GRISEOFULVIN suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Actavis Pharma, Inc.

INN (International Name):

GRISEOFULVIN

Composition:

GRISEOFULVIN 125 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Griseofulvin oral suspension, USP 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

Product summary:

Griseofulvin oral suspension, USP (microsize), 125 mg per 5 mL is an orange-vanilla flavored suspension available in bottles of 4 fl oz (120 mL) NDC 0472-0013-04. Dispense griseofulvin oral suspension, USP in a tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. C 9/2023

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GRISEOFULVIN- GRISEOFULVIN SUSPENSION
ACTAVIS PHARMA, INC.
----------
GRISEOFULVIN ORAL SUSPENSION, USP (MICROSIZE), 125 MG/5 ML
RX ONLY
DESCRIPTION
Griseofulvin microsize contains griseofulvin microsize for oral
administration. The active
ingredient, griseofulvin, USP is a fungistatic antibiotic, derived
from a species of
_Penicillium_. The chemical name of griseofulvin, USP 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, USP 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 oral suspension, USP is an orange colored suspension.
Each 5 mL of
griseofulvin oral suspension, USP contains 125 mg of griseofulvin
microsize and also
contains alcohol 0.2%, artificial orange vanilla flavor, docusate
sodium, FD&C Red No.
40, FD&C Yellow No. 6, magnesium aluminum silicate, menthol,
methylparaben,
propylene glycol, propylparaben, saccharin sodium, simethicone
emulsion, sodium
alginate, sucrose, and purified water.
CLINICAL PHARMACOLOGY
17
17
6
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 2.0
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 the sam