ROFENAC-D 20/DISPERSIBLE TAB

Indications

Approved Uses

Symptomatic treatment of pain and inflammation in rheumatic conditions (e.g., rheumatoid arthritis, osteoarthritis, ankylosing spondylitis) and short-term treatment of acute pain conditions such as primary dysmenorrhea and acute musculoskeletal/post‑operative/dental pain.

Dosage & Administration

Dosing by Condition

Osteoarthritis: 50 mg 2-3 times daily (max 150 mg/day). Rheumatoid arthritis: 50 mg 3-4 times daily (max 200 mg/day). Ankylosing spondylitis: 25 mg 4 times daily or 50 mg 2-3 times daily plus 25 mg at bedtime if needed (max 125 mg/day).

Initial Dose

50mg 2-3 times daily

Maintenance Dose

For osteoarthritis: 50 mg 2-3 times daily (100-150 mg/day). For rheumatoid arthritis: 50 mg 3-4 times daily (150-200 mg/day). For ankylosing spondylitis: 25 mg 4 times daily or 50 mg 2-3 times daily (100-125 mg/day).

Maximum Dose

150mg per day for most indications; up to 200mg per day for rheumatoid arthritis.

Children's Dosage

Not recommended in children; use and dose must be determined by doctor.

Dose Adjustment Notes

Use the lowest effective dose for the shortest duration; avoid in severe renal impairment and severe hepatic impairment; in mild-moderate hepatic impairment use the lowest effective dose with close monitoring; in renal impairment use caution and monitor renal function (no fixed adjustment for mild-moderate impairment); elderly: start at the lower end of the dosing range.

How to Take

Swallow the 50 mg coated tablet whole with a full glass of water; take with or after food (or milk) to reduce GI upset; do not crush or chew.

Side Effects

Common Side Effects

Common: dyspepsia/indigestion, abdominal pain, nausea, vomiting, diarrhea (sometimes constipation), flatulence/bloating, headache, dizziness; may cause elevations in liver enzymes.

Safety & Warnings

Contraindications

Hypersensitivity to diclofenac or other NSAIDs (including aspirin-induced asthma/urticaria/anaphylactoid reactions); active GI bleeding or active peptic ulcer; use for perioperative pain in CABG surgery; third trimester of pregnancy. (Avoid/contraindicated in severe hepatic impairment and advanced/severe renal disease per labeling/clinical guidance.)

Warnings & Precautions

Use the lowest effective dose for the shortest duration; increased risk of CV thrombotic events-use caution/avoid in established CV disease and around CABG; serious GI bleeding/ulcer/perforation can occur without warning-higher risk in elderly, prior ulcer/GI bleed, concomitant anticoagulants/antiplatelets/SSRIs/corticosteroids; monitor renal function in CKD, dehydration, HF, and with ACEi/ARB+diuretic; monitor LFTs during prolonged therapy and stop if liver injury suspected; avoid in aspirin-sensitive asthma/NSAID hypersensitivity; caution in hypertension/edema and in the elderly.

Drug Interactions

Drug Interactions

Major interactions include: anticoagulants (e.g., warfarin/DOACs) and antiplatelets (↑ bleeding); SSRIs/SNRIs (↑ GI bleeding); corticosteroids (↑ GI ulcer/bleed); other NSAIDs/aspirin (additive GI/CV/renal toxicity); ACE inhibitors/ARBs and diuretics (↓ antihypertensive/diuretic effect, ↑ AKI risk-‘triple whammy’); lithium (↑ levels); methotrexate (↑ toxicity); cyclosporine/tacrolimus (↑ nephrotoxicity); digoxin (↑ levels).

Interaction Severity

MAJOR: Warfarin (increased bleeding risk), methotrexate (increased toxicity), lithium (increased lithium levels), other NSAIDs (additive toxicity and GI risk). MODERATE: ACE inhibitors/ARBs (reduced antihypertensive effect, renal impairment), diuretics (reduced efficacy), cyclosporine (nephrotoxicity), SSRIs (increased GI bleeding risk), corticosteroids (increased GI ulceration). MINOR: Digoxin (slightly increased digoxin levels)

Food Interaction

Take with food

Special Populations

Pregnancy

Category C (1st/2nd trimester); contraindicated 3rd trimester.

Children

Not recommended in children; use and dose must be determined by doctor.

Elderly

Use lowest effective dose; start at 25-50mg per dose; monitor renal function, blood pressure, and GI tolerance closely

Kidney Impairment

No formal dose adjustment for mild-moderate renal impairment, but use with caution and monitor renal function; avoid/contraindicated in advanced/severe renal impairment (e.g., CrCl <30 mL/min) or active progressive renal disease.

Liver Impairment

No specific dose adjustment is defined for mild-moderate hepatic impairment, but use the lowest effective dose with close monitoring of LFTs; avoid/contraindicated in severe hepatic impairment or active liver disease.

Storage & Patient Advice

Missed Dose

Take the missed dose as soon as remembered unless it is close to the next dose; if close, skip the missed dose and resume the regular schedule; do not double doses.

Stopping the Medicine

No taper is required; diclofenac can be stopped abruptly, but patients on chronic therapy should stop and seek care if they develop GI bleeding symptoms, chest pain/neurologic symptoms, rash, or signs of liver/kidney injury.

Overdose

Symptoms: nausea/vomiting, epigastric pain, GI bleeding, dizziness/drowsiness, headache; severe cases may include hypotension, metabolic acidosis, acute kidney injury, respiratory depression, and rarely seizures/coma. Management: urgent medical evaluation; supportive care, monitor renal/hepatic function and bleeding; consider activated charcoal if a substantial ingestion presents within ~1-2 hours and airway is protected.

Patient Counseling

Take with/after food; swallow whole; use the lowest effective dose for the shortest time; avoid combining with other NSAIDs (e.g., ibuprofen/naproxen) and be cautious with aspirin/anticoagulants unless directed; seek urgent care for chest pain/shortness of breath, stroke symptoms, black stools/vomiting blood, or severe abdominal pain; inform clinician about history of ulcer/GI bleed, heart disease, hypertension, kidney/liver disease; avoid in the 3rd trimester of pregnancy.

Monitoring Requirements

If used beyond short-term: monitor blood pressure and signs of edema; renal function (SCr/eGFR) in at-risk patients or prolonged therapy; liver function tests (ALT/AST) especially with longer use; CBC if prolonged use or if bleeding/anemia suspected; monitor for GI bleeding symptoms.

Pharmacology

Mechanism of Action

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

Onset of Action

Peak plasma levels in 2 hours (range 1-4 hours) fasting; delayed 1-4.5 hours with food.

Duration of Effect

Approximately 6-8 hours (typical for immediate-release oral diclofenac).

Half-Life

1.2-2 hours.

Bioavailability

Approximately 50-60% oral systemic bioavailability due to first-pass metabolism.

Metabolism

Extensive first-pass hepatic metabolism; ~50% systemically available; plasma half-life ~2 hours; >99% protein bound; renal clearance <1% unchanged drug.

Excretion

Renal clearance of unchanged drug <1%; primarily biliary/fecal excretion as metabolites.

Protein Binding

>99% protein bound (mainly to albumin).

Product Information

Available Dosage Forms

Enteric-coated tablet (25 mg, 50 mg, 75 mg).

Composition per Dose

Each coated tablet: 50mg diclofenac sodium

Generic Availability

Yes

OTC Alternatives

OTC alternatives for mild pain/fever: paracetamol (acetaminophen) and ibuprofen (where OTC).

Pain Type

General, Muscular, Joint

Nsaid

Yes

Opioid

No

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