TRANYLCYPROMINE

Posology Adults Initially, 1 tablet morning and afternoon. If the response is not adequate after the first week add a further tablet at midday, and continue for at least a week. A dosage of 3 tablets a day should only be exceeded with caution.

When a satisfactory response has been obtained, dosage may be reduced to maintenance level often of 1 tablet a day. When given with a tranquillizer, the dosage of `parnate' is not affected when given concurrently with electroconvulsive therapy; the usual dosage is 1 tablet twice a day during the series and 1 tablet a day afterwards as maintenance therapy.

Elderly:

Use with great caution and at a lower dosage. Paediatric population Tranylcypromine is not indicated for children under 18 years of age. Method of administration Tranylcypromine 10mg Tablets/ Parnate 10mg Tablets are for oral administration only.

Tablets should be swallowed whole with a glass of water.

The following undesirable effects may occur with the use of Tranylcypromine in the following frequencies: Rare (≥1/10,000 to <1/1,000); Not known (cannot be estimated from the available data).

The following effects have been reported and are listed below by body system:

System organ class Frequency Undesirable effects Blood and lymphatic system disorders Rare blood dyscrasias Psychiatric disorders Rare Not known Hallucinations Hypomanias Drug dependence1 Insomnia2 Anxiety Agitation, Suicidal ideation6 Suicidal behaviours6 Restlessness Nervous system disorders Rare Not known Paraesthesia Peripheral neuritis Dizziness Somnolence Headache Sleep disturbances Throbbing headache5 Eye disorders Not known Vision blurred Cardiac disorders Not known Palpitations Vascular disorders Not known Orthostatic hypertension3 Hypertensive crisis4 Gastrointestinal disorders Not known Dry mouth, Diarrhoea Nausea Vomiting Hepatobiliary disorders Rare Hepatocellular injury Jaundice Skin and subcutaneous tissue disorders Not known Rash General disorders and administration site conditions Rare Not known Tolerance1 Fatigue weight gain Fluid retention 1Dependence on tranylcypromine with tolerance to high doses has been reported rarely and can occur in patients without past history of drug dependence.

This should be distinguished from the return of features of the original illness on cessation of treatment. , by reducing dosage, or by prescribing a mild hypnotic. 5). On occasions these have been fatal. Symptoms may be pain and stiffness in the neck, multiple extrasystoles, often with substernal pain, sweating and pallor, sometimes followed by flushing, mydriasis and photophobia.

5Throbbing headache may be an early warning of hypertensive crisis. 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Use tranylcypromine with great caution in elderly patients; in those with cardiovascular disease in whom physical activity should be regulated, as the drug may suppress anginal pain; and in epileptic patients, as tranylcypromine has a variable effect on the convulsive threshold in animals.

Tranylcypromine may aggravate some co-existing symptoms in depression such as anxiety and agitation. Tranylcypromine should preferably be withdrawn at least two weeks before elective surgery because of possible drug interaction. Caution should be exercised in prescribing tranylcypromine for patients with a previous history of dependence on drugs or alcohol.

Tranylcypromine therapy should be withdrawn gradually. Suicide/suicidal thoughts or clinical worsening Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events). This risk persists until significant remission occurs.

As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery.

Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.

A meta-analysis of placebo controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.

Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.

1. Do not give tranylcypromine until at least two weeks after stopping treatment with other MAOIs. Allow 3 weeks to elapse after stopping tranylcypromine before starting clomipramine or imipramine. Tranylcypromine should not be taken by patients suffering from porphyria.

Do not give tranylcypromine with indirectly acting sympathomimetic amines such as amphetamine, fenfluramine or similar anti-obesity agents, ephedrine or phenylpropanolamine (certain cold cures may contain such agents) or with levodopa or dopamine, as severe hypertensive reactions may result; with pethidine and closely related narcotic analgesics, and nefopam, as potentiation may occur; with dextromethorphan as a similar reaction has been reported; with other MAO Inhibitors, as symptoms of overdosage are possible; or with buspirone, since increased blood pressure may occur.

Reports of hyperactivity, hypertonicity, hyperpyrexia, coma and death have been associated with the use of tranylcypromine in combination with tricyclic antidepressants; Tetracyclic antidepressants should also be avoided. The use of clomipramine in patients already on tranylcypromine may be particularly hazardous.

Use of MAO inhibitors with or after fluvoxamine has been reported to produce a serotonin syndrome, sometimes fatal. Do not use tranylcypromine in patients with actual or suspected cerebrovascular disease or severe cardiovascular disease; in those with actual or suspected phaeochromocytoma, or with hyperthyroidism; or in those with known liver damage or blood dyscrasias.