SAPOFEN 400/MG FC TAB 30/FC TAB

Indications

Approved Uses

Relief of mild to moderate pain, reduction of fever, and relief of inflammatory conditions (e.g., osteoarthritis, rheumatoid arthritis) and dysmenorrhea.

Dosage & Administration

Dosing by Condition

Pain/Fever (adults): 200-400 mg every 4-6 hours as needed; OTC maximum 1,200 mg/day unless directed by a clinician. Dysmenorrhea: 400 mg every 4-6 hours as needed (do not exceed OTC max unless directed). Inflammatory arthritis (OA/RA): 1,200-3,200 mg/day in divided doses under medical supervision.

Initial Dose

400mg as a single dose

Maintenance Dose

400mg every 4-6 hours as needed

Maximum Dose

OTC maximum: 1200 mg/day; under medical supervision: up to 3200 mg/day (divided doses).

Dose Adjustment Notes

Use the lowest effective dose for the shortest duration; use caution in elderly and in mild-moderate renal or hepatic impairment; avoid use in severe renal impairment and in severe hepatic impairment.

Safety & Warnings

Contraindications

Hypersensitivity to ibuprofen/other NSAIDs; history of NSAID/aspirin-induced hypersensitivity (e.g., bronchospasm, urticaria, rhinitis); active peptic ulcer or active GI bleeding; severe heart failure; severe renal impairment; severe hepatic impairment; third trimester of pregnancy; peri‑operative use in CABG surgery.

Warnings & Precautions

Use the lowest effective dose for the shortest duration; increased risk of CV thrombotic events (higher with longer use/higher dose and in patients with CV disease); increased risk of serious GI bleeding/ulceration (higher in older adults, prior ulcer/GI bleed, concomitant anticoagulants/antiplatelets/SSRIs/corticosteroids); renal risk in CKD, dehydration, diuretics/ACEi/ARB; may cause fluid retention/edema and worsen hypertension/heart failure; may trigger bronchospasm in aspirin-sensitive asthma; may mask infection/fever; avoid in third trimester of pregnancy; avoid peri‑operative CABG use.

Drug Interactions

Drug Interactions

Clinically significant interactions include: anticoagulants (e.g., warfarin) and antiplatelets (incl. aspirin) ↑ bleeding; SSRIs/SNRIs and corticosteroids ↑ GI bleeding; ACE inhibitors/ARBs and diuretics ↑ renal risk/↓ antihypertensive/diuretic effect; lithium ↑ levels; methotrexate ↑ toxicity; cyclosporine/tacrolimus ↑ nephrotoxicity; other NSAIDs ↑ adverse effects; ibuprofen may interfere with low-dose aspirin’s antiplatelet effect if taken concomitantly.

Food Interaction

Take with food

Special Populations

Pregnancy

Avoid in third trimester; use with caution in first and second trimesters

Storage & Patient Advice

Patient Counseling

Take with food or milk if it upsets your stomach; swallow whole with water. Do not exceed 1,200 mg/day OTC or use longer than 3 days for fever or 10 days for pain unless advised by a clinician. Avoid combining with other NSAIDs; if on low‑dose aspirin, separate dosing (take ibuprofen at least 8 hours before or at least 30 minutes after immediate‑release aspirin). Seek urgent care for signs of GI bleeding (black stools/vomiting blood), severe allergic reaction, or chest pain/shortness of breath; use caution/seek advice if you have ulcer history, kidney disease, heart disease/HTN, are dehydrated, or are pregnant (avoid especially in 3rd trimester).

Pharmacology

Mechanism of Action

Non-selective inhibitor of cyclooxygenase (COX-1 and COX-2) enzymes, which reduces the synthesis of prostaglandins, substances in the body that cause pain, fever, and inflammation.

Duration of Effect

4-6 hours

Bioavailability

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

Product Information

Available Dosage Forms

For SAPOFEN specifically: film‑coated tablet (oral), 400 mg.

Composition per Dose

Each film-coated tablet: 400mg ibuprofen

Generic Availability

Yes

Pain Type

General, Migraine, Muscular, Joint

Nsaid

Yes

Opioid

No

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