Brand Name

Trittico (Sold in the US under the brand name Desyrel)

Trittico (Austria; Colombia; Greece; Hong-Kong; Italy; Peru; Switzerland)

Other Brand Names

Desyrel; Sideril; Trazalon; Trazonil

Trazodone is an oral antidepressant drug that affects the chemical messengers (neurotransmitters) within the brain that nerves use to communicate with (stimulate) each other. The major neurotransmitters are acetylcholine, norepinephrine, dopamine and serotonin. Many experts believe that an imbalance among the different neurotransmitters is the cause of depression. Although the exact mechanism of action of trazodone is unknown, it probably improves symptoms of depression by inhibiting the uptake of serotonin by nerves in the brain. This results in more serotonin to stimulate other nerves. Trazodone also may increase directly the action of serotonin. Trazodone is chemically unrelated to the serotonin reuptake inhibitors (SSRIs), the tricyclic antidepressants (TCAs) or the monoamine oxidase inhibitors (MAO inhibitors). It is chemically related to nefazodone (Serzone) and shares its actions. Trazodone was approved by the Food and Drug Administration in 1982.

Trazodone is primarily used for the treatment of depression; however, it is sometimes prescribed as a sedative, and it also is used in combination with other drugs for the treatment of psychiatric conditions other than depression and cocaine withdrawal.

For the treatment of depression, the dose for adults is 150-600 mg per day. The initial starting dose usually is 150 mg per day. Trazodone is given in one or more daily doses, sometimes with the largest dose at night. As with all antidepressants, it may take several weeks for the full effects of treatment to be seen. Doses often are adjusted slowly upwards to find the optimal dose. Elderly patients and debilitated persons may need lower doses. Trazodone should be taken after a meal or light snack to reduce the risk of dizziness. Food also increases the amount of drug absorbed into the body.

All antidepressants that increase concentrations of serotonin in the brain, including trazodone, should not be taken with MAO-inhibitors. Drugs in the MAO-inhibitor class include isocarboxazid (Marplan), phenelzine (Nardil), tranylcypromine (Parnate), and procarbazine (Matulane). Such combinations may lead to confusion, high blood pressure and tremor. This same type of interaction may occur when trazodone is used with selegiline (Eldepryl). If a patient is switched from trazodone to an MAO inhibitor, at least one week should be allowed after stopping the trazodone before the MAO inhibitor is begun.

Increased blood concentrations of digoxin and phenytoin have been reported in persons taking trazodone due to a decrease in the metabolism (break-down and elimination) of these drugs by trazodone.

Foreign Brand Availability

• Azonz (Finland)
• Beneficat (Argentina)
• Bimaran (Argentina)
• Deprax (Spain)
• Depresil (Philippines)
• Depyrel (Israel)
• Desirel (Thailand)
• Manegan (Argentina)
• Molipaxin (England; Ireland; South-Africa)
• Pragmarel (France)
• Reslin (Japan)
• Taxagon (Argentina)
• Thombran (Germany)
• Trazodil (Israel)
• Trazolan (Belgium; India; Netherlands)
• Trazone (Indonesia; Portugal; Taiwan)
• Trittico (Austria; Colombia; Greece; Hong-Kong; Italy; Peru; Switzerland)

Details

Molipaxin® 50 mg tablets

Molipaxin® 100 mg tablets

Scheduling Status

S5

Proprietry Name (and dosage form)

Molipaxin® 50 mg tablets

Molipaxin® 100 mg tablets

Composition

50 mg capsule: trazodone hydrochloride 50 mg.

100 mg capsule: trazodone hydrochloride 100 mg.

Pharmacological Classification

A. 1.2 Psychoanaleptics (antidepressants).

Pharmacological Action

Trazodone hydrochloride is a triazolopyridine anxiolytic/anti-depressant, psychotropic agent.

Indications

Molipaxin is indicated in the treatment of depression, mixed anxiety and depression.

Contra-Indications

Combined use with other psychotropic drugs should only be undertaken with due recognition of the possibility of potentiation.

Pregnancy and lactation: The safety of Molipaxin in human pregnancy has not been established.

Dosage

The dosage is dependent upon the diagnosis and the severity of the condition and the individual patient's response. The daily dosage is usually administered in three divided doses.

Adults

Depression

The optimal dosage is between 300 - 400 mg/day. It is suggested that a starting dose of 150 mg/day is given for the first week, increasing to 300 mg/day or higher according to the clinical response (600 mg/day dosage has been reported).

Mixed anxiety and depression

The recommended starting dose is between 100 - 150 mg/day. When depression is the predominant symptom, a dose of 300 - 400 mg daily may be required to obtain a satisfactory response.

Children

Molipaxin is not recommended for use in children.

Side-Effects and Special Precautions

Molipaxin should be administered with care to patients receiving barbiturates, muscle relaxants and volatile anaesthetics, since it has been shown to potentiate the action of these substances. Patients should be warned about the possibility of their judgement being impaired when handling dangerous machinery and when driving.

The following side-effects have been noted:

• headache
• dizziness
• drowsiness
• nausea and vomiting
• weakness
• decreased alertness
• weight loss
• tremor
• dry mouth
• tachycardia
• constipation
• diarrhoea
• hypertension
• blurred vision
• excitement
• restlessness
• irritability
• confusional states
• insomnia
• skin rashes
• priapism.

Known Symptoms of Overdosage and Particulars of its Treatment

There is no specific antidote to Molipaxin. The stomach should be emptied as quickly as possible and symptomatic and supportive therapy given.

Storage Instructions

Store in a cool, dry place, below 25°C (77°F)

Protect from light.

Keep out of reach of children.

Registration Number

Molipaxin 50 mg tablets ––E/1.2/9

Molipaxin 100 mg tablets ––E/1.2/10