metronidazole vaginal gel 0.75% use after expiration date
 

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MetroGel-Vaginal


Generic Name: metronidazole vaginal (MET roe NYE da zole)
Brand Names: MetroGel-Vaginal, Vandazole

What is MetroGel-Vaginal (metronidazole vaginal)?

Metronidazole is an antibiotic that fights bacteria in the body.

Metronidazole vaginal is used to treat vaginal infections caused by bacteria.

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

What is the most important information I should know about MetroGel-Vaginal (metronidazole vaginal)?

Do not use metronidazole vaginal if you have ever had an allergic reaction to it.

Before using metronidazole vaginal, tell your doctor if you have liver disease, a seizure disorder, problems with circulation (such as Raynaud's syndrome), or if you have taken disulfiram (Antabuse) within the past 14 days.

Avoid having sex until your vaginal infection has been completely treated and you have finished using the medication.

Avoid using other vaginal creams or douches at the same time as metronidazole vaginal unless your doctor approves.

Use metronidazole vaginal for the entire length of time prescribed by your doctor, even during your menstrual period. Your symptoms may get better before the infection is completely treated. If the infection does not clear up after you have finished one course of therapy, or if your symptoms get worse, see your doctor. You may have another type of infection that metronidazole will not treat. What should I discuss with my doctor before using MetroGel-Vaginal (metronidazole vaginal)?

Do not use metronidazole vaginal if you have ever had an allergic reaction to it.

Before using metronidazole vaginal, tell your doctor if you are allergic to any drugs, or if you have:

liver disease;

a seizure disorder; or

problems with circulation (such as Raynaud's syndrome).

If you have any of these conditions, you may need a dose adjustment or special tests to safely use metronidazole vaginal.

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. Metronidazole vaginal may 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 use MetroGel-Vaginal (metronidazole vaginal)?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor.

Wash your hands before and after using this medication.

Insert the cream into your vagina using the applicator as directed.

Your medication may come with disposable applicators. Use each applicator for only 1 day and then throw it away. If you use the medication twice daily, wash and rinse the applicator after your morning dose and use it again for your evening dose. Then throw it away and use a new applicator the next day.

Use metronidazole vaginal for the entire length of time prescribed by your doctor, even during your menstrual period. Your symptoms may get better before the infection is completely treated.

If the infection does not clear up after you have finished one course of therapy, or if your symptoms get worse, see your doctor. You may have another type of infection that metronidazole will not treat.

You may need to use a sanitary napkin during treatment, but do not use a tampon.

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

Store metronidazole vaginal at room temperature away from moisture or heat. Do not allow it to freeze. 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.

An overdose of metronidazole applied in the vagina is not expected to produce life-threatening symptoms.

What should I avoid while using MetroGel-Vaginal (metronidazole vaginal)? Avoid getting this medication in your eyes, nose, or mouth. If it does get into any of these areas, rinse with plenty of cool water.

Avoid wearing tight-fitting, synthetic clothing such as nylon underwear or panty hose that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until your infection is healed.

Avoid having sex until your vaginal infection has been completely treated and you have finished using the medication.

Avoid using other vaginal creams or douches at the same time as metronidazole vaginal unless your doctor approves.

Avoid drinking alcohol while you are using metronidazole vaginal. MetroGel-Vaginal (metronidazole vaginal) 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.

Rare but serious side effects may include:

seizure (convulsions); or

numbness, burning, pain, or tingly feeling in your hands or feet.

Less serious side effects may include:

mild burning or stinging when the medication is applied;

pelvic pain or cramps;

loss of appetite, constipation, upset stomach, vomiting;

dizziness, sleep problems (insomnia);

runny nose;

urinating more than usual;

acne, increased sweating; or

breast discharge or enlargement.

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

What other drugs will affect MetroGel-Vaginal (metronidazole vaginal)?

Tell your doctor if you have taken disulfiram (Antabuse) within the past 14 days. Also tell your doctor if you are using:

cimetidine (Tagamet);

lithium (Eskalith, Lithobid, Lithonate); or

a blood thinner such as warfarin (Coumadin).

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

More MetroGel-Vaginal resources MetroGel-Vaginal Side Effects (in more detail) MetroGel-Vaginal Use in Pregnancy & Breastfeeding MetroGel-Vaginal Drug Interactions MetroGel-Vaginal Support Group 3 Reviews for MetroGel-Vaginal - Add your own review/rating MetroCream Cream MedFacts Consumer Leaflet (Wolters Kluwer) MetroCream Prescribing Information (FDA) MetroGel Prescribing Information (FDA) Metrocream Metrocream Topical Advanced Consumer (Micromedex) - Includes Dosage Information Metrogel-Vaginal Advanced Consumer (Micromedex) - Includes Dosage Information Metrolotion Noritate Prescribing Information (FDA) Rozex Emulsion MedFacts Consumer Leaflet (Wolters Kluwer) Vandazole Prescribing Information (FDA) Vitazol Prescribing Information (FDA) Compare MetroGel-Vaginal with other medications Bacterial Vaginitis Where can I get more information? Your pharmacist can provide more information about metronidazole vaginal.

See also: MetroGel-Vaginal side effects (in more detail)


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Vaginal Dryness Medications


There are currently no drugs listed for "Vaginal Dryness".

Definition of Vaginal Dryness: There are many causes of vaginal dryness. A very common cause of vaginal dryness is lack of the hormone estrogen in postmenopausal women. Other causes can include an infection, foreign body, or a tumor (a rare cause of vaginal dryness).

Learn more about Vaginal Dryness

Medical Encyclopedia:

Vaginal dryness
Drug List:
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Metrotop (Molnlycke Health Care )


1. Name Of The Medicinal Product

Metrotop.

2. Qualitative And Quantitative Composition

Metronidazole BP 0.8% w/v.

3. Pharmaceutical Form

A colourless aqueous gel.

4. Clinical Particulars 4.1 Therapeutic Indications

For the treatment of malodorous fungating tumours, gravitational ulcers and decubitus ulcers (pressure sores).

4.2 Posology And Method Of Administration

For external use only. Adults: All wounds should be cleaned thoroughly. Flat wounds require a liberal application of the gel over the complete area. Cavities should be loosely packed with paraffin gauze which has been smeared in the gel. All wounds should be covered with a non-adherent dressing and a pad of lint or gauze. Sticking may occur if the appropriate dressing is not used. Use once or twice daily as necessary. Elderly: No specific instructions. Children: Where necessary, instructions apply as for adults.

4.3 Contraindications

Known hypersensitivity to metronidazole.

4.4 Special Warnings And Precautions For Use

The following statements take into account the possibility that metronidazole may be absorbed after topical application. However, there is no evidence of any significant systemic concentrations of metronidazole following topical applications. Peripheral neuropathy has been reported in association with prolonged use of metronidazole. The elimination half-life of metronidazole remains unchanged in the presence of renal failure. Such patients, however, retain the metabolite of metronidazole. The clinical significance of this is not known at present. However, in patients undergoing dialysis, metronidazole and metabolites are efficiently removed.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Some potentiation of anticoagulant therapy has been reported when metronidazole has been used with the warfarin type oral anticoagulants. Patients receiving phenobarbitone metabolise metronidazole at a much faster rate than normal, reducing the half-life to approximately 3 hours. Patients are advised not to take alcohol during systemic metronidazole therapy because of the possibility of a disulfiram-like reaction.

4.6 Pregnancy And Lactation

There is inadequate evidence of the use of metronidazole in pregnancy. Metronidazole gel cannot therefore be recommended during pregnancy or lactation where significant systemic absorption may occur unless the physician considers it essential.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

No adverse effects have been reported. Systemic metronidazole therapy may occasionally cause an unpleasant taste in the mouth, furred tongue, nausea, vomiting, gastrointestinal disturbance, urticaria, angioedema and anaphylaxis. Drowsiness, dizziness, headache, ataxia, skin rash, pruritus, and darkening of the urine have been reported, but rarely.

4.9 Overdose

There is no specific treatment for gross overdosage of metronidazole. Gastric lavage is recommended in cases of accidental ingestion. Uneventful recovery has followed overdosage of up to 12g taken orally. Metronidazole is readily removed from the plasma by dialysis.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Metronidazole is a potent agent against the anaerobic bacteria which are believed to produce odorous metabolites as a result of localised tissue colonisation. The aim of the product is to provide a high concentration of metronidazole at and around the site of colonisation in a water-miscible base. This form allows surface spread and penetration within the wound accompanied by ease of aseptic application and up to 24 hours duration of action.

5.2 Pharmacokinetic Properties

There is presently no evidence of any systemic concentrations of metronidazole following topical application.

5.3 Preclinical Safety Data

No further data given.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Hypromellose (4500); benzalkonium chloride solution; purified water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

The shelf life shall not exceed 24 months from the date of manufacture.

6.4 Special Precautions For Storage

Do not store above 25°C. Once opened the contents should be used within 28 days of opening.

6.5 Nature And Contents Of Container

Polypropylene tubes each fitted with a plastic screw cap and tamper-evident seal and enclosed within a printed cardboard carton. Single tubes may sometimes be supplied without a carton. Pack sizes: The 15g, 30g and 60g tubes are available singly or in boxes of 12.

6.6 Special Precautions For Disposal And Other Handling

None given.

7. Marketing Authorisation Holder

Medlock Medical Limited, Tubiton House, Medlock Street, Oldham, OL1 3HS.

8. Marketing Authorisation Number(S)

PL 21248/0040.

9. Date Of First Authorisation/Renewal Of The Authorisation

16th September 2005.

10. Date Of Revision Of The Text

September 2005.


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MetroCream


metronidazole
Dosage Form: topical cream
MetroCream®
(metronidazole topical cream)
Rx Only
FOR TOPICAL USE ONLY
(NOT FOR OPHTHALMIC USE) DESCRIPTION:

MetroCream® Topical Cream contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in an emollient cream consisting of benzyl alcohol, emulsifying wax, glycerin, isopropyl palmitate, purified water, sorbitol solution, lactic acid and/or sodium hydroxide to adjust pH. Metronidazole is a member of the imidazole class of antibacterial agents and is classified therapeutically as an antiprotozoal and anti-bacterial agent. Chemically, metronidazole is 2-methyl-5-nitro-1 H-imidazole-1-ethanol. The molecular formula is C6H9N3O3 and molecular weight is 171.16. Metronidazole is represented by the following structural formula:

CLINICAL PHARMACOLOGY:

The mechanisms by which metronidazole acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect.

INDICATIONS AND USAGE:

MetroCream® (metronidazole topical cream) Topical Cream is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.

CONTRAINDICATIONS:

MetroCream® (metronidazole topical cream) Topical Cream is contraindicated in individuals with a history of hypersensitivity to metronidazole, or other ingredients of the formulation.

PRECAUTIONS:

General: Topical metronidazole has been reported to cause tearing of the eyes. Therefore, contact with the eyes should be avoided. If a reaction suggesting local irritation occurs, patients should be directed to use the medication less frequently or discontinue use. Metronidazole is a nitroimidazole and should be used with care in patients with evidence of, or history of blood dyscrasia.

Information for patients: This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.

Drug interactions: Oral metronidazole has been reported to potentiate the anticoagulant effect of warfarin and coumarin anticoagulants, resulting in a prolongation of prothrombin time. The effect of topical metronidazole on prothrombin time is not known.

Carcinogenesis, mutagenesis, impairment of fertility: Metronidazole has shown evidence of carcinogenic activity in a number of studies involving chronic, oral administration in mice and rats but not in studies involving hamsters.

Metronidazole has shown evidence of mutagenic activity in several in vitro bacterial assay systems. In addition, a dose-response increase in the frequency of micronuclei was observed in mice after intraperitoneal injections and an increase in chromosome aberrations have been reported in patients with Crohn’s disease who were treated with 200-1200 mg/day of metronidazole for 1 to 24 months. However, no excess chromosomal aberrations in circulating human lymphocytes have been observed in patients treated for 8 months.

Pregnancy: Teratogenic effects: Pregnancy category B: There are no adequate and well-controlled studies with the use of MetroCream® (metronidazole topical cream) Topical Cream in pregnant women. Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity was observed after oral metronidazole in rats or mice. However, because animal reproduction studies are not always predictive of human response and since oral metronidazole has been shown to be a carcinogen in some rodents, this drug should be used during pregnancy only if clearly needed.

Nursing mothers: After oral administration, metronidazole is secreted in breast milk in concentrations similar to those found in the plasma. Even though blood levels are significantly lower with topically applied metronidazole than those achieved after oral administration of metronidazole, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric use: Safety and effectiveness in pediatric patients have not been established.

ADVERSE REACTIONS:

In controlled clinical trials, the total incidence of adverse reactions associated with the use of MetroCream® Topical Cream was approximately 10%. Skin discomfort (burning and stinging) was the most frequently reported event followed by erythema, skin irritation, pruritus and worsening of rosacea. All individual events occurred in less than 3% of patients. The following additional adverse experiences have been reported with the topical use of metronidazole: dryness, transient redness, metallic taste, tingling or numbness of extremities and nausea.

DOSAGE AND ADMINISTRATION:

Apply and rub in a thin layer of MetroCream® (metronidazole topical cream) Topical Cream twice daily, morning and evening, to entire affected areas after washing.

Areas to be treated should be washed with a mild cleanser before application. Patients may use cosmetics after application of MetroCream® Topical Cream.

HOW SUPPLIED:

MetroCream® (metronidazole topical cream) Topical Cream, 0.75% is supplied in a 45 g aluminum tube - NDC 0299-3836-45.

Storage conditions: STORE AT CONTROLLED ROOM TEMPERATURE: 68° to 77°F (20° to 25°C).

Marketed by:
GALDERMA LABORATORIES, L.P.
Fort Worth, Texas 76177 USA
Manufactured by:
Galderma Production Canada, Inc.
Montreal, QC
H9X 3N7 Canada
GALDERMA is a registered trademark.
Made in Canada.
P50309-0
Revised: December 2002

PACKAGE LABEL:

MetroCream®
(metronidazole topical cream)

TOPICAL CREAM

0.75%

NET WT. 45 g

NDC 0299-3836-45

Rx only

GALDERMA

FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE.
STORE AT CONTROLLED ROOM TEMPERATURE, 68° TO 77°F (20°-25°C).
Usual dosage: Apply a thin layer to entire affected areas after washing. Use morning and evening or as directed by physician. Avoid application close to the eyes.
Each gram contains: Active: metronidazole 0.75% (7.5 mg). Inactive: benzyl alcohol, emulsifying wax, glycerin, isopropyl palmitate, purified water, sorbitol solution, lactic acid and/or sodium hydroxide to adjust pH.

Marketed by:
GALDERMA LABORATORIES, L.P.
Fort Worth, TX 76177 USA
GALDERMA is a registered trademark.
Manufactured by:
Galderma Production Canada, Inc.
Montreal, QC
H9X 3N7 Canada
Made in Canada.
P50296-1

LOT:
EXP.:


MetroCream  
metronidazole  cream Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0299-3836 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Metronidazole (Metronidazole) Metronidazole 7.5 mg  in 1 g Inactive Ingredients Ingredient Name Strength Benzyl Alcohol   Glycerin   Isopropyl Palmitate   Water   Sorbitol   Lactic Acid   Sodium Hydroxide   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 0299-3836-45 1 TUBE In 1 CARTON contains a TUBE 1 45 g In 1 TUBE This package is contained within the CARTON (0299-3836-45)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020531 09/20/1995
Labeler - Galderma Laboratories, L.P. (047350186) Establishment Name Address ID/FEI Operations DPT Laboratories, Ltd. 832224526 MANUFACTURE Establishment Name Address ID/FEI Operations Galderma Production Canada Inc 251676961 MANUFACTURE Revised: 03/2011Galderma Laboratories, L.P.
More MetroCream resources MetroCream Side Effects (in more detail) MetroCream Use in Pregnancy & Breastfeeding MetroCream Drug Interactions MetroCream Support Group 3 Reviews for MetroCream - Add your own review/rating MetroCream Cream MedFacts Consumer Leaflet (Wolters Kluwer) MetroCream Concise Consumer Information (Cerner Multum) MetroGel-Vaginal Concise Consumer Information (Cerner Multum) Metrocream Metrocream Topical Advanced Consumer (Micromedex) - Includes Dosage Information Metrogel-Vaginal Advanced Consumer (Micromedex) - Includes Dosage Information Metrolotion Rozex Emulsion MedFacts Consumer Leaflet (Wolters Kluwer) Compare MetroCream with other medications Perioral Dermatitis Rosacea
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MetroGel Vaginal



Dosage Form: vaginal gel
MetroGel-Vaginal®
(metronidazole vaginal gel)
0.75% Vaginal Gel

FOR INTRAVAGINAL USE ONLY
NOT FOR OPHTHALMIC, DERMAL, OR ORAL USE

MetroGel Vaginal Description

METROGEL-VAGINAL is the intravaginal dosage form of the synthetic antibacterial agent, metronidazole, USP at a concentration of 0.75%. Metronidazole is a member of the imidazole class of antibacterial agents and is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is a 2-methyl-5-nitroimidazole-1-ethanol. It has a chemical formula of C6H9N3O3, a molecular weight of 171.16, and has the following structure:

METROGEL-VAGINAL is a gelled, purified water solution, containing metronidazole at a concentration of 7.5 mg/g (0.75%). The gel is formulated at pH 4.0. The gel also contains carbomer 934P, edetate disodium, methylparaben, propylparaben, propylene glycol, and sodium hydroxide.

