Article Contents ::

Details About Generic Salt ::  Clozapin

Main Medicine Class:: Antipsychotic   

(KLOE-zuh-PEEN)
Clozapine
Tablets: 25 mg
Tablets: 100 mg
Clozaril
Tablets: 25 mg
Tablets: 100 mg
Class: Antipsychotic

 Indications Management of severely and chronically mentally ill schizophrenic patients who have not responded to or cannot tolerate standard antipsychotic drug treatment.

 Contraindications History of clozapine-induced agranulocytosis or severe granulocytopenia; myeloproliferative disorders; simultaneous administration with other agents known to cause bone marrow suppression; severe CNS depression or comatose states.

 Route/Dosage

Cautious titration and divided dosage schedules are recommended.

ADULTS: Initial dose: PO 25 mg qd or bid; increase by 25 to 50 mg/day up to 300 to 450 mg/day within 2 wk. May then increase dose in increments not to exceed 100 mg once or twice weekly. Usual dosage: 300 to 600 mg/day (max, 900 mg/day).

 Interactions

Agents that suppress bone marrow: Risk or severity of bone marrow suppression may be increased. Anticholinergics: Anticholinergic effects may be potentiated. Antihypertensives: Hypotensive effects may be potentiated. Barbiturates (eg, phenobarbital), phenytoin: May decrease blood levels of clozapine. Caffeine, cimetidine, ritonavir, serotonin reuptake inhibitors (eg, fluoxetine): May increase blood levels of clozapine. CNS drugs: Use with caution because of CNS effects of clozapine. Protein-bound drugs (eg, warfarin, digoxin): Clozapine may cause increase in plasma concentrations of these drugs.

 Lab Test Interferences None well documented.

 Adverse Reactions

CARDIOVASCULAR: Tachycardia; hypotension; hypertension; angina; ECG changes. CNS: Drowsiness; dizziness; headache; tremors; syncope; disturbed sleep; nightmares; restlessness; akinesia; agitation; seizures; rigidity; akathisia; confusion; fatigue; insomnia; hyperkinesia; weakness; lethargy; incoordination; slurred speech; depression; epileptiform movements; anxiety. DERMATOLOGIC: Rash; sweating. EENT: Visual disturbances; nasal congestion; sore tongue; throat discomfort. GI: Constipation; nausea; abdominal discomfort; heartburn; vomiting; diarrhea; anorexia; dry mouth. GU: Urinary abnormalities; incontinence; abnormal ejaculation; urinary urgency or frequency; urinary retention. HEMATOLOGIC: Leukopenia; decreased WBC; neutropenia; agranulocytosis; eosinophilia. HEPATIC: Liver test abnormalities. METABOLIC: Weight gain. RESPIRATORY: Shortness of breath. OTHER: Excessive salivation; fever; muscle weakness; back, neck or leg pain; muscle spasms or pain.

 Precautions

Pregnancy: Category B. Lactation: May be excreted in breast milk. Children: Safety and efficacy in children less than 16 yr not established. ELDERLY or debilitated patients: Lower doses required. At high risk for anticholinergic and hypotensive effects. Special risk patients: Use great caution in patients with narrow-angle glaucoma, enlarged prostate, or history of seizures. Greater likelihood of seizure at higher doses. Agranulocytosis: This very serious and life-threatening adverse reaction has been associated with clozapine. WBC with differential count must be performed weekly. Drug will not be dispensed by pharmacy without these tests demonstrating acceptable results. ECG changes: Some patients experience ECG repolarization changes during treatment. Several have experienced significant cardiac events including ischemic changes, MI, nonfatal arrhythmias, and sudden, unexplained death. Neuroleptic malignant syndrome: This potentially fatal condition has been reported in association with antipsychotic drugs. Signs and symptoms include hyperpyrexia, muscle rigidity, altered mental status, irregular pulse or BP, tachycardia, diaphoresis, and cardiac arrhythmias. Orthostatic hypotension: This may occur throughout therapy but is especially common during titration phase. Seizures: Use with caution in patients having history of seizures or other predisposing factors. Tardive dyskinesia: This syndrome of potentially irreversible, involuntary dyskinetic movements has occurred with other antipsychotic agents. Incidence is highest among elderly, especially women. Withdrawal of medication: For planned discontinuation of therapy, gradually reduce dosage over 1 to 2 wk.

PATIENT CARE CONSIDERATIONS


 Administration/Storage

  • Administer clozapine in divided doses and titrate cautiously to minimize toxic effects.
  • Observe patient carefully to ensure medication is actually taken.
  • Administer tablets with food or milk to decrease GI irritation.
  • Clozapine is available only in 1-wk supply through Clozaril Patient Management System, which combines drug management with laboratory studies for agranulocytosis.

