GRISEOFULVIN suspension

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Physicians Total Care, Inc.

INN (Jina la Kimataifa):

GRISEOFULVIN

Tungo:

GRISEOFULVIN 125 mg in 5 mL

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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

Bidhaa muhtasari:

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

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

GRISEOFULVIN - GRISEOFULVIN SUSPENSION
PHYSICIANS TOTAL CARE, INC.
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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