Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
Vertigo due to Meniere’s Syndrome, labyrinthis and other causes, and for nausea and vomiting from whatever cause including that associated with migraine.
It may also be used for schizophrenia (particularly in the chronic stage), acute mania and as an adjunct to the short-term management of anxiety.
| Indication | Dosage |
|---|---|
| Prevention of nausea and vomiting | 5–10 mg b.d. or t.d.s. |
| Treatment of nausea and vomiting | 20 mg stat, followed if necessary by 10 mg two hours later. |
| Vertigo and Meniere’s syndrome | 5 mg t.d.s. increasing if necessary to a total of 30 mg daily. After several weeks dosage may be reduced gradually to 5–10 mg daily. |
| Adjunct in the short term management of anxiety | 15–20 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 75–100 mg daily. Patients vary widely in response. The following schedule is suggested: Initially 12.5 mg twice daily for 7 days, the daily amount being subsequently increased 12.5 mg at 4–7 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. |
| Indication | Dosage |
|---|---|
| Prevention and treatment of nausea and vomiting | If it is considered unavoidable to use Stemetil for a child, the dosage is 0.25 mg/kg bodyweight two or three a day. Stemetil is not recommended for children weighing less than 10 kg or below 1 year of age. |
A lower dose is recommended (see section 4.4).
Oral administration.
Symptoms of phenothiazine overdose include drowsiness or loss of consciousness, hypotension, tachycardia, ECG changes, ventricular arrhythmias and hypothermia. Severe extrapyramidal dyskinesias may occur.
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.
3 years.
Store in original packaging in order to protect from light.
Stemetil tablets 5mg are available in “securitainers” or HDPE bottles in packs of 25, 250 and 1000 tablets and PVDC coated UPVC/aluminium foil blisters containing 28 or 84 tablets.
Not all pack sizes may be marketed.
No special requirements.
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