INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo PURAZINE TABLETS

SCHEDULING STATUS:
S2

PROPRIETARY NAME:
(and dosage form)

PURAZINE TABLETS

COMPOSITION:
Each tablet contains 25 mg
Cinnarizine.

PHARMACOLOGICAL CLASSIFICATION:
A 5.7 - Antihistamines, anti-emetics and anti-vertigo preparations.

PHARMACOLOGICAL ACTION:
Cinnarizine has the properties of an antihistamine. Its effect lasts for about 4 hours.

INDICATIONS:
Nausea and vertigo due to Meniéres disease and symptoms of other labyrinthine disturbances and for the prevention and treatment of motion sickness.

CONTRA-INDICATIONS:
Cinnarizine should not be administered to patients sensitive to the medicine and to pregnant women, or those who may become so, as this medicine has been demonstrated to have teratogenic effects in laboratory animals.
Cinnarizine is contra-indicated during acute attacks of asthma.

WARNING:
THE USE OF THIS MEDICINE LEADS TO DROWSINESS WHICH IS AGGRAVATED BY THE SIMULTANEOUS INTAKE OF ALCOHOL OR OTHER CENTRAL NERVOUS SYSTEM DEPRESSANT AGENTS.

DOSAGE AND DIRECTIONS FOR USE:
Adults:
One tablet 3 times per day. This may be increased to 9 tablets daily if necessary. Treatment should be started in the early stages of the disease and should continue uninterrupted for several weeks or months or longer periods.
For the prophylaxis of motion sickness, 1 tablet should be given 1 hour before departure and this dosage may be repeated every 6 to 8 hours.
Children:
Children aged 5 to 7 years may be given 15 to 20 mg daily in divided doses and older children up to 30 mg daily according to age.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The most common effect is sedation, varying from slight drowsiness to deep sleep and including lassitude, dizziness and inco-ordination. Other side effects include gastro-intestinal disturbances such as nausea, vomiting, diarrhoea or constipation, anorexia or increased appetite, and epigastric pain.
Cinnarizine may also produce antimuscarinic effects including blurred vision, difficulty in micturition, impotence, dysuria, dryness of the mouth, and tightness of the chest. Other central effects include hypotension, muscular weakness, tinnitus, euphoria and headache.
Paradoxical CNS stimulation may occur especially in children, with insomnia, nervousness, tachycardia, tremors and convulsions.
Cinnarizine may precipitate epileptiform seizures in patients with focal lesions of the cerebral cortex.
Glaucoma may be precipitated in susceptible individuals. It may intensify responses to norepinephrine or stimulation of adrenergic nerves and inhibit responses to tyramine apparently by blocking the amine uptake mechanism in the terminals.
Allergy may develop. Allergic dermatitis is not uncommon. Leucopenia and agranulocytosis have been reported. The possibility of some dulling of mental alertness should be borne in mind when the subject may be called upon to perform potentially hazardous tasks, such as driving a car.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The central effects of cinnarizine constitutes its greatest danger, and, in a severely poisoned individual, gives rise to a constellation of signs and symptoms in which both the depressant and stimulant properties of the medicine are in evidence. In the small child the dominant effect is excitation and the syndrome of poisoning includes hallucinations, excitement, ataxia, inco-ordination, athetosis and convulsions. The convulsions are of the intermittent tonic-clonic type and difficult to control. Fixed, dilated pupils with a flushed face and fever are common and lend the syndrome a remarkable similarity to that of atropine poisoning. Terminally there is a deepening coma with cardiorespiratory collapse and death usually within 2 to 18 hours. In the adult, fever and flushing are not usually in evidence, and the phase of excitement leading to convulsions and postictal depression is not uncommonly preceded by drowsiness and coma, so that there is a cycle of depression followed by stimulation and postictal depression.
Hypotension may also occur. Elderly patients are more susceptible to the CNS depressant and hypotensive effects even at therapeutic doses.
Treatment:
There is no specific therapy for cinnarizine poisoning and treatment is along general symptomatic and supportive lines.
The stomach should be emptied by aspiration and lavage. Emetics may be tried if the patient is alert and there are no symptoms of toxicity, but may be ineffective due to the anti-emetic activity of the antihistamine.
The direct depressant effect of cinnarizine is not as profound as that of barbiturates. Respiration is usually not seriously affected, and blood pressure is fairly well maintained. Should breathing fail, the mechanical support of ventilation offers a safer and more effective means of maintaining respiration than the use of analeptics, which are prone to initiate or intensify the convulsive phase. When convulsions develop, they are best countered by a short-acting depressant such as thiopental to provide a rapid, transient and controllable effect; diazepam is also worthy of a trial. Additive effects may be expected when used in combination with alcohol, sedatives and tranquillisers.

IDENTIFICATION:
White, flat, bevelled edged, bisected tablets, 9 mm diameter, engraved with the mortar and pestle on one side.

PRESENTATION:
Blister packs of 10 tablets.
Securitainers of 30 and 100 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C.
Protect from moisture.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
J/5.7/277.

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited
7 Fairclough Road
Korsten
Port Elizabeth
6020

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
20 April 1977

308511 020923        Harry’s Printers K32487 L04

Updated on this site: April 2005
Source: Hospital Pharmacy

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