Class: Tricyclics and Other Norepinephrine-reuptake Inhibitors
VA Class: CN601
Chemical Name: 3-Chloro-10,11-dihydro-N,N-dimethyl -5H-dibenz[b,f]azepine-5-propanamine monohydrochloride
Molecular Formula: C19H23ClN2•HCl
CAS Number: 17321-77-6
Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need.d e Clomipramine is not approved for use in pediatric patients except patients with obsessive-compulsive disorder.1 (See Pediatric Use under Cautions.)
Appropriately monitor and closely observe all patients who are started on clomipramine therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process.d e f (See Worsening of Depression and Suicidality Risk under Cautions.)
Uses for Clomipramine Hydrochloride
Obsessive-Compulsive Disorder (OCD)
Major Depressive Disorder
Despite comparable efficacy,2 3 255 256 257 258 260 277 282 283 the adverse effect profile (e.g., anticholinergic effects) of clomipramine may limit its usefulness relative to other antidepressants (e.g., TCAs, SSRIs).2 257 258 277 282 283 288 289
Effective antidepressant when obsessive manifestations accompany episode of major depressive disorder.288
Has been used for the management of chronic pain† (e.g., central pain, idiopathic pain disorder, tension headache, diabetic peripheral neuropathy, cancer pain) alone or as adjunct to conventional analgesics.2 3 52 111 112 113 114 115 118 119 120 121 122 123 124 125 343 344
Cataplexy and Associated Narcolepsy
Has been used for the management of repetitive and obsessive-compulsive behaviors and hyperactivity associated with autistic disorder†;134 135 141 285 286 does not treat core symptoms of autistic disorder.b
Has been used for the management of trichotillomania† (an urge to pull out one’s hair) in a limited number of patients with the disorder;3 136 137 138 139 relapse reported in some patients receiving long-term therapy.140
Clomipramine Hydrochloride Dosage and Administration
Allow at least 2 weeks to elapse between discontinuance of therapy with an MAO inhibitor and initiation of clomipramine and vice versa.1 Also allow at least 5 weeks to elapse when switching from fluoxetine.1
Monitor for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustments.d e f (See Worsening of Depression and Suicidality Risk under Cautions.)
Administer orally; initially, in divided doses with meals to lessen adverse GI effects.1 After initial dosage titration, the total daily dose may be given once daily at bedtime1 2 4 271 to minimize adverse effects (e.g., sedation) during waking hours1 2 and enhance patient compliance.2
Available as clomipramine hydrochloride; dosage is expressed in terms of the salt.1
Individualize dosage carefully according to individual requirements and response.1
Allow 2–3 weeks to elapse between any further dosage adjustments after the initial dosage titration period for achievement of steady-state plasma concentrations.1
Children >10 years of age: initially, 25 mg daily.1 Gradually increase dosage, as tolerated, during the first 2 weeks of therapy up to a maximum of 3 mg/kg or 100 mg daily, whichever is lower.1 2 242 Titrate dosage carefully.1 If necessary, dosages may be increased gradually during the next several weeks up to a maximum of 3 mg/kg or 200 mg daily (whichever is lower).1 2 3 4 66 67
Optimum duration not established; 1 78 271 some clinicians recommend that therapy be continued in responding patients at the minimally effective dosage for at least 18 months before attempting to discontinue.1 271 299
Initially, 25 mg daily.1 Gradually increase dosage, as tolerated, during the first 2 weeks of therapy to approximately 100 mg daily.1 If necessary, dosages may be increased gradually during the next several weeks up to a maximum of 250 mg daily.1 2 3 4 66 67
Optimum duration not established; 1 78 271 some clinicians recommend that therapy be continued in responding patients at the minimally effective dosage for at least 18 months before attempting to discontinue.1 271 299
Major Depressive Disorder†
Cataplexy and Associated Narcolepsy†
Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.1
Cautions for Clomipramine Hydrochloride
Concurrent or recent (i.e., within 2 weeks) therapy with an MAO inhibitor.1 (See Specific Drugs under Interactions.)
During the acute recovery phase following MI.1
Known hypersensitivity to clomipramine or other TCAs.1
Risk of seizure; use with caution in patients with a history of seizures or other predisposing factors (e.g., brain damage of various etiology, alcoholism, concurrent use of other drugs that lower the seizure threshold).1
Risk may be dose related.1 (See Prescribing Limits under Dosage and Administration.)
Worsening of Depression and Suicidality Risk
Possible worsening of depression and/or emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior in both adult and pediatric patients, whether or not they are taking antidepressants; may persist until clinically important remission occurs.d e f g However, suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.d e f
Appropriately monitor and closely observe patients receiving clomipramine for any reason, particularly during initiation of therapy (i.e., the first few months) and during periods of dosage adjustments.d e f (See Boxed Warning and also see Pediatric Use under Cautions.)
Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and/or mania may be precursors to emerging suicidality.e f Consider changing or discontinuing therapy in patients whose depression is persistently worse or in those with emerging suicidality or symptoms that might be precursors to worsening depression or suicidality, particularly if severe, abrupt in onset, or not part of patient’s presenting symptoms.d e f (See General under Dosage and Administration and also see Withdrawal Reactions under Cautions.)
Observe these precautions for patients with psychiatric (e.g., major depressive disorder, OCD) or nonpsychiatric disorders.e
Screen for risk of bipolar disorder by obtaining detailed psychiatric history (e.g., family history of suicide, bipolar disorder, depression) prior to initiating therapy.e
Modest orthostatic decreases in BP,1 193 modest tachycardia,1 and/or ECG abnormalities (e.g., VPCs, ST-T wave changes, intraventricular conduction abnormalities) reported; use with caution in patients with known cardiovascular disease.1
Titrate dosage carefully.1
Activation of Mania or Hypomania
Use with caution in patients for whom excess anticholinergic activity could be harmful (e.g., history of urinary retention, increased intraocular pressure, angle-closure glaucoma).1
More than 30 cases of hyperthermia reported,1 most cases occurring in patients receiving clomipramine in combination with other drugs (e.g., antipsychotic agents).1 157 199 When clomipramine and an antipsychotic agent were used concomitantly, the cases sometimes were considered to be examples of neuroleptic malignant syndrome (NMS).1 157 199
Possible cross hepatotoxicity (e.g., elevated values on hepatic function tests, abdominal pain) involving different TCAs including clomipramine.207 (See Hepatic Impairment under Cautions.)
Obtain leukocyte and differential blood cell counts if fever and sore throat occur during therapy.1
Withdrawal reactions (e.g., dizziness, nausea, vomiting, headache, malaise, sleep disturbance, hyperthermia, sweating, irritability, seizures, worsening of psychiatric status) reported following abrupt discontinuance of therapy.1 2 78 148 301
Electroconvulsive Therapy (ECT)
Possible increased ECT risks; limit to patients for whom concomitant use is essential.1
Discontinue therapy for as long as is clinically feasible prior to surgery and advise the anesthetist of such action.1
Adrenal Medulla Tumors
Use with caution in patients with tumors of the adrenal medulla, in whom hypertensive crises may be provoked.1
Possible withdrawal symptoms (e.g., jitteriness,1 71 152 158 tremor,1 71 153 154 seizures1 3 152 153 ) in neonates whose mothers received clomipramine throughout pregnancy;1 avoid use during late pregnancy whenever possible.153
Safety and efficacy for OCD not established in children <10 years of age.1
Potential risks associated with long-term use (e.g., effects on growth, development, or maturation) not systematically evaluated in children and adolescents.1
Adverse effects in children and adolescents >10 years of age generally similar to those in adults.1
FDA warns that a greater risk of suicidal thinking or behavior (suicidality) occurred during first few months of antidepressant treatment (4%) compared with placebo (2%) in children and adolescents with major depressive disorder, OCD, or other psychiatric disorders based on pooled analyses of 24 short-term placebo-controlled trials of 9 antidepressant drugs (SSRIs and others).e However, a more recent meta-analysis of 27 placebo-controlled trials of 9 antidepressants (SSRIs and others) in patients <19 years of age with major depressive disorder, OCD, or non-OCD anxiety disorders suggests that the benefits of antidepressant therapy in treating these conditions may outweigh the risks of suicidal behavior or suicidal ideation.g No suicides occurred in these pediatric trials.e g
Carefully consider these findings when assessing potential benefits and risks of clomipramine in a child or adolescent for any clinical use.d e f g (See Worsening of Depression and Suicidality Risk under Cautions.)
Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.1
In pooled data analyses, a reduced risk of suicidality was observed in adults ≥65 years of age with antidepressant therapy compared with placebo.d e (See Boxed Warning and also see Worsening of Depression and Suicidality Risk under Cautions.)
Possible increased sensitivity to anticholinergic (e.g., dry mouth, constipation, vision disturbance), cardiovascular, orthostatic hypotension, and sedative effects of TCAs.
