Source: Health Products Regulatory Authority (ZA) Revision Year: 2023 Publisher: AstraZeneca Pharmaceuticals (Pty) Limited, Building 2 Northdowns Office Park, 17 Georgian Crescent West, Bryanston, Johannesburg, 2191, South Africa
TRUVALIN is indicated for the treatment of schizophrenia.
TRUVALIN is also indicated for the treatment of manic episodes associated with a bipolar disorder. Safety and efficacy beyond 12 weeks has not been demonstrated.
TRUVALIN should be administered twice daily, with or without food.
For the treatment of schizophrenia, the total daily dose for the first 4 days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4).
From Day 4 onwards, the dose should be titrated to the effective dose range of 300-450 mg/day. Depending on the clinical response and tolerability of the individual patient, the dose may be adjusted in some patients within the range 150-750 mg/day.
For the treatment of manic episodes associated with bipolar disorder, the total daily dose for the first 4 days of therapy is 100 mg (Day 1), 200 mg (Day 2), 300 mg (Day 3) and 400 mg (Day 4). Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day.
The dose may be adjusted depending on the clinical response and tolerability of the individual patient, within the range of 200-800 mg/day. The usual effective dose is in the range of 400-800 mg/day.
TRUVALIN should be used with caution in the elderly, especially during the initial dosing period. Elderly patients should be started on TRUVALIN 25 mg/day. The dose should be increased daily, in increments of 25-50 mg, to an effective dose, which is likely to be lower than that in younger patients.
The clearance of TRUVALIN is reduced by approximately 25% in patients with renal or hepatic impairment. TRUVALIN is extensively metabolised by the liver, and therefore should be used with caution in patients with known hepatic impairment.
In clinical trials, experience with TRUVALIN in overdosage is limited. In post-marketing experience, there have been very rare reports of overdose of TRUVALIN alone resulting in death or coma.
In general, reported signs and symptoms were those resulting from an exaggeration of the medicine’s known pharmacological effects, i.e. drowsiness, sedation, tachycardia, hypotension and anticholinergic effects.
There is no specific antidote to quetiapine. Treatment is symptomatic and supportive. In this context, published reports in the setting of anti-cholinergic symptoms describe a reversal of severe CNS effects, including coma and delirium, with administration of intravenous physostigmine (1-2 mg), under continuous ECG monitoring.
In cases of quetiapine overdose refractory hypotension should be treated with appropriate measures such as intravenous fluids and/or sympathomimetic agents (epinephrine and dopamine should be avoided, since beta stimulation may worsen hypotension in the setting of quetiapine induced alpha blockade).
36 months.
Store at or below 30°C.
Protect from moisture.
Do not remove from carton until required for use.
TRUVALIN tablets are packed into white opaque PVC aluminum foil blisters with each blister strip containing 6 or 10 tablets, packed into unit cartons.
TRUVALIN 25: Packs of 6 or 100 tablets.
TRUVALIN 100: Packs of 60, 90 or 100 tablets.
TRUVALIN 200: Packs of 60, 90 or 100 tablets.
TRUVALIN 300: Packs of 60, 90 or 100 tablets.
Not all pack sizes may be marketed.
No special requirements.
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