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Alternative medicines


Alternative medicines includes various healing systems, such as homeopathy, herbal remedies, naturopathy, chiropractic, acupuncture, etc., that are not regarded as part of orthodox treatment by the medical profession.

Some of these treatments are now accepted to be of value in some circumstances.

See also herbal products nutraceutical products probiotics Drug List:
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Acne Medications


Definition of Acne: An inflammatory skin condition characterized by superficial skin eruptions around hair follicles. More...

Drugs associated with Acne

The following drugs and medications are in some way related to, or used in the treatment of Acne. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

See sub-topics

Topics under Acne Rosacea (77 drugs) Learn more about Acne

Medical Encyclopedia:

Acne Blackheads Comedones Teenagers and acne medicine Whitehead

Harvard Health Guide:

Symptoms and treatment for Acne
Drug List: A-T-S Acanya Accutane Acetoxyl-10-Topical Acne-Treatment-Cream Acne-10-Gel-Topical Acne-Clear Acnex-Topical Acnomel-Skin-Tone-Topical Acnomel-Acne-Mask-Topical Acnomel-Bp-5-Topical Acnotex Aczone Adoxa Adoxa-Ck-Kit Adoxa-Tt-Kit Akne-Mycin-Ointment Akurza-Topical Ala-Tet Aldactone Aliclen-Topical Alquam-X-Acne-Therapy-Gel-Topical Altabax Altinac Amnesteem Atralin Avar-Cream Avar-Cleanser Avar-Gel Avar-Green Avar-Ls-Cleanser Avar-E Avar-E-Emollient Avar-E-Green Avar-E-Ls Avidoxy Avita-Cream Azelex-Cream Bactrim Bactrim-Ds Bencort-Lotion Benprox Benzac-Topical Benzac-Ac-Wash Benzac-W Benzaclin Benzagel-5 5-Benzagel-Acne-Wash-Topical Benzamycin-Gel Benzamycin-Pak-Gel Benzashave-10 Benzefoam-Foam Benzefoam-Ultra-Topical Benziq Benziq-Ls Benziq-Wash Beyaz Binora-Topical Bio-Cef Bioelements-Active-Astringent Bp-10-Wash Bp-Wash Bpo-3-Foaming-Cloths Bpo-6-Foaming-Cloths Bpo-9-Foaming-Cloths Bpo-Foaming-Cloths Bpo-4-Gel-Topical Bps-Gel Brevicon Brevoxyl-Gel Brevoxyl-Acne-Wash-Kit Brevoxyl-Creamy-Wash-Complete-Pack-Wash-And-Cleansing-Bar Brevoxyl-4-Wash Brevoxyl-8-Wash Breze Briellyn Cerisa-Wash Claravis Clarifoam-Ef-Foam Cleanse-Treat Clear-Away-Wart-Removal-System-Topical Clearplex Clearskin-Cream Clenia-Emollient-Cream Clenia-Foaming-Wash Cleocin-T-Gel Clinac-Bpo Clinda-Derm-Topical Clindacin-P Clindagel Clindareach-Pledget Clindets-Swab Co-Trimoxazole Compound-W Cotrim Cyclafem-1-35 Cyclafem-7-7-7 Del-Aqua-Topical Delos-Liquid Dermalzone Dermarest-Psoriasis-Skin-Treatment Desquam-E Desquam-X-10 Desquam-X-5 Desquam-X-Wash Dhs-Sal-Topical Differin Doryx-Delayed-Release-Capsules Doxy-100 Doxy-200 Dr-Scholl-S-Callus-Removers Dr-Scholl-S-Clear-Away-Wart-Remover Dr-Scholl-S-Corn-Removers Dr-Scholl-S-Corn-Callous-Remover-Solution Dr-Scholl-S-Zino-Soft-Corn-Remover-Pads Duac-Cs-Kit-Gel Dulcolax-Milk-Of-Magnesia-Suspension Duofilm-Solution Duoplant-Gel Durasal-Topical Dynacin Emcin-Clear-Pad Emgel-Gel Epiduo Ery-Pads-Pad Erycette Eryderm-Solution Erygel Erymax Erythra-Derm Estrostep-Fe Ethexderm Ethexderm-Bpw-Wash Evoclin Ex-Lax-Milk-Of-Magnesia Femcon-Fe-Chewable-Tablets Femhrt Finacea Finevin Fostex-Cream Fostex-Bar-10 Fostex-Bpo-Bar Fostex-Gel-10 Fostex-Medicated-Soap Fostex-Cream-Topical Fostex-Wash-10 Fostril Freezone-One-Step-Callus-Remover-Pad-Topical Freezone-Liquid Freezone-Corn-Remover Genora-1-35 Gianvi Gildess-Fe-1-5-0-03 Gildess-Fe-1-0-2 Gordofilm-Topical Hydrisalic-Gel Inova-Pads Inova-4-1-Acne-Control-Therapy-Pads Inova-8-2 Ionil-Plus-Shampoo Jenest Jevantique Junel-1-5-30 Junel-1-20 Junel-Fe-1-5-30 Junel-Fe-1-20 Keflex Keralyt-Scalp-Shampoo Keralyt-Shampoo Keralyt-Gel Lavoclen-4 Lavoclen-4-Creamy-Wash Lavoclen-8 Lavoclen-8-Creamy-Wash Leena Liquimat-Light Liquimat-Medium Loestrin-1-20 Loestrin-21-1-5-30 Loestrin-21-1-20 Loestrin_24_Fe Loestrin-Fe-1-5-30 Loestrin-Fe-1-20 Loroxide Loryna Mediplast Meted-Shampoo Microgestin-1-5-30 Microgestin-1-20 Microgestin-Fe-1-5-30 Microgestin-Fe-1-20 Milk-Of-Magnesia Minocin Modicon Monodox Mosco-Corn-Callus-Remover-Topical Myrac Necon-0-5-35 Necon-1-35 Necon-10-11 Necon-7-7-7 Nelova-0-5-35 Neobenz-Micro Neobenz-Micro-Sd Neobenz-Micro-Wash-Plus-Pack-Cream Neutrogena-Acne-Mask Neutrogena-Healthy-Scalp-Shampoo Neutrogena-On-Spot-Acne-Treatment Norethin-1-35-E Norinyl-1-35 Nortrel-0-5-35 Nortrel-1-35 Nortrel-7-7-7 Novacet Nuox-Gel Occlusal-Hp-Liquid Ocella Ocudox-Convenience-Kit Oraxyl Ortho-Tri-Cyclen Ortho-Novum-1-35 Ortho-Novum-7-7-7 Oscion Oscion-Cleanser Ovcon-35 Ovcon-35-Fe Ovcon-50 Oxy-10-Balance Oxy-Balance Oxy-Balance-Deep-Pore-Cleanser-Liquid Oxy-Daily-Wash-Chill-Factor Oxy-Face-Scrub Oxy-10 P-S-Topical Pacnex Panixine Panoxyl-Bar Panoxyl-10 Panoxyl-5 Panoxyl-Aqua-Gel Panoxyl-Maximum-Strength-Foaming-Acne-Wash Pernox-Lotion Peroderm-7-Wash Persa-Gel Phillips-Milk-Of-Magnesia-Suspension Plexion Plexion-Cleanser Plexion-Cleansing-Cloths Plexion-Sct-Cream Plexion-Ts-Emulsion Prascion Prascion-Cleanser Prascion-Fc-Cloths Prascion-Ra Propa-P-H Propa-Ph-Acne-Med-Cleansing-Pads Propa-Ph-Acne-Med-Maximum-Strength-Liquid R-A-Acne-Topical Resinol-Topical Retin-A-Micro-Gel Retin-A-Cream Rezamid Romycin Rosac-Cream Rosac-Wash Rosaderm-Cleanser Rosanil Rosula-Foam Rosula-Cleanser Rosula-Clk-Kit Sal-Acid-Plaster-Topical Sal-Plant-Gel Salac Salactic-Film-Topical Salacyn-Lotion Salex-Lotion Salitop-Lotion Salkera-Foam Salvax-Foam Sastid-Soap Scalpicin-Scalp-Relief Se-10-5-Ss Se-Bpo-Wash Seba-Gel Sebucare Sebulex-Shampoo Septra Septra-Ds Smz-Tmp-Ds Solodyn Soluclenz-Rx Sotret Staticin-Topical Stieva-A-Cream-Forte-Topical Stieva-A-Cream-Topical Stri-Dex Stridex-Body-Focus-Cream Stridex-Maximum-Strength-Pads Sulfacet-R Sulfatol-10-4-Cleansing-Pads Sulfatol-C Sulfatol-Ss Sulfatrim-Suspension Sulfo-Lo Sulfoam Sulforcin Sulfoxyl-Regular-Lotion Sulfoxyl-Strong-Lotion Sulmasque Sulpho-Lac Sulpho-Lac-Soap Sulzee-Wash Sumadan Sumaxin-Wash Sumaxin-Ts-Emulsion Sumycin Suphera Syeda T-Stat Tazorac-Cream Thera-Sal-Topical Theramycin-Z Tilia-Fe Tinamed-Plantar-Pads Topicycline Topisulf Tretin-X-Cream Tri-Legest Tri-Legest-Fe Tri-Norinyl Tri-Previfem Tri-Sprintec Triaz-Cloths Trinessa Trinessa-Lo Vanoxide-Hc-Lotion Veltin Vestura Vibra-Tabs Vibramycin Wart-Off-Treatment Yasmin Yaz Z-Clinz-10 Z-Clinz-5 Zacare-4-Kit-Lotion Zaclir Zenchent-Fe Zencia-Wash Zeosa Zetacet-Emulsion Zetacet-Wash Ziana Zoderm-Cleanser
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Paracetamol 500mg Soluble Tablets


PARACETAMOL 500mg SOLUBLE TABLETS

Paracetamol

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again

If you have further questions, please ask your doctor or pharmacist

Do not pass this medicine on to others. It may harm them, even if their symptoms are the same as yours

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

In this leaflet: 1. What paracetamol is and what it is used for 2. Before you take paracetamol 3. How to take paracetamol 4. Possible side effects 5. How to store paracetamol 6. Further information What Paracetamol Is And What It Is Used For

The name of your medicine is Paracetamol 500mg Soluble Tablets (called paracetamol throughout this leaflet). This medicine contains paracetamol. It belongs to a group of medicines called analgesics (painkillers) and is used to treat pain (including headache, toothache and period pain) and cold or flu symptoms.

Before You Take Paracetamol Do not take paracetamol and tell your doctor if: You are allergic (hypersensitive) to paracetamol or any of the other ingredients in your medicine (listed in Section 6: Further information) Signs of an allergic reaction include a rash and breathing problems. There can also be swelling of the legs, arms, face, throat or tongue The person going to take the tablets is under 12 years of age. Paracetamol 500mg Soluble Tablets must not be given to children under 12 years of age
Do not take paracetamol if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking paracetamol. Take special care and check with your doctor before taking paracetamol if: You have severe kidney or liver problems You have a liver problem caused by alcohol

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because paracetamol can affect the way some other medicines work. Also, some other medicines can affect the way paracetamol works.

While taking paracetamol you should not take any other medicines which contain paracetamol.

This includes some painkillers, cough and cold remedies. It also includes a wide range of other medicines available from your doctor and more widely in shops.

Tell your doctor if you are taking any of the following medicines:

Medicines used to thin the blood such as warfarin Metoclopramide or domperidone - used to stop you feeling sick (nausea) or being sick (vomiting) Colestyramine - for lowering blood cholesterol levels

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking paracetamol.

Pregnancy and breast-feeding

Talk to your doctor before taking these tablets if:

You are pregnant, think you may be pregnant or plan to get pregnant You are breast-feeding or planning to breast-feed Important information about some of the ingredients of your paracetamol tablets Sodium: There is 388mg of sodium per effervescent tablet. This may be harmful to people on a low sodium or low salt diet. Sorbitol: This is a type of sugar. If you have been told by you doctor that you cannot tolerate some sugars, talk to your doctor before taking this medicine. How To Take Paracetamol

Always take paracetamol exactly as it says in this leaflet. You should check with your doctor or pharmacist if you are not sure.

Do not take more than the recommended dose If you need to use this medicine for more than three days at a time, see your doctor Adults and children over 12 The usual dose of paracetamol is 1 to 2 effervescent tablets Dissolve the effervescent tablets in a full glass of water before taking Wait at least 4 hours before taking another dose Do not take more than 4 doses in any 24-hour period If symptoms persist for more than 3 days or get worse contact your doctor Children

Paracetamol 500mg Soluble Tablets should not be given to children under 12 years of age.

If you take more paracetamol than you should Tell your doctor or go to your nearest hospital casualty department straight away - even if you feel well. This is because of the risk of delayed, serious liver damage Remember to take any remaining tablets and the pack with you. This is so the doctor knows what you have taken If you have forgotten to take paracetamol

If you forget to take a dose at the right time, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take two doses at or near the same time. Remember to leave at least 4 hours between doses.

Possible Side Effects

As with all medicines, paracetamol can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Stop taking paracetamol and see a doctor or go to a hospital straight away if: You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria) This may mean you are having an allergic reaction to paracetamol Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days: You get infections or bruise more easily than usual. This could be because of a blood problem (such as agranulocytosis, neutropenia or thrombocytopenia). This side effect has only happened in a few people taking paracetamol

If any of the side effects gets serious, lasts longer than a few days or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Paracetamol

Keep this medicine in a safe place out of the reach and sight of children.

Do not use this medicine after the expiry date shown on the pack.

Store your medicine in the original packaging in order to protect from moisture.

Do not store above 25°C.

Ask your pharmacist how to dispose of medicines no longer required. Do not dispose of medicines by flushing down a toilet or sink or by throwing out with your normal household rubbish. This will help protect the environment.

Further Information What Paracetamol 500mg Soluble Tablets contain The active substance of Paracetamol 500mg Soluble Tablets is paracetamol. Each tablet contains 500mg of paracetamol. The other ingredients are, sorbitol, saccharin sodium, sodium lauryl sulphate, citric acid, sodium carbonate, sodium bicarbonate, povidone, and dimeticone. Contents of pack

Paracetamol 500mg Soluble Tablets come in cartons of 24, 60 and 100.

The Marketing Authorisation Holder is Winthrop Pharmaceuticals PO Box 611 Guildford Surrey GU1 4YS The Manufacturer is Fawdon Manufacturing Centre Edgefield Avenue Fawdon Newcastle upon Tyne NE3 3TT UK

This leaflet was last updated in June 2008

'Winthrop' is a registered trademark. © 2008 Winthrop Pharmaceuticals.


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primaquine


Generic Name: primaquine (PRIM a kwin)
Brand Names:

What is primaquine?

Primaquine is an antimalarial drug. The exact way that primaquine works is unknown.

Primaquine is used to treat and prevent malaria.

Primaquine may also be used for purposes other than those listed in this medication guide.

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

Notify your doctor if your urine turns dark.

Use caution when driving or performing other hazardous activities until you know how this medication affects you. Primaquine may cause visual disturbances such as blurred vision, misty vision, and difficulty focusing. Report any vision or hearing changes to your doctor. Who should not take primaquine?

Before taking this medication, tell your doctor if you have

a history of an allergic reaction to previous primaquine therapy,

glucose-6-phosphate dehydrogenase (G-6-PD) deficiency,

rheumatoid arthritis,

lupus erythematosus, or

quinacrine (Atabrine) therapy.

You may not be able to take primaquine, or you may require a lower dose or special monitoring during your therapy if you have any of the conditions listed above.

It is not known whether primaquine will harm an unborn baby. Do not take primaquine without first talking to your doctor if you are pregnant. It is not known how primaquine will affect a nursing baby. Do not take primaquine without first talking to your doctor if you are breast-feeding a baby. How should I take primaquine?

Take primaquine exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Take primaquine with food to lessen stomach upset. Store primaquine at room temperature away from moisture and heat.

See also: Primaquine dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and only take your next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose? Seek emergency medical attention.

Symptoms of a primaquine overdose include nausea, vomiting, stomach upset, and stomach cramps.

What should I avoid while taking primaquine? Use caution when driving or performing other hazardous activities until you know how this medication affects you. Primaquine may cause visual disturbances such as blurred vision, misty vision, and difficulty focusing. Report any vision or hearing changes to your doctor. Primaquine side effects Stop taking primaquine and seek emergency medical attention if you experience an allergic reaction (flushing; swelling of your lips, tongue, or face, difficulty breathing; closing of your throat; vision problems; a rash; or itching).

Notify your doctor if you experience darkening of your urine.

Nausea, stomach pain or upset, vomiting, and loss of appetite may also occur during therapy.

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.

Primaquine Dosing Information

Usual Adult Dose for Malaria:

Manufacturer recommendation: 15 mg base (26.3 mg salt) orally once a day for 14 days
Centers for Disease Control and Prevention (CDC) recommendation: 30 mg base (52.6 mg salt) orally once a day for 14 days; for patients with borderline glucose-6-phosphate dehydrogenase (G6PD) deficiency or as an alternative regimen, 45 mg base (78.9 mg salt) orally once a week for 8 weeks has been recommended

Usual Adult Dose for Malaria Prophylaxis:

Primary prophylaxis of malaria (including chloroquine-resistant malaria):
CDC recommendation: 30 mg base (52.6 mg salt) orally once a day
Primaquine should be taken 1 to 2 days before travel to malarious areas, while in such areas, and for 7 days after leaving the areas. It is generally used for short-duration travel to areas with primarily P vivax.
Terminal prophylaxis of P vivax or P ovale malaria:
Manufacturer recommendation: 15 mg base (26.3 mg salt) orally once a day for 14 days
CDC recommendation: 30 mg base (52.6 mg salt) orally once a day for 14 days

Usual Adult Dose for Pneumocystis Pneumonia:

15 to 30 mg base (26.3 to 52.6 mg salt) orally once a day for 21 days; effective in combination with clindamycin
Primaquine plus clindamycin is recommended as an alternative regimen by the CDC, National Institutes of Health (NIH), and Infectious Diseases Society of America (IDSA). Seriously ill patients should receive IV trimethoprim-sulfamethoxazole or pentamidine therapy.