Use with caution in patients with clinically important hepatic disease; periodically monitor hepatic enzyme concentrations.1
Use with caution in patients with clinically important renal impairment.1
Common Adverse Effects
Adverse GI (e.g., dry mouth, constipation, nausea, dyspepsia, anorexia, increased appetite), nervous system (e.g., somnolence, tremor, dizziness, nervousness, fatigue, myoclonus), or genitourinary (e.g., changed libido, ejaculatory failure, impotence, micturition disorder) effects; sweating; weight gain; visual changes.1 2 35 65 242
Interactions for Clomipramine Hydrochloride
Drugs Affecting Hepatic Microsomal Enzymes
Inhibitors of CYP2D6 and/or 1A2: Potential pharmacokinetic interaction (increased plasma clomipramine concentrations).a Monitor plasma clomipramine concentrations whenever a CYP2D6 inhibitor is added or discontinued and adjust dosages as needed.a
Drugs Associated with Serotonin Syndrome
Drugs Affecting the Seizure Threshold
Use caution with concurrent administration of clomipramine and drugs (e.g., other antidepressants, antipsychotic agents) that lower the seizure threshold.1
Potential for increased CNS effects of alcohol1
Advise patients of risks of such concomitant use1
Antiarrhythmics: class 1C (e.g., flecainide, propafenone)
Potential for decreased clomipramine metabolisma
Monitor for TCA toxicitya
Antipsychotic agents (e.g., phenothiazines)
Potential for decreased clomipramine metabolismc
Dosage adjustment may be neededc
Barbiturates (e.g., phenobarbital)
Increased plasma phenobarbital concentrations reported1
Advise patients of risks associated with such concomitant use1
Use with caution; dosage adjustment may be neededc
CNS depressants (e.g., alcohol, sedatives, hypnotics)
Use with cautionc
Use with caution; dosage adjustment may be neededc
Hypotensive agents (e.g., clonidine, guanethidine)
May interfere with levodopa absorptionc
Monitor levodopa dosage carefullyc
MAO inhibitors (e.g., phenelzine)
No evidence of interference with clomipramine therapeutic effects159
SSRIs (e.g., fluoxetine, fluvoxamine)
Possible serotonin syndromec
Possible seizures with concomitant fluoxetine use170
Severalfold elevation of plasma clomipramine concentration with concomitant fluvoxamine use171
Sympathomimetic agents (e.g., amphetamines, epinephrine, isoproterenol, norepinephrine, phenylephrine)
Increased vasopressor, cardiac effectsc
Use with caution; dosage adjustment may be requiredc
Thyroid agents (e.g., levothyroxine, liothyronine)
May accelerate the onset of therapeutic effects of TCAc
Possible cardiac arrhythmiasc
Use with cautionc
Possible elevated serum clomipramine concentrations; may precipitate seizures in predisposed individuals298
Clomipramine Hydrochloride Pharmacokinetics
In smokers, steady-state plasma clomipramine concentrations are substantially lower than in nonsmokers;1 41 55 60 smoking appears to have less effect on plasma concentrations of desmethylclomipramine.60
Crosses the blood-brain barrier; desmethylclomipramine concentration in CSF is about 2.6 times higher than in plasma.1
Plasma Protein Binding
Hemodialysis, peritoneal dialysis, forced diuresis, and/or exchange transfusion are unlikely to remove clomipramine and desmethylclomipramine substantially because of the drug’s rapid distribution into body tissues.1
Exhibits marked anticholinergic activity, which may account for 3 4 288 289 sedation,1 65 238 242 adverse cardiovascular effects,1 2 193 222 235 339 and reduced seizure threshold (particularly at relatively high dosages).1 210
Advice to Patients
Risk of suicidality; importance of patients, family, and caregivers being alert to and immediately reporting emergence of suicidality, worsening depression, or unusual changes in behavior, especially during the first few months of therapy or during periods of dosage adjustment.d e f FDA recommends providing written patient information (medication guide) explaining risks of suicidality each time the drug is dispensed.d e f
Importance of informing patients about the risk of seizures associated with the drug.1
Importance of discussing with patients the risk of serious injury to themselves or others resulting from sudden loss of consciousness (e.g., because of seizures) while engaged in certain complex and hazardous activities (e.g., operation of complex machinery, driving a motor vehicle, swimming, climbing).1
Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.1
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1
Importance of informing patients of other important precautionary information.1 (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Anafranil (with parabens)
Clomipramine Hydrochloride Capsules
Mylan, Sandoz, Taro, Teva, Watson
Anafranil (with parabens)
Clomipramine Hydrochloride Capsules
Mylan, Sandoz, Taro, Teva, Watson
Anafranil (with parabens)
Clomipramine Hydrochloride Capsules
Mylan, Sandoz, Taro, Teva, Watson
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Anafranil 25MG Capsules (MALLINCKRODT): 60/$829.02 or 180/$2,384.88
Anafranil 50MG Capsules (MALLINCKRODT): 30/$383.39 or 90/$1,124.57
ClomiPRAMINE HCl 25MG Capsules (TARO): 60/$38.99 or 180/$99.97
ClomiPRAMINE HCl 50MG Capsules (TARO): 60/$40.99 or 180/$106.96
ClomiPRAMINE HCl 75MG Capsules (TARO): 60/$57.99 or 180/$161.96
AHFS DI Essentials. © Copyright, 2004-2016, Selected Revisions June 1, 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
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- Other brands: Anafranil