Metrocream

Name: Metrocream

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Reviewed on 4/2/2015 References Reference: FDA Prescribing Information

Precautions

Before using metronidazole, tell your doctor or pharmacist if you are allergic to it; or to other nitroimidazole antibiotics (such as tinidazole); or to other ingredients in this product; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood disorders (blood dyscrasias).This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.This drug passes into breast milk. Discuss the risks and benefits with your doctor before breast-feeding.

Drug interactions

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: "blood thinners" (e.g., warfarin).This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

MetroCream Drug Class

MetroCream is part of the drug classes:

  • Antiinfectives and antiseptics for local oral treatment

  • Other chemotherapeutics

Inform MD

Before taking metronidazole, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

  • are allergic to metronidazole or to any of its ingredients
  • have or have had Crohn’s disease
  • have or have had liver problems
  • have or have had kidney problems
  • have or have had blood disorders
  • have or are being treated for alcohol dependence
  • are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

MetroCream and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Metronidazole falls into category B. There are no well-done studies that have been done in humans with metronidazole. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

MetroCream Dosage

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

  • the condition being treated
  • other medical conditions you have
  • other medications you are taking
  • how you respond to this medication
  • your weight
  • your height
  • your age

Oral forms:

The recommended dose of metronidazole for the treatment of trichomoniasis is 375 mg two times a day.

The recommended dose of metronidazole for the treatment of amebiasis in adults is 750 mg three times a day.

Topical forms:

The recommended dose of metronidazole for the treatment of rosacea is two applications daily, usually in the morning and evening.

Injectable forms:

The recommended dose range of metronidazole for the treatment of amebiasis in children is 35 to 50 mg/kg every day, divided into three doses.

The recommended dose of metronidazole for the treatment of anaerobic bacterial infections is 7.5 mg/kg every 6 hours. A maximum of 4 grams should not be exceeded within a 24-hour period.

For Healthcare Professionals

Applies to metronidazole topical: topical cream, topical gel, topical kit, topical lotion, vaginal gel with applicator

General

Topical: The most frequently reported side effects were nasopharyngitis, upper respiratory tract infection, and headache.

Vaginal: The most frequently reported side effects were fungal infection, vulvovaginal candidiasis, headache, vulvovaginal pruritus, nausea, diarrhea, metrorrhagia, breast pain, infection, rash, pharyngitis, abdominal pain, pruritus, and dysmenorrhea.[Ref]

Local

Very common (10% or more): Mild dryness (17.1%), mild scaling (16.2%)
Common (1% to 10%): Moderate dryness, moderate scaling, mild pruritus, moderate pruritus, severe pruritus, mild stinging/burning, moderate stinging/burning, severe stinging/burning, local allergic reaction
Uncommon (0.1% to 1%): Severe dryness, severe scaling
Frequency not reported: Application site reaction, condition aggravated, transient redness[Ref]

Genitourinary

Common (1% to 10%): Dysmenorrhea, breast pain, metrorrhagia, vulvovaginal candidiasis, vulvovaginal pruritus, urinary tract infection, vaginal itching/irritation/burning/numbness, pelvic discomfort, vaginal discharge
Uncommon (0.1% to 1%): Vaginal mycosis, urine discolored, vulva edema, menstrual discomfort/irregularities, vaginal spotting/bleeding
Frequency not reported: Breast enlargement, dysuria, female lactation, labial edema, leucorrhoea, menorrhagia, salpingitis, urinary frequency, vaginitis, vulvovaginal disorder[Ref]

Gastrointestinal

Common (1% to 10%): Abdominal pain, nausea, diarrhea, gastritis, tooth disorder, gastrointestinal discomfort, abdominal cramps, vomiting
Uncommon (0.1% to 1%): Constipation, dry mouth, abdominal bloating/noise
Frequency not reported: Dyspepsia, flatulence, gingivitis[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness
Uncommon (0.1% to 1%): Tingling/numb extremities, taste metallic, dysgeusia, paresthesia, hypothesia
Frequency not reported: Peripheral neuropathy, ataxia
Postmarketing reports: Taste perversion[Ref]

Respiratory

Common (1% to 10%): Pharyngitis, bronchitis, nasopharyngitis, sinusitis, upper respiratory tract infection, nasal congestion
Frequency not reported: Asthma, rhinitis[Ref]

Cardiovascular

Common (1% to 10%): Hypertension[Ref]

Dermatologic

Common (1% to 10%): Pruritus, rash, contact dermatitis, dry skin, skin discomfort, burning/stinging, erythema, worsening of rosacea, skin irritation
Frequency not reported: Acne, sweating, urticaria, skin exfoliation, facial edema, zoster lesion, nose pustule, vesicular bullous eruption
Postmarketing reports: Hyperpigmentation, pigmentation disorder, hypertrichosis[Ref]

Other

Very common (10% or more): Fungal infection (12%), flu syndrome (up to 11%)
Common (1% to 10%): Infection, influenza, abscess, pain
Uncommon (0.1% to 1%): Fatigue
Frequency not reported: Mucous membrane disorder[Ref]

Psychiatric

Uncommon (0.1% to 1%): Depression, difficult sleep, irritability
Frequency not reported: Insomnia[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Back pain, cramp[Ref]

Oncologic

Uncommon (0.1% to 1%): Basal cell carcinoma
Frequency not reported: Skin cancer[Ref]

Ocular

Frequency not reported: Eye irritation, watery eye
Postmarketing reports: Eyelid edema[Ref]

Hepatic

Frequency not reported: Liver function test abnormal[Ref]

Immunologic

Frequency not reported: Allergic reaction[Ref]

Metabolic

Common (1% to 10%): Appetite decreased
Frequency not reported: Anorexia, hypomagnesemia[Ref]

Renal

Frequency not reported: Pyelonephritis[Ref]

Some side effects of MetroCream may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Contraindications

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

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.

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:  59° to 86°F (15° to 30°C).

Caution:   Federal law prohibits dispensing without prescription.

Marketed by:

GALDERMA Laboratories, Inc.

Fort Worth, Texas 76133 USA

Manufactured by:

DPT Laboratories, Inc.

San Antonio, Texas 78215 USA

GALDERMA is a registered trademark.

225029-0695

Revised:  June 1995

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