ADOL 120/MG/5/ML SYRUP 100ML

Indications

Approved Uses

Symptomatic treatment of mild to moderate pain and fever (antipyretic/analgesic).

Off-Label Uses

No specific off-label use is necessary to state for this OTC syrup; paracetamol is commonly used for osteoarthritis pain as an analgesic option (use has declined due to limited efficacy).

Dosage & Administration

Dosing by Condition

Fever/mild-moderate pain: Children: 10-15 mg/kg/dose orally every 4-6 hours as needed (max 4 doses/24 h; typical max 60 mg/kg/day). Adults/adolescents: 500-1000 mg every 4-6 hours as needed (max 4 g/day; lower max in hepatic risk). For this syrup (24 mg/mL): dose volume (mL) = (weight(kg) × 10-15 mg/kg) ÷ 24 mg/mL.

Initial Dose

Children: 10-15 mg/kg per dose orally every 4-6 hours as needed (max 4 doses/24 h). For this 24 mg/mL syrup: dose volume (mL) = (weight in kg × 10-15) ÷ 24.

Maintenance Dose

10-15 mg/kg/dose every 4-6 hours as needed

Maximum Dose

Children: max 60 mg/kg/day (do not exceed 15 mg/kg per dose; max 4 doses/24 h). Adults: max 4,000 mg/day (consider ≤3,000 mg/day if risk factors for hepatotoxicity).

Children's Dosage

3-6 months: 2.5ml (60mg) every 4-6 hours; 6 months-2 years: 5ml (120mg) every 4-6 hours; 2-4 years: 7.5ml (180mg) every 4-6 hours; 4-6 years: 10ml (240mg) every 4-6 hours; maximum 4 doses per 24 hours; dose based on weight: 10-15 mg/kg/dose

Dose Adjustment Notes

Renal impairment: if CrCl <30 mL/min, extend dosing interval (e.g., every ≥6-8 hours) and avoid excessive total daily dose; hepatic impairment/chronic alcohol use/malnutrition: use the lowest effective dose, consider reduced maximum daily dose, and avoid prolonged high-dose use.

How to Take

Oral use: shake well before each dose; measure with a calibrated oral syringe/cup; give every 4-6 hours as needed; do not exceed 4 doses in 24 hours; may be given with or without food.

Side Effects

Common Side Effects

Usually well tolerated; possible nausea, vomiting, and abdominal discomfort; rash/hypersensitivity is uncommon; constipation is not a typical common effect.

Side Effect Frequency

At therapeutic doses: adverse effects are uncommon/rare; may include nausea/vomiting and hypersensitivity reactions (rash/urticaria/bronchospasm). Rare: blood dyscrasias (e.g., thrombocytopenia), severe cutaneous adverse reactions (SJS/TEN), and hepatic injury primarily with overdose or prolonged high dosing

Safety & Warnings

Contraindications

Hypersensitivity to paracetamol, severe hepatic impairment, active liver disease, chronic alcoholism

Warnings & Precautions

Do not exceed recommended dose; do not use with other paracetamol-containing products; use caution in hepatic disease, chronic alcohol use, malnutrition/low glutathione states (e.g., dehydration), and renal impairment; stop and seek care if rash or hypersensitivity occurs. (G6PD deficiency is not a standard major precaution for paracetamol compared with other analgesics.)

Age Restriction

Usable from birth, but infants <3 months should only be treated on a doctor’s advice (especially for fever); routine OTC use is generally for ≥3 months.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Key interactions: warfarin/coumarins (↑INR with regular/prolonged paracetamol use), alcohol and other hepatotoxins (↑hepatotoxicity risk), enzyme inducers such as rifampicin, carbamazepine, phenytoin, phenobarbital (↑toxic metabolite formation/hepatotoxicity risk), isoniazid (↑hepatotoxicity risk), cholestyramine (↓absorption if given close together), metoclopramide/domperidone (↑rate of absorption).

Interaction Severity

MAJOR: chronic heavy alcohol use or active alcohol misuse (increased hepatotoxicity risk, especially with supratherapeutic dosing). MODERATE: warfarin with repeated regular paracetamol use (e.g., ≥2 g/day for several days) may increase INR; isoniazid and enzyme inducers (carbamazepine, phenytoin, phenobarbital, rifampicin) increase hepatotoxicity risk. MINOR: cholestyramine (reduced absorption if given close together), metoclopramide/domperidone (faster absorption/onset).