Usual Pediatric Dose for Malaria:

Manufacturer recommendation: 0.3 mg/kg base (0.526 mg/kg salt) orally once a day for 14 days (not to exceed 15 mg base/day)
CDC recommendation: 0.5 mg/kg base (0.88 mg/kg salt) orally once a day for 14 days (not to exceed 30 mg base/day); for patients with borderline G6PD deficiency or as an alternative regimen, 0.75 mg/kg base (1.3 mg/kg salt) orally once a week for 8 weeks (not to exceed 45 mg base/week) has been recommended

Usual Pediatric Dose for Malaria Prophylaxis:

Primary prophylaxis of malaria (including chloroquine-resistant malaria):
CDC recommendation: 0.5 mg/kg base (0.88 mg/kg salt) orally once a day (not to exceed 30 mg base/day)
Primaquine should be taken 1 to 2 days before travel to malarious areas, while in such areas, and for 7 days after leaving the areas. It is generally used for short-duration travel to areas with primarily P vivax.
Terminal prophylaxis of P vivax or P ovale malaria:
Manufacturer recommendation: 0.3 mg/kg base (0.526 mg/kg salt) orally once a day for 14 days (not to exceed 15 mg base/day)
CDC recommendation: 0.5 mg/kg base (0.88 mg/kg salt) orally once a day for 14 days (not to exceed 30 mg base/day)

Usual Pediatric Dose for Pneumocystis Pneumonia:

0.3 mg/kg base (0.526 mg/kg salt) orally once a day for 21 days (not to exceed 30 mg base/day); effective in combination with clindamycin
Primaquine plus clindamycin is recommended as an alternative regimen by the CDC, NIH, IDSA, Pediatric Infectious Diseases Society, and American Academy of Pediatrics. Seriously ill patients should receive IV trimethoprim-sulfamethoxazole or pentamidine therapy.

What other drugs will affect primaquine?

Do not take primaquine if you have recently taken quinacrine (Atabrine). These two drugs are similar and can cause dangerous side effects if they are taken together.

Drugs other than those listed here may also interact with primaquine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More primaquine resources Primaquine Side Effects (in more detail) Primaquine Dosage Primaquine Use in Pregnancy & Breastfeeding Primaquine Drug Interactions Primaquine Support Group 0 Reviews for Primaquine - Add your own review/rating primaquine Advanced Consumer (Micromedex) - Includes Dosage Information Primaquine MedFacts Consumer Leaflet (Wolters Kluwer) Primaquine Prescribing Information (FDA) Primaquine Phosphate Monograph (AHFS DI) Compare primaquine with other medications Malaria Malaria Prevention Pneumocystis Pneumonia Where can I get more information? Your pharmacist can provide more information about primaquine.

See also: primaquine side effects (in more detail)


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Entocort Enema


Entocort Enema

budesonide 0.02 mg/ml

Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Entocort Enema is and what it is used for 2. Before you use Entocort Enema 3. How to use Entocort Enema 4. Possible side effects 5. How to store Entocort Enema 6. Further information What Entocort Enema is and what it is used for

Entocort Enema contains a medicine called budesonide. This belongs to a group of medicines called ‘corticosteroids’. These are used to reduce inflammation.

An enema is a liquid that is inserted into the back passage (rectum). Entocort Enema is used to treat inflammation and ulcers in the large intestine (colon) and rectum. This is known as ulcerative colitis. Before you use Entocort Enema Do not use Entocort Enema if:

You are allergic (hypersensitive) to budesonide or any of the other ingredients of Entocort Enema (listed in Section 6: Further information).

Take special care with Entocort Enema

Check with your doctor or pharmacist before using Entocort Enema if:

You have recently had a bowel infection. You or a member of your family has ever had mental health problems. Taking other medicines

Please tell your doctor or pharmacist before using Entocort Enema if you are taking, or have recently taken, any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Entocort Enema can affect the way some medicines work and some medicines can have an effect on Entocort Enema.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

Steroid medicines, such as prednisolone or dexamethasone. Ketoconazole or itraconazole, used to treat infections caused by a fungus. Medicines that contain oestrogen, such as hormone replacement therapy (HRT) and some oral contraceptives. Pregnancy and breast-feeding

Talk to your doctor before using Entocort Enema if you are pregnant, may become pregnant or are breast-feeding.

Driving and using tools and machines

Entocort Enema is not likely to affect you being able to drive or use any tools or machines.

Important information about some of the ingredients

Entocort Enema contains propyl parahydroxybenzoate (E216) and methyl parahydroxybenzoate (E218), these may cause allergic reactions (possibly delayed).

How to use Entocort Enema

Always use Entocort Enema exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Entocort Enema should only be used in your back passage (rectum), as directed by your doctor.

Entocort Enema is not recommended for use by children.

When to use Entocort Enema and how long to use it for It is important to use each enema at the right time. Usually this will be once a day, just before bedtime. Normally, your treatment will last for 4 weeks. However, your doctor may decide that you need to use Entocort Enema for longer. Preparing Entocort Enema for use

To prepare one enema, dissolve one tablet in one bottle of liquid. To do this, follow the instructions below:

1. Take one of the plastic bottles containing a liquid. Unscrew the complete nozzle section and protective cap in one piece. 2. Take one of the tablets from its foil strip. Then drop it into the bottle. 3. Put the nozzle and protective cap back onto the bottle. Then screw them up until they are tight. 4. Shake the bottle well for at least 15 seconds, or until you cannot see the tablet in the liquid any more.
5. The enema is now ready. Use it straight away. You will find it more comfortable to use Entocort Enema if you empty your bowels and bladder before using it. Entocort Enema can stain your bedclothes. It is best to protect your bedclothes with a plastic sheet in case any liquid is spilled. Inserting the enema into your back passage

To insert the enema into your back passage, follow the instructions below:

1. Shake the bottle again. Then only take off the protective cap. This will reveal the nozzle.
2. Undress from the waist down, then lie down on your side.
Choose whichever side is most comfortable.
Try to lie down so that your bottom is slightly higher than the rest of your body. For example, you can raise the bottom of the bed onto blocks or place one or two pillows under your bottom. This will help to keep the liquid in your back passage.
3. If you wish, hold the bottle using one of the plastic bags. 4. Gently ease the nozzle into your back passage as far as is comfortable.
5. Squeeze the bottle, this will push most of the liquid into your back passage. However, you will not be able to empty the whole bottle. It has been designed to keep some liquid after being used.
6. Then remove the nozzle from your back passage.
7. If you used a plastic bag, remove it from your hand by pulling it forward over the bottle. This will leave the bottle inside the bag, ready to be disposed of. 8. Now, roll over onto your stomach. Stay like this for 5 minutes to stop any liquid coming out of your back passage.
9. Then, find a comfortable position to sleep in that helps you to keep the liquid in your back passage for as long as possible.

Entocort Enema is a ‘retention enema’. This means that the liquid is meant to be held in the back passage for as long as possible. The longer it is kept there the more time it has to work and the better the results should be.

If you use more Entocort Enema than you should

If you use more enemas than prescribed by your doctor, talk to a doctor or pharmacist straight away.

If you forget to use Entocort Enema If you forget a dose of Entocort Enema, use it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Do not use a double dose (two doses at the same time) to make up for a forgotten dose. If you stop using Entocort Enema

Do not stop using Entocort Enema without talking to your doctor first. If you stop using your enema suddenly it may make you ill.

Entocort Enema Side Effects

Like all medicines, Entocort Enema can cause side effects, although not everybody gets them.

If you have an allergic reaction, see a doctor straight away. The signs may include raised lumps on your skin (weals), or swelling of your face, lips, mouth, tongue or throat. This may make it difficult to breathe.

The most common side effects are:

Feeling sick. Diarrhoea. Trapped wind. Skin rash.

Less common side effects are:

Feeling agitated. Difficulty sleeping.

Rarely, medicines like Entocort Enema (corticosteroids) can affect the normal production of steroid hormones in your body.

The effects include:

Changes in bone mineral density (thinning of the bones). Glaucoma (increased pressure in the eye). A slowing of the rate of growth of children and adolescents. An effect on the adrenal gland (a small gland near the kidney).

A very rare side effect is:

A severe allergic reaction (called anaphylaxis) which may cause difficulty in breathing or shock.

Mental health problems can happen while taking steroids like Entocort Enema. Talk to a doctor if you (or someone taking this medicine), show any signs of mental health problems. This is particularly important if you are depressed, or might be thinking about suicide. Very rarely mental health problems have happened when high doses have been taken for a long time.

Do not be concerned by this list of possible side effects. You may not get any of them. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Entocort Enema Do not use your enemas after the expiry date shown on the bottle or foil. Keep your medicine in a safe place where children cannot reach or see it. Do not store this medicine above 30°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment. Further information What Entocort Enema contains

The active ingredient is budesonide. Each bottle provides a dose of approximately 2 mg of budesonide at a concentration of 0.02 mg of budesonide per ml of solution.

The other ingredients are lactose anhydrous, polyvidone, riboflavine sodium phosphate, lactose monohydrate, magnesium stearate, colloidal anhydrous silica, sodium chloride, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216) and water purified.

What Entocort Enema looks like and contents of the pack

Entocort Enema, once prepared, is a whitish yellow liquid.

Entocort Enema comes in a box containing the following:

7 tablets wrapped in foil, inside a small box. 7 plastic bottles containing solution. 7 plastic bags to be used when giving the enema. Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation for Entocort Enema is held by

AstraZeneca UK Ltd 600 Capability Green Luton LU1 3LU UK

Entocort Enema is manufactured by

Nycomed Pharma AS Solbaervegen 5 N-2409 Elverum Norway

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name Entocort Enema

Reference number 17901/0123

This is a service provided by the Royal National Institute of Blind People.

Leaflet prepared: September 2009

© AstraZeneca 2009

Entocort is a trade mark of the AstraZeneca group of companies.

GI 09 0008a

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Proctofoam HC


Proctofoam HC 1% w/w & 1% w/w Rectal Foam

(Hydrocortisone acetate & pramocaine hydrochloride)

Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again If you have any further questions, ask your doctor or pharmacist This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours Throughout this leaflet Proctofoam HC 1 % w/w & 1 % w/w Rectal Foam is called Proctofoam. Important: Proctofoam is a steroid medicine, prescribed for many different conditions, including serious illnesses You need to use it regularly to get the maximum benefit Don't stop using this medicine without talking to your doctor - you may need to reduce the dose gradually Proctofoam can cause side effects in some people (read section 4 below). Some problems such as mood changes (feeling depressed, or 'high'), or stomach problems can happen straight away. If you feel unwell in any way, keep using your medicine, but see your doctor straight away Some side effects only happen after weeks or months. These include weakness of arms and legs, or developing a rounder face (read section 4 for more information) Keep away from people who have chicken-pox or shingles, if you have never had them. They could affect you severely. If you do come into contact with chicken pox or shingles, see your doctor straight away. Now read the rest of this leaflet.

It includes other important information on the safe and effective use of this medicine that might be especially important for you.

In this leaflet: 1. What Proctofoam is for 2. Before you use Proctofoam 3. How to use Proctofoam 4. Possible side effects 5. How to store Proctofoam 6. Further information What Proctofoam is for Proctofoam - benefit information

Proctofoam belongs to a group of medicines called steroids. Their full name is corticosteroids. These corticosteroids occur naturally in the body, and help to maintain health and well-being. Boosting your body with extra corticosteroid (such as Proctofoam) is an effective way to treat various illnesses involving inflammation in the body.

Proctofoam reduces this inflammation, which could otherwise go on making your condition worse You must use this medicine regularly to get maximum benefit from it. Proctofoam is used for the relief of inflammation, itching, pain, swelling and irritation associated with haemorrhoids (piles) and certain other conditions of the anus (bottom) and anal region.

Before you use Proctofoam Do not use Proctofoam: If you are allergic to pramocaine hydrochloride or to any other ingredient in Proctofoam (see section 6) If you are suffering from a bacterial infection, viral infection or fungal infection

Proctofoam is not for use in children

If any of the above applies to you talk to your doctor or pharmacist.

Check with your doctor first: If you have ever had severe depression or manic-depression (bipolar disorder). This includes having had depression before while using steroid medicines like Proctofoam. If any of your close family has had these illnesses If you have diseases of the bowel (rectum).

If any of these applies to you, talk to your doctor before using Proctofoam.

Taking other medicines

Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

If you are pregnant, trying to become pregnant or breast-feeding ask your doctor or pharmacist for advice before using Proctofoam.

How to use Proctofoam

Always use Proctofoam exactly as your doctor has told you.

Important:

Your doctor will choose the dose that is right for you. Your dose will be shown clearly on the label that your pharmacist puts on your medicine. If it is not, or you are not sure, ask your doctor or pharmacist.

Remember: Do not use Proctofoam for more than 7 days Talk to your doctor if symptoms worsen, or do not improve within 7 days or if bleeding occurs You need to use your medicine regularly to get the maximum benefit. Adult dose

Proctofoam can be applied in the rectum (internal use) or to the skin around the anus (external use).

The usual dose into the rectum is one applicator of foam two or three times per day and after each bowel evacuation up to a maximum of 4 times daily For the anal area expel a small amount of foam onto two fingers and apply to the affected area. For internal use 1. Shake the canister vigorously for 30 seconds before each use. 2. Withdraw the plunger until it stops at the catch line. 3. Hold the applicator upright and insert the canister top into the applicator tip. Make sure you hold the plunger and applicator body FIRMLY with your fingers. 4. Press down gently on the canister top with your fingers, so that the foam fills about ? of the applicator body. Only a short press is needed to do this. 5. Wait for a few seconds until the foam stops expanding.
DO NOT fill the applicator in one go. Always release the canister top after a short press. 6. Repeat steps 4 & 5 above until the foam expands to just reach the 'Fill' line. This normally takes 2 to 4 short press/wait. 7. Stand with one leg raised on a chair, or lie down on your side. Hold the applicator as shown. Insert gently into the back passage and push the plunger fully into the applicator. For topical use

Shake the canister vigorously for 30 seconds before each use. Expel a small quantity of foam onto a tissue, pad or two fingers and apply the foam to the affected area.

After using the applicator Always take the applicator apart and wash it thoroughly after use The canister top should also be removed and washed Replace the canister top with care. Make sure it is placed vertically on top of the canister, and not at an angle. If you use more Proctofoam than you should

If you use too much go to your doctor as soon as possible.

If you repeatedly use too much Proctofoam you may experience fattening of the face, neck and body, hair growing on your body (women), a dusky complexion with purple patches and skin thinning.

If you forget to use Proctofoam

Do not use double the dose to make up for a missed dose. Simply take your next dose as planned.

If you stop using Proctofoam

Do not stop using Proctofoam without talking to your doctor. Your doctor may reduce your dose gradually.

Mental problems while using Proctofoam

Mental health problems can happen while using steroids like Proctofoam (see also section 4 Possible Side Effects).

These illnesses can be serious Usually they start within a few days or weeks of starting the medicine. They are more likely to happen at high doses. Most of these problems go away if the dose is lowered or the medicine is stopped. However, if problems do happen they might need treatment.

Talk to a doctor if you (or someone using this medicine), show any signs of mental problems. This is particularly important if you are depressed, or might be thinking about suicide. In a few cases, mental problems have happened when doses are being lowered or stopped.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Proctofoam HC Side Effects

Like all medicines, Proctofoam can cause side effects, although not everybody gets them.

Serious effects: tell your doctor straight away

Steroids can cause serious mental health problems. These are common in both adults and children. They can affect about 5 in every 100 people taking medicines that contain steroids.

Feeling depressed, including thinking about suicide Feeling high (mania) or moods that go up and down Feeling anxious, having problems sleeping, difficulty in thinking or being confused and losing your memory Feeling, seeing or hearing things which do not exist. Having strange and frightening thoughts, changing how you act or having feelings of being alone.

If you notice any of these problems talk to a doctor straight away.

Other side effects

If you get any of the following, keep using the medicine but tell your doctor:

Unexpected fattening of the face, neck and body Irregular periods Hair starts to grow on your body (women) Dusky complexion with purple patches Skin thinning Allergic skin reaction Infection Burning sensation Itching.

If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Proctofoam

Keep out of the reach and sight of children.

Do not use Proctofoam after the expiry date which is stated on the canister and carton. The expiry date refers to the last day of that month.

Do not expose to temperatures above 50°C. Keep in the original packaging to protect from sunlight Do not refrigerate Keep away from sources of ignition Do not spray on a naked flame or anything hot Do not pierce or burn the container even after use.

Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist.

Further information What Proctofoam contains:

The active substances in Proctofoam are hydrocortisone acetate (1 % w/w) and pramocaine hydrochloride (1% w/w).

The other ingredients are cetyl alcohol, emulsifying wax (cetyl alcohol, sorbitan solution), methyl parahydroxybenzoate (E218), polyoxyethylene (10); stearyl ether, propylene glycol, propyl parahydroxybenzoate (E216), trolamine, purified water and propellant HP-70 consisting of isobutane and propane.

What Proctofoam looks like

Proctofoam is a white rectal foam contained in a pressurised canister.

Contents of the pack

Each pack contains canister and a plastic applicator.

Each canister contains approximately 40 doses.

Marketing Authorisation Holder in the UK: Meda Pharmaceuticals Ltd Skyway House Parsonage Road Takeley Bishop's Stortford CM22 6PU UK Manufacturer Pharmasol Limited North Way Walworth Industrial Estate Andover SP10 5AZ UK

This leaflet was last approved in January 2010.

If this leaflet is difficult to see or read or you would like it in a different format, please contact:

In the UK -

Meda Pharmaceuticals Ltd
Skyway House
Parsonage Road
Takeley
Bishop's Stortford
CM22 6PU
UK

Proctofoam is a registered trademark of Meda AB.

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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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Ascorbic Acid Tablets BP 500mg (Actavis UK Ltd)


1. Name Of The Medicinal Product

ASCORBIC ACID TABLETS BP 500mg

2. Qualitative And Quantitative Composition

Each tablet contains 500mg ascorbic acid.

3. Pharmaceutical Form

White uncoated tablets.

White, circular, flat bevelled-edge uncoated tablets impressed “C” and the identifying letters “AN” on one face; or, as an alternative, plain tablets devoid of surface markings.

4. Clinical Particulars 4.1 Therapeutic Indications

1) Ascorbic acid is a synthetic vitamin C and is specific in the treatment of scurvy.

4.2 Posology And Method Of Administration

Tablets should be chewed before swallowing.

Adults including elderly: 500mg-1g two or three times daily.

Children over 12 years: 500mg two or three times daily.

Children 6-12 years: 500mg twice a day.

For oral administration.

4.3 Contraindications

Hyperoxaluria.

4.4 Special Warnings And Precautions For Use

Increased intake of ascorbic acid over a prolonged period may result in an increase in renal clearance and deficiency may result if it is withdrawn too rapidly.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Concomitant administration of aluminium-containing antacids may increase urinary aluminium elimination. Concurrent administration of antacids and ascorbic acid is not recommended, especially in patients with renal insufficiency.

Concomitant administration of aspirin and ascorbic acid may interfere with absorption of ascorbic acid. Renal excretion of salicylate is not affected and does not lead to reduced anti-inflammatory effects of aspirin.

