Tranazole-100 capsules ( itraconazole)

TRANAZOLE 100 NAFDAC NO: A4 – 4081

COMPOSITION

Each hard gelatin capsules contains

ltraconazole BP 100mg

Excipients           Q.S

Pharmacological Classiification

Antifungal agent

Properties

Itraconazole has a half life of about 21 hours.

Bioavailability is maximally 55% when taken with a full meal.

 

Indications                                                                          Dosage

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.

 

Side effects.

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.

 

 

Interactions

-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.

 

PRESENTATION;

10 capsule in Alu-Alu blister pack.

 

STORAGE CONDITIONS

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.