Each applicator full of 5 grams of vaginal gel contains approximately 37.5 mg of metronidazole.

MetroGel Vaginal - Clinical Pharmacology Normal Subjects

Following a single, intravaginal 5 gram dose of metronidazole vaginal gel (equivalent to 37.5 mg of metronidazole) to 12 normal subjects, a mean maximum serum metronidazole concentration of 237 ng/mL was reported (range: 152 to 368 ng/mL). This is approximately 2% of the mean maximum serum metronidazole concentration reported in the same subjects administered a single, oral 500 mg dose of metronidazole (mean Cmax = 12,785 ng/mL, range: 10,013 to 17,400 ng/mL). These peak concentrations were obtained in 6 to 12 hours after dosing with metronidazole vaginal gel and 1 to 3 hours after dosing with oral metronidazole.

The extent of exposure [area under the curve (AUC)] of metronidazole, when administered as a single intravaginal 5 gram dose of metronidazole vaginal gel (equivalent to 37.5 mg of metronidazole), was approximately 4% of the AUC of a single oral 500 mg dose of metronidazole (4977 ng-hr/mL and approximately 125,000 ng-hr/mL, respectively).

Dose-adjusted comparisons of AUCs demonstrated that, on a mg to mg comparison basis, the absorption of metronidazole, when administered vaginally, was approximately half that of an equivalent oral dosage.

Patients with Bacterial Vaginosis

Following single and multiple 5 gram doses of metronidazole vaginal gel to 4 patients with bacterial vaginosis, a mean maximum serum metronidazole concentration of 214 ng/mL on day 1 and 294 ng/mL (range: 228 to 349 ng/mL) on day five were reported. Steady state metronidazole serum concentrations following oral dosages of 400 to 500 mg BID have been reported to range from 6,000 to 20,000 ng/mL.

Microbiology

The intracellular targets of action of metronidazole on anaerobes are largely unknown. The 5-nitro group of metronidazole is reduced by metabolically active anaerobes, and studies have demonstrated that the reduced form of the drug interacts with bacterial DNA. However, it is not clear whether interaction with DNA alone is an important component in the bactericidal action of metronidazole on anaerobic organisms.

Culture and sensitivity testing of bacteria are not routinely performed to establish the diagnosis of bacterial vaginosis. (See INDICATIONS AND USAGE.)

Standard methodology for the susceptibility testing of the potential bacterial vaginosis pathogens, Gardnerella vaginalis, Mobiluncus spp., and Mycoplasma hominis, has not been defined. Nonetheless, metronidazole is an antimicrobial agent active in vitro against most strains of the following organisms that have been reported to be associated with bacterial vaginosis:

  Bacteroides spp.   Gardnerella vaginalis   Mobiluncus spp.   Peptostreptococcus spp. Indications and Usage for MetroGel Vaginal

METROGEL-VAGINAL is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis).

NOTE: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a "fishy" amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram's stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood cells.

Other pathogens commonly associated with vulvovaginitis, e.g., Trichomonas vaginalis, Chlamydia trachomatis, N. gonorrhoeae, Candida albicans, and Herpes simplex virus should be ruled out.

Contraindications

METROGEL-VAGINAL is contraindicated in patients with a prior history of hypersensitivity to metronidazole, parabens, other ingredients of the formulation, or other nitroimidazole derivatives.

Warnings Convulsive Seizures and Peripheral Neuropathy

Convulsive seizures and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity, have been reported in patients treated with oral or intravenous metronidazole. The appearance of abnormal neurologic signs demands the prompt discontinuation of metronidazole vaginal gel therapy. Metronidazole vaginal gel should be administered with caution to patients with central nervous system diseases.

Psychotic Reactions

Psychotic reactions have been reported in alcoholic patients who were using oral metronidazole and disulfiram concurrently. Metronidazole vaginal gel should not be administered to patients who have taken disulfiram within the last two weeks.

Precautions

METROGEL-VAGINAL affords minimal peak serum levels and systemic exposure (AUCs) of metronidazole compared to 500 mg oral metronidazole dosing. Although these lower levels of exposure are less likely to produce the common reactions seen with oral metronidazole, the possibility of these and other reactions cannot be excluded presently. Data from well-controlled trials directly comparing metronidazole administered orally to metronidazole administered vaginally are not available.

General

Patients with severe hepatic disease metabolize metronidazole slowly. This results in the accumulation of metronidazole and its metabolites in the plasma. Accordingly, for such patients, metronidazole vaginal gel should be administered cautiously.

Known or previously unrecognized vaginal candidiasis may present more prominent symptoms during therapy with metronidazole vaginal gel. Approximately 6–10% of patients treated with METROGEL-VAGINAL developed symptomatic Candida vaginitis during or immediately after therapy.

Disulfiram-like reaction to alcohol has been reported with oral metronidazole, thus the possibility of such a reaction occurring while on metronidazole vaginal gel therapy cannot be excluded.

METROGEL-VAGINAL contains ingredients that may cause burning and irritation of the eye. In the event of accidental contact with the eye, rinse the eye with copious amounts of cool tap water.

Information for the Patient

The patient should be cautioned about drinking alcohol while being treated with metronidazole vaginal gel. While blood levels are significantly lower with METROGEL-VAGINAL than with usual doses of oral metronidazole, a possible interaction with alcohol cannot be excluded.

The patient should be instructed not to engage in vaginal intercourse during treatment with this product.

Drug Interactions

Oral metronidazole has been reported to potentiate the anticoagulant effect of warfarin and other coumarin anticoagulants, resulting in a prolongation of prothrombin time. This possible drug interaction should be considered when metronidazole vaginal gel is prescribed for patients on this type of anticoagulant therapy.

In patients stabilized on relatively high doses of lithium, short-term oral metronidazole therapy has been associated with elevation of serum lithium levels and, in a few cases, signs of lithium toxicity.

Use of cimetidine with oral metronidazole may prolong the half-life and decrease plasma clearance of metronidazole.

Drug/Laboratory Test Interactions

Metronidazole may interfere with certain types of determinations of serum chemistry values, such as aspartate aminotransferase (AST, SGOT), alanine aminotransferase (ALT, SGPT), lactate dehydrogenase (LDH), triglycerides, and glucose hexokinase. Values of zero may be observed. All of the assays in which interference has been reported involve enzymatic coupling of the assay to oxidation-reduction of nicotinamide-adenine dinucleotides (NAD + NADH). Interference is due to the similarity in absorbance peaks of NADH (340 nm) and metronidazole (322 nm) at pH 7.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Metronidazole has shown evidence of carcinogenic activity in a number of studies involving chronic oral administration in mice and rats. Prominent among the effects in the mouse was the promotion of pulmonary tumorigenesis. This has been observed in all six reported studies in that species, including one study in which the animals were dosed on an intermittent schedule (administration during every fourth week only). At very high dose levels (approximately 500 mg/kg/day), there was a statistically significant increase in the incidence of malignant liver tumors in males. Also, the published results of one of the mouse studies indicate an increase in the incidence of malignant lymphomas as well as pulmonary neoplasms associated with lifetime feeding of the drug. All these effects are statistically significant. Several long-term oral dosing studies in the rat have been completed. There were statistically significant increases in the incidence of various neoplasms, particularly in mammary and hepatic tumors, among female rats administered metronidazole over those noted in the concurrent female control groups. Two lifetime tumorigenicity studies in hamsters have been performed and reported to be negative.

These studies have not been conducted with 0.75% metronidazole vaginal gel, which would result in significantly lower systemic blood levels than those obtained with oral formulations.

Although metronidazole has shown mutagenic activity in a number of in vitro assay systems, studies in mammals (in vivo) have failed to demonstrate a potential for genetic damage.

Fertility studies have been performed in mice up to six times the recommended human oral dose (based on mg/m2) and have revealed no evidence of impaired fertility.

Pregnancy Teratogenic Effects Pregnancy Category B

There has been no experience to date with the use of METROGEL-VAGINAL in pregnant patients. Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity or teratogenicity was observed when metronidazole was administered orally to pregnant mice at six times the recommended human dose (based on mg/m2); however, in a single small study where the drug was administered intraperitoneally, some intrauterine deaths were observed. The relationship of these findings to the drug is unknown.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, and because metronidazole is a carcinogen in rodents, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

Specific studies of metronidazole levels in human milk following intravaginally administered metronidazole have not been performed. However, metronidazole is secreted in human milk in concentrations similar to those found in plasma following oral administration of metronidazole.

Because of the potential for tumorigenicity shown for metronidazole in mouse and rat studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in children have not been established.

ADVERSE EVENTS Clinical Trials

There were no deaths or serious adverse events related to drug therapy in clinical trials involving 800 non-pregnant women who received METROGEL-VAGINAL.

In a randomized, single-blind clinical trial of 505 non-pregnant women who received METROGEL-VAGINAL once or twice a day, 2 patients (one from each regimen) discontinued therapy early due to drug-related adverse events. One patient discontinued drug because of moderate abdominal cramping and loose stools, while the other patient discontinued drug because of mild vaginal burning. These symptoms resolved after discontinuation of drug.

Medical events judged to be related, probably related, or possibly related to administration of METROGEL-VAGINAL once or twice a day were reported for 195/505 (39%) patients. The incidence of individual adverse reactions were not significantly different between the two regimens. Unless percentages are otherwise stipulated, the incidence of individual adverse reactions listed below was less than 1%:

   Reproductive:    Vaginal discharge (12%),    Symptomatic Candida cervicitis/vaginitis (10%),    Vulva/vaginal irritative symptoms (9%),    Pelvic discomfort (3%).    Gastrointestinal:    Gastrointestinal discomfort (7%),    Nausea and/or vomiting (4%),    Unusual taste (2%),    Diarrhea/loose stools (1%),    Decreased appetite (1%),    Abdominal bloating/gas; thirsty, dry mouth.    Neurologic:    Headache (5%),    Dizziness (2%),    Depression.    Dermatologic:    Generalized itching or rash.    Other:    Unspecified cramping (1%),    Fatigue,    Darkened urine.

In previous clinical trials submitted for approved labeling of METROGEL-VAGINAL the following was also reported:

  Laboratory:   Increased/decreased white blood cell counts (1.7%). Other Metronidazole Formulations

Other effects that have been reported in association with the use of topical (dermal) formulations of metronidazole include skin irritation, transient skin erythema, and mild skin dryness and burning. None of these adverse events exceeded an incidence of 2% of patients.

METROGEL-VAGINAL affords minimal peak serum levels and systemic exposure (AUC) of metronidazole compared to 500 mg oral metronidazole dosing. Although these lower levels of exposure are less likely to produce the common reactions seen with oral metronidazole, the possibility of these and other reactions cannot be excluded presently.

The following adverse reactions and altered laboratory tests have been reported with the oral or parenteral use of metronidazole:

   Cardiovascular: Flattening of the T-wave may be seen in electrocardiographic tracings.    Central Nervous System: (See WARNINGS.) Headache, dizziness, syncope, ataxia, confusion, convulsive seizures, peripheral neuropathy, vertigo, incoordination, irritability, depression, weakness, insomnia.    Gastrointestinal: Abdominal discomfort, nausea, vomiting, diarrhea, an unpleasant metallic taste, anorexia, epigastric distress, abdominal cramping, constipation, "furry" tongue, glossitis, stomatitis, pancreatitis, and modification of taste of alcoholic beverages.    Genitourinary: Overgrowth of Candida in the vagina, dyspareunia, decreased libido, proctitis.    Hematopoietic: Reversible neutropenia, reversible thrombocytopenia.    Hypersensitivity Reactions: Urticaria; erythematous rash; flushing; nasal congestion; dryness of the mouth, vagina, or vulva; fever; pruritus; fleeting joint pains.    Renal: Dysuria, cystitis, polyuria, incontinence, a sense of pelvic pressure, darkened urine. Overdosage

There is no human experience with overdosage of metronidazole vaginal gel. Vaginally applied metronidazole gel, 0.75% could be absorbed in sufficient amounts to produce systemic effects. (See WARNINGS.)

MetroGel Vaginal Dosage and Administration

The recommended dose is one applicator full of METROGEL-VAGINAL (approximately 5 grams containing approximately 37.5 mg of metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, METROGEL-VAGINAL should be administered at bedtime.

How is MetroGel Vaginal Supplied

METROGEL-VAGINAL (metronidazole vaginal gel) 0.75% Vaginal Gel is supplied in a 70 gram tube and packaged with 5 vaginal applicators.

The NDC number for the 70 gram tube is 99207-130-70.

Store at controlled room temperature 15° to 30°C (59° to 86°F). Protect from freezing.

Clinical Studies

In a randomized, single-blind clinical trial of non-pregnant women with bacterial vaginosis who received METROGEL-VAGINAL daily for 5 days, the clinical cure rates for evaluable patients determined at 4 weeks after completion of therapy for the QD and BID regimens were 98/185 (53%) and 109/190 (57%), respectively.

Rx only

Manufactured for:
Medicis, The Dermatology Company
Scottsdale, AZ 85256

by:
DPT Laboratories, Inc.
San Antonio, TX 78215

129800
Rev 12/11

DIRECTIONS FOR USE 1. Filling the applicator Remove cap and puncture metal seal on tube with the pointed tip of cap. (See Figure 1) Screw end of applicator onto tube. (See Figure 2) Gently squeeze the tube from the bottom to fill applicator. Plunger will stop when the applicator is full. (See Figure 3) Unscrew applicator and replace cap on tube. 2. Inserting the applicator The applicator may be inserted while lying on your back with your knees bent or in any comfortable position. Hold filled applicator by barrel, and gently insert into vagina as far as it will comfortably go. (See Figure 4) Slowly press the plunger until it stops to deposit gel into vagina and then withdraw the applicator. 3. Care of the applicator
If physician prescribes twice-a-day dosing: After use, pull the plunger out of the barrel. (See Figure 5) Wash both plunger and barrel in warm soapy water and rinse thoroughly. To reassemble applicator, gently push plunger back into barrel.

IMPORTANT:

For once-a-day dosing, apply one applicator full at bedtime. For twice-a-day dosing, apply one applicator full each morning and evening for five days, or as directed by physician.

WARNINGS:

If significant irritation develops from the use of this medication, discontinue use and consult your physician. Do not use during pregnancy except under the supervision of a physician. Keep this and all medications out of reach of children. For vaginal use only. Not for use in the eyes, on the skin or in the mouth.

Store at room temperature. Avoid exposure to extreme heat or cold.

See end of carton and bottom of tube for lot number and expiration date.

Scottsdale, AZ 85256

129800
Rev 12/11

PRINCIPAL DISPLAY PANEL - 70 g Carton

NDC 99207-130-70

MetroGel-Vaginal®

(metronidazole vaginal gel)
0.75% Vaginal Gel
with 5 applicators

FOR INTRAVAGINAL USE ONLY.
(NOT FOR OPHTHALMIC, DERMAL, OR ORAL USE.)

