INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
ADCO-KIDDIPAYNE Syrup

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

ADCO-KIDDIPAYNE Syrup

COMPOSITION

Each 5 mL contains:
Paracetamol	120 mg
Codeine Phosphate	5 mg
Promethazine Hydrochloride	6,5 mg
Alcohol	10,5% v/v
Preservative:
Nipastat	0,1 % m/v

PHARMACOLOGICAL CLASSIFICATION
A 2.8 Special Analgesic Combinations

PHARMACOLOGICAL ACTION
ADCO-KIDDIPAYNE Syrup has analgesic, antipyretic and antihistaminic properties.

INDICATIONS
For the relief of mild to moderate pain, associated with fever.

CONTRA-INDICATIONS
Hypersensitivity to paracetamol, opiates or phenothiazines. Codeine should not be given during an attack of bronchial asthma or in heart failure secondary to chronic lung disease. It is contra-indicated in the presence of acute alcoholism, head injuries and conditions in which intracranial pressure is raised. Codeine should be administered with extreme caution to patients taking monoamine oxidase inhibitors or within 14 days of stopping such treatment.
Phenothiazines are contra-indicated in patients with pre-existing CNS depression or coma, bone marrow depression or phaeochromocytoma.

WARNINGS
If the patient does not respond a doctor should be consulted.
Do not use continuously for more than 10 days without consulting a doctor.
This medicine may cause drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other central nervous system depressant agents.
Pigments should be examined periodically for abnormal skin pigmentation or eye changes.
Dosage of paracetamol in excess of those recommended may cause severe liver damage.
Patients suffering from liver or kidney disease should take paracetamol under medical supervision.
Exceeding the prescribed dose, together with prolonged and continuous use of this medication, may lead to dependency and addiction.

