GRISEOFULVIN tablet

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Rising Pharmaceuticals Inc.

ІПН (Міжнародна Ім'я):

GRISEOFULVIN

Склад:

GRISEOFULVIN 500 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Griseofulvin is 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 is not effective in the following: Bacterial infections Candidiasis (Moniliasis) Histoplasmosis Actinomycosis Sporotrichosis C

Огляд продуктів:

Griseofulvin Tablets, USP (microsize) 500 mg are white, capsule shaped, bisected tablets, debossed with ‘Σ’ and ‘12’ on either side of the bisection and plain on the other side, and supplied in bottles of 30s (NDC 64980-186-03) and 100s (NDC 64980-186-01). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP. Rx ONLY Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401 Manufactured by: Sigmapharm Laboratories, LLC Bensalem, PA 19020 OS012-05 REV.0216

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

GRISEOFULVIN- GRISEOFULVIN TABLET
RISING PHARMACEUTICALS INC.
----------
GRISEOFULVIN TABLETS, USP (MICROSIZE) RX ONLY
PRESCRIBING INFORMATION
DESCRIPTION
Griseofulvin 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:
C
H ClO M.W = 352.77
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) 500 mg are white, capsule
shaped, bisected tablets, debossed
with ‘Σ’ and ‘12’ on either side of the bisection and plain
on the other side. Each Griseofulvin Tablet,
USP (microsize) 500 mg contains 500 mg of griseofulvin microsize, and
also contains corn starch,
povidone, polyethylene glycol 400, polyethylene glycol 8000, lactose
monohydrate, crospovidone,
silicon dioxide and magnesium stearate.
Meets USP Dissolution Test 2.
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 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 concentrations approximately
four-fold greater than th