PANADREX 500/MG TAB 48/TAB

Indications

Approved Uses

Temporary relief of mild to moderate pain such as headache, menstrual periods, backache, toothache, and other minor aches and pains, and for the reduction of fever.

Off-Label Uses

No specific off-label uses need to be listed for this OTC product; common clinical uses are labeled indications for pain and fever.

Dosage & Administration

Dosing by Condition

Pain/fever: Adults and ≥12 years: 500-1000 mg every 4-6 hours as needed (max 4,000 mg/day). Children: use weight-based dosing 10-15 mg/kg per dose every 4-6 hours as needed (max 60 mg/kg/day; do not exceed 4 doses/24 h).

Initial Dose

500-1000mg as a single dose

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 2-6 years: 120-250mg every 4-6 hours (max 4 doses/24h). Children 6-12 years: 250-500mg every 4-6 hours (max 4 doses/24h). Weight-based dosing: 10-15mg/kg/dose every 4-6 hours. Not recommended in neonates without medical supervision

Dose Adjustment Notes

Hepatic impairment/chronic alcohol use/malnutrition: use the lowest effective dose and consider a lower maximum daily dose; severe renal impairment (CrCl <30 mL/min): extend dosing interval (e.g., every 6-8 hours).

How to Take

Swallow the tablet with water; may be taken with or without food.

Side Effects

Common Side Effects

Uncommon: nausea, vomiting, abdominal discomfort. Rare: hypersensitivity reactions such as rash/urticaria.

Side Effect Frequency

Uncommon: nausea, vomiting, abdominal discomfort. Rare: hypersensitivity reactions (rash/urticaria), blood dyscrasias (e.g., thrombocytopenia, agranulocytosis). Very rare: serious skin reactions (SJS/TEN). Hepatic enzyme elevations/hepatotoxicity are mainly associated with overdose or risk factors.

Safety & Warnings

Contraindications

Known hypersensitivity to paracetamol or any excipients; severe hepatic impairment or active liver disease.

Warnings & Precautions

Do not exceed the recommended dose; avoid taking with any other paracetamol-containing products; seek urgent medical advice after any suspected overdose even if well; use caution/medical advice in hepatic impairment, chronic alcohol use, renal impairment, dehydration, chronic malnutrition/low body weight, and with long-term regular use (especially with warfarin); discontinue and seek care if rash or signs of hypersensitivity occur.

Age Restriction

This product is a 500 mg oral tablet: generally suitable for adults and adolescents; for children, 500 mg tablets are typically appropriate from ~12 years (or ≥40 kg). Younger children should use age/weight-appropriate paracetamol formulations (e.g., liquid/125-250 mg) rather than 500 mg tablets.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Warfarin/coumarins (regular/prolonged paracetamol may increase INR/bleeding risk); alcohol and other hepatotoxic drugs; enzyme inducers (e.g., carbamazepine, phenytoin, phenobarbital, rifampicin) and isoniazid (↑ hepatotoxicity risk); cholestyramine (↓ absorption if given close together); metoclopramide or domperidone (↑ rate of absorption); probenecid (↓ clearance/↑ exposure); flucloxacillin (rare risk of high anion gap metabolic acidosis with paracetamol, especially with risk factors).

Interaction Severity

MAJOR/clinically significant: chronic heavy alcohol use (↑ hepatotoxicity risk), warfarin with regular repeated dosing (↑ INR/bleeding risk). MODERATE: enzyme inducers (carbamazepine, phenytoin, phenobarbital, rifampicin) and isoniazid (↑ hepatotoxicity risk), probenecid (↑ paracetamol exposure), flucloxacillin (rare high anion gap metabolic acidosis esp. with risk factors). MINOR: metoclopramide (↑ absorption rate), cholestyramine (↓ absorption if co-administered).

Food Interaction

No restriction.

Alcohol Interaction

Dangerous

Special Populations

Pregnancy

FDA Pregnancy Category B; use during pregnancy only if clearly needed.