Rx only

MEDICIS®

Net Wt. 70g


METROGEL-VAGINAL 
metronidazole  gel Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 99207-130 Route of Administration VAGINAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength metronidazole (metronidazole) metronidazole 7.5 mg  in 1 g Inactive Ingredients Ingredient Name Strength CARBOMER 934P   EDETATE DISODIUM   METHYLPARABEN   PROPYLPARABEN   PROPYLENE GLYCOL   SODIUM HYDROXIDE   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 99207-130-70 1 TUBE In 1 CARTON contains a TUBE, WITH APPLICATOR 1 70 g In 1 TUBE, WITH APPLICATOR This package is contained within the CARTON (99207-130-70)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020014 11/28/2011
Labeler - Medicis Pharmaceutical Corp (182837492) Establishment Name Address ID/FEI Operations DPT Laboratories Inc. 832224526 MANUFACTURE Revised: 01/2012Medicis Pharmaceutical Corp

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Metronidazole topical


Class: Antibacterials
VA Class: DE101
Chemical Name: 2-Methyl-5-nitro-1H-imidazole-1-ethanol
Molecular Formula: C6H9N3O3
CAS Number: 443-48-1
Brands: MetroCream, MetroGel, MetroGel-Vaginal, MetroLotion, Noritate, Vandazole

Introduction

Antibacterial and antiprotozoal;1 2 27 29 47 183 also has anti-inflammatory and immunosuppressive effects;1 2 14 17 21 28 180 nitroimidazole derivative.3

Uses for Metronidazole Rosacea

Treatment of inflammatory lesions (papules and pustules) associated with rosacea (acne rosacea);1 2 8 9 10 16 17 18 19 20 21 47 180 184 207 topical gel designated an orphan drug by FDA for use in this condition.23

Has no beneficial effects on telangiectasia,2 9 10 17 19 21 47 rhinophyma,47 or ocular manifestations of rosacea.47 83

Optimal treatment not determined; inflammatory lesions may respond to long-term treatment with topical anti-infectives (e.g., metronidazole) or oral anti-infectives (e.g., doxycycline, tetracycline, erythromycin, ampicillin, metronidazole).10 11 12 13 15 16 17 20 21 47 80 82 2 8 9 10 16 17 18 19 20 21 47 80 81 82 Topical metronidazole may be preferred to oral metronidazole;17 147 has been effective in patients with inadequate response or relapse with other therapies (e.g., oral tetracycline).2 10 17 21 62

Effects appear palliative;17 18 19 47 81 61 99 manifestations recur commonly following discontinuance of therapy.17 18 19 47 61 99

Adjunctive measures recommended to decrease exposure to factors that exacerbate rosacea (e.g., excessive sunlight, wind, hot liquids, spicy food, alcohol, extremes of heat and cold).2 12 80

Bacterial Vaginosis

Treatment of bacterial vaginosis (formerly called Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, anaerobic vaginosis)109 111 112 114 115 119 120 122 123 139 153 183 214 in nonpregnant women.214

CDC recommends treatment of bacterial vaginosis in all symptomatic women (including pregnant women).109 In addition, asymptomatic pregnant women at high risk for complications of pregnancy should be screened (preferably at the first prenatal visit) and treatment initiated if needed.109

Treatment recommendations for bacterial vaginosis in HIV-infected women are the same as those for women without HIV infection.109

Regimens of choice in nonpregnant women are a 7-day regimen of oral metronidazole, a 5-day regimen of intravaginal metronidazole gel, or a 7-day regimen of intravaginal clindamycin cream;109 114 alternative regimens are a 7-day regimen of oral clindamycin or 3-day regimen of intravaginal clindamycin suppositories.109 114 The preferred regimens for pregnant women are a 7-day regimen of oral metronidazole or a 7-day regimen of oral clindamycin.109

Regardless of regimen used, relapse or recurrence is common;109 110 120 122 138 153 162 an alternative regimen (e.g., oral therapy when topical was used initially) may be used in such situations.109 122

Routine treatment of asymptomatic male sexual contacts of women who have relapsing or recurrent bacterial vaginosis not recommended.109 113 201 202 203

Decubitus and Other Ulcers

Treatment of infected decubitus ulcers†;27 39 40 41 42 212 topical metronidazole designated an orphan drug by FDA for use in treatment of grade III or IV, anaerobically infected, decubitus ulcers.23

Perioral Dermatitis

Treatment of perioral dermatitis†;210 211 topical gel designated an orphan drug by FDA for treatment of this condition.23

Trichomoniasis

Has been used intravaginally as an adjunct to oral metronidazole for treatment of trichomoniasis caused by Trichomonas vaginalis† in selected cases (e.g., refractory infections),156 205 but not included in CDC recommendations for treatment of trichomoniasis.109 Intravaginal metronidazole not effective used alone.114

Drug of choice for treatment of trichomoniasis is oral metronidazole or oral tinidazole.109 114 123 215 216

Metronidazole Dosage and Administration Administration

Administer topically to the skin2 180 184 207 or intravaginally183 214 in appropriate formulations.

Topical skin preparations (cream, gel, lotion) are for external use only and should not be used orally, intravaginally, or near or in eyes.1 177 180 184 207

Intravaginal preparations are for intravaginal administration only and should not be used orally, topically on the skin, or near or in eyes.183 214

Topical Administration

Apply topically to the skin as a 0.75 or 1% cream, 1% gel, or 0.75% lotion.1 19 180 184 207

Prior to topical application, wash affected area with mild, nonirritating cleanser.1 2 180 184 207 To minimize risk of local irritation, some clinicians suggest application be delayed until about 15–20 minutes after skin cleansing.99

Rub cream, gel, or lotion into affected area.1 19 180 184 207 Avoid contact with eyes.1 19 180 184 207

If irritation occurs at application site, reduce application frequency or discontinue.1 19 180 184 207

Cosmetics may be applied to skin after application of cream, gel, or lotion;1 47 180 184 207 allow lotion to dry ?5 minutes before applying cosmetics.207

Intravaginal Topical Administration

Administer intravaginally as a 0.75% gel using vaginal applicators provided by the manufacturers.183 214

If once-daily regimen used, administer dose at bedtime.183 214

If once-daily regimen used, use new vaginal applicator for each dose.214 If twice-daily regimen used, use new applicator each day; wash, rinse, and dry applicator after morning dose and discard after evening dose.214

Dosage Pediatric Patients Bacterial Vaginosis Treatment in Nonpregnant Postmenarchal Females Intravaginal

0.75% gel: One applicatorful (approximately 37.5 g of metronidazole) once daily (at bedtime) or twice daily (in morning and evening) given for 5 consecutive days.214

Adults Rosacea Topical

0.75% cream or lotion: Apply thin film to cleansed, affected area twice daily (morning and evening)180 207 or as directed by clinician.207

1% cream or gel: Apply thin film to cleansed, affected area once daily.1 184

Optimum treatment duration not established;10 17 18 19 21 47 81 has been continued for ?21 weeks in clinical studies.2 9 10 16 17 18 19 20 21 29

Chronic therapy (usually intermittent) may be necessary, particularly for moderate to severe disease.61 99

Clinical improvement usually occurs within 3 weeks.17 21 Once adequate response occurs, adjust frequency and duration of treatment according to disease course.47

Although disease may remit during treatment,17 18 19 relapse occurs commonly following discontinuance.17 18 19 47 61 99

Bacterial Vaginosis Treatment in Nonpregnant Women Intravaginal

0.75% gel: One applicatorful (approximately 37.5 g of metronidazole) once daily (at bedtime) or twice daily (in morning and evening) given for 5 consecutive days.109 111 112 114 115 183 214

Cautions for Metronidazole Contraindications

Known hypersensitivity to metronidazole, other nitroimidazole derivatives, or any ingredient in the formulation.1 180 183 184 207 214

Warnings/Precautions Warnings Seizures and Peripheral Neuropathy

Convulsive seizures and peripheral neuropathy (characterized by numbness or paresthesia of an extremity) reported with oral or IV nitroimidazoles (e.g., metronidazole, tinidazole).183 217 214

If abnormal neurologic signs develop with vaginal gel, promptly discontinue drug.183 214

Use vaginal gel with caution in patients with history of CNS disease.183 214

Interactions

Psychotic reactions reported in alcoholic patients receiving oral metronidazole and disulfiram concurrently;183 214 disulfiram-like reactions to alcohol reported in patients receiving oral metronidazole.106 183 214 Similar reactions could occur with intravaginal metronidazole.183 214

Avoid intravaginal metronidazole in patients who have received disulfiram within the last 2 weeks.183 214 Caution patients to avoid drinking alcohol while being treated with intravaginal metronidazole.183 214 (See Specific Drugs under Interactions.)

General Precautions Administration Precautions

Avoid contact with the eyes.1 180 183 184 207 214

Topical cream, gel, or lotion may cause tearing.1 180 184 207

Vaginal gel may cause ocular burning and irritation.183 214

Iirrigate eyes with copious amounts of cool water if contact occurs.183 214

Local Irritation

If reaction suggesting local irritation occurs, advise patient to use the topical preparation less frequently or discontinue use.1 180 184 207

History of Blood Dyscrasia

Use with caution in patients with evidence or history of blood dyscrasia.1 180 184 207

Transient leukopenia and neutropenia reported with systemic metronidazole;30 adverse hematologic abnormalities not reported to date with topical metronidazole.2 21 47

Vaginal Intercourse and Use of Vaginal Products

Patients treated with vaginal gel should not engage in vaginal intercourse111 112 113 183 214 and should not use other vaginal products (tampons, douches) during entire treatment course.111 112 113 214

Vaginal intercourse or other vaginal products could reduce efficacy of intravaginal metronidazole (e.g., by dislodgment and/or dilution, by increased vaginal pH secondary to deposition of semen).111 112 113 214

Superinfection

Symptoms of known or previously unrecognized vaginal candidiasis may become more prominent during intravaginal metronidazole therapy.183 214 Symptomatic Candida vaginitis reported during or immediately after therapy.183 214

Systemic Adverse Effects

Although topical application to skin results in lower systemic absorption than oral or IV administration, adverse systemic effects (e.g., metallic taste,1 180 207 nausea,1 180 207 paresthesia,184 tingling or numbness of extremities1 180 207 ) have been reported with topical metronidazole.1 180

Although intravaginal administration results in lower systemic absorption than oral or IV administration, consider possibility that adverse effects reported with systemic metronidazole could occur when drug is given intravaginally.115 119 183 214

Specific Populations Pregnancy

Category B.1 180 183 184 207 214

Safety and efficacy of intravaginal metronidazole for treatment of bacterial vaginosis in pregnant women not established.109 119 183 214 Existing data do not support use of intravaginal agents during pregnancy and intravaginal metronidazole not included in current CDC recommendations for treatment of bacterial vaginosis in pregnant women.109

Lactation

Distributed into milk following oral or IV administration;1 30 45 131 180 183 184 207 214 not known whether distributed into milk following topical or intravaginal administration.183 f 214

Discontinue nursing or the drug.1 180 183 184 207 214

Pediatric Use

Safety and efficacy of topical1 180 184 207 or intravaginal183 metronidazole not established in pediatric patients.

One manufacturer states safety and efficacy of vaginal gel established in postmenarchal females based on extrapolation of data from adult women; safety and efficacy of vaginal gel not established in premenarchal females.214

Geriatric Use

Safety and efficacy of topical gel in geriatric patients ?65 years of age appear similar to those in younger adults.1

Insufficient experience with vaginal gel in patients ?65 years of age to determine whether geriatric patients respond differently than younger adults.214

Hepatic Impairment

Use vaginal gel with caution in severe hepatic impairment.183 214

Reduced elimination and increased plasma concentrations may occur in severe hepatic dysfunction.183 214

Common Adverse Effects

Topical application to skin: Local effects such as erythema, irritation, stinging/burning, local allergic reactions, contact dermatitis, drying, pruritus, aggravated rosacea.1 47 180 184 207

Intravaginal administration: Vaginal discharge,183 symptomatic Candida cervicitis/vaginitis,183 fungal infection,214 vulvovaginal irritation,183 dysmenorrhea,214 GI effects (abdominal pain, GI discomfort, nausea, vomiting, diarrhea),183 214 headache,183 214 pruritus.214

Interactions for Metronidazole

Because metronidazole can be absorbed systemically following topical application to skin1 2 9 10 21 47 207 or following intravaginal administration,119 131 132 183 214 the possibility that drug and laboratory test interactions could occur with these routes should be considered.106 183 f

Specific Drugs and Laboratory Tests

Drug

Interaction

Comments

Alcohol

Disulfiram-like reactions reported rarely when alcohol ingested during intravaginal metronidazole treatment;106 183 214 such reactions not reported to date with topical application of metronidazole to skin21 47 61 99

Caution patients to avoid alcohol ingestion during intravaginal metronidazole treatment183 214

Anticoagulants, oral (warfarin)

Prolonged PT reported with systemic metronidazole 1 30 45 92 93 94 95 96 183 214

Consider possibility of potentiated anticoagulant effect if topical or intravaginal metronidazole used with oral anticoagulant therapy180 183 214

Cimetidine

Possible prolonged half-life and decreased clearance of metronidazole with concomitant cimetidine and oral or IV metronidazole182 183 214

Consider possibility of increased metronidazole adverse effects182

Disulfiram

Psychotic reactions reported in alcoholic patients receiving oral metronidazole and disulfiram concurrently92 97 168 169 183 214

Avoid concomitant use;92 97 214 do not initiate intravaginal metronidazole until 2 weeks after discontinuance of disulfiram183 214

Lithium

Increased lithium concentrations resulting in lithium toxicity reported after initiation of short-term oral metronidazole therapy in patients stabilized on relatively high lithium dosages181 183 214

Tests based on ultraviolet (UV) absorbance

Falsely decreased serum concentrations (including undetectable concentrations) of AST, ALT, LDH, triglycerides, or hexokinase glucose may be reported during metronidazole therapy if results are based on decreases in UV absorbance that occur during oxidation-reduction of NADH/NAD30 183 214

UV absorbance peaks of NADH and metronidazole are similar30 183 214

Use caution when interpreting test results based on UV absorbance during metronidazole therapy30 183 214

Metronidazole Pharmacokinetics Absorption Bioavailability

Absorbed systemically following topical application to skin; extent of absorption depends on formulation used (cream, gel, lotion).1 2 9 10 21 47 207

Absorbed systemically following intravaginal administration;119 131 132 183 214 systemic bioavailability of vaginal gel averages 50–56%.119 131 132 183 186

Following repeated topical application to the face of 1% cream (approximately 3.75 mg per dose) in adults with rosacea, serum concentrations were minimal or undetectable.9 Following topical application to the face of 1 g of 1% cream in healthy individuals, serum concentrations were minimal or undetectable and peak serum concentrations were attained within 8–12 hours after the dose.184

Following topical application to the face of 1 g of 1% topical gel in adults with rosacea, peak serum concentrations of metronidazole were attained 6–10 hours after the dose and were <1% of concentrations reported with a single 250-mg oral dose.1

Following topical application to the face of 1 g of 0.75% topical lotion (approximately 7.5 mg of metronidazole) twice daily for 4 days, drug was detectable in plasma of all patients and peak plasma concentrations were approximately 80 times lower than peak concentrations attained with a single 250-mg oral dose.207

Following intravaginal administration of 5 g of 0.75% vaginal gel (approximately 37.5 mg of metronidazole) in healthy women, peak serum concentrations were attained 4–17 hours after the dose and were approximately 2% of that attained after a single 500-mg oral dose.119 132 183 186 214

Distribution Extent

Not fully characterized following topical application to skin10 or intravaginal administration.176 177

Crosses placenta following oral or IV administration;1 30 45 56 131 180 183 184 207 not known whether crosses placenta following topical application to skin1 or intravaginal administration.183

Distributed into milk following oral or IV administration;1 30 45 56 131 180 183 184 207 214 not known whether distributed into milk following topical application to skin1 or intravaginal administration.183

Elimination Metabolism

Not fully characterized following topical application to skin10 or intravaginal administration.176 177

Elimination Route

Any systemically absorbed drug probably metabolized in liver and excreted in urine.10 61

Stability Storage Topical Cream

20–25°C.180 184

Gel

20–25°C (may be exposed to 15–30°C).1

Lotion

20–25°C; do not freeze.207

Intravaginal Gel

MetroGel-Vaginal: 15–30°C; do not freeze.183

Vandazole: 20–25°C; do not freeze.214

ActionsActions

Bactericidal, amebicidal, and trichomonacidal in action.2 30 48 52 56

Un-ionized at physiologic pH49 and readily taken up by anaerobic organisms or cells.48 49 50 56 72 In susceptible organisms or cells, metronidazole reduced by low-redox-potential electron transport proteins (e.g., nitroreductases such as ferredoxin);48 49 50 56 64 65 66 68 69 70 71 72 the reduction product(s) apparently are responsible for cytotoxic and antimicrobial effects of the drug (e.g., disruption of DNA, inhibition of nucleic acid synthesis).48 56 63 64 65 66 67 68 70 71 72

Has direct anti-inflammatory effects2 14 17 21 28 180 and effects on neutrophil motility, lymphocyte transformation, and some aspects of cell-mediated immunity.2 10 32 33 34 35

Mechanism of reducing inflammatory lesions (papules and pustules) and erythema in patients with rosacea not elucidated to date;1 2 6 10 11 17 19 21 28 29 184 207 these effects may result from anti-inflammatory or immunosuppressive actions of the drug.1 2 3 10 17 28 29 207

Suppression of skin bacteria does not appear to play a major role in the mechanism of action of the drug in treatment of inflammatory lesions of rosacea;2 10 11 29 inactive in vitro against Propionibacterium acnes,2 4 5 48 staphylococci, and streptococci,2 48 and has no appreciable effects on the aerobic or anaerobic microflora of the skin of patients with rosacea.2 10 29

Spectrum of activity includes most obligately anaerobic bacteria2 7 29 30 45 48 53 56 64 and many protozoa.2 29 30 48 52 64 Inactive against fungi2 3 48 and viruses48 and most aerobic or facultatively anaerobic bacteria.2 7 30 45 48 73 74

Gram-positive anaerobes: Active against Clostridium,2 30 45 48 53 55 C. difficile,54 55 C. perfringens,48 55 Eubacterium,2 30 45 48 53 54 Peptococcus,2 30 45 48 53 54 55 and Peptostreptococcus.2 7 30 45 48 53 55 124 128 Actinomyces, Lactobacillus,48 Propionibacterium acnes,2 4 5 48 P. avidum,5 and P. granulosum5 generally are resistant.

