COMPOSITION

FAP - 500 TM : Each tablet contains Paracetamol BP 500 mg.

PHARMACOLOGICAL INFORMATION

Pharmacological Action

Paracetamol is one of the safest and most widely used analgesic and antipyretic drug.

Mechanism of Action

Paracetamol produces analgesia by elevation of the pain threshold and antipyresis through action on the hypothalamic heat-regulating center. New, cyclooxygenase enzyme COX-3, found in the brain and spinal cord which is selectively inhibited by paracetamol and is distinct from the two already known cyclooxygenase enzymes COX-1 and COX-2. This selective inhibition of the enzyme COX-3 in the brain and spinal cord explains the effectiveness of paracetamol in relieving pain and reducing fever.

Pharmacokinetic properties

Absorption:

Paracetamol is absorbed readily and completely from the small intestine after oral administration. Peak plasma concentrations occur 30 to 120 minutes after oral administration.

Distribution:

It is uniformly distributed throughout most body fluids with an apparent volume of distribution of 1 to 1.2 L/kg. Plasma protein binding is negligible at the usual therapeutic concentrations but increases with increasing concentrations.

Metabolism:

Approximately 90 to 95% of a dose of paracetamol is metabolized by the hepatic microsomal system. In adults at therapeutic dose, paracetamol is mainly conjugated with glucuronide (45-55%) or sulphate (20-30%). A minor proportion (less than 20%) is metabolized to catechol derivatives. Paracetamol is metabolized differently by infants and children compared with adults, the sulphate conjugate being predominant.

Elimination:

Paracetamol is excreted in the urine mainly as the glucuronide and sulphate conjugates. Less than 5% is excreted as unchanged paracetamol with 85-90% of the dose being eliminated in the urine within 24 hours of ingestion. The elimination half-life of paracetamol varies from about 1 to 4 hours.

CLINICAL INFORMATION

Indication and uses

It is indicated for the relief of pain and fever such as headache, migraine, neuritis, common cold and flu, sore throat, earache, toothache, backache, rheumatic and muscular pain, neuralgia and period pain.

Dosage and Administration

Adults : 1-2 tablets 4-6 times daily, up to a maximum of 4 gm in 24 hours. Children (6-12 years) : ½ of one tablet 3 to 4 times daily. For long term treatment, it is wise not to exceed the dose beyond 2.6 gm/day.

Use in Pregnancy & Lactation

Paracetamol is safe in all stages of pregnancy and lactation.

Side effects

Side effects are significantly mild, though haematological reactions have been reported. Pancreatitis, skin rashes, and other allergic reactions occur occasionally.

Drug Interactions

Possible drug interactions may occur with: Other sedating medications, Phenothiazines, Some antidepressant medications, Anticoagulant agents.

Cautionss

Avoid alcohol while taking this medicine. Alcohol can increase side effects such as dizziness or drowsiness. Be cautious when driving or performing other hazardous activities. This medicine can impair judgment.

Over dose and treatment

In massive overdosage exceeding 10 gm may cause liver damage. Early symptoms may cause pallor, nausea, vomiting and malaise. Over dose should be promptly treated by gastric lavage followed by intravenous N-acetylcysteine or methionine.

Contraindications

Paracetamol is contraindicated in patients with severe renal function impairment and hepatic disease (Viral Hepatitis), known hypersensitivity to paracetamol.

PHARMACEUTICAL INFORMATION

Storage Conditions

Store in a cool and dry place away from light. Keep out of reach of children.

Presentation & Packaging

FAP-500TM Tablet: Each commercial box contains 200 tablets in blister pack.LF01201TM-Trade MarkManufactured ByMymensingh, Bangladesh.