Indications of Sperid 4 mg

Sperid 4 mg tablet is indicated for the treatment of acute and chronic schizophrenic psychoses, and other psychotic conditions, in which positive symptoms (such as hallucinations, delusions, thought disturbances, hostility, suspiciousness), and/or negative symptoms (such as blunted affect, emotional and social withdrawal, poverty of speech) are prominent. Sperid 4 mg also alleviate affective symptoms (such as depression, guilt feelings, anxiety) associated with schizophrenia. Sperid 4 mg is also effective inmaintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Sperid 4 mg is in dicated for the treatment of mania in bipolar disorder.

Theropeutic Class

Atypical neuroleptic drugs

Pharmacology

Sperid 4 mg is a selective monoaminergic antagonist having a high affinity for serotoninergic 5-HT2 and dopaminergic D2 receptors. Sperid 4 mg binds also to alpha1 adrenergic receptors and with lower affinity, to H1 histamine and alpha2 adrenergic receptors. Sperid 4 mg has no affinity for cholinergic receptors. Sperid 4 mg, as a potent D2 antagonist, improves the positive symptoms of schizophrenia but causes less depression of motor activity. Balanced central serotonin and dopamine antagonism may reduce extrapyramidal side effect liability and extend the therapeutic activity to the negative and affective symptoms of schizophrenia.

Dosage and Administration of Sperid 4 mg

Psychoses: 2 mg in 1-2 divided doses on 1st day then 4 mg in 1-2 divided doses on second day (Slower titration appropriate in some patients); usual dose range 4-6 mg daily; doses above 10 mg daily only if benefit considered to outweigh risk (max. 16 mg daily). Elderly (or in hepatic or renal impairment) initially 1 mg daily in two divided doses increased in steps of 1-2 mg twice daily. Child under 15 years not recommended.Mania: Initially 2 mg once daily increased if necessary in step of 1 mg daily; usual dose range 1-6 mg daily; Elderly (or in hepatic or renal impairment) initially 1 mg daily in two divided doses increased in steps of 1-2 mg twice daily.Schizophrenia: Sperid 4 mg should be generally administered at 1 mg BID initially, with increases in increments of 1 mg BID on the second and third day, as tolerated, to a target dose of 3 mg BID by the third day. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 1 week. When dosage adjustments are necessary, small dose increments or decrements of 1-2 mg are recommended.

Interaction of Sperid 4 mg

Sperid 4 mg May antagonize the effects of levodopa and dopamine agonists. Chronic administration with Carbamazepine reduces plasma clearance of Sperid 4 mg. Chronic administration with Clozapine may decrease the clearance of Sperid 4 mg. Sperid 4 mg may enhance the effects of certain antihypertensives.

Contraindications

Sperid 4 mg is contraindicated in patients with a known hypersensitivity to the product.

Side Effects of Sperid 4 mg

Insomnia, agitation, anxiety, headache, less commonly drowsiness, impaired concentration, fatigue, blurred vision, constipation, nausea and vomiting, dyspepsia, abdominal pain, hyperprolactinaemia, urine incontinence, tachycardia, hypertension, edema, rash, rhinitis, cerebrovascular accident, neurtropenia and thrombocytopenia have been reported.

Pregnancy and Lactation

Pregnancy: Although, in experimental animals, Sperid 4 mg did not show direct reproductive toxicity, some indirect, prolactin- and CNS-mediated effects were observed, No teratogenicity effect of Sperid 4 mg was noted in any study. The safety of Sperid 4 mg for use during human pregnancy has not been established.Lactation: In animal studies, Sperid 4 mg and 9-hydroxySperid 4 mg are excreted in the milk. It has been demonstrated that Sperid 4 mg and 9-hydroxySperid 4 mg are also excreted in human breast milk. Therefore, women receiving Sperid 4 mg should not breast feed.

Precautions and Warnings

Special precaution should be taken in case of preexisting cardiovascular diseases, discontinue use if signs and symptoms of tardive dyskinesia occur, renal and hepatic impairment, elderly epilepsy, Parkinson's disease and in pregnancy.

Overdose Effects of Sperid 4 mg

Drowsiness, sedation, tachycardia, hypotension, and extrapyramidal symptoms may occur. In case of severe extrapyramidal symptoms, anticholinergic medication should be administered. Close medical supervision and monitoring should continue until the patient recovers. There is no specific antidote to Sperid 4 mg.

Storage Conditions

Store in a cool and dry place, protected from light.