 1% Cream in children is still limited and its use in children under 16 years cannot therefore be recommended.

Use in the elderly

There is no evidence to suggest that elderly patients require different dosages or experience side-effects different to those of younger patients.

Method of administration

Topical administration.

4.3 Contraindications

Hypersensitivity to terbinafine or any of the excipients contained in the cream.

4.4 Special Warnings And Precautions For Use

Lamisil AT 1% cream is for external use only. Contact with the eyes should be avoided. In case of accidental contact with the eyes, rinse the eyes thoroughly with running water.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

There are no known drug interactions with Lamisil AT 1% Cream.

4.6 Pregnancy And Lactation

Foetal toxicity and fertility studies in animals suggest no adverse effects.

There is no clinical experience with Lamisil AT 1% Cream in pregnant women. Therefore, unless the potential benefits outweigh any potential risks, Lamisil AT 1% Cream should not be administered during pregnancy.

Terbinafine is excreted in breast milk, and therefore mothers should not receive Lamisil AT 1% Cream whilst breast-feeding. Infants should also not be allowed to come into contact with any treated skin, including the breast.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Redness, itching or stinging occasionally occur at the site of application; however, treatment rarely has to be discontinued for this reason. These harmless symptons must be distinguished from allergic reactions such as pruritus, rash, bullous eruptions and hives, which are rare but require discontinuation.

4.9 Overdose

No adverse events in relation to ingestion of Lamisil AT 1% Cream have been reported to the company. However, if accidental ingestion of Lamisil AT 1% Cream occurs, an appropriate method of gastric emptying may be used if considered appropriate.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Terbinafine is an allylamine that has a broad spectrum of antifungal activity. At low concentrations Terbinafine is fungicidal against dermatophytes, moulds and certain dimorphic fungi.

Terbinafine interferes specifically with fungal sterol biosynthesis at an early step. This leads to a deficiency in ergosterol and to an intracellular accumulation of squalene, resulting in fungal cell death. Terbinafine acts by inhibition of squalene epoxidase in the fungal cell membrane.

The enzyme squalene epoxidase is not linked to the cytochrome P-450 system. Terbinafine does not influence the metabolism of hormones or other drugs.

Terbinafine provides long-lasting protection. More than 90% of patients with interdigital tinea pedis (athlete's foot) treated with Terbinafine 1 % cream for one week show no mycological evidence of relapse or re-infection by three months after start of treatment. No such data on tinea cruris are available.

5.2 Pharmacokinetic Properties

Less than 5% of the dose is absorbed after topical application to humans: systemic exposure is therefore very slight.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sodium hydroxide

benzyl alcohol

sorbitan stearate

cetyl palmitate

cetyl alcohol

stearyl alcohol

polysorbate 60

isopropyl myristate

purified water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

Aluminium tube: 5 years

Polypropylene dispenser: 3 years

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

Aluminium tube with membrane, with an interior coating of phenol-epoxy based lacquer, closed with a polypropylene cap, containing 7 g, 7.5 g, 10 g, or 15 g Lamisil AT 1% Cream.

Polypropylene dispenser tube with polypropylene screw-cap closure containing 7 g, 7.5 g, 10 g, or 15 g LAMISIL AT.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Novartis Consumer Health UK Ltd, trading as Novartis Consumer Health

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

8. Marketing Authorisation Number(S)

PL 00030/0144

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 18 August 2000

Date of last renewal: 10 February 2009.

10. Date Of Revision Of The Text

27 April 2009.

Legal Category GSL


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loracarbef


Generic Name: loracarbef (lor a KAR bef)
Brand Names: Lorabid, Lorabid Pulvules

What is loracarbef?

Loracarbef is an antibiotic that fights bacteria in your body.

Loracarbef is used to treat many different types of infections caused by bacteria.

Loracarbef may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about loracarbef? Do not take this medication if you are allergic to loracarbef, or to similar antibiotics, such as Ceftin, Cefzil, Duricef, Fortaz, Keflex, Omnicef, Spectracef, Suprax, and others.

Before taking this medication, tell your doctor if you are allergic to any drugs (especially penicillin).

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Loracarbef will not treat a viral infection such as the common cold or flu.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

What should I discuss with my healthcare provider before taking loracarbef? Do not take this medication if you are allergic to loracarbef or to any cephalosporin antibiotic, such as:

cefadroxil (Duricef);

cefdinir (Omnicef);

cefditoren (Spectracef);

cefixime (Suprax);

cefprozil (Cefzil);

ceftazidime (Fortaz);

cefuroxime (Ceftin);

cephalexin (Keflex); and others.

Before taking loracarbef, tell your doctor if you have:

kidney disease;

a history of intestinal problems (especially colitis); or

are allergic to any drugs, especially penicillins.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take loracarbef.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether loracarbef passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

The liquid form of loracarbef may contain sucrose (sugar). Talk to your doctor before using this form of loracarbef if you have diabetes.

How should I take loracarbef?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take this medicine with a full glass of water. Take loracarbef on an empty stomach, at least 1 hour before or 2 hours after a meal. Shake the suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Take loracarbef for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Loracarbef will not treat a viral infection such as the common cold or flu.

Contact your doctor if your infection does not improve or if your symptoms get worse.

Store this medication at room temperature away from moisture and heat.

Throw away any unused liquid medication that is older than 14 days.

What happens if I miss a dose?

Take the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include nausea, vomiting, stomach pain, and diarrhea.

What should I avoid while taking loracarbef? Avoid using antacids within 1 hour before or after taking loracarbef. Antacids can make it harder for your body to absorb loracarbef.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Loracarbef side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

diarrhea that is watery or bloody;

seizure (convulsions);

fever, sore throat, and joint pain with a severe blistering, peeling, and red skin rash;

easy bruising or bleeding, unusual weakness; or

skin rash, bruising, severe tingling, numbness, pain, muscle weakness.

Less serious side effects may include:

mild itching or skin rash;

mild nausea, vomiting, stomach pain, loss of appetite;

warmth, redness, or tingling under your skin;

headache;

dizziness, drowsiness; or

vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

Loracarbef Dosing Information

Usual Adult Dose for Bronchitis:

Secondary bacterial infection of acute bronchitis: 200 to 400 mg orally every 12 hours for 7 days
Acute bacterial exacerbation of chronic bronchitis: 400 mg orally every 12 hours for 7 days

Usual Adult Dose for Cystitis:

Uncomplicated: 200 mg orally every 24 hours for 7 days

Usual Adult Dose for Pneumonia:

Mild to moderate: 400 mg orally every 12 hours for 14 days

Usual Adult Dose for Pyelonephritis:

Uncomplicated: 400 mg orally every 12 hours for 14 days

Usual Adult Dose for Sinusitis:

400 mg orally every 12 hours for 10 days

Usual Adult Dose for Skin or Soft Tissue Infection:

Uncomplicated: 200 mg orally every 12 hours for 7 days

Usual Adult Dose for Tonsillitis/Pharyngitis:

200 mg orally every 12 hours for 10 days

Usual Adult Dose for Upper Respiratory Tract Infection:

Mild to moderate: 200 to 400 mg orally every 12 hours for approximately 7 to 10 days, depending on the nature and severity of the infection

Usual Pediatric Dose for Otitis Media:

6 months to 12 years: 15 mg/kg of the suspension orally every 12 hours for 10 days, not to exceed 800 mg/24 hours

Usual Pediatric Dose for Sinusitis:

6 months to 12 years: 15 mg/kg orally every 12 hours for 10 days, not to exceed 800 mg/day
13 years or older: 400 mg orally every 12 hours for 10 days

Usual Pediatric Dose for Skin or Soft Tissue Infection:

6 months to 12 years: 7.5 mg/kg orally every 12 hours for 7 days, not to exceed 400 mg/24 hours
13 years or older: 200 mg orally every 12 hours for 7 days

Usual Pediatric Dose for Impetigo:

6 months to 12 years: 7.5 mg/kg orally every 12 hours for 7 days, not to exceed 400 mg/24 hours
13 years or older: 200 mg orally every 12 hours for 7 days

Usual Pediatric Dose for Tonsillitis/Pharyngitis:

6 months to 12 years: 7.5 mg/kg orally every 12 hours for 10 days, not to exceed 400 mg/24 hours
13 years or older: 200 mg orally every 12 hours for 10 days

What other drugs will affect loracarbef?

