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Paralgin

 

COMPOSITION
PARALGIN
Paracetamol 500mg, Codeine phosphate hemihydrate 8mg (White, round convex, 13mm diameter tablet inscribed with "SL" on one side)

PARALGIN FORTE
Paracetamol 400mg, Codeine phosphate sesquihydrate 30mg (White, round convex, 12 mm diameter tablet inscribed with "SL" on one side and breakline on the other).

CLINICAL FEATURES
Paracetamol appears to produce analgesia at a subcorticol site of the brain, and may also block pain impulses by a depressant effect on peripheral chemoreceptors, mainly by inhibiting and interfering with the prostaglandin synthesis. Paracetamol lowers body temperature by acting in the hypothalamus to produce antipyresis.

Codeine phosphate has a central action especially in the cortex, thereby raising the threshold of pain.

PHARMACOLOGY
Paracetamol and Codeine phosphate are well absorbed from the gastro-intestinal tract. The peak concentrations in plasma are attained in about 1 hour. The half-life is about 1 to 3 hours for paracetamol and about 2.5 to 3 hours for Codeine phosphate after therapeutic doses. The duration of action varies between 4-6 hours.

Metabolism and Excretion
Following therapeutic doses, about 80% of the paracetamol undergoes conjugation with glucoronic acid in the liver, and only 3 % is excreted as unchanged drug.

Codeine phosphate is metabolised in the liver and excreted primarily as an inactive metabolites, two-third of these within 6 hours of ingestion

INDICATIONS
For the relief of moderate to severe pain such as headache and dysmenorrhea.


CONTRA-INDICATIONS
Hypersensitivity to the active ingredients. Acute hepatitis. It should be given with care to patients with impaired kidney or liver function, and also patients taking other drugs that affect the liver.


SIDE-EFFECTS
Mild drowsiness. Sensitive patients may experience constipation and biliary dyskinesia. High doses of paracetamol may increase the activity of coumarin anticoagulant.


Codeine phosphate potentiates the effect of alcohol and other central depressive drugs. Other adverse reactions include allergic reactions, euphoria, dysphoria, abdominal pain and prutitus.


PRECAUTIONS
Do not exceed the recommended dose. At high doses codeine has most of the disadvantages of morphine, including respiratory depression. Codeine can produce drug dependence and therefore has the potential of being abused. Codeine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks.


DOSAGE
Adults: 1-2 tablets every 4-6 hours

Children:
Over 12 years old 1 tab up to 4 times daily

6-12 years old 1/2 tab up to 4 times daily


OVERDOSAGE
Paracetamol:
Pallor, nausea, vomiting, anorexia, and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias have been reported.


Codeine phosphate:
Overdosage may produce central nervous stimulation, nausea, drowsiness, respiratory depression, cyanosis, coma. Convulsion may occur in infants and children.

Treatment

General:
Aspiration or gastric lavage, followed by oral administration of activated charcoal.


Codeine phosphate:
If necessary, combined with anti-convulsion therapy and control of respiration. Antidote, 0.4 mg Naloxone hydrochloride may be given intravenously and repeated every 3-4 minutes until normal respiration is restored. Observed the patient for 24 hours.

Paracetamol:
Intravenous administration of 300mg N-acetylcysteine per kg over 20-hour period or oral treatment with 1330 mg N-acetylcysteine per kg over 72-hour period is accepted. Treatment should be started within 8 hours after overdose but is still indicated at least as late as 24 hours after ingestion.


Blister pack of 100x10's / box

Blister pack of 50x10's / box

STORAGE/SHELF-LIFE
Store in a dry place, protected from direct light and humidity and at below 25C.

Paralgin -- 3 years;
Paralgin Forte -- 4 years.

 

This preparation contains PARACETAMOL. Do not take any other pracetamol containing medicines at the same time.

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