Clofranil Tablet

Clofranil Tablet is used for: Depression, Panic disorder, Obsessive compulsive disorder, Cataplexy, Narcolepsy, Phobias, Premature ejaculation, Enuresis, Trichotillomania

Oral Adjunct for cataplexy associated with narcolepsy Adult: Initially, 10 mg daily gradually increased to 10-75 mg daily. Elderly: Dose reduction may be needed. Obsessive-compulsive disorder; Panic disorder; Phobias Adult: Initially, 25 mg daily, gradually increased to 100-150 mg daily over 2 weeks. Max: 250 mg daily. Depression Adult: Initially, 10 mg daily; may increase gradually to 30-150 mg daily if needed. Up to 250 mg daily or more may be required in more severe cases. Max Dosage: 100-150 mg daily.

Obsessive-Compulsive Disorder <10 years: Safety and efficacy not established >10 years: 25 mg PO qDay initially Gradually increase to maximum 3 mg/kg/day or 100 mg/day, whichever is less May further increase to maximum 3 mg/kg/day or 200 mg/day, whichever is less; may give as single dose qHS once tolerated

Should be taken with food.

Hypersensitivity. Concomitant use of MAOIs; recovery phase following MI, heartblock or other arrhythmias; mania; childn.

In short-term studies, antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults (<24 yr of age) taking antidepressants for major depressive disorders and other psychiatric illnesses This increase was not seen in patients aged >24 years; a slight decrease in suicidal thinking was seen in adults >65 years In children and young adults, risks must be weighed against the benefits of taking antidepressants Patients should be monitored closely for changes in behavior, clinical worsening, and suicidal tendencies; this should be done during initial 1-2 months of therapy and dosage adjustments The patient’s family should communicate any abrupt changes in behavior to the healthcare provider Worsening behavior and suicidal tendencies that are not part of the presenting symptoms may require discontinuation of therapy This drug is not approved for use in pediatric patients except for patients with obsessive-compulsive disorder (OCD) BPH, urinary/GI retention, hyperthyroidism, seizure disorder, brain tumor, respiratory impairment Risk of mydriasis; may trigger angle closure attack in patients with angle closure glaucoma with anatomically narrow angles without a patent iridectomy Clinical worsening and suicide ideation may occur despite medication in adolescents and young adults (18-24 yr) Potentially life-threatening serotonin syndrome reported when coadministered with drugs that impair serotonin metabolism (in particular, MAOIs, including nonpsychiatric MAOIs, such as linezolid and IV methylene blue) Risk of anticholinergic side-effects Rare cases of drug rash with eosinophilia and systemic symptoms (DRESS) reported with use; in event of severe acute reactions such as DRESS, discontinue clomipramine therapy immediately and institute appropriate treatment Hyponatremia Appears to be the result of syndrome of inappropriate antidiuretic hormone secretion (SIADH) Elderly patients may be at greater risk of developing hyponatremia, especially with a serotonergic antidepressant Patients taking diuretics or who are otherwise volume-depleted can be at greater risk Discontinue therapy in patients with symptomatic hyponatremia and institute appropriate medical intervention MONITORING PARAMETERS Advises monitoring cardiac and hepatic function during long-term use.

Pregnancy Category: C Lactation: distributed in breast milk, do not nurse (AAP states effect on nursing infants is unknown but may be of concern)

The risks of using Anafranil in combination with other drugs have not been systematically evaluated. Given the primary CNS effects of Anafranil, caution is advised in using it concomitantly with other CNS-active drugs (see Information for Patients). Anafranil should not be used with MAO inhibitors. Several tricyclic antidepressants have been reported to block the pharmacologic effects of guanethidine, clonidine, or similar agents, and such an effect may be anticipated with CMI because of its structural similarity to other tricyclic antidepressants. The plasma concentration of CMI has been reported to be increased by the concomitant administration of haloperidol; plasma levels of several closely related tricyclic antidepressants have been reported to be increased by the concomitant administration of methylphenidate or hepatic enzyme inhibitors (e.g., cimetidine, fluoxetine) and decreased by the concomitant administration of hepatic enzyme inducers (e.g., barbiturates, phenytoin), and such an effect may be anticipated with CMI as well. Administration of CMI has been reported to increase the plasma levels of phenobarbital, if given concomitantly. Barbiturates increase metabolism of tricyclic antidepressants; conversely cimetidine, guanethidine, haloperidol and phenothiazines block the tricyclic metabolism. CNS effects of alcohol enhanced. Potentially Fatal: If clomipramine is to be substituted for MAOIs, at least 3 wk should elapse after discontinuing MAOIs. Risk of hypertension and arrhythmias if co-administered with adrenaline and noradrenaline. Contraindicated (21) artemether/lumefantrine disopyramide dronedarone eliglustat ibutilide indapamide iobenguane I 123 isocarboxazid lumefantrine mavorixafor pentamidine phenelzine pimozide procainamide procarbazine quinidine safinamide selegiline sotalol thioridazine tranylcypromine

Side effects of Clomipramine Hydrochloride : >10% Xerostomia (84%),Headache (50-55%),Constipation (47%),Ejaculation failure (42%),Fatigue (35-40%),Nausea (30-35%),Impotence (20-25%),Weight gain (18%) 1-10% Weight loss (5%),Hepatotoxicity (1-3%) Frequency Not Defined Common, Dizziness, mainia, somnolence, tremor, Dyspepsia, Blurred vision, Urinary retention, Orgasm incapacity, libido change Potentially Fatal: Death, rare (except in patients with preexisting significant heart block and patients on MAOI therapy). Induction of mania in individuals with underlying manic-depressive illness or worsening of psychoses in already psychotic individuals.

Clomipramine is a potent inhibitor of serotonin re-uptake in the brain. Significant antagonism at cholinergic and ?1-receptors. Weak antagonism at dopamine receptors. It has also antidepressant, sedative and anticholinergic effects.

Clofranil 25mg Tablet manufactured by Sun Pharmaceutical (Bangladesh) Ltd.. Its generic name is Clomipramine Hydrochloride. Clofranil is availble in Bangladesh. Farmaco BD drug index information on Clofranil Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.