Before you take loracarbef, tell your doctor if you are also taking:

probenecid (Benemid); or

a diuretic (water pill) such as amiloride (Midamor, Moduretic), furosemide (Lasix), hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Lopressor, Vasoretic, Zestoretic), metolazone (Mykrox, Zarxolyn), spironolactone (Aldactazide, Aldactone), triamterene (Dyrenium, Maxzide, Dyazide), and others.

This list is not complete and there may be other drugs that can interact with loracarbef. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start taking a new medication without telling your doctor.

More loracarbef resources Loracarbef Side Effects (in more detail) Loracarbef Use in Pregnancy & Breastfeeding Loracarbef Drug Interactions Loracarbef Support Group 1 Review for Loracarbef - Add your own review/rating loracarbef Advanced Consumer (Micromedex) - Includes Dosage Information Loracarbef MedFacts Consumer Leaflet (Wolters Kluwer) Loracarbef Monograph (AHFS DI) Lorabid Prescribing Information (FDA) Compare loracarbef with other medications Bladder Infection Bronchitis Impetigo Kidney Infections Otitis Media Pneumonia Sinusitis Skin Infection Strep Throat Tonsillitis/Pharyngitis Upper Respiratory Tract Infection Where can I get more information? Your pharmacist can provide more information about loracarbef.

See also: loracarbef side effects (in more detail)


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panitumumab


Generic Name: panitumumab (pan i TUE moo mab)
Brand Names: Vectibix

What is panitumumab?

Panitumumab is a cancer medication. It interferes with the growth of cancer cells and slows their growth and spread in your body.

Panitumumab is used to treat metastatic colorectal cancer that has progressed after treatment with other chemotherapy.

Panitumumab may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about panitumumab?

Before receiving this medication, tell your doctor if you have any allergies or breathing problems. You may not be able to receive panitumumab, or you may need a dosage adjustment or special tests during treatment.

Panitumumab may cause severe skin problems such as acne, itching, redness, skin rash, dryness, peeling, cracking, or oozing, and swelling or infection around your fingernails or toenails. This medication can also cause redness or irritation of your eyes or eyelids. More severe forms of skin problems can lead to widespread infection and possibly death. Seek emergency medical attention at the first sign of any skin rash.

Some people receiving a panitumumab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, itchy, short of breath, or if you have a fever or chills during the injection.

The side effects of panitumumab may not appear when you first start using the medication. Severe skin or eye reactions may occur up to 2 weeks after the start of your treatment. These effects may not clear up for weeks or even months after you stop receiving panitumumab.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Panitumumab can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

This medication may affect a woman's fertility (ability to have children). You may also have irregular menstrual periods while receiving panitumumab.

What should I discuss with my health care provider before receiving panitumumab? This medication may cause severe skin problems such as acne, itching, redness, skin rash, dryness, peeling, cracking, or oozing, and swelling or infection around your fingernails or toenails. More severe forms of skin problems can lead to widespread infection and possibly death. Seek emergency medical attention at the first sign of any skin rash. Do not use this medication if you are allergic to panitumumab.

Before receiving this medication, tell your doctor if you have any allergies or breathing problems. You may not be able to receive panitumumab, or you may need a dose adjustment or special tests to safely receive this medication.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether panitumumab passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

This medication may affect a woman's fertility (ability to have children). You may also have irregular menstrual periods while receiving panitumumab.

How is panitumumab given?

Panitumumab is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. The medicine must be given slowly through an IV infusion, and can take up to 90 minutes to complete.

Before you receive this medication, you may need to undergo a biopsy to make sure panitumumab is the right medication to treat your cancer.

Panitumumab is usually given once every 2 weeks. Follow your doctor's instructions.

What happens if I miss a dose?

Contact your doctor if you miss an appointment for your panitumumab injection.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine. Symptoms of a panitumumab overdose are unknown.

What should I avoid while taking panitumumab? Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Panitumumab can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun. Panitumumab side effects

Some people receiving a panitumumab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, itchy, short of breath, or if you have a fever or chills during the injection.

Some of the side effects of panitumumab may not appear when you first start using the medication. Severe skin or eye reactions may occur up to 2 weeks after the start of your treatment. These effects may not clear up for weeks or even months after you stop receiving panitumumab.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

swelling of your hands or ankles;

acne, dryness, peeling, cracking, bleeding, oozing, pus, or any other sign of skin infection;

cough or wheezing, running out of breath easily;

white patches or sores inside your mouth or on your lips;

drowsiness, restless feeling, confusion, muscle stiffness, fast or uneven heart rate, chest pain;

redness, swelling, or irritation of your eyes or eyelids; or

swelling or infection around your fingernails or toenails.

Less serious side effects may include:

nausea, vomiting, stomach pain;

diarrhea or constipation; or

tired feeling.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Panitumumab Dosing Information

Usual Adult Dose for Colorectal Cancer:

6 mg/kg administered as an intravenous infusion over 60 minutes every 14 days

What other drugs will affect panitumumab?

There may be other drugs that can interact with panitumumab. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More panitumumab resources Panitumumab Side Effects (in more detail) Panitumumab Dosage Panitumumab Use in Pregnancy & Breastfeeding Panitumumab Drug Interactions Panitumumab Support Group 0 Reviews for Panitumumab - Add your own review/rating panitumumab Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information Panitumumab Professional Patient Advice (Wolters Kluwer) Panitumumab MedFacts Consumer Leaflet (Wolters Kluwer) Panitumumab Monograph (AHFS DI) Vectibix Prescribing Information (FDA) Vectibix Consumer Overview Compare panitumumab with other medications Colorectal Cancer Where can I get more information? Your doctor can provide more information about panitumumab.

See also: panitumumab side effects (in more detail)


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Lamisil Cream


1. Name Of The Medicinal Product

LAMISIL® Cream

2. Qualitative And Quantitative Composition

Terbinafine hydrochloride 1.0% w/w

3. Pharmaceutical Form

White, smooth or almost smooth glossy cream

4. Clinical Particulars 4.1 Therapeutic Indications

Fungal infections of the skin caused by Trichophyton (eg. T. Rubrum, T.Mentagrophytes, T. Verrucosum, T. Violaceum), Microsporum canis and Epidermophyton floccosum.

Yeast infections of the skin, principally those caused by the genus Candida (eg. C. albicans).

Pityriasis (tinea) versicolor due to Pityrosporum orbiculare (also known as Malassezia furfur).

4.2 Posology And Method Of Administration

LAMISIL can be applied once or twice daily. Cleanse and dry the affected areas thoroughly before application of LAMISIL. Apply the cream to the affected skin and surrounding area in a thin layer and rub in lightly. In the case of intertriginous infections (submammary, interdigital, intergluteal, inguinal) the application may be covered with a gauze strip, especially at night.

The likely durations of treatment are as follows:

Tinea corporis, cruris: 1 to 2 weeks

Tinea pedis: 1 week

Cutaneous candidiasis: 2 weeks

Pityriasis versicolor: 2 weeks

Relief of clinical symptoms usually occurs within a few days. Irregular use or premature discontinuation of treatment carries the risk of recurrence. If there are no signs of improvement after two weeks, the diagnosis should be verified.

Children

The experience with topical LAMISIL in children is still limited and its use cannot therefore be recommended.

Use in the elderly

There is no evidence to suggest that elderly patients require different dosages or experience side-effects different to those of younger patients.

Method of administration

Via the topical route.

4.3 Contraindications

Hypersensitivity to terbinafine or any of the excipients contained in the cream.

4.4 Special Warnings And Precautions For Use

LAMISIL Cream is for external use only. Contact with the eyes should be avoided. In case of accidental contact with the eyes, rinse the eyes thoroughly with running water.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

There are no known drug interactions with LAMISIL Cream.

4.6 Pregnancy And Lactation

Foetal toxicity and fertility studies in animals suggest no adverse effects.

