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CLOPIXOL DEPOT Injection

COMPOSITION:
CLOPIXOL DEPOT Injection is a 200 mg/mL sterile solution of
zuclopenthixol decanoate intended for intramuscular injection.

PHARMACOLOGICAL ACTION:
CLOPIXOL DEPOT acts as a combined absorption and conversion depot. Absorption depots retain the active substance, releasing it gradually. In conversion depots the active substance is made available as a derivative which is slowly converted to the active substance. By the esterification of zuclopenthixol with decanoic acid, zuclopenthixol has been converted into a highly lipophilic substance, zuclopenthixol decanoate. When dissolved in oil and injected intramuscularly this substance diffuses slowly into the surrounding aqueous tissue fluids, where it undergoes enzymatic breakdown into the active component zuclopenthixol and decanoic acid.
Zuclopenthixol is a neuroleptic of the thioxanthene group.
It is relatively short-acting whereas CLOPIXOL DEPOT - the decanoic acid ester of zuclopenthixol - has a considerably prolonged action.
According to pharmacological and pharmacokinetic animal experiments the effect of CLOPIXOL DEPOT lasts for 10 days to 3 weeks after intramuscular injection, except for the cataleptogenic action which is rather weak and of appreciably shorter duration. Significant serum levels of zuclopenthixol are maintained throughout the dosage interval.

INDICATIONS:
Maintenance treatment of schizophrenia including agitation, psychomotor disturbances, hostility, suspiciousness, aggression and affective reactions.

CONTRA-INDICATIONS:
Acute alcohol, barbiturate and opiate poisoning. CLOPIXOL DEPOT should (preferably) not be administered to pregnant patients. Patients suffering from or with a history of hepatic disease.

WARNINGS:
Patients on long-term therapy should be watched carefully. CLOPIXOL DEPOT should be used with caution in patients with convulsive disorders or advanced hepatic, renal or cardiovascular disease. Alcohol tolerance and the ability to drive motor vehicles and operate machines may be affected. Therefore, caution should be exerted initially, until the individual reaction to the treatment is known.
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