Griseofulvin Information
Griseofulvin (Griseofulvin, microcrystalline) Description
Griseofulvin (Griseofulvin, microcrystalline) is an antibiotic derived from a species of . Each 5 mL of Griseofulvin (Griseofulvin, microcrystalline) Oral Suspension
(microsize) contains 125 mg of Griseofulvin (Griseofulvin, microcrystalline) 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.
Griseofulvin (Griseofulvin, microcrystalline) Clinical Pharmacology
Griseofulvin (Griseofulvin, microcrystalline) Oral Suspension acts systemically to inhibit the
growth of , and genera of fungi. Fungistatic amounts are
deposited in the keratin, which is gradually exfoliated and replaced by
noninfected tissue.
Griseofulvin (Griseofulvin, microcrystalline) 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.
Griseofulvin (Griseofulvin, microcrystalline) Indications And Usage
Major indications for Griseofulvin (Griseofulvin, microcrystalline) 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 (Griseofulvin, microcrystalline) Oral Suspension inhibits the growth of those genera of fungi
that commonly cause ringworm infections of the hair, skin, and nails, such as:
It is effective in:
Bacterial infections
Candidiasis (Moniliasis)
Histoplasmosis
Actinomycosis
Sporotrichosis
Chromoblastomycosis
Coccidioidomycosis
North American Blastomycosis
Cryptococcosis (Torulosis)
Tinea versicolor
Nocardiosis
Griseofulvin (Griseofulvin, microcrystalline) Contraindications
This drug is contraindicated in patients with porphyria,
hepatocellular failure, and in individuals with a history of hypersensitivity to
Griseofulvin (Griseofulvin, microcrystalline) .
Two cases of conjoined twins have been reported in patients taking
Griseofulvin (Griseofulvin, microcrystalline) during the first trimester of pregnancy. Griseofulvin (Griseofulvin, microcrystalline) should not be
prescribed to pregnant patients.
Griseofulvin (Griseofulvin, microcrystalline) Warnings
Safety and efficacy of prophylactic use of Griseofulvin (Griseofulvin, microcrystalline) Oral
Suspension has not been established.
Chronic feeding of Griseofulvin (Griseofulvin, microcrystalline) , at levels ranging from 0.5-2.5% of the diet,
resulted in the development of liver tumors in several strains of mice,
particularly in males. Smaller particle sizes result in an enhanced effect.
Lower oral dosage levels have not been tested. Subcutaneous administration of
relatively small doses of Griseofulvin (Griseofulvin, microcrystalline) once a week during the first three weeks
of life has also been reported to induce hepatomata in mice.Although studies in
other animal species have not yielded evidence of tumorigenicity, these studies
were not of adequate design to form a basis for conclusions in this regard.
In subacute toxicity studies, orally administered Griseofulvin (Griseofulvin, microcrystalline) produced
hepatocellular necrosis in mice, but this has not been seen in other species.
Disturbances in porphyrin metabolism have been reported in Griseofulvin (Griseofulvin, microcrystalline) -treated
laboratory animals. Griseofulvin (Griseofulvin, microcrystalline) has been reported to have a colchicine-like
effect on mitosis and cocarcinogenicity with methylcholanthrene in cutaneous
tumor induction in laboratory animals.
Reports of animal studies in the Soviet literature state that a Griseofulvin (Griseofulvin, microcrystalline)
preparation was found to be embryotoxic and teratogenic on oral administration
to pregnant Wistar rats. Rat reproduction studies done in the United States and
Great Britain were inconclusive in this regard. Pups with abnormalities have
been reported in the litters of a few bitches treated with Griseofulvin (Griseofulvin, microcrystalline) . Because
the potential for adverse effects on the human fetus cannot be ruled out,
additional contraceptive precautions should be taken during treatment with
Griseofulvin (Griseofulvin, microcrystalline) and for a month after termination of treatment. Griseofulvin (Griseofulvin, microcrystalline) Oral
Suspension should not be prescribed to women intending to become pregnant within
one month following cessation of therapy.
