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Metronidazole Topical

Also sold as METRONIDAZOLE

From 1 official FDA drug label · RxNorm 311679

This comes from U.S. FDA labels. Brand names, strengths and advice can differ in your country; check with a local health professional. Set your country.

What it is used for

These are the uses the FDA has approved for this label. Using it for anything else is “off-label”: ask your prescriber why.

INDICATIONS AND USAGE Metronidazole gel USP (topical), 0.75%, is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.

How to take it

DOSAGE AND ADMINISTRATION Apply and rub in a thin film of metronidazole gel USP (topical), 0.75%, twice daily, morning and evening, to entire affected areas after washing. Areas to be treated should be cleansed before application of metronidazole gel USP (topical), 0.75%. Patients may use cosmetics after application of metronidazole gel USP (topical), 0.75%.

Do not take it if

CONTRAINDICATIONS Metronidazole gel USP (topical), 0.75%, is contraindicated in individuals with a history of hypersensitivity lo metronidazole, parabens, or other ingredients of the formulation.

Common side effects

From the label’s clinical-trial and reporting data. Serious problems are under the warnings above.

ADVERSE REACTIONS The following adverse experiences have been reported with the topical use of metronidazole: burning, skin irritation, dryness, transient redness, metallic taste, tingling or numbness of extremities and nausea.

Taking it with other medicines

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

If you are pregnant or breastfeeding

Pregnancy Teratogenic effects Teratogenic effects: Pregnancy category B: There has been no experience to date with the use of metronidazole gel USP (topical), 0.75%, in pregnant patients. 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.

Forms and strengths available

40 MG/ML · Oral Suspension375 MG · Oral Capsule200 MG · Oral Tablet400 MG · Oral Tablet500 MG · Rectal Suppository0.008 MG · Topical Gel1000 MG · Rectal Suppository100 MG/ML · Oral Suspension125 MG · Oral Tablet7.5 MG/ML · Topical Cream0.0075 MG · Topical Gel10 MG/ML · Topical Cream500 MG · Oral Tablet250 MG · Oral Tablet0.01 MG · Topical Gel

From RxNorm. Which forms and strengths are actually stocked varies by pharmacy and country.

Reactions people have reported

pyrexia 4maternal exposure during pregnancy 4amniotic cavity infection 4lymphadenopathy 2bone marrow failure 2meconium stain 2foetal death 2odynophagia 2bone pain 1implant site erythema 1

These are counts from 11 voluntary reports to the FDA. They show what has been reported — they are not how common a side effect is, and they do not prove the medicine caused it.

Recalls

Class I · Jun 1, 2016
Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Single Dose Container bag, Rx only, Baxter USA, Product Code 2B3421, NDC 0338-1055-48.
Reason: Presence of Particulate Matter: identified as a cloth fiber.
Class II · Jul 10, 2013
Metronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Baxter, Deerfield, IL 60015, NDC 0338-1055-48
Reason: Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.

Research & studies

Recent higher-quality studies about Metronidazole Topical, from PubMed. We link to the source — titles only. This is not medical advice.

Similar medicines

Metronidazole Topical belongs to the Antiinfectives and antiseptics for local oral treatment class. Other medicines in it:

Questions to ask your doctor or pharmacist

Why you can trust this

Everything above comes from official FDA drug labels (openFDA), not written by us. Here are the exact labels used.

This information explains the official label. It cannot tell you whether this medicine is right or safe for you personally — only a qualified health professional who knows your history can do that. Do not start, stop, or change a medicine based on this page alone.