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Clomipramine is authorised in the world under the following brand names: Anafranil, Hydiphen.

(British Approved Name Modified, US Adopted Name, rINNM)

Drug Nomenclature

INNs in main languages (French, Latin, Russian, and Spanish):

Pharmacopoeias. In China, Europe, Japan, and US.

European Pharmacopoeia, 6th ed. (Clomipramine Hydrochloride). A white or slightly yellow, slightly hygroscopic, crystalline powder. Freely soluble in water and in dichloromethane soluble in alcohol. A 10% solution in water has apH of 3.5 to 5.0. Protect from light.

The United States Pharmacopeia 31, 2008 (Clomipramine Hydrochloride). A white to faintly yellow crystalline powder. Very soluble in water. pH of a 10% solution in water is between 3.5 and 5.0.

Adverse Effects, Treatment, and Precautions

As for tricyclic antidepressants in general (see Amitriptyline).

Breast feeding. For comments on the use of tricyclic antidepressants in breast feeding patients, see under Precautions for Amitriptyline.

Porphyria. Clomipramine is considered to be unsafe in patients with porphyria because it has been shown to be porphyrinogenic in in-vitro systems, although there is conflicting evidence of porphyrinogenicity.

Interactions

For interactions associated with tricyclic antidepressants, see Amitriptyline.

MAOIs. The combination of clomipramine and tranylcypromine is considered particularly hazardous. The serotonin syndrome has occurred in patients receiving clomipramine and moclobemide (see under Interactions of Antidepressants in Phenelzine).

Pharmacokinetics

Clomipramine is readily absorbed from the gastrointestinal tract, and extensively demethylated during first-pass metabolism in the liver to its primary active metabolite, desmethylclomipramine. Clomipramine and desmethylclomipramine are widely distributed throughout the body and are extensively bound to plasma and tissue protein. Clomipramine has been estimated to have a plasma elimination half-life of about 21 hours, which may be considerably extended in overdosage that of desmethylclomipramine is longer (about 36 hours).

Paths of metabolism of both clomipramine and desmethylclomipramine include hydroxylation and N-oxidation. About two-thirds of a single dose of clomipramine is excreted in the urine, mainly in the form of its metabolites, either free or in conjugated form the remainder of the dose is excreted in the faeces. Clomipramine crosses the placenta and is distributed into breast milk.

Uses and Administration

Clomipramine is a dibenzazepine tricyclic antidepressant with actions and uses similar to those of amitriptyline. It has antimuscarinic properties and is also a potent serotonin reuptake inhibitor. Clomipramine is one of the more sedating tricyclics. It is used as the hydrochloride.

In the treatment of depression in adults, clomipramine hydrochloride is given in oral doses of 10 mg daily initially, increasing gradually to 30 to 150 mg daily if required up to 250 mg daily or higher may be given in severe cases. A suggested initial dose for the elderly is 10 mg daily increasing gradually over 10 days to 30 to 75 mg daily if required. Clomipramine may be given in divided doses throughout the day, but since it has a prolonged half-life, once-daily dosage regimens are also suitable, usually given at night.

In the treatment of obsessive-compulsive disorder and phobias, clomipramine hydrochloride may be given in an initial oral dose of 25 mg daily (or 10 mg daily for elderly patients or those sensitive to tricyclics) increased gradually over two weeks to 100 to 150 mg daily. In some countries, maximum doses of 250 mg daily have been used. Similar doses have also been used in the management of panic disorder. In some countries clomipramine hydrochloride is also used for the treatment of obsessive-compulsive disorder in children and adolescents aged 10 years and over (see below for doses).

In some countries clomipramine may be given for depression or obsessive-compulsive disorder by the intramuscular or intravenous routes if giving it orally is impracticable or inadvisable. The initial dose of clomipramine hydrochloride by intramuscular injection is 25 to 50 mg daily, increasing to a maximum of 100 to 150 mg daily oral dosage should be substituted as soon as possible. Clomipramine hydrochloride may also be given by intravenous infusion in doses of 50 to 75 mg daily diluted in 250 to 500 mL of sodium chloride 0.9% or glucose 5% and infused over 1.5 to 3 hours. When a satisfactory response to parenteral doses has been obtained oral therapy should be substituted, initially giving double the parenteral dose by mouth and subsequently adjusting if necessary. Patients must be carefully supervised during intravenous infusion of clomipramine hydrochloride and the blood pressure carefully monitored owing to the risk of hypotension.

In the adjunctive treatment of cataplexy associated with narcolepsy, clomipramine hydrochloride is given in an initial oral dose of 10 mg daily and gradually increased until a satisfactory response occurs, usually within the range of 10 to 75 mg daily.

Clomipramine should be withdrawn gradually to reduce the risk of withdrawal symptoms.

