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

Logo KODAPON (TABLETS)

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

KODAPON (TABLETS)

COMPOSITION:
Each tablet contains:

Paracetamol 500 mg
Codeine Phosphate 10 mg

PHARMACOLOGICAL CLASSIFICATION:
A 2.8 Analgesic Combinations

PHARMACOLOGICAL ACTION:
KODAPON has analgesic and antipyretic actions.

INDICATIONS:
For the relief of mild to moderate pain and fever.

CONTRA-INDICATIONS:
Hypersensitivity to Paracetamol or Codeine Phosphate.
KODAPON is contra-indicated in respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion and after operations on the biliary tract; in the presence of acute alcoholism, head injuries and conditions in which intracranial pressure is raised, during an attack of bronchial asthma or in heart failure secondary to lung disease.

WARNINGS:
DOSAGES IN EXCESS OF THOSE RECOMMENDED MAY CAUSE SEVERE LIVER DAMAGE.
DO NOT USE CONTINUOUSLY FOR LONGER THAN 10 DAYS WITHOUT CONSULTING YOUR DOCTOR.
Codeine should be given with extreme caution to patients taking monoamine oxidase inhibitors, or within 14 days of stopping such treatment.
Patients suffering from liver or kidney disease should only take paracetamol under medical supervision.
Paracetamol should also be given with care to patients taking other drugs that affect the liver.
Exceeding the prescribed dose, together with prolonged and continuous use of this medication may lead to dependency and addiction.

In the event of overdosage or suspected overdose and not withstanding the fact that the person may be asymptomatic, the nearest doctor, hospital or Poison Centre must be contacted immediately.

DOSAGE AND DIRECTIONS FOR USE:
DO NOT EXCEED THE RECOMMENDED DOSE
Adults and Children over 12 years: One to two tablets every three to four hours as required with a maximum of 8 tablets daily.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
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. In a few cases, the use of paracetamol has been associated with the occurrence of neutropenia, pancytopenia, and leucopenia. The dose should be reduced in renal functional impairment.
Codeine may cause nausea, vomiting, constipation, drowsiness, confusion, dry mouth, sweating, facial flushing, vertigo, bradycardia, palpitations, orthostatic hypotension, hypothermia, restlessness, change of mood and miosis. Micturition may be difficult and there may be ureteric or biliary spasm; there is also an anti-diuretic effect. Raised intracranial pressure may occur. Reactions such as urticaria and pruritus may occur.
Larger doses of codeine produce respiratory depression and hypotension, with circulatory failure and deepening coma. Respiratory failure could result, and in infants and children, convulsions may occur. The administration of codeine during labour may cause respiratory depression in the newborn infant. Codeine should be given with caution to patients with hypothyroidism, adreno-cortical insufficiency, impaired kidney or liver function, prostatic hypertrophy or shock. It should be used with caution in patients with inflammatory or obstructive bowel disorders. Opioid analgesics should be used with caution in patients with myasthenia gravis. The dosage should be reduced in elderly and debilitated patients. The depressant effects of codeine are enhanced by depressants of the central nervous system such as alcohol, anaesthetics, hypnotics and sedatives, tricyclic antidepressants and phenothiazines. The prolonged use of high doses of codeine has produced dependence.

KNOWN SYMPTOMS OF OVER DOSAGE AND PARTICULARS OF ITS TREATMENT:
Prompt treatment is essential
. In the event of an overdosage, consult a doctor immediately, or take the person to a hospital directly. A delay in starting treatment may mean that antidote is given too late to be effective. Evidence of liver damage is often delayed until after the time for effective treatment has lapsed.
Susceptibility to paracetamol toxicity is increased in patients who have taken repeated high doses (greater than 5 -10 g/day) of paracetamol for several days, in chronic alcoholism, chronic liver disease, AIDS, malnutrition, and with the use of drugs that induce liver microsomal oxidation such as barbiturates, isoniazid, rifampicin, phenytoin and carbamazepine.
Symptoms of paracetamol overdosage in the first 24 hours include pallor, nausea, vomiting, anorexia and possibly abdominal pain. Mild symptoms during the first two days of acute poisoning do not reflect the potential seriousness of the overdosage. Liver damage may become apparent 12 to 48 hours, or later after ingestion, initially by elevation of the serum transaminase and lactic dehydrogenase activity, increased serum bilirubin concentration and prolongation of the prothrombin time. Liver damage may lead to encephalopathy, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Abnormalities of glucose metabolism and metabolic acidosis may occur. Cardiac arrhythmias have been reported.
Treatment for Paracetamol overdosage:
Although evidence is limited it is recommended that any adult person who has ingested 5 - 10 grams or more of paracetamol (or a child who has had more than 140 mg/kg) within the preceding four hours, should have the stomach emptied by lavage (emesis may be adequate for children) and a single dose of 50 g activated charcoal given via the lavage tube. Ingestion of amounts of paracetamol smaller than this may require treatment in patients susceptible to paracetamol poisoning (see above). In patients who are stuperose or comatose endotracheal intubation should precede gastric lavage in order to avoid aspiration.
N-acetylcysteine should be administered to all cases of suspected overdose as soon as possible preferably within eight hours of overdosage, although treatment up to 36 hours after ingestion may still be of benefit, especially if more than 150 mg/kg of paracetamol was taken.
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 1 000 mL over the next 16 hours. The volume of intravenous fluids should be modified for children.
Orally: Although the oral formulation is not the treatment of choice, 140 mg/kg dissolved in water may be administered initially, followed by a 70 mg/kg solution every 4 hours for 17 doses.
A plasma paracetamol level should be determined four hours after ingestion in all cases of suspected overdosage. Levels done before four hours, unless high, may be misleading. Patients at risk of liver damage, and hence requiring continued treatment with N-acetylcysteine, can be identified according to their plasma paracetamol level. The plasma paracetamol level can be plotted against time since ingestion in the normogram below.
Those, whose plasma paracetamol levels are above the “normal treatment line”, should continue N-acetylcysteine treatment with 100 mg/kg IV over sixteen hours repeatedly until recovery. Patients with increased susceptibility to liver damage as identified above, should continue treatment if concentrations are above the “high risk treatment line”. Prothrombin index correlates best with survival.
Monitor all patients with significant ingestions for at least ninety six hours.
The signs of codeine intoxication are central nervous system depression, restlessness, excitement, respiratory depression, miosis and slow breathing, hypotension with circulatory failure and coma. Administration should be stopped immediately in cases of over dosage. 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 dose of opioid analgesics. A dose of 0,4 to 2 mg is given intravenously, repeated at intervals of 2 to 3 minutes if necessary, up to 10 mg.
Further treatment is supportive and symptomatic.
In the event of over dosage consult your doctor or immediately take the patient to the nearest hospital. Specialised treatment is essential as soon as possible. The latest information regarding the treatment of over dosage can be obtained from the nearest poison centre.

IDENTIFICATION:
KODAPON is a green, bisected tablet with bevelled edges.

PRESENTATION:
In plastic containers of 20, 100, 500, 1000 and 5000 tablets and blister packs of 20 tablets.
Patient ready packs of 20 tablets.

STORAGE INSTRUCTIONS:
Store in a well-closed container protected from light, below 25ºC.
Exposure to air should be minimal.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
B/2.8/1473

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Gulf Drug Company (Pty) Ltd.
22 Burnside Drive
Old Mill Industrial Park
Mount Edgecombe, 4300

www.gulfdrug.co.za

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
06 March 1992.

New addition to this site: July 2010
Source: Pharmaceutical Industry

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