Concurrent administration of ascorbic acid with desferrioxamine enhances urinary iron excretion. Cases of cardiomyopathy and congestive heart failure have been reported in patients with idiopathic haemochromatosis and thalassaemias receiving desferrioxamine who were subsequently given ascorbic acid. Ascorbic acid should be used with caution in these patients and cardiac function monitored.

Ascorbic acid may interfere with biochemical determinations of creatinine, uric acid and glucose in samples of blood and urine.

4.6 Pregnancy And Lactation

Ascorbic acid in doses greater than 1g should not be administered during pregnancy as the effect of large doses on the foetus is not known.

No problems are anticipated with the administration of ascorbic acid tablets during lactation.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Nausea, vomiting and stomach cramps.

Flushing or redness of skin, headache, mild increase in urination with doses greater than 600mg per day.

Large doses of ascorbic acid (greater than 1g per day) may cause diarrhoea.

4.9 Overdose

Ascorbic acid may cause acidosis or haemolytic anaemia in certain individuals with a deficiency of glucose 6-phosphate dyhydrogenase. Renal failure can occur with massive ascorbic acid overdosage.

Gastric lavage may be given if ingestion is recent otherwise general supportive measures should be employed as required.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Ascorbic Acid is a synthetic vitamin C.

5.2 Pharmacokinetic Properties

Ascorbic acid is readily absorbed from the gastrointestinal tract and is widely distributed in the body tissues. Ascorbic acid in excess of the body's needs is rapidly eliminated in the urine.

The most established function of vitamin C in the body is the control of the formation of colloidal intercellular substances. Deficiency of vitamin C leads to scurvy and in the absence of this water-soluble vitamin, a typical nutritional anaemia develops; the vitamin acts directly on the blood-forming centres and is essential for the maturation of the red blood cells.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Also contains: stearic acid, E223, E460.

6.2 Incompatibilities

None known.

6.3 Shelf Life

Shelf-life

Three years from the date of manufacture.

Shelf-life after dilution/reconstitution

Not applicable.

Shelf-life after first opening

Not applicable.

6.4 Special Precautions For Storage

Store in a cool dry place. Protect from light. Avoid contact with metal.

6.5 Nature And Contents Of Container

The product containers are J & J standard securitainers or Wragby snap-secure containers with jayfilla or polyfoam wad headspace filler and snap-on lids; in case any supply difficulties should arise the alternative is amber glass containers with screw caps with polyfoam wad or cotton wool.

Pack sizes: 7s, 10s, 14s, 20s, 21s, 28s, 30s, 56s, 60s, 84s, 90s, 100s, 112s, 500s, 1000s

Polyethylene container with a polypropylene lid.

Pack size: 28

Product may also be supplied in bulk packs, for reassembly purposes only, in polybags contained in tins, skillets or polybuckets filled with suitable cushioning material.

Maximum size of bulk packs: 25,000.

6.6 Special Precautions For Disposal And Other Handling

Not applicable

Administrative Data 7. Marketing Authorisation Holder

Name or style and permanent address of registered place of business of the holder of the Marketing Authorisation:

Actavis UK Limited

(Trading style: Actavis)

Whiddon Valley

BARNSTAPLE

N Devon EX32 8NS

8. Marketing Authorisation Number(S)

PL 0142/6435 R

9. Date Of First Authorisation/Renewal Of The Authorisation

11.7.86

Renewed: 28.10.91; 14.3.02

10. Date Of Revision Of The Text

02/07/09


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pyrimethamine


Generic Name: pyrimethamine (PIR i METH a meen)
Brand Names: Daraprim

What is pyrimethamine?

Pyrimethamine is an antiparasitic drug. It prevents the growth and reproduction of parasites.

Pyrimethamine is used to treat and prevent malaria. Pyrimethamine is also used in the treatment of toxoplasmosis.

Pyrimethamine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about pyrimethamine? Stop taking pyrimethamine and seek medical attention at the first sign of a skin rash, sore throat, paleness of the skin, unusual bruising under the skin, or swelling of the tongue. These may be early symptoms of serious side effects of pyrimethamine. Pyrimethamine may cause stomach upset or vomiting. Take each dose with food to lessen this side effect. What should I discuss with my healthcare provider before taking pyrimethamine?

Before taking pyrimethamine, tell your doctor if you have

had an allergic reaction to previous treatment with pyrimethamine,

megaloblastic anemia due to folate deficiency,

seizures or epilepsy,

kidney disease, or liver disease.

You may not be able to take pyrimethamine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Pyrimethamine is in the FDA pregnancy category C. This means that it is not known whether pyrimethamine will be harmful to an unborn baby. Do not take pyrimethamine without first talking to your doctor if you are pregnant or could become pregnant during treatment. Pyrimethamine passes into breast milk and may be harmful to a nursing infant. Do not take pyrimethamine without first talking to your doctor if you are breast-feeding a baby. How should I take pyrimethamine?

Take pyrimethamine exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Take pyrimethamine with food to lessen stomach upset. Store pyrimethamine at room temperature away from moisture and heat.

See also: Pyrimethamine dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and only take the next regularly scheduled dose. Do not take a double dose of the medication.

What happens if I overdose? Seek emergency medical attention.

Symptoms of a pyrimethamine overdose may include abdominal pain, nausea, severe vomiting (possibly with blood in the vomit), anxiety or excitability, and seizures.

What should I avoid while taking pyrimethamine?

There are no restrictions on foods, beverages, or activities during treatment with pyrimethamine unless otherwise directed by your doctor.

Pyrimethamine side effects Stop taking pyrimethamine and seek emergency medical attention if you experience an allergic reaction (swelling of the lips, tongue, or face; difficulty breathing; closing of the throat; or hives) during treatment with pyrimethamine. Stop taking pyrimethamine and seek medical attention at the first sign of a skin rash, sore throat, paleness of the skin, unusual bruising under the skin, or swelling of the tongue. These may be early symptoms of serious side effects of pyrimethamine.

Other, less serious side effects may be more likely to occur. Continue to take pyrimethamine and talk to your doctor if you experience

nausea, vomiting, or loss of appetite;

insomnia;

headache;

lightheadedness; or

dryness of the mouth.

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.

Pyrimethamine Dosing Information

Usual Adult Dose for Malaria Prophylaxis:

25 mg orally once a week. Prophylaxis should begin one week prior to departure and continue for at least 6 to 10 weeks following exposure.

Usual Adult Dose for Toxoplasmosis:

Initially: 50 to 75 mg orally once a day with 1 to 4 g of a sulfonamide (e.g., sulfadoxine, sulfadiazine). Continue for 1 to 3 weeks, depending on response and tolerance. Dosage for each drug may then be reduced by one-half and continued for an additional 4 or 5 weeks. Patients receiving pyrimethamine should also receive folinic acid.

Usual Adult Dose for Toxoplasmosis -- Prophylaxis:

1 mg/kg or 15 mg/m2 (max 25 mg) orally every day plus folinic acid (leucovorin) 5 mg orally every 3 days plus sulfadiazine 85 to 120 mg/kg/day divided into 2 to 4 oral doses. Clindamycin 20 to 30 mg/kg/day may be used in place of sulfadiazine as an alternative regimen.

Usual Adult Dose for Pneumocystis Pneumonia Prophylaxis:

50 to 75 mg orally once a week. Pyrimethamine is used in combination with dapsone and leucovorin. This is considered an alternative regimen for patients who do not tolerate trimethoprim-sulfamethoxazole.

Usual Pediatric Dose for Malaria Prophylaxis:

Less than 4 years: 6.25 mg orally once a week.
4 to 10 years: 12.5 mg orally once a week.

Usual Pediatric Dose for Toxoplasmosis:

Newborns and infants:
Initial: 2 mg/kg/day orally divided every 12 hours for 2 days, then 1 mg/kg/day once daily given with sulfadiazine for the first 6 months; next 6 months: 1 mg/kg/day 3 times per week with sulfadiazine; oral folinic acid 5 to 10 mg 3 times per week should be administered to prevent hematological toxicity.
1 to 12 years: 2 mg/kg/day divided every 12 hours for 3 days followed by 1 mg/kg/day (maximum 25 mg/day) once daily or divided twice daily for 4 weeks given with sulfadiazine; oral folinic acid 5 to 10 mg 3 times per week should be administered to prevent hematological toxicity.

What other drugs will affect pyrimethamine?

Before taking pyrimethamine, tell your doctor if you are taking any of the following medicines:

auranofin (Ridaura);

aurothioglucose (Solganal); or

or gold sodium thiomalate (Aurolate, Myochrysine).

You may not be able to take pyrimethamine, or you may require a dosage adjustment or special monitoring during treatment.

Drugs other than those listed here may also interact with pyrimethamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

More pyrimethamine resources Pyrimethamine Side Effects (in more detail) Pyrimethamine Dosage Pyrimethamine Use in Pregnancy & Breastfeeding Pyrimethamine Drug Interactions Pyrimethamine Support Group 0 Reviews for Pyrimethamine - Add your own review/rating pyrimethamine Advanced Consumer (Micromedex) - Includes Dosage Information Pyrimethamine Professional Patient Advice (Wolters Kluwer) Pyrimethamine MedFacts Consumer Leaflet (Wolters Kluwer) Daraprim Prescribing Information (FDA) Daraprim Monograph (AHFS DI) Compare pyrimethamine with other medications Malaria Prevention Pneumocystis Pneumonia Prophylaxis Toxoplasmosis Toxoplasmosis, Prophylaxis Where can I get more information? Your pharmacist can provide more information about pyrimethamine.

See also: pyrimethamine side effects (in more detail)


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Remifentanil 5 mg powder for concentrate for solution for injection / infusion


1. Name Of The Medicinal Product

Remifentanil 5 mg powder for concentrate for solution for injection/infusion

2. Qualitative And Quantitative Composition

Remifentanil 5 mg powder for concentrate for solution for injection/infusion:

1 vial contains 5 mg remifentanil (as remifentanil hydrochloride).

After reconstitution the solution contains 1 mg/ml remifentanil (as hydrochloride), if prepared as recommended (see section 6.6)

Excipients: sodium 1.15 mg

3. Pharmaceutical Form

Powder for concentrate for solution for injection/infusion

Lyophilized white to slightly yellow cake or powdery mass.

4. Clinical Particulars 4.1 Therapeutic Indications

Remifentanil is indicated as an analgesic agent for use during induction and/or maintenance of general anaesthesia.

Remifentanil is indicated for provision of analgesia in mechanically ventilated intensive care patients of 18 years of age and older.

4.2 Posology And Method Of Administration

Remifentanil should be administered only in a setting fully equipped for the monitoring and support of respiratory and cardiovascular function and by persons specifically trained in the use of anaesthetic drugs and the recognition and management of the expected adverse effects of potent opioids, including respiratory and cardiac resuscitation. Such training must include the establishment and maintenance of a patent airway and assisted ventilation.

Continuous infusions of remifentanil must be administered by a calibrated infusion device into a fast flowing IV line or via a dedicated IV line. This infusion line should be connected at, or close to, the venous cannula to minimise the potential dead space (see section 6.6 for additional information, including tables with examples of infusion rates by body weight to help titrate remifentanil to the patient's anaesthetic needs). Care should be taken to avoid obstruction or disconnection of infusion lines and to adequately clear the lines to remove residual remifentanil after use (see section 4.4). IV lines/infusion system should be removed after cessation of use to avoid inadvertent administration.

Remifentanil may be given by target-controlled infusion (TCI) with an approved infusion device incorporating the Minto pharmacokinetic model with covariates for age and lean body mass (LBM).

Congestion of the infusion drips or tearing off should be avoided, and the infusion drips should be sufficiently rinsed in order to remove residual Remifentanil after discontinuation of medication (see also section 4.4).

Remifentanil is for intravenous use only and must not be administered by epidural or intrathecal injection (see section 4.3).

Dilution

Remifentanil should not be administered without further dilution after reconstitution of the lyophilized powder. See section 6.3 for storage conditions and section 6.6 for recommended diluents and instructions on reconstitution / dilution of the product before administration.

For manually-controlled infusion [Invented name] can be diluted to concentrations of 20 to 250 micrograms /ml (50 micrograms /ml is the recommended dilution for adults and 20 to 25 micrograms /ml for paediatric patients aged 1 year and over).

For TCI the recommended dilution of Remifentanil is 20 to 50 micrograms /ml.

General Anaesthesia

The administration of Remifentanil must be individualised based on the patient's response.

Adults

Administration by manually-controlled infusion (MCI)

DOSING GUIDELINES FOR ADULTS

 

REMIFENTANIL BOLUS INJECTION

(micrograms /kg)

REMIFENTANIL CONTINUOUS INFUSION

(micrograms/kg/min)

 

Starting Rate

Range

     

1 (within at least 30 seconds)

0.5 to 1

_

 

Maintenance of anaesthesia in ventilated patients

   

• Nitrous oxide (66 %)

0.5 to 1

0.4

0.1 to 2

• Isoflurane (starting dose 0.5 MAC)

0.5 to 1

0.25

0.05 to 2

• Propofol (Starting dose 100 microtrams /kg/min)

0.5 to 1

0.25

0.05 to 2

When given by bolus injection at induction Remifentanil should be administered over not less than 30 seconds.

At the doses recommended above, remifentanil significantly reduces the amount of hypnotic agent required to maintain anaesthesia. Therefore, isoflurane and propofol should be administered as recommended above to avoid an increase of haemodynamic effects (hypotension and bradycardia) of remifentanil.

No data are available for dosage recommendations for simultaneous use of other hypnotics other than those listed in the table with remifentanil.

Induction of anaesthesia

Remifentanil should be co-administered with a hypnotic agent, such as propofol, thiopentone, or isoflurane, for the induction of anaesthesia. Administering Remifentanil after a hypnotic agent will reduce the incidence of muscle rigidity. Remifentanil can be administered at an infusion rate of 0.5 to 1 micrograms /kg/min, with or without an initial bolus injection of 1 micrograms /kg given over not less than 30 seconds. If endotracheal intubation is to occur more than 8 to 10 minutes after the start of the infusion of [Invented name], then a bolus injection is not necessary.

Maintenance of anaesthesia in ventilated patients

After endotracheal intubation, the infusion rate of Remifentanil should be decreased, according to anaesthetic technique, as indicated in the above table. Due to the fast onset and short duration of action of remifentanil, the rate of administration during anaesthesia can be titrated upward in 25% to 100% increments or downward in 25% to 50% decrements, every 2 to 5 minutes to attain the desired level of ?-opioid response. In response to light anaesthesia, supplemental bolus injections may be administered every 2 to 5 minutes.

Anaesthesia in spontaneously breathing patients

In spontaneously breathing anaesthetised patients with a secured airway respiratory depression is likely to occur. Therefore attention must be given to respiratory effects eventually combined with muscular rigidity. Special care is needed to adjust the dose to the patient requirements and ventilatory support may be required. Adequate facilities should be available for monitoring of patients administered remifentanil. It is essential that these facilities be fully equipped to handle all degrees of respiratory depression (intubation equipment must be available) and/or muscle rigidity (for more information see section 4.4).

The recommended starting infusion rate for supplemental analgesia in spontaneously breathing anaesthetised patients is 0.04 ?g/kg/min with titration to effect. A range of infusion rates from 0.025 to 0.1 ?g/kg/min has been studied.

Bolus injections are not recommended in spontaneously breathing anaesthetised patients.

Remifentanil should not be used as an analgesic in procedures where patients remain conscious or do not receive any airway support during the procedure.

Concomitant medication

Remifentanil decreases the amounts or doses of inhalational anaesthetics, hypnotics and benzodiazepines required for anaesthesia (see section 4.5).

Doses of the following agents used in anaesthesia: isoflurane, thiopentone, propofol and temazepam have been reduced by up to 75 % when used concurrently with remifentanil.

Guidelines for discontinuation/continuation during immediate postoperative period

Due to the very rapid offset of action of remifentanil no residual opioid activity will be present within 5 to 10 minutes after discontinuation. For those patients undergoing surgical procedures where post-operative pain is anticipated, analgesics should be administered prior to discontinuation of remifentanil. Sufficient time must be allowed to reach the maximum effect of the longer acting analgesic. The choice of analgesic should be appropriate for the patient's surgical procedure and the level of post-operative care.

In case the longer acting analgesic has not reached the appropriate effect before the end of surgery, the administration of remifentanil can be continued to maintain analgesia during immediate postoperative period until the longer acting analgesic has reached the maximum effect.

If remifentanil is continued post-procedural, it should only be used in a setting fully equipped for the monitoring and support of respiratory and cardiovascular function, under the close supervision of persons specifically trained in the recognition and management of the respiratory effects of potent opioids.

Furthermore it is recommended that patients should be closely monitored post-operatively for pain, hypotension and bradycardia.

Further information about the administration in mechanically ventilated intensive care patients is given in section 4.2.

In spontaneously breathing patients the initial infusion rate of remifentanil may be decreased to 0.1 µg/kg/min and thereafter can be increased or decreased every 5 min in steps of 0.025 µg/kg/min to balance the extent of analgesia against the degree of respiratory depression.

In spontaneously breathing patients bolus doses for analgesia are not recommended during postoperative period.

Administration by Target-Controlled Infusion (TCI)

Induction and maintenance of anaesthesia in ventilated patients

Remifentanil TCI should be used in association with an intravenous or inhalational hypnotic agent during the induction and maintenance of anaesthesia in ventilated adult patients (see table 1 above for manually controlled infusion). In association with these agents, adequate analgesia for induction of anaesthesia and surgery can generally be achieved with target blood remifentanil concentrations ranging from 3 to 8 ng/ml. Remifentanil should be titrated to individual patient response. For particularly stimulating surgical procedures target blood concentrations up to 15 ng/ml may be required.

At the doses recommended above, remifentanil significantly reduces the amount of hypnotic agent required to maintain anaesthesia. Therefore, isoflurane and propofol should be administered as recommended to avoid an increase of haemodynamic effects (hypotension and bradycardia) of remifentanil (see table 1 above for manually controlled infusion).

The following table provides the equivalent blood remifentanil concentration using a TCI approach for various manually controlled infusion rates at steady state:

Remifentanil blood concentrations (nanograms/ml) estimated using the Minto (1997) pharmacokinetic model in a 70 kg, 170 cm, 40 year old male patient for various manually controlled infusion rates (micrograms/kg/min) at steady state

Remifentanil Infusion Rate

(micrograms /kg/min)

Remifentanil Blood Concentration

(nanograms/ml)

0.05

1.3

0.10

2.6

0.25

6.3

0.40

10.4

0.50

12.6

1.0

25.2

2.0

50.5

As there are insufficient data, the administration of remifentanil by TCI for spontaneous ventilation anaesthesia is not recommended.

