RUMAFEN 50/MG TAB 20/TAB

Indications

Approved Uses

Symptomatic treatment of pain and inflammation in rheumatic conditions (e.g., rheumatoid arthritis, osteoarthritis, ankylosing spondylitis) and acute pain conditions such as primary dysmenorrhea.

Dosage & Administration

Dosing by Condition

Adults (delayed-release diclofenac sodium): Osteoarthritis: 100-150 mg/day in divided doses (50 mg 2-3 times daily or 75 mg twice daily). Rheumatoid arthritis: 150-200 mg/day in divided doses (50 mg 3-4 times daily or 75 mg twice daily). Ankylosing spondylitis: 100-125 mg/day (25 mg 4 times daily, plus 25 mg at bedtime if needed)

Initial Dose

50mg two to three times daily for osteoarthritis or rheumatoid arthritis.

Maintenance Dose

For osteoarthritis: 100-150 mg/day in divided doses (50 mg 2-3 times daily or 75 mg twice daily); For rheumatoid arthritis: 150-200 mg/day in divided doses (50 mg 3-4 times daily or 75 mg twice daily); For ankylosing spondylitis: 100-125 mg/day (25 mg 4 times daily, plus 25 mg at bedtime if needed)

Maximum Dose

Maximum total daily dose (immediate-release oral diclofenac sodium): 150 mg/day.

Dose Adjustment Notes

Use the lowest effective dose for the shortest duration; use caution and consider lower starting doses in the elderly; avoid in severe/advanced renal disease and in severe hepatic impairment; monitor and adjust based on tolerability and renal/hepatic function.

How to Take

Swallow the coated tablet whole with water; take with or immediately after food (or milk) to reduce gastrointestinal irritation; do not crush or chew.

Side Effects

Common Side Effects

Dyspepsia, abdominal pain, nausea, diarrhea (sometimes constipation), headache, dizziness; rash/pruritus and edema can occur; liver enzyme elevations may occur.

Safety & Warnings

Contraindications

Contraindications: Hypersensitivity to diclofenac or other NSAIDs; history of asthma/urticaria/other allergic-type reactions after aspirin/NSAIDs (AERD); use in the setting of CABG surgery; active GI bleeding or active peptic ulcer. Avoid/contraindicated in late pregnancy (3rd trimester).

Warnings & Precautions

Key warnings/precautions: CV thrombotic risk (use lowest effective dose/shortest duration; caution in CVD risk); contraindicated with CABG; GI bleeding/ulcer risk (higher in elderly, prior PUD/GI bleed; consider gastroprotection when indicated); renal toxicity/AKI risk (caution with CKD, dehydration, ACEi/ARB+diuretic); hepatotoxicity (check/monitor LFTs; stop if persistent elevation/symptoms); fluid retention/HTN/HF worsening (monitor BP/edema); severe hypersensitivity and serious skin reactions; avoid in AERD; avoid in late pregnancy.

Drug Interactions

Food Interaction

Take with food

Special Populations

Pregnancy

Avoid in third trimester; use in first and second trimesters only if benefit outweighs risk (FDA Pregnancy Category C first/second trimester, D third trimester)

Elderly

Use lowest effective dose (start with 50mg twice daily), monitor renal function, blood pressure, and GI tolerance closely; increased risk of adverse effects

Storage & Patient Advice

Stopping the Medicine

Safe to stop anytime; no tapering required for short-term use. For long-term use, consult prescriber before stopping

Overdose

Overdose: symptoms may include nausea/vomiting, epigastric pain, GI bleeding, dizziness/drowsiness, headache, tinnitus; severe cases may cause hypotension, acute kidney injury, metabolic acidosis, respiratory depression, seizures/coma. Management: supportive care; consider activated charcoal if recent ingestion; monitor renal/hepatic function and GI bleeding; no specific antidote.

Patient Counseling

Take with or after food and swallow whole; do not exceed the prescribed dose (usual max 150 mg/day). Avoid combining with other NSAIDs/aspirin unless directed. Limit/avoid alcohol. Seek urgent care for GI bleeding (black stools/vomiting blood), severe abdominal pain, allergic reactions, or cardiovascular symptoms (chest pain, shortness of breath, sudden weakness). Inform clinician about pregnancy (avoid in 3rd trimester) and about anticoagulants, lithium, methotrexate, and kidney/liver disease. Store below 25°C.

Monitoring Requirements

If used beyond short courses: monitor blood pressure, renal function (SCr/eGFR), hepatic transaminases, and CBC periodically; assess for GI bleeding/ulceration and cardiovascular risk throughout therapy.

Pharmacology

Mechanism of Action

Inhibits cyclooxygenase (COX-1 and COX-2), decreasing prostaglandin synthesis and thereby reducing inflammation, pain, and fever.

Bioavailability

Approximately 50% systemic bioavailability due to first-pass metabolism (often cited ~50-60%).

Metabolism

Extensive first-pass hepatic metabolism; primarily metabolized to 4'-hydroxy-diclofenac via CYP2C9 (major), with minor contributions from CYP2C8 and CYP3A4; metabolites undergo glucuronidation.

Protein Binding

>99% protein bound (mainly to albumin).

Product Information

Available Dosage Forms

For this product: oral coated tablet 50 mg (blister pack of 20).

Composition per Dose

Each coated tablet: 50mg diclofenac sodium

Generic Availability

Yes

Pain Type

Muscular, Joint, General

Nsaid

Yes

Opioid

No

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