COMPOSITION: Tablets each containing: Promethazine Theoclate 25 mg
PHARMACOLOGICAL CLASSIFICATION: A 5.7.2 Anti-emetics and antivertigo preparations.
PHARMACOLOGICAL ACTION: AVOMINE is an active, well tolerated, anti-emetic for use in the prevention and treatment of travel sickness.
INDICATIONS: AVOMINE gives highly successful results in the prevention and treatment of seasickness, car-sickness, train-sickness and air-sickness; it may be used routinely for prevention and also for the treatment of established cases.
CONTRA-INDICATIONS: This product should not be used in children under 2 years of age because the safety of such use has not been established. Safety in pregnancy and lactation has not been established.
WARNINGS: The use of this medicine may lead to drowsiness and impaired concentration which may be aggravated by the simultaneous intake of alcohol or other central nervous system depressant agents.
Patients should be warned against taking charge of vehicles or machinery or performing potentially hazardous tasks where loss of concentration may lead to accidents.
DOSAGE AND DIRECTIONS FOR USE:
Long journeys: one tablet each night at bedtime commencing on the night before travelling.
Short journeys: one tablet to be taken 1 - 2 hours before the journey commences.
For Treatment One tablet, followed by a second tablet the same evening and a third tablet on the following evening. Prompt treatment is important.
Additional tablets may safely be taken for prophylaxis or when they appear to be needed but it will seldom be necessary to give more than four tablets in 24 hours or to repeat a dose in less than 8 hours.
CHILDREN: 5 - 10 years: one half the corresponding adult dosage.
Over 10 years: corresponding adult dosage.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: The most common side-effect of promethazine is sedation, varying from slight drowsiness to deep sleep, and including lassitude, dizziness and incoordination.
Sedative effects, when they occur, may diminish after a few days of treatment.
Paradoxical CNS stimulation may occur especially in children, with insomnia, nervousness, euphoria, irritability, tremors, nightmares, hallucinations, and convulsions. In high doses, CNS stimulation may be attributed to antimuscarinic activity.
Extrapyramidal symptoms may develop.
Other adverse effects include dry mouth, thickened respiratory tract secretions and tightness of the chest, blurred vision, urinary difficulty and retention, a reduction in tone and motility of the gastro-intestinal tract resulting in constipation and increased gastric reflux; at high doses, transient bradycardia followed by tachycardia with palpitations and arrhythmias; also at high doses, CNS stimulation. In addition, constipation and gastro-intestinal disturbances such as nausea, vomiting, diarrhoea or epigastric pain have occurred. Anorexia has been observed.
Systemic or topical therapy may produce hypersensitivity reactions, particularly of the skin, and cross-sensitivity to related drugs may occur. Photosensitivity has been reported. Blood disorders, including agranulocytosis, leucopenia, haemolytic anaemia, and thrombocytopenia, have been reported; these may have an immune basis.
Other adverse effects that have been reported include hypotension, tinnitus, headache and paraesthesias.
Jaundice has been reported and extrapyramidal effects may occur at high doses. Precautions: False negative and positive results have been reported with some pregnancy tests.
Elderly patients are also more susceptible to many adverse effects of promethazine, including antimuscarinic effects, sedation, and hypotension.
Promethazine should be used with care in conditions such as closed-angle glaucoma, urinary retention, prostatic hypertrophy, or pyloroduodenal obstruction.
Other adverse effects of promethazine suggest caution in patients with epilepsy, severe cardiovascular disorders, or in those with liver disorders.
Promethazine may enhance the sedative effects of central nervous system depressants including alcohol, barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives, and neuroleptics. MAOIs may enhance the antimuscarinic effects of promethazine and promethazine has an additive antimuscarinic action with other antimuscarinic agents, such as atropine and tricyclic antidepressants. It has been suggested that promethazine could mask the warning signs of damage caused by ototoxic drugs such as aminoglycoside antibiotics.
Promethazine may suppress positive skin test results and should be stopped several days before the test.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: See "Side-effects and Special Precautions" above. Treatment is symptomatic and supportive.
IDENTIFICATION: White, round, slightly biconvex tablets, imprinted AVOMINE. Reverse side has a breakline.
PRESENTATION: Blister packs of 10.
STORAGE INSTRUCTIONS: Store below 25°C.
Protect from light.
KEEP OUT OF REACH OF CHILDREN.
APPLICATION NUMBER: C851 (Act 101/1965).
NAME AND BUSINESS ADDRESS OF APPLICANT: PHARMACARE LIMITED
(Co. Reg. No. 1898/000252/06)
7 Fairclough Road
DATE OF PUBLICATION OF THIS PACKAGE INSERT: December 1979.
Harry's Printers K00000 E03
New addition to this site: April 2005
Source: Pharmaceutical Industry