Guidelines for discontinuation/continuation into the immediate post-operative period

At the end of surgery when the TCI infusion is stopped or the target concentration reduced, spontaneous respiration is likely to return at calculated remifentanil concentrations in the region of 1 to 2 ng/ml. As with manually controlled infusion, post-operative analgesia should be established before the end of surgery with longer acting analgesics (see also Guidelines for discontinuation / continuation during immediate postoperative period in section above for Manually Controlled Infusion).

As there are insufficient data, the administration of [Invented name] by TCI for the management of post-operative analgesia is not recommended.

Paediatric patients (1 to12 years of age)

Co-administration of remifentanil with induction agents has not been studied. The use of remifentanil for induction of anaesthesia by TCI in patients aged 1 to12 years is not recommended as there are no data available in this patient population.

Maintenance of anaesthesia

The following doses of remifentanil (see table) are recommended for maintenance of anaesthesia:

DOSING GUIDELINES FOR PAEDIATRIC PATIENTS (1 to12 years of age)

*CONCOMITANT ANAESTHETIC AGENT

REMIFENTANIL BOLUS INJECTION

(micrograms /kg)

REMIFENTANIL CONTINUOUS INFUSION

 

Starting Rate

(micrograms /kg/min)

Range for maintenance of anaesthesia

(micrograms /kg/min)

   

Halothane (starting dose 0.3 MAC)

1

0.25

0.05 to 1.3

Sevoflurane (starting dose 0.3 MAC)

1

0.25

0.05 to 0.9

Isoflurane (starting dose 0.5 MAC)

1

0.25

0.06 to 0.9

*co-administered with nitrous oxide/oxygen in a ratio of 2:1

When given by bolus injection, Remifentanil should be administered over not less than 30 seconds. Surgery should not commence until at least 5 minutes after the start of the Remifentanil infusion, if a simultaneous bolus dose has not been given.

For exclusive administration of nitrous oxide (70 %) and Remifentanil infusion rates for maintenance of anaesthesia should be between 0.4 und 3 micrograms/kg/min. Data gained from adults suggest that 0.4 micrograms/kg/min may be a convenient initial dose although specific studies are lacking.

Paediatric patients should be monitored and the dose titrated to the depth of analgesia appropriate for the surgical procedure.

Concomitant medication

At the doses recommended above, remifentanil significantly reduces the amount of hypnotic agent required to maintain anaesthesia. Therefore, isoflurane, halothane and sevoflurane should be administered as recommended above to avoid an increase of haemodynamic effects (hypotension and bradycardia) of remifentanil. No data are available for dosage recommendations for simultaneous use of other hypnotics with remifentanil (see in section above: Administration by Manually Controlled Infusion (MCI), Concomitant medication).

Guidelines for patient management in the immediate post-operative period

Establishment of alternative analgesia prior to discontinuation of Remifentanil:

Due to the very rapid offset of action of remifentanil, no residual activity will be present within 5 to 10 minutes after discontinuation. For those patients undergoing surgical procedures where post-operative pain is anticipated, analgesics should be administered prior to discontinuation of remifentanil. Sufficient time must be allowed to reach the therapeutic effect of the longer acting analgesic. The choice of agent(s), the dose and the time of administration should be planned in advance and individually tailored to be appropriate for the patient's surgical procedure and the level of post-operative care anticipated (see section 4.4).

Neonates/infants (aged less than 1 year):

The pharmacokinetic profile of remifentanil in neonates and infants (aged less than 1 year) is comparable to that seen in adults after correction for body weight differences. However, because there are insufficient clinical data, the administration of remifentanil is not recommended for this age group.

Special Patient groups

For dosage recommendations for special patient groups (elderly and obese patients, renally and hepatically impaired patients, patients undergoing neurosurgery and ASA III/IV patients; see section 4.2).

Cardiac Surgery

Administration by Manually-Controlled Infusion

For dosage recommendations in patients undergoing cardiac surgery see table below:

DOSING GUIDELINES FOR CARDIAC ANAESTHESIA

INDICATION

REMIFENTANIL BOLUS INJECTION

(micrograms /kg)

REMIFENTANIL CONTINUOUS INFUSION

(micrograms /kg/min)

 

Starting Rate

Typical infusion rates

   

Intubation

Not recommended

1

_

Maintenance of anaesthesia

     

• Isoflurane

(starting dose 0.4 MAC)

0.5 to 1

1

0.003 to 4

• Propofol

(Starting dose 50 micrograms /kg/min)

0.5 to 1

1

0.01 to 4.3

Continuation of post-operative analgesia, prior to extubation

Not recommended

1

0 to 1

Induction of anaesthesia

After administration of hypnotic to achieve loss of consciousness, Remifentanil should be administered at an initial infusion rate of 1 micrograms /kg/min. The use of bolus injections of Remifentanil during induction in cardiac surgical patients is not recommended. Endotracheal intubation should not occur until at least 5 minutes after the start of the infusion.

Maintenance period of anaesthesia

After endotracheal intubation the infusion rate of Remifentanil should be titrated according to the patient need. Supplemental bolus doses may also be administered as required. High risk cardiac patients, such as those undergoing valve surgery or with poor left ventricular function, should be administered a maximum bolus dose of 0.5 micrograms/kg.

These dosing recommendations also apply during hypothermic cardiopulmonary bypass (see section 5.2).

Concomitant medication

At the doses recommended above, remifentanil significantly reduces the amount of hypnotic agent required to maintain anaesthesia. Therefore, isoflurane and propofol should be administered as recommended above to avoid an increase of haemodynamic effects (hypotension and bradycardia) of remifentanil. No data are available for dosage recommendations for simultaneous use of other hypnotics with remifentanil (see in section above: Administration by Manually Controlled Infusion (MCI), Concomitant medication).

Guidelines for postoperative supply of patient

Continuation of Remifentanil post-operatively to provide analgesia prior to extubation

It is recommended that the infusion of Remifentanil is maintained at the final intra-operative rate during transfer of patients to the post-operative care area. The patient's level of analgesia and sedation should be closely monitored and the Remifentanil infusion rate adjusted to meet the individual patient's requirements (see Intensive care, below, for further information on management of intensive care patients.

Establishment of alternative analgesia prior to discontinuation of Remifentanil

Due to the very rapid offset of action of remifentanil, no residual opioid activity will be present within 5 to 10 minutes after discontinuation. Prior to discontinuation of Remifentanil, patients must be given alternative analgesic and sedative agents at a sufficient time in advance to allow the therapeutic effects of these agents to become established. It is therefore recommended that the choice of agent(s), the dose and the time of administration are planned, before weaning the patient from the ventilator.

Guidelines for discontinuation of Remifentanil

Due to the very rapid offset of action of Remifentanil, hypertension, shivering and aches have been reported in cardiac patients immediately following discontinuation of Remifentanil (see section 4.8 Undesirable effects). To minimise the risk of these events, adequate alternative analgesia must be established (as described above), before the Remifentanil infusion is discontinued. The infusion rate should be reduced by 25% decrements in at least 10-minute intervals until the infusion is discontinued.

During weaning from the ventilator the Remifentanil infusion should not be increased and only down titration should occur, supplemented as required with alternative analgesics. Haemodynamic changes such as hypertension and tachycardia should be treated with alternative agents as appropriate.

When other opioid agents are administered as part of the regimen for transition to alternative analgesia, the patient must be carefully monitored. The benefit of providing adequate post-operative analgesia must always be balanced against the potential risk of respiratory depression with these agents.

Administration by Target-Controlled Infusion

Induction and maintenance of anaesthesia in ventilated patients

Remifentanil TCI should be used in association with an intravenous or inhalational hypnotic agent during the induction and maintenance of anaesthesia in ventilated adult patients (see the table in section 4.2 under Cardiac surgery/Administration by Manually-Controlled Infusion/Dosing guidelines for cardiac anaesthesia). In association with these agents, adequate analgesia for cardiac surgery is generally achieved at the higher end of the range of target blood remifentanil concentrations used for general surgical procedures. Following titration of remifentanil to individual patient response, blood concentrations as high as 20 nanograms /ml have been achieved in clinical studies.

At the doses recommended above, remifentanil significantly reduces the amount of hypnotic agent required to maintain anaesthesia. Therefore, isoflurane and propofol should be administered as recommended above to avoid an increase of haemodynamic effects (hypotension and bradycardia) of remifentanil (see table in section 4.2 under Cardiac surgery/Administration by Manually-Controlled Infusion/Dosing guidelines for cardiac anaesthesia).

For information on blood remifentanil concentrations achieved with manually controlled infusion see Table 6

Guidelines for discontinuation/continuation into the immediate post-operative period

At the end of surgery when the TCI infusion is stopped or the target concentration reduced, spontaneous respiration is likely to return at calculated remifentanil concentrations in the range of 1 to 2 nanograms /ml. As with manually-controlled infusion, post-operative analgesia should be established before the end of surgery with longer acting analgesics (see section 4.2 under Cardiac surgery/Administration by Manually-Controlled Infusion/Guidelines for discontinuation of Remifentanil.

As there are insufficient data, the administration of Remifentanil by TCI for the management of post-operative analgesia is not recommended.

Intensive Care – Adults

Remifentanil can be used in mechanically ventilated intensive care patients. If required, additionally sedating drugs should be applied.

Remifentanil has been studied in intensive care patients in well controlled clinical trials for up to three days. As patients were not studied beyond three days, no evidence of safety and efficacy for longer treatment has been established. Therefore, a usage longer than three days is not recommended.

Due to the lack of data the administration of remifentanil by TCI is not recommended for ICU patients.

In adults, it is recommended that Remifentanil is initiated at an infusion rate of 0.1 micrograms /kg/min (6 micrograms /kg/h) to 0.15 micrograms /kg/min (9 micrograms /kg/h). The infusion rate should be titrated in increments of 0.025 micrograms /kg/min (1.5 micrograms /kg/h) to achieve the desired level of analgesia. A period of at least 5 minutes should be allowed between dose adjustments. The patient should be carefully monitored, regularly reassessed and the Remifentanil infusion rate adjusted accordingly. If an infusion rate of 0.2 micrograms /kg/min (12 micrograms /kg/h) is reached and the desired level of sedation is not achieved, it is recommended that dosing with an appropriate sedative agent is initiated (see below). The dose of the sedative agent should be titrated to obtain the desired level of sedation. Further increases to the [Invented name] infusion rate in increments of 0.025 micrograms /kg/min (1.5 micrograms /kg/h) may be made if additional analgesia is required.

The following table summarises the starting infusion rates and typical dose range for provision of analgesia in individual patients:

DOSING GUIDELINES FOR USE OF REMIFENTANIL WITHIN THE INTENSIVE CARE SETTING

CONTINUOUS INFUSION micrograms /kg/min (micrograms /kg/h)

 

Starting Rate

Range

0.1 (6) to 0.15 (9)

0.006 (0.36) to 0.74 (44.4)

Bolus doses of Remifentanil are not recommended in the intensive care setting.

The use of Remifentanil will reduce the dosage requirement of any concomitant sedative agents. Typical starting doses for sedative agents, if required, are given below.

RECOMMENDED STARTING DOSE OF SEDATIVE AGENTS, IF REQUIRED

Sedative Agent

Bolus (mg/kg)

Infusion rate (mg/kg/h)

Propofol

Up to 0.5

0.5

Midazolam

Up to 0.03

0.03

To allow separate titration of the respective agents, sedative agents should not be administered as an admixture.

Additional analgesia for ventilated patients undergoing painful procedures

An increase in the existing Remifentanil infusion rate may be required to provide additional analgesic cover for ventilated patients undergoing stimulating and/or painful procedures such as endotracheal suctioning, wound dressing and physiotherapy. It is recommended that a Remifentanil infusion rate of at least 0.1 micrograms /kg/min (6 micrograms /kg/h) is maintained for at least 5 minutes prior to the start of the stimulating procedure. Further dose adjustments may be made every 2 to 5 minutes in increments of 25%-50% in anticipation of, or in response to, additional requirement for analgesia. A mean infusion rate of 0.25 micrograms /kg/min (15 micrograms /kg/h), maximum 0.75 micrograms kg/min (44,4 micrograms /kg/h), has been administered for provision of additional analgesia during stimulating procedures.

Establishment of alternative analgesia prior to discontinuation of Remifentanil

Due to the very rapid offset of action of remifentanil, no residual opioid activity will be present within 5 to 10 minutes after discontinuation regardless of the duration of infusion. After administration of remifentanil the potential for the development of tolerance and hyperalgesia should be attended. Therefore, prior to discontinuation of remifentanil, patients must be given alternative analgesic and sedative agents at a sufficient time in advance to allow the therapeutic effects of these agents to become established and to prevent hyperalgesia and concomitant haemodynamic changes. It is therefore recommended that the choice of agent(s), the dose and the time of administration are planned prior to discontinuation of remifentanil. Long acting analgetics or intravenous or local analgetics, which can be controlled by the health care staff or the patient are alternative options for analgesia and should be chosen carefully according to the patients needs.

Prolonged administration of µ-opioid agonists may induce development of tolerance.

Guidelines for extubation and discontinuation of Remifentanil

In order to ensure a smooth emergence from a remifentanil-based regimen it is recommended that the infusion rate of Remifentanil is titrated gradually to 0.1 micrograms /kg/min (6 micrograms /kg/h) over a period up to 1 hour prior to extubation.

Following extubation, the infusion rate should be reduced by 25% decrements in at least 10-minute intervals until the infusion is discontinued. During weaning from the ventilator the Remifentanil infusion should not be increased and only down titration should occur, supplemented as required with alternative analgesics.

Upon discontinuation of Remifentanil, the IV cannula should be cleared or removed to prevent subsequent inadvertent administration.

When other opioid agents are administered as part of the regimen for transition to alternative analgesia, the patient must be carefully monitored. The benefit of providing adequate analgesia must always be balanced against the potential risk of respiratory depression.

The following tables 1-5 give guidelines for infusion rates of Remifentanil for manually-controlled infusion:

Table 1: Remifentanil – Infusion rates (ml/kg/h)

Medicinal prodcuct delivery rate

(µg/kg/min)

Infusion delivery rate (ml/kg/h) for solution concentrations of

     

20 micrograms /ml

1 mg/50 ml

25 micrograms /ml

1 mg/40 ml

50 micrograms /ml

1 mg/20 ml

250 micrograms /ml

10 mg/40 ml

 

0.0125

0.025

0.05

0.075

0.1

0.15

0.2

0.25

0.5

0.75

1.0

1.25

1.5

1.75

2.0

0.038

0.075

0.15

0.23

0.3

0.45

0.6

0.75

1.5

2.25

3.0

3.75

4.5

5.25

6.0

0.03

0.06

0.12

0.18

0.24

0.36

0.48

0.6

1.2

1.8

2.4

3.0

3.6

4.2

4.8

0.015

0.03

0.06

0.09

0.12

0.18

0.24

0.3

0.6

0.9

1.2

1.5

1.8

2.1

2.4

Not recommended

Not recommended

0.012

0.018

0.024

0.036

0.048

0.06

0.12

0.18

0.24

0.3

0.36

0.42

0.48

Table 2: Remifentanil – Infusion rates (ml/h) for a 20 micrograms /ml solution

Infusion rate

(micrograms /kg/min)

Patient weight (kg)

           

5

10

20

30

40

50

60

 

0.0125

0.188

0.375

0.75

1.125

1.5

1.875

2.25

0.025

0.375

0.75

1.5

2.25

3.0

3.75

4.5

0.05

0.75

1.5

3.0

4.5

6.0

7.5

9.0

0.075

1.125

2.25

4.5

6.75

9.0

11.25

13.5

0.1

1.5

3.0

6.0

9.0

12.0

15.0

18.0

0.15

2.25

4.5

9.0

13.5

18.0

22.5

27.0

0.2

3.0

6.0

12.0

18.0

24.0


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Micardis 80mg Tablets


Micardis 80 mg tablets

Telmisartan

Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Micardis is and what it is used for 2. Before you take Micardis 3. How to take Micardis 4. Possible side effects 5. How to store Micardis 6. Further information What Micardis Is And What It Is Used For

Micardis belongs to a class of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in your body which causes your blood vessels to narrow, thus increasing your blood pressure. Micardis blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered.

Micardis is used to treat essential hypertension (high blood pressure). ‘Essential’ means that the high blood pressure is not caused by any other condition.

High blood pressure, if not treated, can damage blood vessels in several organs, which could lead sometimes to heart attack, heart or kidney failure, stroke, or blindness. There are usually no symptoms of high blood pressure before damage occurs. Thus it is important to regularly measure blood pressure to verify if it is within the normal range.

Micardis is also used to reduce cardiovascular events (i.e. heart attack or stroke) in patients who are at risk because they have a reduced or blocked blood supply to the heart or legs, or have had a stroke or have high risk diabetes. Your doctor can tell you if you are at high risk for such events.

Before You Take Micardis Do not take Micardis if you are allergic (hypersensitive) to telmisartan or any other ingredients included in Micardis tablets (see section Further information for a list of other ingredients). if you are more than 3 months pregnant. (It is also better to avoid Micardis in early pregnancy – see pregnancy section.) if you have severe liver problems such as cholestasis or biliary obstruction (problems with drainage of the bile from the liver and gall bladder) or any other severe liver disease.

If any of the above applies to you, tell your doctor or pharmacist before taking Micardis.

Take special care with Micardis

Please tell your doctor if you are suffering or have ever suffered from any of the following conditions or illnesses:

Kidney disease or kidney transplant. Renal artery stenosis (narrowing of the blood vessels to one or both kidneys). Liver disease. Heart trouble. Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals). Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy (‘water tablets’), low-salt diet, diarrhoea, or vomiting. Elevated potassium levels in your blood. Diabetes.

You must tell your doctor if you think you are (or might become) pregnant. Micardis is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

In case of surgery or anaesthesia, you should tell your doctor that you are taking Micardis.

The use of Micardis in children and adolescents up to the age of 18 years is not recommended.

As with all other angiotensin antagonists, Micardis may be less effective in lowering the blood pressure in black patients.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Your doctor may need to change the dose of these other medicines or take other precautions. In some cases you may have to stop taking one of the medicines. This applies especially to the medicines listed below taken at the same time with Micardis:

Lithium containing medicines to treat some types of depression. Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain ‘water tablets’), ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen), heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim. Diuretics (‘water tablets’), especially if taken in high doses together with Micardis, may lead to excessive loss of body water and low blood pressure (hypotension).

As with other blood pressure lowering medicines, the effect of Micardis may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen) or corticosteroids.

Micardis may increase the blood pressure lowering effect of other medicines used to treat high blood pressure.

Taking Micardis with food and drink

You can take Micardis with or without food.