Gram-negative anaerobes: Active against Bacteroides fragilis,2 3 30 45 48 53 54 55 124 126 130 B. distasonis,30 45 54 55 124 B. ovatus,30 45 55 124 B. thetaiotaomicron,30 45 54 55 124 B. vulgatus,30 45 54 55 124 B. ureolyticus,124 126 Fusobacterium,2 7 30 45 48 53 55 Prevotella bivia,53 124 126 128 129 P. disiens,54 128 P. intermedia,7 124 P. melaninogenica,48 54 124 126 128 129 P. oralis,54 124 126 129 Porphyromonas,124 129 and Veillonella.7 54 55

Other organisms: Active against Campylobacter fetus.48 Most strains of Gardnerella vaginalis (formerly Haemophilus vaginalis) are susceptible only to relatively high concentrations in vitro.119 126 129 135 140 141 142 Concentrations readily achievable locally (750 mcg/mL) following intravaginal application of 0.75% vaginal gel have inhibited approximately 90% of strains tested in vitro.119 177

Natural and acquired resistance has been reported in some T. vaginalis.48 52 75 76 77 78 79 Resistance also reported rarely in B. fragilis and other anaerobic bacteria following long-term therapy.44 48 215

Advice to Patients

Importance of using topical or intravaginal metronidazole only as directed and only for the disorder for which drug was prescribed.1 180 183 184 207 f

Advise patients that topical cream, gel, and lotion are for external use only and to avoid contact with eyes.1 180 184 207 (See Administration under Dosage and Administration.)

Advise patients that vaginal gel is for intravaginal administration only and to avoid contact with eyes.183 214 (See Administration under Dosage and Administration.) If such contact occurs, importance of irrigating eyes with copious amounts of cool water.177 183

Instruct patients receiving vaginal gel regarding appropriate use of vaginal applicator.f

Advise women using vaginal gel not to engage in vaginal intercourse111


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Topcare Tioconazole 1



Dosage Form: ointment
Topco Tioconazole 1 Drug Facts Active ingredient (in each applicator)

Tioconazole 300 mg (6.5%)

Purpose

Vaginal antifungal

Uses treats vaginal yeast infections Warnings

For vaginal use only

Do not use

if you have never had a vaginal yeast infection diagnosed by a doctor

Ask a doctor before use if you have vaginal itching and discomfort for the first time lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition. vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. been exposed to human immunodeficiency virus (HIV) that causes AIDS When using this product do not use tampons, douches, spermicides, or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted disease (STDs). do not have vaginal intercourse mild increase in vaginal burning, itching or irritation may occur Stop use and ask a doctor if symptoms do not get better after 3 days symptoms last more than 7 days you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions before using this product read the enclosed brochure and instructions on foil packet for complete directions and information adults and children 12 years and over: open the foil packet just before use and remove purple cap insert entire contents of applicator into the vagina at bedtime. Throw applicator away after use. children under 12 years of age: ask a doctor Other information this product is a 1-dose treatment, most women do not experience complete relief of their symptoms in just one day. Most women experience some relief within one day and complete relief of symptoms within 7 days. if you have questions about vaginal yeast infections, consult your doctor store at 20° - 25°C (68° - 77°F) see end flap of carton for lot number and expiration date Inactive ingredients

butylated hydroxyanisole, magnesium aluminum silicate, white petrolatum

Questions or comments?

1-888-423-0139

Principal Display Panel

1-Dose Vaginal Treatment

Tioconazole 1

Tioconazole Ointment 6.5%

Vaginal Antifungal

Cures Most Vaginal Yeast Infections

1 Ready-to-Use Convenient Prefilled Applicator

Compare to 1-Day™ active ingredient

Tioconazole 1 Carton


Topcare Tioconazole 1 
tioconazole  ointment Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 36800-426 Route of Administration VAGINAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TIOCONAZOLE (TIOCONAZOLE) TIOCONAZOLE 6.5 g  in 100 g Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color BROWN (light to dark tan) Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 36800-426-54 1 APPLICATOR In 1 CARTON contains a APPLICATOR 1 4.6 g In 1 APPLICATOR This package is contained within the CARTON (36800-426-54)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075915 03/03/2008
Labeler - Topco Associates LLC (006935977) Revised: 11/2009Topco Associates LLC
More Topcare Tioconazole 1 resources Topcare Tioconazole 1 Side Effects (in more detail) Topcare Tioconazole 1 Use in Pregnancy & Breastfeeding Topcare Tioconazole 1 Support Group 7 Reviews for Topcare Tioconazole - Add your own review/rating Compare Topcare Tioconazole 1 with other medications Vaginal Yeast Infection
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Up and Up Tioconazole 1



Dosage Form: vaginal ointment
Target Corp. Tioconazole 1 Drug Facts Active ingredient (in each applicator)

Tioconazole 300 mg (6.5%)

Purpose

Vaginal antifungal

Uses treats vaginal yeast infections Warnings

For vaginal use only

Do not use

if you have never had a vaginal yeast infection diagnosed by a doctor

Ask a doctor before use if you have vaginal itching and discomfort for the first time lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition. vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. been exposed to human immunodeficiency virus (HIV) that causes AIDS When using this product do not use tampons, douches, spermicides, or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted disease (STDs). do not have vaginal intercourse mild increase in vaginal burning, itching or irritation may occur Stop use and ask a doctor if symptoms do not get better after 3 days symptoms last more than 7 days you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions before using this product read the enclosed brochure and instructions on foil packet for complete directions and information adults and children 12 years and over: open the foil packet just before use and remove purple cap insert entire contents of applicator into the vagina at bedtime. Throw applicator away after use. children under 12 years of age: ask a doctor Other information this product is a 1-dose treatment, most women do not experience complete relief of their symptoms in just one day. Most women experience some relief within one day and complete relief of symptoms within 7 days. if you have questions about vaginal yeast infections, consult your doctor store at 20° - 25°C (68° - 77°F) see end flap of carton for lot number and expiration date Inactive ingredients

butylated hydroxyanisole, magnesium aluminum silicate, white petrolatum

Questions or comments?

1-800-910-6874

Principal Display Panel

1-Dose Treatment

Tioconazole 1

Tioconazole Ointment 6.5%

Vaginal Antifungal

Compare to active ingredient in 1-Day™

Cures Most Vaginal Yeast Infections

1 Ready-to-Use Prefilled Applicator

Educational Brochure Enclosed

1 Dose

Tioconazole 1 Carton


Up and Up Tioconazole 1 
tioconazole  ointment Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 11673-426 Route of Administration VAGINAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TIOCONAZOLE (TIOCONAZOLE) TIOCONAZOLE 6.5 g  in 100 g Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color BROWN (light to dark tan) Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 11673-426-54 1 POUCH In 1 CARTON contains a POUCH 1 1 APPLICATOR In 1 POUCH This package is contained within the CARTON (11673-426-54) and contains a APPLICATOR 1 4.6 g In 1 APPLICATOR This package is contained within a POUCH and a CARTON (11673-426-54)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075915 07/08/2009
Labeler - Target Corporation (006961700) Revised: 11/2009Target Corporation
More Up and Up Tioconazole 1 resources Up and Up Tioconazole 1 Side Effects (in more detail) Up and Up Tioconazole 1 Use in Pregnancy & Breastfeeding Up and Up Tioconazole 1 Support Group 7 Reviews for Up and Up Tioconazole - Add your own review/rating Compare Up and Up Tioconazole 1 with other medications Vaginal Yeast Infection
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Vandazole


Generic Name: metronidazole (Vaginal route)

met-roe-NYE-da-zole

Commonly used brand name(s)

In the U.S.

Metrogel-Vaginal Vandazole

In Canada

Flagyl Neo-Metric Nidagel

Available Dosage Forms:

Suppository Gel/Jelly Cream

Therapeutic Class: Antibacterial

Chemical Class: Nitroimidazole

Uses For Vandazole

Metronidazole vaginal is used to treat women with vaginal infections (e.g., bacterial vaginosis).

Metronidazole belongs to the class of medicines known as antibiotics. It works by killing the bacteria or preventing their growth. However, this medicine will not work for vaginal fungus or yeast infections.

This medicine is available only with your doctor's prescription.

Before Using Vandazole

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

In deciding whether to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For vaginal metronidazole, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies on the relationship of age to the effects of metronidazole vaginal gel have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medication in teenagers are not expected. This medicine may be used for bacterial vaginosis in teenage females but should not be used before the start of menstruation.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of metronidazole vaginal gel in the elderly.

Pregnancy Pregnancy Category Explanation All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Amprenavir Disulfiram

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Amiodarone Busulfan Fluorouracil Mycophenolate Mofetil Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Carbamazepine Cholestyramine Cyclosporine Lithium Milk Thistle Tacrolimus Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Aseptic meningitis, history of or Encephalopathy (brain disorder), history of or Leukopenia (low white blood cells), history of or Optic neuropathy (eye disease with vision changes), history of or Peripheral neuropathy (nerve disease with pain, numbness, or tingling), history of or Seizures or epilepsy, history of—Use with caution. May make these conditions worse. Liver disease, severe—Patients with severe liver disease may have an increase in side effects. Proper Use of metronidazole

This section provides information on the proper use of a number of products that contain metronidazole. It may not be specific to Vandazole. Please read with care.

Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine is to be used only in the vagina. Use it at bedtime, unless your doctor tells you otherwise.

Do not get it in your eyes, nose, mouth, or skin. If this medicine does get into your eyes, wash them out right away with large amounts of cool tap water. If your eyes still burn or are painful, check with your doctor.

This medicine usually come with patient directions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Wash your hands with soap and water before and after using this medicine.

Metronidazole vaginal gel is in a tube. You will use an applicator to put the gel into your vagina. The applicator has a plastic tube called a barrel that is open at one end and has a plunger (another piece of plastic that can move inside the barrel) at the other end.

To fill the applicator: For cream or gel dosage forms: Break the metal seal at the opening of the tube by using the point on the top of the cap. Screw the applicator onto the tube. Squeeze the medicine into the applicator slowly until it is full. Remove the applicator from the tube. Replace the cap on the tube. For vaginal tablet dosage form: Place the vaginal tablet into the applicator. Wet the vaginal tablet with water for a few seconds. To insert vaginal metronidazole using the applicator For all dosage forms: Relax while lying on your back with your knees bent (or in any position that you feel comfortable). Hold the full applicator in one hand. Insert it slowly into the vagina. Stop before it becomes uncomfortable. Slowly press the plunger until it stops. Withdraw the applicator. The medicine will be left behind in the vagina. Remove the applicator from your vagina. Use each applicator only once, and then throw it away.

To help clear up your infection completely, it is very important that you keep using this medicine for the full time of treatment, even if your symptoms begin to clear up after a few days. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses. Also, continue using this medicine even if your menstrual period starts during the time of treatment.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For bacterial vaginal infections: For vaginal dosage form (cream): Adults and teenagers—One applicatorful (500 milligrams [mg]), inserted into the vagina. Use the medicine one or two times a day for 10 or 20 days. Children—Use and dose must be determined by your doctor. For vaginal dosage form (gel): Adults and teenagers—One applicatorful (5000 milligrams [mg]) inserted into the vagina once a day (at bedtime) for 5 days. Each applicatorful contains 37.5 mg of metronidazole. Children—Use and dose must be determined by your doctor. For vaginal dosage form (tablets): Adults and teenagers—One 500 milligram (mg) tablet, inserted high into the vagina. Use the medicine once a day in the evening for 10 or 20 days. Children—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Vandazole

It is important that your doctor check your progress after you finish using this medicine. This is to make sure that the infection is cleared up.

If your symptoms do not improve within a few days after you start this medicine or if they become worse, check with your doctor.

You should not use this medicine if you have taken disulfiram (Antabuse®) within the last 2 weeks. Disulfiram is used to help people who have a drinking problem. If these 2 medicines are taken close together, serious unwanted effects may occur.

Drinking alcoholic beverages while using this medicine may cause stomach pain, nausea, vomiting, headache, or flushing or redness of the face. Alcohol-containing medicines (e.g., elixirs, cough syrups, tonics) may also cause problems. The chance of these problems occurring may continue for at least a day after you stop using metronidazole. You should not drink alcoholic beverages or take other alcohol-containing medicines while you are using this medicine and for at least 3 days after stopping it.

Stop using this medicine and check with your doctor right away if you have dizziness, problems with muscle control or coordination, shakiness or an unsteady walk, slurred speech, or trouble with speaking. These may be symptoms of a serious brain condition called encephalopathy.

Stop using this medicine and call your doctor right away if you have confusion, drowsiness, fever, a general feeling of illness, a headache, loss of appetite, nausea, a stiff neck or back, or vomiting. These could be symptoms of a serious condition called aseptic meningitis.

Stop using this medicine and check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

This medicine may cause some people to become dizzy or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert. If these reactions are especially bothersome, check with your doctor.

Vaginal medicines usually leak out of the vagina during treatment. To keep the medicine from getting on your clothing, wear a mini-pad or sanitary napkin. Do not use tampons (like those used for menstrual periods) since they may soak up the medicine.

To help clear up your infection completely and to help make sure it does not return, good health habits are also required.

Wear cotton panties (or panties or pantyhose with cotton crotches) instead of synthetic (e.g., nylon or rayon) panties. Wear only freshly washed panties daily.

Do not have sexual intercourse while you are using this medicine. Having sexual intercourse may reduce the strength of the medicine. This may keep the medicine from working properly. Also, oils in the cream and vaginal tablets (but not the vaginal gel) may damage latex (rubber) contraceptive devices (e.g., cervical caps, condoms, or diaphragms), causing them to leak, wear out sooner, or not work properly.

Avoid using douches or other vaginal products unless your doctor tells you to.

Many vaginal infections (e.g., trichomoniasis) are spread by having sexual intercourse. You can give the infection to your sexual partner, and the infection could be given back to you. Your partner may also need to be treated for some infections. Until you are sure that the infection is completely cleared up after your treatment with this medicine, your partner should wear a condom during sexual intercourse . If you have any questions about this, check with your doctor.

Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Vandazole Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common Itching in the vagina pain during sexual intercourse thick, white vaginal discharge with no odor or with a mild odor Less common Abdominal or stomach cramping or pain burning on urination or need to urinate more often burning or irritation of penis of sexual partner itching, stinging, or redness of the genital area

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common Diarrhea dizziness or lightheadedness dryness of the mouth feeling of a furry tongue headache loss of appetite metallic taste or other change in taste sensation nausea vomiting

Metronidazole may cause your urine to become dark. This is harmless and will go away when you stop using this medicine.

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

Any vaginal or genital irritation or itching pain during sexual intercourse thick, white vaginal discharge not present before treatment, with no odor or with a mild odor

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Vandazole side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Vandazole resources Vandazole Side Effects (in more detail) Vandazole Use in Pregnancy & Breastfeeding Vandazole Drug Interactions Vandazole Support Group 2 Reviews for Vandazole - Add your own review/rating Vandazole Prescribing Information (FDA) Vandazole Concise Consumer Information (Cerner Multum) MetroCream Cream MedFacts Consumer Leaflet (Wolters Kluwer) MetroCream Concise Consumer Information (Cerner Multum) MetroCream Prescribing Information (FDA) MetroGel Prescribing Information (FDA) Metrocream Metrolotion Noritate Prescribing Information (FDA) Rozex Emulsion MedFacts Consumer Leaflet (Wolters Kluwer) Vitazol Prescribing Information (FDA) Compare Vandazole with other medications Bacterial Vaginitis
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terconazole vaginal


Generic Name: terconazole vaginal (ter KON a zole VAJ in al)
Brand Names: Terazol 3, Terazol 7, Zazole

What is terconazole vaginal?

