Paracetamol: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Full Generic Medicine Info

Dosage/Direction for Use Administration Contraindications Special Precautions Adverse Reactions Pregnancy Category (US FDA) Overdosage Drug Interactions Food Interaction Lab Interference Action Storage CIMS Class ATC Classification

This information is not country-specific. Please refer to the India prescribing information.

Generic Medicine Info

Administration

May be taken with or without food.

Contraindications

Severe hepatic impairment or active liver disease (IV).

Special Precautions

Patient with G6PD deficiency; chronic alcoholism or malnutrition. Dehydrated patient; severe hypovolaemia (IV). Renal and hepatic impairment. Children. Pregnancy and lactation. Monitoring Parameters Monitor serum paracetamol levels in patients with hepatic disease during prolonged use. Assess relief of pain or fever.

Adverse Reactions

Blood and lymphatic system disorders: Rarely, anaemia, thrombocytopenia, agranulocytosis. Cardiac disorders: Tachycardia. Gastrointestinal disorders: Nausea, vomiting; redness of rectal mucus membranes (rectal supp). General disorders and administration site conditions: Inj site reactions (e.g. pain, burning sensation), fatigue, peripheral oedema. Investigations: Increased transaminase levels, abnormal breath sounds. Metabolism and nutrition disorders: Hypokalaemia. Musculoskeletal and connective tissue disorders: Muscle spasm, trismus. Psychiatric disorders: Insomnia, anxiety. Respiratory, thoracic and mediastinal disorders: Dyspnoea; bronchospasm (in asthmatic patients sensitive to aspirin or other NSAIDs). Skin and subcutaneous tissue disorders: Rash, pruritus, erythema, urticaria. Vascular disorders: Hypotension, hypertension, flushing.
Potentially Fatal: Hepatic injury (in doses higher then recommended), anaphylaxis. Rarely, serious skin reactions such as acute generalised exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN).

Pregnancy Category (US FDA)

ROUTE(S) : PO: B

ROUTE(S) : Parenteral / IV: C

Drug Interactions

Reduced rate of absorption with colestyramine. Increased absorption with metoclopramide and domperidone. Prolonged use of paracetamol may enhance the anticoagulant effect of warfarin and other coumarins, thus increasing the risk of bleeding. Concomitant use of other potentially hepatotoxic drugs or drugs that induce liver microsomal enzymes (e.g. barbiturates) may increase the risk of paracetamol toxicity. Reduced clearance with probenecid and isoniazid. Elimination half-life may be prolonged with salicylamide. Reduced bioavailability and efficacy of lamotrigine. May increase the plasma concentration of chloramphenicol and busulfan. Increased risk of high anion gap metabolic acidosis with flucloxacillin.

CIMS Class

Analgesics (Non-Opioid) & Antipyretics

ATC Classification

N02BE01 - paracetamol ; Belongs to the class of anilide preparations. Used to relieve pain and fever.

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