Source: Health Products Regulatory Authority (ZA) Publisher: Adcock Ingram Limited, 1 New Road, Erand Gardens, Midrand, 1685, Customer Care: 0860/ADCOCK (232625)
TRINTOGEN is indicated for the treatment of major depressive disorder and to reduce the risk of relapse.
The starting and recommended dose of TRINTOGEN is 10 mg once daily.
Depending on the individual patient response, the dose may be increased to a maximum of 20 mg daily or reduced to a minimum of 5 mg daily.
If a dose increase is required, this should be in periods of not less than one week of treatment. A dose decrease may be considered for patients who do not tolerate higher doses.
After the depressive symptoms resolve, treatment for a least 6 months is recommended for consolidation of the anti-depressive response.
Patients being treated with TRINTOGEN can abruptly stop taking TRINTOGEN without the need for a gradual reduction in dose.
The safety and efficacy of TRINTOGEN have been established in elderly patients. However, caution should be exercised when treating the elderly. Treatment should be initiated with 5 mg daily and, depending on the individual response, the dose may be increased to 10 mg daily. Limited data are available with doses exceeding 10 mg daily.
No dose adjustment is needed for patients with renal impairment or for patients with end-stage renal disease. However, caution should be exercised when treating patients with severe renal insufficiency (see section 5.2).
No dose adjustment is needed for patients with mild or moderate hepatic impairment. TRINTOGEN has not been studied in patients with severe hepatic impairment and caution should be exercised when prescribing to these patients (see section 5.2).
The safety and efficacy of TRINTOGEN in children and adolescents aged less than 18 years have not been established. No data are available.
Depending on individual patient response, a lower dose of TRINTOGEN may be considered if strong CYP2D6 inhibitors (e.g. bupropion, quinidine, fluoxetine, paroxetine) are added to TRINTOGEN treatment (see section 4.5).
Depending on individual patient response, a dose adjustment of TRINTOGEN may be considered if a broad cytochrome P450 inducer (e.g. rifampicin, carbamazepine, phenytoin) is added to TRINTOGEN treatment (see section 4.5)
TRINTOGEN is for oral use in adults.
TRINTOGEN can be taken without regard to meals.
There is limited experience with TRINTOGEN overdosage. In clinical studies, no patient ingested more than 75 mg vortioxetine (as in TRINTOGEN) on a single occasion.
Ingestion of vortioxetine in clinical trials in the dose range of 40 mg to 75 mg has caused an aggravation of the following adverse reactions: nausea, postural dizziness, diarrhoea, abdominal discomfort, generalised pruritus, somnolence and flushing.
Management of overdose should consist of treating clinical symptoms and relevant monitoring. Medical follow-up in a specialised environment is recommended.
No information.
24 months.
Store at or below 25°C.
Do not remove the blister from the carton until required for use.
TRINTOGEN does not require any special storage condition (please refer to section 6.3).
TRINTOGEN is packed in Alu/Alu blister pack of cold form blister (made of OPA film, soft tempered aluminium foil and PVC film) and aluminium foil. Such blisters are further packed in a carton along with the professional information and patient information leaflet.
Available in pack sizes of 28's and 30's.
Not all pack sizes may be marketed.
Any unused medicine or waste material should be disposed of in accordance with local requirements.
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