Composition:

Each film coated tablet contains 10mg or 25mg Clomipramine HCl.

Mechanism of Action:

Clomi-Franil is a tricyclic antidepressant and its pharmacological action includes alpha-adrenolytic, anticholinergic, anti-histaminic, and 5HT receptor blocking properties.

Indications:

Clomi-Franil is indicated for the treatment of:

• Depressive cases.
• Obsessional and phobic states.
• As an adjunctive treatment of cataplexy associated with narcolepsy.

Clomi-Franil is also  licensed for oral use in the management of nocturnal enuresis in children 

Dosage:

For the treatment of depressive cases: 

• Adults: Initial dose 10mg daily, increased gradually to 30 – 150mg daily in divided doses through the day or as single dose at bed time. Higher doses may be needed in some patients.
• Elderly: Initial dose 10mg daily, increased with caution under close supervision to a maximum of 30 – 75mg daily.

For the treatment of obsessional and phobic states:

• Adults: Initial dose 10mg daily, increased gradually to 100 – 150mg daily.
• Elderly and sensitive: Initial dose 10mg daily.

As an adjunctive treatment of cataplexy associated with narcolepsy: 10 – 75mg daily.

Side - Effects:

Drowsiness, dryness of the mouth, constipation, orthostatic hypotension, tachycardia, palpitations, allergic skin reactions and pruritis.

Contra - Indications:

Hypersensitivity to the drug, or cross-sensitivity to tricyclic antidepressants of the dibenzazepine group. Recent myocardial infarction, heart block, mania, severe hepatic disease, retention of urine, narrow angle glaucoma, and concomitant use with MAO Inhibitor(or within 3 weeks before or after treatment with MAO Inhibitors).

Drug - Interactions:

It should be left 3 weeks at least between the treatment of the drug and monoamine oxidase inhibitors. The drug should not be given with sympathomimetic agent such as: Adrenaline, ephedrine, and phenylephrine including nasal drops. Side effects may be enhanced by the concurrent administration of C.N.S depressants such as: Alcohol, antimuscarinic agents, and barbiturates. Cimetidine, calcium channel blockers may increase the plasma concentrations of the drug and toxicity.

Precautions:

• Before initiating treatment it is advisable to check the patient’s blood pressure, because individuals with hypotension or a labile circulation may react to the drug with a fall in blood pressure.
• It is advisable to monitor cardiac and hepatic function during long-term therapy with the drug.
• The drug should be withdrawn gradually to reduce the risk of withdrawal symptoms.
• Caution should be taken in patients with epilepsy and other predisposing factors.

Use in Pregnancy or Lactation:

It should not be used especially during the first and last trimesters. Nursing mother should be advised to withdraw the medication, or cease breast-feeding.