Progil 200 mg/5 ml

INDICATIONS

Voriconazole is an azole antifungal medicine. It is indicated for use in patients 12 years of age and older in the treatment of following fungal infections-

Invasive aspergillosis
Candidemia (nonneutropenic) and disseminated candidiasis in skin, abdomen, kidney, bladder wall and wounds
Esophageal candidiasis
Serious infections caused by Scedosporium apiospermum and Fusarium Species including Fusarium solani
Patients intolerant of, or refractory to other therapy.

PHARMACOLOGY

Voriconazole is a triazole antifungal medication used to treat serious fungal infections. Voriconazole binds and inhibits ergosterol synthesis by inhibiting CYP450-dependent 14-alpha sterol demethylase. The inhibition of 14-alpha sterol demethylase results in a depletion of ergosterol in fungal cell membrane.

DOSAGE & ADMINISTRATION

Oral-Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal

At or over 40 kg body weight: Loading dose regimen is 400 mg or 10 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 200 mg or 5 ml twice daily.
Below 40 Kg body weight: Loading dose regimen is 200 mg or 5 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 100 mg or 2.5 ml twice daily. Or, as directed by the registered physician.

Injection-Invasive Aspergillosisd :

Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
Maintenance Dose: 4 mg/kg 12 hourly.

Candidemia in nonneutropenic patients and other deep tissue Candida infections:

Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
Maintenance Dose: 3-4 mg/kg 12 hourly.

Scedosporiosis and Fusariosis:

Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
Maintenance Dose: 4 mg/kg 12 hourly.

INTERACTION

CYP3A4, CYP2C9 and CYP2C19 inhibitors and inducers: Adjust Voriconazole dosage and monitor for adverse reactions or lack of efficacy
Voriconazole may increase the concentrations and activity of drugs that are CYP3A4, CYP2C9 and CYP2C19 substrates. Reduce doses of these other drugs and monitor for adverse reactions
Increase maintenance oral and intravenous dosage of Voriconazole with co-administration of Phenytoin or Efavirenz

SIDE EFFECTS

The most common side effects are abdominal pain, anemia, blurred vision, headache, chest pain, nausea and diarrhea.

PREGNANCY & LACTATION

There are no adequate and well-controlled studies in pregnant woman. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

PRECAUTIONS & WARNINGS

Long term exposure (treatment or prophylaxis) greater than 180 days requires careful assessment of the benefit-risk balance. Squamous cell carcinoma of the skin (SCC) has been reported in relation with long-term voriconazole treatment.

USE IN SPECIAL POPULATIONS

The efficacy to the children under 12 years of age is not established.

THERAPEUTIC CLASS

Other Antifungal preparations

STORAGE CONDITIONS

Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light. Store Voriconazole powder for suspension between 2° to 8°C temperature.