There is no clinical experience with LAMISIL Cream in pregnant women, therefore, unless the potential benefits outweigh any potential risks, LAMISIL Cream should not be administered during pregnancy.

Terbinafine is excreted in breast milk and therefore mothers should not receive LAMISIL whilst breast-feeding. Infants should also not be allowed to come into contact with any treated skin, including the breast.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Redness, itching or stinging occasionally occur at the site of application; however, treatment rarely has to be discontinued for this reason. This must be distinguished from allergic reactions such as pruritus, rash, bullous eruptions and hives which are very rare but require discontinuation.

4.9 Overdose

The low systemic absorption of topical terbinafine cream renders overdosage extremely unlikely. Accidental ingestion of the contents of one 30g tube of LAMISIL Cream, which contains 300mg terbinafine hydrochloride, is comparable to one LAMISIL 250mg tablet (adult oral unit dose).

No case of overdosage has been reported with LAMISIL Cream. However, should a larger amount of LAMISIL Cream be inadvertently ingested, adverse effects similar to those observed with an overdosage of LAMISIL tablets are to be expected. These include headache, nausea, epigastric pain and dizziness.

The recommended treatment of overdosage consists of eliminating the drug, primarily by the administration of activated charcoal, and giving symptomatic supportive therapy, if needed.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Antifungal for topical use (ATC code D01A E15)

Terbinafine is an allylamine which has a broad spectrum of antifungal activity. At low concentrations terbinafine is fungicidal against dermatophytes, moulds and certain dimorphic fungi. The activity versus yeasts is fungicidal or fungistatic depending of the species.

Terbinafine interferes specifically with fungal sterol biosynthesis at an early step. This leads to a deficiency in ergosterol and to an intracellular accumulation of squalene, resulting in fungal cell death. Terbinafine acts by inhibition of squalene epoxidase in the fungal cell membrane. The enzyme squalene epoidase is not linked to the cytochrome P450 system.

5.2 Pharmacokinetic Properties

Less than 5% of the dose is absorbed after topical application to humans; systemic exposure is therefore very slight.

5.3 Preclinical Safety Data

None stated

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sodium hydroxide, benzyl alcohol, sorbitan monostearate, cetyl palmitate, cetyl alcohol, stearyl alcohol, polysorbate 60, isopropyl myristate, demineralised water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

Aluminium tube: 5 years.

Polypropylene dispenser tube: 3 years.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

Aluminium tube with membrane, with an interior coating of phenol-epoxy based lacquer, closed with a polypropylene cap, containing 15g or 30g LAMISIL Cream.

Polypropylene dispenser tube with polypropylene screw-cap closure containing 15 or 30g LAMISIL cream

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Novartis Consumer Health UK Limited

Wimblehurst Road

Horsham

West Sussex

RH 12 5AB

United Kingdom

8. Marketing Authorisation Number(S)

PL 00030/0421

9. Date Of First Authorisation/Renewal Of The Authorisation

3 October 1990 / 18 April 2001

10. Date Of Revision Of The Text

27th April 2009

Legal category: POM


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Maxipime


Generic Name: Cefepime Hydrochloride
Class: Fourth Generation Cephalosporins
Chemical Name: [6R - (6?,7?(Z)]] - 1 - [[7 - [[(2 - amino - 4 - thiazolyl)(methoxyimino)acetyl]amino] - 2 - carboxy - 8 - oxo - 5 - thia - 1 - azabicyclo[4.2.0]oct - 2 - en - 3 - yl]methyl] -1-methylpyrrolidinium chloride monohydrochloride monohydrate
Molecular Formula: C19H25ClN6O5S2•HCl•H 2O
CAS Number: 123171-59-5

Introduction

Antibacterial; ?-lactam antibiotic; fourth generation cephalosporin.1 2 6

Uses for Maxipime Intra-abdominal Infections

Treatment of complicated intra-abdominal infections caused by Escherichia coli, viridans streptococci, Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterobacter, or Bacteroides fragilis; used in conjunction with IV metronidazole.1 37 69 70 92

Has been used alone for treatment of acute obstetric and gynecologic infections† (e.g., pelvic inflammatory disease [PID], pelvic surgical wound infection, postpartum endometritis),41 but safety and efficacy of cefepime monotherapy in these infections not established.1

Respiratory Tract Infections

Treatment of moderate to severe pneumonia (with or without concurrent bacteremia) caused by susceptible Streptococcus pneumoniae.1 5 8 14 15 92

Treatment of moderate to severe pneumonia caused by susceptible P. aeruginosa, K. pneumoniae, or Enterobacter.1 5 8 14 15 92

Treatment of community-acquired pneumonia (CAP)40 43 caused by S. pneumoniae, Haemophilus influenzae†, Moraxella catarrhalis†, and Staphylococcus aureus†.43 ATS and IDSA recommend use of cefepime for treatment of CAP only when Ps. aeruginosa is known or suspected to be involved.56 For empiric treatment of CAP in patients with risk factors for Ps. aeruginosa, IDSA and ATS recommend a combination regimen that includes an antipneumococcal, antipseudomonal ?-lactam (cefepime, imipenem, meropenem, fixed combination of piperacillin and tazobactam) and ciprofloxacin or levofloxacin; one of these ?-lactams, an aminoglycoside, and azithromycin; or one of these ?-lactams, an aminoglycoside, and an antipneumococcal fluoroquinolone.56 If Ps. aeruginosa has been identified by appropriate microbiologic testing, these experts recommend treatment with a regimen that includes an antipseudomonal ?-lactam (cefepime, ceftazidime, aztreonam, imipenem, meropenem, piperacillin, ticarcillin) and ciprofloxacin, levofloxacin, or an aminoglycoside.56

Treatment of nosocomial pneumonia.67 68 69 For empiric therapy in severely ill patients or in those with late-onset disease or risk factor for multidrug-resistant bacteria, used in conjunction with either an aminoglycoside (amikacin, gentamicin, tobramycin) or an antipseudomonal fluoroquinolone (ciprofloxacin, levofloxacin).69 In hospitals where methicillin-resistant (oxacillin-resistant) Staphylococcus is common or if there are risk factors for these strains, initial regimen also should include vancomycin or linezolid.67 68 69

Skin and Skin Structure Infections

Treatment of uncomplicated skin and skin structure infections caused by susceptible S. aureus (oxacillin-susceptible [methicillin-susceptible] strains only) or susceptible S. pyogenes (group A ?-hemolytic streptococci).1 3 5 6 7 8 14 17 92

Urinary Tract Infections (UTIs)

Treatment of mild to moderate uncomplicated and complicated UTIs (including those associated with pyelonephritis and/or with concurrent bacteremia) caused by susceptible E. coli, K. pneumoniae, or Proteus mirabilis.1 3 5 6 8 9 16 92

Treatment of severe uncomplicated and complicated UTIs (including those associated with pyelonephritis and/or concurrent bacteremia) caused by susceptible E. coli or K. pneumoniae.1 6 7 14 45 92

Meningitis and Other CNS Infections

Treatment of meningitis† caused by susceptible gram-negative bacteria (e.g., H. influenzae, Neisseria meningitidis, E. coli, E. aerogenes, Ps. aeruginosa) or gram-positive bacteria (e.g., S. pneumoniae, S. aureus, S. epidermidis).46 69 75 77 79 83 84

Safety and efficacy not established.1 92 Manufacturers caution that patients in whom meningeal seeding from a distant infection site or in whom meningitis is suspected or documented should receive an alternative anti-infective with demonstrated clinical efficacy in this setting.1 92 Some clinicians state additional study is needed regarding efficacy for treatment of meningitis, particularly for infections caused by penicillin- and/or cefotaxime-resistant S. pneumoniae.46 79 In addition, cefepime may not be a good choice for empiric treatment of meningitis if Acinetobacter may be involved.83