Breastfeeding

Safe

Children

Children 2-6 years: 120-250mg every 4-6 hours (max 4 doses/24h). Children 6-12 years: 250-500mg every 4-6 hours (max 4 doses/24h). Weight-based dosing: 10-15mg/kg/dose every 4-6 hours. Not recommended in neonates without medical supervision

Elderly

Standard adult dosing; consider reducing maximum daily dose to 3000mg in frail elderly patients or those with low body weight

Kidney Impairment

Use with caution; extend dosing interval in significant renal impairment: CrCl 10-50 mL/min give no more frequently than every 6 hours; CrCl <10 mL/min give no more frequently than every 8 hours.

Liver Impairment

Severe hepatic impairment/active liver disease: avoid/contraindicated. Mild-moderate hepatic impairment or chronic liver disease: use with caution and consider reducing total daily dose and/or extending dosing interval (individualize; do not exceed usual adult maximum and consider lower maxima in chronic liver disease).

Storage & Patient Advice

Storage Conditions

Store below 30°C; protect from light

Missed Dose

Take as soon as remembered; skip missed dose if it is nearly time for the next dose; do not double the dose

Stopping the Medicine

No tapering is required. May be stopped when no longer needed. Do not exceed the recommended dose or combine with other paracetamol-containing products. Seek medical advice if pain/fever persists or if prolonged/high-dose use has occurred, especially in patients with liver disease or heavy alcohol use.

Overdose

Early symptoms may be mild/non-specific (nausea, vomiting, abdominal pain, pallor); serious hepatotoxicity can be delayed (typically 24-72 h) progressing to jaundice, coagulopathy, hypoglycaemia, encephalopathy and acute liver failure; management requires urgent medical assessment, serum paracetamol level (nomogram where applicable), activated charcoal if within ~1 hour, and N-acetylcysteine as the antidote (most effective when started within 8-10 hours but indicated later if needed).

Patient Counseling

Take 1-2 tablets (500-1000 mg) every 4-6 hours as needed; do not exceed 4,000 mg in 24 hours; avoid taking with any other paracetamol-containing products; avoid or limit alcohol; seek urgent care immediately after overdose even if asymptomatic; consult a clinician if fever >3 days or pain >5 days or if you have liver disease, heavy alcohol use, or are on warfarin.

Monitoring Requirements

No routine monitoring for short-term OTC use; check liver function (and consider INR if on warfarin) with prolonged/high-dose use or in hepatic risk factors; serum paracetamol levels are for suspected overdose, not routine therapy monitoring.

Pharmacology

Mechanism of Action

Analgesic/antipyretic action primarily via central inhibition of prostaglandin synthesis (COX activity) and modulation of central pain pathways; antipyresis via hypothalamic heat-regulating center.

Onset of Action

Approximately 30-60 minutes after an oral immediate-release dose.

Duration of Effect

4-6 hours

Half-Life

Approximately 2 hours (typical range ~1.5-3 hours in healthy adults)

Bioavailability

Approximately 70-90% (variable due to first-pass metabolism).

Metabolism

Primarily hepatic: ~90% via glucuronidation and sulfation; a minor fraction (~5-10%) via CYP (mainly CYP2E1; also CYP1A2/CYP3A4) to NAPQI, detoxified by glutathione at therapeutic doses

Excretion

Renal excretion mainly as glucuronide and sulfate conjugates; ~85-95% recovered in urine within 24 hours as metabolites, with ~2-5% excreted unchanged.

Protein Binding

Low protein binding: ~10-25% (generally <20% at therapeutic concentrations)

Product Information

Available Dosage Forms

Tablet, Capsule, Orally disintegrating tablet, Oral suspension, Oral powder, Effervescent tablet, Suppository, Intravenous infusion.

Composition per Dose

Each tablet: 500mg paracetamol (acetaminophen)

Generic Availability

Yes

OTC Alternatives

Other paracetamol 500 mg tablets (same ingredient) and, if appropriate, ibuprofen; aspirin is an alternative for adults when not contraindicated.

Pain Type

General

Nsaid

No

Opioid

No

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