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Indications and usage:

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.

Contraindications:

Anafranil pills are contraindicated in patients with a history of hypersensitivity to clomipramine 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.

Starting clomipramine in a patient who is being treated with linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome.

Myocardial Infarction

This medication is contraindicated during the acute recovery period after a myocardial infarction.

Dosage forms and strengths:

Anafranil (Clomipramine Hydrochloride) is available as capsules of 25, 50, and 75 mg for oral administration.

Overdosage:

Deaths may occur from overdosage with this class of drugs. Multiple drug ingestion (including alcohol) is common in deliberate tricyclic overdose. As the management is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment. Signs and symptoms of toxicity develop rapidly after tricyclic overdose. Therefore, hospital monitoring is required as soon as possible.

Warnings and precautions:

Clinical worsening and suicide risk

Screening patients for bipolar disorder

Serotonin syndrome

Seizures

Cardiovascular effects

Psychosis, confusion, other neuropsychiatric phenomena

Mania/hypomania

Hepatic changes

Hematologic changes

Central nervous system changes

Sexual dysfunction

Weight changes

Electroconvulsive therapy

Surgery

Use in concomitant illness

Withdrawal symptoms

Clinical worsening and suicide risk

Information for patients:

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with clomipramine hydrochloride and should counsel them in its appropriate use. A patient Medication Guide about "Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions" is available for clomipramine hydrochloride. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.

Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking clomipramine hydrochloride.

Adverse reactions, side effects:

The most commonly observed adverse events associated with the use of Anafranil and not seen at an equivalent incidence among placebo-treated patients were gastrointestinal complaints, including dry mouth, constipation, nausea, dyspepsia, and anorexia; nervous system complaints, including somnolence, tremor, dizziness, nervousness, and myoclonus; genitourinary complaints, including changed libido, ejaculatory failure, impotence, and micturition disorder; and other miscellaneous complaints, including fatigue, sweating, increased appetite, weight gain, and visual changes.

Drug Interactions:

The risks of using Anafranil in combination with other drugs have not been systematically evaluated. Given the primary CNS effects of clomipramine, caution is advised in using it concomitantly with other CNS-active drugs. This drug should not be used with MAO inhibitors.

Drug abuse and dependence:

Anafranil (Clomipramine) 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, there is no evidence for drug-seeking behavior, except for a single report of potential clomipramine abuse by a patient with a history of dependence on codeine, benzodiazepines, and multiple psychoactive drugs. The patient received ths medication 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 clomipramine 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.

Usage in specific populations:

Pregnancy

No teratogenic effects were observed in studies performed in rats and mice at doses up to 100 mg/kg, which is 24 times the maximum recommended human daily dose (MRHD) on a mg/kg basis and 4 times (rats) and 2 times (mice) the MRHD on a mg/m2 basis.

Slight nonspecific embryo/fetotoxic effects were seen in the offspring of treated rats given 50 and 100 mg/kg and of treated mice given 100 mg/kg.

There are no adequate or well-controlled studies in pregnant women. Withdrawal symptoms, including jitteriness, tremor, and seizures, have been reported in neonates whose mothers had taken Anafranil until delivery. Anafranil should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing mothers Clomipramine has been found in human milk. Because of the potential for adverse reactions, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric use

Safety and effectiveness in the pediatric population other than pediatric patients with OCD have not been established. Anyone considering the use of Anafranil in a child or adolescent must balance the potential risks with the clinical need.

Geriatric use

Clinical studies of this medicine did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently from younger subjects; 152 patients at least 60 years of age participating in various U.S. clinical trials received Anafranil for periods of several months to several years. No unusual related adverse events were identified in this population. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.

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Here is a list of popular medications containing clomipramine as a main active pharmaceutical ingredient; their trade names, forms, doses, companies - manufacturers, distributors, suppliers, researchers and developers:

Trade name of the drug	Pharmaceutical forms and doses	Companies
Anafranil	Capsules; Oral; Clomipramine Hydrochloride 25 mg, 50 mg, 75 mg Injectable; Injection; Clomipramine Hydrochloride 25 mg / 2 ml Tablets, Film-Coated; Oral; Clomipramine Hydrochloride 10 mg, 25 mg, 50 mg, 75 mg Tablets, Retard; Oral; Clomipramine Hydrochloride 75 mg	Novartis Aspen Biofutura Pharma Cobalt Pharmaceuticals Defiante Farmaceutica Dolorgiet Lynapharm Laboratoire Mallinckrodt Nycomed Oryx Pharmaceuticals Polfa Kutno Sepracor Pharmaceuticals Sigma-Tau Pharmaceuticals Sunovion Pharmaceuticals Tyco Healthcare
Anafranil Retard	Tablets, Film-Coated; Oral; Clomipramine Hydrochloride 75 mg	Novartis
Ausentron	Tablets, Film-Coated; Oral; Clomipramine 25 mg, 75 mg	Chile Laboratorios
Clomicalm	Tablets; Oral; Clomipramine Hydrochloride 5 mg, 20 mg, 80 mg	Novartis
Clomipramin	Tablets, Film-Coated; Oral; Clomipramine 10 mg, 25 mg	CT-Arzneimittel Neuraxpharm Arzneimittel Ratiopharm