Fulvicin (Griseofulvin)

FULVICIN® P/G

Schering

Griseofulvin (Ultramicrosize)

Antifungal Antibiotic

Indications And Clinical Uses: 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 susceptible strains of the following genera of fungi: T. rubrum, T. tonsurans, T. mentagrophytes, T. interdigitale, T. verrucosum, T. sulphureum, T. schoenleinii, T. megninii, T. gallinae, T. crateriform, M. audouini, M. canis, M. gypseum and E. floccosum.

Concomitant use of appropriate topical (keratolytic) agents is usually required.

Since other fungal diseases are not affected by Fulvicin P/G, careful mycological study with identification of the responsible organism is the only basis on which therapy can be selected accurately.

Fulvicin P/G is not effective in the following conditions: bacterial infections, candidiasis (moniliasis), histoplasmosis, actinomycosis, sporotrichosis, chromoblastomycosis, coccidioidomycosis, North American blastomycosis, cryptococcosis (torulosis), tinea versicolor, and nacardiosis.

Fulvicin P/G is not indicated in the prophylaxis of fungal infections.

Contra-Indications: Porphyria, hepatocellular failure, and individuals with a history of hypersensitivity to griseofulvin.

Pregnancy: Griseofulvin may have harmful effects on the genotype. For this reason, it is recommended to male persons who are treated with griseofulvin not to beget a child during the next 6 months after termination of the treatment. Female persons should not become pregnant during the treatment with griseofulvin.

Griseofulvin should not be administered during pregnancy.

Fulvicin P/G therapy is not indicated in minor infections that will respond to topical agents alone.

Manufacturers’ Warnings In Clinical States: Photosensitivity reactions may be associated with Fulvicin P/G therapy and patients should be warned to avoid exposure to intense, natural or artificial, sunlight. Should a photosensitivity reaction occur, lupus erythematosus may be aggravated.

Alcoholic beverages should be forbidden during treatment with Fulvicin P/G since griseofulvin may augment or potentiate the effects of alcohol which may lead to tachycardia and flush and can be the cause of more serious consequences.

Precautions: Patients on prolonged therapy should be under close observation, and periodic monitoring of organ system functions, including renal, hepatic, and hematopoietic, should be done.

Fulvicin P/G should be discontinued if granulocytopenia occurs.

Griseofulvin can potentiate an increase in hepatic enzymes that metabolize estrogens at an enhanced rate, including the estrogen component of oral contraceptives, thereby causing possible decreased contraceptive effects and menstrual irregularities.

As Fulvicin P/G has been shown to cause induction of liver metabolizing enzymes, the activity of oral anticoagulants may be reduced and dosage adjustment of the anticoagulant may be required during and after treatment.

Similarly, barbiturates, by inducing liver metabolizing enzymes, usually decrease griseofulvin plasma levels, and concomitant administration may require a dosage adjustment of Fulvicin P/G.

The possibility of cross sensitivity with penicillin exists since Fulvicin P/G is derived from species of Penicillium, however, known penicillin-sensitive patients have been treated with Fulvicin P/G without difficulty.

As with all antibiotics, the use of Fulvicin P/G may result in an overgrowth of nonsusceptible organisms, particularly monilia.

Adverse Reactions: CNS: headache (sometimes severe and usually disappears as therapy is continued or when drug is taken with meals), paresthesia of hands and feet, peripheral neuritis, lethargy, fever, mental confusion, impairment of performance of routine efforts, fatigue, syncope, vertigo, blurred vision, transient macular edema and augmentation of the effects of alcohol.

Gastrointestinal: Nausea, vomiting, diarrhea, heartburn, flatulence, dry mouth, oral thrush, thirst, angular stomatitis, glossodynia, black and furred tongue.

Hematological (which often disappear despite continuation of therapy): Leukopenia, neutropenia, punctate basophilia, monocytosis, granulocytopenia. Serum sickness syndromes develop rarely.

Renal: Albuminuria and cylinduria without evidence of renal insufficiency are common. Proteinuria is rare.

Allergic: Urticaria, photosensitivity, lichen planus, erythema, erythematous multiform-like rashes, vesicular and morbilliform eruptions, lupus erythematosus, and angioneurotic edema occur rarely.

Estrogen-like effects in children: In children, enlargement of the breast and hyperpigmentation of mammary areolae, nipple and external genitalia have been reported.

Other: Hepatotoxicity has been observed (see Contraindications). A moderate but inconsistent increase of fecal protoporphyrins has been noted when the drug is used for a long period of time.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: No toxicity has been reported even when taken in massive doses. Should toxicity occur, withdrawal of the drug is indicated.

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.

Adults: Daily administration of 1 x 330 mg. Fulvicin P/G Tablet(s) will provide a satisfactory response in most patients with tinea corporis, tinea cruris and tinea capitis. For those fungal infections that are most difficult to eradicate, such as tinea pedis and tinea unguium, a daily 660 mg dose is recommended.

Children 2 years of age and older: Approximately 5.5 mg/kg/day is an effective dose for most children. Medication must be continued until the infecting organism is completely eradicated. It is advisable to continue therapy for at least 2 weeks after all signs of infection have disappeared. General hygienic measures should be observed to control sources of infection or reinfection. Adjunctive therapy with keratolytic agents generally is indicated in areas of hyperkeratosis.

Duration of Therapy: Tinea capitis: 4 to 6 weeks. Tinea corporis: 2 to 4 weeks. Tinea pedis: 4 to 8 weeks. Tinea unguium: Depending on the rate of growth of: fingernails: at least 4 months; toenails: at least 6 months.

Availability And Storage: Each tablet contains: ultramicrosize griseofulvin 330 mg. Nonmedicinal ingredients: cornstarch, lactose, magnesium stearate, polyethylene glycol 8 000 and sodium lauryl sulfate. Tartrazine-free. Bottles of 100. Store between 2 and 30°C.

FULVICIN® P/G Schering Griseofulvin (Ultramicrosize) Antifungal Antibiotic

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