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Codeine Compound

 

DESCRIPTION
Clean, dry, round, uniform, biconvex, even edged tablets, scored on one side and white in colour.


Each tablet contains :
Paracetamol BP ................ 500 mg
Codeine Phosphate BP ..... 8 mg


ACTIONS AND MODE OR MECHANISMS OF ACTON

PARACETAMOL
Analgesic - The mechanism of analgesic action has not been fully determined. Paracetamol may act by inhibiting prostaglandin synthesis in Me central nervous system and through a peripheral action by blocking pain-impulse generation. The peripheral actions may also be due to inhibition of the synthesis of prostaglandins or the synthesis or actions of other substances, which sensitize pain receptors to mechanical or chemical stimulation.


Antipyretic - Paracetamol probably produces antipyresis by acting centrally on the hypothalamic heat-regulating centre to produce peripheral vasodilation re suiting in increased blood flow through the skin, sweating and heat loss. The central action probably involves inhibition of prostaglandin synthesis in the hypothalamus.


CODEINE PHOSPHATE
Analgesic - Binds with stereospecific receptors at many sites within the central nervous system (CNS) to alter processes affecting both the perception of pain and the emotional response to pain. Precise sites and mechanisms of action have not been fully determined, but may partially involve alterations in release of various neurotransmitters from afferent nerves sensitive to painful stimuli. It has been proposed that there are multiple subtypes of opioid receptors. each mediating various therapeutic and/or side effects of opioid drugs. The actions of an opioid analgesic may therefore depend upon its binding affinity for each type of receptor and whether it acts as a full agonist or a partial agonist or is inactive at each type of receptor. At least two of these types of receptors (mu and kappa) mediate analgesia. Mu receptors are widely distributed throughout the CNS, especially in the limbic system (frontal cortex, temporal cortex, amygdala and hippocampus), thalamus striatum, hypothalamus and midbrain as well as laminae I, II, IV and V of the dorsal horn in the spinal cord. Kappa receptors are localized primarily in the spinal cord and in the cerebral cortex.

 

A third type of receptor (sigma) may not mediate analgesia; actions at this receptor may produce the subjective and psychotomimetic effects, characteristic of opioids, having mixed agonist/antagonist activity


PHARMACOLOGY
PARACETAMOL :
Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 30 minutes to 2 hours after ingestion. It is metabolised in the liver and excreted in the urine mainly as glucuronide and sulphate conjugates. Less than 5% is excreted as unchanged paracetamol. The elimination half-life vanes from about 1 to 4 hours. Plasma-protein binding is negligible at usual therapeutic concentrations but increases with increasing concentrations.

 

A minor hydroxylated metabolite which is usually produced in very small amounts by mixed-function oxidases in the liver and which is usually detoxified by conjugation with liver glutathione, may accumulate following paracetamol overdosage and cause liver damage.


CODEINE PHOSPHATE : Codeine Phosphate is absorbed from the gastrointestinal tract and produces peak plasma - codeine concentrations in about one hour. Codeine is metabolised by O - and N - demethylation in the liver to morphine and norcodeine. Codeine and its metabolites are excreted almost entirely by the kidney, mainly as conjugates with glucuronic acid.


The plasma half-life has been reported to be between 3 and 4 hours after administration by mouth.

 

INDICATIONS
Codeine Compound Tablet is indicated for the relief of mild to moderate pain and to reduce fever.

 

CONTRAINDICATIONS
Patients with known hypersensitivity to any of its components. Diarrhoea caused by poisoning or pseudomembranous colitis induced by antibiotic. until toxin materials have been eliminated from G.I.T.


Acute respiratory depression.


SIDE EFFECTS/ADVERSE REACTIONS
PARACETAMOL :
Side effects of paracetamol are usually mild, though haematological reactions have been reported. Skin rashes and other allergic reactions occur occasionally. Large toxic doses may produce nausea, vomiting anorexia and abdominal pain.
Liver damage, hepatic failure, coma and death may occur with severe poisoning.


CODEINE PHOSPHATE : Side-effects may include nausea, vomiting, constipation, drowsiness and confusion. Micturition may be difficult and there may be ureteric or biliary spasm; there is also an antidiuretic effect. Dry mouth, sweating, facial flushing, vertigo, bradycardia, palpitations, orthostatic hypotension, restlessness, change of mood, and miosis may also occur. These effects may occur more commonly in ambulant patients than those at rest in the bed. Raised intracranial pressure occurs in some patients.

Following large doses of codeine. excitement and in children, convulsions may also occur.

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