PARAGORIESE-ELIKSER
SCHEDULING STATUS:
S2
PROPRIETARY NAME
(and dosage form):
PARAGORIESE-ELIKSER
COMPOSITION:
Each 5mL contains:
Opium Tincture0,25mL; AniseedOil0,015mL; Camphor14,97mg; BenzoicAcid24,95mg; Ethanol(100%) 58,5%v/v.
PHARMACOLOGICAL CLASSIFICATION:
A 2.7 Narcotic Analgesics.
PHARMACOLOGICAL ACTION:
Paragoriese-Elikser in addition to having analgesic and narcotic actions also has central stimulant actions. It depresses the thalamus, sensory cortex and respiratory and cough centres. It increases tone in involuntary muscle, especially the sphincters of the gastro-intestinal tract.
INDICATIONS:
The principal use of Paragoriese-Elikser is for the treatment of diarrhoea, abdominal pain and for the treatment of cough.
CONTRA-INDICATIONS:
It is contra-indicated in respiratory depression especially in the presence of cyanosis and excessive bronchial secretion. It is also contra-indicated in the presence of acute alcoholism, delirium tremens and convulsive disorders. It should not be given during an attack of bronchial asthma or in heart failure secondary to chronic lung disease.
It should be given with caution to patients with hypothyroidism, adrenocortical insufficiency, impaired liver function, prostatic hypertrophy, or shock.
DOSAGE AND DIRECTIONS FOR USE:
NOT TO BE USED FOR CHILDREN UNDER 2YEARS
Adults: One to two medicine measures (5- 10mL) up to four times daily.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The commonest are nausea, loss of appetite, constipation, confusion and sweating. Dry mouth, facial flushing, vertigo, bradycardia, palpitations, faintness, sedation, restlessness and changes of mood.
Habitual use may lead to drug dependence of the morphine type.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Coma, pinpoint pupils, depressed respiration and cyanosis, fall in body temperature and flaccid skeletal muscles.
The stomach should be emptied by aspiration and lavage; a 0,02% aqueous solution of potassium permanganate may be employed. A saline purgative such as sodium sulphate 30g in 250mL water should be given to aid peristalsis. Intensive supportive therapy may be necessary to correct respiratory failure and shock. In addition, the specific antagonist naloxone hydrochloride is used to counteract very rapidly the severe respiratory depression and coma produced by excessive doses of narcotic analgesics. Naloxone hydrochloride 400µg is given subcutaneously, intramuscularly, or intravenously repeated at intervals of 2or 3minutes if necessary. In children a dose of 5- 10µg per kg body weight may be given, while in neonates a dose of 10µg per kg body weight may be given.
IDENTIFICATION:
A bright, brown liquid with the odour of camphor.
PRESENTATION:
Bottles of 20mL.
STORAGE INSTRUCTIONS:
Store below 25°C
Keep container tightly closed
KEEP OUT OF REACH OF CHILDREN
APPLICATION NUMBER:
B888 (Act/Wet 101/1965).
NAME AND BUSINESS ADDRESS OF APPLICANT:
Lennon Limited
7 Fairclough Road
Port Elizabeth 6001
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
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