GRISEOFULVIN tablet

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

GRISEOFULVIN (UNII: 32HRV3E3D5) (GRISEOFULVIN - UNII:32HRV3E3D5)

から入手可能:

Sandoz Inc

INN（国際名）:

GRISEOFULVIN

構図:

GRISEOFULVIN 250 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Griseofulvin tablets, USP are indicated for the treatment of dermatophyte infections of the skin not adequately treated by topical therapy, hair and nails, namely: Tinea corporis Tinea pedis Tinea cruris Tinea barbae Tinea capitis Tinea unguium when caused by one or more of the following species of fungi: Epidermophyton floccosum Microsporum audouinii Microsporum canis Microsporum gypseum Trichophyton crateriform Trichophyton gallinae Trichophyton interdigitalis Trichophyton megnini Trichophyton mentagrophytes Trichophyton rubrum Trichophyton schoenleini Trichophyton sulphureum Trichophyton tonsurans Trichophyton verrucosum Note: Prior to therapy, a dermatophyte should be identified as responsible for the infection. Prior to initiating treatment, appropriate specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis. Griseofulvin tablets, USP are not effective in the following: Bacterial infections Candidiasis (Moniliasis) H

製品概要:

Griseofulvin tablets, USP (microsize) are available as follows: 250 mg, white to off-white round, flat, beveled edge, scored tablets engraved with 'I27' on one side and score on the other. 500 mg, white to off-white round, flat, beveled edge, scored tablets engraved with 'I26' on one side and score on the other. Dispense griseofulvin tablets, USP (microsize) in a tight container as defined in the USP. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Manufactured by USV Private Limited, Mahatma Gandhi Udyog Nagar, Dabhel, Daman 396210, India for Sandoz Inc., Princeton, NJ 08540 Rev. December 2016

認証ステータス:

Abbreviated New Drug Application

製品の特徴

GRISEOFULVIN- GRISEOFULVIN TABLET
SANDOZ INC
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GRISEOFULVIN TABLETS, USP (MICROSIZE)
250 MG AND 500 MG
PRESCRIBING INFORMATION
DESCRIPTION
Griseofulvin tablets, USP (microsize) contains griseofulvin microsize
for oral administration. The
active ingredient, griseofulvin, is a fungistatic antibiotic, derived
from a species of _Penicillium_. The
chemical name of griseofulvin is
7-chloro-2’,4,6-trimethoxy-6’β-methylspiro[benzofuran-2(3H),1’-
[2]cyclohexane]-3-4’-dione. Its structural formula is:
Griseofulvin occurs as a white to creamy white, bitter tasting powder
which is very slightly soluble in
water and sparingly soluble in alcohol. Griseofulvin microsize
contains particles of approximately 2 to
4 µm in diameter.
Griseofulvin tablets, USP (microsize) are available as follows:
250 mg, white to off-white round, flat, beveled edge, scored tablets
engraved with 'I27' on one side and
score on the other.
500 mg, white to off-white round, flat, beveled edge, scored tablets
engraved with 'I26' on one side and
score on the other.
Each tablet contains 250 mg or 500 mg of griseofulvin microsize, and
also contains calcium stearate,
colloidal silicon dioxide, corn starch, crospovidone, dibasic calcium
phosphate, and sodium starch
glycolate.
CLINICAL PHARMACOLOGY
Griseofulvin absorption from the gastrointestinal tract varies
considerably among individuals, mainly
because of insolubility of the drug in aqueous media of the upper GI
tract. Drug absorption has been
estimated to range between 27 and 72%. After an oral dose,
griseofulvin is primarily absorbed from the
duodenum with some absorption occurring from the jejunum and ileum.
The peak serum level in fasting
adults given 0.5 g of griseofulvin microsize occurs at about four
hours and ranges between 0.5 to 2
mcg/mL. The serum level may be increased by giving the drug with a
meal with a high fat content. In one
study in pediatric patients 19 months to 11 years of age, 10 mg/kg of
griseofulvin microsize given with
milk resulted in mean peak serum concentratio