Food Interaction

No food restriction; food may delay onset by slowing absorption, but overall exposure is not clinically meaningfully reduced.

Alcohol Interaction

Dangerous

Special Populations

Pregnancy

FDA Category B; Australian Category A

Breastfeeding

Safe

Children

3-6 months: 2.5ml (60mg) every 4-6 hours; 6 months-2 years: 5ml (120mg) every 4-6 hours; 2-4 years: 7.5ml (180mg) every 4-6 hours; 4-6 years: 10ml (240mg) every 4-6 hours; maximum 4 doses per 24 hours; dose based on weight: 10-15 mg/kg/dose

Elderly

Use standard adult dosing but consider a lower maximum daily dose in older/frail adults: do not exceed 3,000 mg/day; use the lowest effective dose and extend dosing interval if hepatic impairment or significant renal impairment.

Kidney Impairment

Renal impairment: extend dosing interval-CrCl 10-50 mL/min give every 6 hours; CrCl <10 mL/min give every 8 hours (and keep within max daily dose).

Liver Impairment

Mild-moderate hepatic impairment: use with caution and reduce total daily dose and/or extend dosing interval; severe hepatic impairment or active liver disease: avoid/contraindicated.

Storage & Patient Advice

Missed Dose

Take as soon as remembered; skip if near next scheduled dose; do not double the dose

Stopping the Medicine

May be stopped abruptly when no longer needed; no taper required.

Overdose

Early (0-24 h): nausea, vomiting, diaphoresis, pallor, abdominal pain; delayed (24-72 h+): rising transaminases, RUQ pain, jaundice, coagulopathy, hypoglycemia, encephalopathy/acute liver failure. Management: urgent medical evaluation, consider activated charcoal if within ~1 hour, measure level and use nomogram where applicable, and give N-acetylcysteine (most effective if started within 8-10 h but beneficial later) with supportive care and LFT/INR monitoring.

Patient Counseling

Measure doses accurately and shake well; dose by weight when possible; give every 4-6 hours as needed and do not exceed 4 doses/24 h; do not use with any other paracetamol-containing products; seek urgent help after overdose even if well; use caution/seek advice in liver disease, chronic alcohol use, malnutrition, or if taking warfarin; see a clinician if fever persists >3 days or pain >5 days or if rash/allergy occurs; store below 30°C (per SFDA).

Monitoring Requirements

No routine monitoring for short-term, therapeutic OTC use; consider liver function tests (and INR if on warfarin) with prolonged regular use, high doses, or hepatic risk factors.

Pharmacology

Mechanism of Action

Central inhibition of prostaglandin synthesis (COX activity) leading to analgesic and antipyretic effects; antipyresis via hypothalamic heat-regulating center; additional contribution from serotonergic descending pathways has been proposed.

Onset of Action

30-60 minutes.

Duration of Effect

4-6 hours.

Half-Life

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

Bioavailability

Approximately 60-90% (variable; may be dose-dependent)

Metabolism

Hepatic metabolism mainly via glucuronidation and sulfation; a minor fraction undergoes CYP-mediated oxidation (primarily CYP2E1, also CYP1A2/CYP3A4) to NAPQI, detoxified by glutathione at therapeutic doses

Excretion

Renal excretion predominantly as conjugated metabolites; >90% recovered in urine within 24 hours, with <5% excreted unchanged

Protein Binding

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

Product Information

Available Dosage Forms

Paracetamol is available (market-wide) as oral liquid (syrup/suspension), tablets/caplets, effervescent tablets, suppositories, and IV infusion/injection; capsules and ODT exist in some markets.

Composition per Dose

Each 5ml: 120mg paracetamol

Generic Availability

Yes

OTC Alternatives

Ibuprofen (age-appropriate) is the main OTC alternative for pain/fever; avoid aspirin for children/teens due to Reye’s syndrome risk; non-drug options include hydration and tepid measures for comfort.

Pain Type

General

Nsaid

No

Opioid

No

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