United States - English - NLM (National Library of Medicine)

specgx llc - clomipramine hydrochloride (unii: 2lxw0l6gwj) (clomipramine - unii:nuv44l116d) - clomipramine hydrochloride 25 mg - anafranil™ (clomipramine hydrochloride) capsules usp is indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (ocd). the obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the dsm-iii-r (circa 1989) diagnosis of ocd. obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. the effectiveness of anafranil for the treatment of ocd was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. patients in all studies had moderate-to-severe ocd (dsm-iii), with mean baseline ratings on the yale-brown obsessive compulsive scale (ybocs) ranging from 26 to 28 and a mean baseline rating of 10 on the nimh clinical global obsessive compulsive scale (nimh-oc). patients taking cmi experienced a mean reduction of approximately 10 on the ybocs, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. cmi-treated patients experienced a 3.5 unit decrement on the nimh-oc. patients on placebo showed no important clinical response on either scale. the maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. the effectiveness of anafranil for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. the physician who elects to use anafranil for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see dosage and administration ). anafranil is contraindicated in patients with a history of hypersensitivity to anafranil or other tricyclic antidepressants. monoamine oxidase inhibitors (maois) the use of maois intended to treat psychiatric disorders with anafranil or within 14 days of stopping treatment with anafranil is contraindicated because of an increased risk of serotonin syndrome.  the use of anafranil within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated (see  warnings   and dosage and administration ). starting anafranil in a patient who is being treated with linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see  warnings   and dosage and administration ). myocardial infarction anafranil is contraindicated during the acute recovery period after a myocardial infarction. anafranil has not been systematically studied in animals or humans for its potential for abuse, tolerance, or physical dependence. while a variety of withdrawal symptoms have been described in association with anafranil discontinuation (see precautions, withdrawal symptoms ), there is no evidence for drug-seeking behavior, except for a single report of potential anafranil abuse by a patient with a history of dependence on codeine, benzodiazepines, and multiple psychoactive drugs. the patient received anafranil for depression and panic attacks and appeared to become dependent after hospital discharge. despite the lack of evidence suggesting an abuse liability for anafranil in foreign marketing, it is not possible to predict the extent to which anafranil might be misused or abused once marketed in the u.s. consequently, physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely.

Australia - English - Department of Health (Therapeutic Goods Administration)

pharmaco australia ltd - clomipramine hydrochloride, quantity: 25 mg - tablet, sugar coated - excipient ingredients: lactose monohydrate; maize starch; microcrystalline cellulose; povidone; purified talc; glycerol; titanium dioxide; hypromellose; magnesium stearate; stearic acid; colloidal anhydrous silica; sucrose; macrogol 8000; iron oxide yellow; copovidone - major depression. obsessive-compulsive disorders and phobias in adults. cataplexy associated with narcolepsy

Singapore - English - HSA (Health Sciences Authority)

novartis (singapore) pte ltd - clomipramine hcl - tablet, film coated - 75 mg - clomipramine hcl 75 mg

Ireland - English - HPRA (Health Products Regulatory Authority)

novartis pharmaceuticals uk ltd - clomipramine hydrochloride - capsule - 50 milligram(s) - non-selective monoamine reuptake inhibitors; clomipramine

Ireland - English - HPRA (Health Products Regulatory Authority)

novartis pharmaceuticals uk ltd - clomipramine hydrochloride - capsule - 10 milligram(s) - non-selective monoamine reuptake inhibitors; clomipramine

Ireland - English - HPRA (Health Products Regulatory Authority)

novartis pharmaceuticals uk ltd - clomipramine hydrochloride - capsule - 25 milligram(s) - non-selective monoamine reuptake inhibitors; clomipramine

Israel - English - Ministry of Health

tzamal bio-pharma ltd - clomipramine hydrochloride - tablets slow release - clomipramine hydrochloride 75 mg - clomipramine - clomipramine - depression of varying origin: in children and adolescents there is not sufficient evidence of safety and efficacy of anafranil in the treatment of depressive states of varying aetiology and symptomatology. the use of anafranil in children and odolescents ( 0 - 17 years of age ) in this indication is therefore not recommended. obsessive compulcive syndromes: no experience is available in children younger than 5 years of age.

Israel - English - Ministry of Health

tzamal bio-pharma ltd - clomipramine hydrochloride - coated tablets - clomipramine hydrochloride 25 mg - clomipramine - clomipramine - depression of varying origin: in children and adolescents there is not sufficient evidence of safety and efficacy of anafranil in the treatment of depressive states of varying aetiology and symptomatology. the use of anafranil in children and odolescents ( 0 - 17 years of age ) in this indication is therefore not recommended. obsessive compulcive syndromes: no experience is available in children younger than 5 years of age.

Malta - English - Medicines Authority

novartis pharmaceuticals uk limited - clomipramine hydrochloride 10 mg - coated tablet

Malta - English - Medicines Authority

novartis pharmaceuticals uk limited - clomipramine hydrochloride 25 mg - coated tablet