Trittico XR (trazodone hydrochloride) coated prolonged release tablets 300 mg. №30

Description

Trittico XR (trazodone hydrochloride) coated prolonged release tablets 300 mg. №30

Composition

active substance: trazodone hydrochloride;

1 tablet contains trazodone hydrochloride 150 mg or 300 mg;

Excipients: hypromellose, colloidal anhydrous silica, sodium stearyl fumarate, modified pregelatinized starch (E 1442);

shell composition:

• 150 mg tablets: Opadry II, Yellow 85F92421 coating mixture (polyvinyl alcohol, talc, macrogol, titanium dioxide (E 171), iron oxide yellow (E 172), iron oxide red (E 172));
• 300 mg tablets: Opadry II, Pink 85F94306 coating mixture (polyvinyl alcohol, talc, macrogol, titanium dioxide (E 171), iron oxide yellow (E 172), iron oxide red (E 172)).

Dosage form

Prolonged-release film-coated tablets.

Basic physical and chemical properties:

• 150 mg tablets: yellow-beige oblong film-coated tablets with a central fracture line on both sides;
• 300 mg tablets: Beige-orange oblong film-coated tablets with a center line on both sides.

Pharmacotherapeutic group

Psychoanaleptics. Antidepressants. Other antidepressants. ATX code N06A X05.

Pharmacological properties

The drug Trittico XR tablets combines antidepressant (thymoleptic) with anxiolytic (tranquilizing) action. Selectively inhibits neuronal reuptake of serotonin, blocks α-adrenergic receptors.
It is quickly and completely absorbed in the digestive tract; simultaneous food intake slows down the absorption of trazodone. Cmax in blood plasma is reached approximately 1 hour after administration. Penetrates through histohematogenous barriers, including the BBB. Penetrates into tissues and secretions (bile, saliva, breast milk, etc.). In the liver, it undergoes biotransformation. Elimination is biphasic with T1 / 2 in the first phase 36 hours, and 59 hours in the second. Cumulation in the body is possible. It is excreted mainly in the urine unchanged and in the form of metabolites.

Indications

Depressive disorders with/without anxiety.

Contraindications:

• known hypersensitivity to the drug or its components;
• alcohol intoxication and intoxication with sleeping pills;
• acute myocardial infarction.

Method of application and dosage

Trittico XR tablets is for use in adult patients only.

Trittico XR tablets can be divided, which allows for a gradual increase in dosage depending on the severity of the disease, body weight, age and general condition of the patient.

Trittico XR tablets should be taken before a meal with a glass of water; when used once a day, it is desirable to take the drug in the evening or just before bedtime.

To ensure the prolonged action of the tablets, they should not be crushed or chewed; if necessary, the tablets are divided by pressing the halves of the tablet on both sides of the center line of the fracture on both sides.

The initial dose is 75 ̶ 150 mg per day and can be increased by 75 mg per day (half a tablet of 150 mg) every three days (for example, up to 225 mg per day on the fourth day of treatment) to a maximum dose of 300 mg per day for one reception.

The long-term efficacy of long-acting trazodone in maintaining the antidepressant effect has not been studied.

Children

Do not use in children.

Overdose

The most common overdose is drowsiness, dizziness, nausea and vomiting. In severe cases, coma, tachycardia, hypotension, hyponatremia, convulsions, and respiratory failure occurred.

Cardiac symptoms may include bradycardia, QT prolongation, and polymorphic ventricular tachycardia (torsade de pointes).

Symptoms may appear within 24 hours of an overdose or later.

Concomitant overdose of trazodone and other antidepressants may cause serotonin syndrome.

Side effects

Cases of suicidal ideation and suicidal behaviors have been reported during or shortly after trazodone therapy.

The following symptoms have also been reported in patients receiving trazodone therapy, some of which are common in untreated depression.