Tranazole-100 capsules ( itraconazole)
TRANAZOLE 100 NAFDAC NO: A4 – 4081
Each hard gelatin capsules contains
ltraconazole BP 100mg
Itraconazole has a half life of about 21 hours.
Bioavailability is maximally 55% when taken with a full meal.
Vulvovaginal Candidiasis 200mg twice daily for 1day
Oral Candidiasis 100mg daily for 15days
200mg daily for 7 days
Dermatomycosis 100mg daily for 15days
Tinea pedis and Tinea manuun 100mg daily for 30days
200mg twice daily for 7days
Fungal Keratitis 200mg daily for 21days
Onychomycosis 200mg daily for 3months.
Gastrointestinal disorders: abdominal pain, vomiting, dyspepsia
Nervous system disorder: Peripheral neuropathy, dizziness, headache
Skin disorders: hypersensitivity reaction e.g. puritis, rash.
Metabolism and Nutrition Disorders: Hypokalemia.
-Enzyme-inducing drugs such as rifampicin,carbamazepine significantly reduce the bioavailability of itraconazole.
-Severe hypoglycemia has been reported in patients concomitantly receiving azole antifungal agents and oral hypoglycemic agents such as tolbutamide,glipizide,chlopropamide.
-Itraconazole can inhibit the metabolism of calcium channel blockers therefore caution should be used when co administering them.
CONTRAINDICATION – Pregnancy and lactation
-Hypersensitivity to itraconazole or any of its components.
-Itraconazole should not be used in patients with congestive heart failure(CHF) or with a history of CHF unless the benefits clearly outweighs the risk.
10 capsule in Alu-Alu blister pack.
Store below 25c in a dry place
Protect from light.
Keep out of reach of children.
ADVICE TO PATIENTS
– Administer capsule whole after a full meal to ensure absorption.
-Advice patients that prolonged treatment may be needed to control infection and prevent relapse, even if symptoms abate in first few days of therapy.
-In Patients with achlorhydria,it is advisable to administer Tranazole capsules with a cola beverage.