Psychotherapeutic- unti-Psychotic

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    Clozapine 100 mg

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Mechanism Of Action CLOZAPINE KANAWATI (Clozapine) is classified as an 'atypical' antipsychotic drug because its profile of binding to dopamine receptors and its effects on various dopamine mediated behaviors differ from those exhibited by more typical antipsychotic drug products. In particular, although CLOZAPINE KANAWATI (Clozapine) does interfere with the binding of dopamine at D1, D2, D3 and D5 receptors, and has a high affinity for the D4 receptor, it does not induce catalepsy nor inhibit apomorphine-induced stereotypy. CLOZAPINE KANAWATI (Clozapine) also acts as an antagonist at adrenergic, cholinergic, histaminergic and serotonergic receptors.
INDICATIONS Treatment-Resistant Schizophrenia: CLOZAPINE KANAWATI (Clozapine) is indicated for the management of severely ill schizophrenic patients who fail to respond adequately to standard drug treatment for schizophrenia. Because of the significant risk of agranulocytosis and seizure associated with its use, CLOZAPINE KANAWATI should be used only in patients who have failed to respond adequately to treatment with appropriate courses of standard drug treatments for schizophrenia, either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those drugs. Because of the significant risk of agranulocytosis and seizure, events which both present a continuing risk over time, the extended treatment of patients failing to show an acceptable level of clinical response should ordinarily be avoided. In addition, the need for continuing treatment in patients exhibiting beneficial clinical responses should be periodically re-evaluated. Reduction in the Risk of Recurrent Suicidal Behavior in Schizophrenia or Schizoaffective Disorders: CLOZAPINE KANAWATI is indicated for reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior, based on history and recent clinical state. Suicidal behavior refers to actions by a patient that puts him/herself at risk for death.
CONTRAINDICATIONS CLOZAPINE KANAWATI (Clozapine) is contraindicated in patients with a previous hypersensitivity to Clozapine or any other component of this drug, in patients with myeloproliferative disorders, uncontrolled epilepsy, or a history of Clozapine-induced agranulocytosis or severe granulocytopenia. As with more typical antipsychotic drugs, CLOZAPINE KANAWATI is contraindicated in severe central nervous system depression or comatose states from any cause. CLOZAPINE KANAWATI should not be used simultaneously with other agents having a well-known potential to cause agranulocytosis or otherwise suppress bone marrow function.
Side EFFECTS Drooling, drowsiness, dizziness, headache, shaking (tremor), vision problems (e.g., blurred vision) and constipation may occur. Many of these effects (especially drowsiness) lessen as your body gets used to the medication. Tell your doctor immediately if any of these unlikely but serious side effects occur: facial/muscle twitching, signs of infection (e.g., severe tiredness, fever, persistent sore throat), seizures, uncontrollable movements, change in the amount of urine. Seek immediate medical attention if any of these rare but very serious side effects occur: high fever, fast/irregular heartbeat, muscle stiffness, mental/mood changes, difficulty breathing with exercise, swollen legs/feet, sudden weakness, pain/redness/swelling of the arms/legs, chest pain, dark urine, persistent nausea/vomiting, stomach/abdominal pain, yellowing of eyes/skin. A very serious allergic reaction to this drug is unlikely to occur, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing.
WARNINGS This drug may make you dizzy or drowsy or cause blurred vision; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages. Clozapine can cause a big drop in blood pressure, which can make you dizzy or cause you to faint when you stand up. Be sure to get up slowly while taking this medication. This is more likely to occur when your dose of Clozapine is increased or if you are also taking a benzodiazepine (e.g., clonazepam, lorazepam, diazepam). Before having surgery, tell your doctor or dentist that you are using this medication. This drug may infrequently make your blood sugar level rise, causing or worsening diabetes. Tell your doctor immediately if you develop symptoms of high blood sugar, such as increased thirst or urination. If you already have diabetes, be sure to check your blood sugar regularly. This drug may also cause significant weight gain. These effects, along with diabetes, may increase your risk for developing heart disease. This medication can cause a serious immune system problem called agranulocytosis (low white blood cells). To make sure you have enough white blood cells, you will need to have a blood test before you begin taking Clozapine and then have your blood tested regularly during your treatment. Clozapine can also cause seizures, especially in higher doses. Let your doctor know if you have ever had seizures. While taking this medication, avoid driving or other activities during which a sudden loss of consciousness could be dangerous (e.g., operating heavy machinery, swimming). This medication may rarely cause an inflammation of the heart muscle (myocarditis). Seek immediate medical attention if you have weakness, difficult/rapid breathing, chest pain, or swelling of the ankles/legs. Your risk is highest in the first month of treatment. There have been several reported cases of Neuroleptic Malignant Syndrome NMS in patients receiving Clozapine alone or in combination with lithium or other CNS-active agents. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmias). If signs and symptoms of tardive dyskinesia appear in a patient on Clozapine, drug discontinuation should be considered. However, some patients may require treatment with Clozapine despite the presence of the syndrome. During Clozapine therapy, patients may experience transient temperature elevations above 100.4°F (38°C), with the peak incidence within the first 3 weeks of treatment. On occasion, there may be an associated increase or decrease in WBC count. Patients with fever should be carefully evaluated to rule out the possibility of an underlying infectious process or the development of agranulocytosis. In the presence of high fever, the possibility of Neuroleptic Malignant Syndrome (NMS) must be considered. The possibility of pulmonary embolism should be considered in patients receiving Clozapine, who present with deep vein thrombosis, acute dyspnea, chest pain or with other respiratory signs and symptoms. Caution is advised in patients using Clozapine who have concurrent hepatic disease. Hepatitis has been reported in both patients with normal and preexisting liver function abnormalities. In patients who develop nausea, vomiting, and/or anorexia during Clozapine treatment, liver function tests should be performed immediately. If the elevation of these values is clinically relevant or if symptoms of jaundice occur, treatment with Clozapine should be discontinued. Clozapine has potent anticholinergic effects and care should be exercised in using this drug in the presence of narrow angle glaucoma and prostatic enlargement.
