PROF 100/MG/5/ML SUSP 100ML

Indications

Approved Uses

Symptomatic relief of mild to moderate pain and fever; anti-inflammatory use in rheumatic/musculoskeletal conditions (e.g., juvenile idiopathic arthritis/arthritis) where clinically indicated.

Dosage & Administration

Dosing by Condition

Children (≥6 months): 5-10 mg/kg/dose every 6-8 hours as needed (max 40 mg/kg/day). Adults/≥12 years (OTC analgesia/fever): 200-400 mg every 4-6 hours as needed (max 1200 mg/day OTC; higher doses only under medical supervision). Anti-inflammatory adult dosing (prescription): typically 1200-3200 mg/day in divided doses per clinician direction.

Initial Dose

Children: 5-10mg/kg per dose. Adults: 200-400mg per dose

Maintenance Dose

Children 6 months up to 2 years: 5-10 mg/kg every 6-8 hours (max 40 mg/kg/day). Adults: OTC not directed; prescription 1200-3200 mg/day divided doses.

Maximum Dose

Adults: OTC maximum 1200 mg/day; under medical supervision (prescription): up to 3200 mg/day in divided doses. Pediatrics: typically 40 mg/kg/day (max) in divided doses (subject to local product labeling).

Children's Dosage

Children 3-6 months: 50mg (2.5ml) every 6-8 hours (under medical supervision). Children 6 months-1 year: 50mg (2.5ml) every 6-8 hours. Children 1-4 years: 100mg (5ml) every 6-8 hours. Children 4-7 years: 150mg (7.5ml) every 6-8 hours. Children 7-10 years: 200mg (10ml) every 6-8 hours. Children 10-12 years: 300mg (15ml) every 6-8 hours. Dose based on 5-10mg/kg every 6-8 hours, max 40mg/kg/day

How to Take

Shake well before each dose; measure using the supplied oral syringe/cup (not a household spoon); may be taken with food or milk to reduce GI upset.

How to Prepare

N/A - ready-to-use oral suspension (no reconstitution required); shake well before each dose.

Side Effects

Common Side Effects

Dyspepsia/indigestion, nausea, abdominal pain, diarrhea, constipation, vomiting, headache, dizziness, rash.

Side Effect Frequency

Common (1-10%): dyspepsia/indigestion, nausea, abdominal pain, diarrhea, constipation, vomiting, headache, dizziness, rash. Uncommon (0.1-1%): gastritis, peptic ulcer, gastrointestinal bleeding, fluid retention/edema, hypersensitivity reactions, elevated liver enzymes, tinnitus, renal impairment.

Safety & Warnings

Contraindications

Hypersensitivity to ibuprofen/other NSAIDs (including history of NSAID/aspirin-induced asthma, urticaria, or anaphylaxis); active peptic ulcer or gastrointestinal bleeding; severe heart failure; severe hepatic impairment; severe renal impairment; third trimester of pregnancy; peri-operative use for CABG pain.

Warnings & Precautions

Use the lowest effective dose for the shortest duration; increased risk of CV events and serious GI events (higher in elderly/history of ulcer/with anticoagulants, steroids, SSRIs); avoid use around CABG surgery; caution in renal impairment, heart failure, dehydration, and with ACEI/ARB/diuretics; may exacerbate asthma (avoid in aspirin/NSAID-sensitive asthma); avoid in third trimester of pregnancy; avoid duplicate therapy with other ibuprofen/NSAID-containing products; consider monitoring for GI bleeding, BP/edema, and renal function in at-risk patients.

Age Restriction

Do not use in children under 6 months of age unless directed by a doctor; for children under 24 lbs or under 2 years, ask a doctor.

Drug Interactions

Interaction Severity

MAJOR/clinically significant: anticoagulants (e.g., warfarin/DOACs) and antiplatelets (incl. aspirin) → bleeding risk; high-dose methotrexate → toxicity; lithium → increased levels/toxicity. MODERATE: ACE inhibitors/ARBs and diuretics (incl. 'triple whammy' with ACEi/ARB+diuretic) → reduced effect/AKI risk; SSRIs/SNRIs and corticosteroids → increased GI bleeding risk; cyclosporine/tacrolimus → nephrotoxicity. MINOR: antacids may alter absorption rate (usually not clinically important).

Food Interaction

Take with food

Special Populations

Children

Children 3-6 months: 50mg (2.5ml) every 6-8 hours (under medical supervision). Children 6 months-1 year: 50mg (2.5ml) every 6-8 hours. Children 1-4 years: 100mg (5ml) every 6-8 hours. Children 4-7 years: 150mg (7.5ml) every 6-8 hours. Children 7-10 years: 200mg (10ml) every 6-8 hours. Children 10-12 years: 300mg (15ml) every 6-8 hours. Dose based on 5-10mg/kg every 6-8 hours, max 40mg/kg/day

Storage & Patient Advice

Storage Conditions

Store below 30°C; keep the bottle tightly closed; shake well before use. This is a ready-to-use oral suspension (no reconstitution required); no special post-reconstitution storage applies.

Preparation Instructions

N/A - ready-to-use oral suspension (no reconstitution required); shake well before each dose.

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

Safe to stop anytime when used for short-term pain or fever relief.

Overdose

Symptoms: nausea, vomiting, abdominal pain, dizziness/drowsiness, headache, tinnitus; severe toxicity may include hypotension, metabolic acidosis, seizures, coma, acute kidney injury, and GI bleeding. Management: urgent medical evaluation/poison center; activated charcoal if a potentially toxic ingestion presents within ~1 hour (and airway protected), plus supportive care and monitoring (vitals, acid-base status, renal function/electrolytes).

Patient Counseling

Shake well; measure with a dosing device; take with food/milk if stomach upset; do not exceed recommended dose or combine with other ibuprofen/NSAID products; watch for GI bleeding (black stools/vomiting blood), allergy/wheezing, and reduced urine/swelling; seek medical advice if symptoms persist (commonly >3 days for fever or >10 days for pain) or if the child is <6 months unless directed; avoid in the last 3 months of pregnancy; use caution with anticoagulants, steroids, SSRIs, ACEi/ARBs/diuretics, lithium, and methotrexate.

Pharmacology

Mechanism of Action

Reversibly inhibits COX-1 and COX-2, decreasing prostaglandin synthesis, producing analgesic, antipyretic, and anti-inflammatory effects.

Duration of Effect

4-6 hours.

Metabolism

Extensively hepatic metabolism, mainly via CYP2C9, to inactive hydroxy- and carboxy-ibuprofen metabolites.

Product Information

Available Dosage Forms

For this product: oral suspension 20 mg/mL (100 mg/5 mL) in a 100 mL bottle for oral use.

Composition per Dose

Each 5ml: 100mg ibuprofen

Generic Availability

Yes

Pain Type

General/Muscular/Joint

Nsaid

Yes

Opioid

No

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