METRONIDAZOLE capsule

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Alembic Pharmaceuticals Inc.

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Symptomatic Trichomoniasis . Metronidazole capsules USP 375 mg are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis . Metronidazole capsules USP 375 mg are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Sexual Partners . T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asympt

產品總結:

Metronidazole capsules USP 375 mg have an opaque grey / opaque yellow size ‘1’ hard gelatin capsules, linearly imprinted with ‘HP66’ on body and ‘HP66’ on cap in black ink, filled with off-white to yellowish white powder. NDC Number                           Size   62332-018-30                                    Bottle of 30 62332-018-50                                    Bottle of 50 62332-018-31                                    Bottle of 100 62332-018-71                                    Bottle of 500 62332-018-91                                    Bottle of 1000 Storage and Stability:  Store at 20° - 25°C (68° - 77°F).  [See USP Controlled Room Temperature]. Dispense in a well-closed, child resistant container. Call your doctor for medical advice about side effects. You may report side effects to Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Rx only   Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Revised: 10/2023

授权状态:

Abbreviated New Drug Application

产品特点

METRONIDAZOLE - METRONIDAZOLE CAPSULE
ALEMBIC PHARMACEUTICALS INC.
----------
METRONIDAZOLE CAPSULES USP 375 MG
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
metronidazole capsules USP 375 mg and other antibacterial drugs,
metronidazole
capsules USP 375 mg should be used only to treat or prevent infections
that are
proven or strongly suspected to be caused by bacteria.
WARNING
Metronidazole has been shown to be carcinogenic in mice and rats (See
PRECAUTIONS). Unnecessary use of the drug should be avoided. Its use
should
be reserved for the conditions described in the INDICATIONS AND USAGE
section below.
DESCRIPTION
Metronidazole capsules USP 375 mg is an oral formulation of the
synthetic nitroimidazole
antimicrobial agent, 2-methyl-5-nitro-1_H_-imidazole-1-ethanol, which
has the following
structural formula:
Metronidazole capsules USP 375 mg contain 375 mg of metronidazole USP.
Inactive
ingredients include corn starch, magnesium stearate, gelatin, titanium
dioxide, FD&C
Yellow No. 5 and iron oxide black.
CLINICAL PHARMACOLOGY
ABSORPTION
Disposition of metronidazole in the body is similar for both oral and
intravenous dosage
forms.
Metronidazole capsules 375 mg have been shown to have a rate and
extent of
absorption similar to metronidazole tablets and were bioequivalent at
an equal single
dose of 750 mg. In a study conducted with 23 adult, healthy, female
volunteers, oral
administration of two 375 mg metronidazole capsules under fasted
conditions produced
a mean (±1 SD) peak plasma concentration (C
) of 21.4 (±2.8) mcg/mL with a mean
T
of 1.6 (± 0.7) hours and a mean area under the plasma
concentration-time curve
(AUC) of 223 (±44) mcg·hr/mL. In the same study, three 250 mg
metronidazole tablets
produced a mean C
of 20.4 (± 3.8) mcg/mL with a mean T
of 1.4 (± 0.4) hours
and a mean AUC of 218 (± 50) mcg·hr/mL.
Administration of metronidazole capsules 375 mg with food does not
affect the extent
of absorption of metronidazole; however, the presence of food results
in