Terconazole is an antifungal antibiotic that fights infections caused by fungus.

Terconazole vaginal is used to treat candida (yeast) infections of the vagina.

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

What is the most important information I should know about terconazole vaginal?

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Terconazole vaginal will not treat a viral infection such as the common cold or flu.

Avoid wearing tight-fitting, synthetic clothing (e.g., panty hose) that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water. What should I discuss with my healthcare provider before using terconazole vaginal? You should not use terconazole vaginal if you are allergic to it, or if you have:

a fever;

stomach pain; or

foul-smelling vaginal discharge.

To make sure you can safely use terconazole vaginal, tell your doctor if you have any of these other conditions:

diabetes;

HIV or AIDS.; or

if you have ever had an allergic reaction to similar medications such as butoconazole (Femstat, Mycelex), clotrimazole (Lotrimin, Femcare), econazole (Spectazole), fluconazole (Diflucan), ketoconazole (Nizoral), itraconazole (Sporanox), miconazole (Monistat), and others.

FDA pregnancy category C. It is not known whether terconazole vaginal will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether terconazole passes into breast milk. Do not use terconazole vaginal without first talking to your doctor if you are breast-feeding a baby. How should I use terconazole vaginal?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Terconazole vaginal is usually applied once daily at bedtime for 3 days in a row. Follow your doctor's instructions.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Wash your hands before and after using this medication.

Insert the suppository or cream into the vagina using the applicator as directed.

You can use a sanitary napkin to prevent the medication from staining clothing but do not use a tampon.

Use this medication for the full prescribed length of time, even during your menstrual period. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Terconazole vaginal will not treat a viral infection such as the common cold or flu.

Call your doctor if your symptoms do not improve, or if they get worse while using terconazole vaginal. Do not use terconazole vaginal to treat any vaginal condition that has not been checked by your doctor. Store at room temperature away from moisture and heat. What happens if I miss a dose?

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

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while using terconazole vaginal? Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water.

Avoid using other vaginal medications or douches during your treatment with terconazole vaginal, unless you doctor tells you to.

Avoid wearing tight-fitting, synthetic clothing (e.g., panty hose) that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Avoid sexual intercourse or use a condom to prevent the infection from spreading to a sexual partner.

Avoid exposure to sunlight or tanning beds. Terconazole can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Terconazole vaginal side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using terconazole vaginal and call your doctor at once if you have a serious side effect such as:

severe vaginal burning or irritation; or

fever, chills, flu symptoms.

Less serious side effects may include:

headache; or

menstrual cramps.

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.

Terconazole vaginal Dosing Information

Usual Adult Dose for Vaginal Candidiasis:

Vaginal suppositories: 1 suppository intravaginally once a day at bedtime for 3 consecutive days
0.8% vaginal cream: 1 applicatorful intravaginally once a day at bedtime for 3 consecutive days
0.4% vaginal cream: 1 applicatorful intravaginally once a day at bedtime for 7 consecutive days

What other drugs will affect terconazole vaginal?

It is not likely that other drugs you take orally or inject will have an effect on vaginally applied terconazole. But many drugs can interact with each other. 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 terconazole vaginal resources Terconazole vaginal Side Effects (in more detail) Terconazole vaginal Dosage Terconazole vaginal Use in Pregnancy & Breastfeeding Terconazole vaginal Support Group 6 Reviews for Terconazole - Add your own review/rating Compare terconazole vaginal with other medications Vaginal Yeast Infection Where can I get more information? Your pharmacist can provide more information about terconazole vaginal.

See also: terconazole side effects (in more detail)


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Micon 7


Generic Name: miconazole vaginal (my CAW nah zole)
Brand Names: M-Zole Dual Pack, Micon 7, Monistat 3, Monistat 5, Monistat 7

What is Micon 7 (miconazole vaginal)?

Miconazole is an antifungal medication. It prevents fungus from growing.

Miconazole vaginal is used to treat vaginal candida (yeast) infections.

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

What is the most important information I should know about Micon 7 (miconazole vaginal)?

Use this medication for the full amount of time prescribed by your doctor or recommended in the package even if you begin to feel better. The symptoms may improve before the infection is completely healed.

Avoid wearing tight-fitting, synthetic clothing (e.g., panty hose) that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Avoid getting this medication in the eyes, nose, or mouth. What should I discuss with my healthcare provider before using Micon 7 (miconazole vaginal)?

If this is the first time that you have ever had symptoms of a vaginal yeast infection, consult your doctor before using this medication.

Do not use miconazole vaginal if you have ever had an allergic reaction to it.

Before using miconazole vaginal, talk to your doctor if you have

a fever,

abdominal pain,

foul-smelling discharge,

diabetes, or

HIV or AIDS.

You may not be able to use miconazole vaginal, or you may require special monitoring during treatment if you have any of the conditions listed above.

Do not use miconazole vaginal without first talking to your doctor if you are pregnant. Do not use miconazole vaginal without first talking to your doctor if you are breast-feeding a baby. How should I use Micon 7 (miconazole vaginal)? Use miconazole vaginal exactly as directed by your doctor or follow the directions that accompany the package. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after using the medication.

Insert the tablet, suppository, or cream into the vagina using the applicator as directed.

Use this medication for the full amount of time prescribed by your doctor or recommended in the package even if you begin to feel better. The symptoms may improve before the infection is completely healed.

Use this medication continuously, even during your menstrual period.

You can use a sanitary napkin to prevent the medication from staining your clothing but do not use a tampon.

If the infection does not clear up after you have finished one course of therapy, or if it appears to get worse, see your doctor. You may have another type of infection.

Avoid getting this medication in the eyes, nose, or mouth. Store miconazole vaginal at room temperature away from moisture and heat. What happens if I miss a dose?

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

What happens if I overdose?

An overdose of miconazole vaginal is unlikely. If you do suspect that a much larger than normal dose has been used or that miconazole vaginal has been ingested, contact an emergency room or a poison control center.

What should I avoid while using Micon 7 (miconazole vaginal)?

Avoid wearing tight-fitting, synthetic clothing (e.g., panty hose) that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Miconazole may damage a condom or diaphragm. Use another form of birth control while using miconazole vaginal.

Micon 7 (miconazole vaginal) side effects Stop using miconazole vaginal and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of your throat; swelling of your lips, face, or tongue; or hives).

Other, less serious side effects may be more likely to occur. These include burning, itching, irritation of the skin, and an increased need to urinate.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Micon 7 (miconazole vaginal)? Do not use miconazole vaginal without first talking to your doctor if you are taking warfarin (Coumadin). Special monitoring or a dosage adjustment may be necessary.

Avoid using other vaginal creams or douches at the same time as miconazole vaginal unless otherwise directed by your doctor.

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

More Micon 7 resources Micon 7 Side Effects (in more detail) Micon 7 Use in Pregnancy & Breastfeeding Micon 7 Drug Interactions Micon 7 Support Group 0 Reviews for Micon 7 - Add your own review/rating Baza Antifungal Topical Advanced Consumer (Micromedex) - Includes Dosage Information Cruex Prescription Strength Topical Advanced Consumer (Micromedex) - Includes Dosage Information Lotrimin AF Lotion MedFacts Consumer Leaflet (Wolters Kluwer) Micatin Cream MedFacts Consumer Leaflet (Wolters Kluwer) Monistat 3 Cream MedFacts Consumer Leaflet (Wolters Kluwer) Monistat 3 Prescribing Information (FDA) Monistat 7 Cream MedFacts Consumer Leaflet (Wolters Kluwer) Zeasorb-AF Gel MedFacts Consumer Leaflet (Wolters Kluwer) Compare Micon 7 with other medications Vaginal Yeast Infection Where can I get more information? Your pharmacist has additional information about miconazole vaginal written for health professionals that you may read.

See also: Micon 7 side effects (in more detail)


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Rosiced 7.5mg / g cream


ROSICED 7.5 mg/g Cream

Active substance: metronidazole

For adult use

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 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 ROSICED 7.5mg/g Cream is and what it is used for 2. Before you use ROSICED 7.5mg/g Cream 3. How to use ROSICED 7.5mg/g Cream 4. Possible side effects 5. How to store ROSICED 7.5mg/g Cream 6. Further information WHAT ROSICED 7.5mg/g Cream IS AND WHAT IT IS USED FOR

ROSICED 7.5mg/g Cream is used to treat inflammation caused by rosacea. Inflammatory rosacea is a skin condition that causes redness, papules (pink bumps) and pustules (pus-filled spots) on the face.

BEFORE YOU USE ROSICED 7.5mg/g Cream Do not use ROSICED 7.5mg/g Cream if you are allergic (hypersensitive) to metronidazole or any of the other ingredients of ROSICED 7.5mg/g Cream . All ingredients used in ROSICED 7.5mg/g Cream are listed in section 6 of this leaflet. If you are not sure whether you are allergic, please ask your doctor or pharmacist. if you are in the first 3 months of pregnancy.

If you have any of the following:

severe liver damage (e.g. cirrhosis of the liver), problems affecting blood formation (e.g. anaemia), diseases affecting the brain, bone marrow or nerves

please tell your doctor. In such cases, treatment with ROSICED 7.5mg/g Cream must be carefully considered.

Take special care with ROSICED 7.5mg/g Cream: when using it near the eyes or mucous membranes. Such contact should be avoided. If contact occurs, the cream should be washed away carefully with water. when exposing your skin to sunlight or ultraviolet (UV) light (e.g. sun beds or solarium visits). Avoid strong sunlight or UV light as metronidazole is not stable under UV light and it may lose its effectiveness, or its effectiveness may be altered. if you have, or have ever had, a blood condition (dyscrasia). A dyscrasia may manifest among other symptoms as a blood clotting disorder. Using ROSICED 7.5mg/g Cream with 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.

To date, there are no known interactions with other drugs applied to the skin.

Pregnancy and breast-feeding

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

Pregnancy

ROSICED 7.5mg/g Cream should not be used in the first three months of pregnancy. To be on the safe side, if you are not sure whether you are pregnant, you should undergo a pregnancy test. ROSICED 7.5mg/g Cream should only be used in the last six months of pregnancy if other treatments have proved ineffective.

Breast-feeding

Metronidazole (the active substance of ROSICED 7.5mg/g Cream) passes into breast milk.

During the breast-feeding period, you should either stop breast-feeding or refrain from using ROSICED 7.5mg/g Cream.

Children and adolescents

ROSICED 7.5mg/g Cream is not recommended for use in children.

As rosacea does not affect children, no trials have been performed on children with regard to safety and tolerability.

Driving and using machines

ROSICED 7.5mg/g Cream has no effect on the ability to drive vehicles.

Important information about some of the ingredients of ROSICED 7.5mg/g Cream

ROSICED 7.5mg/g Cream contains propylene glycol, which can cause skin irritations.

HOW TO USE ROSICED 7.5mg/g Cream

Always use ROSICED 7.5mg/g Cream exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Always wash and dry your face gently before each application.

Non-comedogenic cosmetics (that do not clog pores and cause blackheads) and non-astringent cosmetics (that do not draw together or constrict skin and wound tissue e.g. styptic pen) may be used following application of the cream. If you are unsure, ask your doctor or pharmacist which cosmetics you can use.

How much and how often you should apply ROSICED 7.5mg/g Cream

Dosage and method of administration

Unless otherwise prescribed by your doctor, the usual dose is as follows:

Apply the cream as a thin film twice daily to the affected areas of the face and gently rub it in.

Please consult your doctor or pharmacist if you have the impression that the action of ROSICED 7.5mg/g Cream is too strong or too weak.

How long you should use ROSICED 7.5mg/g Cream

You should normally use ROSICED 7.5mg/g Cream for a period of 6 weeks. If necessary, treatment can be extended. If no clinical improvement is achieved, treatment should be discontinued.

If you use more ROSICED 7.5mg/g Cream than you should:

Overdosage is extremely unlikely. If necessary, the product should by removed by washing with warm water.

If you forget to use ROSICED 7.5mg/g Cream:

Do not increase the dose to make up for a forgotten dose. Simply carry on using ROSICED 7.5mg/g Cream at the dosage schedule prescribed by your doctor.

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

Possible Side Effects

Like all medicines, ROSICED 7.5mg/g Cream can cause side effects, although not everybody gets them.

The evaluation of side effects is based on the following frequencies:

very common: more than 1 in 10 cases treated
common: fewer than 1 in 10, but more than 1 in 100 cases treated
uncommon: fewer than 1 in 100, but more than 1 in 1,000 cases treated
rare: fewer than 1 in 1,000, but more than 1 in 10,000 cases treated
very rare: fewer than 1 in 10,000 cases treated, including isolated reports

Common side effects include dry skin, inflammation and a burning sensation on the skin.

In rare cases, swelling of the face and neck, sudden itching, fainting and breathlessness can occur.

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 ROSICED 7.5mg/g Cream

Keep out of the reach and sight of children.

Do not use ROSICED 7.5mg/g Cream after the expiry date which is stated on the tube and carton after Exp. The expiry date refers to the last day of that month.

Storage conditions

Do not store above 25?C.

Storage once ROSICED 7.5mg/g Cream has been opened

The cream can be used for up to 28 days after opening.

Do not use ROSICED 7.5mg/g Cream if you notice that the tube is damaged.

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 ROSICED 7.5mg/g Cream contains

The active substance is: metronidazole. One gram of cream contains 7.5 mg of metronidazole.

The other ingredients are:

glyceryl monolaurate, glyceryl monomyristate, propylene glycol, citric acid anhydrous, sodium hydroxide, carbomers, purified water.

What ROSICED 7.5mg/g Cream looks like and contents of the pack

ROSICED 7.5mg/g Cream is available in synthetic (polyethylene) tubes containing 25 g, 30 g, 40 g and 50 g. Not all pack sizes may be marketed in all countries.

Marketing authorisation holder Pierre Fabre Dermatologie 45 place Abel Gance 92100 Boulogne France Manufacturer Bioglan AB PO Box 50310 S-202 13 Malm? Sweden

This leaflet was last approved in:

26/02/2008


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metronidazole Oral, Intravenous


met-roe-NYE-da-zole

Oral route(Tablet;Tablet, Extended Release;Capsule)

Metronidazole has been shown to be carcinogenic in mice and rats. Unnecessary use of the drug should be avoided. Its use should be reserved only for conditions for which it is approved .

Commonly used brand name(s)

In the U.S.

Flagyl Flagyl ER

Available Dosage Forms:

Tablet, Extended Release Capsule Tablet Suspension

Therapeutic Class: Antibiotic

Chemical Class: Nitroimidazole

Uses For metronidazole

Metronidazole is used to treat bacterial infections in different areas of the body. The extended-release tablets are used to treat women with vaginal infections (bacterial vaginosis).

Metronidazole belongs to the class of medicines known as antibiotics. It works by killing bacteria or preventing their growth. However, metronidazole will not work for colds, flu, or other virus infections.

metronidazole is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, metronidazole is used in certain patients with the following medical conditions:

Clostridium difficile diarrhea or colitis (antibiotic-associated colitis). Crohn's disease (inflammatory bowel disease). Gastritis or stomach ulcers due to Helicobacter pylori. Giardiasis (parasite infection in the intestines). Before Using metronidazole

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For metronidazole, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to metronidazole or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of metronidazole to treat bacterial infections in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of metronidazole in children with amebiasis.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of metronidazole in the elderly. However, elderly patients are more likely to have age-related liver problems, which may require caution and an adjustment in the dose for patients receiving metronidazole.

Pregnancy Pregnancy Category Explanation All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking metronidazole, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using metronidazole with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Amprenavir Disulfiram

Using metronidazole with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Amiodarone Busulfan Fluorouracil Mycophenolate Mofetil Warfarin

Using metronidazole with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Carbamazepine Cholestyramine Cyclosporine Lithium Milk Thistle Tacrolimus Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using metronidazole with any of the following is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol Other Medical Problems

The presence of other medical problems may affect the use of metronidazole. Make sure you tell your doctor if you have any other medical problems, especially:

Leukopenia (low white blood cells), history of or Optic neuropathy (eye disease with vision changes), history of or Oral thrush (Candida infection) or Peripheral neuropathy (nerve disease with pain, numbness, or tingling), history of or Seizures, history of or Vaginal yeast infection (Candida infection)—Use with caution. May make these conditions worse. Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body. Proper Use of metronidazole

Take metronidazole only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

The regular tablet or capsule can be taken with or without food. If the medicine upsets your stomach, it is best to take it with a meal or snack.

The extended–release tablet must be taken without food, one hour before or two hours after a meal.

Swallow the extended-release tablet whole. Do not break, crush, or chew it.