 Assessment/Interventions

  • Obtain patient history, including drug history and any known allergies.
  • If seizures occur, institute precautions and notify health care provider.
  • Relieve anticholinergic effects by offering chipped ice, sugarless gum or hard candy, and fluids.
  • Give a high-fiber diet to prevent constipation.
  • Monitor patient’s mental status throughout therapy.
  • Monitor lying, sitting and standing BP, and pulse during titration.
  • Monitor patient’s temperature. Temperature elevations sometimes occur within first 3 wk of treatment. Such elevations are usually benign but may indicate underlying infection or developing agranulocytosis.
  • Assess for adverse reactions to drug (eg, seizures, agranulocytosis).
  • Assess for side effects (eg, sedation, dizziness, hypotension, constipation, increased salivation).
  • Notify health care provider if extrapyramidal side effects occur; be prepared to discontinue or reduce dosage and give antiparkinson drugs for these symptoms.
OVERDOSAGE: SIGNS & SYMPTOMS
  Excessive salivation, hypotension, drowsiness, delirium, coma, seizures, tachycardia, respiratory depression

 Patient/Family Education

  • Advise patient to change positions slowly and to sit up 1 to 2 min before standing to minimize hypotension.
  • Encourage patient to maintain high-fiber, high-fluid diet to prevent constipation.
  • Teach patient that psychiatric symptoms will not improve until after several weeks of therapy.
  • Inform patient of risk of seizures and importance of taking medication as prescribed.
  • Stress the importance of regular follow-up care, including laboratory studies for agranulocytosis (CBC).
  • Teach patient to recognize and report signs of urinary retention, an anticholinergic effect.
  • Instruct patient to report these symptoms to health care provider: lethargy, weakness, fever, sore throat, malaise, mucous membrane ulceration, or other possible signs of infection.
  • Teach patient to take sips of water frequently, suck on ice chips or sugarless hard candy, or chew sugarless gum if dry mouth occurs.
  • Instruct patient to avoid intake of alcoholic beverages or other CNS depressants.
  • Advise patient that drug may cause drowsiness and to use caution while driving or performing other tasks requiring mental alertness.
  • Instruct patient not to take OTC medications without consulting health care provider.

 

Drugs Class ::

(KLOE-zuh-PEEN)
Clozapine
Tablets: 25 mg
Tablets: 100 mg
Clozaril
Tablets: 25 mg
Tablets: 100 mg
Class: Antipsychotic

Indications for Drugs ::

 Indications Management of severely and chronically mentally ill schizophrenic patients who have not responded to or cannot tolerate standard antipsychotic drug treatment.

Drug Dose ::

 Route/Dosage

Cautious titration and divided dosage schedules are recommended.

ADULTS: Initial dose: PO 25 mg qd or bid; increase by 25 to 50 mg/day up to 300 to 450 mg/day within 2 wk. May then increase dose in increments not to exceed 100 mg once or twice weekly. Usual dosage: 300 to 600 mg/day (max, 900 mg/day).

Contraindication ::

 Contraindications History of clozapine-induced agranulocytosis or severe granulocytopenia; myeloproliferative disorders; simultaneous administration with other agents known to cause bone marrow suppression; severe CNS depression or comatose states.

Drug Precautions ::

 Precautions

Pregnancy: Category B. Lactation: May be excreted in breast milk. Children: Safety and efficacy in children less than 16 yr not established. ELDERLY or debilitated patients: Lower doses required. At high risk for anticholinergic and hypotensive effects. Special risk patients: Use great caution in patients with narrow-angle glaucoma, enlarged prostate, or history of seizures. Greater likelihood of seizure at higher doses. Agranulocytosis: This very serious and life-threatening adverse reaction has been associated with clozapine. WBC with differential count must be performed weekly. Drug will not be dispensed by pharmacy without these tests demonstrating acceptable results. ECG changes: Some patients experience ECG repolarization changes during treatment. Several have experienced significant cardiac events including ischemic changes, MI, nonfatal arrhythmias, and sudden, unexplained death. Neuroleptic malignant syndrome: This potentially fatal condition has been reported in association with antipsychotic drugs. Signs and symptoms include hyperpyrexia, muscle rigidity, altered mental status, irregular pulse or BP, tachycardia, diaphoresis, and cardiac arrhythmias. Orthostatic hypotension: This may occur throughout therapy but is especially common during titration phase. Seizures: Use with caution in patients having history of seizures or other predisposing factors. Tardive dyskinesia: This syndrome of potentially irreversible, involuntary dyskinetic movements has occurred with other antipsychotic agents. Incidence is highest among elderly, especially women. Withdrawal of medication: For planned discontinuation of therapy, gradually reduce dosage over 1 to 2 wk.

