NAUTISOL Tablet Ref.[28284] Active ingredients: Prochlorperazine

Posology

Adults

• Prevention of nausea and vomiting: 5 mg to 10 mg two or three times a day.
• Treatment of nausea and vomiting: 20 mg stat, followed if necessary by 10 mg two hourslater.
• Vertigo and Meniere’s syndrome: 5 mg three times a day increasing if necessary to a total of 30 mg daily. After several weeks dosage may be reduced gradually to 5 mg – 10 mg daily.
• Adjunct in the short term management of anxiety: 15 mg – 20 mg daily, in divided doses initially, but this may be increased if necessary to a maximum of 40 mg daily, in divided doses.
• Schizophrenia and other psychotic disorders: Usual effective daily oral dosage is in the order of 75 mg – 100 mg daily. Patients vary widely in response. The following schedule is suggested: Initially 12.5 mg twice daily for 7days, the daily amount being subsequently increased 12.5 mg at 4 to 7 days interval until a satisfactory response is obtained. After some weeks at the effective dosage, an attempt should be made reduce this dosage. Total daily amounts as small as 50 mg, or even 25 mg, have sometimes been found to be effective.

Paediatric population

Prevention and treatment of nausea and vomiting. If it is considered unavoidable to use prochlorperazine for a child, the dosage is 0.25 mg/kg bodyweight two or three times a day. Prochlorperazine is not recommended for children weighing less than 10 kg or below 1 year of age.

Elderly

A lower dose is recommended. Please see section 4.4).

Method of administration

Oral administration.

Symptoms

Symptoms of phenothiazine overdosage include drowsiness or loss of consciousness, hypotension, tachycardia, ECG changes, ventricular arrhythmias and hypothermia. Severe extrapyramidal dyskinesias may occur.

Management

If the patient is seen sufficiently soon (up to 6 hours) after ingestion of a toxic dose, gastric lavage may be attempted. Pharmacological induction of emesis is unlikely to be of any use. Activated charcoal should be given. There is no specific antidote. Treatment is supportive.

Generalised vasodilatation may result in circulatory collapse; raising the patient’s legs may suffice. In severe cases, volume expansion by intravenous fluids may be needed; infusion fluids should be warmed before administration in order not to aggravate hypothermia.

Positive inotropic agents such as dopamine may be tried if fluid replacement is insufficient to correct the circulatory collapse. Peripheral vasoconstrictor agents are not generally recommended. Avoid the use of adrenaline.

Ventricular or supraventricular tachy-arrhythmias usually respond to restoration of normal body temperature and correction of circulatory or metabolic disturbances. If persistent or life threatening, appropriate anti-arrhythmic therapy may be considered. Avoid lidocaine and, as far as possible, long acting anti-arrhythmic drugs.

Pronounced central nervous system depression requires airway maintenance or, in extreme circumstances, assisted respiration. Severe dystonic reactions usually respond to procyclidine (5-10 mg) or orphenadrine (20-40 mg) administered intramuscularly or intravenously. Convulsions should be treated with intravenous diazepam.

Neuroleptic malignant syndrome should be treated with cooling. Dantrolene sodium may be tried.

5 years.

This medicinal product does not require any special storage conditions.

Tablets are packed in aluminium foil – polyvinylchloride film blisters, with a patient information leaflet, in cartons of 20, 50 or 60 tablets.

Tablets are also packed in polyvinylchloride securitainers containing 100, 500 or 1000 tablets.

Not all pack sizes may be marketed.

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.