• Zotepine is an atypical antipsychotic drug (second generation drug with fewer side effects compared to the first generation antipsychotic drugs) which is used to treat psychosis.
Zotepine is an antipsychotic drug which is used to treat acute (sudden onset) and chronic (long-term) schizophrenia, a mental illness where the person’s ability to think and feel as well as behavior is affected.
Although zotepine shows positive results in various clinical trials for the treatment of mania, it is primarily used to treat schizophrenia.
Zotepine should not be used in:
• Breastfeeding mothers as it may pass through breast milk and harm the baby. Also, it should not be taken in pregnancy particularly in the third trimester as the newborn may suffer from abnormal muscle movements and breathing difficulties.
• Patients with a history of seizures in self or family.
• Patients with prolonged QT interval, a type of ECG abnormality.
• Patients who take sibutramine for treating obesity. Sibutramine is currently banned in most countries.
• Children under 18 years of age.
• Patients allergic to zotepine.
• Patients with acute gout or a history of kidney stones.
• Elderly patients with dementia.
• Patients taking other CNS depressants like alcohol.
For the treatment of schizophrenia:
• The dose should be initially started with 25mg three times daily.
• The dosage can be increased accordingly as per physician advice, however, the maximum dose should not exceed 100mg thrice daily or 75mg thrice a day in the elderly.
Zotepine comes as a tablet to be taken by mouth with food or on an empty stomach.
• Treatment with zotepine should be stopped immediately if the patient develops neuroleptic malignant syndrome, a life-threatening reaction that occurs with the use of the antipsychotic medicines.
• Weight should be monitored especially in patients with diabetes or high cholesterol as zotepine treatment results in weight gain.
• Alcohol leads to additive effects and patients on zotepine treatment should avoid taking alcohol.
• Caution is required in patients with liver or kidney damage and dosage adjustments must be made accordingly.
• Caution is also required in patients with angina or other heart disease, severe hypertension, prostate enlargement, urinary retention, angle-closure glaucoma, paralytic ileus, parkinson's disease or tumors of the adrenal medulla.
• Gastrointestinal: Diarrhea, dyspepsia, constipation, dry mouth
• Central Nervous System: Anxiety, depression, agitation, headache, insomnia, fluctuations in body temperature, drowsiness, seizures and hyperprolactinemia
• Cardiovascular: Increased heartbeat, decreased blood pressure, heart rhythm abnormalities
• Eye: Blurred vision, angle-closure glaucoma (eye disease that results in optic nerve damage or vision loss induced by raised pressure in the eye)
• Others: Movement disorders like tardive dyskinesia, neuroleptic malignant syndrome, increased liver function tests, weight gain, sweating, abnormal blood cell counts, weakness
• Elderly patients should monitor blood pressure before starting zotepine treatment and for the first few weeks of treatment.
• ECG, electrolytes levels, complete blood cell count and liver function tests have to be monitored at regular intervals.
• Rapid discontinuation of zotepine is not advised as it leads to rebound psychosis and hence the drug requires gradual decreasing of dose.
• Zotepine may increase the risk of seizures when used along with phenothiazine group drugs such as chlorpromazine.
• The effects of levodopa are decreased with zotepine.
• Plasma concentrations of zotepine are increased by diazepam and fluoxetine resulting in accumulation of zotepine in blood.
• Concomitant administration of zotepine with phenytoin could result in raised plasma levels of phenytoin.
• Abnormal heart rhythm or cardiac arrest could occur if zotepine is administered with other drugs that prolong QT interval (e.g. quinidine or amiodarone) or those that reduce blood potassium levels (e.g. diuretics like furosemide) or those that could increase the blood levels of zotepine (e.g. fluvoxamine).
• Zotepine should be avoided with alcohol or other CNS depressants like sedatives due to additional CNS depression.
• Zotepine can increase the antimuscarinic effects of drugs like scopolamine resulting in symptoms of dry mouth, blurring of vision, constipation and urinary retention.
• Additional fall in blood pressure may occur when taken with antihypertensive drugs.
• To be stored at room temperature away from excess temperature.
• Keep out of reach of the children.
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