Pregnancy and breast-feeding

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Micardis before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Micardis. Micardis is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Micardis is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Driving and using machines

No information is available on the effect of Micardis on the ability to drive or operate machinery. Some people feel dizzy or tired when they are treated for high blood pressure. If you feel dizzy or tired, do not drive or operate machinery.

Important information about some of the ingredients of Micardis

Micardis contains sorbitol.

If you are intolerant to some sugars, consult your doctor before taking Micardis.

How To Take Micardis

Always take Micardis exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose of Micardis is one tablet a day. Try to take the tablet at the same time each day. You can take Micardis with or without food. The tablets should be swallowed with some water or other non-alcoholic drink. It is important that you take Micardis every day until your doctor tells you otherwise. If you have the impression that the effect of Micardis is too strong or too weak, talk to your doctor or pharmacist.

For treatment of high blood pressure, the usual dose of Micardis for most patients is one 40 mg tablet once a day to control blood pressure over the 24 hour period. However, sometimes your doctor may recommend a lower dose of 20 mg or a higher dose of 80 mg. Alternatively, Micardis may be used in combination with diuretics (‘water tablets’) such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with Micardis.

For reduction of cardiovascular events, the usual dose of Micardis is one 80 mg tablet once a day. At the beginning of the preventive therapy with Micardis 80mg, blood pressure should be frequently monitored.

If your liver is not working properly, the usual dose should not exceed 40 mg once daily.

If you take more Micardis than you should

If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital emergency department immediately.

If you forget to take Micardis

If you forget to take a dose, do not worry. Take it as soon as you remember then carry on as before. If you do not take your tablet on one day, take your normal dose on the next day. Do not take a double dose to make up for forgotten individual doses.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible Side Effects

Like all medicines, Micardis can cause side effects, although not everybody gets them. These side effects may occur with certain frequencies, which are defined as follows:

very common: affects more than 1 user in 10 common: affects 1 to 10 users in 100 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency cannot be estimated from the available data.

Common side effects may include:

Low blood pressure (hypotension) in users treated for reduction of cardiovascular events.

Uncommon side effects may include:

Upper respiratory tract infections (e.g. sore throat, inflamed sinuses, common cold), urinary tract infections, deficiency in red blood cells (anaemia), high potassium levels, feeling sad (depression), fainting (syncope), difficulty falling asleep, feeling of spinning (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness on standing up (orthostatic hypotension), shortness of breath, abdominal pain, diarrhoea, discomfort in the abdomen, bloating, vomiting, increased sweating, itching, drug rash, muscle pain (myalgia), back pain, muscle cramps, kidney impairment including acute kidney failure, pain in the chest, feeling of weakness, and increased level of creatinine in the blood.

Rare side effects may include:

Low platelet count (thrombocytopenia), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), feeling anxious, impaired vision, fast heart beat (tachycardia), upset stomach, dry mouth, abnormal liver function, severe drug rash, redness of skin, rapid swelling of the skin and mucosa (angioedema), eczema (a skin disorder), joint pain (arthralgia), pain in extremity, flu-like-illness, increased levels of uric acid, hepatic enzymes or creatine phosphokinase in the blood, and decreased haemoglobin (a blood protein).

Side effects of unknown frequency may include:

Increase in certain white blood cells (eosinophilia), severe allergic reaction (anaphylactic reaction), hives (urticaria), tendon pain, and sepsis* (often called “blood poisoning”, is a severe infection with whole-body inflammatory response which can lead to death).

*In a long-term study involving more than 20,000 patients, more patients treated with telmisartan experienced sepsis compared with patients who received no telmisartan. The event may have happened by chance or could be related to a mechanism currently not known.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Micardis

Keep out of the reach and sight of children.

Do not use Micardis after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions. You should store your medicine in the original package in order to protect the tablets from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information What Micardis contains

The active substance is telmisartan. Each tablet contains 80 mg telmisartan.

The other ingredients are povidone, meglumine, sodium hydroxide, sorbitol (E420) and magnesium stearate.

What Micardis looks like and contents of the pack

Micardis 80 mg tablets are white, oblong-shaped and engraved with the code number ‘52H’ on one side and the company logo on the other side.

Micardis is available in blister packs containing 14, 28, 30, 56, 84, 90 or 98 tablets, or unit dose blister packs containing 28 x 1 tablets.

Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder Boehringer Ingelheim International GmbH Binger Str. 173 D-55216 Ingelheim am Rhein Germany Manufacturer Boehringer Ingelheim Pharma GmbH & Co. KG Binger Str. 173 D-55216 Ingelheim am Rhein Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

United Kingdom Boehringer Ingelheim Ltd. Tel:+44 1344 424 600

This leaflet was last approved in 11/2009

Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.

62567-08


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Adcortyl Intra-Articular / Intradermal Injection 10mg / ml


The wording of leaflets is regularly updated. This electronic text is the most up-to-date version and may differ from the leaflet in your pack. If you have any questions about the information provided, please ask your doctor or pharmacist.

ADCORTYL

INTRA-ARTICULAR/INTRADERMAL INJECTION 10 mg/ml

Triamcinolone acetonide

Adcortyl IA/ID Injection is a steroid medicine, prescribed for many different conditions, including serious illnesses. You need to take it regularly to get the maximum benefit. Don’t stop taking this medicine without talking to your doctor – you may need to reduce the dose gradually. Adcortyl IA/ID Injection can cause side effects in some people (read section 4 below). Some problems such as mood changes (feeling depressed or ‘high’), or stomach problems can happen straight away. If you feel unwell in any way, keep taking your tablets, but see your doctor straight away. Some side effects only happen after weeks or months. These include weakness of arms and legs, or developing a rounder face (read section 4 for more information). If you take it for more than 3 weeks, you will get a blue ‘steroid card’: always keep it with you and show it to any doctor or nurse treating you. Keep away from people who have chicken pox or shingles, if you have never had them. They could affect you severely. If you do come into contact with chicken pox or shingles, see your doctor straight away.

Now read the rest of this leaflet. It includes other important information on the safe and effective use of this medicine that might be especially important for you.

Your doctor has prescribed Adcortyl injection for you. This leaflet gives a summary of information about your medicine. If you want to know more, or are not sure about anything, ask your doctor or pharmacist.

REMEMBER: This medicine is for YOU. Only a doctor can prescribe it. Never give it to anyone else. It may harm them even if they have the same symptoms as you.

Q. What Is In Adcortyl Intra-Articular / Intradermal (Ia/Id) Injection?

A. Adcortyl IA/ID Injection belongs to a group of medicines called steroids. Their full name is corticosteroids. These corticosteroids occur naturally in the body, and help to maintain health and well-being. Boosting your body with extra corticosteroid (such as Adcortyl IA/ID Injection) is an effective way to treat various illnesses involving inflammation in the body. Adcortyl IA/ID Injection reduces this inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get maximum benefit from it.

The injection contains triamcinolone acetonide 10mg/ml and is supplied in packs of 5 x 1.0ml glass ampoules or a single 5ml glass vial. The other ingredients are benzyl alcohol, polysorbate 80, carmellose, sodium chloride and water for injection.

UK PRODUCT LICENCE

Held by:

E. R. Squibb & Sons Limited Uxbridge UB8 1DH England Tel.:0800 7311736

IRISH PRODUCT AUTHORISATION

Held by:

Bristol-Myers Squibb Pharmaceuticals Ltd. Swords County Dublin Tel.:1-800-749-749

MANUFACTURER

Bristol-Myers Squibb S.r.l. Contrada Fontana del Ceraso 03012 Anagni (FR) Italy Q. What Is This Medicine For?

A. Adcortyl IA/ID Injection is for the treatment of joint pain, swelling and stiffness in inflammatory disorders such as rheumatoid arthritis. It is also used to treat various forms of allergic dermatitis, skin overgrowths such as thickened scar tissue, and patchy baldness, which is usually reversible.

Before Receiving Your Medicine Q. Should I be receiving Adcortyl IA/ID injection?

A. You should not receive this medicine if you have ever had an allergic reaction to similar medicines or to any of the ingredients in Adcortyl IA/ID injection. You should not receive this medicine if you are suffering from an infection unless your doctor has also prescribed a treatment for the infection.

Q. Is there anything else I should discuss with my doctor before receiving Adcortyl IA/ID injection?

A. Check with your doctor before receiving Adcortyl IA/ID injection if you have had any recent infection, tuberculosis (TB), bowel disorders, an ulcer, blood clots, cancer, thin (brittle) bones, high blood pressure or heart failure, mental disorders, epilepsy, myasthenia gravis or glaucoma (increased pressure in your eyes).

Check with your doctor first:

If you have ever had severe depression or manic-depression (bipolar disorder). This includes having had depression before while taking steroid medicines like Adcortyl IA/ID Injection. If any of your close family has had these illnesses.

If either of these applies to you, talk to a doctor before taking Adcortyl IA/ID Injection.

Q. What if I have been in contact with someone who has an infectious disease such as Chickenpox, Shingles or Measles?

A. Steroid medicines suppress your body's natural immune response. Therefore, if you come into contact with anyone who has an infectious disease such as chickenpox, shingles or measles, consult your doctor promptly, especially if you have not had the disease before. You should take particular care to avoid these diseases.

Q. Can I be immunised (vaccinated)?

A. While you are being treated with this medicine (or if you have recently stopped a course of treatment) do not have any immunisation without consulting your doctor.

Q. What if I am pregnant or think I may be pregnant? What if I am planning to become pregnant? What if I am breast-feeding?

A. You should make sure you discuss this with your doctor as soon as possible before receiving Adcortyl IA/ID injection.

Q. What if I have had problems with my kidneys, liver or thyroid?

A. Remind your doctor as the dose of Adcortyl may need to be adjusted.

Q. Can I take other medicines?

A. Corticosteroids can increase the chance of bleeding from the gut caused by aspirin, ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs). If you have hypothrombinaemia (a tendency to bleed), your doctor will be more careful about giving you Adcortyl IA/ID injection if you are taking ibuprofen or another NSAID. Always tell your doctor about all other medicines you are taking, even those you have bought at a pharmacy or other places, e.g. supermarket. Some medicines used to treat epilepsy, tuberculosis or breast cancer can reduce the effectiveness of Adcortyl. On the other hand, Adcortyl can affect the action of some medicines used to treat diabetes, high blood pressure or to thin the blood.

Always tell your doctor if you are taking oral contraceptives, hormone replacement therapy (HRT), growth hormone, thyroid drugs, cyclosporin, or medicines for treating fungal infections, or if you are to be vaccinated or to be given an anaesthetic.

Q. Is it all right to take exercise?

A. You must take care not to over-use a joint which feels better after you receive Adcortyl IA/ID injection as the joint will still need to recover from the inflammation which caused your symptoms.

Q. Is it all right to drive?

A. This medicine does not usually affect your ability to drive but it can affect your eyesight. Tell your doctor immediately if you have any pain in the eyes or visual disturbances.

Q. Is it all right to drink alcohol?

A. There is no known interaction between Adcortyl and alcohol.

Q. What if I am diabetic?

A. Remind your doctor as your insulin dose may need to be changed.

Q. Who should I tell that I have received this injection?

A. Your doctor or pharmacist will have given you a Steroid Treatment Card with your prescription or medicine. YOU SHOULD ALWAYS CARRY THIS CARD WITH YOU as it must be shown to any of the following persons:

Doctor or Nurse - before having any surgery or emergency treatment or if any new treatment is prescribed. Dentist - before having any dental surgery Pharmacist - before buying any medicine Optician - it is advisable to have regular eye tests Q. Is there any important information about the ingredients of Adcortyl that I need to know?

A. Adcortyl IA/ID Injection contains 15mg/ml benzyl alcohol which may cause harmful or allergic reactions in infants and children. Adcortyl IA/ID injection must not be given to premature or newly born babies.

Administraton Of Your Medicine Q. How will Adcortyl IA/ID injection be given and how often?

A. The effect of the injection will vary from patient to patient and further injections may be given when symptoms return and not at regular intervals.

Use in inflammatory joint disorders:

The dose of injection to be given into a joint or into a tendon sheath depends upon the size of the joint to be treated and the severity of the condition. Doses of 2.5 - 5mg (0.25-0.5ml) for smaller joints and 5-15mg (0.5-1.5ml) for larger joints usually give relief of symptoms. This medicine should not be used for injection into the Achilles tendon.

Use in allergic dermatitis:

The dose is usually 2-3mg (0.2-0.3ml) depending on the size of the problem area of the skin but no more than 5mg (0.5ml) should be injected at any one site. If several sites are injected the total dose given should not exceed 30mg (3ml). Further doses may be given if necessary at one or two week intervals.

Children: Adcortyl IA/ID is not recommended for children under 6 years of age. It may be given to older children but the dose is adjusted according to their size and weight and is always kept as low as possible for the shortest possible time.

During times of illness or stress, patients on long-term treatment may require the addition of oral steroid tablets or, if they have recently finished a course of Adcortyl IA/ID injections, may need to start taking oral steroid tablets for a while.

Q. How long should I continue receiving Adcortyl IA/ID injection?

A. Your doctor will advise you whether it is wise for you to have further injections.

Treatment with steroids is usually kept as short as possible and must not be stopped abruptly. Joints may become permanently damaged by repeated injections over a long period of time.

When the treatment is stopped you may notice flu-like symptoms, runny nose or itchy eyes or skin.

Mental problems while taking Adcortyl IA/ID injection

Mental health problems can happen while taking steroids like Adcortyl IA/ID Injection (see also section 4 Possible Side Effects).

These illnesses can be serious. Usually they start within a few days or weeks of starting the medicine. They are more likely to happen at high doses. Most of these problems go away if the dose is lowered or the medicine is stopped. However, if problems do happen they might need treatment.

Talk to a doctor if you (or someone taking this medicine), shows any signs of mental problems. This is particularly important if you are depressed, or might be thinking about suicide. In a few cases, mental problems have happened when doses are being lowered or stopped.

Undesirable Effects Q. Are there any unwanted effects of Adcortyl IA/ID injection?

A. All medicines may cause some unwanted or “side” effects. Some which can occur with steroid treatment are as follows. Tell your doctor immediately if you get ulcer pains in your stomach or severe pain in your abdomen, facial swelling or an unexpected rash. Patients have reported increased appetite, weight gain, indigestion, sickness, feeling tired or weak. Steroid treatment may cause increased risk of infection, thinning of bones or tendons causing fractures or torn muscles, water retention, irregular heart beat, high blood pressure or blood clots. Skin disorders or eye problems, including glaucoma and cataracts, may occur and wounds or broken bones may be slow to heal. Treatment with steroids can stop the body from producing some hormones and may slow or stop children’s growth rate. If you are female, your periods may become irregular. Elevation or depression of mood, sleeplessness and severe headaches have been reported. Very rare instances of blindness have been reported following injection to the face.

In particular, when Adcortyl IA/ID is injected into a joint you may notice some indentation appearing after a while in the surrounding area. There may also be some temporary worsening of the pain and discomfort after the injection. Similarly, injections given under the skin may cause slight changes in skin colour around the site of injection. These changes should disappear in time.

Serious effects: tell a doctor straight away

Steroids including Adcortyl IA/ID injection can cause serious mental health problems. These are common in both adults and children. They can affect about 5 in every 100 people taking medicines like Adcortyl IA/ID injection.

Feeling depressed, including thinking about suicide. Feeling high (mania) or moods that go up and down. Feeling anxious, having problems sleeping, difficulty in thinking or being confused and losing your memory. Feeling, seeing or hearing things which do not exist. Having strange and frightening thoughts, changing how you act or having feelings of being alone.

If you notice any of these problems talk to a doctor straight away.

Tell your doctor or pharmacist if you notice any other troublesome side effects.

Looking After Your Medicine

Adcortyl IA/ID injection will be kept in the pharmacy until it is given to you by your doctor or nurse. It should be stored upright, at a temperature not exceeding 25°C and should not be allowed to freeze. After first opening, the 5ml multidose vial may be stored for 28 days below 25°C. It should not be used after the expiry date shown on the outer packaging. Keep out of reach and sight of children.

DATE OF LAST REVISION April 2008

1041116A7


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Perindopril Tablets


Perindopril 2mg, 4mg and 8mg Tablets

Perindopril tert-butylamine

Read all of this leaflet carefully before you start taking this medicine Keep this leaflet. You may need to read it again. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours. If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What are Perindopril tablets and what they are used for? 2. What you should know before you take Perindopril tablets. 3. How is Perindopril tablets taken? 4. Possible side effects. 5. How to store Perindopril tablets. 6. Further information. What are Perindopril tablets and what they are used for

Perindopril belongs to a group of medicines called ACE inhibitors. These work by widening the blood vessels. This makes it easier for your heart to pump blood through the body.

Perindopril 2mg or 4mg tablets are used to:

treat high blood pressure (hypertension) treat heart failure (a condition where the heart is unable to pump enough blood to meet the body’s needs) reduce the risk of cardiac events, such as heart attack, in patients with stable coronary artery disease (a condition where the blood supply to the heart is reduced or blocked) and who have already had a heart attack and/or an operation to improve the blood supply to the heart by widening the vessels that supply it.

Perindopril 8mg tablets are used to:

treat high blood pressure (hypertension) reduce the risk of cardiac events, such as heart attack, in patients with stable coronary artery disease (a condition where the blood supply to the heart is reduced or blocked) and who have already had a heart attack and/or an operation to improve the blood supply to the heart by widening the vessels that supply it. Before you take Perindopril tablets Do not take Perindopril tablets: If you are allergic (hypersensitive) to perindopril or to any of the other ingredients of Perindopril tablets or to any other ACE inhibitor (see Further Information, section 6), if you have in the past suffered from acute swelling of the face, tongue or larynx (angioneurotic syndrome), regardless of whether or not it has been caused by treatment with a similar medicine (ACE inhibitor). If you are more than 3 months pregnant. (it is also better to avoid Perindopril tablets in early pregnancy (see pregnancy section).

Children

Perindopril tablets are not for use in children.

Take special care with Perindopril tablets

Talk to your doctor before taking Perindopril tablets if:

you have narrowing of the heart valves (aortic or mitral stenosis) or heart muscle disease (hypertrophic cardiomyopathy) or narrowing of the artery supplying the kidney with blood (renal artery stenosis) if you have recently had a kidney transplant you have any other heart or liver or kidney problems, or if you are having dialysis you have diabetes which is not well controlled you have been told to limit the salt in your diet or to use a salt-substitute containing potassium you have a collagen disease such as systemic lupus erythematosus or scleroderma. you are going to have or are having treatment to reduce the effects of an allergy to bee or wasp stings you are going to have cholesterol removed from your blood by a machine (LDL apheresis). You must tell your doctor if you think you are (or might become) pregnant.
Perindopril tablets are not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after that stage (see pregnancy section).

