FEVADIL SF 120/MG/1/MG SYRUP 100ML (WASFATY)

Indications

Approved Uses

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

Off-Label Uses

Adjunct analgesia in osteoarthritis and other musculoskeletal pain (use is common, though efficacy may be modest).

Dosage & Administration

Dosing by Condition

Children (pain/fever): 10-15 mg/kg/dose orally every 4-6 hours as needed; max 60 mg/kg/day (and no more than 4 doses/24 h). Adults (pain/fever): 500-1,000 mg every 4-6 hours as needed; max 4 g/day (lower max in hepatic risk).

Initial Dose

Children (by weight): 10-15mg/kg per dose every 4-6 hours; Adults: 500-1000mg

Maintenance Dose

10-15mg/kg every 4-6 hours in children; 500-1000mg every 4-6 hours in adults

Maximum Dose

Children: 60mg/kg/day (max 4 doses in 24 hours); Adults: 4000mg/day (4g/day)

Children's Dosage

Neonates (0-3 months): 10mg/kg every 8-12 hours (only under medical supervision); 3 months-1 year: 60-120mg every 4-6 hours; 1-2 years: 120-180mg; 2-4 years: 180-240mg; 4-6 years: 240-300mg every 4-6 hours. Weight-based dosing: 10-15mg/kg/dose, max 4 doses/24 hours

Dose Adjustment Notes

Renal impairment: if CrCl <30 mL/min, extend dosing interval to at least every 6-8 hours; hepatic impairment/chronic alcohol use/malnutrition: use lowest effective dose, avoid prolonged high-dose use, and consider a reduced maximum daily dose (often ≤2-3 g/day in adults depending on risk).

How to Take

Oral use: shake well before each dose; measure with an accurate dosing device (oral syringe/medicine spoon/cup); administer directly by mouth (may be given with a small amount of water/juice if needed); rinse device after use.

Side Effects

Common Side Effects

Generally well tolerated; possible nausea, vomiting, and abdominal discomfort; constipation is uncommon.

Side Effect Frequency

At therapeutic doses: adverse effects are uncommon; rare hypersensitivity reactions (rash/urticaria) and very rare serious skin reactions (SJS/TEN) and blood dyscrasias (e.g., thrombocytopenia/agranulocytosis); nausea/vomiting are uncommon and more associated with higher doses/overdose

Safety & Warnings

Contraindications

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

Warnings & Precautions

Do not exceed recommended dose; avoid concurrent paracetamol-containing products; seek urgent care after overdose; use caution in hepatic disease, chronic alcohol use, malnutrition/dehydration, and renal impairment; limit duration without medical advice (e.g., persistent fever/pain warrants evaluation).

Age Restriction

Usable in children and adults; in infants <3 months (especially <2 months) only with medical advice/supervision.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Warfarin (INR/bleeding risk with regular/prolonged use), alcohol (hepatotoxicity risk), enzyme inducers (e.g., carbamazepine, phenytoin, phenobarbital, rifampicin) and isoniazid (↑ hepatotoxicity risk), cholestyramine (↓ absorption), metoclopramide/domperidone (↑ absorption rate), probenecid (↓ clearance/↑ exposure).

Interaction Severity

MAJOR: chronic heavy alcohol use (increased hepatotoxicity risk), repeated supratherapeutic dosing/duplicate paracetamol-containing products. MODERATE: warfarin (regular use over several days may increase INR), enzyme inducers (carbamazepine, phenytoin, phenobarbital, rifampicin) and isoniazid (↑ hepatotoxicity risk), cholestyramine (↓ absorption if given close), probenecid (↑ paracetamol levels via reduced clearance). MINOR: metoclopramide/domperidone (↑ rate of absorption).

Food Interaction

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

Alcohol Interaction

Dangerous

Special Populations

Pregnancy

FDA Category B; TGA Category A

Breastfeeding

Safe

Children

Neonates (0-3 months): 10mg/kg every 8-12 hours (only under medical supervision); 3 months-1 year: 60-120mg every 4-6 hours; 1-2 years: 120-180mg; 2-4 years: 180-240mg; 4-6 years: 240-300mg every 4-6 hours. Weight-based dosing: 10-15mg/kg/dose, max 4 doses/24 hours

Elderly

Standard adult dosing; use minimum effective dose; ensure adequate hydration; monitor for hepatic and renal function with prolonged use

Kidney Impairment

If CrCl 10-50 mL/min: dose every 6 hours; if CrCl <10 mL/min: dose every 8 hours (or extend interval in severe impairment).

Liver Impairment

Severe hepatic impairment/active liver disease: avoid or use only under specialist direction at the lowest effective dose; mild-moderate impairment or chronic alcohol use/malnutrition: use with caution and consider reduced total daily dose and/or longer interval.

Storage & Patient Advice

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 no longer needed; do not exceed the recommended dose or duration. Seek medical advice if symptoms persist (e.g., fever >3 days or pain >5 days) or if frequent/prolonged use is needed.

Overdose

Early (0-24 h): nausea, vomiting, diaphoresis, abdominal pain; 24-72 h: rising transaminases/RUQ pain; 72-96 h: hepatic failure (jaundice, coagulopathy, encephalopathy) ± renal failure; management: urgent medical care, consider activated charcoal if within ~1 hour, obtain level and use Rumack-Matthew nomogram, give N-acetylcysteine (most effective within 8-10 h but beneficial even later).

Patient Counseling

Shake well; measure doses accurately; dose by weight (10-15 mg/kg) every 4-6 h as needed and do not exceed 4 doses/24 h (or max daily dose). Do not use with any other paracetamol/acetaminophen-containing products. Seek urgent help after overdose even if well. If fever persists >3 days or pain persists >3-5 days, or if child <3 months with fever, seek medical advice. Use caution/seek advice in liver disease, chronic alcohol use, or malnutrition; store below 30°C and keep out of reach of children.

Monitoring Requirements

No routine monitoring for short-term OTC use; check LFTs if prolonged/high-dose use or in hepatic disease/risk factors, and monitor INR if used regularly with warfarin.

Pharmacology

Mechanism of Action

Primarily central analgesic/antipyretic: inhibits CNS prostaglandin synthesis (functional COX inhibition) and reduces fever via hypothalamic heat-regulating centers; additional central pathways (e.g., AM404-related effects) may contribute but are not required to explain clinical effect.

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 70-90% (variable; may be dose- and formulation-dependent)

Metabolism

Hepatic metabolism primarily via glucuronidation and sulfation; a minor fraction undergoes CYP2E1 (±CYP1A2/3A4) oxidation to NAPQI, detoxified by glutathione at therapeutic doses

Excretion

Renal excretion predominantly as conjugated metabolites; <5% excreted unchanged, with the majority eliminated in urine within ~24 hours

Protein Binding

Low protein binding at therapeutic concentrations (~10-25%), increasing at higher concentrations

Product Information

Available Dosage Forms

For this product: oral syrup. For paracetamol generally: oral liquids (syrup/solution/suspension), tablets/caplets (including effervescent and dispersible/orodispersible forms depending on market), suppositories, and IV infusion.

Composition per Dose

Each 5ml: 120mg paracetamol

Generic Availability

Yes

OTC Alternatives

For fever/pain in children: ibuprofen (age/weight-appropriate) as an alternative; for adults: ibuprofen/naproxen (if no contraindications). Avoid aspirin in children/adolescents; aspirin may be an adult alternative in select patients but has more GI/bleeding risk.

Pain Type

General

Nsaid

No

Opioid

No

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