PANADREX 500/MG TAB 24/TAB

Indications

Approved Uses

Temporary relief of mild to moderate pain (e.g., headache, toothache, musculoskeletal/back pain, dysmenorrhea, minor arthritis/osteoarthritis pain) and reduction of fever, including fever/pain associated with colds/flu.

Dosage & Administration

Dosing by Condition

Adults and adolescents: 500-1000 mg every 4-6 hours as needed; maximum 4000 mg/day (lower maximum may be appropriate in hepatic risk factors).

Maintenance Dose

500-1000mg every 4-6 hours as needed

Maximum Dose

4000mg per 24 hours in healthy adults; 2000mg per 24 hours in patients with hepatic impairment or chronic alcohol use

Children's Dosage

Children 6-12 years: 250-500mg every 4-6 hours (max 4 doses/24 hours). Children 1-5 years: 120-250mg every 4-6 hours (max 4 doses/24 hours). Children under 1 year: 60-120mg per dose (weight-based: 10-15mg/kg every 4-6 hours). Do not exceed 5 doses in 24 hours in children

Dose Adjustment Notes

Renal impairment: extend dosing interval in severe impairment (e.g., CrCl <30 mL/min use at least 6-hour intervals). Hepatic impairment/chronic alcohol use/malnutrition/low body weight: use the lowest effective dose and consider a lower maximum daily dose (often ≤2-3 g/day) and avoid prolonged high-dose use.

Side Effects

Common Side Effects

Adverse effects are uncommon at recommended doses; may include nausea, vomiting/abdominal discomfort, and hypersensitivity reactions such as rash/urticaria.

Side Effect Frequency

At therapeutic doses, adverse effects are uncommon/rare; reported events include hypersensitivity reactions (rash/urticaria), gastrointestinal upset (nausea), transient liver enzyme elevations; rare but serious reactions include severe cutaneous adverse reactions (SJS/TEN) and blood dyscrasias, with hepatotoxicity primarily in overdose.

Safety & Warnings

Contraindications

Hypersensitivity to paracetamol (acetaminophen) or any excipients; severe hepatic impairment/active severe liver disease.

Warnings & Precautions

Do not exceed the recommended dose; avoid concurrent use with other paracetamol-containing products; use caution in hepatic disease, chronic alcohol use, malnutrition/dehydration, and renal impairment; stop and seek care if rash/skin reaction occurs; seek medical advice if symptoms persist (commonly >3 days for fever or persistent pain).

Drug Interactions

Drug Interactions

Warfarin (INR/bleeding risk with regular/prolonged use), alcohol and other hepatotoxic drugs (↑ hepatotoxicity risk), enzyme inducers such as rifampicin/carbamazepine/phenytoin (↑ toxic metabolite formation), isoniazid (↑ hepatotoxicity risk), cholestyramine (↓ absorption if given close together), metoclopramide/domperidone (↑ rate of absorption), probenecid (↓ clearance).

Interaction Severity

MAJOR: Chronic heavy alcohol use and other hepatotoxic risk factors (increased hepatotoxicity risk with overdose/high doses). MODERATE: Warfarin (regular/prolonged paracetamol may increase INR-monitor), isoniazid and enzyme inducers (rifampicin, carbamazepine, phenytoin, phenobarbital) (increased hepatotoxicity risk), flucloxacillin (rare high anion gap metabolic acidosis in predisposed patients). MINOR: Metoclopramide/domperidone (faster absorption), cholestyramine (reduced absorption if taken close together).

Food Interaction

No food restriction; food may slightly delay onset of action but does not significantly affect overall exposure.

Alcohol Interaction

Dangerous

Special Populations

Pregnancy

FDA Category B; TGA Category A

Children

Children 6-12 years: 250-500mg every 4-6 hours (max 4 doses/24 hours). Children 1-5 years: 120-250mg every 4-6 hours (max 4 doses/24 hours). Children under 1 year: 60-120mg per dose (weight-based: 10-15mg/kg every 4-6 hours). Do not exceed 5 doses in 24 hours in children

Liver Impairment

Use with caution in hepatic impairment; consider lower total daily dose and/or longer dosing interval; avoid in severe hepatic impairment or active severe liver disease.

Storage & Patient Advice

Patient Counseling

Do not exceed 4000 mg/day (8 tablets of 500 mg) and keep at least 4-6 hours between doses; check all other products for paracetamol/acetaminophen to avoid accidental overdose; avoid alcohol and seek advice if you have liver disease, severe kidney disease, are underweight/malnourished, or use warfarin; seek urgent medical care immediately after any overdose even if asymptomatic; see a clinician if fever persists >3 days or pain persists >5 days.

Monitoring Requirements

No routine monitoring for short-term OTC use at recommended doses; consider liver function monitoring with prolonged high-dose use or in patients with hepatic risk factors, and monitor INR if used regularly with warfarin.

Pharmacology

Mechanism of Action

Analgesic/antipyretic via inhibition of central prostaglandin synthesis (COX activity) with antipyresis through hypothalamic heat-regulating centers; peripheral anti-inflammatory activity is minimal.

Onset of Action

30-60 minutes.

Half-Life

Approximately 2 hours in healthy adults (typical range ~1-3 hours).

Bioavailability

Approximately 63-89% (variable; may be dose- and formulation-dependent).

Metabolism

Primarily hepatic metabolism via glucuronidation and sulfation (~90%); a small fraction (~5-10%) undergoes CYP-mediated oxidation (mainly CYP2E1, also CYP1A2/CYP3A4) to NAPQI, which is detoxified by glutathione at therapeutic doses.

Excretion

Renal excretion predominantly as glucuronide and sulfate conjugates; a small fraction is excreted unchanged (typically <5%).

Protein Binding

10-25%.

Product Information

Available Dosage Forms

For this product: oral tablet (500 mg). In general for paracetamol: tablets/caplets, capsules, oral liquid (solution/suspension), orally disintegrating tablets, effervescent tablets, suppositories, and IV infusion/injection (where available).

Composition per Dose

Each tablet: 500mg paracetamol (acetaminophen)

Generic Availability

Yes

Pain Type

General

Nsaid

No

Opioid

No

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