IDSA states cefepime is one of several alternatives that can be used for treatment of meningitis caused by H. influenzae or E. coli or treatment of meningitis caused by S. pneumonia susceptible to penicillins and third generation cephalosporins.75 For treatment of meningitis caused by Ps. aeruginosa, IDSA and other experts recommend a regimen that consists of an antipseudomonal cephalosporin (cefepime or ceftazidime) or carbapenem (imipenem or meropenem) given with or without an aminoglycoside (amikacin, gentamicin, tobramycin).69 75 76 Treatment should be guided by results of in vitro susceptibility tests.75

IDSA also recommends a regimen of cefepime and vancomycin as one of several regimens that can be used for empiric treatment of penetrating head trauma or postneurosurgical infections caused by S. aureus, coagulase-negative staphylococci (especially S. epidermidis), or aerobic gram-negative bacilli (including Ps. aeruginosa).75

Septicemia

Treatment of septicemia† caused by susceptible gram-negative bacteria.69

Select anti-infective for treatment of sepsis syndrome based on probable source of infection, gram-stained smears of appropriate clinical specimens, immune status of the patient, and current patterns of bacterial resistance within the hospital and local community.69 Some clinicians suggest that certain parenteral cephalosporins (i.e., cefepime, cefotaxime, ceftriaxone, ceftazidime) are good choices for treatment of gram-negative sepsis.69

For initial treatment of life-threatening sepsis in adults, some clinicians suggest that a third or fourth generation cephalosporin (i.e., cefepime, cefotaxime, ceftriaxone, ceftazidime), fixed combination of piperacillin and tazobactam, or a carbapenem (imipenem or meropenem) be used in conjunction with vancomycin with or without an aminoglycoside (amikacin, gentamicin, tobramycin).69

Empiric Therapy in Febrile Neutropenic Patients

Empiric treatment of presumed bacterial infections in febrile neutropenic patients.1 26 34 35 36 58 59 62 69 92

Has been effective as monotherapy for empiric therapy in febrile neutropenic patients;34 35 36 58 59 62 used in conjunction with an aminoglycoside in more seriously ill patients.69 Manufacturers caution that safety and efficacy data are limited to date and monotherapy may not be appropriate in patients at severe risk of infection (e.g., those with a history of recent bone marrow transplantation, hypotension on presentation, underlying hematologic malignancy, or severe or prolonged neutropenia).1

Consult published protocols for the treatment of infections in febrile neutropenic patients for specific recommendations regarding selection of the initial empiric regimen, when to change the initial regimen, possible subsequent regimens, and duration of therapy in these patients.26 Consultation with an infectious disease expert knowledgeable about infections in immunocompromised patients also is advised.26 32 38

Maxipime Dosage and Administration Administration

Administer by IV infusion or deep IM injection.1 2 3 5 6 12 14 92

IM route should be used only for treatment of mild to moderate, uncomplicated or complicated UTIs caused by E. coli when this route is considered more appropriate.1 2 5

IV Infusion

If a Y-type administration set is used, discontinue other solution flowing through the tubing during cefepime infusion.1 2 92

Manufacturers recommend that aminoglycosides, ampicillin (>40 mg/mL), metronidazole, vancomycin, or aminophylline be administered separately from cefepime.1 2 92 (See Drug Compatibility under Compatibility.)

Reconstitution and Dilution

Reconstitute vials for IV infusion with 0.9% sodium chloride, 5 or 10% dextrose, (1/6) M sodium lactate, 5% dextrose and 0.9% sodium chloride, lactated Ringer’s and 5% dextrose injection, Normosol-R, or Normosol-M in 5% dextrose injection.1

Reconstitute vials containing 500 mg, 1 g, or 2 g of cefepime with 5, 10, or 10 mL of one of these IV solutions, respectively, to provide solutions containing approximately 100, 100, or 160 mg/mL, respectively, and then dilute the appropriate dose in a compatible IV solution.1

Reconstitute ADD-Vantage vials containing 1 or 2 g of cefepime with 50 or 100 mL of 0.9% sodium chloride or 5% dextrose injection according to the manufacturer’s directions.1

Thaw the commercially available premixed injection (frozen) at room temperature (25°C) or under refrigeration (5°C); do not thaw by immersion in a water bath or by exposure to microwave radiation.92 A precipitate may have formed in the frozen injection, but should dissolve with little or no agitation after reaching room temperature.92 Discard thawed injection if an insoluble precipitate is present or if container seals or outlet ports are not intact or leaks are found.92 The injection should not be used in series connections with other plastic containers, since such use could result in air embolism from residual air being drawn from the primary container before administration of fluid from the secondary container is complete.92

Rate of Administration

Administer by IV infusion over approximately 30 minutes.1 92

IM Injection Reconstitution

For IM injection, reconstitute vial containing 500 mg or 1 g of cefepime with 1.3 or 2.4 mL, respectively, of sterile water for injection, 0.9% sodium chloride, 5% dextrose, 0.5 or 1% lidocaine hydrochloride, or bacteriostatic water for injection (with parabens or benzyl alcohol) to provide a solution containing approximately 280 mg/mL.1 2

Dosage

Available as cefepime hydrochloride; dosage expressed in terms of cefepime, calculated on the anhydrous basis.1 92

Pediatric Patients General Pediatric Dosage IV or IM

Children 2 months to 16 years of age weighing <40 kg: 50 mg/kg every 12 hours.1 92

AAP recommends 100–150 mg/kg daily in 3 divided doses for treatment of mild to moderate infections and 150 mg/kg daily in 3 divided doses for treatment of severe infections in children >1 month of age.64

Respiratory Tract Infections Pneumonia IV

Children 2 months to 16 years of age weighing <40 kg: 50 mg/kg every 12 hours for 10 days.1 92

Skin and Skin Structure Infections Uncomplicated Infections IV

Children 2 months to 16 years of age weighing <40 kg: 50 mg/kg every 12 hours for 10 days.1 92

Urinary Tract Infections (UTIs) Uncomplicated or Complicated UTIs IV or IM

Children 2 months to 16 years of age weighing <40 kg: 50 mg/kg every 12 hours for 7–10 days.1 92

Empiric Therapy in Febrile Neutropenic Patients IV

Children 2 months to 16 years of age weighing <40 kg: 50 mg/kg every 8 hours for 7 days or until neutropenia resolves.1 92

Frequently reevaluate need for continued anti-infective therapy if fever resolves but neutropenia remains for >7 days.1 92

Adults Intra-abdominal Infections Complicated Infections IV

2 g every 12 hours for 7–10 days; use in conjunction with IV metronidazole.1 92

Respiratory Tract Infections Moderate to Severe Pneumonia IV

1–2 g every 12 hours for 10 days.1 92

1–2 g every 8–12 hours recommended for initial therapy of hospital-acquired pneumonia, ventilator-associated pneumonia, or healthcare-associated pneumonia.67 92

Skin and Skin Structure Infections Moderate to Severe Uncomplicated Infections IV

2 g every 12 hours for 10 days.1 92

Urinary Tract Infections (UTIs) Mild to Moderate Uncomplicated or Complicated UTIs IV or IM

0.5–1 g every 12 hours for 7–10 days.1 92

Severe Uncomplicated or Complicated UTIs IV

2 g every 12 hours for 10 days.1 92

Empiric Therapy in Febrile Neutropenic Patients IV

2 g every 8 hours for 7 days or until neutropenia resolves.1 34 35 36 92

Frequently reevaluate need for continued anti-infective therapy if fever resolves but neutropenia remains for >7 days.1 92

Prescribing Limits Pediatric Patients

Dosage should not exceed recommended adult dosage.1 92

Special Populations Hepatic Impairment

Dosage adjustments not required.1 92

Renal Impairment

Dosage adjustments necessary in patients with Clcr ?60 mL/minute.1 92

Adults with Clcr ?60 mL/minute: Give an initial loading dose using the usually recommended adult dosage followed by maintenance dosage based on Clcr.1 92 (See Table 1 and Table 2.)

