METRONIDAZOLE cream

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

METRONIDAZOLE (UNII: 140QMO216E) (METRONIDAZOLE - UNII:140QMO216E)

Dostępny od:

Cosette Pharmaceuticals, Inc.

INN (International Nazwa):

Metronidazole

Skład:

Metronidazole 7.5 mg in 1 g

Droga podania:

TOPICAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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.

Podsumowanie produktu:

Metronidazole Topical Cream, 0.75% is supplied in a 45 g tube  NDC 0713-0633-37.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

METRONIDAZOLE- METRONIDAZOLE CREAM
COSETTE PHARMACEUTICALS, INC.
----------
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
antibacterial agents and is classified therapeutically as an
antiprotozoal and antibacterial
agent. Chemically, metronidazole is 2-methyl-5-nitro-1
_H_-imidazole-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
6
9
3
3
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.
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.