Administration in children. In the UK, the use of clomipramine in children under 18 years is not recommended in the treatment of depressive states, phobias, or cataplexy associated with narcolepsy. However, in some countries clomipramine hydrochloride is used for the treatment of obsessive-compulsive disorder in children and adolescents aged 10 years and over. Initial oral doses are 25 mg daily, increased gradually during the first 2 weeks to a maximum daily dose of 3 mg/kg or 100 mg, whichever is smaller, and given in divided doses. Further increases are permitted, over several weeks to a maximum daily dose of 3 mg/kg or 200 mg, whichever is smaller. Once titration has been achieved the dose may be given as a single dose at bedtime.

Clomipramine hydrochloride is also licensed for oral use in the management of nocturnal enuresis in some countries (for a discussion of tricyclic use in nocturnal enuresis see Micturition Disorders under Amitriptyline). The age ranges and licensed doses vary somewhat from country to country, however. For example, in France, use is licensed in children over 6 years of age, at a daily dose of 10 to 30 mg, or 0.5 to 1 mg/kg, whereas in Austria and Switzerland the licensed dose is: 6 to 8 years, 20 to 30 mg 9 to 12 years, 25 to 50 mg over 12 years, 25 to 75 mg.

Anxiety disorders. Tricyclic antidepressants that inhibit serotonin reuptake, such as clomipramine and imipramine, have been given in the management of anxiety disorders including obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder, and trichotillomania.

Autism. Clomipramine reduced adventitious movements when tried in 5 boys with autistic disorder. However, in a small study in 7 children no improvement in symptoms was noted and adverse effects were common and serious. In another study, although clomipramine was found to be as effective as haloperidol in the treatment of some autistic symptoms, patients on clomipramine were significantly less likely to complete the trial for reasons that included the onset of adverse effects.

Micturition disorders. In some countries, clomipramine is used in children for the treatment of nocturnal enuresis for further details, see Administration in Children, above.

Pain. Antidepressants, usually amitriptyline or another tricyclic, are useful in alleviating some types of pain (see Choice of Analgesic). In a number of countries, clomipramine hydrochloride is licensed for the treatment of chronic pain oral doses range from 10 to 150 mg daily. Parenteral doses are licensed in some countries.

Premenstrual syndrome. Clomipramine reduced premenstrual irritability and depressed mood when given during the luteal phase doses of clomipramine ranged from 25 to 75 mg daily. It was postulated that the efficacy of clomipramine in relieving premenstrual symptoms is related to its serotonin reuptake inhibitor activity. For the overall management of premenstrual syndrome.

Sexual dysfunction. Clomipramine has been used for its inhibitory effect on ejaculation in the management of premature ejaculation. In some men with very short latencies (less than 1 minute) continuous therapy with a low daily dose of clomipramine, typically 20 or 30 mg, may be more effective than taking 25 mg as required. Any benefits may relate to its effect as a serotonin reuptake inhibitor other antidepressants with serotonin reuptake inhibiting actions, such as fluoxetine and sertraline, have also been tried in this condition.

Stuttering. Clomipramine was of modest success in a controlled study of 17 patients with developmental stuttering. It was suggested that its efficacy may be related to its serotonin reuptake inhibitor activity.

Preparations

British Pharmacopoeia 2008: Clomipramine Capsules

The United States Pharmacopeia 31, 2008: Clomipramine Hydrochloride Capsules.

Proprietary Preparations

Argentina: Anafranil Clomipram †

Australia:: Anafranil Clopram Placil

Austria: Anafranil

Belgium: Anafranil

Brazil: Anafranil Clo Clomipran

Canada: Anafranil Novo-Clopamine †

Chile: Anafranil Atenual Ausentron Deprelin

Czech Republic: Anafranil Hydiphen †

Denmark: Anafranil

Finland: Anafranil

France: Anafranil

Germany: Anafranil Hydiphen †

Greece: Anafranil

Hong Kong: Anafranil Zoiral

Hungary: Anafranil

India: Anafranil

Indonesia: Anafranil

Ireland: Anafranil

Israel: Anafranil Maronil

Italy: Anafranil

Malaysia: Anafranil

Mexico: Anafranil

The Netherlands: Anafranil

Norway: Anafranil

New Zealand: Anafranil Clopress

Philippines: Anafranil

Poland: Anafranil Hydiphen

Portugal: Anafranil

Russia: Anafranil Clofranil

South Africa: Anafranil Clomidep Equinorm

Singapore Anafranil

Spain: Anafranil

Sweden: Anafranil

Switzerland: Anafranil

Thailand: Anafranil Clofranil †

Turkey: Anafranil

UK: Anafranil

USA: Anafranil

Venezuela: Anafranil.