CATAFLAM 50/MG COATED TAB 20/TAB

Indications

Approved Uses

Relief of pain and inflammation in musculoskeletal and joint disorders (e.g., osteoarthritis, rheumatoid arthritis, ankylosing spondylitis), acute pain (e.g., postoperative/dental), primary dysmenorrhea, and acute gout.

Dosage & Administration

Dosing by Condition

Acute pain/primary dysmenorrhea: 50 mg t.i.d. (max 150 mg/day).

Initial Dose

50mg to 100mg.

Maintenance Dose

For treatment of pain or primary dysmenorrhea the recommended dosage is 50 mg t.i.d.

Maximum Dose

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

Dose Adjustment Notes

Use the lowest effective dose for the shortest duration; avoid in severe renal impairment and severe hepatic impairment; in hepatic impairment consider dose reduction/close monitoring; use caution in elderly and in patients at risk of renal dysfunction (e.g., dehydration, HF, diuretics/ACEI/ARB).

How to Take

Swallow the coated tablet whole with water; take with or 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/flatulence), headache, dizziness; possible elevations in liver enzymes with systemic use.

Side Effect Frequency

Common (1-10%): GI symptoms (dyspepsia, abdominal pain, nausea, diarrhea), headache, dizziness; Uncommon (0.1-1%): rash/pruritus and liver enzyme elevations; Rare/very rare: GI ulcer/bleeding, hepatitis, severe cutaneous reactions, anaphylaxis, renal failure, and thrombotic events.

Safety & Warnings

Contraindications

Hypersensitivity to diclofenac or any NSAID; history of asthma/urticaria/other allergic-type reactions after aspirin or other NSAIDs (aspirin-sensitive asthma triad); use for perioperative pain in the setting of CABG surgery; active GI bleeding or active peptic ulcer (avoid/contraindicated in many product labels); third trimester of pregnancy.

Warnings & Precautions

Use the lowest effective dose for the shortest duration due to CV thrombotic risk; avoid/use extreme caution in patients with cardiovascular disease or risk factors. Serious GI bleeding/ulceration/perforation can occur without warning-higher risk in older adults, prior ulcer/GI bleed, concomitant anticoagulants/antiplatelets/SSRIs/corticosteroids. Monitor blood pressure and for edema/heart failure worsening. Monitor renal function in at-risk patients (elderly, dehydration, CKD, ACEi/ARB+diuretic). Monitor liver enzymes; discontinue if persistent elevations or signs of liver injury. Discontinue at first sign of rash or hypersensitivity; avoid in aspirin-exacerbated respiratory disease. Avoid in late pregnancy (especially 3rd trimester).

Age Restriction

Not recommended under 14 years

Drug Interactions

Drug Interactions

Anticoagulants (e.g., warfarin) and antiplatelets (including aspirin) ↑ bleeding; other NSAIDs ↑ GI/CV/renal toxicity; SSRIs/SNRIs and systemic corticosteroids ↑ GI bleeding; ACE inhibitors/ARBs and diuretics ("triple whammy") ↑ renal risk and may blunt antihypertensive/diuretic effect; lithium ↑ lithium levels; methotrexate ↑ MTX toxicity; cyclosporine/tacrolimus ↑ nephrotoxicity; digoxin ↑ digoxin levels.

Interaction Severity

MAJOR/clinically significant: anticoagulants/antiplatelets (e.g., warfarin), other NSAIDs, SSRIs/SNRIs, systemic corticosteroids (↑ GI bleeding), methotrexate (↑ toxicity), lithium (↑ levels). MODERATE: ACE inhibitors/ARBs and diuretics (↓ antihypertensive/diuretic effect; ↑ renal risk), cyclosporine/tacrolimus (↑ nephrotoxicity).

Food Interaction

Take with food

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Category D (FDA) - contraindicated in third trimester

Elderly

Use the lowest effective dose; increased risk of GI bleeding, cardiovascular events, and renal impairment. Monitor renal function, blood pressure, and GI symptoms closely

Kidney Impairment

No specific dose adjustment for mild to moderate renal impairment, but use with caution and monitor renal function; avoid in advanced renal disease (e.g., severe impairment/CrCl <30 mL/min) unless benefits outweigh risks.

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

Overdose

Symptoms: nausea, vomiting, epigastric pain, GI bleeding, dizziness/drowsiness, headache; severe cases may include hypotension, acute kidney injury, metabolic acidosis, respiratory depression, and seizures. Management: supportive/symptomatic care; consider activated charcoal if a potentially toxic ingestion presents within ~1 hour; monitor renal/hepatic function and treat complications; seek urgent medical attention/poison center guidance.

Patient Counseling

Take with/after food; use the lowest effective dose for the shortest time and do not exceed 150 mg/day unless specifically directed; avoid combining with other NSAIDs; seek urgent care for black stools/vomiting blood, severe abdominal pain, chest pain/shortness of breath, or allergic reactions; inform clinician about history of ulcer/bleeding, heart disease, kidney or liver disease, and all anticoagulant/antiplatelet medicines; avoid excess alcohol.

Monitoring Requirements

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

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

15-30 minutes.

Duration of Effect

4-6 hours

Half-Life

1-2 hours.

Bioavailability

Approximately 50% oral bioavailability (range ~50-60%) due to first-pass metabolism.

Metabolism

Extensive hepatic metabolism primarily by CYP2C9 (major), CYP2C8, CYP3A4 (minor), with metabolites undergoing glucuronidation.

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 potassium

Generic Availability

Yes

Pain Type

General/Muscular/Joint/Migraine

Nsaid

Yes

Opioid

No

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