Cetamol Dosage & Drug Information

Concise Prescribing Info Bahasa Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Warnings Special Precautions Use In Pregnancy & Lactation Adverse Reactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Paracetamol

Indications/Uses

Short-term treatment of moderate pain, especially following surgery & for the short-term treatment of fever, when administration by IV route is clinically justified by an urgent need to treat pain or hyperthermia &/or when other routes of administration are not possible.

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Dosage/Direction for Use

Adult & adolescents >50 kg 1 g/administration (ie, one 100 mL bottle), up to 4 times daily. Min interval between each administration: 4 hr. Max daily dose: Not to exceed 4 g. Adult & adolescents <50 kg, childn >33 kg (approx 11 yr) 15 mg/kg/administration (ie, 1.5 mL soln/kg), up to 4 times daily. Min interval between each administration: 4 hr. Max daily dose: Not to exceed 60 mg/kg (w/o exceeding 3 g). Childn >10 kg (approx 1 yr) & <33 kg 15 mg/kg/administration (ie, 1.5 mL soln/kg), up to 4 times daily. Min interval between each administration: 4 hr. Max daily dose: Not to exceed 60 mg/kg (w/o exceeding 2 g). Severe renal impairment (CrCl ≤30 mL/min) Increase the min interval between each administration to 6 hr.

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Overdosage

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Contraindications

Hypersensitivity to paracetamol or to propacetamol HCl. Severe hepatocellular insufficiency. Hepatic failure or active liver disease.

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Warnings

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Special Precautions

Use a suitable analgesic oral treatment as soon as this administration route is possible. Check that other medicines administered do not contain paracetamol to avoid the risk of overdose. Risk for very serious liver damage in doses higher than recommended. Chronic alcoholism & malnutrition (low reserves of hepatic glutathione). Dehydration. Hepatocellular insufficiency. Severe renal insufficiency (CrCl ≤30 mL/min). Pregnancy.

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Use In Pregnancy & Lactation

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Adverse Reactions

Hypersensitivity reaction. Dizziness, headache, dystonia, nausea, vomiting, constipation. Simple skin rash or urticaria to anaphylactic shock. Malaise. Hypotension. Increased level of hepatic transaminases. Thrombocytopenia, leucopenia, neutropenia.

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Drug Interactions

Not to be mixed w/ other medicinal product.

Caution For Usage

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Storage

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Description

View Cetamol description for details of the chemical structure and excipients (inactive components).

Action

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MIMS Class

Analgesics (Non-Opioid) & Antipyretics

ATC Classification

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

Regulatory Classification

Presentation/Packing

Form

Cetamol infusion 1,000 mg/100 mL

Packing/Price

1's (Rp60,000/botol)

Cetamol

paracetamol

Manufacturer:

Caprifarmindo

Marketer:

Caprifarmindo