ADOL 500/MG CAPLET 24/CAPLET

Indications

Approved Uses

Short-term symptomatic relief of mild to moderate pain and fever (e.g., headache, toothache, sore throat/colds & flu aches).

Dosage & Administration

Dosing by Condition

Adults and adolescents ≥16 years: 1-2 tablets every 4-6 hours as needed; maximum 8 tablets (4 g paracetamol) in 24 hours.

Initial Dose

1-2 tablets (500mg-1000mg paracetamol) as a single dose

Maintenance Dose

1 to 2 tablets every 4 to 6 hours as needed.

Maximum Dose

4 tablets per 24 hours (equivalent to 2000mg paracetamol per day)

Children's Dosage

For children 10 to 15 years: 1 tablet up to 4 times daily. Do not give to children under 10 years of age. Other pediatric formulations of paracetamol are available for younger children, with dosing based on weight.

Dose Adjustment Notes

Hepatic impairment/chronic alcohol use/malnutrition/low body weight: use the lowest effective dose and consider a reduced maximum daily dose (often ≤3 g/day) and longer dosing intervals; severe renal impairment: extend dosing interval (e.g., every 6-8 hours).

How to Take

Swallow 1-2 tablets/caplets whole with a full glass of water; may be taken with or without food; do not crush or chew.

Side Effects

Common Side Effects

Usually well tolerated; may cause nausea, vomiting, abdominal discomfort; sodium bicarbonate may cause belching/flatulence.

Side Effect Frequency

Adverse effects are uncommon/rare at therapeutic doses; GI upset (nausea/vomiting) can occur, hypersensitivity reactions (rash/urticaria) are rare, and serious hepatotoxicity is rare and primarily associated with overdose; severe skin reactions and blood dyscrasias are very rare

Safety & Warnings

Contraindications

Hypersensitivity to paracetamol or any component; severe hepatic impairment/active severe liver disease.

Warnings & Precautions

Do not exceed recommended dose; avoid concurrent use with other paracetamol-containing products; seek advice/limit dose in liver disease, chronic alcohol use, malnutrition/low body weight, and renal impairment; consider sodium load due to sodium bicarbonate in patients on sodium-restricted diets/heart failure/hypertension/renal disease; avoid prolonged continuous use without medical supervision.

Age Restriction

Not recommended for children under 12 years (unless specifically directed by a clinician).

Driving Warning

Safe

Drug Interactions

Drug Interactions

Warfarin/coumarins (INR may increase with regular/prolonged paracetamol use); alcohol and other hepatotoxic drugs (increased hepatotoxicity risk); enzyme inducers (e.g., carbamazepine, phenytoin, phenobarbital, rifampicin) and isoniazid (increase hepatotoxicity risk and may reduce analgesic effect); cholestyramine (reduces absorption if given close in time); metoclopramide/domperidone (increase absorption rate).

Interaction Severity

MAJOR: Chronic heavy alcohol use (↑ hepatotoxicity risk). MODERATE: Warfarin with regular/repeated paracetamol use (may ↑ INR/bleeding risk); isoniazid; enzyme inducers (rifampicin, carbamazepine, phenytoin, phenobarbital) (↑ hepatotoxicity risk). MINOR: Cholestyramine (↓ absorption if taken close); metoclopramide/domperidone (↑ absorption rate).

Food Interaction

No clinically significant food restriction; food may delay onset (slower absorption) but does not meaningfully reduce overall effect.

Alcohol Interaction

Dangerous

Special Populations

Pregnancy

Caution

Breastfeeding

Safe

Children

For children 10 to 15 years: 1 tablet up to 4 times daily. Do not give to children under 10 years of age. Other pediatric formulations of paracetamol are available for younger children, with dosing based on weight.

Elderly

Standard adult dosing can be used, but a lower dose may be appropriate for frail elderly patients or those with risk factors for hepatotoxicity.

Kidney Impairment

CrCl 10-50 mL/min: dose every 6 hours; CrCl <10 mL/min: dose every 8 hours (avoid exceeding usual daily maximum).

Liver Impairment

Chronic liver disease/mild-moderate impairment: use with caution and reduce maximum daily dose to 2-3 g/day (and avoid prolonged continuous use); severe hepatic impairment/active severe liver failure: avoid/contraindicated.

Storage & Patient Advice

Storage Conditions

Store below 25°C, in a dry place, away from light

Missed Dose

Take as soon as remembered; skip if it is almost time for the next dose. Do not take a double dose.

Stopping the Medicine

No tapering is required; may be stopped when symptoms resolve. If used regularly for several days or at high doses, avoid exceeding the maximum daily dose and consult a clinician if ongoing use is needed.

Overdose

Early: nausea, vomiting, diaphoresis, pallor, abdominal pain; delayed (24-72 h): rising transaminases, RUQ pain, jaundice, coagulopathy, hypoglycemia, encephalopathy and possible acute liver failure; management: urgent medical assessment, activated charcoal if within ~1-2 h of significant ingestion, and N-acetylcysteine (NAC) guided by nomogram/time since ingestion plus supportive care.

Patient Counseling

Max 8 tablets/24 hours (4 g paracetamol); avoid taking with any other paracetamol-containing products; seek urgent help after overdose even if well; avoid or limit alcohol; consult a clinician before use if liver disease, severe kidney disease, chronic malnutrition/low body weight, or on warfarin; if symptoms persist >3 days, seek medical advice; contains sodium (sodium bicarbonate)-use caution with low-sodium diet, heart failure, or uncontrolled hypertension.

Monitoring Requirements

No routine monitoring for short-term OTC use; if prolonged/repeated use or in at-risk patients (liver disease, chronic alcohol use, malnutrition, concomitant hepatotoxins), consider monitoring liver function (and renal function if prolonged/high-dose use).

Pharmacology

Mechanism of Action

Paracetamol provides analgesic/antipyretic effects primarily via central prostaglandin synthesis inhibition; sodium bicarbonate acts as a buffer/alkalinizing agent that enhances tablet dissolution and can speed gastric emptying/absorption, leading to faster onset.

Onset of Action

Approximately 15-30 minutes (may be faster than standard paracetamol due to the bicarbonate-containing rapid-absorption formulation).

Duration of Effect

4-6 hours.

Half-Life

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

Bioavailability

Approximately 70-90% (high oral bioavailability; not meaningfully increased by sodium bicarbonate beyond faster absorption/onset)

Metabolism

Hepatic metabolism primarily via glucuronidation and sulfation; a small fraction via CYP (mainly CYP2E1, also CYP1A2/CYP3A4) forms NAPQI, detoxified by glutathione at therapeutic doses

Excretion

Renal excretion predominantly as metabolites; ~90%+ excreted in urine as glucuronide/sulfate conjugates, with ~2-5% excreted unchanged

Protein Binding

Low protein binding at therapeutic concentrations (~10-25%); increases in overdose

Product Information

Available Dosage Forms

Tablet (oral).

Composition per Dose

Each tablet: Paracetamol 500mg + Sodium Bicarbonate 630mg

Generic Availability

Yes

OTC Alternatives

Paracetamol (standard immediate-release) and ibuprofen are common OTC alternatives; aspirin is an alternative in appropriate adults when not contraindicated.

Pain Type

General

Nsaid

No

Opioid

No

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