Trade Names:Anafranil- Capsules 25 mg- Capsules 50 mg- Capsules 75 mgApo-Clopamine (Canada)CO Clomipramine (Canada)Gen-Clomipramine (Canada)
Inhibits reuptake of serotonin in CNS.
C max is approximately 92 ng/mL (single 50 mg dose). T max is approximately 4.7 h (single 50 mg dose). C max at steady state is approximately 218 ng/mL (multiple 150 mg doses). Concentrations and AUC are not dose-proportional. Time to steady state is 7 to 14 days.
Distributes into brain, breast milk, and CSF. Approximately 97% protein bound, principally to albumin.
Extensively biotransformed to desmethylclomipramine (active) and other metabolites.
The t ½ is 19 to 37 h. Metabolites are excreted in the urine and feces following biliary elimination.
Relief of obsessive-compulsive disorder.
Treatment of panic disorder; treatment of premenstrual symptoms.
Hypersensitivity to any tricyclic antidepressant. Not to be given in combination with or within 14 days of treatment with MAOIs. Not to be given during acute recovery phases of MI.
PO 25 mg/day; gradually increase dose to 100 mg/day during first 2 wk. Dose then may be gradually increased to max of 250 mg/day.Children 10 yr of age and younger Initial dose
PO 25 mg/day; gradually increase dose to 3 mg/kg/day or 100 mg/day (whichever is less) during first 2 wk; then slowly increase dose to max 3 mg/kg/day or 200 mg/day (whichever is less).
Store at 68° to 77°F. Protect from moisture.
Effects may be increased.Charcoal
May increase effects of clomipramine.Cisapride
Cisapride is contraindicated in patients receiving tricyclic antidepressants.Clonidine
May result in hypertensive crisis.CNS depressants
Depressant effects may be additive.Drugs highly protein bound (eg, digoxin, warfarin)
Clomipramine may displace these agents from their plasma protein-binding sites, resulting in transient increases in plasma concentrations.Guanethidine
Antihypertensive effects may be decreased.Hepatic enzyme inducers (eg, barbiturates, hydantoins, rifamycins)
May decrease effects of clomipramine.Hepatic enzyme inhibitors (cimetidine, fluoxetine, haloperidol, oral contraceptives, phenothiazine antipsychotics)
May increase effects of clomipramine.MAOIs
Sweating, convulsions, and death may occur. Coadministration or use within 14 days before or after treatment with an MAOI is contraindicated.Phenobarbital
Levels may be elevated by clomipramine, increasing the pharmacologic and adverse effects.Quinolones (gatifloxacin, levofloxacin, moxifloxacin, sparfloxacin)
The risk of life-threatening cardiac arrhythmias may be increased.
None well documented.
Postural hypotension (6%); palpitation, tachycardia (4%); syncope (2%).
Dizziness, somnolence, tremor (54%); headache (52%); insomnia (25%); libido change (21%); nervousness (18%); myoclonus (13%); increased appetite (11%); anxiety, impaired memory, paresthesia (9%); twitching (7%); depression, impaired coordination (5%); hypertonia, sleep disorder (4%); abnormal dreaming, agitation, confusion, migraine, psychosomatic disorder, speech disorder, yawning (3%); aggressive reaction, asthenia, depersonalization, emotional lability, irritability, panic disorder, paresis (2%); abnormal thinking, vertigo (at least 1%); confusion, delusion, hallucinations, hypomania, mania, paranoia, psychotic episodes.
Increased sweating (29%); flushing, rash (8%); pruritus (6%); abnormal skin odor, acne, dermatitis, dry skin (2%); urticaria (1%).
Abnormal vision (18%); pharyngitis (14%); rhinitis (12%); tinnitus (6%); otitis media (4%); abnormal lacrimation (3%); anisocoria, blepharospasm, laryngitis, mydriasis, ocular allergy, vestibular disorder (2%); conjunctivitis (1%).
Dry mouth (84%); constipation (47%); nausea (33%), dyspepsia (22%); diarrhea (13%); anorexia (12%); abdominal pain (11%); vomiting (7%); flatulence (6%); tooth disorder (5%); dysphagia, eructation, GI disorder, halitosis, ulcerative stomatitis (2%); esophagitis (1%).
Ejaculation failure (42%); impotence (20%); micturition disorder (14%); dysmenorrhea (12%); urinary retention (7%); UTI (6%); micturition frequency (5%); menstrual disorder, nonpuerperal lactation (4%); breast enlargement, cystitis, dysuria, leucorrhea, vaginitis (2%); amenorrhea, breast pain (1%).
Agranulocytosis, anemia, leucopenia, pancytopenia, thrombocytopenia.
Elevated ALT (3%); elevated AST (1%).
Weight increase (18%); weight decrease (7%).
Bronchospasm (7%); coughing, sinusitis (6%); dyspnea, epistaxis (2%).
Fatigue (39%); allergy (7%); hot flashes (5%); chest pain, fever, pain (4%); chills, local edema (2%).
Antidepressants increase the risk of suicidal thinking and behavior in short-term studies in children and adolescents with major depressive disorders and other psychiatric disorders. Closely observe patients who are started on therapy for clinical worsening, suicidal, or unusual changes in behavior.
Monitor blood counts (CBC with differential), blood sugars (in patients with diabetes), ECG, and LFTs as needed.
Category C . Neonatal withdrawal symptoms have been reported.
Excreted in breast milk.
Not recommended for children younger than 10 yr of age.
Use with caution in patients with angle-closure glaucoma or increased IOP, CV disorders, hepatic or renal function impairment, history of seizures, urethral or ureteral spasm, or urinary retention; hyperthyroid patients or those receiving thyroid medication; and schizophrenic or paranoid patients.
May precipitate hypomania or mania.
Cases have been reported.
Signs and symptoms (eg, confusion, delusions, hallucinations, paranoia, psychotic episodes) have been reported.
Closely monitor patients at risk. Prescribe the smallest quantity consistent with good patient management to reduce the risk of overdose.
Symptoms including dizziness, headache, hyperthermia, irritability, malaise, nausea, sleep disturbances, and vomiting have been associated with sudden withdrawal of clomipramine.
Agitation, anuria, ataxia, athetoid and choreiform movement, cardiac dysrhythmias, CNS depression including coma, convulsions, cyanosis, delirium, drowsiness, ECG changes (particularly in QRS axis or width), hyperactivity reflexes, hyperpyrexia, muscle rigidity, mydriasis, oliguria, rare cardiac arrest, respiratory depression, restlessness, severe hypotension, severe perspiration, shock, signs of CHF, stupor, tachycardia, and vomiting.
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