TRITTICO TABLETS 50 MG [SIN10777P]
Active ingredients: TRITTICO TABLETS 50 MG
Product Info
TRITTICO TABLETS 50 MG
[SIN10777P]
Product information
Active Ingredient and Strength | TRAZODONE HCL - 50 MG |
Dosage Form | TABLET, FILM COATED |
Manufacturer and Country | AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO ACRAF SPA - ITALY |
Registration Number | SIN10777P |
Licence Holder | INDRUGCO PTE LTD |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | N06AX05 |
Prescription-only Medicines with Exemptions for Supply without Prescription | NA |
Indication
4.1 Therapeutic indications
Treatment of depression, with or without anxiety, in adults.
Dosing
4.2 Posology and method of administration
Posology
The dosage should be determined with caution and treatment initiated with the minimum effective dose. The patient should be reassessed regularly. It is recommended to start treatment with a night-time dose and increasing daily doses. The course of treatment should last at least one month.
TABLETS
The tablets can be split to enable gradual dosing with divided doses, depending on the severity of the disease and the patient's weight, age and general condition.
Adults:
initially 75 – 150 mg daily, administered in divided doses after meals. The night-time dose must be taken before bedtime
The dose may be increased to up to 300 mg daily, to be taken in divided doses, with the largest part taken at bedtime.
In hospitalised patients, the dose may be increased further, to up to 600 mg daily in divided doses.
Elderly and frail patients
The recommended starting dose is 100 mg daily, administered in a single daily dose or divided into several doses. The daily dose may be increased to up to 150 mg daily if well tolerated. Patients should not exceed the maximum dose of 300 mg per day.
Paediatric population
Trittico is contraindicated in children and adolescents (see section 4.3).
Hepatic and renal impairment
Caution should be exercised in the event of hepatic impairment or severe renal impairment (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Method of administration
Take the tablet with water or other liquid. Should preferably be taken on a full stomach.
Taking Trittico after meals reduces the occurrence of undesirable effects.
Contraindications
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Alcohol intoxication and intoxication with hypnotics.
Acute myocardial infarction.
Children and adolescents.