Table 1. Maintenance Dosage for Treatment of Infections in Adults with Renal Impairment192

Clcr (mL/minute)

Initial dose: 500 mg

Initial dose: 1 g

Initial dose: 2 g

30–60

500 mg every 24 h

1 g every 24 h

2 g every 24 h

11–29

500 mg every 24 h

500 mg every 24 h

1 g every 24 h

<11

250 mg every 24 h

250 mg every 24 h

500 mg every 24 h

Table 2. Maintenance Dosage for Empiric Therapy in Febrile Neutropenic Adults with Renal Impairment192

Clcr (mL/minute)

Initial Dose: 2 g

30–60

2 g every 12 h

11–29

2 g every 24 h

<11

1 g every 24 h

Adults undergoing hemodialysis: 1 g on the first day of treatment followed by 500 mg every 24 hours for treatment of infections or 1 g on the first day followed by 1 g every 24 hours for empiric therapy in febrile neutropenic patients.1 92 Administer the dose at the same time each day (given at completion of procedure on hemodialysis days).1 92

Adults undergoing CAPD: Give usually recommended dose once every 48 hours.1 2 6 10 12 92

Pediatric patients with renal impairment: Dosage adjustments required similar to those recommended for adults.1 92

Cautions for Maxipime Contraindications

Immediate hypersensitivity to cefepime, other cephalosporins, penicillins, or other ?-lactams.1 92

Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.92

Warnings/Precautions Warnings Superinfection/Clostridium difficile-associated Diarrhea and Colitis

Possible emergence and overgrowth of nonsusceptible organisms with prolonged therapy.1 92 Careful observation of the patient is essential.1 92 Institute appropriate therapy if superinfection occurs.1 92

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile.1 92 C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) has been reported with nearly all anti-infectives, including cefepime, and may range in severity from mild diarrhea to fatal colitis.1 92 Hypertoxin producing strains of C. difficile are associated with increased morbidity and mortality since they may be refractory to anti-infectives and colectomy may be required.1 92

Consider CDAD if diarrhea develops and manage accordingly.1 92 Careful medical history is necessary since CDAD has been reported to occur as late as 2 months or longer after anti-infective therapy is discontinued.1 92

If CDAD is suspected or confirmed may need to discontinue anti-infective therapy not directed against C. difficile.1 Some mild cases may respond to discontinuance alone.1 Manage moderate to severe cases with fluid, electrolyte, and protein supplementation, anti-infective therapy active against C. difficile (e.g., oral metronidazole or vancomycin), and surgical evaluation when clinically indicated.1 92

Neurotoxicity

Serious adverse events, including life-threatening or fatal encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, coma), myoclonus, and seizures reported rarely.1 85 86 87 88 92 91 Nonconvulsive status epilepticus, characterized by alteration of consciousness without convulsions that is associated with continuous epileptiform EEG activity, also reported.85 91

Most cases of cefepime-associated neurotoxicity occurred in patients with renal impairment who received dosages of the drug inappropriately high for their renal status;1 85 86 87 88 91 92 some cases occurred in patients who received dosage adjusted for renal function1 92 or in patients with normal renal function.87 88

Symptoms of neurotoxicity generally were reversible and resolved after cefepime was discontinued and/or after hemodialysis.1 92

If seizures occur, discontinue the drug.1 92 Use anticonvulsant therapy if clinically indicated.1 92

Increased Mortality

In November 2007, FDA announced that a safety review of cefepime was initiated after a published meta-analysis described a higher risk of all-cause mortality in patients treated with cefepime compared with patients treated with comparator ?-lactams.72 73 74 The published meta-analysis looked at all-cause mortality data from 57 randomized controlled trials that compared cefepime with other ?-lactams for various indications.71 FDA began working with Bristol-Myers Squibb to further evaluate the findings presented in the published meta-analysis and additional safety data.72 73

On June 17, 2009, FDA announced that, although the safety review is ongoing, it has determined that cefepime remains an appropriate therapy for its approved indications based on results of FDA's additional meta-analyses.74 FDA performed meta-analyses based on both trial- and patient-level data derived from all available cefepime comparative clinical trials.74 Results of the trial-level meta-analysis indicated that all-cause mortality rates 30 days after treatment were 6.21% for cefepime-treated patients and 6% for comparator-treated patients.74 FDA's patient-level meta-analysis indicated that all-cause mortality rates 30 days after treatment were 5.63% for cefepime-treated patients and 5.68% for comparator-treated patients.74 In addition, in a trial-level meta-analysis of 24 febrile neutropenia trials, there was no statistically significant increase in mortality in cefepime-treated patients compared with comparator-treated patients.74 A review of deaths reported in 7 of these febrile neutropenia trials indicated that most patients appeared to have died from their underlying malignancies and/or comorbid conditions.74

As part of the continuing cefepime safety review, FDA and Bristol-Myers Squibb are in the process of using hospital drug utilization data to conduct additional separate analyses of cefepime-associated mortality.74 Results from these studies are unlikely to be available until at least summer 2010.74

Sensitivity Reactions Hypersensitivity Reactions

Possible hypersensitivity reactions, including rash (maculopapular or erythematous), pruritus, fever, eosinophilia, urticaria, anaphylaxis, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis.1 92 a

If an allergic reaction occurs, discontinue cefepime and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, and maintenance of an adequate airway and oxygen).1 92

Cross-hypersensitivity

Partial cross-sensitivity among cephalosporins and other ?-lactam antibiotics, including penicillins and cephamycins.1 92 a

Prior to initiation of therapy, make careful inquiry concerning previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs.1 92 Cautious use recommended in individuals hypersensitive to penicillins:1 92 a avoid use in those who have had an immediate-type (anaphylactic) hypersensitivity reaction and administer with caution in those who have had a delayed-type (e.g., rash, fever, eosinophilia) reaction.a

General Precautions Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of cefepime and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.1 92

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.1 92 In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.1 92

History of GI Disease

Use with caution in patients with a history of GI disease, particularly colitis.1 92 (See Superinfection/Clostridium difficile-associated Diarrhea and Colitis under Cautions.)

Arginine Content

Commercially available cefepime preparations contain l-arginine to adjust pH.1 92

At concentrations 33 times higher than the amount provided by the maximum recommended human cefepime dosage, arginine has altered glucose metabolism and transiently increased serum potassium concentrations.1 92 The effect of lower arginine concentrations not known.1 92

Specific Populations Pregnancy

Category B.1 92

Lactation

Distributed into milk;1 6 92 use with caution.1 92

Pediatric Use

Safety and efficacy not established in neonates or infants <2 months of age.1 92

Safety and efficacy have been established for use in pediatric patients 2 months to 16 years of age for treatment of uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, and pneumonia and for empiric therapy for febrile neutropenic patients.1 92 Use of cefepime in this age group supported by evidence from adequate and well-controlled adult studies and additional pharmacokinetic and safety data from pediatric studies.1 92

Not recommended for treatment of serious infections suspected or known to be caused by Haemophilus influenzae type b (Hib); manufacturers recommend use of an alternative anti-infective if the possibility of meningeal seeding from a distant infection site or meningitis is suspected or documented.1 92 (See Uses: Meningitis and Other CNS Infections.)

The commercially available premixed injection (frozen) containing 1 or 2 g of cefepime should not be used in pediatric patients unless the entire 1- or 2-g dose is required.92

Pharmacokinetic and adverse effect profiles similar to those reported in adults.1 92

Geriatric Use

Safety and efficacy in those ?65 years of age similar to that in younger adults.1 92

Serious adverse effects (including life-threatening or fatal encephalopathy, myoclonus, and seizures) have occurred in geriatric patients who received cefepime dosage inappropriately high for their renal status.1 92

Substantially eliminated by kidneys; risk of toxicity may be greater in those with impaired renal function.1 92 Select dosage with caution and assess renal function periodically because of age-related decreases in renal function.1 92 (See Renal Impairment under Dosage and Administration.)

Hepatic Impairment

Pharmacokinetics not affected.1 92

Renal Impairment

Possible decreased clearance and increased serum half-life.1 6 92

Serious adverse events, including life-threatening or fatal encephalopathy, may occur if inappropriately high dosage is used in patients with renal impairment.1 85 86 87 91 92 (See Neurotoxicity under Cautions.)