To help clear up your infection completely, keep using metronidazole for the full time of treatment, even if you begin to feel better after a few days. If you stop using metronidazole too soon, your infection may return.

metronidazole works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times during the day. If you need help planning the best times to take your medicine, check with your doctor.

If you have taken a medicine called disulfiram (Antabuse®) within the last 2 weeks, do not take metronidazole until you talk to your doctor. Disulfiram is used to help people who have a drinking problem. If these 2 medicines are taken close together, serious unwanted effects may occur.

Dosing

The dose of metronidazole will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of metronidazole. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage forms (capsules or tablets): For amebiasis infections: Adults and teenagers—500 or 750 milligrams (mg) 3 times per day for 5 to 10 days. Children—Dose is based on body weight and must be determined by your doctor. The dose is usually 35 to 50 milligrams (mg) per kilogram (kg) of body weight per day, divided and given in 3 doses, for 10 days. For bacterial infections: Adults and teenagers—Dose is based on body weight and must be determined by your doctor. The dose is usually 7.5 milligrams (mg) per kilogram (kg) of body weight, up to a maximum dose of 1 gram, every 6 hours for 7 to 10 days. Children—Use and dose must be determined by your doctor. For trichomoniasis infections: Adults and teenagers—The tablet can be given 3 different ways: as a single dose of 2 grams; or as 1 gram 2 times per day for 1 day; or as 250 milligrams (mg) 3 times per day for 7 days. The capsule dose is 375 mg 2 times per day for 7 days. Children—Use and dose must be determined by your doctor. For oral dosage form (extended-release tablets): For bacterial vaginosis: Adults and teenagers—750 milligrams (mg) once a day for 7 days. Children—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of metronidazole, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using metronidazole

It is important that your doctor check your progress after you finish taking metronidazole. This is to make sure that the infection is cleared up. Blood tests may be needed to check for unwanted effects.

If your symptoms do not improve within a few days after you start metronidazole or if they become worse, check with your doctor.

Drinking alcoholic beverages while using metronidazole may cause stomach pain, nausea, vomiting, headache, or flushing or redness of the face. Other alcohol-containing preparations (e.g., elixirs, cough syrups, tonics) may also cause problems. These problems may last for at least one day after you stop using metronidazole. metronidazole may also cause alcoholic beverages to taste different. You should not drink alcoholic beverages or take other alcohol-containing preparations while you are using metronidazole and for at least 3 days after stopping it.

Using metronidazole while you are pregnant (especially during the first 3 months of pregnancy) can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

If you are using metronidazole for trichomoniasis (an infection of the sex organs in men or women), your doctor may want to treat your sexual partner at the same time you are being treated, even if he or she has no symptoms. Also, it may be desirable to use a condom (rubber) during sexual intercourse. These measures will help to keep you from getting the infection back again from your partner. If you have any questions about this, check with your doctor.

Check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

Check with your doctor right away if you have dizziness, problems with muscle control or coordination, shakiness or an unsteady walk, slurred speech, or trouble with speaking. These may be symptoms of a serious brain condition called encephalopathy.

Call your doctor right away if you have confusion, drowsiness, fever, a general feeling of illness, a headache, loss of appetite, nausea, a stiff neck or back, or vomiting. These could be symptoms of a serious condition called aseptic meningitis.

Metronidazole may cause dry mouth, an unpleasant or sharp metallic taste, and a change in taste sensation. For temporary relief of dry mouth, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. If your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

metronidazole Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common Agitation back pain blindness blurred vision burning, numbness, tingling, or painful sensations in the hands or feet changes in speech patterns confusion convulsions decreased vision depression dizziness drowsiness eye pain fever hallucinations headache irritability lack of coordination mood or mental changes nausea seizures shakiness and unsteady walk slurred speech stiff neck or back trouble with speaking unsteadiness, trembling, or other problems with muscle control or coordination unusual tiredness or weakness vomiting weakness in the arms, hands, legs, or feet Less common Black, tarry stools blood in the urine or stools body aches or pain chills clumsiness or unsteadiness difficulty with breathing ear congestion feeling of pelvic pressure frequent or painful urination loss of voice nasal congestion pinpoint red spots on the skin runny nose skin rash, hives, redness, or itching sneezing stomach and back pain (severe) unusual bleeding or bruising vaginal irritation, discharge, or dryness not present before taking the medicine Rare Bleeding gums bloating chest pain constipation cough dark-colored urine fast heartbeat indigestion loss of appetite painful or difficult urination pains in the stomach, side, or abdomen, possibly radiating to the back shortness of breath sore throat sores, ulcers, or white spots on the lips or in the mouth swollen glands yellow eyes or skin Incidence not known Blistering, peeling, or loosening of the skin bloody or cloudy urine burning while urinating continuing diarrhea continuing stomach pain diarrhea feeling of warmth increased volume of pale, dilute urine joint or muscle pain loss of bladder control red irritated eyes red skin lesions, often with a purple center redness of the face, neck, arms, and occasionally, upper chest redness of the skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Abdominal or stomach cramps dizziness or lightheadedness feeling of constant movement of self or surroundings heartburn sensation of spinning sleeplessness trouble sleeping unable to sleep weight loss Less common or rare Change in taste sensation congestion dry mouth pain or tenderness around the eyes and cheekbones stuffy nose tender, swollen glands in the neck trouble with swallowing unpleasant or sharp metallic taste voice changes Incidence not known Decreased interest in sexual intercourse inability to have or keep an erection loss in sexual ability, desire, drive, or performance painful sexual intercourse

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More metronidazole Oral, Intravenous resources Metronidazole Oral, Intravenous Use in Pregnancy & Breastfeeding Drug Images Metronidazole Oral, Intravenous Drug Interactions Metronidazole Oral, Intravenous Support Group 107 Reviews for Metronidazole Oral, Intravenous - Add your own review/rating Compare metronidazole Oral, Intravenous with other medications Amebiasis Aspiration Pneumonia Bacteremia Bacterial Infection Bacterial Vaginitis Bone infection Clostridial Infection Crohn's Disease, Acute Crohn's Disease, Maintenance Deep Neck Infection Dental Abscess Diverticulitis Dracunculiasis Endocarditis Giardiasis Helicobacter Pylori Infection Intraabdominal Infection Joint Infection Meningitis Pelvic Inflammatory Disease Peritonitis Pneumonia Pseudomembranous Colitis Skin Infection Surgical Prophylaxis Trichomoniasis
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Monistat 7 Cream



Dosage Form: vaginal cream
Monistat 7 Cream

Drug Facts

Active ingredient

Miconazole nitrate 2% (100 mg in each applicatorful)

Purpose

Vaginal antifungal

Uses treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection Warnings

For vaginal use only

Do not use if you have never had a vaginal yeast infection diagnosed by a doctor

Ask a doctor before use if you have

vaginal itching and discomfort for the first time lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition. vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. been exposed to the human immunodeficiency virus (HIV) that causes AIDS

Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur

When using this product

do not use tampons, douches, spermicides or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs). do not have vaginal intercourse mild increase in vaginal burning, itching or irritation may occur if you do not get complete relief ask a doctor before using another product

Stop use and ask a doctor if

symptoms do not get better in 3 days symptoms last more than 7 days you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions before using this product, read the enclosed consumer information leaflet for complete directions and information adults and children 12 years of age and over: applicator: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Throw away applicator after use. use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze a small amount of cream onto your fingertip. Apply to itchy, irritate skin outside the vagina (vulva). Use 2 times daily for up to 7 days as needed. children under 12 years of age: ask a doctor Other information

do not use if seal over tube opening has been punctured or embossed design

do not purchase if carton is open store at 20°-25°C (68°-77°F) Inactive ingredients benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol Questions?

If you have any questions or comments, please call 1-877-666-4782

PRINCIPAL DISPLAY PANEL - 45g Tube Carton

NDC 30014-024-15

MONISTAT® 7
Miconazole Nitrate Vaginal Cream (2%)
Vaginal Antifungal

(Miconazole Nitrate 100 mg per application)

CURES MOST VAGINAL YEAST INFECTIONS
AND RELIEVES ASSOCIATED EXTERNAL ITCHING AND IRRITATION

ORTHO

7 Day Vaginal Cream
with Disposable Applicators

Net Wt.
1.59 oz. (45g) tube


MONISTAT 7   7-DAY DISPOSABLE APPLICATORS
miconazole nitrate  cream Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 30014-024 Route of Administration VAGINAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Miconazole Nitrate (Miconazole) Miconazole Nitrate 20 mg  in 1 g Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 30014-024-15 7 TUBE In 1 CARTON contains a TUBE, WITH APPLICATOR 1 45 g In 1 TUBE, WITH APPLICATOR This package is contained within the CARTON (30014-024-15)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA017450 04/15/2010
Labeler - McNeil-PPC, Inc. (801375143) Revised: 04/2010McNeil-PPC, Inc.
More Monistat 7 Cream resources Monistat 7 Cream Use in Pregnancy & Breastfeeding Monistat 7 Cream Drug Interactions Monistat 7 Cream Support Group 8 Reviews for Monistat 7 - Add your own review/rating Compare Monistat 7 Cream with other medications Cutaneous Candidiasis Oral Thrush Tinea Corporis Tinea Cruris Tinea Pedis Tinea Versicolor Vaginal Yeast Infection
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Vitazol Topical


Generic Name: metronidazole (Topical route)

met-roe-NYE-da-zole

Commonly used brand name(s)

In the U.S.

Metrocream Metrogel Metrolotion Noritate Rozex Vitazol

Available Dosage Forms:

Cream Lotion Gel/Jelly Emulsion

Therapeutic Class: Antiacne Antibacterial

Chemical Class: Nitroimidazole

Uses For Vitazol

Topical metronidazole is applied to the skin in adults to help control rosacea , also known as acne rosacea and “adult acne.” This medicine helps to reduce the redness of the skin and the number of pimples, usually found on the face, in patients with rosacea.

Topical metronidazole is available only with your doctor's prescription.

Before Using Vitazol

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Rosacea is usually considered an adult disease. Therefore, topical metronidazole is not generally used in children.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of topical metronidazole in the elderly with use in other age groups.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Blood disease or a history of blood disease—Metronidazole may make the condition worse Proper Use of metronidazole

This section provides information on the proper use of a number of products that contain metronidazole. It may not be specific to Vitazol. Please read with care.

Do not use this medicine in or near the eyes. Watering of the eyes may occur when the medicine is used too close to the eyes.

If this medicine does get into your eyes, wash them out immediately, but carefully, with large amounts of cool tap water. If your eyes still burn or are painful, check with your doctor.

Before applying this medicine, thoroughly wash the affected area(s) with a mild, nonirritating cleanser, rinse well, and gently pat dry.

To use:

After washing the affected area(s), apply this medicine with your fingertips. Apply and rub in a thin film of medicine, using enough to cover the affected area(s) lightly. You should apply the medicine to the whole area usually affected by rosacea, not just to the pimples themselves . Wash the medicine off your hands.

To help keep your rosacea under control, keep using this medicine for the full time of treatment. You may have to continue using this medicine every day for 9 weeks or longer. Do not miss any doses.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For topical dosage forms (cream, gel, and lotion): For rosacea: Adults—Apply to the affected area(s) of skin two times a day, morning and evening, for nine weeks. Children—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Vitazol

If your rosacea does not improve within 3 weeks, or if it becomes worse, check with your doctor. However, treatment of rosacea may take up to 9 weeks or longer before you see full improvement.

Stinging or burning of the skin may be expected after this medicine is applied. These effects may last up to a few minutes or more. If irritation continues, check with your doctor. You may have to use the medicine less often or stop using it altogether. Follow your doctor's directions.

You may continue to use cosmetics (make-up) while you are using this medicine for rosacea. However, it is best to use only “oil-free” cosmetics. Also, it is best not to use cosmetics too heavily or too often. They may make your rosacea worse. If you have any questions about this, check with your doctor.

Vitazol Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common Dry skin redness or other signs of skin irritation not present before use of this medicine stinging or burning of the skin watering of eyes Rare Metallic taste in the mouth nausea tingling or numbness of arms, legs, hands, or feet

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Vitazol Topical side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Vitazol Topical resources Vitazol Topical Side Effects (in more detail) Vitazol Topical Use in Pregnancy & Breastfeeding Vitazol Topical Drug Interactions Vitazol Topical Support Group 0 Reviews for Vitazol Topical - Add your own review/rating Compare Vitazol Topical with other medications Rosacea
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Metrolotion Topical


Generic Name: metronidazole (Topical route)

met-roe-NYE-da-zole

Commonly used brand name(s)

In the U.S.

Metrocream Metrogel Metrolotion Noritate Rozex Vitazol

Available Dosage Forms:

Cream Lotion Gel/Jelly Emulsion

Therapeutic Class: Antiacne Antibacterial

Chemical Class: Nitroimidazole

Uses For Metrolotion

Topical metronidazole is applied to the skin in adults to help control rosacea , also known as acne rosacea and “adult acne.” This medicine helps to reduce the redness of the skin and the number of pimples, usually found on the face, in patients with rosacea.

Topical metronidazole is available only with your doctor's prescription.

Before Using Metrolotion

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Rosacea is usually considered an adult disease. Therefore, topical metronidazole is not generally used in children.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of topical metronidazole in the elderly with use in other age groups.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Blood disease or a history of blood disease—Metronidazole may make the condition worse Proper Use of metronidazole

This section provides information on the proper use of a number of products that contain metronidazole. It may not be specific to Metrolotion. Please read with care.

Do not use this medicine in or near the eyes. Watering of the eyes may occur when the medicine is used too close to the eyes.

If this medicine does get into your eyes, wash them out immediately, but carefully, with large amounts of cool tap water. If your eyes still burn or are painful, check with your doctor.

Before applying this medicine, thoroughly wash the affected area(s) with a mild, nonirritating cleanser, rinse well, and gently pat dry.

To use:

After washing the affected area(s), apply this medicine with your fingertips. Apply and rub in a thin film of medicine, using enough to cover the affected area(s) lightly. You should apply the medicine to the whole area usually affected by rosacea, not just to the pimples themselves . Wash the medicine off your hands.

To help keep your rosacea under control, keep using this medicine for the full time of treatment. You may have to continue using this medicine every day for 9 weeks or longer. Do not miss any doses.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For topical dosage forms (cream, gel, and lotion): For rosacea: Adults—Apply to the affected area(s) of skin two times a day, morning and evening, for nine weeks. Children—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Metrolotion

If your rosacea does not improve within 3 weeks, or if it becomes worse, check with your doctor. However, treatment of rosacea may take up to 9 weeks or longer before you see full improvement.

Stinging or burning of the skin may be expected after this medicine is applied. These effects may last up to a few minutes or more. If irritation continues, check with your doctor. You may have to use the medicine less often or stop using it altogether. Follow your doctor's directions.

You may continue to use cosmetics (make-up) while you are using this medicine for rosacea. However, it is best to use only “oil-free” cosmetics. Also, it is best not to use cosmetics too heavily or too often. They may make your rosacea worse. If you have any questions about this, check with your doctor.

