Griseofulvin Suspension

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Side Effects & Adverse Reactions

Prophylactic Usage

Safety and efficacy of prophylactic use of Griseofulvin Oral Suspension has not been established.

Chronic feeding of griseofulvin, 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 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 produced hepatocellular necrosis in mice, but this has not been seen in other species. Disturbances in porphyrin metabolism have been reported in griseofulvin-treated laboratory animals. Griseofulvin 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 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. Because the potential for adverse effects on the human fetus cannot be ruled out, additional contraceptive precautions should be taken during treatment with griseofulvin and for a month after termination of treatment. Griseofulvin 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 interferes with chromosomal distribution during cell division, causing aneuploidy in plant and mammalian cells. These effects have been demonstrated in vitro at concentrations that may be achieved in the serum with the recommended therapeutic dosage.

Since griseofulvin has demonstrated harmful effects in vitro on the genotype in bacteria, plants, and fungi, males should wait at least six months after completing griseofulvin therapy before fathering a child.

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

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Uses

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 infections

Candidiasis (Moniliasis)

Histoplasmosis

Actinomycosis

Sporotrichosis

Chromoblastomycosis

Coccidioidomycosis

North American Blastomycosis

Cryptococcosis (Torulosis)

Tinea versicolor

Nocardiosis

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History

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Other Information

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.

Sources

Griseofulvin Suspension Manufacturers

Physicians Total Care, Inc.

Griseofulvin Suspension | Physicians Total Care, Inc.

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 will not eradicate the bacterial or monilial infection.
Adults
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.
Children
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:
Children weighing 30 to 50 pounds – 125 mg to 250 mg daily. Children weighing over 50 pounds – 250 mg to 500 mg daily.

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Perrigo New York Inc

Griseofulvin Suspension | Perrigo New York Inc

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 will not eradicate the bacterial or monilial infection.
Adults:
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 gram is recommended.
Children:
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:

Children weighing 30 to 50 pounds - 125 mg to 250 mg daily.

Children weighing over 50 pounds - 250 mg to 500 mg daily.

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Qualitest Pharmaceuticals

Griseofulvin Suspension | Qualitest Pharmaceuticals

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 tinea pedis, yeasts and bacteria may be involved as well as dermatophytes. Griseofulvin will not eradicate these associated bacterial or yeast infections.

ADULTS: 0.5 g daily (125 mg q.i.d., 250 mg b.i.d., or 500 mg/day). Patients with less severe or 300 extensive infections may require less, whereas those with widespread lesions may require a starting dose of 0.75 g to 1 g/day. This may be reduced gradually to 0.5 g or less after a response has been noted. In all cases, the dosage should be individualized.

PEDIATRIC PATIENTS (older than 2 years): A dosage of 10 mg/kg daily is usually adequate (pediatric patients from 30 to 50 lb, 125 mg to 250 mg daily; pediatric patients over 50 lb, 250 mg to 500 mg daily, in divided doses). Dosage should be individualized, as with adults. Clinical relapse will occur if the medication is not continued until the infecting organism is eradicated.

Safety is not established at higher doses than recommended.

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Actavis Mid Atlantic Llc

Griseofulvin Suspension | Actavis Mid Atlantic Llc

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 tinea pedis, yeasts and bacteria may be involved as well as dermatophytes. Griseofulvin will not eradicate these associated bacterial or yeast infections.

Adults: 0.5 g daily (125 mg four times a day, 250 mg twice a day, or 500 mg/day). Patients with less severe or 300 extensive infections may require less, whereas those with widespread lesions may require a starting dose of 0.75 g to 1.0 g/day. This may be reduced gradually to 0.5 g or less after a response has been noted. In all cases, the dosage should be individualized.

Pediatric patients (older than 2 years): A dosage of 10 mg/kg daily is usually adequate (pediatric patients from 30 to 50 lbs, 125 mg to 250 mg daily; pediatric patients over 50 lbs, 250 mg to 500 mg daily, in divided doses). Dosage should be individualized, as with adults. Clinical relapse will occur if the medication is not continued until the infecting organism is eradicated.

Safety is not established at higher doses than recommended.

No Recall
Teva Pharmaceuticals Usa Inc

Griseofulvin Suspension | Teva Pharmaceuticals Usa Inc

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 tinea pedis, yeasts and bacteria may be involved as well as dermatophytes. Griseofulvin will not eradicate these associated bacterial or yeast infections.

ADULTS: 0.5 g daily (125 mg q.i.d., 250 mg b.i.d., or 500 mg/day). Patients with less severe or 300 extensive infections may require less, whereas those with widespread lesions may require a starting dose of 0.75 g to 1 g/day. This may be reduced gradually to 0.5 g or less after a response has been noted. In all cases, the dosage should be individualized.

PEDIATRIC PATIENTS (older than 2 years): A dosage of 10 mg/kg daily is usually adequate (pediatric patients from 30 to 50 lb, 125 mg to 250 mg daily; pediatric patients over 50 lb, 250 mg to 500 mg daily, in divided doses). Dosage should be individualized, as with adults. Clinical relapse will occur if the medication is not continued until the infecting organism is eradicated.

Safety is not established at higher doses than recommended.

No Recall