In the event of the occurrence of a feeling of tightness in the chest and swelling of the face and tongue (angioneurotic oedema), you should immediately notify your doctor and stop the treatment with Perindopril tablets 2mg, 4mg or 8mg. This applies to all ACE inhibitors.

Tell the doctor or pharmacist that you are taking Perindopril tert-butylamine if:

you are about to have an operation or a general anaesthetic you have recently had diarrhoea or vomited your blood pressure is not sufficiently lowered due to ethnic affiliation
(particularly in patients with black skin colour) Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.

In particular, talk to your doctor before taking Perindopril tert-butylamine if you are taking:

medicines for high blood pressure including water tablets (diuretics) water tablets (diuretics) which affect potassium, such as spironolactone, triamterene or amiloride medicines to increase your level of potassium heparin (for thinning the blood) can also affect potassium levels in your blood medicines for diabetes (insulin or tablets) lithium (for mania or depression) medicines for mental illness such as depression, anxiety, schizophrenia or other psychosis allopurinol for gout medicines to treat auto-immune disorders (such as rheumatoid arthritis) or given after transplant surgery. These are called immunosupressants. procainamide (for irregular heartbeat) non-steroidal anti-inflammatory drugs (NSAIDs such as ibuprofen, diclofenac), including aspirin for pain medicines for low blood pressure, shock or asthma (including ephedrine, noradrenaline or adrenaline) medicines that make the blood vessels wider (vasodilators, such as nitrates).

Ask your doctor if you are not sure what these medicines are. Tell the doctor if you have taken any of the medicines listed above in the past, but have now stopped.

Taking Perindopril tablets with food and drink

It is recommended to take Perindopril tablets in the morning before a meal to reduce the influence of food on the way in which the medicine works. Potassium containing food additives or salt substitutes should not be used if you use Perindopril.

Pregnancy and Breastfeeding:

Ask your doctor or pharmacist for advice before taking any medicine

Pregnancy:

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Perindopril tablets before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Perindopril tablets. Perindopril tablets are not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding:

Tell your doctor if you are breast-feeding or about to start breast-feeding. Perindopril tablets are not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Driving and using machines

You may feel dizzy or tired when taking Perindopril tert-butylamine, just as with other ACE inhibitors. If this happens, do not drive or use machines. You must talk to your doctor about this

Important information about some of the ingredients of Perindopril tablets

The tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine

How to take Perindopril tablets

Your doctor will decide on the amount of perindopril tert-butylamine you should start to take. This may be increased depending on your condition and other medicines you are taking. Always take Perindopril tert-butylamine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Do not change the amount of medicine you take unless your doctor tells you. Perindopril tert-butylamine may be used on its own, or with other medicines which lower blood pressure.

Take Perindopril tablets by mouth only. Take them in the morning, before a meal. It is best to take your tablet(s) with a glass of water at the same time each day.

Perindopril tert-butylamine is not for use in children.

The usual dose is:

High blood pressure:

Starting dose - 4mg Perindopril tert-butylamine each day after a month, this may be raised to 8mg each day.
8mg each day is the highest amount normally used.

In older people with high blood pressure the daily amounts are usually:

2mg each day after a month, this may be raised to 4mg each day.
8mg each day is the highest amount used.

Perindopril tert-butylamine 2mg, 4mg or 8mg should only be used with other medicines for high blood pressure which are not also ACE inhibitors.

If you are taking water tablets (diuretics):

your doctor may stop them 2 to 3 days before you start taking Perindopril tert-butylamine. This is to prevent a fall in your blood pressure. if needed, you can start taking water tablets again after you have started Perindopril tert-butylamine. if it is not possible to stop your water tablets, then you can take 2mg of perindopril tert-butylamine as well.

Your doctor or pharmacist will tell you exactly what you should do.

The doctor may start you with 2mg perindopril tert-butylamine if:

your blood pressure is very high you do not have enough water in your body (dehydrated). you have a low level of salt in your blood. you have a heart problem which means that it has difficulty in pumping blood through the body (cardiac decompensation). you have high blood pressure due to the blood vessels in the kidneys being blocked (constriction of the arteries). you have an excessive drop in blood pressure following the initial dose.

Heart failure:

The 8mg strength is not suitable for treatment of this condition.

Starting dose 2mg Perindopril tert-butylamine each day. after 2 weeks, this may be raised to 4mg each day.

Stable coronary artery disease:

the usual starting dose is 4mg Perindopril tert-butylamine once daily after two weeks, this may be raised to 8mg each day.

In older people with stable coronary artery disease the daily amounts are usually:

2mg each day after one week, this may be raised to 4mg each day and after a further week to 8mg each day which is the highest amount used. If you take more perindopril tert-butylamine than you should

Immediately contact your doctor if you have taken too high a dose.

The following effects may happen: low blood pressure, shock, kidney problems, fast breathing, fast heartbeat, uneven heartbeat (palpitations), slow heartbeat, feeling dizzy or anxious and cough.

If you forget to take perindopril tert-butylamine

Do not take a double dose to make up for a forgotten dose.

If you have forgotten to take one or more tablets, you should skip the tablets which you have forgotten. Contact your doctor if in doubt.

If you stop taking perindopril tert-butylamine

Do not stop taking Perindopril tablets without talking to your doctor.

Medicines for high blood pressure or heart failure will normally have to be taken for the rest of your life. If you stop taking Perindopril tablets your condition may get worse.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Perindopril Tablets Side Effects

Like all medicines, perindopril tert-butylamine can cause side effects, although not everyone gets them.

If any of the following effects happen, stop taking your tablets and tell your doctor immediately: swelling of the face, lips, mouth, tongue or throat difficulty in breathing feeling dizzy or faint very fast or uneven heartbeat.

This is a very rare but serious reaction called angioedema, which can happen with all medicines of this type (ACE inhibitors). You must get treatment immediately, usually in hospital.

Common (affecting 1 or more than 1 in 100 but less than 1 in 10 patients) cough, shortness of breath feeling faint due to low blood pressure (especially when you start Perindopril tert-butylamine, or when the amount is increased, or when you also take water tablets) headache, feeling dizzy or tired, feeling dizzy with a spinning sensation (vertigo), pins and needles, muscle cramps, blurred vision, eye pain, sensation of noises in the ears (tinnitus) feeling or being sick, stomach pain or indigestion, changes in your sense of taste, diarrhoea, constipation, skin rash, itching. Uncommon (affecting 1 or more than 1 in 1000 but less than 1 in 100 patients) changes in mood or sleep tight feeling in the chest, wheezing and short of breath (bronchospasm) dry mouth kidney problems unable to get an erection sweating wheezing, swelling of the face, tongue or throat, intense itching, skin rash, fainting or feeling dizzy (angioedema). Very rare (affecting less than 1 in 10,000 patients) feeling confused uneven heartbeat, chest pain that happens in heart disease (angina), heart attack and stroke (these have happened with ACE inhibitors in people with low blood pressure) chest infection (eosinophilic pneumonia), blocked up or runny nose (rhinitis) inflamed pancreas (pancreatitis) inflamed liver (hepatitis) skin reaction like an allergy (erythema multiforme) changes in the blood. Your doctor may carry out blood tests to check for this. acute kidney problems

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Perindopril tablets Keep out of the reach and sight of children. Do not store above 30°C.

Do not use Perindopril tablets after the expiry date which appears on the packet after “do not use after” or “exp”. The first 2 figures show the month, while the last figures show the year.

Medicines should not be disposed of via wastewater or in the household refuse. Ask your pharmacist what you should do with medicines which are no longer required. These measures will help to protect the environment.

Further information What Perindopril tablets contains

The active substance is: perindopril tert-butylamine.

Each Perindopril 2mg tablet contains 2mg of perindopril tert-butylamine salt equivalent to 1.669mg of perindopril.

Each Perindopril 4mg tablet contains 4mg of perindopril tert-butylamine salt equivalent to 3.338mg of perindopril.

Each Perindopril Tablets 8mg tablet contains 8mg of perindopril tert-butylamine salt equivalent to 6.676mg perindopril.

Other ingredients (excipients) are:

Hydrophobic colloidal silica, microcrystalline cellulose, lactose and magnesium stearate.

What Perindopril tablets looks like and contents of the pack

2 mg: White, round, biconvex tablets, plain on both sides.

4 mg: White, oblong tablets with a break line on both sides, ‘PP’ on one side and ‘4’ on the other.

8 mg: White, round, biconvex tablets with ‘PP’ on one side and ‘8’ on the other.

Each strength of tablet is available in packaging containing 14, 20, 28, 30, 56, 60 and 90 tablets in alu-alu blister packaging.

Not all pack sizes may be marketed.

Marketing Authorisation holder and Manufacturer

Marketing Authorisation holder

Actavis Group PTC ehf Reykjavikurvegur 76-78 220 Hafnarfjordur Iceland

Manufacturers

Tillomed Laboratories Ltd 3 Howard Road Eaton Socon St Neots Cambridgeshire PE19 3ET United Kingdom Medicamenta a.s. B?lohorsk? 39/260 169 00 Prague 6 Czech Republic Actavis BV Baarnsche Dijk 1 3741 LN Baarn The Netherlands

This leaflet was last approved in June 2009

Actavis Barnstaple EX32 8NS UK

GLEPL003


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Hexopal 500mg Tablets


1. Name Of The Medicinal Product

Hexopal Tablets 500mg / Inositol Nicotinate Tablets BP 500mg.

2. Qualitative And Quantitative Composition

Inositol Nicotinate BP 500mg.

3. Pharmaceutical Form

Tablet.

4. Clinical Particulars 4.1 Therapeutic Indications

Hexopal is indicated for the symptomatic relief of severe intermittent claudication and Raynaud's phenomenon.

4.2 Posology And Method Of Administration

For oral administration.

Adults (including the elderly): The usual dose is 3g daily (i.e. 2 tablets three times a day). The dose may be increased to 4g daily if necessary.

Children: Not recommended.

4.3 Contraindications

Use in patients who have suffered a recent myocardial infarction or are in the acute phase of a cerebrovascular accident.

Use in patients hypersensitive to the active ingredient.

4.4 Special Warnings And Precautions For Use

This product should be used with caution in the presence of cerebrovascular insufficiency or unstable angina.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None.

4.6 Pregnancy And Lactation

There is no evidence of the safety of Hexopal in human pregnancy nor is there adequate evidence from animal work that it is free from hazard. The use of Hexopal in pregnancy should therefore be avoided unless there is no safer alternative.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

Side effects are uncommon, but may include flushing, dizziness, headache, nausea, vomiting, syncope, paraesthesia, rash, oedema, and postural hypotension.

4.9 Overdose

Despite extensive clinical experience in Britain since 1959, no case of poisoning or overdosage with Hexopal has been reported. In an emergency, it is suggested that the stomach be emptied by gastric lavage and the patient be treated symptomatically.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

The mode of action of inositol nicotinate in Raynaud's phenomenon and in intermittent claudication remains to be determined. Inositol nicotinate does not appear to produce general peripheral vasodilation.

5.2 Pharmacokinetic Properties

Radiolabelled tracer studies indicate that with orally administered inositol nicotinate very low concentrations of nicotinic acid are found in the plasma. These levels appear to be maintained for approximately 24 hours.

5.3 Preclinical Safety Data

There are no preclinical safety 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

Pregelatinised starch, Maize starch, Purified talc, Magnesium stearate, Stearic acid, Sodium lauryl sulphate.

6.2 Incompatibilities

None.

6.3 Shelf Life

60 months.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

Amber glass bottle with wadless polypropylene screws caps.

Pack size: 100 and 500 tablets.

200µm white opaque PVC/20µm aluminium blister pack.

Pack size: 100 tablets.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Genus Pharmaceuticals Limited (trading as Genus Pharmaceuticals)

Park View House

65 London Road

Newbury

Berkshire

RG14 1JN UK

8. Marketing Authorisation Number(S)

PL 06831/0147

9. Date Of First Authorisation/Renewal Of The Authorisation

10th May 2005

10. Date Of Revision Of The Text

15 January 2008


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POSALFILIN Ointment


POSALFILIN Ointment

Salicylic Acid BP 25% w/w and Podophyllum Resin BP 20%w/w

Read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription but you still need to use POSALFILIN 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 If any of the side effects become serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

If you need the information on this leaflet in an alternative format, such as large text, or Braille please ring from the UK: 0800 198 5000.

In this leaflet: 1. What POSALFILIN Ointment is and what it is used for 2. Before you use POSALFILIN Ointment 3. How to use POSALFILIN Ointment 4. Possible side effects 5. How to store POSALFILIN Ointment 6. Further information What Posalfilin Ointment Is And What It Is Used For

POSALFILIN Ointment is used to treat warts (verrucas) on the soles of the feet. Verrucas are infectious, small growths of the skin caused by a specific virus. If left untreated they can grow and spread.

POSALFILIN Ointment contains salicylic acid and podophyllum resin which work together to treat the verrucas by softening the skin (salicylic acid) and killing the virus (podophyllum resin).

Before You Use Posalfilin Ointment Do not use POSALFILIN if: You are pregnant, thinking of becoming pregnant or are breast-feeding You are diabetic, You have poor circulation, or have little feeling in your feet (peripheral neuropathy) The wart is bleeding or crumbling

POSALFILIN should not be used on the skin of the face, armpits, or the bottom or genital (sex) regions.

Take care when using POSALFILIN ointment as it may burn healthy skin. Stop using POSALFILIN if your skin becomes red and inflamed. If you do get any ointment on your healthy skin wipe off with a tissue immediately.

Taking/using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Do not use POSALFILIN Ointment if you are pregnant or thinking of becoming pregnant or are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

How To Use Posalfilin Ointment

Always use POSALFILIN Ointment exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. POSALFILIN ointment should be used daily.

To use POSALFILIN ointment: Place a corn ring (available from your pharmacist) around the wart. You may need to cut the ring to fit the area. Apply as little ointment as you can to the wart. Take care not to get any POSALFILIN ointment on your normal skin. If you do get any ointment on your healthy skin wipe off with a tissue immediately. Now cover the wart and corn ring with a plaster. Wash your hands. Repeat this every day until the wart is soft and spongy. Stop the treatment and do not cover with a plaster. After a few days the wart should drop off. If it does not, start using POSALFILIN ointment again. If you use more POSALFILIN ointment than you should

Using too much POSALFILIN ointment may burn your skin and you may need to see your doctor. If you do get any ointment on your healthy skin wipe off with a tissue immediately.

If you forget to use POSALFILIN ointment

Do not double the dose, use POSALFILIN ointment the next day when you remember.

If you have any further questions on the use of this product, ask your doctor or pharmacist

POSALFILIN Ointment Side Effects

Like all medicines, POSALFILIN ointment can cause side effects, although not everybody gets them.

POSALFILIN ointment can burn healthy skin. If this happens stop using POSALFILIN Ointment until it heals. Tell your doctor if you think POSALFILIN ointment is causing a problem.

If any of the side effects become serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Posalfilin Ointment

Keep all medicines out of the reach and sight of children.

Do not store above 25°C.

Do not use POSALFILIN Ointment after the expiry date which is stated on the carton and tube as month/year. The expiry date refers to the last day of the month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information What POSALFILIN ointment contains

The active substances are podophyllum resin BP and salicylic acid BP. Each tube contains 20% w/w podophyllum resin BP and 25% w/w salicylic acid BP.

The other ingredients are yellow soft paraffin and liquid paraffin.

What POSALFILIN ointment looks like and contents of the pack

POSALFILIN ointment is a dark brown ointment that comes in a 10g tube. Each pack contains one tube.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder is

Norgine Ltd. Moorhall Road Harefield Middlesex UB9 6NS UK

It is made by

Norgine Ltd. Hengoed Mid Glamorgan CF82 8SJ UK

UK Marketing Authorisation Holder: PL 00322/5901R

The leaflet was last approved in: 11 August 2008


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Methylsulfonylmethane


Pronunciation: Not applicable.
Generic Name: Methylsulfonylmethane
Brand Name: Generics only. No brands available.
Methylsulfonylmethane is used for:

Pain and swelling in muscles and joints. It may have other uses as well. Check with your pharmacist for more details regarding the particular brand you use.

This product is a naturally occurring chemical, which provides a dietary source of sulfur. It is thought to work by reducing pain and swelling in the joints.

Do NOT use Methylsulfonylmethane if: you are allergic to any ingredient in Methylsulfonylmethane or to any other sulfa or sulfonamide (eg, sulfisoxazole, sulfamethoxazole)

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

Before using Methylsulfonylmethane:

Some medical conditions may interact with Methylsulfonylmethane. 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 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 Methylsulfonylmethane. However, no specific interactions are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Methylsulfonylmethane 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 Methylsulfonylmethane:

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

Dosing depends on the use and the source of the product. Use as directed on the package, unless instructed otherwise by your doctor. If you miss taking a dose of Methylsulfonylmethane for 1 or more days, there is no cause for concern. If your doctor recommended that you take it, try to remember your dose every day.

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

Important safety information: Keep all doctor and laboratory appointments while you are taking this product. This product has not been approved by the Food and Drug Administration (FDA) as safe and effective for any medical condition. The long-term safety of dietary supplements is not known. Before using any alternative medicine, talk with your doctor or pharmacist. PREGNANCY and BREAST-FEEDING: Do not use this product if you are pregnant. Do not breast-feed while using this product. Possible side effects of Methylsulfonylmethane:

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.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; 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: Methylsulfonylmethane 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. Symptoms may include lethargy; paralysis.

Proper storage of Methylsulfonylmethane:

Store at room temperature away from heat, moisture, and light unless otherwise directed on the package label. Do not store in the bathroom. Most dietary supplements are not in childproof containers. Keep Methylsulfonylmethane out of the reach of children and away from pets.

General information: If you have any questions about Methylsulfonylmethane, please talk with your doctor, pharmacist, or other health care provider. Methylsulfonylmethane 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 Methylsulfonylmethane. 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 Methylsulfonylmethane resources Methylsulfonylmethane Side Effects (in more detail) Methylsulfonylmethane Use in Pregnancy & Breastfeeding Methylsulfonylmethane Support Group 2 Reviews for Methylsulfonylmethane - Add your own review/rating Compare Methylsulfonylmethane with other medications Dietary Supplementation Muscle Pain
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Radian B Muscle Rub


1. Name Of The Medicinal Product

Radian B Muscle Rub or Askit Muscle Rub or Radian Massage Cream or Radian B Sport Muscle Rub.

