SAPOFEN 600/MG FC TAB 30/FC TAB

Indications

Approved Uses

Relief of signs and symptoms of rheumatoid arthritis and osteoarthritis; relief of mild to moderate pain; treatment of primary dysmenorrhea; reduction of fever.

Dosage & Administration

Dosing by Condition

Rheumatoid arthritis / Osteoarthritis: 1200-3200 mg/day orally in 3-4 divided doses (e.g., 600 mg 3-4 times daily), individualized to response; max 3200 mg/day.
Mild to moderate pain: 200-400 mg every 4-6 hours as needed; prescription regimens may use 400-600 mg every 6-8 hours; max 3200 mg/day (prescription).
Primary dysmenorrhea: 400 mg every 4 hours as needed (or 400 mg every 4-6 hours); max 3200 mg/day (prescription).
Fever: 200-400 mg every 4-6 hours as needed; max 3200 mg/day (prescription).

Initial Dose

400-600mg orally

Maintenance Dose

400 mg every 4 to 6 hours as necessary for relief of pain

Dose Adjustment Notes

Use the lowest effective dose for the shortest duration; use caution and consider lower starting doses in older adults; avoid in severe renal impairment and use caution/monitor in mild-moderate renal impairment; in hepatic impairment use caution (avoid in severe hepatic failure).

Side Effects

Common Side Effects

Nausea, vomiting, dyspepsia/heartburn, abdominal pain, diarrhea, constipation, dizziness, headache, rash; may also cause fluid retention/edema and increased blood pressure.

Safety & Warnings

Contraindications

Hypersensitivity to ibuprofen/other NSAIDs (including aspirin-induced asthma/urticaria/anaphylactoid reactions); active peptic ulcer or GI bleeding; use for peri-operative pain in CABG surgery; third trimester of pregnancy.

Warnings & Precautions

Use lowest effective dose for shortest duration; monitor/avoid in patients with cardiovascular disease/risk factors (MI/stroke risk), hypertension/heart failure/edema, history of GI ulcer/bleed (consider gastroprotection if needed), renal impairment or volume depletion, hepatic impairment, asthma/NSAID hypersensitivity, and with concomitant anticoagulants/antiplatelets/SSRIs/corticosteroids; avoid in 3rd trimester; may mask infection signs.

Driving Warning

Not safe; dizziness and drowsiness are reported adverse effects; patients should avoid driving or operating machinery if these effects occur

Drug Interactions

Drug Interactions

Key interactions: anticoagulants/antiplatelets (↑ bleeding); aspirin (may reduce aspirin antiplatelet effect and ↑ GI risk); ACEi/ARB + diuretics (↓ antihypertensive/diuretic effect, ↑ AKI risk-"triple whammy"); lithium (↑ levels); methotrexate (↑ toxicity); corticosteroids and SSRIs/SNRIs (↑ GI bleeding); cyclosporine/tacrolimus (↑ nephrotoxicity); other NSAIDs (↑ adverse effects).

Food Interaction

Take with food

Alcohol Interaction

Avoid

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 and a full glass of water; use the lowest effective dose for the shortest time and do not exceed the prescribed dose; avoid combining with other NSAIDs and limit alcohol; seek urgent care for black/tarry stools, vomiting blood, severe stomach pain, chest pain, shortness of breath, sudden weakness/slurred speech, or facial/lip swelling; inform your clinician about history of ulcer/bleeding, kidney disease, heart disease/HTN, asthma, and all anticoagulants/antiplatelets; avoid in the 3rd trimester of pregnancy.

Monitoring Requirements

If used long term or at high doses: monitor renal function (SCr/eGFR), liver enzymes, and CBC periodically; monitor blood pressure and for edema; monitor for GI bleeding/ulcer symptoms.

Pharmacology

Mechanism of Action

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

Product Information

Available Dosage Forms

For this product (SAPOFEN): film‑coated tablet for oral use (600 mg).

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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