PATIENT CARE CONSIDERATIONS


Drug Side Effects ::

 Adverse Reactions

CARDIOVASCULAR: Tachycardia; hypotension; hypertension; angina; ECG changes. CNS: Drowsiness; dizziness; headache; tremors; syncope; disturbed sleep; nightmares; restlessness; akinesia; agitation; seizures; rigidity; akathisia; confusion; fatigue; insomnia; hyperkinesia; weakness; lethargy; incoordination; slurred speech; depression; epileptiform movements; anxiety. DERMATOLOGIC: Rash; sweating. EENT: Visual disturbances; nasal congestion; sore tongue; throat discomfort. GI: Constipation; nausea; abdominal discomfort; heartburn; vomiting; diarrhea; anorexia; dry mouth. GU: Urinary abnormalities; incontinence; abnormal ejaculation; urinary urgency or frequency; urinary retention. HEMATOLOGIC: Leukopenia; decreased WBC; neutropenia; agranulocytosis; eosinophilia. HEPATIC: Liver test abnormalities. METABOLIC: Weight gain. RESPIRATORY: Shortness of breath. OTHER: Excessive salivation; fever; muscle weakness; back, neck or leg pain; muscle spasms or pain.

Drug Mode of Action ::  

(KLOE-zuh-PEEN)
Clozapine
Tablets: 25 mg
Tablets: 100 mg
Clozaril
Tablets: 25 mg
Tablets: 100 mg
Class: Antipsychotic

Drug Interactions ::

 Interactions

Agents that suppress bone marrow: Risk or severity of bone marrow suppression may be increased. Anticholinergics: Anticholinergic effects may be potentiated. Antihypertensives: Hypotensive effects may be potentiated. Barbiturates (eg, phenobarbital), phenytoin: May decrease blood levels of clozapine. Caffeine, cimetidine, ritonavir, serotonin reuptake inhibitors (eg, fluoxetine): May increase blood levels of clozapine. CNS drugs: Use with caution because of CNS effects of clozapine. Protein-bound drugs (eg, warfarin, digoxin): Clozapine may cause increase in plasma concentrations of these drugs.

Drug Assesment ::

 Assessment/Interventions

  • Obtain patient history, including drug history and any known allergies.
  • If seizures occur, institute precautions and notify health care provider.
  • Relieve anticholinergic effects by offering chipped ice, sugarless gum or hard candy, and fluids.
  • Give a high-fiber diet to prevent constipation.
  • Monitor patient’s mental status throughout therapy.
  • Monitor lying, sitting and standing BP, and pulse during titration.
  • Monitor patient’s temperature. Temperature elevations sometimes occur within first 3 wk of treatment. Such elevations are usually benign but may indicate underlying infection or developing agranulocytosis.
  • Assess for adverse reactions to drug (eg, seizures, agranulocytosis).
  • Assess for side effects (eg, sedation, dizziness, hypotension, constipation, increased salivation).
  • Notify health care provider if extrapyramidal side effects occur; be prepared to discontinue or reduce dosage and give antiparkinson drugs for these symptoms.
OVERDOSAGE: SIGNS & SYMPTOMS
  Excessive salivation, hypotension, drowsiness, delirium, coma, seizures, tachycardia, respiratory depression

Drug Storage/Management ::

 Administration/Storage

  • Administer clozapine in divided doses and titrate cautiously to minimize toxic effects.
  • Observe patient carefully to ensure medication is actually taken.
  • Administer tablets with food or milk to decrease GI irritation.
  • Clozapine is available only in 1-wk supply through Clozaril Patient Management System, which combines drug management with laboratory studies for agranulocytosis.

Drug Notes ::

 Patient/Family Education

  • Advise patient to change positions slowly and to sit up 1 to 2 min before standing to minimize hypotension.
  • Encourage patient to maintain high-fiber, high-fluid diet to prevent constipation.
  • Teach patient that psychiatric symptoms will not improve until after several weeks of therapy.
  • Inform patient of risk of seizures and importance of taking medication as prescribed.
  • Stress the importance of regular follow-up care, including laboratory studies for agranulocytosis (CBC).
  • Teach patient to recognize and report signs of urinary retention, an anticholinergic effect.
  • Instruct patient to report these symptoms to health care provider: lethargy, weakness, fever, sore throat, malaise, mucous membrane ulceration, or other possible signs of infection.
  • Teach patient to take sips of water frequently, suck on ice chips or sugarless hard candy, or chew sugarless gum if dry mouth occurs.
  • Instruct patient to avoid intake of alcoholic beverages or other CNS depressants.
  • Advise patient that drug may cause drowsiness and to use caution while driving or performing other tasks requiring mental alertness.
  • Instruct patient not to take OTC medications without consulting health care provider.

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