Dosage adjustments necessary in patients with Clcr ?60 mL/minute.1 2 92 (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Diarrhea,1 24 33 92 nausea,1 24 33 92 vomiting,1 23 33 92 rash,92 local reactions (e.g., phlebitis, pain, inflammation).1 92

Interactions for Maxipime Specific Drugs and Laboratory Tests

Drug or Test

Interaction

Comments

Aminoglycosides

Possible increased risk of nephrotoxicity and ototoxicity1 92

Closely monitor renal function if used concomitantly1 92

Tests for glucose

Possible false-positive reactions in urine glucose tests using Clinitest, Benedict’s solution, or Fehling’s solution1 92 a

Use glucose tests based on enzymatic glucose oxidase reactions (e.g., Clinistix, Tes-Tape)1 92 a

Maxipime Pharmacokinetics Absorption Bioavailability

Not appreciably absorbed from GI tract; must be administered parenterally.1

Almost completely absorbed following IM administration;1 44 peak serum concentrations attained within 1.4–1.6 hours.1

Distribution Extent

Widely distributed into tissues and fluids, including blister fluid,1 39 48 bronchial mucosa,1 sputum,1 bile,1 27 peritoneal fluid,1 27 appendix,1 gallbladder,1 27 and prostate.1

Distributed into CSF following IV administration in adults or pediatric patients.1 5 46 78 81 82 84 92

Distributed into milk.1 6

Plasma Protein Binding

20%.1

Elimination Metabolism

Partially metabolized in vivo to N-methylpyrrolidine (NMP), which is rapidly converted to the N-oxide (NMP-N-oxide).1

Elimination Route

Eliminated principally unchanged in urine by glomerular filtration.1 47 49

In adults with normal renal function, 80–82% of a single dose excreted unchanged in urine;1 42 47 49 < 1% of the dose eliminated as NMP, 6.8% as NMP-N-oxide, and 2.5% as an epimer of the drug.1

Half-life

Adults with normal renal function: 2–2.3 hours.1 3 39 49

Children 2 months to 16 years of age: 1.5-1.9 hours.44

Neonates <2 months of age: 4.9 hours.80

Special Populations

Pharmacokinetics not affected by hepatic impairment.1

Patients with renal impairment: Clearance decreased and plasma half-life prolonged.1 42 Half-life averages 4.9, 10.5, 13.5 hours in those with Clcr 31–60, 11–30, or <10 mL/minute, respectively.42

Stability Storage Parenteral Powder for Injection or Infusion

2–25° C; protect from light.1

Powder and reconstituted solutions may darken; does not indicate loss of potency.1

Reconstituted IV solutions containing 1–40 mg/mL are stable for 24 hours at 20–25°C or 7 days at 2–8°C.1

IV solutions in ADD-Vantage vials are stable for 24 hours at 20–25°C or 7 days at 2–8°C at concentrations of 10–40 mg/mL in 0.9% sodium chloride or 5% dextrose injection.1

Reconstituted IM solutions containing 280 mg/mL are stable for 24 hours at 20–25°C or 7 days at 2–8°C.1 2

Injection (Frozen) for IV Infusion

-20°C or lower.92 Thawed solutions are stable for 24 hours at room temperature (25°C) or 7 days under refrigeration (5°C).92

Do not refreeze after thawing.92

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral Solution Compatibility

Compatible

Amino acids 4.25%, dextrose 25% with electrolytesHID

Dextrose 5% in Ringer’s injection, lactated1 HID

Dextrose 5% in sodium chloride 0.9%1 HID

Dextrose 5 or 10% in water1 HID

Normosol M in dextrose 5%1 HID

Normosol R1 HID

Normosol R in dextrose 5%

Sodium chloride 0.9%1 HID

Drug Compatibility Admixture CompatibilityHID

Compatible

Amikacin sulfate

Clindamycin phosphate

Heparin sodium

Potassium chloride

Theophylline

Vancomycin HCl

Incompatible

Aminophylline

Gentamicin sulfate

Tobramycin sulfate

Variable

Ampicillin sodium

Metronidazole

Metronidazole HCl

Y-Site CompatibilityHID

Compatible

Amikacin sulfate

Ampicillin sodium–sulbactam sodium

Anidulafungin

Aztreonam

Bivalirudin

Bleomycin sulfate

Bumetanide

Buprenorphine HCl

Butorphanol tartrate

Calcium gluconate

Carboplatin

Carmustine

Co-trimoxazole

Cyclophosphamide

Cytarabine

Dactinomycin

Dexamethasone sodium phosphate

Dexmedetomidine HCl

Docetaxel

Doxorubicin HCl liposome injection

Fenoldopam mesylate

Fluconazole

Fludarabine phosphate

Fluorouracil

Furosemide

Gentamicin sulfate

Granisetron HCl

Hetastarch in lactated electrolyte injection (Hextend)

Hydrocortisone sodium phosphate

Hydrocortisone sodium succinate

Hydromorphone HCl

Imipenem–cilastatin sodium

Leucovorin calcium

Lorazepam

Melphalan

Mesna

Methotrexate sodium

Methylprednisolone sodium succinate

Metronidazole

Milrinone lactate

Paclitaxel

Piperacillin sodium–tazobactam sodium

Ranitidine HCl

Remifentanil HCI

Sargramostim

Sodium bicarbonate

Sufentanil citrate

Thiotepa

Ticarcillin disodium–clavulanate potassium

Tobramycin sulfate

Valproate sodium

Zidovudine

Incompatible

Acetylcysteine

Acyclovir sodium

Amphotericin B

Amphotericin B cholesteryl sulfate complex

Chlordiazepoxide HCl

Chlorpromazine HCl

Cimetidine HCl

Ciprofloxacin

Cisplatin

Dacarbazine

Daunorubicin HCl

Diazepam

Diphenhydramine HCl

Doxorubicin HCl

Droperidol

Enalaprilat

Erythromycin lactobionate

Etoposide

Etoposide phosphate

Famotidine

Filgrastim

Floxuridine

Gallium nitrate

Ganciclovir sodium

Haloperidol lactate

Hydroxyzine HCl

Idarubicin HCl

Ifosfamide

Lansoprazole

Magnesium sulfate

Mannitol

Mechlorethamine HCl

Meperidine HCl

Metoclopramide HCl

Midazolam HCI

Mitomycin

Mitoxantrone HCl

Nalbuphine HCl

Nicardipine HCI

Ofloxacin

Ondansetron HCl

Phenytoin sodium

Plicamycin

Prochlorperazine edisylate

Promethazine HCl

Streptozocin

Theophylline

Vinblastine sulfate

Vincr


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Lacrisert


hydroxypropyl cellulose
Dosage Form: ophthalmic insert

STERILE OPHTHALMIC INSERT

Lacrisert Description

Lacrisert1 (hydroxypropyl cellulose ophthalmic insert) is a sterile, translucent, rod-shaped, water soluble, ophthalmic insert made of hydroxypropyl cellulose, for administration into the inferior cul-de-sac of the eye.

The chemical name for hydroxypropyl cellulose is cellulose, 2-hydroxypropyl ether. It is an ether of cellulose in which hydroxypropyl groups (-CH2CHOHCH3) are attached to the hydroxyls present in the anhydroglucose rings of cellulose by ether linkages. A representative structure of the monomer is:

The molecular weight is typically 1 ? 106.

Hydroxypropyl cellulose is an off-white, odorless, tasteless powder. It is soluble in water below 38°C, and in many polar organic solvents such as ethanol, propylene glycol, dioxane, methanol, isopropyl alcohol (95%), dimethyl sulfoxide, and dimethyl formamide.

Each Lacrisert is 5 mg of hydroxypropyl cellulose. Lacrisert contains no preservatives or other ingredients. It is about 1.27 mm in diameter by about 3.5 mm long.

Lacrisert is supplied in packages of 60 units, together with illustrated instructions and a special applicator for removing Lacrisert from the unit dose blister and inserting it into the eye. A spare applicator is included in each package.

1 Registered trademark of ATON PHARMA, INC.
COPYRIGHT © ATON PHARMA, INC., 2007
All rights reserved Lacrisert - Clinical Pharmacology Pharmacodynamics

Lacrisert acts to stabilize and thicken the precorneal tear film and prolong the tear film breakup time which is usually accelerated in patients with dry eye states. Lacrisert also acts to lubricate and protect the eye.