Suppression of spermatogenesis has been reported to occur in rats but
investigation in man failed to confirm this. Griseofulvin (Griseofulvin, microcrystalline) interferes with
chromosomal distribution during cell division, causing aneuploidy in plant and
mammalian cells. These effects have been demonstrated at concentrations that may be achieved in the serum with the
recommended therapeutic dosage.
Since Griseofulvin (Griseofulvin, microcrystalline) has demonstrated harmful effects on the genotype in bacteria, plants, and fungi, males should wait
at least six months after completing Griseofulvin (Griseofulvin, microcrystalline) therapy before fathering a
child.
Griseofulvin (Griseofulvin, microcrystalline) Precautions
Patients on prolonged therapy with any potent medication should
be under close observation. Periodic monitoring of organ system function,
including renal, hepatic and hemopoietic, should be done.
Since Griseofulvin (Griseofulvin, microcrystalline) is derived from species of penicillin, the possibility of
cross sensitivity with penicillin exists; however, known penicillin-sensitive
patients have been treated without difficulty.
Since a photosensitivity reaction is occasionally associated with
Griseofulvin (Griseofulvin, microcrystalline) therapy, patients should be warned to avoid exposure to intense
natural or artificial sunlight. Should a photosensitivity reaction occur, lupus
erythematosus may be aggravated.
Griseofulvin (Griseofulvin, microcrystalline) Drug Interactions
Patients on warfarin-type anticoagulant therapy may require
dosage adjustment of the anticoagulant during and after Griseofulvin (Griseofulvin, microcrystalline) therapy.
Concomitant use of barbiturates usually depresses Griseofulvin (Griseofulvin, microcrystalline) activity and may
necessitate raising the dosage.
The concomitant administration of Griseofulvin (Griseofulvin, microcrystalline) has been reported to reduce
the efficacy of oral contraceptives and to increase the incidence of
breakthrough bleeding.
Griseofulvin (Griseofulvin, microcrystalline) Adverse Reactions
When adverse reactions occur, they are most commonly of the
hypersensitivity type such as skin rashes, urticaria and rarely, angioneurotic
edema or erythema multiforme-like drug reaction, and may necessitate withdrawal
of therapy and appropriate countermeasures. Paresthesias of the hands and feet
have been reported rarely after extended therapy. Other side effects reported
occasionally are oral thrush, nausea, vomiting, epigastric distress, diarrhea,
headache, fatigue, dizziness, insomnia, mental confusion and impairment of
performance of routine activities.
Proteinuria and leukopenia have been reported rarely. Administration of the
drug should be discontinued if granulocytopenia occurs.
When rare, serious reactions occur with Griseofulvin (Griseofulvin, microcrystalline) , they are usually
associated with high dosages, long periods of therapy, or both.
Griseofulvin (Griseofulvin, microcrystalline) 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 since in some forms
of athlete's foot, yeasts and bacteria may be involved. Griseofulvin (Griseofulvin, microcrystalline) will not
eradicate the bacterial or monilial infection.
A daily dose of 500 mg 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 daily dose of 1.0 gram is recommended.
Approximately 5 mg per pound of body weight per day is an
effective dose for most children. On this basis the following dosage schedule
for children is suggested:
Griseofulvin (Griseofulvin, microcrystalline) How Supplied
Griseofulvin (Griseofulvin, microcrystalline) Oral Suspension 125 mg per 5 mL in bottles of 4 fl
oz (120 mL) ().
Dispense Griseofulvin (Griseofulvin, microcrystalline) Oral Suspension in a tight, light-resistant container
as defined in the USP.
STORE AT ROOM TEMPERATURE
Griseofulvin (Griseofulvin, microcrystalline) Principal Display Panel - Ml Label
Each 5 mL (one teaspoonful) contains 125 mg Griseofulvin (Griseofulvin, microcrystalline) microsize in a
palatable suspension, colored orange. Also contains alcohol 0.2%.
Store at room temperature.
Pharmacist: This product is protected
by a tamper- resistant seal around the neck opening. If the seal has
been broken or is removed, the
product. Return the product to place of purchase.
