PHARMACOLOGICAL CLASSIFICATION: A. 2.9Other analgesics
Doxyfene combines the analgesic effect of propoxyphene which acts on the central nervous system by blocking the transmission at the synapsis with the analgesic effect of paracetamol, which acts peripherally. Paracetamol also acts as an antipyretic.
INDICATIONS: For the relief of pain and fever.
CONTRA-INDICATIONS: Not to be taken during pregnancy.
Alcohol and central nervous system depressants should not be taken with propoxyphene. Not to be given to patients with known sensitivity to individual ingredients.
WARNING: Do not use continuously for more than 10 days without consulting your doctor.
DOSAGE AND DIRECTIONS FOR USE:
Children: 6 - 12 years:
1 Capsule four times daily.
1 - 2 capsules four-hourly.
Not intended for children younger than 6 years.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Care should be taken in prescribing this product to persons susceptible to drug dependence. Hepatotoxiciry can occur. Nausea, dizziness (propoxyphene)- Allergic reactions (paracetamol and propoxyphene).
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The manifestations of serious overdosage with propoxyphene are similar to those of narcotic overdosage and include: respiratory depression (a decrease in respiratory rate and/or tidal volume, CheyneStokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, pupillary constriction, and circulatory collapse. In addition to these characteristics typical of narcotic poisoning, focal and generalized convulsions constitute a prominent feature in most cases of severe propoxyphene poisoning, cardiac arrythmias and pulmonary oedema have occasionally been reported. Apnoea, cardiac arrest and death have occured. Paracetamol:
Nausea, vomiting, restlessness, drowsiness, abdominal pain, gastrointestinal haemorrhage, potentially fatal liver damage, cerebral oedema and renal tubular necrosis,hyperglycaemia or hypoglycaemia. Central stimulation and exhilaration, followed by cardiovascular collapse, respiratory depression and coma. Liver damage which may be fatal may only appear after a few days. Kidney failure has been described following acute intoxication. Treatment:
Primary attention should be given to the re-establishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. The narcotic antagonists, naloxone, nalorphine and levallorphan, are specific antidotes against the respiratory depression produced by propoxyphene. An appropriate dose of one of these antagonists should be administered, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation, and the administering of the antogonist should be repeated as necessary until the patient's condition remains satisfactory. In addition to the use of a narcotic antagonist, the patient may require careful titration with an anticonvulsant to control convulsions. Analeptlc drugs (e.g. caffeine or amphetamine) should not be used because of their tendency to precipitate convulsions. Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Gastric lavage may be helpful. Activated charcoal can absorb a significant amount of ingested propoxyphene. Dialysis is of little value In poisoning by propoxyphene alone.
in the event of an overdosage of Paracetamol, consult a doctor or take the patient to the nearest hospital immediately. Specialised treatment is essential as soon as possible. The latest information regarding the treatment of overdosage can be obtained from the nearest poison centre.
IDENTIFICATION: Opaque blue and grey capsule.
PRESENTATION: Containers with 20, 100and 1 000 capsules.
STORAGE INSTRUCTIONS: Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER: E/2.9/97
NAME AND BUSINESS ADDRESS OF THE APPLICANT: The Premier Pharmaceutical Company Limited
17 Harrison Avenue
Bryanston Ext. 77
Private Bag X69
DATE OF PUBLICATION OF THIS PACKAGE INSERT: 31 July 1973
New addition to this site: April 2004
Source: Pharmaceutical Industry