ROFENAC 50/MG TAB 20/TAB

Indications

Approved Uses

Relief of pain and inflammation in rheumatic conditions such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis; and short-term treatment of acute pain conditions such as primary dysmenorrhea and acute migraine attacks.

Dosage & Administration

Dosing by Condition

Osteoarthritis/Rheumatoid arthritis: 50 mg orally 2-3 times daily (max 150 mg/day). Ankylosing spondylitis: 25 mg 4 times daily or 50 mg 2-3 times daily (typical max 150 mg/day). Primary dysmenorrhea/acute pain: 50 mg up to 3 times daily (max 150 mg/day). Acute gout: 50 mg 3 times daily short term (max 150 mg/day).

Initial Dose

50mg three times a day for pain or menstrual cramps; a 100mg first dose may be used.

Maintenance Dose

50mg 2-4 times daily, maximum 150-200 mg/day depending on condition.

Maximum Dose

150mg per day.

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 severe hepatic impairment, and use caution with dose/interval adjustments in mild-moderate impairment based on tolerability and labs.

How to Take

Swallow the 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

Dyspepsia/heartburn, abdominal pain, nausea, diarrhea, constipation, flatulence, headache, dizziness; less commonly elevated liver enzymes; tinnitus can occur.

Side Effect Frequency

Very common (≥10%): GI symptoms such as dyspepsia/abdominal pain, nausea (rates vary by study/label). Common (1-10%): diarrhea, constipation, flatulence, headache, dizziness/vertigo, rash/pruritus, edema/fluid retention, and increased liver enzymes. Uncommon/rare: peptic ulcer, GI bleeding/perforation, hepatotoxicity, renal impairment, hypertension/heart failure exacerbation, serious skin reactions (e.g., SJS/TEN), and cardiovascular thrombotic events.

Safety & Warnings

Contraindications

Hypersensitivity to diclofenac/other NSAIDs; history of NSAID/aspirin-induced asthma/urticaria (NSAID hypersensitivity); active GI bleeding or active peptic ulcer; peri-operative pain in CABG surgery; third trimester of pregnancy.

Warnings & Precautions

Use the lowest effective dose for the shortest duration; assess CV risk (avoid in established high CV risk when possible), monitor for GI bleeding (higher risk in elderly/history of ulcer; consider gastroprotection), monitor renal function in at-risk patients (CKD, HF, dehydration, diuretics/ACEi/ARB), monitor liver enzymes with prolonged therapy or if symptoms occur, avoid in NSAID hypersensitivity/aspirin-sensitive asthma, and avoid around CABG surgery.

Age Restriction

Not recommended for children <14 years for this 50 mg oral coated tablet unless specifically prescribed by a specialist; pediatric use depends on indication and availability of pediatric formulations.

Drug Interactions

Interaction Severity

MAJOR: Anticoagulants/antiplatelets (e.g., warfarin, DOACs, clopidogrel) and SSRIs/SNRIs (increased bleeding risk); methotrexate (increased toxicity, especially at higher doses); other NSAIDs/aspirin (additive GI/renal toxicity). MODERATE: ACE inhibitors/ARBs and diuretics (reduced antihypertensive/diuretic effect and increased AKI risk-"triple whammy"); lithium (increased levels); cyclosporine/tacrolimus (increased nephrotoxicity).

Food Interaction

Take with food

Alcohol Interaction

Avoid

Special Populations

Pregnancy

FDA Pregnancy Category D (2nd/3rd trimester); avoid in 3rd trimester

Elderly

Start at the lowest effective dose (25-50mg), use for the shortest duration, monitor renal function, blood pressure, and GI tolerability closely

Kidney Impairment

No formal dose adjustment for mild-moderate renal impairment, but use with caution and monitor renal function; avoid/not recommended in advanced renal disease (e.g., eGFR/CrCl <30 mL/min) or if renal function is deteriorating.

Liver Impairment

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

Storage & Patient Advice

Missed Dose

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

Stopping the Medicine

Safe to stop anytime; no tapering required for short-term use. For long-term use, gradual dose reduction is advisable to avoid rebound symptoms

Overdose

Symptoms: nausea/vomiting, epigastric pain, GI bleeding, dizziness/drowsiness, headache; severe cases may include hypotension, metabolic acidosis, acute kidney injury, hepatotoxicity, respiratory depression, and rarely seizures. Management: supportive care, consider activated charcoal if early after ingestion, monitor renal/hepatic function; no specific antidote-urgent medical evaluation required.

Patient Counseling

Take 1 tablet (50 mg) by mouth with food or milk and a full glass of water; use the lowest effective dose for the shortest duration. Do not exceed 150 mg/day (3 tablets/day) unless specifically directed. Avoid taking with other NSAIDs (e.g., ibuprofen, naproxen) and avoid alcohol due to increased GI bleeding risk; low‑dose aspirin only if prescribed (note bleeding risk may increase). Seek urgent care for signs of GI bleeding (black/tarry stools, vomiting blood), severe abdominal pain, chest pain/shortness of breath/weakness (possible CV event), severe rash, or facial/lip swelling/wheezing (allergy). Tell your prescriber before use if you have a history of peptic ulcer/GI bleed, cardiovascular disease or risk factors (e.g., hypertension), kidney or liver disease, asthma/NSAID allergy, or if you are on anticoagulants/antiplatelets/SSRIs/steroids. Avoid use in the 3rd trimester of pregnancy; use in earlier pregnancy only if clearly needed and advised by a clinician.

Monitoring Requirements

If used beyond short term or in at-risk patients: monitor blood pressure, renal function (SCr/BUN), liver enzymes (ALT/AST), and CBC (for anemia/bleeding).

Pharmacology

Mechanism of Action

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

Onset of Action

30-60 minutes

Duration of Effect

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

Half-Life

1.2-2 hours.

Metabolism

Extensive hepatic metabolism mainly via CYP2C9; minor contribution from CYP3A4 (and other CYPs), producing hydroxylated metabolites followed by glucuronidation/sulfation.

Excretion

Primarily excreted as metabolites: ~60-70% in urine and ~30-35% via bile/feces.

Protein Binding

>99% protein bound (primarily to albumin).

Product Information

Available Dosage Forms

For this SFDA product: oral coated tablet.

Composition per Dose

Each coated tablet: 50mg diclofenac sodium

Generic Availability

Yes

OTC Alternatives

Ibuprofen (OTC) and naproxen (OTC, where available) for mild-moderate pain; diclofenac topical gel may be OTC in some countries but is often prescription-only locally.

Pain Type

General/Muscular/Joint

Nsaid

Yes

Opioid

No

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