CRIXIVAN Hard capsule Ref.[8780] Active ingredients: Indinavir

CRIXIVAN should be administered by physicians who are experienced in the treatment of HIV infection. On the basis of current pharmacodynamic data, indinavir must be used in combination with other antiretroviral agents. When indinavir is administered as monotherapy resistant viruses rapidly emerge (see section 5.1).

Posology

The recommended dose of indinavir is 800 mg orally every 8 hours.

Data from published studies suggest that CRIXIVAN 400 mg in combination with ritonavir 100 mg, both administered orally twice daily, may be an alternative dosing regimen. The suggestion is based on limited published data (see section 5.2).

A dose reduction of indinavir to 600 mg every 8 hours should be considered when administering itraconazole or ketoconazole concurrently (see section 4.5).

Special populations

Hepatic impairment

In patients with mild-to-moderate hepatic impairment due to cirrhosis, the dose of indinavir should be reduced to 600 mg every 8 hours. The recommendation is based on limited pharmacokinetic data (see section 5.2). Patients with severe hepatic impairment have not been studied; therefore, no dosing recommendations can be made (see section 4.4).

Renal impairment

Safety in patients with impaired renal function has not been studied; however, less than 20% of indinavir is excreted in the urine as unchanged medicinal product or metabolites (see section 4.4).

Paediatric population

The safety and efficacy of CRIXIVAN in children under the age of 4 years have not been established (see sections 5.1 and 5.2). Currently available data in children above the age of 4 years are described in sections 4.8, 5.1, and 5.2.

Method of administration

The hard capsules should be swallowed whole.

Since CRIXIVAN must be taken at intervals of 8 hours, a schedule convenient for the patient should be developed. For optimal absorption, CRIXIVAN should be administered without food but with water 1 hour before or 2 hours after a meal. Alternatively, CRIXIVAN may be administered with a low-fat, light meal.

If co-administered with ritonavir, CRIXIVAN may be administered with or without food

To ensure adequate hydration, it is recommended that adults drink at least 1.5 litres of liquids during the course of 24 hours.

There have been reports of human overdose with CRIXIVAN. The most commonly reported symptoms were gastro-intestinal (e.g., nausea, vomiting, diarrhoea) and renal (e.g., nephrolithiasis, flank pain, haematuria).

It is not known whether indinavir is dialyzable by peritoneal or haemodialysis.

Shelf life: 3 years for HDPE bottles containing 90 and 180 hard capsules.

Store in the original bottle. Keep the bottle tightly closed in order to protect from moisture.

HDPE bottles with a polypropylene cap and a foil induction cap containing 90 or 180 capsules.

Not all pack sizes may be marketed.

The bottles contain desiccant canisters that should remain in the container. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.