METRONIDAZOLE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

metronidazole (UNII: 140QMO216E) (metronidazole - UNII:140QMO216E)

Available from:

Fougera Pharmaceuticals Inc.

INN (International Name):

metronidazole

Composition:

metronidazole 7.5 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Metronidazole Topical Cream is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea. Metronidazole topical cream is contraindicated in individuals with a history of hypersensitivity to metronidazole, or other ingredients of the formulation.

Product summary:

Metronidazole Topical Cream 0.75% is supplied in a 45 gram tube, NDC 0168-0323-46 Storage conditions: Store at 20°C to 25°C (68°F to 77°F), excursions permitted 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]. E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. MELVILLE, NEW YORK 11747 46273863A R07/2020 #29

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METRONIDAZOLE- METRONIDAZOLE CREAM
FOUGERA PHARMACEUTICALS INC.
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METRONIDAZOLE
TOPICAL CREAM 0.75%
FOR TOPICAL USE ONLY
NOT FOR OPHTHALMIC USE
RX ONLY
DESCRIPTION
Metronidazole Topical Cream contains metronidazole, USP, at a
concentration of 7.5 mg
per gram (0.75%) in an emollient cream consisting of emulsifying wax,
sorbitol solution,
glycerin, isopropyl palmitate, benzyl alcohol, lactic acid, and/or
sodium hydroxide to
adjust pH, and purified water. Metronidazole is a member of the
imidazole class of anti-
bacterial agents and is classified therapeutically as an antiprotozoal
and antibacterial
agent. Chemically, metronidazole is
2-Methyl-5-nitroimidazole-1-ethanol. The molecular
formula is C H N O 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
Metronidazole Topical Cream is indicated for topical application in
the treatment of
inflammatory papules and pustules of rosacea.
CONTRAINDICATIONS
Metronidazole 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.
6
9
3
3
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 eff