2. Qualitative And Quantitative Composition

Menthol

2.54% w/w

Camphor

1.41% w/w

Methyl Salicylate

0.42% w/w

Camphor Oil, White

0.32%w/w

Oleoresin Capsicum 500,000 Water soluble (equivalent to 0.000125% capsaicin)

0.005% w/w

Camphor and Camphor Oil, White are collectively declared as: Camphor BP

1.43% w/w

3. Pharmaceutical Form

Cream

4. Clinical Particulars 4.1 Therapeutic Indications

For the symptomatic relief of muscular and rheumatic aches and pains, including; muscular stiffness, bruising, sprains, fibrositis.

4.2 Posology And Method Of Administration

For external use application.

Adult and children over 6

Apply to the affected parts and slowly massage well into the skin. For muscular strains and stiffness it is best used after a hot bath.

Elderly

The adult dose is appropriate

Children

Not recommended for children under 6.

4.3 Contraindications

Not to be used on children under 6 years old.

Do not apply to skin abrasions.

Do not apply to irritated skin

4.4 Special Warnings And Precautions For Use

Keep away from eyes and sensitive areas. If symptoms persist consult a doctor.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

There have been reports that topical salicylates may potentiate the anticoagulant effects of warfarin.

4.6 Pregnancy And Lactation

There is no, or inadequate evidence of safety in human pregnancy. Use in pregnancy only when there is no safer alternative. Use in lactation is acceptable.

4.7 Effects On Ability To Drive And Use Machines

Not applicable

4.8 Undesirable Effects

Use sparingly on tender skin and do not cover immediately after application. If an adverse reaction occurs discontinue use immediately. Known side effects of menthol - contact dermatitis or eczema, hypersensitivity reactions characterised by urticaria, flushing and headache.

4.9 Overdose

When used externally as directed, overdose is unlikely.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Radian Massage Cream is a smooth, off-white cream which incorporates menthol, camphor, methyl salicylate, capsicine and white camphor oil as active ingredients and glycerol as emollient.

Menthol relieves itching, dilates the vessels causing a sensation of coldness followed by an analgesic effect. Camphor acts as a rubefacient and mild analgesic and is employed as a counter-irritant. Methyl salicylate has the actions of the salicylates. It is readily absorbed through the skin and has counter-irritant properties. Capsicine has counter-irritant properties and white camphor oil is a rubefacient and mild counter-irritant.

5.2 Pharmacokinetic Properties

None available

5.3 Preclinical Safety Data

Not applicable

6. Pharmaceutical Particulars 6.1 List Of Excipients

Argobase S.1

(contains: Lanolin, Lanolin alcohol, Cetostearyl alcohol, Liquid paraffin)

Emulsifying Wax

White Petroleum Jelly

2,4-dichlorobenzyl alcohol

Imidurea

Industrial Mehtylated Spirit 95

Purified Water

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

Lacquered aluminium tube and plastic cap. White plastic screw-cap jar. Pack sizes: 15, 25, 40, 70, 100, 650gm.

6.6 Special Precautions For Disposal And Other Handling

No special precautions necessary.

7. Marketing Authorisation Holder

Thornton & Ross Limited

Linthwaite

Huddersfield

West Yorkshire

HD7 5QH

United Kingdom

8. Marketing Authorisation Number(S)

PL 00240/0360

9. Date Of First Authorisation/Renewal Of The Authorisation

30th April 2002

10. Date Of Revision Of The Text

December 2003


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Shark Cartilage


Pronunciation: Not applicable.
Generic Name: Shark Cartilage
Brand Name: Generics only. No brands available.
Shark Cartilage is used for:

An addition to cancer therapy to lessen pain and improve appetite. Shark cartilage is also claimed to be useful in psoriasis and arthritis. It may also have other uses. Check with your pharmacist for more details regarding the particular brand you use.

Shark Cartilage is finely ground cartilage from sharks. It is thought to work by providing a protein substance that blocks new blood networks from forming. Tumors and certain other diseases are dependent on new blood networks.

Do NOT use Shark Cartilage if: you are allergic to any ingredient in Shark Cartilage

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

Before using Shark Cartilage:

Some medical conditions may interact with Shark Cartilage. 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 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 high calcium levels in the blood or a history of liver disease

Some MEDICINES MAY INTERACT with Shark Cartilage. However, no specific interactions are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Shark Cartilage 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 Shark Cartilage:

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

Dosing depends on the use and the source of the product. Use as directed on the package, unless instructed otherwise by your doctor. If you miss taking a dose of Shark Cartilage for 1 or more days, there is no cause for concern. If your doctor recommended that you take it, try to remember your dose every day.

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

Important safety information: Check with your doctor before you begin taking any new medicine, either prescription or over-the-counter. This product has not been approved by the Food and Drug Administration (FDA) as safe and effective for any medical condition. The long-term safety of dietary supplements is not known. Before using any alternative medicine, talk with your doctor or pharmacist. Keep all doctor and laboratory appointments while taking Shark Cartilage. PREGNANCY and BREAST-FEEDING: Do not take this product if you are pregnant. Do not breast-feed while taking this product. Possible side effects of Shark Cartilage:

All medicines may cause side effects, but many people have no, or minor, side effects. 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); behavior changes; hyperactivity; severe mood swings or unusual irritability.

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: Shark Cartilage 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 Shark Cartilage:

Store at room temperature away from heat, moisture, and light unless otherwise directed on the package label. Do not store in the bathroom. Most dietary supplements are not in childproof containers. Keep Shark Cartilage out of the reach of children and away from pets.

General information: If you have any questions about Shark Cartilage, please talk with your doctor, pharmacist, or other health care provider. Shark Cartilage 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 Shark Cartilage. 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 Shark Cartilage resources Shark Cartilage Side Effects (in more detail) Shark Cartilage Use in Pregnancy & Breastfeeding Shark Cartilage Support Group 0 Reviews for Shark Cartilage - Add your own review/rating Compare Shark Cartilage with other medications Herbal Supplementation
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penicillin G potassium


Generic Name: penicillin G potassium (PEN i SIL in G poe TAS ee um)
Brand Names: Pfizerpen

What is penicillin G potassium?

Penicillin G potassium is a fast-acting antibiotic that fights bacteria in your body.

Penicillin G potassium is used to treat many different types of severe infections, including strep and staph infections, diphtheria, meningitis, gonorrhea, and syphilis.

Penicillin G potassium is also used to prevent infections of the heart valves in people with certain heart conditions who need to have dental work or surgery.

Penicillin G potassium may also be used for purposes not listed in this medication guide.

What is the most important information I should know about penicillin G potassium? You should not use this medication if you are allergic to penicillin. Tell your doctor if you have ever had an allergic reaction to a cephalosporin antibiotic such as Ceftin, Cefzil, Omnicef, Keflex, and others.

Before using penicillin G potassium, tell your doctor if you have asthma or a history of allergies, liver disease, kidney disease, or heart disease.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Penicillin G potassium will not treat a viral infection such as the common cold or flu.

After you have finished your treatment with penicillin G potassium, your doctor may want to do tests to make sure your infection has completely cleared up.

What should I discuss with my healthcare provider before taking penicillin G potassium? You should not use this medication if you are allergic to penicillin. Tell your doctor if you have ever had an allergic reaction to a cephalosporin antibiotic such as Ceftin, Cefzil, Omnicef, Keflex, and others.

To make sure you can safely use penicillin G potassium, tell your doctor if you have any of these other conditions:

asthma or a history of allergies;

liver disease;

kidney disease; or

heart disease.

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. Penicillin G potassium 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 penicillin G potassium?

Penicillin G potassium is injected into a muscle or into a vein through an IV. You may be shown how to use an injection at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Penicillin G potassium may also be injected into the membrane surrounding the lungs, or into the fluid surrounding the spinal cord. The medicine must be given slowly through an IV infusion, and can take up to 24 hours to complete.

Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Penicillin G potassium will not treat a viral infection such as the common cold or flu.

If you use this medication long-term, your blood may need to be tested to make sure the medicine is not causing harmful effects. Your kidney or liver function may also need to be tested. Visit your doctor regularly.

This medication can cause false results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using penicillin G potassium.

After you have finished your treatment with penicillin G potassium, your doctor may want to do tests to make sure your infection has completely cleared up.

Store the powder at room temperature away from moisture and heat. After mixing the powder with a diluent, store in the refrigerator and use it within 7 days. Do not freeze. Penicillin G potassium that is supplied as a frozen solution should be stored in a deep freezer at a temperature of 4 degrees below 0 (F).

Thaw the solution either in a refrigerator or at room temperature. Do not heat the medicine to thaw it more quickly.

Penicillin G potassium that is thawed in the refrigerator should be used within 14 days. If you have thawed the medicine at room temperature, you must use it within 24 hours. Do not refreeze.

Once the solution has been thawed, it should look clear. Do not use the medicine if it looks cloudy or has particles in it, or if the medicine container leaks. Call your doctor or pharmacist for a new prescription.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the 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 confusion, agitation, hallucinations, or seizure (convulsions).

What should I avoid while taking penicillin G potassium?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking this medication and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Penicillin G potassium 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;

blood in your urine;

feeling like you might pass out;

fever, chills, swollen glands, body aches, flu symptoms, rash or itching, muscle or joint pain, night sweats, general ill feeling;

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

urinating less than usual or not at all;

skin rash with bruising, severe tingling, numbness, pain, muscle weakness;

swelling in your hands or feet;

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

easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

twitching or uncontrollable muscle movements; or

increased thirst, feeling restless, increased urination, muscle pain or weakness, irregular heart rate, weak pulse, tingly feeling, feeling light-headed, fainting, or seizure (convulsions).

Less serious side effects may include:

overactive reflexes;

nausea, vomiting;

black or hairy tongue; or

pain, swelling, bruising, or irritation around the IV needle.

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.

Penicillin G potassium Dosing Information

Usual Adult Dose for Streptococcal Infection:

Serious infections due to susceptible strains of streptococci (including Streptococcus pneumoniae): 12 million to 24 million units/day IV in divided doses every 4 to 6 hours, depending on the nature and severity of the infection
Such infections include septicemia, empyema, pneumonia, pericarditis, endocarditis, and meningitis.

Usual Adult Dose for Bacterial Infection:

Serious infections due to susceptible strains of staphylococci: 5 million to 24 million units/day IV in divided doses every 4 to 6 hours, depending on the nature and severity of the infection
Such infections include septicemia, empyema, pneumonia, pericarditis, endocarditis, and meningitis.
Pasteurella infections (including bacteremia and meningitis): 4 million to 6 million units/day IV in divided doses every 4 to 6 hours for 2 weeks

Usual Adult Dose for Pneumonia:

Serious infections due to susceptible strains of streptococci: 12 million to 24 million units/day IV in divided doses every 4 to 6 hours, depending on the nature and severity of the infection
Serious infections due to susceptible strains of staphylococci: 5 million to 24 million units/day IV in divided doses every 4 to 6 hours, depending on the nature and severity of the infection

Usual Adult Dose for Septicemia:

Serious infections due to susceptible strains of streptococci: 12 million to 24 million units/day IV in divided doses every 4 to 6 hours, depending on the nature and severity of the infection
Serious infections due to susceptible strains of staphylococci: 5 million to 24 million units/day IV in divided doses every 4 to 6 hours, depending on the nature and severity of the infection

Usual Adult Dose for Endocarditis:

Serious infections due to susceptible strains of streptococci: 12 million to 24 million units/day IV in divided doses every 4 to 6 hours, depending on the nature and severity of the infection
Serious infections due to susceptible strains of staphylococci: 5 million to 24 million units/day IV in divided doses every 4 to 6 hours, depending on the nature and severity of the infection
Erysipelothrix rhusiopathiae: 2 million to 20 million units/day IV in divided doses every 4 to 6 hours for 4 to 6 weeks
Listeria monocytogenes: 15 million to 20 million units/day IV in divided doses every 4 to 6 hours for 4 weeks

Usual Adult Dose for Meningitis:

Serious infections due to susceptible strains of streptococci: 12 million to 24 million units/day IV in divided doses every 4 to 6 hours, depending on the nature and severity of the infection
Serious infections due to susceptible strains of staphylococci: 5 million to 24 million units/day IV in divided doses every 4 to 6 hours, depending on the nature and severity of the infection
Listerial meningitis: 15 million to 20 million units/day IV in divided doses every 4 to 6 hours for 2 weeks
Pasteurella meningitis: 4 million to 6 million units/day IV in divided doses every 4 to 6 hours for 2 weeks

Usual Adult Dose for Meningitis -- Meningococcal:

Meningococcal meningitis and/or septicemia: 1 million to 2 million units IM every 2 hours or 20 million to 30 million units/day as a continuous IV infusion for at least 10 to 14 days
If meningococcal meningitis is suspected, immediate treatment with penicillin is required, and should be started before lumbar puncture confirmation of the diagnosis. The mortality of this disease is 50% within the first 24 hours.

Usual Adult Dose for Meningitis -- Pneumococcal:

Serious infections due to susceptible strains: 12 million to 24 million units/day IV in divided doses every 4 to 6 hours, depending on the nature and severity of the infection

Usual Adult Dose for Neurosyphilis:

Manufacturers recommendation: 2 million to 4 million units IV every 4 hours for 10 to 14 days
Centers for Disease Control and Prevention (CDC) recommendation: 3 million to 4 million units IV every 4 hours or 18 million to 24 million units/day as a continuous infusion for 10 to 14 days
Many experts recommend additional therapy with penicillin G benzathine 2.4 million units IM once a week for up to 3 weeks following completion of IV therapy.

Usual Adult Dose for Actinomycosis:

Cervicofacial disease: 1 million to 6 million units/day IV in divided doses every 4 to 6 hours
Thoracic and abdominal disease: 10 million to 20 million units/day IV in divided doses every 4 to 6 hours
Duration: Prolonged therapy (1.5 to 18 months or longer) may be necessary. Four to 6 weeks followed by oral therapy for 6 to 12 months, depending on the nature and severity of the infection, has been recommended for patients with pulmonary actinomycosis or other severe infections caused by the organism.

Usual Adult Dose for Inhalation Bacillus anthracis:

Treatment of penicillin-susceptible anthrax:
As the result of naturally occurring or endemic anthrax exposure: Minimum of 8 million units/day IV in divided doses every 6 hours; higher doses may be needed depending on susceptibility of organism
Dosages up to 20 million units/day IV have been used to treat anthrax septicemia and intestinal, pulmonary, and meningeal anthrax. Some clinicians recommend 8 million to 12 million units/day in divided doses every 4 to 6 hours for the treatment of anthrax due to natural or endemic anthrax exposures.
Duration: At least 14 days after symptoms abate
As the result of exposure to B anthracis spores during biologic warfare or bioterrorism: 4 million units IV every 4 hours; oral therapy may be substituted once the patient's clinical condition improves
Treatment of inhalation anthrax should be started with a multiple-drug parenteral regimen that includes ciprofloxacin or doxycycline plus 1 or 2 additional antibiotics with activity against the causative organism. A multiple-drug parenteral regimen is also recommended for initial treatment of cutaneous anthrax if there are signs of systemic involvement, extensive edema, or lesions on the head or neck. Due to concerns regarding resistance, penicillin alone is not recommended for inhalation anthrax that occurs as the result of biologic warfare or bioterrorism since high concentrations of the organism are expected, but it can be included in appropriate combination therapies.
Duration: 60 days (including IV and oral therapy)

Usual Adult Dose for Cutaneous Bacillus anthracis:

Treatment of penicillin-susceptible anthrax:
As the result of naturally occurring or endemic anthrax exposure: Minimum of 8 million units/day IV in divided doses every 6 hours; higher doses may be needed depending on susceptibility of organism
Dosages up to 20 million units/day IV have been used to treat anthrax septicemia and intestinal, pulmonary, and meningeal anthrax. Some clinicians recommend 8 million to 12 million units/day in divided doses every 4 to 6 hours for the treatment of anthrax due to natural or endemic anthrax exposures.
Duration: At least 14 days after symptoms abate
As the result of exposure to B anthracis spores during biologic warfare or bioterrorism: 4 million units IV every 4 hours; oral therapy may be substituted once the patient's clinical condition improves
Treatment of inhalation anthrax should be started with a multiple-drug parenteral regimen that includes ciprofloxacin or doxycycline plus 1 or 2 additional antibiotics with activity against the causative organism. A multiple-drug parenteral regimen is also recommended for initial treatment of cutaneous anthrax if there are signs of systemic involvement, extensive edema, or lesions on the head or neck. Due to concerns regarding resistance, penicillin alone is not recommended for inhalation anthrax that occurs as the result of biologic warfare or bioterrorism since high concentrations of the organism are expected, but it can be included in appropriate combination therapies.
Duration: 60 days (including IV and oral therapy)

Usual Adult Dose for Botulism:

Adjunctive therapy to antitoxin: 20 million units/day IV in divided doses every 4 to 6 hours
Wound botulism (as an adjunct to antitoxin, supportive care, and surgical debridement): 2 million units IV every 4 hours plus metronidazole 250 mg IV every 6 hours

Usual Adult Dose for Tetanus:

Adjunctive therapy to human tetanus immune globulin: 20 million units/day in divided doses every 4 to 6 hours

Usual Adult Dose for Clostridial Infection:

Gas gangrene (debridement and/or surgery as indicated): 20 million units/day in divided doses every 4 to 6 hours

Usual Adult Dose for Diphtheria:

As an adjunct to antitoxin and to prevent carrier state: 2 million to 3 million units/day IV in divided doses every 4 to 6 hours for 10 to 12 days
To eliminate carrier state: 300,000 to 400,000 units/day IM in divided doses for 10 to 12 days

Usual Adult Dose for Fusospirochetosis:

Severe infections of the oropharynx (Vincent's), lower respiratory tract, and genital area: 5 million to 10 million units/day IV in divided doses every 4 to 6 hours

Usual Adult Dose for Bacteremia:

Pasteurella bacteremia: 4 million to 6 million units/day IV in divided doses every 4 to 6 hours for 2 weeks

Usual Adult Dose for Rat-bite Fever:

Infections due to Streptobacillus moniliformis (rat-bite fever or Haverhill fever) or Spirillum minus (rat-bite fever): 12 million to 20 million units/day IV in divided doses every 4 to 6 hours for 3 to 4 weeks

Usual Adult Dose for Lyme Disease -- Neurologic:

Early Lyme disease with acute neurologic disease manifested by meningitis or radiculopathy: 18 million to 24 million units/day IV in divided doses every 4 hours
Late Lyme disease and associated neurologic disease affecting the CNS or peripheral nerve disease (e.g., neuropathy, encephalopathy) and documented by CSF analysis: 18 million to 24 million units/day IV in divided doses every 4 to 6 hours
Duration: 14 to 28 days
Penicillin G is recommended as an alternative to IV ceftriaxone. Ceftriaxone is considered the parenteral drug of choice.