Lacrisert usually reduces the signs and symptoms resulting from moderate to severe dry eye syndromes, such as conjunctival hyperemia, corneal and conjunctival staining with rose bengal, exudation, itching, burning, foreign body sensation, smarting, photophobia, dryness and blurred or cloudy vision. Progressive visual deterioration which occurs in some patients may be retarded, halted, or sometimes reversed.

In a multicenter crossover study the 5 mg Lacrisert administered once a day during the waking hours was compared to artificial tears used four or more times daily. There was a prolongation of tear film breakup time and a decrease in foreign body sensation associated with dry eye syndrome in patients during treatment with inserts as compared to artificial tears; these findings were statistically significantly different between the treatment groups. Improvement, as measured by amelioration of symptoms, by slit lamp examination and by rose bengal staining of the cornea and conjunctiva, was greater in most patients with moderate to severe symptoms during treatment with Lacrisert. Patient comfort was usually better with Lacrisert than with artificial tears solution, and most patients preferred Lacrisert.

In most patients treated with Lacrisert for over one year, improvement was observed as evidenced by amelioration of symptoms generally associated with keratoconjunctivitis sicca such as burning, tearing, foreign body sensation, itching, photophobia and blurred or cloudy vision.

During studies in healthy volunteers, a thickened precorneal tear film was usually observed through the slit-lamp while Lacrisert was present in the conjunctival sac.

Pharmacokinetics and Metabolism

Hydroxypropyl cellulose is a physiologically inert substance. In a study of rats fed hydroxypropyl cellulose or unmodified cellulose at levels up to 5% of their diet, it was found that the two were biologically equivalent in that neither was metabolized.

Studies conducted in rats fed 14C-labeled hydroxypropyl cellulose demonstrated that when orally administered, hydroxypropyl cellulose is not absorbed from the gastrointestinal tract and is quantitatively excreted in the feces.

Dissolution studies in rabbits showed that hydroxypropyl cellulose inserts became softer within 1 hour after they were placed in the conjunctival sac. Most of the inserts dissolved completely in 14 to 18 hours; with a single exception, all had disappeared by 24 hours after insertion. Similar dissolution of the inserts was observed during prolonged administration (up to 54 weeks).

Indications and Usage for Lacrisert

Lacrisert is indicated in patients with moderate to severe dry eye syndromes, including keratoconjunctivitis sicca. Lacrisert is indicated especially in patients who remain symptomatic after an adequate trial of therapy with artificial tear solutions.

Lacrisert is also indicated for patients with:
Exposure keratitis
Decreased corneal sensitivity
Recurrent corneal erosions

Contraindications

Lacrisert is contraindicated in patients who are hypersensitive to hydroxypropyl cellulose.

Warnings

Instructions for inserting and removing Lacrisert should be carefully followed.

Precautions General

If improperly placed, Lacrisert may result in corneal abrasion (see DOSAGE AND ADMINISTRATION). Information for Patients

Patients should be advised to follow the instructions for using Lacrisert which accompany the package.

Because this product may produce transient blurring of vision, patients should be instructed to exercise caution when operating hazardous machinery or driving a motor vehicle.

Drug Interactions

Application of hydroxypropyl cellulose ophthalmic inserts to the eyes of unanesthetized rabbits immediately prior to or two hours before instilling pilocarpine, proparacaine HCl (0.5%), or phenylephrine (5%) did not markedly alter the magnitude and/or duration of the miotic, local corneal anesthetic, or mydriatic activity, respectively, of these agents. Under various treatment schedules, the anti-inflammatory effect of ocularly instilled dexamethasone (0.1%) in unanesthetized rabbits with primary uveitis was not affected by the presence of hydroxypropyl cellulose inserts.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Feeding of hydroxypropyl cellulose to rats at levels up to 5% of their diet produced no gross or histopathologic changes or other deleterious effects.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Adverse Reactions

The following adverse reactions have been reported in patients treated with Lacrisert, but were in most instances mild and transient:
Transient blurring of vision (See PRECAUTIONS)
Ocular discomfort or irritation
Matting or stickiness of eyelashes
Photophobia
Hypersensitivity
Edema of the eyelids
Hyperemia

Lacrisert Dosage and Administration

One Lacrisert ophthalmic insert in each eye once daily is usually sufficient to relieve the symptoms associated with moderate to severe dry eye syndromes. Individual patients may require more flexibility in the use of Lacrisert; some patients may require twice daily use for optimal results.

Clinical experience with Lacrisert indicates that in some patients several weeks may be required before satisfactory improvement of symptoms is achieved.

Lacrisert is inserted into the inferior cul-de-sac of the eye beneath the base of the tarsus, not in apposition to the cornea, nor beneath the eyelid at the level of the tarsal plate. If not properly positioned, it will be expelled into the interpalpebral fissure, and may cause symptoms of a foreign body. Illustrated instructions are included in each package. While in the licensed practitioner's office, the patient should read the instructions, then practice insertion and removal of Lacrisert until proficiency is achieved.

NOTE: Occasionally Lacrisert is inadvertently expelled from the eye, especially in patients with shallow conjunctival fornices. The patient should be cautioned against rubbing the eye(s) containing Lacrisert, especially upon awakening, so as not to dislodge or expel the insert. If required, another Lacrisert ophthalmic insert may be inserted. If experience indicates that transient blurred vision develops in an individual patient, the patient may want to remove Lacrisert a few hours after insertion to avoid this. Another Lacrisert ophthalmic insert maybe inserted if needed.

If Lacrisert causes worsening of symptoms, the patient should be instructed to inspect the conjunctival sac to make certain Lacrisert is in the proper location, deep in the inferior cul-de-sac of the eye beneath the base of the tarsus. If these symptoms persist, Lacrisert should be removed and the patient should contact the practitioner.

How is Lacrisert Supplied

Lacrisert, a sterile, translucent, rod-shaped, water-soluble, ophthalmic insert made of hydroxypropyl cellulose, 5 mg, is supplied as follows:

NDC 25010-805-68 in packages containing 60 unit doses (each wrapped in an aluminum blister), two reusable applicators, and a plastic storage container to store the applicators after use.

Storage

Store below 30°C (86°F).

Distributed by:
ATON PHARMA, INC.
Lawrenceville, NJ 08648, USA

Manufactured by:
Merck and Co., Inc.
West Point, PA 19486 USA

Issued June 2007

Printed in USA

INSTRUCTIONS FOR USING Lacrisert® (HYDROXYPROPYL CELLULOSE OPHTHALMIC INSERT)

Note: Your licensed practitioner or a trained associate can demonstrate the proper use of Lacrisert2. Please read and follow these instructionscarefully for your subsequent use.

Clinical experience with Lacrisert indicates that in some patients several weeks may be required before satisfactory improvement of symptoms is achieved.

Two applicators (one spare) are supplied with each package.

Before opening the package of Lacrisert, wash your hands thoroughly with soap and water.

STEP 1: On a flat surface, open blister pocket slowly and smoothly by peeling back label area. Each blister pocket contains one Lacrisert ophthalmic insert.

STEP 2: Open applicator package with label side up. Avoid touching grooved tip of the applicator. Pick up applicator by the wide end and rinse the tip thoroughly under hot running tap water. Gently shake off excess water.

STEP 3: Hold applicator with tip facing down and with forefinger on top to guide and apply gentle pressure. Lightly press the grooved tip of the applicator onto the Lacrisert ophthalmic insert and it will adhere to the applicator.

It is important to follow STEPS 4 and 5 carefully or you might experience difficulty in keeping Lacrisert (hydroxypropyl cellulose ophthalmic insert) in your eye.

STEP 4: Look into a mirror. Starting with the right eye, turn your head to the right so that the colored part of the eye is close to your nose. Use your free hand to grasp the lower lid between the thumb and index finger. Pull the lid away from the eyeball and create a pocket between the white part of the eyeball and the lid.

STEP 5: Place the tip of the applicator containing Lacrisert into the pocket. Avoid touching the colored part of the eye.

