Drug Class Description
Antineoplastic agents (MAOIs).

Generic Name
Generic

Drug Description
Each capsule contains 58.3mg Procarbazine hydrochloride (equivalent to 50mg of Procarbazine).

Presentation
Capsules with white opaque cap and body. Marked 'CL 50' on cap.

Indications
The main indication is Hodgkin's disease (lymphadenoma).Procarbazine may also be useful in other advanced lymphomata and a variety of solid tumours which have proved resistant to other forms of therapy.

Adult Dosage
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 scheme1st day:50mg4th day:200mg2nd day:100mg5th day:250mg3rd day:150mg6th day et seq:250-300mgFurther 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 Dosage
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.

Contra Indications
Pre-existing severe leucopenia or thrombocytopenia from any cause; severe hepatic or renal damage.Procarbazine should not be used in the management of non-malignant disease.Procarbazine is contraindicated during breast-feeding.Hypersensitivity to the active substance (Procarbazine) or to any of the excipients.

Special Precautions
Procarbazine should be given only under the supervision of a physician who is experienced in cancer chemotherapy and having facilities for regular monitoring of clinical and haematological effects during and after administration.Introduction of therapy should only be effected under hospital conditions.Caution is advisable in patients with hepatic or renal dysfunction and Procarbazine should be avoided in patients with severe hepatic or renal disease. Its use should be avoided if creatinine clearance is less than 10mL/min. Caution is also advised in cardiovascular or cerebrovascular disease, phaeochromocytoma, or epilepsy.Regular blood counts are of great importance. If during the initial treatment the total white cell count falls to 3,000 per mm3or the platelet count to 80,000 per mm3, treatment should be suspended temporarily until the leucocyte and/or platelet levels recover, when therapy with the maintenance dose may be resumed.Treatment should be interrupted on the appearance of allergic skin reactions.Procarbazine has been shown to be carcinogenic in animals. The increased risk of carcinogenicity in man should be borne in mind when long-term management of patients is proposed.

Interactions
Procarbazine is a weak MAO inhibitor and therefore interactions with certain foodstuffs and drugs, although very rare, must be borne in mind. Thus, owing to possible potentiation of the effect of barbiturates, narcotic analgesics (especially Pethidine), drugs with anticholinergic effects (including phenothiazine derivatives and tricyclic antidepressants), other central nervous system depressants (including anaesthetic agents) and anti-hypertensive agents, these drugs should be given concurrently with caution and in low doses.Cytotoxics may reduce the absorption of phenytoin and cardiac glycosides.Concomitant use of clozapine may increase the risk of agranulocytosis. Use with enzyme-inducing antiepileptics is associated with an increased risk of hypersensitivity reactions to procarbazine.Intolerance to alcohol (Disulfiram-like reaction) may occur.

Adverse Reactions
Loss of appetite and nausea occur in most cases, sometimes with vomiting. These symptoms are usually confined to the first few days of treatment and then tend to disappear.Procarbazine causes leucopenia and thrombocytopenia. These haematological changes are almost always reversible and seldom require complete cessation of therapy.

Manufacturer
Cambridge Laboratories

Drug Availability
(POM)

Updated
11 November 2011