Fulvicin U/F (Griseofulvin)

FULVICINĀ® U/F

Schering

Griseofulvin (Microsize)

Antifungal Antibiotic

Indications And Clinical Uses: Orally effective against superficial infections caused by those fungi responsible for dermatomycoses in man and animals, namely: M. canis, M. gypseum, M. audouini, E. floccosum, T. tonsurans, T. rubrum, T. mentagrophytes, T. megninii, T. gallinae, T. verrucosum, T. sulfureum, T. interdigitale, T. schoenleinii, T. crateriform. Griseofulvin is inactive against: C. albicans (monilia), C. neoformans, B. dermatitidis, A. israelii, H. capsulatum, C. immitis, M. furfur (tinea versicolor) and bacteria. The drug is useful in the treatment of fungal infections of the scalp and those of the glabrous skin. The drug is less effective in chronic infections of the feet, palms, and nails. Since these chronic fungal infections tend to cause hyperkeratosis, concomitant topical keratolytic therapy is almost always necessary.

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.

Manufacturers’ Warnings In Clinical States: Alcoholic beverages should be forbidden during treatment with Fulvicin U/F 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: As with all antibiotics, the use of this drug may result in an overgrowth of nonsusceptible organisms, particularly monilia. Periodic blood cell counts should be done during griseofulvin therapy, and its administration should be discontinued if granulocytopenia occurs. Albuminuria and hyaline casts have been associated with the use of griseofulvin, but renal function tests have revealed no impairment. The urine of patients on prolonged therapy should be examined for porphobilinogen. Since griseofulvin is derived from a species of penicillin, the possibility of cross sensitivity with penicillin exists, however known penicillin sensitive patients have been treated without difficulty.

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 griseofulvin may alter prothrombin activity in some patients, it is recommended that prothrombin times be determined at least 2 or 3 times a week with patients on anticoagulant therapy if griseofulvin is added to the regimen.

Concomitant administration of phenobarbital and griseofulvin may result in reduced blood levels of griseofulvin due to the enzymatic acceleration of griseofulvin metabolism. During therapy with griseofulvin, patients should be advised to avoid exposure to intense natural or artificial sunlight.

Adverse Reactions: Severe reactions occur infrequently. Headache may occur, but usually disappears when the drug is taken with meals. Nausea, epigastric distress, heartburn, abdominal cramps, vomiting or diarrhea have been reported in a few patients. Chest pain, dryness of the mouth, breathlessness, arthralgia, neuritic pains, vertigo, and fever have also been reported. Allergic reactions, occurring rarely, include urticaria and angioneurotic edema, serum sickness, lupus erythematosus. Fatigue, lethargy, vertigo, decreased mental acuity, and secondary monilial skin infections have been reported as well as a few cases of photosensitivity. Proteinuria and leukopenia have been reported rarely. If granulocytopenia occurs, the administration of the drug should be discontinued. In children receiving griseofulvin, enlargement of the breast and hyperpigmentation of mammary areolae, nipples and external genitalia have been reported. tag_DosageDosage

Dosage: Dosage must be individualized. Adults: 500 mg daily (125 mg 4 times a day or 250 mg twice daily). Children: A dosage of 10 mg/kg is usually adequate (children from 14 to 23 kg, 125 to 250 mg daily; children over 23 kg, 250 to 500 mg, in divided doses). Patients with less severe infections may require less, whereas those with widespread lesions may require a starting dose of 0.75 to 1 g per day.

Availability And Storage: Each white, scored tablet contains: ultra fine griseofulvin USP 250 mg or 500 mg. Nonmedicinal ingredients: 250 mg: cornstarch, magnesium stearate and polysorbate 80. 500 mg: colloidal silicon dioxide, cornstarch, magnesium stearate and pluronic F-68. Tartrazine-free. Bottles of 100.

FULVICINĀ® U/F Schering Griseofulvin (Microsize) Antifungal Antibiotic

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