Remove the applicator. It is important, after removing the applicator, to look down, then release the lower eyelid. Lacrisert (hydroxypropyl cellulose ophthalmic insert) should remain deep in the lower pocket recess of the eye and not near the edge of the lower eyelid.

Repeat procedure with left eye, turning head to the left so that the colored part of the eye is close to your nose.

Rinse the applicator thoroughly under hot running tap water after use. Gently shake off visible water droplets and promptly return it to the storage container. Note that the storage container provides space for a strip of two Lacrisert ophthalmic inserts next to the applicator storage compartment.

IMPORTANT

If Lacrisert causes worsening of symptoms, or if new symptoms develop, it should be removed and your prescriber contacted.

Should the removal of the Lacrisert ophthalmic insert be necessary, follow these instructions.

Locate Lacrisert by pulling the lid away from the eyeball while looking for Lacrisert in a mirror. Then close the eyelids. When located, move Lacrisert upward with your fingers through the closed eyelids. Keep the lids against the eyeball and Lacrisert should slip over the lid margin so that you can remove it with a clean facial tissue without touching the colored part of the eye.

CAUTION: Because this product may produce transient blurring of vision, you should exercise caution when operating hazardous machinery or driving a motor vehicle.

Store below 30°C (86°F).

Issued May 2007

ATON PHARMA, INC.
LAWRENCEVILLE, NJ 08648, USA

2 Registered trademark of ATON PHARMA, INC.
Lacrisert 
hydroxypropyl cellulose  pellet Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 25010-805 Route of Administration OPHTHALMIC DEA Schedule      INGREDIENTS Name (Active Moiety) Type Strength hydroxypropyl cellulose (hydroxypropyl cellulose) Active 5 MILLIGRAM  In 1 PELLET Product Characteristics Color white (translucent) Score no score Shape OVAL (rod-shaped) Size 4mm Flavor Imprint Code Contains          Coating false Symbol false Packaging # NDC Package Description Multilevel Packaging 1 25010-805-68 12 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 5 PELLET In 1 BLISTER PACK This package is contained within the CARTON (25010-805-68)
Revised: 03/2008Aton Pharma, Inc. More Lacrisert resources Lacrisert Side Effects (in more detail) Lacrisert Use in Pregnancy & Breastfeeding Lacrisert Support Group 0 Reviews for Lacrisert - Add your own review/rating Lacrisert Concise Consumer Information (Cerner Multum) Lacrisert Advanced Consumer (Micromedex) - Includes Dosage Information Lacrisert Insert MedFacts Consumer Leaflet (Wolters Kluwer) FreshKote Drops MedFacts Consumer Leaflet (Wolters Kluwer) Genteal Advanced Consumer (Micromedex) - Includes Dosage Information Lacri-Lube S.O.P. Ointment MedFacts Consumer Leaflet (Wolters Kluwer) Murine Tears Drops MedFacts Consumer Leaflet (Wolters Kluwer) Murocel Eye Drops MedFacts Consumer Leaflet (Wolters Kluwer) Refresh Redness Relief Drops MedFacts Consumer Leaflet (Wolters Kluwer) Refresh liquigel Compare Lacrisert with other medications Eye Dryness/Redness
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Furadantin


Generic Name: nitrofurantoin (NYE troe fue RAN toin)
Brand Names: Furadantin, Macrobid, Macrodantin

What is Furadantin (nitrofurantoin)?

Nitrofurantoin is an antibiotic that fights bacteria in the body.

Nitrofurantoin is used to treat urinary tract infections.

Nitrofurantoin may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Furadantin (nitrofurantoin)? You should not take nitrofurantoin if you are allergic to it, or if you have severe kidney disease, urination problems, or a history of jaundice or liver problems caused by nitrofurantoin. Do not take nitrofurantoin if you are in the last 2 to 4 weeks of pregnancy.

Before you take nitrofurantoin, tell your doctor if you have kidney disease, anemia, diabetes, an electrolyte imbalance or vitamin B deficiency, a genetic enzyme deficiency, or any type of debilitating disease.

Take nitrofurantoin with food. Avoid using antacids without your doctor's advice. Use only the type of antacid your doctor recommends. Some antacids can make it harder for your body to absorb nitrofurantoin. Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Nitrofurantoin will not treat a viral infection such as the common cold or flu. Stop taking this medication and call your doctor at once if you have sudden chest pain, dry cough, or breathing problems. What should I discuss with my healthcare provider before taking Furadantin (nitrofurantoin)? You should not take nitrofurantoin if you are allergic to it, or if you have: severe kidney disease;

a history of jaundice or liver problems caused by taking nitrofurantoin;

if you are urinating less than usual or not at all; or

if you are in the last 2 to 4 weeks of pregnancy.

To make sure you can safely take nitrofurantoin, tell your doctor if you have any of these other conditions:

kidney disease;

anemia;

diabetes;

an electrolyte imbalance or vitamin B deficiency;

glucose-6-phosphate dehydrogenase (G6PD) deficiency; or

any type of debilitating disease.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby, unless it is used during the last 2 to 4 weeks of pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Nitrofurantoin can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are taking nitrofurantoin. How should I take Furadantin (nitrofurantoin)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take each dose with a full glass of water. Take nitrofurantoin with food. Shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

You may mix your liquid dose with water, milk, or fruit juice to make it easier to swallow. Drink the entire mixture right away.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Nitrofurantoin is usually given for up to 1 week after lab tests show that the infection has cleared. Nitrofurantoin will not treat a viral infection such as the common cold or flu.

If you use this medication long-term, your kidney, liver, and lung function will need to be tested often. Visit your doctor regularly.

This medication can cause you to have unusual results with certain urine glucose (sugar) tests. Tell any doctor who treats you that you are using nitrofurantoin.

Store at room temperature away from moisture, heat, and light. Do not freeze. What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while taking Furadantin (nitrofurantoin)?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Avoid using antacids without your doctor's advice. Use only the type of antacid your doctor recommends. Some antacids can make it harder for your body to absorb nitrofurantoin. Furadantin (nitrofurantoin) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using nitrofurantoin and call your doctor at once if you have a serious side effect such as:

diarrhea that is watery or bloody;

shortness of breath, running out of breath easily;

sudden chest pain or discomfort, wheezing, dry cough or hack;

fever, chills, body aches, unexplained weight loss;

peripheral neuropathy - numbness, tingling, or pain in your hands or feet;

nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

pale skin, easy bruising, confusion or weakness;

patchy skin color, red spots, or a severe blistering, peeling, and red skin rash; or

severe headache, ringing in your ears, dizziness, vision problems, pain behind your eyes.

Less serious side effects may include:

upset stomach, vomiting;

mild diarrhea;

rust-colored or brownish urine; or

vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Furadantin (nitrofurantoin)?

Tell your doctor about all other medicines you use, especially:

magnesium salicylate (Nuprin Backache, Doan's Pills);

choline magnesium salicylate (Tricosal, Trilisate); or

probenecid (Benemid) or other gout medications.

This list is not complete and other drugs may interact with nitrofurantoin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Furadantin resources Furadantin Side Effects (in more detail) Furadantin Use in Pregnancy & Breastfeeding Furadantin Drug Interactions Furadantin Support Group 0 Reviews for Furadantin - Add your own review/rating Furadantin Prescribing Information (FDA) Furadantin Advanced Consumer (Micromedex) - Includes Dosage Information Furadantin Suspension MedFacts Consumer Leaflet (Wolters Kluwer) Nitrofurantoin Professional Patient Advice (Wolters Kluwer) Nitrofurantoin Monograph (AHFS DI) Macrobid Prescribing Information (FDA) Macrobid MedFacts Consumer Leaflet (Wolters Kluwer) Macrobid Consumer Overview Macrodantin Prescribing Information (FDA) Macrodantin MedFacts Consumer Leaflet (Wolters Kluwer) Compare Furadantin with other medications Bladder Infection Prevention of Bladder infection Urinary Tract Infection Where can I get more information? Your pharmacist can provide more information about nitrofurantoin.

See also: Furadantin side effects (in more detail)


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