ANDROCUR Tablet / Solution for injection Ref.[50194] Active ingredients: Cyproterone

4.1 Dosing Considerations

Patients with Hepatic Impairment

The use of ANDROCUR is contraindicated in patients with liver diseases and/or with hepatic dysfunction.

Patients with Renal Impairment

A pharmacokinetic study in patients with renal impairment has not been conducted. As 33% of cyproterone acetate is excreted via the kidney, caution should be taken when ANDROCUR is administered in this patient population.

4.2 Recommended Dose and Dosage Adjustment

Oral Tablets: The usual daily initial and maintenance dose of ANDROCUR (cyproterone acetate) is 4 to 6 tablets (200-300 mg) divided into 2 to 3 doses and taken with some liquid after meals.

The maximum daily dose is 300 mg. After orchiectomy, a lower daily dose of 2 to 4 tablets (100-200 mg) is recommended.

Injectable: The usual initial and maintenance dose of ANDROCUR DEPOT is one weekly intramuscular injection of 3 mL (300 mg). For orchiectomized patients, the recommended dose is one intramuscular injection of 3 mL (300 mg) every two weeks.

ANDROCUR or ANDROCUR DEPOT therapy should not be interrupted nor the dosage reduced after remission or improvement occurs.

Because of their pharmacokinetic properties, ANDROCUR (oral) and ANDROCUR DEPOT (IM) can be interchanged in the course of long-term treatment. The dosage may be reduced if side effects are intolerable, but should be kept within the oral range of 2 to 6 tablets daily (100-300 mg) or intramuscular injections of 300 mg at weekly intervals, or every two weeks.

Health Canada has not authorized an indication for pediatric use.

4.3 Reconstitution

This information is not available.

4.4 Administration

ANDROCUR DEPOT is strictly for intramuscular injection. The injections must be administered very slowly. Special care must be given to avoid intravascular injection (see 7. WARNINGS AND PRECAUTIONS).

There have been no reports of fatal overdosage in man with ANDROCUR (cyproterone acetate). There are no specific antidotes and treatment should be symptomatic. If oral overdosage is discovered within two to three hours, gastric lavage can safely be used if indicated.

For management of a suspected drug overdose, contact your regional poison control centre.

This information is not available for this drug product.