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Axpain - 650
COMPOSITION
Each caplet contains:
Paracetamol 650mg
PRESENTATION
White, oblong caplet, 17.9mm in diameter.
INDICATIONS
As a mild analgesic and antipyretic and weak anti-inflammatory. It is
recommended for the relieve of painful and febrile conditions, for example,
headache, migraine, backache, toothache, aches due to the colds and flu,
muscular rheumatism, dysmenorrhea and fever. It is a substitute for aspirin
for its analgesic or antipyretic uses in patients who are allergic to
aspirin or when aspirin is contraindicated as in patients with gout or
peptic ulcer.
PHARMACOLOGY
Mechanism of Action
Paracetamol has analgesic and antipyretic properties and weak inflammatory
activity. Paracetamol relieves mild to moderate pain, such as headache and
dysmenorrhea, in many muscle joint, and peripheral nerve disorders.
Analgesia is mediated peripherally and also centrally, whereas antipyresis
is produced by a central action on hypothalamic regulatory center.
Pharmacokinetics
Paracetamol is metabolised primarily by the hepatic microsomal enzymes. It
is rapidly and practically completely absorbed from the gastrointestinal
tract. Peak plasma concentrations occurring about 10 to 60 minutes after
oral administration and the plasma half-time is 1 - 3 hours. Paracetamol is
distributed into most body tissues. Binding of the drug to plasma proteins
is variable; 20 - 50% may be bound at the concentrations encountered during
acute intoxication.
Paracetamol is metabolised predominantly in the liver and excreted in the
urine mainly as the glucuronide and sulphate conjugates. Less than 5% is
excreted as unchanged paracetamol. A minor hydroxylated metabolite
(N-acetyl-p-benzoquinoneimine). is usually produced in very small amounts by
cytochrome P450 isoenzymes (mainly CYP2E1 and CYP3A4) in the liver and
kidney. It is usually detoxified by conjugation with glutathione but may
accumulate following paracetamol overdosage and cause tissue damage.
DOSAGE AND ADMINISTRATION
Adult and children above 12 years old : 1 caplet, every 4-6 hours. Not more
than 6 caplets per day.
CONTRAINDICATION
Contraindicated in patients with known hypersensitive to Paracetamol.
PRECAUTION
Warning
This preparation contains Paracetamol. Do not take any other Paracetamol
containing medicines at the same time. Paracetamol overdose may harm the
liver. Follow the recommended dose.
Precaution
It should be given with care to patients with impaired kidney or liver
function. Chronic use should be avoided.
Use in Pregnancy and Lactation
Paracetamol is generally considered to be the analgesic choice of
pregnant patients. No adverse effects have been observed in breast-feeding
infant whose mothers are receiving Paracetamol.
SIDE EFFECTS
When taken as directed, Paracetamol is virtually free of side effects. Skin
rash and other allergic reactions occur occasionally. Patients allergic to
the salicylates do not exhibit cross-sensitivity to paracetamol.
DRUG INTERACTIONS
Paracetamol toxicity may be increased in patients receiving other
potentially hepatotoxic drugs or drugs that induce liver microsomal enzymes.
The absorption of paracetamol may be accelerated by drugs such as
metoclopramide. Excretion may be affected and plasma concentrations altered
when given with probenecid. Colestyramine reduces the absorption of
paracetamol if given within 1 hour of paracetamol.
The prothrombinopenic effect of the oral anticoagulants may be increased
by chronic administration of full doses of Paracetamol; occasional doses of
Paracetamol have no significant effect.
OVERDOSAGE AND TREATMENT
Paracetamol overdose can result in severe liver damage and sometimes acute
renal tubular necrosis. Immediate medical attention is essential in the
event of overdose, even when there are no obvious symptoms. Administration
of antidote such as acetylcysteine or methionine may be required. Activated
charcoal may be used to reduce gastrointestinal absorption, if it can be
given within 1 hour of the overdose, and if more than 150mg/kg of
paracetamol has been ingested. However, if acetylcysteine or methionine is
to be given by mouth the charcoal is best cleared from the stomach to
prevent it reducing the absorption of the antidote.
STORAGE
Store below 30°C. Protect from
light
PACK QUANTITIES
Available in blister packs of 8's
x 10. |
