clomipramine hydrochloride(redirected from Gen-Clomipramine)
Pharmacologic class: Tricyclic anti-depressant (TCA)
Therapeutic class: Antiobsessional agent, antidepressant
Pregnancy risk category C
FDA Box Warning
• Drug may increase risk of suicidal thinking and behavior in children and adolescents with major depressive disorder and other psychiatric disorders. Risk must be balanced with clinical need, as depression itself increases suicide risk. With patient of any age, observe closely for clinical worsening, suicidality, and unusual behavior changes when therapy begins. Advise family to observe patient closely and communicate with prescriber as needed.
• Drug isn't approved for use in pediatric patients, except those with obsessive-compulsive disorder.
Unknown. Selectively inhibits norepinephrine and serotonin reuptake at presynaptic neurons in brain; also possesses moderate anticholinergic properties.
Aerosol foam: 1%
Capsules: 25 mg, 50 mg, 75 mg
Indications and dosages
➣ Obsessive-compulsive disorder
Adults: Initially, 25 mg/day P.O., increased over 2 weeks to 100 mg/day given in divided doses. May be increased further over several weeks, up to 250 mg/day given in divided doses.
Children ages 10 to 17: Initially, 25 mg/day P.O., increased over 2 weeks to 3 mg/kg/day or 100 mg/day (whichever is smaller) given in divided doses. May be increased further to 3 mg/kg/day or 200 mg/day (whichever is smaller) given in divided doses.
• Elderly patients
• Panic disorder
• Hypersensitivity to drug or other TCAs
• Recent myocardial infarction (MI)
• Concurrent MAO inhibitor or clonidine use
Use cautiously in:
• glaucoma, hyperthyroidism, prostatic hypertrophy, preexisting cardiovascular disease
• elderly patients
• pregnant or breastfeeding patients
• children younger than age 10 (safety not established).
• Don't give with grapefruit juice.
• Once stabilizing dosage is reached, entire daily dose may be given at bedtime.
CNS: lethargy, sedation, weakness, aggressive behavior, extrapyramidal reactions, poor concentration, feeling of unreality, delusions, anxiety, restlessness, panic, asthenia, syncope, insomnia, seizures, suicidal ideation or behavior (especially in child or adolescent)
CV: orthostatic hypotension, hypertension, ECG changes, tachycardia, palpitations, vasculitis,
arrhythmias, MI, precipitation of heart block
EENT: blurred vision, dry eyes, vestibular disorder, nasal congestion, laryngitis
GI: nausea, vomiting, constipation, abdominal cramps, belching, epigastric distress, flatulence, dysphagia, increased salivation, stomatitis, parotid gland swelling, black tongue, dry mouth, paralytic ileus
GU: urinary retention, urinary hesitancy, urinary tract dilation, male sexual dysfunction, testicular swelling, gynecomastia, breast enlargement, menstrual irregularities, galactorrhea, libido changes
Hematologic: eosinophilia, purpura, anemia, bone marrow depression, agranulocytosis, thrombocytopenia, leukopenia
Metabolic: hyperthermia, hypothermia, syndrome of inappropriate antidiuretic hormone secretion Musculoskeletal: muscle weakness
Skin: sweating, dry skin, photosensitivity, rash, pruritus, petechiae, flushing
Other: abnormal taste, chills, edema, increased appetite, weight gain
Drug-drug. Adrenergics, anticholinergics: additive adrenergic or anticholinergic effects
Cimetidine, hormonal contraceptives, phenothiazines, selective serotonin reuptake inhibitors: increased clomipramine effects, greater risk of toxicity
Clonidine: hypertensive crisis
CNS depressants (including antihistamines, opioid analgesics, sedative-hypnotics): additive CNS depression
Disulfiram: transient delirium
Guanethidine: interference with anti-hypertensive response
MAO inhibitors: severe or life-threatening adverse reactions
Levofloxacin, moxifloxacin: increased risk of adverse cardiovascular reactions
Drug-diagnostic tests. Blood glucose, prolactin: elevated levels
Drug-food. Grapefruit juice: increased clomipramine blood level and effects
Drug-herbs. Chamomile, hops, kava, skullcap, valerian: increased CNS depression
S-adenosylmethionine (SAM-e), St. John's wort: increased serotonergic effects, possibly causing serotonin syndrome
Drug-behaviors. Alcohol use: additive CNS depression
Nicotine use: increased metabolism and decreased efficacy of clomipramine
Sun exposure: photosensitivity
• Monitor patient for cardiovascular, CNS, and hematologic adverse reactions.
☞ Assess for suicidal ideation. If necessary, institute suicide precautions.
☞ Advise patient (especially children or their parents) to immediately report suicidal thoughts or severe depression.
• Instruct patient not to drink grapefruit juice during therapy.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.
• Instruct patient to avoid alcohol, because it increases drowsiness.
• Tell patient to move slowly when sitting up or standing, to avoid dizziness or light-headedness caused by sudden blood pressure drop.
• Caution patient not to stop taking drug abruptly, because this may cause nausea, headache, or malaise.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, foods, herbs, and behaviors mentioned above.