Paracetamol

Indication

Treatment of mild to moderate painful conditions such as

To reduce febrile conditions such as

It is used as adjunct with opioids in the severe pain such as cancer pain.

Dosage and Administration

Adult: 1 to 2 tablets, 3 or 4 times up to a maximum of 8 tablets daily.

Should be taken as a whole tablet and do not break the tablet in half. Paracetamol should not be administered many days without prescription from the physicians or pharmacists. Use in pregnancy and lactation. Paracetamol is generally considered the choice of analgesic in pregnant patients. However m...read more

Composition

Each film-coated tablet contains:

Paracetamol B.P ... 500 mg.

Description

Paracetamol is N-acetyl para-amino phenol derivatives. It is non-steroidal anti-inflammatory drug and it has analgesic, antipyretic and weak anti-inflammatory activity. Chemical formula is C8H9NO, and its molecular weight is 151.2.

Clinical Pharmacology

Paracetamol is also known as acetaminophen. It is inhibitor of the enzyme cyclo-oxygenase and inhibits the synthesis of prostaglandins in the central nervous system and peripherally blocks pain impulse generation; produces antipyresis from inhibition of hypothalamic heat-regulating center. Therefore...read more

Pharmacokinetics

Paracetamol is readily absorbed from the GI tract. Peak plasma concentration occurs at 10 - 60 minutes after oral dose. Tt is distributed into most body tissues. It crosses the placenta and present in breast milk. Plasma protein binding is negligible at usual therapeutic concentration but increase w...read more

Contraindication

It is contraindicated in patients who have hypersensitivity to acetaminophen or any component of the formulation and patients with known G6PD deficiency. Repeated administration is contraindicated in patient with anaemia, cardiac, pulmonary, renal and hepatic disease.

Precaution

It should be given with care to patients with impaired liver or kidney functions and alcohol dependence. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.

Adverse Effects

Adverse effects of paracetamol are rare and usually mild but may occur hypersensitivity such as skin rash, dyspnoea, hypotention, angioedema , toxic epidermal necrolysis. Haematological reactions including thrombocytopenia, leucopenia, pancytopenia, neutropenia and agranulocytosis have been reported...read more

Overdose

Acute overdose whether accidental or deliberate, is relatively common and can be extremely serious because of the narrow margin between therapeutic and toxic dose. Ingestion of as little as 10 - 15 g of paracetamol by adults may cause severe hepatocellular necrosis and less often, renal tubular necr...read more

Activated charcoal and N-acetylcysteine are used as antidote for paracetamol poisoning.

Drug Interaction

Increased effects/ Toxicity: Barbiturate, carbamazepine, hydantoins, isoniazid, rifampicin, sulfinpyrazone and zidovudine may increase hepatotoxic potential of aceta­ minophen; chronic ethanol abuse increase risk for para­ cetamol toxicity; effect of warfarin and antiviral effect of interferon alpha...read more

Decreased effects: Barbiturate, carbamazepine, hydant­ oins, rifampicin and sulfinpyrazone may decrease anal­ gesic effect of paracetamol.

Cholestyramine may decrease paracetamol absorption. Domperidone and metoclopramide may accelerate paracetamol absorption.

Probenecid - Pretreatment with probenecid can decrease paracetamol clearance.

Lamotrigine - Paracetamol reduce AUC and half-life for lamotrigine and increase percentage of lamotrigine recovered in the urine.

Storage

Store below 30°C in cool, dry place. Protect from light and moisture. Keep out of reach and sight of children.

Presentation

10 x 10's Blisters.