Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Focus Pharmaceuticals Limited, Capital House, 85 King William Street, London, EC4N 7BL, United Kingdom
Low dosage: Trifluoperazine oral solution is indicated as an adjunct in the short-term management of anxiety states, depressive symptoms secondary to anxiety and agitation. Orally it is also indicated in the symptomatic treatment of nausea and vomiting.
High dosage: Trifluoperazine oral solution is intended for the treatment of symptoms and prevention of relapse in schizophrenia and in other psychoses, especially of the paranoid type, but not in depressive psychoses. It may also be used as an adjunct in short-term management of severe psychomotor agitation and of dangerously impulsive behaviour in, for example, mental subnormality.
Low dosage: 2-4 mg a day given in divided doses, according to the severity of the patient’s condition. If necessary, dosage may be increased to 6 mg a day, but above this level extrapyramidal symptoms are more likely to occur in some patients.
High dosage: The recommended starting dosage for physically fit adults is 5 mg twice a day after a week this may be increased to 15 mg a day. If necessary, further increases of 5 mg may be made at three-day intervals, but not more often. When satisfactory control has been achieved, dosage should be reduced gradually until an effective maintenance level has been established.
As with all major tranquillisers, clinical improvement may not be evident for several weeks after starting treatment, and there may be delay before recurrence of symptoms after stopping treatment. Gradual withdrawal from high dosage treatment is advisable.
Low dosage: For children 3-5 years, up to 1 mg a day given in divided doses.
For children aged 6-12 years, the dosage may be increased to a maximum of 4 mg a day.
High dosage: For children aged 6-12 years, the initial oral dosage should not exceed 5 mg a day, given in divided doses. Any subsequent increase should be made with caution, at intervals of not less than three days, and taking into account age, body weight and severity of symptoms.
Reduce starting dose in elderly or frail patients by at least half.
Oral use.
A graduated oral syringe, a Press-In bottle Adaptor and a graduated dosing cup are provided with the product.
Signs and symptoms will be predominantly extrapyramidal; hypotension may occur. Treatment consists of gastric lavage together with supportive and symptomatic measures. Do not induce vomiting. Extrapyramidal symptoms may be treated with an anticholinergic antiparkinsonism drug. Treat hypotension with fluid replacement; if severe or persistent, noradrenaline may be considered. Adrenaline is contraindicated.
24 months unopened.
Once the bottle is opened use within 2 months.
Keep bottle in the original carton to protect from light.
Amber (Type III) glass bottle of 150 ml fill volume, with child-resistant, tamper-evident screw cap with an LDPE liner.
A 5 ml dosing syringe with intermediate graduations of 0.1 ml and a “press-in” syringe/bottle adaptor are provided. A 20 ml dosing cup with intermediate graduations is also provided with the product.
None.
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