PROCARBAZINE Capsule Ref.[8648] Active ingredients: Ibenzmethyzine

In combination chemotherapeutic regimens

Procarbazine is usually administered concomitantly with other appropriate cytostatic drugs in repeated four- to six-weekly cycles. In most such combination chemotherapy regimens currently in use (eg. the so-called MOPP schedule with mustine, Vincristine and Prednisone) Procarbazine is given daily on the first 10 – 14 days of each cycle in a dosage of 100mg per sq. metre of body surface (to nearest 50mg).

As sole therapeutic agent

Adults

Treatment should begin with small doses which are increased gradually up to a maximum daily dose of 250 or 300mg divided as evenly as possible throughout the day.

Initial dosage scheme:

1^st day: 50mg

2^nd day: 100mg

3^rd day: 150mg

4^th day: 200mg

5^th day: 250mg

6^th day et seq: 250-300mg

Further procedure: Treatment should be continued with 250 or 300mg daily until the greatest possible remission has been obtained, after which a maintenance dose is given.

Maintenance dose: 50-150mg daily. Treatment should be continued until a total dose of at least 6g has been given. Otherwise, a negative result is not significant.

Elderly

Procarbazine should be used with caution in the elderly. Patients in this group should be observed very closely for signs of early failure or intolerance of treatment.

Children

The pro m² dose used in most published trials was analogous to the dose used in adults (100 mg/m² for up to 14 days).

The dose should be adjusted according to:

• The chemotherapy protocol used
• The functional state of the bone marrow
• Previous chemo- and radiotherapy cycles
• The myelosuppressive effect of other cytostatics used

The treatment and the maintenance doses of Procarbazine should be determined only by a physician experienced in the use of potent antineoplastic drugs in children.

Procarbazine capsules are for oral administration.

Signs of overdosage include severe nausea and vomiting, dizziness, hallucinations, depression and convulsions; hypotension or tachycardia may occur.

The benefit of gastric decontamination is uncertain. Consider activated charcoal if the patient presents within 1 hour of ingestion of any amount (because of risk of myelosuppression at all doses).

General supportive treatment should be performed, with prophylactic treatment against possible infection, and frequent blood counts weekly for at least 3 weeks, or more frequently if unwell or clinically symptomatic from myelosuppression (evidence of bleeding or infection).

Consider further haematological monitoring after 3 weeks only if white cells and platelets not recovering (discuss with haematologist/oncologist).

Three years.

Store in a dry place. Do not store above 25°C.

Blister packs of 50 capsules.

Handling guidelines

Undamaged capsules present minimal risk of contamination, but in accordance with good hygiene requirements, direct handling should be avoided. As with all cytotoxics, precautions should be taken to avoid exposing staff during pregnancy.

Urine produced for up to 48 hours after a dose of procarbazine should be handled wearing protective clothing.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.