PHARMACOLOGICAL CLASSIFICATION: A. 10.1 Antitussives and expectorants.
INDICATIONS: For the alleviation of cough.
CONTRA-INDICATIONS: Known hypersensitivity to diphenhydramine or ammonium chloride.
Tusquit Elixir should be used with caution in patients with glaucoma and prostatic hypertrophy. It should also be used with caution in patients receiving aminoglycoside antibiotics since it could mask warning symptoms of ototoxicity. Tusquit Elixir is contra-indicated in the presence of impaired hepatic or renal failure and in patients receiving mono-amine oxidase inhibitors. The safety of this preparation during pregnancy has not been established.
WARNING: The use of this medicine may lead to drowsiness and dulling of mental alertness which may be aggravated by the simultaneous intake of alcohol. Diphenhydramine hydrochloride may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers.
When using Tusquit Elixir, it may be dangerous to take charge of vehicles, or other means of transport or machinery where loss of attention may lead to accidents.
DOSAGE AND DIRECTIONS FOR USE:
Adults: 10 mL every three to four hours, with meals. As a guideline: 3 - 4 hourly 1 3 years: 2,5 mL
4 7 years: 5 mL
8 - 14 years: 7,5 mL
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: The most common effect is drowsiness and reduced reactions. This includes drowsiness, inability to concentrate, lassitude, dizziness, hypotension, muscular weakness, and inco-ordination.
Other side effects include gastro-intestinal disturbances such as nausea, vomiting, diarrhoea or constipation, and epigastric pain. By giving the elixir with meals their incidence may be reduced. Tusquit Elixir may also produce headache, blurred vision, tinnitus, elation or depression, irritability, nightmares, anorexia, difficulty in micturition, dryness of the mouth, tightness of the chest, and tingling, heaviness and weakness of the hands.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: In infants and children the dominant effect is excitation including hallucinations, excitement, ataxia, inco-ordination, athetosis, and convulsions (tonic-clonic). Fixed, dilated pupils with a flushed face and fever are common.
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 there is a cycle of depression followed by stimulation and postictal depression.
Large doses may precipitate convulsions in epileptics.
Large doses of ammonium chloride may cause nausea and vomiting, thirst, headache, hyperventilation, and progressive drowsiness and lead to profound acidosis and hypokalaemia.
If the drug has recently been ingested by mouth the stomach should be emptied by aspiration and lavage. Emetics should not be given. Treatment is symptomatic with rapid acting anti-convulsant therapy.
Acidosis and electrolyte loss may be corrected by intravenous administration of sodium bicarbonate or sodium lactate and hypokalaemia by oral potassium tablets.
IDENTIFICATION: A dark brown liquid, with a blackcurrant flavour.
PRESENTATION: 100 mL amber glass bottles; 50 mL, 100 mL and 200 mL amber polyvinyl chloride bottles and 2,5 litre amber polyethylene cans.
STORAGE INSTRUCTIONS: Store below 25°C in tightly closed containers. Protect from light
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER: T/10.1/44
NAME AND BUSINESS ADDRESS OF THE APPLICANT: XIXIA Pharmaceuticals (Pty) Ltd
15 Thora Crescent,
Wynberg Ext. 3,
P.O. Box 2080, Gallo Manor, 2052.