Metrolotion Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common Dry skin redness or other signs of skin irritation not present before use of this medicine stinging or burning of the skin watering of eyes Rare Metallic taste in the mouth nausea tingling or numbness of arms, legs, hands, or feet

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Metrolotion Topical side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Metrolotion Topical resources Metrolotion Topical Side Effects (in more detail) Metrolotion Topical Use in Pregnancy & Breastfeeding Metrolotion Topical Drug Interactions Metrolotion Topical Support Group 0 Reviews for Metrolotion Topical - Add your own review/rating Compare Metrolotion Topical with other medications Perioral Dermatitis Rosacea
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Sentry AQ Mardel Tablet



Dosage Form: FOR ANIMAL USE ONLY
Medication for Saltwater and Freshwater Fish Indications and Usage for Sentry AQ Mardel Tablet For the treatment and control of visible parasites that  cause symptoms of gasping for air, rapid breathing, flicking, listless behavior and excess mucus production.
Treats Parasites including:  Leaches, Lice (Argulus), Flukes, Hexamita, Ick, Anchor Worms (Lernia), Protozoan/Parasites.
DIRECTIONS FOR USE It is recommended to treat infected fish in a separate isolation tank.  Remove carbon from the filter but do not discontinue filtration.  Take a disposable cup and half fill with aquarium water.  Dissolve one tablet for every 10 gallons (38 liters) of aquarium water.  Dispense the medication throughout the treatment aquarium.  One treatment should be adequate.  If parasites or symptoms are still present 24 hours after initial treatment, change 25% of the water and treat again.  Replace filter carbon 24 hours after final treatment.  If fish show signs of stress during treatment, change 50-75% of the water immediately. 
Warnings This product contains a chemical known to the State of California to cause cancer.  For aquarium use only.  Not for use on fish intended for human consumption  Do not use on paranhas, Metyniss species, scaleless fish, bottom feeders, marine sharks, lionfish, live rock, invertebrates and amphibians.  Clout may stain silicon sealant and aquarium decorations.
KEEP OUT OF REACH OF CHILDREN
STORAGE Store at room temperature.
INGREDIENTS 4-[p-(dimethylamino)-)O-phenylbenzylidene]-2, 5-cyclohexadien-1-xylidene dimethylammonium chloride; dimethyl (2,2,2-trichloro-1-hydroxyethel) phosphonate; 1,2-dimethyl-5-nitroimidazole and inert ingredients as non-toxic binders.
QUESTIONS OR COMMENTS Sentry is committed to providing high quality products.  If you have questions or comments about this product, please write:
Sentry Consumer Response
P O Box 540399
Omaha NE 68154-0399 How is Sentry AQ Mardel Tablet Supplied Sentry AQ Mardel Clout - 10 count
Sentry AQ Mardel Clout - 100 count
PACKAGE LABEL PRINCIPAL DISPLAY PANEL Sentry AQ Mardel Clout
Distributed by:
Sergeant's Pet Care Products, Inc., Omaha NE 68130
Made in USA
www.sentrypetcare.com
SENTRY AQ MARDEL CLOUT 
microcrystalline cellulose  tablet Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 21091-301 Route of Administration EXTRACORPOREAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CELLULOSE, MICROCRYSTALLINE (CELLULOSE, MICROCRYSTALLINE ) CELLULOSE, MICROCRYSTALLINE 0.29 g METRONIDAZOLE (METRONIDAZOLE) METRONIDAZOLE 0.19 g TRICHLORFON (TRICHLORFON) TRICHLORFON 0.0095 g MALACHITE GREEN (MALACHITE GREEN) MALACHITE GREEN 0.0038 g Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color blue (blue-green with dark blue specks) Score no score Shape ROUND Size 11mm Flavor Imprint Code None Contains          Packaging # NDC Package Description Multilevel Packaging 1 21091-301-10 1 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 10 TABLET In 1 BLISTER PACK This package is contained within the CARTON (21091-301-10) 2 21091-301-00 100 TABLET In 1 BOTTLE, PLASTIC None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/10/2010
Labeler - Sergeant's Pet Care Products, Inc. (876995171) Establishment Name Address ID/FEI Operations Sulzbach Enterprises, Inc. 616846528 manufacture Revised: 07/2010Sergeant's Pet Care Products, Inc.

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Vaginal anti-infectives


A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Vaginal anti-infectives are available as creams, pessaries (tablets), gels or solutions to treat either bacterial or fungal vaginal infections. Vaginal antifungal products are used to treat vaginal thrush. Antibacterial vaginal products are used for bacterial infections such as bacterial vaginosis. Other products are used to manage irritation or minor soreness.

See also

Medical conditions associated with vaginal anti-infectives:

AcneBacterial VaginitisCutaneous CandidiasisFungal Infection ProphylaxisOral ThrushPerioral DermatitisRosaceaTinea CorporisTinea CrurisTinea PedisTinea VersicolorVaginal Yeast Infection Drug List:/tags/gyne-lotrimin-cream/
/tags/vandazole/
/tags/monistat-7-cream/
/tags/gynazole-1-cream/
/tags/metrogel-vaginal-gel/
/tags/clindamax-cream/
/tags/derma-gran-af-topical/
/tags/aloe-vesta/
/tags/avc/
/tags/betadine-cream/
/tags/canesten-topical/
/tags/clindacin-p/
/tags/clotrimazole-7/
/tags/desenex-spray/
/tags/fungicure-pump-spray/
/tags/fungoid-kit/
/tags/gyne-sulf/
/tags/micatin-cream/
/tags/micatin-foot-powder/
/tags/micatin-jock-itch/
/tags/micon-7/
/tags/minidyne-solution/
/tags/mitrazol/
/tags/monistat-1-combo-pack-cream/
/tags/mycelex-cream/
/tags/ony-clear/
/tags/polydine-solution/
/tags/secura-antifungal-topical/
/tags/terazol-3-suppositories/
/tags/tetterine-cream/
/tags/trysul/
/tags/v-v-s/

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Metronidazole Hydrochloride


Class: Antiprotozoals, Miscellaneous
VA Class: AM900
CAS Number: 443-48-1
Brands: Flagyl, Helidac Therapy

Carcinogenic in mice and rats.152 156 197 430 495

Avoid unnecessary use; reserve for use in approved indications..152 156 197 430 495 (See Uses.)

Introduction

Antibacterial and antiprotozoal;.152 197 430 494 495 nitroimidazole derivative.494

Uses for Metronidazole Hydrochloride Bone and Joint Infections

Adjunct for treatment of bone and joint infections caused by Bacteroides, including the B. fragilis group (B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus).152 197 495

Endocarditis

Treatment of endocarditis caused by Bacteroides (including the B. fragilis group).152 197 495

Gynecologic Infections

Treatment of gynecologic infections (including endometritis, endomyometritis, tubo-ovarian abscess, postsurgical vaginal cuff infection) caused by Bacteroides (including the B. fragilis group), Clostridium, Peptococcus niger, or Peptostreptococcus.152 197 495

Treatment of acute pelvic inflammatory disease (PID); used in conjunction with other anti-infectives.199 341 496 Metronidazole is included in PID regimens to provide coverage against anaerobes.341

When a parenteral regimen is indicated for PID, an initial regimen of IV cefoxitin and IV or oral doxycycline is recommended followed by oral doxycycline; if tubo-ovarian abscess is present, some experts recommend that the oral follow-up regimen include metronidazole (or clindamycin) in addition to doxycycline.341

When an oral regimen is indicated for PID, an single IM dose of ceftriaxone, cefoxitin (with oral probenecid), or cefotaxime is recommended in conjunction with oral doxycycline (with or without oral metronidazole).199 341 496 Alternatively, if a parenteral cephalosporin is not feasible and the community prevalence and individual risk for gonorrhea is low, a regimen of oral levofloxacin or oral ofloxacin (with or without oral metronidazole) may be considered.496

Intra-abdominal Infections

Treatment of intra-abdominal infections (including peritonitis, intra-abdominal abscess, liver abscess) caused by susceptible Bacteroides (including the B. fragilis group), Clostrium, Eubacterium, P. niger, or Peptostreptococcus.152 197 495

Meningitis and Other CNS Infections

Treatment of CNS infections (including meningitis, brain abscess) caused by Bacteroides (including the B. fragilis group).152 197 495

Respiratory Tract Infections

Treatment of respiratory tract infections (including pneumonia) caused by Bacteroides (including the B. fragilis group).152 197 495

Septicemia

Treatment of septicemia caused by Bacteroides (including the B. fragilis group) or Clostridium.152 197 495

Skin and Skin Structure Infections

Treatment of skin and skin structure infections caused by Bacteroides (including the B. fragilis group), Clostridium, Fusobacterium, P. niger, or Peptostreptococcus.152 197 495

Amebiasis

Treatment of acute intestinal amebiasis and amebic liver abscess caused by Entamoeba histolytica.100 152 153 197 364 368 370 Oral metronidazole or oral tinidazole followed by a luminal amebicide (iodoquinol, paromomycin) is the regimen of choice for mild to moderate or severe intestinal disease and for amebic hepatic abscess.100 153 364 368 370

Bacterial Vaginosis

Treatment of bacterial vaginosis (formerly called Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis) in pregnant or nonpregnant women.199 292 297 298 302 341 365 366 430

CDC recommends treatment of bacterial vaginosis in all symptomatic women (including pregnant women).341 In addition, asymptomatic pregnant women at high risk for complications of pregnancy should be screened (preferably at the first prenatal visit) and treatment initiated if needed.341

Treatment recommendations for bacterial vaginosis in HIV-infected women are the same as those for women without HIV infection.341

Regimens of choice in nonpregnant women are a 7-day regimen of oral metronidazole, a 5-day regimen of intravaginal metronidazole gel, or a 7-day regimen of intravaginal clindamycin cream;341 alternative regimens are a 7-day regimen of oral clindamycin or 3-day regimen of intravaginal clindamycin suppositories.341 The preferred regimens for pregnant women are a 7-day regimen of oral metronidazole or a 7-day regimen of oral clindamycin.341

Regardless of regimen used, relapse or recurrence is common;287 295 297 298 300 302 307 341 365 an alternative regimen (e.g., topical therapy when oral therapy was used initially) may be used in such situations.297 341

Routine treatment of asymptomatic male sexual contacts of women who have relapsing or recurrent bacterial vaginosis not recommended.341

Balantidiasis

Alternative to tetracycline for treatment of balantidiasis† caused by Balantidium coli.100 153

Blastocystis hominis Infections

Treatment of infections caused by Blastocystis hominis†.100 153 368 371 372 May be effective, but metronidazole resistance may be common.153

Clinical importance of B. hominis as a cause of GI pathology is controversial;100 153 368 371 372 unclear when treatment is indicated.100 368 371 Some clinicians suggest treatment be reserved for certain individuals (e.g., immunocompromised patients) when symptoms persist and no other pathogen or process is found to explain their GI symptoms.100 368

Clostridium difficile-associated Diarrhea and Colitis

Treatment of Clostridium difficile-associated diarrhea and colitis† (CDAD; also known as antibiotic-associated diarrhea and colitis, C. difficile diarrhea, C. difficile colitis, and pseudomembranous colitis).100 125 126 127 128 129 131 132 312 313 314 315 316 344 345 443 444 445 446 447

Drugs of choice are metronidazole and vancomycin; 100 312 313 314 315 316 metronidazole generally preferred and vancomycin reserved for those with severe or potentially life-threatening colitis, patients in whom metronidazole-resistant C. difficile is suspected, patients in whom metronidazole is contraindicated or not tolerated, or those who do not respond to metronidazole.100 126 127 312 313 314 315 316 322 323 406 443 444 445 446 447 448

Crohn’s Disease

Mangement of Crohn’s disease† as an adjunct to conventional therapies.101 102 103 104

Has been used with467 468 471 475 476 477 485 or without ciprofloxacin;101 102 103 104 105 469 470 471 472 473 474 478 479 484 485 486 for induction of remission of mildly to moderately active Crohn’s disease†.101 102 103 104 105 467 468 469 471 472 473 474 475 476 477 478 479 484

Has been used for refractory perianal Crohn’s disease†.102 104 105 470 471 474 478 479 485 486

Dientamoeba fragilis Infections

Treatment of infections caused by Dientamoeba fragilis†.153 Drugs of choice are iodoquinol, paromomycin, tetracycline, or metronidazole.153

Dracunculiasis

Treatment of dracunculiasis† caused by Dracunculus medinensis (guinea worm disease).153

Treatment of choice is slow extraction of worm combined with wound care.153 Metronidazole is not curative, but decreases inflammation and facilitates worm removal.153

Giardiasis

Treatment of giardiasis†.100 153 367 452 Drugs of choice are metronidazole, tinidazole, or nitazoxanide;100 153 367 452 alternatives are paromomycin, furazolidone (no longer commercially available in the US), or quinacrine (not commercially available in the US).100 153 367

Treatment of asymptomatic carriers of giardiasis†.100 367 Treatment of such carriers not generally recommended, except possibly in patients with hypogammaglobulinemia or cystic fibrosis or in an attempt to prevent household transmission of the disease from toddlers to pregnant women.100

Helicobacter pylori Infection and Duodenal Ulcer Disease

Treatment of Helicobacter pylori infection and duodenal ulcer disease (active or a history of duodenal ulcer); eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.

Used in a multiple-drug regimen that includes metronidazole, tetracycline, and bismuth subsalicylate and a histamine H2-receptor antagonist.455 If initial 14-day regimen does not eradicate H. pylori, a retreatment regimen that does not include metronidazole should be used.455

Nongonococcal Urethritis

Treatment of recurrent and persistent urethritis† in patients with nongonococcal urethritis who have already been treated with a recommended regimen (i.e., azithromycin, doxycycline, erythromycin, ofloxacin or levofloxacin).341

Oral metronidazole or oral tinidazole used in conjunction with oral azithromycin (if azithromycin was not used in the initial regimen) is the regimen recommended by CDC for recurrent and persistent urethritis in patients who were compliant with their initial regimen and have not been re-exposed.341

Rosacea

Treatment of inflammatory lesions (papules and pustules) and erythema associated with rosacea† (acne rosacea).137 139 145 146 148 168 180 181 Topical metronidazole may be preferred to oral metronidazole.137 181

Tetanus

Adjunct in treatment of tetanus caused by C. tetani.100 489

Trichomoniasis

Treatment of symptomatic and asymptomatic trichomoniasis when Trichomonas vaginalis has been demonstrated by an appropriate diagnostic procedure (e.g., wet smear and/or culture, OSOM Trichomonas Rapid Test, Affirm VP III).100 152 153 197 199 297 298 302 337 338 339 341

Drug of choice is metronidazole or tinidazole.100 153 199 297 302 337 338 339 341 Goal of treatment is to provide symptomatic relief, achieve microbiologic cure, and reduce transmission; to achieve this goal, both the index patient and sexual (particularly steady) partner(s) should be treated.153 199 297 302 339 341

If treatment failure occurs with initial metronidazole treatment and reinfection is excluded, alternative regimens using metronidazole or tinidazole can be used.153 199 341 If retreatment is ineffective, consultation with an expert (available through CDC) is recommended.341

Perioperative Prophylaxis

Perioperative prophylaxis to reduce the incidence of postoperative anaerobic bacterial infections in patients undergoing colorectal surgery.109 110 111 112 156 495 Preferred regimens are IV cefoxitin alone; IV cefazolin and IV metronidazole; oral erythromycin and oral neomycin; or oral metronidazole and oral neomycin.110 112 490

Perioperative prophylaxis in patients undergoing appendectomy†;109 111 110 112 113 used in conjunction with cefazolin.110 Preferred regimens for appendectomy (nonperforated) are IV cefoxitin alone or IV cefazolin and IV metronidazole.110

Prophylaxis in Sexual Assault Victims

Empiric anti-infective prophylaxis in sexual assault victims†; used in conjunction with IM ceftriaxone and oral azithromycin or doxycycline.199 341

Metronidazole Hydrochloride Dosage and Administration Administration

Administer orally152 197 430 or by continuous or intermittent IV infusion.156 495 Do not administer by rapid IV injection because of the low pH of the reconstituted product.156 495

In the treatment of serious anaerobic infections, parenteral route usually is used initially and oral metronidazole substituted when warranted by patient’s condition.152 197

Oral Administration

Administer extended-release tablets at least 1 hour before or 2 hours after meals.430

IV Infusion

For solution and drug compatibility information, see Compatibility under Stability.

