BRUFEN 400/MG FC TAB 30/FC TAB

Indications

Approved Uses

Relief of mild to moderate pain and fever; anti‑inflammatory/analgesic treatment of rheumatic conditions such as osteoarthritis and rheumatoid arthritis; primary dysmenorrhea.

Off-Label Uses

Acute pericarditis (adjunct/first-line NSAID), acute gout flares (when appropriate), and closure of patent ductus arteriosus applies to IV ibuprofen formulations (not oral tablets).

Dosage & Administration

Dosing by Condition

[Indication: Pain/Fever (OTC)
Initial Dose: 200-400mg every 4-6 hours as needed
Maintenance Dose: 200-400mg every 4-6 hours as needed
Max Dose: 1200mg/day, Indication: Osteoarthritis/Rheumatoid Arthritis (Prescription)
Initial Dose: 400-800mg 3-4 times daily
Maintenance Dose: 1200-3200mg/day in 3-4 divided doses
Max Dose: 3200mg/day]

Initial Dose

400mg

Maintenance Dose

400mg every 4-6 hours as needed

Maximum Dose

1200mg/day (OTC self-medication); 3200mg/day (under medical supervision)

Dose Adjustment Notes

Use the lowest effective dose for the shortest duration; use caution in older adults and in renal/hepatic impairment, and avoid use in severe renal failure; higher/long-term anti‑inflammatory dosing should be under medical supervision.

How to Take

Swallow the 400 mg film‑coated tablet whole with a full glass of water; take with food or milk to reduce gastrointestinal irritation; do not crush or chew.

Side Effects

Common Side Effects

Gastrointestinal upset (dyspepsia/heartburn, abdominal pain, nausea, vomiting, diarrhea or constipation, flatulence) and CNS effects (dizziness, headache); rash can occur.

Side Effect Frequency

Common (1-10%): dyspepsia, nausea, abdominal pain, diarrhea; also headache and dizziness are commonly reported. Uncommon (0.1-1%): vomiting, flatulence, constipation, gastritis, rash, insomnia. Rare (<0.1%): peptic ulceration/GI bleeding or perforation, hepatic dysfunction (e.g., elevated LFTs/hepatitis), renal impairment/failure, severe hypersensitivity reactions, aseptic meningitis, tinnitus.

Safety & Warnings

Contraindications

Hypersensitivity to ibuprofen/other NSAIDs (including history of asthma/urticaria/allergic-type reactions after aspirin/NSAIDs); active peptic ulcer or GI bleeding (and generally avoid with history of recurrent ulcer/bleed unless protected/clinician-directed); severe heart failure; severe renal impairment; severe hepatic impairment; third trimester of pregnancy; peri-operative pain in CABG surgery.

Warnings & Precautions

Use the lowest effective dose for the shortest duration; increased risk of CV events (higher with longer use and in patients with CV disease/risk factors); serious GI events can occur without warning (higher risk in elderly, prior ulcer/bleed, concomitant anticoagulants/antiplatelets/SSRIs/corticosteroids); renal risk higher with CKD, dehydration, diuretics/ACEI/ARB, and elderly; caution in hypertension/heart failure/edema; avoid in aspirin-sensitive asthma/NSAID hypersensitivity; monitor for skin reactions and hepatic/renal dysfunction; may mask fever/inflammation.

Drug Interactions

Drug Interactions

Clinically important interactions include: anticoagulants (e.g., warfarin/DOACs) and antiplatelets (↑ bleeding); aspirin (ibuprofen may reduce aspirin’s antiplatelet effect if taken concomitantly-separate dosing); other NSAIDs (additive GI/renal/CV toxicity); ACE inhibitors/ARBs and diuretics (↓ antihypertensive/diuretic effect, ↑ AKI risk-"triple whammy"); lithium (↑ levels); methotrexate (↑ toxicity, especially high-dose); SSRIs/SNRIs and corticosteroids (↑ GI bleeding); cyclosporine/tacrolimus (↑ nephrotoxicity).

Interaction Severity

MAJOR: Warfarin/other anticoagulants (↑ bleeding), concomitant NSAIDs including high-dose aspirin (↑ GI bleeding); MODERATE: ACE inhibitors/ARBs and diuretics (↓ antihypertensive/diuretic effect, ↑ AKI risk-"triple whammy"), lithium (↑ levels), methotrexate (↑ toxicity), SSRIs/SNRIs and corticosteroids (↑ GI bleeding/ulcer risk), ciclosporin/tacrolimus (↑ nephrotoxicity); MINOR: antacids may alter absorption rate; ibuprofen can reduce low-dose aspirin’s antiplatelet effect if taken at the wrong time.

Food Interaction

Take with food or milk if stomach upset occurs (food may slightly delay onset but improves GI tolerability).

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Contraindicated

Elderly

Use lowest effective dose for shortest duration. Increased risk of GI bleeding, renal impairment, and cardiovascular events. Monitor renal function and blood pressure regularly

Storage & Patient Advice

Overdose

Symptoms: nausea/vomiting, epigastric pain, dizziness/drowsiness, tinnitus; severe toxicity may cause metabolic acidosis, hypotension, seizures, coma, and acute kidney injury. Management: urgent medical evaluation/poison center, consider activated charcoal if early after large ingestion, and provide supportive care with monitoring of vitals, acid-base status, electrolytes, and renal function.

Patient Counseling

Take with food or milk if it upsets your stomach; use the lowest effective dose for the shortest time; do not exceed OTC maximum daily dose (commonly 1200 mg/day) or use >10 days for pain or >3 days for fever without medical advice; avoid alcohol and other NSAIDs; seek care for black/tarry stools, vomiting blood, severe stomach pain, chest pain/shortness of breath, swelling, or allergic reaction; ask a clinician before use if pregnant (avoid in 3rd trimester), or if you have kidney disease, ulcers/bleeding history, heart disease, or take anticoagulants/antiplatelets.

Monitoring Requirements

OTC short-term use: no routine labs, but monitor clinically for GI bleeding, allergic reactions, and worsening asthma; long-term/high-dose use: periodic renal function, liver enzymes, CBC (for anemia/bleeding), and blood pressure/edema assessment.

Pharmacology

Mechanism of Action

Reversibly and nonselectively inhibits COX‑1 and COX‑2, decreasing prostaglandin synthesis to reduce pain, inflammation, and fever.

Onset of Action

30-60 minutes.

Duration of Effect

4-6 hours

Half-Life

Approximately 2 hours (range ~1.8-2 hours in healthy adults)

Bioavailability

Approximately 80% (often cited range ~80-100%).

Product Information

Available Dosage Forms

Film-coated tablet, tablet, capsule, oral suspension, oral drops, topical gel, IV solution

Composition per Dose

Each film-coated tablet: 400mg ibuprofen

Generic Availability

Yes

OTC Alternatives

Paracetamol (acetaminophen) for pain/fever; naproxen (where available OTC) for pain/inflammation; aspirin for adults only when appropriate (avoid in children/teens and in higher bleeding-risk patients).

Pain Type

General/Muscular/Joint

Nsaid

Yes

Opioid

No

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