PROF 600/MG FC TAB 30/FC TAB

Indications

Approved Uses

Symptomatic relief of pain and inflammation in rheumatic conditions (e.g., rheumatoid arthritis, osteoarthritis, ankylosing spondylitis) and for mild-moderate pain including dysmenorrhea; antipyretic use (fever) is also an accepted indication for ibuprofen.

Dosage & Administration

Dosing by Condition

Adults (oral): Mild-moderate pain/dysmenorrhea: 400 mg every 4-6 hours as needed (some patients may require 600 mg per dose); typical prescription maximum 2400 mg/day (up to 3200 mg/day may be used for inflammatory arthritis under medical supervision). Rheumatoid arthritis/osteoarthritis/ankylosing spondylitis: 1200-3200 mg/day in 3-4 divided doses. Fever: 200-400 mg every 4-6 hours as needed (adult antipyretic use), not exceeding usual daily maxima above.

Initial Dose

400 mg every 4 to 6 hours as necessary

Maintenance Dose

For mild to moderate pain: 400 mg every 4 to 6 hours as necessary. For dysmenorrhea: 400 mg every 4 hours as necessary. For rheumatoid arthritis and osteoarthritis: 1200 mg to 3200 mg daily in divided doses (400 mg, 600 mg or 800 mg three or four times daily)

Maximum Dose

Maximum 3200 mg/day (prescription) in divided doses under medical supervision; typical maximum for many pain indications is 2400 mg/day.

Dose Adjustment Notes

Use the lowest effective dose for the shortest duration; use caution in older adults and in renal, hepatic, or cardiovascular disease; avoid in severe renal impairment and in advanced/severe hepatic impairment unless specialist-directed; reassess regularly and titrate to response/tolerability.

How to Take

Swallow the 600 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

Dyspepsia/indigestion (including heartburn), nausea (± vomiting), abdominal pain, diarrhea or constipation, headache, dizziness, and rash; fluid retention and increased blood pressure can occur (especially with higher doses/longer use).

Side Effect Frequency

Common (1-10%): dyspepsia, nausea, abdominal pain, diarrhea, constipation, flatulence, vomiting, headache, dizziness. Uncommon (0.1-1%): gastritis, GI ulceration, rash/urticaria. Rare/very rare (<0.1%): GI bleeding/perforation, severe renal impairment/failure, hepatic dysfunction, serious hypersensitivity/skin reactions.

Safety & Warnings

Contraindications

Contraindicated in: hypersensitivity to ibuprofen/other NSAIDs; history of NSAID/aspirin‑induced asthma/urticaria/bronchospasm (AERD); active peptic ulcer or GI bleeding; severe renal failure; severe hepatic failure; severe heart failure; 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 thrombotic events and worsening hypertension/heart failure/edema; increased risk of serious GI bleeding/ulceration (higher in elderly, prior ulcer/GI bleed, concomitant anticoagulants/antiplatelets/SSRIs/corticosteroids); renal toxicity risk (CKD, dehydration, ACEi/ARB+diuretic use); avoid in aspirin-sensitive asthma; may mask fever/inflammation; discontinue if rash or hypersensitivity occurs.

Drug Interactions

Food Interaction

Take with food

Special Populations

Pregnancy

Contraindicated

Storage & Patient Advice

Storage Conditions

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat 40°C (104°F). Dispense in a tight, light-resistant container.

Overdose

Symptoms: GI upset (nausea/vomiting/epigastric pain), dizziness/drowsiness, headache, tinnitus; severe toxicity may include metabolic acidosis, hypotension, seizures, coma, and acute kidney injury. Management: urgent medical evaluation, supportive care, consider activated charcoal if early after large ingestion, monitor vitals/renal function/electrolytes/acid-base.

Patient Counseling

Take with food/milk and water; do not exceed prescribed dose/duration and avoid taking with other NSAIDs/aspirin unless directed; seek urgent care for GI bleeding (black stools/vomiting blood), severe abdominal pain, allergic reaction, or cardiovascular symptoms (chest pain, shortness of breath, weakness); avoid alcohol and inform your clinician about history of ulcers/bleeding, kidney disease, hypertension/heart disease, and all anticoagulant/antiplatelet medicines; avoid use in the 3rd trimester of pregnancy.

Monitoring Requirements

If prolonged/high‑dose therapy: monitor blood pressure, renal function (SCr/eGFR), and for GI bleeding; consider CBC (for anemia/bleeding) and liver enzymes periodically, especially in higher-risk patients.

Product Information

Available Dosage Forms

For this specific product: film‑coated tablet (oral). For ibuprofen generally: tablets/caplets (including film‑coated), capsules, oral suspension, and topical gel are common; injectable/IV forms exist in some markets but are not applicable to this PROF 600 mg tablet listing.

Composition per Dose

Each film-coated tablet: 600mg ibuprofen

Generic Availability

Yes

Pain Type

General/Muscular/Joint

Nsaid

Yes

Opioid

No

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