Usual Adult Dose for Lyme Disease -- Carditis:

Third-degree atrioventricular (AV) heart block or a PR interval exceeding 0.3 seconds: 18 million to 24 million units/day IV in divided doses every 4 to 6 hours, with cardiac monitoring and a temporary pacemaker for complete heart block
Duration: 14 to 21 days
Penicillin G is recommended as an alternative to IV ceftriaxone. Ceftriaxone is considered the parenteral drug of choice.

Usual Adult Dose for Lyme Disease -- Arthritis:

Recurrent arthritis after oral treatment: 18 million to 24 million units/day IV in divided doses every 4 hours for 14 to 28 days
Penicillin G is recommended as an alternative to IV ceftriaxone for patients with late Lyme disease who have arthritis and objective proof of neurologic disease. It is also recommended as an alternative for patients with persistent or recurrent arthritis after oral treatment; IV therapy is only recommended in those patients whose arthritis showed no improvement or worsened. Ceftriaxone is considered the parenteral drug of choice.

Usual Adult Dose for Prevention of Perinatal Group B Streptococcal Disease:

5 million units IV at onset of labor or after membrane rupture followed by 2.5 million units IV every 4 hours until delivery

Usual Adult Dose for Leptospirosis:

1.5 million units IV every 6 hours for 7 days

Usual Adult Dose for Deep Neck Infection:

2 million to 4 million units IV or IM every 4 to 6 hours for 2 to 3 weeks, depending on the nature and severity of the infection
The addition of metronidazole to high-dose penicillin therapy is recommended by many experts to treat parapharyngeal infections because of the increasing frequency of penicillin-resistant anaerobes. Removal of abscessed material is also necessary for successful treatment.

Usual Adult Dose for Skin or Soft Tissue Infection:

Erysipelas: 1 million to 2 million units IV every 4 to 6 hours
Streptococcal cellulitis: 1 million to 2 million units IV every 6 hours for 7 to 10 days

Usual Adult Dose for Aspiration Pneumonia:

2 million to 3 million units IV every 4 to 6 hours plus metronidazole 500 mg IV every 8 hours for 7 to 14 days, depending on the nature and severity of the infection

Usual Adult Dose for Joint Infection:

2 million to 3 million units IV every 4 hours for 2 weeks, depending on the nature and severity of the infection

Usual Adult Dose for Gonococcal Infection -- Disseminated:

Infections (such as meningitis, endocarditis, arthritis, etc.) caused by penicillin-susceptible organisms: 10 million units/day IV in divided doses every 4 to 6 hours
Duration: Depends on the nature and severity of the infection
Due to resistance, penicillin G is not recommended by the CDC. Ceftriaxone is the drug of choice.

Usual Adult Dose for Gram Negative Infection:

Gram-negative bacillary bacteremia (Escherichia coli, Enterobacter aerogenes, Alcaligenes faecalis, Salmonella, Shigella, and Proteus mirabilis): 20 million to 80 million units per day
Penicillin G is not the drug of choice in the treatment of gram-negative bacillary infections. Other more effective anti-infectives are usually used for the treatment of these infections.

Usual Pediatric Dose for Bacterial Infection:

American Academy of Pediatrics (AAP) recommendations:
Neonates:
7 days or less:
2000 g or less: 25,000 to 50,000 units/kg IM or IV every 12 hours
Greater than 2000 g: 25,000 to 50,000 units/kg IM or IV every 8 hours
Greater than 7 days:
Less than 1200 g: 25,000 to 50,000 units/kg IM or IV every 12 hours
1200 to 2000 g: 25,000 to 50,000 units/kg IM or IV every 8 hours
Greater than 2000 g: 25,000 to 50,000 units/kg IM or IV every 6 hours
Infants and children:
Mild to moderate infections: 100,000 to 250,000 units/kg/day IM or IV in divided doses every 4 to 6 hours
Severe infections: 250,000 to 400,000 units/kg/day IM or IV in 4 to 6 divided doses
Maximum dose: 24 million units/day

Usual Pediatric Dose for Endocarditis:

Manufacturers recommendation:
Serious infections, such as pneumonia and endocarditis, due to susceptible strains of streptococci (including S pneumoniae) and meningococcus: 150,000 to 300,000 units/kg/day IV in divided doses every 4 to 6 hours
The duration of therapy depends on the nature and severity of the infection.

Usual Pediatric Dose for Pneumonia:

Manufacturers recommendation:
Serious infections, such as pneumonia and endocarditis, due to susceptible strains of streptococci (including S pneumoniae) and meningococcus: 150,000 to 300,000 units/kg/day IV in divided doses every 4 to 6 hours
The duration of therapy depends on the nature and severity of the infection.

Usual Pediatric Dose for Streptococcal Infection:

Manufacturers recommendation:
Serious infections, such as pneumonia and endocarditis, due to susceptible strains of streptococci (including S pneumoniae) and meningococcus: 150,000 to 300,000 units/kg/day IV in divided doses every 4 to 6 hours
The duration of therapy depends on the nature and severity of the infection.

Usual Pediatric Dose for Meningitis -- Meningococcal:

Manufacturers recommendation: 250,000 units/kg/day IV in divided doses every 4 hours for 7 to 14 days, depending on the nature and severity of the infection
Maximum dose: 12 million to 20 million units/day

Usual Pediatric Dose for Meningitis -- Pneumococcal:

Manufacturers recommendation: 250,000 units/kg/day IV in divided doses every 4 hours for 7 to 14 days, depending on the nature and severity of the infection
Maximum dose: 12 million to 20 million units/day
AAP recommendation:
1 month or older: 250,000 to 400,000 units/kg/day IV in 4 to 6 divided doses

Usual Pediatric Dose for Meningitis -- Streptococcus Group B:

AAP recommendation:
Neonates 7 days or younger: 250,000 to 450,000 units/kg/day IV in 3 divided doses
Neonates older than 7 days: 450,000 units/kg/day IV in 4 divided doses

Usual Pediatric Dose for Congenital Syphilis:

Less than 1 month (symptomatic neonates and neonates with proven or presumed congenital syphilis): 50,000 units/kg IV every 12 hours during the first 7 days of life and every 8 hours thereafter for 10 days total; if more than 1 day of therapy is missed in patients with proven or highly probable disease, the entire course should be repeated
1 month or older: 50,000 units/kg IV every 4 to 6 hours for 10 days; some clinicians recommend following this regimen with penicillin G benzathine 50,000 units/kg IM once a week for 1 to 3 weeks

Usual Pediatric Dose for Neurosyphilis:

Manufacturers recommendation:
1 month or older: 50,000 units/kg IV every 4 to 6 hours for 10 to 14 days
CDC recommendation:
Adolescents: 3 million to 4 million units IV every 4 hours or 18 million to 24 million units/day as a continuous infusion for 10 to 14 days; many experts recommend additional therapy with penicillin G benzathine 2.4 million units IM once a week for up to 3 weeks following completion of IV therapy

Usual Pediatric Dose for Inhalation Bacillus anthracis:

Treatment of penicillin-susceptible anthrax:
As the result of naturally occurring or endemic anthrax exposure:
Children: Some clinicians recommend 100,000 to 150,000 units/kg/day in divided doses every 4 to 6 hours.
Duration: At least 14 days after symptoms abate
As the result of exposure to B anthracis spores during biologic warfare or bioterrorism:
Children less than 12 years: 50,000 units/kg IV every 6 hours; oral therapy may be substituted once the patient's clinical condition improves
Treatment of inhalation anthrax should be started with a multiple-drug parenteral regimen that includes ciprofloxacin or doxycycline plus 1 or 2 additional antibiotics with activity against the causative organism. A multiple-drug parenteral regimen is also recommended for initial treatment of cutaneous anthrax if there are signs of systemic involvement, extensive edema, or lesions on the head or neck. Due to concerns regarding resistance, penicillin alone is not recommended for inhalation anthrax that occurs as the result of biologic warfare or bioterrorism since high concentrations of the organism are expected, but it can be included in appropriate combination therapies.
Duration: 60 days (including IV and oral therapy)

Usual Pediatric Dose for Cutaneous Bacillus anthracis:

Treatment of penicillin-susceptible anthrax:
As the result of naturally occurring or endemic anthrax exposure:
Children: Some clinicians recommend 100,000 to 150,000 units/kg/day in divided doses every 4 to 6 hours.
Duration: At least 14 days after symptoms abate
As the result of exposure to B anthracis spores during biologic warfare or bioterrorism:
Children less than 12 years: 50,000 units/kg IV every 6 hours; oral therapy may be substituted once the patient's clinical condition improves
Treatment of inhalation anthrax should be started with a multiple-drug parenteral regimen that includes ciprofloxacin or doxycycline plus 1 or 2 additional antibiotics with activity against the causative organism. A multiple-drug parenteral regimen is also recommended for initial treatment of cutaneous anthrax if there are signs of systemic involvement, extensive edema, or lesions on the head or neck. Due to concerns regarding resistance, penicillin alone is not recommended for inhalation anthrax that occurs as the result of biologic warfare or bioterrorism since high concentrations of the organism are expected, but it can be included in appropriate combination therapies.
Duration: 60 days (including IV and oral therapy)

Usual Pediatric Dose for Diphtheria:

Manufacturers recommendation:
As an adjunct to antitoxin and to prevent carrier state: 150,000 to 250,000 units/kg/day IV in divided doses every 6 hours for 7 to 10 days
AAP recommendation:
As an adjunct to antitoxin: 100,000 to 150,000 units/kg/day IV in 4 divided doses for 14 days

Usual Pediatric Dose for Rat-bite Fever:

Infections due to S moniliformis (rat-bite fever or Haverhill fever [with endocarditis]) or S minus (rat-bite fever): 150,000 to 250,000 units/kg/day in divided doses every 4 hours for 4 weeks

Usual Pediatric Dose for Lyme Disease -- Neurologic:

Children: 200,000 to 400,000 units/kg/day IV in divided doses every 4 to 6 hours for 14 to 28 days
Maximum dose: 18 million to 24 million units/day
Penicillin G is recommended as an alternative to IV ceftriaxone or IV cefotaxime for patients with early Lyme disease who have acute neurologic disease manifested by meningitis or radiculopathy. It is also recommended as an alternative for patients with late Lyme disease and associated neurologic disease affecting the CNS or peripheral nerve disease (e.g., neuropathy, encephalopathy) and documented by CSF analysis. Ceftriaxone is considered the parenteral drug of choice.

Usual Pediatric Dose for Lyme Disease -- Carditis:

Third-degree AV heart block or a PR interval exceeding 0.3 seconds during early Lyme disease:
Children: 200,000 to 400,000 units/kg/day IV in divided doses every 4 to 6 hours for 14 to 21 days
Maximum dose: 18 million to 24 million units/day
Ceftriaxone is considered the parenteral drug of choice.

Usual Pediatric Dose for Lyme Disease -- Arthritis:

Children: 200,000 to 400,000 units/kg/day IV in divided doses every 4 hours for 14 to 28 days
Maximum dose: 18 million to 24 million units/day
Penicillin G is recommended as an alternative to IV ceftriaxone or IV cefotaxime for patients with late Lyme disease who have arthritis and objective proof of neurologic disease. It is also recommended as an alternative for patients with persistent or recurrent arthritis after oral treatment; IV therapy is only recommended in those patients whose arthritis showed no improvement or worsened. Ceftriaxone is considered the parenteral drug of choice.

Usual Pediatric Dose for Gonococcal Infection -- Disseminated:

Penicillin-susceptible strains:
Less than 45 kg:
Arthritis: 100,000 units/kg/day in 4 divided doses for 7 to 10 days
Meningitis: 250,000 units/kg/day in divided doses every 4 hours for 10 to 14 days
Endocarditis: 250,000 units/kg/day in divided doses every 4 hours for 4 weeks
45 kg or more:
Arthritis, meningitis, endocarditis: 10 million units/day in 4 divided doses; duration depends on the type of infection
Due to resistance, penicillin G is not recommended by the CDC. Ceftriaxone is the drug of choice.

What other drugs will affect penicillin G potassium?

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

aspirin or indomethacin (Indocin);

birth control pills;

methotrexate (Rheumatrex, Trexall(;

probenecid (Benemid);

an antibiotic such as chloramphenicol (Chloromycetin) or erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin);

a diuretic (water pill) such as furosemide (Lasix) or ethacrynic acid (Edecrin);

sulfa drugs (Bactrim, Septra, Sulfatrim, SMX-TMP, and others); or

a tetracycline antibiotic, such as doxycycline (Doryx, Oracea, Periostat, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).

This list is not complete and other drugs may interact with penicillin G potassium. 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 penicillin G potassium resources Penicillin G potassium Side Effects (in more detail) Penicillin G potassium Use in Pregnancy & Breastfeeding Drug Images Penicillin G potassium Drug Interactions Penicillin G potassium Support Group 11 Reviews for Penicillin G potassium - Add your own review/rating Penicillin G Potassium MedFacts Consumer Leaflet (Wolters Kluwer) Pfizerpen Prescribing Information (FDA) Pfizerpen Advanced Consumer (Micromedex) - Includes Dosage Information Compare penicillin G potassium with other medications Actinomycosis Anthrax Anthrax Prophylaxis Aspiration Pneumonia Bacterial Infection Clostridial Infection Congenital Syphilis Cutaneous Bacillus anthracis Deep Neck Infection Diphtheria Endocarditis Fusospirochetosis, Trench Mouth Joint Infection Leptospirosis Lyme Disease, Arthritis Lyme Disease, Carditis Lyme Disease, Erythema Chronicum Migrans Lyme Disease, Neurologic Meningitis Meningitis, Meningococcal Meningitis, Pneumococcal Neurosyphilis Otitis Media Pneumonia Prevention of Perinatal Group B Streptococcal Disease Rat-bite Fever Rheumatic Fever Prophylaxis Skin Infection Strep Throat Syphilis, Early Syphilis, Latent Tertiary Syphilis Tonsillitis/Pharyngitis Upper Respiratory Tract Infection Where can I get more information? Your pharmacist can provide more information about penicillin G potassium.

See also: penicillin G potassium side effects (in more detail)


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Dobutamine Concentrate 250 mg / 20 ml.


Dobutamine Concentrate

Important information about your medicine Your doctor or nurse will give you the injection If this injection causes you any problems talk to your doctor, nurse or pharmacist Please tell your doctor or pharmacist, if you have any other medical conditions or have an allergy to any of the ingredients of this medicine Please tell your doctor or pharmacist, if you are taking any other medicines Read all of this leaflet carefully before you start using this medicine. In some circumstances this may not be possible and this leaflet will be kept in a safe place should you wish to read it. Keep this leaflet. You may need to read it again If you have any further questions, please ask your doctor or your pharmacist. This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. Where to find information in this leaflet 1. What Dobutamine Concentrate is and what it is used for 2. Before you are given Dobutamine Concentrate 3. How to use Dobutamine Concentrate 4. Possible side effects 5. Storing Dobutamine Concentrate 6. Further information What Dobutamine Concentrate is and what it is used for

Dobutamine Concentrate belongs to a group of medicines known as inotropes, which make your heart beat more strongly. It is used:

in open heart surgery to treat heart disease to treat heart failure in shock as an alternative to exercise for stress testing the heart. Before you are given Dobutamine Concentrate You should NOT be given Dobutamine Concentrate if you: Are sensitive or allergic to Dobutamine Concentrate, sodium metabisulphite or any of the other ingredients in this injection. suffer from high blood pressure due to a tumour near the kidney (Phaeocromocytoma). Please tell your doctor or nurse before being given the injection if you: have recently had a heart attack are asthmatic have unstable angina have heart disease have high blood pressure have any condition that would make exercise dangerous for you. Using other medicines:

Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is especially important with the following medicines as they may interact with your Dobutamine Concentrate:

beta blockers (medicines used to relieve certain heart conditions, anxiety and migraine). anaesthetics. entacapone (a medicine to treat Parkinson’s Disease). Pregnancy or breast feeding:

Please tell your doctor or nurse before being given this injection if you are pregnant or breast feeding. The doctor will then decide if the injection is suitable for you.

Driving and using machines:

You should not drive or use machinery if you are affected by the administration of Dobutamine Concentrate.

How to use Dobutamine Concentrate

Your nurse or doctor will give you the injection.

Your doctor will decide the correct dosage for you and how and when the injection will be given. Dobutamine Concentrate is not normally given to children.

Since the injection will be given to you by a doctor or nurse, it is unlikely that you will be given too much. If you think you have been given too much, feel sick, are sick, feel anxious, feel palpitations, have a headache, feel short of breath or have chest pain you must tell the person giving you the injection.

Possible side effects

Like all medicines, Dobutamine Concentrate can cause side effects, although not everybody gets them.

Intravenous infusions may cause inflammation of the vein and damage to the skin at the injection site. The surrounding skin may feel warm and tender and redness may be present.

Death due to rupture of the heart muscle has occurred very rarely after giving dobutamine to assess the response of the heart to stress in patients with a recent heart attack. Your doctor will examine your heart before giving you Dobutamine Concentrate to decide if you are suitable to receive the drug.

The following side-effects have been reported: Hypersensitivity reactions involving rash and difficulty breathing including life threatening asthmatic episodes Changes in the levels of certain chemicals in the blood. Increased heart rate, palpitations, chest pain and changes to the rhythm of your heart. Changes to your blood pressure including both an increase and a decrease. difficulty in breathing (your breathing may stop) asthma headache nausea (feeling sick) Sudden, involuntary twitching of a muscle or group of muscles.

If you think this injection is causing you any problems, or you are at all worried, talk to your doctor, nurse or pharmacist.

Storing Dobutamine Concentrate

Your injection will be stored at less than 21°C and protected from light. The nurse or doctor will check that the injection is not past its expiry date before giving you the injection.

Further information What Dobutamine Concentrate contains:

This injection contains the active ingredient dobutamine hydrochloride. Each 1 ml contains dobutamine hydrochloride equivalent to 12.5 mg dobutamine in a sterile solution for injection.

This injection contains the following inactive ingredients: sodium metabisulphite, sodium hydroxide, hydrochloric acid, sterile water for injections and carbon dioxide.

What Dobutamine Concentrate looks like and contents of the pack:

Dobutamine Concentrate is supplied in 20 ml clear glass ampoules, in cartons containing one, five or ten ampoules. Not all sizes may be marketed.

The marketing authorisation number of this medicine is: PL 01502/0054

Marketing Authorisation Holder: hameln pharmaceuticals ltd Gloucester United Kingdom Manufacturer: hameln pharmaceuticals gmbh Langes Feld 13 31789 Hameln Germany

For any information about this medicine, please contact the Marketing Authorisation Holder

This leaflet was last approved 12.08.2008

43821/20/09


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