Commercially available metronidazole injection for IV infusion does not need to be diluted or neutralized prior to IV administration.156 495

Metronidazole hydrochloride powder for injection must by reconstituted, diluted, and then neutralized prior to IV administration.156

Reconstitution and Dilution

Reconstitute metronidazole hydrochloride powder for injection by adding 4.4 mL of sterile or bacteriostatic water for injection, 0.9% sodium chloride injection, or bacteriostatic sodium chloride injection to the vial containing 500 mg of metronidazole.156 The reconstituted solution contains approximately 100 mg of metronidazole/mL and has a pH of 0.5–2.156

The reconstituted metronidazole hydrochloride solution must be further diluted with 0.9% sodium chloride injection, 5% dextrose injection, or lactated Ringer’s injection to a concentration of ?8 mg/mL.156

The reconstituted and diluted metronidazole hydrochloride solution must then be neutralized by adding approximately 5 mEq of sodium bicarbonate injection for each 500 mg of metronidazole.156 The addition of sodium bicarbonate to the metronidazole hydrochloride solution may generate carbon dioxide gas and it may be necessary to relieve gas pressure in the container.156

Rate of Administration

IV infusions usually are infused over 1 hour.156 495

Dosage

Available as metronidazole152 156 197 430 495 and metronidazole hydrochloride;156 dosage expressed in terms of metronidazole.156

Pediatric Patients General Dosage in Neonates† Oral or IV

Neonates <1 week of age: AAP recommends 7.5 mg/kg every 24–48 hours in those weighing <1.2 g, 7.5 mg/kg every 24 hours in those weighing 1.2–2 kg, or 7.5 mg/kg every 12 hours in those weighing >2 kg.100

Neonates 1–4 weeks of age: AAP recommends 7.5 mg/kg every 24–48 hours in those weighing <1.2 kg, 7.5 mg/kg every 12 hours in those weighing 1.2–2 kg, and 15 mg/kg every 12 hours in those weighing >2 kg.100

General Dosage in Children ?1 Month of Age† Oral

15–35 mg/kg daily in 3 divided doses.100 AAP states oral route inappropriate for severe infections.100

Amebiasis Entamoeba histolytica Infections Oral

35–50 mg/kg daily in 3 divided doses given for 7–10 (usually 10) days;152 153 197 370 follow-up with a luminal amebicide (e.g., iodoquinol, paromomycin).153

Bacterial Vaginosis† Oral

Children weighing <45 kg: 15 mg/kg daily (up to 1 g) in 2 divided doses given for 7 days.100

Adolescents: 500 mg twice daily for 7 days.100

Balantidiasis† Oral

35–50 mg/kg daily in 3 divided doses given for 5 days.153

Blastocystis hominis Infections† Oral

20–35 mg/kg daily in 3 divided doses given for 10 days may improve symptoms in some patients.100

Crohn’s Disease† Oral

10–20 mg/kg daily (up to 1 g daily) has been recommended for children with mild perianal Crohn’s disease† or those intolerant to sulfasalazine or mesalamine.487

Clostridium difficile-associated Diarrhea and Colitis† Oral

30–50 mg/kg daily in 3 or 4 equally divided doses given for 7–10 days (not to exceed adult dosage).100 445 446

Dientamoeba fragilis Infections† Oral

20–40 mg/kg daily in 3 divided doses given for 10 days.153

Dracunculiasis† Oral

25 mg/kg daily (up to 750 mg) in 3 divided doses given for 10 days.153 Is not curative, but may decrease inflammation and facilitate worm removal.153

Giardiasis† Oral

15 mg/kg daily in 3 divided doses given for 5–7 days.153 367 452

Nongonococcal Urethritis† Oral

Recurrent or persistent urethritis in adolescents: A single 2-g dose given in conjunction with a single 1-g dose of oral azithromycin (if azithromycin not used in the initial regimen).341

Tetanus† Oral

30 mg/kg daily (up to 4 g daily) in 4 doses given for 10–14 days.100

IV

30 mg/kg daily (up to 4 g daily) in 4 doses given for 10–14 days.100

Trichomoniasis† Oral

Prepubertal children weighing <45 kg: 15 mg/kg daily in 3 divided doses (up to 2 g daily) given for 7 days.100 153

Adolescents: A single 2-g dose or 500 mg twice daily for 7 days.100

Prophylaxis in Sexual Assault Victims† Oral

Preadolescent children weighing <45 kg: 15 mg/kg daily given in 3 divided doses for 7 days given in conjunction with IM ceftriaxone and either oral azithromycin or oral erythromycin.100 341

Adolescents and preadolescent children weighing ?45 kg: A single 2-g dose given in conjunction with IM ceftriaxone and either oral azithromycin or oral doxycycline.100 341

Adults Anaerobic Bacterial Infections Serious Infections Oral

7.5 mg/kg every 6 hours (up to 4 g daily).152 156 197

IV, then Oral

An initial IV loading dose of 15 mg/kg followed by IV maintenance doses of 7.5 mg/kg every 6 hours.156 495 After clinical improvement occurs, switch to oral metronidazole (7.5 mg/kg every 6 hours).156 495

Total duration of treatment usually is 7–10 days, but infections of bone and joints, lower respiratory tract, or endocardium may require longer treatment.156 495

Gynecologic Infections Pelvic Inflammatory Disease Oral

500 mg twice daily given for 14 days; used in conjunction with a single IM dose of ceftriaxone (250 mg), cefoxitin (2 g with oral probenecid 1 g), or another parenteral cephalosporin (e.g., cefotaxime) and 14-day regimen of oral doxycycline (100 mg twice daily).341 496

Alternatively, 500 mg twice daily given for 14 days; used in conjunction with a 14-day regimen of oral ofloxacin (400 mg twice daily) or levofloxacin (500 mg once daily).199 341 496 Regimens containing a fluoroquinolone should only be considered when a parenteral cephalosporin is not feasible and the community prevalence and individual risk of gonorrhea is low.496

Amebiasis Entamoeba histolytic Infections Oral

750 mg 3 times daily given for 5–10 (usually 10) days for intestinal amebiasis152 153 197 364 368 370 or 500–750 mg 3 times daily given for 5–10 (usually 10) days for amebic liver abscess.152 197 364 368 370 Alternatively, amebic liver abscess has been treated with 2.4 g once daily given for 1 or 2 days.364

Follow-up with a luminal amebicide (e.g., iodoquinol, paromomycin) after metronidazole.153 364 368 370

IV

500 mg every 6 hours for 10 days.364

Bacterial Vaginosis Nonpregnant Women Oral

Conventional tablets: 500 mg twice daily given for 7 days.100 199 286 297 298 300 301 302 341 366 A single 2-g dose has been used (e.g., for patients who may be noncompliant with the multiple-dose regimen),120 122 199 292 297 but appears to be less effective than other regimens and is no longer recommended by CDC.341

Extended-release tablets: 750 mg once daily given for 7 days.199 341 416 417 430

Pregnant Women Oral

Conventional tablets: 500 mg twice daily or 250 mg 3 times daily given for 7 days.341 416 417

Contraindicated during first trimester of pregnancy.152 197 430 In addition, single-dose regimens not recommended in pregnant women because of the slightly higher serum concentrations attained, which may reach fetal circulation.152

Balantidiasis† Oral

750 mg 3 times daily given for 5 days.153

Blastocystis hominis Infections† Oral

750 mg 3 times daily given for 10 days may improve symptoms in some patients.100 153

Crohn’s Disease† Oral

400 mg twice daily101 103 105 or 1 g daily has been effective for treatment of active Crohn’s disease†.467 472 473 475 476 482 For treatment of refractory perineal disease, 20 mg/kg (1–1.5 g) given in 3–5 divided doses daily has been employed.102 103 104 105 478 486

Clostridium difficile-associated Diarrhea and Colitis† Oral

750 mg to 2 g daily in 3 or 4 divided doses given for 7–14 days.125 126 129 131 132 133 313 314

Dose-ranging studies to determine comparative efficacy have not been performed; most commonly employed regimens are 250 mg 4 times daily or 500 mg 3 times daily given for 10 days.443 444 445 446

IV

500–750 mg every 6–8 hours; use when oral therapy is not feasible.134 161 162 313 342 343 445

Dientamoeba fragilis Infections† Oral

500–750 mg 3 times daily given for 10 days.153

Dracunculiasis† Oral

250 mg 3 times daily given for 10 days.153 Is not curative, but may decrease inflammation and facilitate worm removal.153

Giardiasis† Oral

250 mg 3 times daily given for 5–7 days.153 367 452

Helicobacter pylori Infection and Duodenal Ulcer Disease Oral

250 mg in conjunction with tetracycline (500 mg) and bismuth subsalicylate (525 mg) 4 times daily (at meals and at bedtime) for 14 days; these drugs should be given concomitantly with an H2-receptor antagonist in recommended dosage.455

Nongonococcal Urethritis† Oral

Recurrent or persistent urethritis: A single 2-g dose given in conjunction with a single 1-g dose of oral azithromycin (if azithromycin not used in the initial regimen).341

Tetanus† IV

500 mg every 6 hours given for 7–10 days.489

Trichomoniasis Initial Treatment Oral

2 g as a single dose152 153 199 341 or in 2 divided doses.152 Alternatively, 500 mg twice daily given for 7 days153 199 341 or 375 mg twice daily given for 7 days.199 197 Manufacturer also recommends 250 mg 3 times daily given for 7 days.152

Retreatment Oral

500 mg twice daily given for 7 days.297 341 If repeated failure occurs, CDC recommends 2 g once daily given for 5 days.297 341 Others recommend retreatment with 2–4 g daily for 7–14 days if metronidazole-resistant strains are involved.153 199

Do not administer repeat courses of treatment unless presence of T. vaginalis is confirmed by wet smear and/or culture and an interval of 4–6 weeks has passed since the initial course.152 197

If treatment of resistant infection is guided by in vitro susceptibility testing under aerobic conditions, some clinicians recommend that T. vaginalis strains exhibiting low-level resistance (minimum lethal concentration [MLC] <100 mcg/mL) be treated with 2 g daily for 3–5 days, those with moderate (intermediate) resistance (MLC 100–200 mcg/mL) be treated with 2–2.5 g daily for 7–10 days, and those with high-level resistance (MLC >200 mcg/mL) be treated with 3–3.5 g daily for 14–21 days.124 302 338 340 Because strains with high-level resistance are difficult to treat,124 297 302 338 340 CDC recommends that patients with culture-documented infection who do not respond to repeat regimens at dosages up to 2 g daily for 3–5 days and in whom the possibility of reinfection has been excluded should be managed in consultation with an expert (available through CDC).297 341

Perioperative Prophylaxis Colorectal Surgery IV

0.5 g given at induction of anesthesia (within 0.5–1 hour prior to incision); used in conjunction with IV cefazolin (1–2 g).110

Manufacturer recommends 15 mg/kg by IV infusion over 30–60 minutes 1 hour prior to the procedure and, if necessary, 7.5 mg/kg by IV infusion over 30–60 minutes at 6 and 12 hours after the initial dose.156 495 The initial preoperative dose must be completely infused approximately 1 hour prior to surgery to ensure adequate serum and tissue concentrations of metronidazole at the time of incision.156 495 Prophylactic use of metronidazole should be limited to the day of surgery and should not be continued for more than 12 hours after surgery.156 495

Oral

2 g with oral neomycin sulfate (2 g) given at 7 p.m. and 11 p.m. on day before surgery; used in conjunction with appropriate diet and catharsis.110

Prophylaxis in Sexual Assault Victims† Oral

A single 2-g dose given in conjunction with IM ceftriaxone and either oral azithromycin or oral doxycycline.100 341

Special Populations Hepatic Impairment

Decrease dosage in patients with severe hepatic impairment and monitor plasma concentrations of the drug.152 156 160 197 430 495

Geriatric Patients

Select dosage with caution because of age-related decreases in hepatic function.152 197 430

Cautions for Metronidazole Hydrochloride Contraindications

Hypersensitivity to metronidazole or other nitroimidazole derivatives.152 156 197 430 495 Cautious desensitization has been used in some situations when use of metronidazole was considered necessary.341 436 (See Hypersensitivity Reactions and Desensitization under Cautions.)

First trimester of pregnancy.152 197 430

Helidac Therapy (kit containing tetracycline, metronidazole, bismuth subsalicylate) contraindicated in pregnant or nursing women, pediatric patients, patients with hepatic or renal impairment, patients with known allergy to aspirin or salicylates, and those with known hypersensitivity to any component of the kit.455

Warnings/Precautions Warnings Seizures and Peripheral Neuropathy

Seizures and peripheral neuropathy (characterized by numbness or paresthesia of an extremity) reported with metronidazole.152 156 197 430 495

Persistent peripheral neuropathy reported in some patients receiving prolonged therapy.430 If abnormal neurologic signs develop, promptly discontinue drug..152 156 197 430

Use with caution in those with CNS diseases.152 197 430

Sensitivity Reactions Hypersensitivity Reactions and Desensitization

Hypersensitivity reactions, including urticaria, pruritus, erythematous rash, flushing, nasal congestion, fever, and fleeting joint pains sometimes resembling serum sickness, have been reported with metronidazole.152 156 197 430 495

Because there are no effective alternatives to metronidazole in the US for treatment of trichomoniasis, CDC states that desensitization can be attempted in patients with metronidazole hypersensitivity.341 The possibility that desensitization may be hazardous should be considered435 and adequate procedures (e.g., established IV access, BP monitoring) and therapies (e.g., epinephrine, corticosteroids, antihistamines, oxygen) for management of an acute hypersensitivity reaction should be readily available.435 Pretreatment (e.g., with an antihistamine and/or corticosteroid) also should be considered.435

Desensitization has been performed by administering increasing doses of IV metronidazole incrementally until a therapeutic dose was achieved, at which time oral dosing was initiated.435 In this regimen, an initial 5-mcg dose of IV metronidazole was given and the dose increased at 15- to 20-minute intervals to 15, 50, 150, and 500 mcg and then to 1.5, 5, 15, 30, 60, and 125 mg.435 After the 125-mg IV dose, dosing was switched to oral metronidazole and doses of 250, 500, and 2 g were given at 1-hour intervals.435 For trichomoniasis, desensitization dosing can be stopped after the 2-g dose.435 Patient should be monitored for ?4 hours after the last dose (24 hours if there was any evidence of a reaction).435

General Precautions Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of metronidazole and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.152 197 430 495

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.152 197 430 495 In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.152 197 430 495

Surgical procedures should be performed in conjunction with metronidazole therapy when indicated.152 156 197 430 495

In mixed aerobic and anaerobic infections, anti-infectives appropriate for treatment of aerobic bacteria should be used in conjunction with metronidazole.152 156 197 430 495

History of Blood Dyscrasia

Use with caution in patients with evidence or history of blood dyscrasias.152 156


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Monistat 7 Combination Pack


miconazole nitrate
Dosage Form: cream
Monistat 7 Combination Pack Triple Action

Drug Facts

Active ingredients Purpose Miconazole nitrate 2% (100 mg in each applicatorful) Vaginal antifungal Miconazole nitrate 2% (external cream) Vaginal antifungal Uses treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection Warnings

For vaginal use only

Do not use if you have never had a vaginal yeast infection diagnosed by a doctor

Ask a doctor before use if you have

vaginal itching and discomfort for the first time lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition. vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. been exposed to the human immunodeficiency virus (HIV) that causes AIDS

Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur

When using this product

do not use tampons, douches, spermicides or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs). do not have vaginal intercourse mild increase in vaginal burning, itching or irritation may occur if you do not get complete relief ask a doctor before using another product

Stop use and ask a doctor if

symptoms do not get better in 3 days symptoms last more than 7 days you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions before using this product, read the enclosed consumer information leaflet for complete directions and information adults and children 12 years of age and over: applicators: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Throw away applicator after use. external cream: squeeze a small amount of cream onto your fingertip. Apply the cream onto the itchy, irritated skin outside the vagina (vulva). Use 2 times daily for up to 7 days, as needed. children under 12 years of age: ask a doctor Other information

do not use if seal over tube opening has been punctured or embossed design

do not purchase if carton is open store at 20°-25°C (68°-77°F) Inactive ingredients benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol Questions?

If you have any questions or comments, please call 1-877-666-4782

PRINCIPAL DISPLAY PANEL - Kit Carton

NDC-30014-003-07

MONISTAT®7
COMBINATION PACK
Miconazole Nitrate Cream (2%) and Miconazole Nitrate Cream (2%)

(Miconazole Nitrate 100 mg per applicator)

ORTHO
CLINICALLY PROVEN
Multi-Symptom Relief

VAGINAL ANTIFUNGAL

CURES MOST VAGINAL YEAST INFECTIONS AND
RELIEVES ASSOCIATED EXTERNAL ITCHING AND IRRITATION

7-Day Vaginal Cream with Disposable Applicators
PLUS External Cream

Net Wt. 1.59 oz. (45g)
+ 0.32 oz. (9g) Tube


Monistat 7 Combination Pack  TRIPLE ACTION
miconazole nitrate  kit Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 30014-003 Packaging # NDC Package Description Multilevel Packaging 1 30014-003-07 1 KIT In 1 PACKAGE, COMBINATION None QUANTITY OF PARTS Part # Package Quantity Total Product Quantity Part 1 1 TUBE, WITH APPLICATOR   0.1 g Part 2 1 TUBE   0.009 g Part 1 of 2 MICONAZOLE NITRATE 
miconazole nitrate  cream Product Information       Route of Administration VAGINAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Miconazole Nitrate (Miconazole) Miconazole Nitrate 20 mg  in 1 g Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 0.1 g In 1 TUBE, WITH APPLICATOR None Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA017450 04/10/2010
Part 2 of 2 MICONASOLE NITRATE 
miconazole nitrate  cream Product Information       Route of Administration VAGINAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Miconazole Nitrate (Miconazole) Miconazole Nitrate 20 mg  in 1 g Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 0.009 g In 1 TUBE None Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA017450 04/10/2010
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA017450 04/10/2010
Labeler - McNeil, PPC, Inc. (801375143) Revised: 04/2010McNeil, PPC, Inc.
More Monistat 7 Combination Pack resources Monistat 7 Combination Pack Side Effects (in more detail) Monistat 7 Combination Pack Use in Pregnancy & Breastfeeding Monistat 7 Combination Pack Drug Interactions Monistat 7 Combination Pack Support Group 0 Reviews for Monistat 7 Combination Pack - Add your own review/rating Compare Monistat 7 Combination Pack with other medications Vaginal Yeast Infection
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