Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
GRISEOFULVIN (UNII: 32HRV3E3D5) (GRISEOFULVIN - UNII:32HRV3E3D5)
Chartwell RX, LLC.
ORAL
PRESCRIPTION DRUG
Major indications for Griseofulvin Oral Suspension, USP 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, USP 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 ther
Griseofulvin Oral Suspension, USP (microsize) 125 mg per 5 mL is available as follows: 4 fl oz (120 mL) bottle (NDC 62135-968-41) Dispense Griseofulvin Oral Suspension, USP in a tight, light-resistant container as defined in the USP. STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Manufactured by: Chartwell Pharmaceuticals, LLC. Congers, NY 10920 Manufactured for: Chartwell RX, LLC. Congers, NY 10920 L70567 Rev: 08/2021
Abbreviated New Drug Application
GRISEOFULVIN- GRISEOFULVIN (MICROSIZE) SUSPENSION CHARTWELL RX, LLC. ---------- GRISEOFULVIN ORAL SUSPENSION, USP (MICROSIZE) 125 MG/5 ML RX ONLY DESCRIPTION Griseofulvin is an antibiotic derived from a species of _Penicillium._ Each 5 mL of Griseofulvin Oral Suspension, USP contains 125 mg of griseofulvin (microsize) and also contains alcohol (0.2%), docusate sodium, FD&C Red No. 40, FD&C Yellow No. 6, magnesium aluminum silicate, menthol, methylparaben, orange cream flavors, propylene glycol, propylparaben, purified water, saccharin sodium, simethicone emulsion, sodium alginate and sucrose. CLINICAL PHARMACOLOGY Griseofulvin Oral Suspension, USP 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 griseofulvin is administered after a meal with a high fat content. INDICATIONS AND USAGE Major indications for Griseofulvin Oral Suspension, USP 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, USP 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 menta Citiți documentul complet