Griso Ultra

Ultramicrosize is indicated for the treatment of the following tinea infections;

• tinea corporis
• onychomycosis
• tinea pedis
• tinea cruris
• tinea barbae

tinea capitis etc.

Griseofulvin is an orally active antibiotic derived from a species of Penicillium which is used to treat tinea infections. Griseofulvin has a fungistatic effect by its ability to disrupt the mitotic spindle structure of the fungal cell which arrests metaphase in cell division. After oral administration, griseofulvin is deposited in the keratin precursor cells and has a greater affinity for diseased tissue. The drug is tightly bound to the new keratin which becomes highly resistant to fungal invasions. The efficiency of gastrointestinal absorption of ultramicrocrystalline griseofulvin is approximately one and one-half times that of the conventional microsize griseofulvin. This factor permits the oral intake of two-thirds as much ultramicrocrystalline griseofulvin as the microsize form. However, there is currently no evidence that this lower dose confers any significant clinical differences with regard to safety and/or efficacy.

Tinea Capitis: 375 mg (as a single dose or in divided doses) 4 to 6 weeks. Tinea corporis: 375 mg (as a single dose or in divided doses) 2 to 4 weeks Tinea cruris: 375 mg (as a single dose or in divided doses) Tinea pedis: 375 mg (as a single dose or in divided doses) 4 to 8 weeks Fingernails onychomycosis: divided dose of 750 mg at least 4 months Toenail onychomycosis: divided dose of 750 mg at least 6 months Pediatric Use: Approximately 7.3 mg per kg of body weight per day of ultramicrosize griseofulvin is an effective dose for most pediatric patients. On this basis, the following dosage schedule is suggested:

16-27 kg: 125 mg to 187.5 mg daily.

over 27 kg: 187.5 mg to 375 mg daily.

Children and infants 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.

There have been reports in the literature of possible interactions between Griso Ultra and oral contraceptives. The effect of alcohol may be potentiated by Griso Ultra, producing such effects as tachycardia and flush.

This drug is contraindicated in patients with porphyria or hepatocellular failure and in individuals with a history of hypersensitivity to griseofulvin.

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.

Griseofulvin should not be prescribed to pregnant patients. If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Patients on prolonged therapy with any potent medication should be under close observation. Periodic monitoring of organ system function, including renal, hepatic and hematopoietic, should be done. Since Griso Ultra is derived from species of Penicillium, 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 Griso Ultra therapy, patients should be warned to avoid exposure to intense natural or artificial sunlight. Lupus erythematosus or lupus-like syndromes have been reported in patients receiving Griso Ultra. Griso Ultra decreases the activity of warfarin-type anticoagulants so that patients receiving these drugs concomitantly may require dosage adjustment of the anticoagulant during and after Griso Ultra therapy. Barbiturates usually depress Griso Ultra activity and concomitant administration may require a dosage adjustment of the antifungal agent.

Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light.