DRUG INTERACTIONS This drug should not be used with sibutramine, because a very serious interaction may occur. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: antispasmodic, benzodiazepines, carbamazepine, certain antidepressants, lithium, medications for high blood pressure, drugs affecting liver enzymes that remove Clozapine from the body (such as azole antifungals including itraconazole, macrolide antibiotics including erythromycin, tobacco and other nicotine-containing products, cimetidine, ciprofloxacin, rifampin, certain anti-seizure medicines including phenytoin, antiarrhythmics such as propafenone/flecainide/quinidine). Tell your doctor or pharmacist about any medications or treatment that may decrease your blood cell count such as chemotherapy, radiation therapy, or medications for autoimmune disorders such as rheumatoid arthritis (e.g., methotrexate, azathioprine). Also report the use of drugs which might increase seizure risk (decrease seizure threshold) when combined with Clozapine such as isoniazid (INH), phenothiazines, theophylline, or tricyclic antidepressants. Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., valproate), medicines for sleep or anxiety (e.g., alprazolam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, trazodone).
Pregnancy And lactations This medication should be used only when clearly needed during pregnancy. This medication may pass into breast milk and have undesirable effects on a nursing infant. Breast feeding is not recommended while taking Clozapine.
Dosage And Administration Treatment-Resistant Schizophrenia, AND Reducing the Risk of Recurrent Suicidal Behavior in Patients with Schizophrenia or Schizoaffective Disorder: Initial Treatment: It is recommended that treatment with CLOZAPINE KANAWATI begin with one-half of a 25-mg tablet (12.5 mg) once or twice daily and then be continued with daily dosage increments of 25-50 mg/day, if well tolerated, to achieve a target dose of 300-450 mg/day by the end of 2 weeks. Subsequent dosage increments should be made no more than once or twice weekly, in increments not to exceed 100 mg. Cautious titration and a divided dosage schedule are necessary to minimize the risks of hypotension, seizure, and sedation. Therapeutic Dose Adjustment: Daily dosing should continue on a divided basis as an effective and tolerable dose level is sought. While many patients may respond adequately at doses between 300-600 mg/day, it may be necessary to raise the dose to the 600-900 mg/day range to obtain an acceptable response. Dosing should not exceed 900 mg/day. Discontinuation of Treatment: In the event of planned termination of CLOZAPINE KANAWATI therapy, gradual reduction in dose is recommended over a 1-2 week period. However, should a patient's medical condition require abrupt discontinuation (e.g., leukopenia), the patient should be carefully observed for the recurrence of psychotic symptoms and symptoms related to cholinergic rebound such as headache, nausea, vomiting, and diarrhea.
OVERDOSE The most commonly reported signs and symptoms associated with Clozapine overdose are: altered states of consciousness, including drowsiness, delirium and coma; tachycardia; hypotension; respiratory depression or failure; hypersalivation. Aspiration pneumonia and cardiac arrhythmias have also been reported. Seizures have occurred in a minority of reported cases. Fatal overdoses have been reported with Clozapine, generally at doses above 2500 mg. There have also been reports of patients recovering from overdoses well in excess of 4 g. Management of Overdose: Establish and maintain an airway; ensure adequate oxygenation and ventilation. Activated charcoal, which may be used with sorbitol, may be as or more effective than emesis or lavage, and should be considered in treating overdosage. Cardiac and vital signs monitoring is recommended along with general symptomatic and supportive measures. Additional surveillance should be continued for several days because of the risk of delayed effects. Avoid epinephrine and derivatives when treating hypotension, and quinidine and procainamide when treating cardiac arrhythmia.
Storage Conditions Keep out of reach of children. Store below 30° C. Prescription only medicine.