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

Logo DOSTIL PED (syrup)

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

DOSTIL PED (syrup)

COMPOSITION:
Each 5 mL syrup contains:
Paracetamol         150 mg
Codeine phosphate         4 mg
Alcohol         9,6% v/v
Preservative: 
Nipasept         0,06% m/v

PHARMACOLOGICAL CLASSIFICATION:
A.2.8 Analgesic combinations

PHARMACOLOGICAL ACTION:
Dostil Ped has analgesic and antipyretic actions.

INDICATIONS:
For the symptomatic relief of mild to moderate pain, and fever in children.

CONTRA-INDICATIONS:
Hypersensitivity to paracetamol.
Dostil Ped is contra-indicated in respiratory depression and in patients receiving monoamine oxidase inhibitors or within 10 days of stopping such treatment.

WARNING:
Dosages in excess of those recommended may cause severe liver damage. Do not use continuously for more than 10 days without consulting your doctor.
Patients suffering from liver or kidney disease should take paracetamol under medical supervision. Paracetamol should also be given with care to patients taking other drugs that affect the liver. Consult your doctor if no relief is obtained from the recommended dosage.
Exceeding the prescribed dose, together with prolonged and continued use of this medication, may lead to dependency and addiction.

DOSAGE AND DIRECTIONS FOR USE:
Infants 6 months - 1 year: 2,5 mL (half a medicine measure) every four hours.
Children 1 - 3 years: 5 mL (one medicine measure) every four hours.
Children over 5 years: 5 -10 mL (one to two medicine measures) every four hours.
Should not be administered more than four times daily.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Paracetamol:
Pancreatitis, skin rashes and other allergic reactions may occur. The rash is usually erythematous or urticarial but sometimes more serious and may be accompanied by drug fever and mucosal lesions. The use of paracetamol has been associated with the occurrence of neutropenia, pancytopenia, leucopenia, thrombocytopenia and agranulocytosis. The dose should be reduced in renal functional impairment.
Codeine phosphate: The most common side-effects are nausea, vomiting, constipation, drowsiness and confusion. Micturition may be difficult and there may, be ureteric and biliary spasm; there is also an antidiuretic effect. Dry mouth, sweating, facial flushing, vertigo, bradycardia, palpitations, orthostatic hypotension, hypothermia, restlessness, change of mood, and miosis also occur. These effects occur more commonly in ambulant patients than in those at rest in bed. Raised intracranial pressure may occur.
Reactions such as urticaria and pruritis may occur. Contact dermatitis has been reported.
Codeine should be given with caution to patients with hypothyroidism, adrenocortical insufficiency, impaired liver function and shock. It should be used with caution in patients with inflammatory or obstructive bowel disorders.
The depressant effects of codeine are enhanced by depressants of the central nervous system as anaesthetics, hypnotics and sedatives, and phenothiazines.
The prolonged use of high doses of codeine has produced dependence.
Consult your doctor if no relief is obtained with the recommended dosage.
Do not use continuously, for longer than ten days without consulting your doctor.
Store in a safe place, out of reach of children.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The most serious adverse effect of acute overdosage of paracetamol is dose-dependent, potentially fatal hepatic necrosis. Renal tubular necrosis and hypoglycaemic coma may also occur. Cardiac arrhythmias have been reported. Paracetamol has caused thrombocytopenia. Symptoms during the first 2 days of acute poisoning do not reflect the potential seriousness of the intoxication. Nausea, vomiting, anorexia and abdominal pain occur during the initial 24 hours and may persist for a week or more. Liver injury may become manifest on the second day, initially by elevation of serum transaminase and lactic dehydrogenase activity, increased serum bilirubin concentration and prolongation of prothrombin time. The hepatotoxicity may progress to encephalopathy coma and death. Both metabolic acidosis and metabolic alkalosis have been noted; cerebral oedema and nonspecific myocardial depression have also occurred. In non-fatal cases hepatic lesions are reversible over a period of weeks or months. In the event of overdosage consult your doctor or take the patient to the nearest hospital immediately. Treatment of overdosage should be prompt, and vigorous supportive therapy is essential in severe intoxication. Since the hepatic injury is dose dependent and occurs early in the course of intoxication, procedures to limit continuing absorption of the medicine must be initiated promptly. Induction of vomiting or gastric lavage should be performed in all cases where the patient has ingested 7,5 g in the preceding 4 hours.
Specific therapy with an antidote such as acetylcysteine is generally needed when the blood paracetamol concentration, lies above a line that is drawn between the 2 points, 200 mg/L at 4 hours, and 30 mg/L at 15 hours after the overdose is taken. Treatment is as follows:
Acetylcysteine: can be given either intravenously, or by mouth.
IV:        An initial dose of 150 mg/kg in 200 mL glucose injection, given intravenously over 15 minutes, followed by an intravenous infusion of 50 mg/kg in 500 mL of glucose injection over the next 4 hours, and then 100 mg/kg in 1 litre over the next 16 hours. The volume of intravenous fluids should be modified for children.
Orally: 140 mg/kg as a 5% solution initially, followed by a 70 mg/kg solution every 4 hours for 17 doses. Acetylcysteine is very effective if administered within 8 hours of overdosage
The signs of codeine intoxication are central nervous system depression, restlessness, excitement, respiratory depression, miosis and slow breathing, hypotension with circulatory failure and coma. Death may occur from respiratory failure. Administration should be stopped immediately in cases of overdosage.
Convulsions may occur in infants and children.
In acute poisoning by codeine taken by mouth, the stomach should be emptied by aspiration and lavage. A laxative may be given to aid peristalsis.
Intensive supportive therapy may be required 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 opioid analgesics. A dose of 10 g per kg is given intravenously, repeated at intervals of 2 to 3 minutes if necessary.
Further treatment is supportive and symptomatic.
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:
A plum coloured syrup, with an odour of caramel and peppermint.

PRESENTATION:
100 mL amber glass bottles

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

REGISTRATION NUMBER:
N/2.8/175

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Triomed (Pty) Limited
Parc Du Cap Building No. 3
cnr Willie van Schoor and Mispel Road
BELVILLE
7530

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
23.05.1988
                G213B

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