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

Logo LENNON CODEINE PHOSPHATE TABLETS 30 mg

SCHEDULING STATUS:
S6

PROPRIETARY NAME
(and dosage form):

LENNON CODEINE PHOSPHATE TABLETS 30 mg

COMPOSITION:
Tablets containing 30 mg
Codeine Phosphate.

PHARMACOLOGICAL CLASSIFICATION:
A 2.7 Narcotic Analgesics.

PHARMACOLOGICAL ACTION:
Codeine phosphate is a powerful analgesic which is effective due to its action on the central nervous system. It resembles morphine in its pharmacodynamic actions although much weaker in its effects. It has little sedative effects.

INDICATIONS:
For the relief of moderate pain.

CONTRA-INDICATIONS:
Codeine Phosphate is contra-indicated in respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion, as well as acute alcoholism and head injuries, and conditions in which intracranial pressure is raised.
It should not be given during an attack of bronchial asthma or in heart failure secondary to chronic lung disease. The administration of codeine phosphate is contra-indicated in patients taking monoamine oxidase inhibitors or within 10 days of stopping such treatment.

WARNINGS:
Exceeding prescribed dose, together with prolonged and continuous use of this medication, may lead to dependency and addiction.
KEEP OUT OF REACH OF CHILDREN

DOSAGE AND DIRECTIONS FOR USE:
15 mg to 60 mg daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Codeine phosphate may cause nausea, vomiting, constipation, drowsiness, confusion, dry mouth, sweating, facial flushing, vertigo, bradycardia, palpitations, orthostatic hypotension, hypothermia, restlessness, changes of mood and miosis.
Micturition may be difficult, and there may be ureteric or biliary spasm; there is also an antidiuretic effect. Raised intracranial pressure may occur. Reactions such as urticaria and pruritis may occur. Contact dermatitis has been reported.
Special Precautions:
Codeine phosphate should be given with caution to patients with hypothyroidism, adrenocortical insufficiency, impaired liver function, prostatic hypertrophy or shock.
The dosage should be reduced in elderly and debilitated patients.
It should be used with caution in patients with inflammatory or obstructive bowel disorders.
Should be used with caution in patients with myasthenia gravis.
The prolonged use of high doses of codeine phosphate has produced dependence.
The administration of codeine phosphate during labour may cause respiratory depression in the newborn infant.
Interactions:
The depressant effects of codeine phosphate are enhanced by depressants of the central nervous system such as alcohol, anaesthetics, hypnotics and sedatives, tricyclic antidepressants, and phenothiazines.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage produces central stimulation with exhilaration followed by vomiting, drowsiness, respiratory depression, hypotension and cyanosis, and coma. Convulsions may occur in infants and children. Death may occur from respiratory failure.
Treatment:
Treatment of overdosage is symptomatic and supportive.
In acute poisoning 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.
The specific antagonist, naloxone hydrochloride, is used to counteract very rapidly the severe respiratory depression and coma produced by excessive doses.
A dose of 0,4 to 2 mg is given IV, repeated at intervals of 2 to 3 minutes if necessary, up to 10 mg.
Naloxone may also be given by subcutaneous or intramuscular injection.

IDENTIFICATION:
White biconvex tablet, engraved “C1”on one side. Diameter 5,6 mm.

PRESENTATION:
Packs of 100 tablets.

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

REFERENCE NUMBER:
B1192 (Act 101/1965).

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited
Building 12
Healthcare Park
Woodlands Drive
Woodmead
Sandton
2148

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
5/12/69

        A198
        A & S PRINTERS

Updated on this site: April 2005
Source: Hospital Pharmacy

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