国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
GRISEOFULVIN (UNII: 32HRV3E3D5) (GRISEOFULVIN - UNII:32HRV3E3D5)
Physicians Total Care, Inc.
GRISEOFULVIN
GRISEOFULVIN 125 mg in 5 mL
ORAL
PRESCRIPTION DRUG
Major indications for Griseofulvin Oral Suspension are: Tinea capitis (ringworm of the scalp) Tinea corporis (ringworm of the body) Tinea pedis (athlete's foot) Tinea unguium (onychomycosis; ringworm of the nails) Tinea cruris (ringworm of the thigh) Tinea barbae (barber's itch) Griseofulvin Oral Suspension inhibits the growth of those genera of fungi that commonly cause ringworm infections of the hair, skin, and nails, such as: Trichophyton rubrum Trichophyton tonsurans Trichophyton mentagrophytes Trichophyton interdigitalis Trichophyton verrucosum Trichophyton sulphureum Trichophyton schoenleini Microsporum audouini Microsporum canis Microsporum gypseum Epidermophyton floccosum Trichophyton megnini Trichophyton gallinae Trichophyton crateriform Note: Prior to therapy, the type of fungi responsible for the infection should be identified. The use of the drug is not justified in minor or trivial infections which will respond to topical anti-fungal agents alone. It is not effective in: Bacterial infection
Griseofulvin Oral Suspension 125 mg per 5 mL in bottles of 4 fl oz (120 mL) (NDC 54868-5234-0 ). Dispense Griseofulvin Oral Suspension in a tight, light-resistant container as defined in the USP. STORE AT ROOM TEMPERATURE For more information call 1-800-510-0383. Manufactured by: Ortho-McNeil Pharmaceutical, Inc. Raritan, NJ 08869 Distributed by: Patriot Pharmaceuticals, LLC Plymouth Meeting, PA 19462 Printed in U.S.A., © OMP 2005 Revised July 2005 10094000 Relabeling of "Additional Barcode Label" by: Physicians Total Care, Inc. Tulsa, OK 74146
Abbreviated New Drug Application
GRISEOFULVIN - GRISEOFULVIN SUSPENSION PHYSICIANS TOTAL CARE, INC. ---------- DESCRIPTION Griseofulvin is an antibiotic derived from a species of _Penicillium_. Each 5 mL of Griseofulvin Oral Suspension (microsize) contains 125 mg of griseofulvin microsize and also contains alcohol 0.2%, docusate sodium, FD&C Red No. 40, FD&C Yellow No. 6, flavors, magnesium aluminum silicate, menthol, methylparaben, propylene glycol, propylparaben, saccharin sodium, simethicone emulsion, sodium alginate, sucrose, and purified water. CLINICAL PHARMACOLOGY Griseofulvin Oral Suspension acts systemically to inhibit the growth of _Trichophyton, Microsporum_, and _Epidermophyton_ genera of fungi. Fungistatic amounts are deposited in the keratin, which is gradually exfoliated and replaced by noninfected tissue. Griseofulvin absorption from the gastrointestinal tract varies considerably among individuals, mainly because of insolubility of the drug in aqueous media of the upper G.I. tract. The peak serum level found in fasting adults given 0.5 gm occurs at about four hours and ranges between 0.5 and 2.0 mcg/mL. It should be noted that some individuals are consistently "poor absorbers" and tend to attain lower blood levels at all times. This may explain unsatisfactory therapeutic results in some patients. Better blood levels can probably be attained in most patients if administered after a meal with a high fat content. INDICATIONS AND USAGE Major indications for Griseofulvin Oral Suspension are: Tinea capitis (ringworm of the scalp) Tinea corporis (ringworm of the body) Tinea pedis (athlete's foot) Tinea unguium (onychomycosis; ringworm of the nails) Tinea cruris (ringworm of the thigh) Tinea barbae (barber's itch) Griseofulvin Oral Suspension inhibits the growth of those genera of fungi that commonly cause ringworm infections of the hair, skin, and nails, such as: _Trichophyton rubrum_ _Trichophyton tonsurans_ _Trichophyton mentagrophytes_ _Trichophyton interdigitalis_ _Trichophyton verrucosum_ _Trichophyton sulphureum_ _Trichophyton sch 完全なドキュメントを読む