MICONAZOLE NITRATE suppository

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)

Fáanlegur frá:

Actavis Pharma, Inc.

INN (Alþjóðlegt nafn):

MICONAZOLE NITRATE

Samsetning:

MICONAZOLE NITRATE 200 mg

Stjórnsýsluleið:

VAGINAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Miconazole Nitrate Vaginal Suppositories USP, 200 mg are indicated for the local treatment of vulvovaginal candidiasis (moniliasis). Effectiveness in pregnancy has not been established. As miconazole nitrate is effective only for candidal vulvovaginitis, the diagnosis should be confirmed by KOH smear and/or cultures. Other pathogens commonly associated with vulvovaginitis (Trichomonas and Haemophilus vaginalis [Gardnerella] ) should be ruled out by appropriate laboratory methods. Patients known to be hypersensitive to this drug.

Vörulýsing:

Miconazole Nitrate Vaginal Suppositories USP, 200 mg are available as elliptically shaped white to off-white suppositories in packages of three with a vaginal applicator NDC 0472-1738-03. Store at controlled room temperature 15° to 30°C (59° to 86°F). Manufactured for: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054 Rev. A 7/2020

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

MICONAZOLE NITRATE- MICONAZOLE NITRATE SUPPOSITORY
ACTAVIS PHARMA, INC.
----------
MICONAZOLE NITRATE VAGINAL SUPPOSITORIES USP, 200 MG
PHYSICIAN’S INSERT
RX ONLY
DESCRIPTION
Miconazole Nitrate Vaginal Suppositories USP, 200 mg are white to
off-white suppositories, each
containing the antifungal agent, miconazole nitrate, USP
1-[2,4-Dichloro-β-[(2,4- dichlorobenzyl)oxy]
phenethyl]-imidazole mononitrate, 200 mg, in a hydrogenated vegetable
oil base. The molecular
formula is C
H Cl
N O•HNO ; the molecular weight is 479.14 and the structural formula
may be
represented as follows:
CLINICAL PHARMACOLOGY
Miconazole nitrate exhibits fungicidal activity _in vitro _against
species of the genus _Candida. _The
pharmacologic mode of action is unknown. Following intravaginal
administration of miconazole nitrate,
small amounts are absorbed. Administration of a single dose of
miconazole nitrate vaginal suppositories
(100 mg) to healthy subjects resulted in total recovery from the urine
and feces of 0.85% (±0.43%) of
the administered dose.
Animal studies indicate that the drug crossed the placenta and doses
above those used in humans result
in embryo and fetotoxicity (80 mg/kg, orally), although this has not
been reported in human subjects (See
PRECAUTIONS).
In multi-center clinical trials in 440 women with vulvovaginal
candidiasis, the efficacy of treatment with
the Miconazole Nitrate Vaginal Suppositories USP, 200 mg for 3 days
was compared with treatment for
7 days with Miconazole Nitrate Vaginal Cream 2%. The clinical cure
rates (free of microbiological
evidence and clinical signs and symptoms of candidiasis at 8 to 10
days and 30 to 35 days post therapy)
were numerically lower, although not statistically different, with the
3-Day Suppository when compared
with the 7-Day Cream.
INDICATIONS AND USAGE
Miconazole Nitrate Vaginal Suppositories USP, 200 mg are indicated for
the local treatment of
vulvovaginal candidiasis (moniliasis). Effectiveness in pregnancy has
not been established. As
18
14
4
2
3
miconazole nitrate is