DOSAGE AND DIRECTIONS FOR USE
Children

6 to 12 months:	Half a medicine measureful (2,5 mL) three times a day.
1 to 5 years:	One medicine measureful (5 mL) three times a day.
6 to 12 years:	One to two medicine measuresful (5 to 10 mL) three times a day.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Paracetamol: Side effects of paracetamol are usually mild, though haematological reactions including thrombocytopenia, leucopenia, pancytopenia, neutropenia and agranulocytosis have been reported. Pancreatitis, skin rashes and other allergic reactions occur occasionally.
Interactions: Paracetamol should be given with care to patients taking other drugs that affect the liver.
Promethazine Hydrochloride: Promethazine Hydrochloride may give rise to sedation, varying from slight drowsiness to deep sleep, and including lassitude, dizziness, and in-coordination. Sedative effects when they occur, may diminish after a few days of treatment. Paradoxical CNS stimulation may occur especially in children. Symptoms of cerebral stimulation with insomnia, nervousness, euphoria, depression, irritability, anorexia, restlessness tremors and rarely nightmares, hallucinations and convulsions. In high doses CNS stimulation may be attributed to antimuscarinic activity.
Extrapyramidal symptoms may develop.
Promethazine Hydrochloride possesses antimuscarinic properties and may give rise to side-effects including:
dry mouth, thickened respiratory tract secretions and tightness of chest, blurred vision, urinary difficulty and retention, constipation and increased gastric reflux, in high doses transient bradycardia followed by tachycardia with palpitations and arrhythmias. Gastro-intestinal disturbances such as nausea, vomiting, diarrhoea or epigastric pain have occurred with antihistamines. Hypersensitivity reactions particulary of the skin and cross sensitivity to related drugs may occur. Hypersensitivity reactions include urticaria, exfoliative dermatitis, erythema multiforme and contact sensitivity. Photosensitivity, has also been reported. Blood disorders including agranulocytosis, leucopenia, haemolytic anaemia, thrombocytopenia, purpura and jaundice although rare have been reported, particularly with phenothiazines. A syndrome resembling systemic lupus erythematous has been reported. Other side-effects that have been reported with antihistamines include hypotension, tinnitus, headache, weakness of hands and paraesthesia. Idiosyncrasy may occur.
Deposition of pigment in the eyes, corneal and lens opacities. Other side-effects of Phenothiazines include polyuria, tiredness, weakness and lowering of blood temperature (occasionally pyrexia). Promethazine Hydrochloride should be used with care in patients suffering from conditions such as closed-angle glaucoma, parkinsonism, diabetes mellitus, hypothyroidism, myasthenia gravis, urinary retention, prostatic hypertrophy or pyloroduodenal obstruction.
Caution should be taken in patients with epilepsy or severe cardiovascular, cerebrovascular and respiratory function disorders.
Promethazine HCl may mask the warning signs of damage caused by ototoxic drugs such as aminoglycoside antibiotics. May suppress positive skin test results and should be stopped several days before the test.
Interactions: Promethazine Hydrochloride may enhance the sedative effects of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers.
Monoamine oxidase inhibitors may enhance the effects of antihistamines. Promethazine Hydrochloride may have an additive antimuscarinic action with other antimuscarinics such as atropine and tricyclic antidepressants.
Codeine may cause nausea, vomiting, constipation, drowsiness and confusion. Urinary retention, ureteric and biliary spasm, and an antidiuretic effect. Dry mouth, sweating, flushing, vertigo, bradycardia, palpitations, orthostatic hypotension, hypothermia, restlessness, mood changes, euphoria and miosis can occur. Raised intracranial pressure and muscle rigidity have been reported following high doses.
Codeine should be used in extreme caution in patients with decreased respiratory reserve.
Codeine should be used with caution in patients with obstructive bowel disorders, liver impairment, myasthenia gravis, prostatic hypertrophy, impaired renal function or shock. It should be used with caution or in reduced doses in patients with adrenocortical insufficiency and hypothyroidism.
Interactions: Codeine may affect the activity of other medicines by delaying their absorption. The depressant effects are aggravated by alcohol, anaesthetics, hypnotics, sedatives, tricyclic antidepressants and phenothiazines.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose and metabolic acidosis may occur. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias have been reported. Symptoms during the first 2 days of acute poisoning do not reflect the potential seriousness of the overdosage. Nausea, vomiting, anorexia and abdominal pain may persist for a week or more. Liver injury may manifest on the second day, (or later) initially by elevation of serum transaminase and lactic dehydrogenase activity, increased serum bilirubin concentration and prolongation of prothrombin time. The liver damage may progress to encephalopathy, coma and death. Cerebral oedema and nonspecific myocardial depression have also occurred. In the event of an overdosage consult a doctor or take the patient to the nearest hospital immediately. Specialised treatment is essential as soon as possible.
Prompt treatment is essential. Any patient who has ingested about 7,5 g of paracetamol in the preceding 4 hours should undergo gastric lavage. Specific therapy with an antidote such as acetylcysteine or methionine may be necessary. If decided upon, acetylcysteine should be administered IV as soon as possible.
Acetylcysteine
Acetylcysteine should be administered as soon as possible, preferably within 8 hours of overdosage.
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 1000 mL 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 effective if administered within 8 hours of overdosage.
Overdosage of antihistamines may be fatal especially in children. Overdosage with Promethazine Hydrochloride is associated with antimuscarinic, extrapyramidal, gastro-intestinal and CNS effects. In children CNS stimulation predominates. In adults CNS depression is more common with drowsiness, coma and convulsions, progressing to respiratory failure or possible cardiovascular collapse.
In severe overdosage with antihistamines the stomach should be emptied. Activated charcoal has been given, as have saline laxatives. Convulsions may be controlled with diazepam although it has been suggested that CNS depressants should be avoided with overdose of antihistamines. Cerebral stimulants may increase the risk of convulsions and should be avoided.
Large doses of Codeine produce respiratory depression and hypotension, with circulatory failure and deepening coma. Convulsions may occur especially in children. Rhabdomyolysis progressing to renal failure has been reported in overdose. Coma, pinpoint pupils and respiratory depression is considered indicative of overdosage.
Codeine phosphate: In acute poisoning the stomach should be emptied by aspiration and lavage.
See also " Side-effects and special precautions ". Other treatment is symptomatic and supportive.

IDENTIFICATION
Clear bright red viscous syrup with a cherry and vanilla odour and taste.

PRESENTATION
Amber bottles containing 100 mL of syrup.

STORAGE INSTRUCTIONS
Store in a cool place below 25°C and protect from light.
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBER
X/2.8/413

NAME AND BUSINESS ADDRESS OF APPLICANT
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue
Bryanston, Ext 77
Private Bag X69, Bryanston, 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT
13 August 1990

New addition to this site: May 2004
Source: Pharmaceutical Industry
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