A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Gris Peg Indications, Dosage, Storage, Stability - Griseofulvin
Gris Peg Indications, Dosage, Storage, Stability - Griseofulvin
INDICATIONS
Griseofulvin Tablets are indicated for the treatment
of ringworm infections
of the skin, hair, and
nails, namely: tinea corporis,
tinea pedis, tinea cruris,
tinea barbae, tinea
capitis, tinea unguium
(onychomycosis) when caused by one or more of the following genera
of fungi:
Trichophyton rubrum, Trichophyton
tonsurans, Trichophyton
mentagrophytes, Trichophyton interdigitale, Trichophyton
verrucosum Trichophyton
megninii, Trichophyton gallinae, Trichophyton
crateriforme, Trichophyton
sulphureum, Trichophyton schoenleinii, Microsporum
audouini, Microsporum
canis, Microsporum gypseum, and Epidermophyton
floccosum.
Note: Prior to therapy,
the type of fungi responsible
for the infection should be identified.
The use of this drug is
not justified in minor
or trivial infections which will
respond to topical agents
alone.
Griseofulvin is not effective in the following: bacterial infections,
candidiasis (moniliasis), histoplasmosis,
actinomycosis, sporotrichosis, chromoblastomycosis, coccidioidomycosis,
North American blastomycosis, cryptococcosis (torulosis), tinea
versicolor, and nocardiosis.
DOSAGE AND ADMINISTRATION
Accurate diagnosis
of the infecting organism
is essential. Identification should be made either by direct microscopic
examination of a
mounting of infected
tissue in a solution
of potassium hydroxide
or by culture on an
appropriate medium.
Medication must be continued until the infecting organism
is completely eradicated as indicated by appropriate
clinical or laboratory
examination. Representative treatment
periods are tinea capitis,
4 to 6 weeks; tinea corporis, 2 to 4 weeks; tinea
pedis, 4 to 8 weeks; tinea
unguium-depending on rate
of growth-fingernails at least 4 months; toenails, at least 6 months.
General measures in regard to hygiene
should be observed to control sources of infection
or reinfection. Concomitant use of appropriate
topical agents is usually required particularly in treatment
of tinea pedis. In some
forms of athlete's foot, yeasts and bacteria
may be involved as well as fungi. Griseofulvin will
not eradicate the bacterial or monilial infection.
Adults: Daily administration
of 330 mg (as a single dose
or in divided amounts) will
give a satisfactory response
in most patients with tinea corporis, tinea
cruris, and tinea capitis.
For those fungus infections
more difficult to eradicate, such
as tinea pedis and tinea
unguium, a divided daily dosage
of 660 mg is recommended.
Children: Approximately 3.3 mg
per pound
of body weight
per day is an effective
dose for most children.
On this basis the following
dosage schedule is suggested: Children weighing 30 to 50 pounds-82.5
mg to 165 mg daily. Children
weighing over 50 pounds -165 mg
to 330 mg daily.
Children 2 years of age
and younger-dosage has not been established.
Clinical experience
with griseofulvin
in children with tinea
capitis indicates that a single daily dose
is effective. Clinical relapse
will occur if the medication
is not continued until the infecting organism
is eradicated.
HOW SUPPLIED
Griseofulvin 330 Tablets, 330 mg, off-white, oval
compressed scored tablets impressed with Warrick and product
identification
numbers 1624; bottle of 100 (NDC 59930-1624-1).
Store between 2° and 30°C (36° and 86°F).
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