DICLOMAX 50/MG TAB 20/TAB

Indications

Approved Uses

Relief of pain and inflammation in rheumatic diseases (e.g., osteoarthritis, rheumatoid arthritis, ankylosing spondylitis) and acute pain conditions such as primary dysmenorrhea; other acute pain uses (e.g., postoperative/dental/musculoskeletal) depend on local labeling.

Off-Label Uses

Off‑label examples: acute migraine treatment (oral diclofenac potassium more commonly), renal colic (adjunct), and biliary colic (adjunct); gout is generally an acute pain/inflammation use but may be labeled in some regions and is not reliably off‑label.

Dosage & Administration

Dosing by Condition

Typical adult dosing for diclofenac sodium immediate‑release: 50 mg orally 2-3 times daily (max 150 mg/day) for OA/RA/AS; dysmenorrhea/acute pain: 50 mg up to 3 times daily (max 150 mg/day).

Initial Dose

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

Maintenance Dose

100-150mg daily in divided doses for osteoarthritis; 150-200mg daily in divided doses for rheumatoid arthritis.

Maximum Dose

150mg/day for osteoarthritis; 200mg/day for rheumatoid arthritis.

Dose Adjustment Notes

Use the lowest effective dose for the shortest duration; use caution in older adults and in renal/hepatic impairment (avoid in severe renal failure and severe hepatic impairment; monitor and consider dose reduction in hepatic disease).

How to Take

Swallow the 50 mg tablet whole with water; take with or after food (or milk) to reduce gastrointestinal irritation. Do not crush/chew if the specific product is enteric‑coated or modified‑release.

Side Effects

Common Side Effects

Common: dyspepsia/indigestion, abdominal pain, nausea, diarrhea, constipation, flatulence, headache, dizziness; rash/pruritus can occur; liver enzyme elevations may occur (more relevant with ongoing use).

Safety & Warnings

Contraindications

Hypersensitivity to diclofenac; history of asthma/urticaria/other allergic-type reactions after aspirin or other NSAIDs (AERD); use for perioperative pain in CABG surgery; active peptic ulcer or GI bleeding (or active GI ulceration); pregnancy in the third trimester (contraindicated due to risk of premature closure of the fetal ductus arteriosus and fetal renal dysfunction/oligohydramnios).

Warnings & Precautions

Use lowest effective dose for shortest duration; increased CV thrombotic risk (caution in CVD/risk factors); serious GI bleeding can occur without warning (higher risk in elderly/prior ulcer/GI bleed; consider gastroprotection when indicated); monitor BP and for fluid retention/HF; monitor renal function in at-risk patients (CKD, elderly, diuretics/ACEi/ARB, dehydration); monitor liver enzymes with prolonged use or if symptoms; avoid in aspirin-sensitive asthma; avoid concomitant NSAIDs.

Age Restriction

Not recommended for routine use in children/adolescents; generally avoid <14 years for 50 mg immediate-release diclofenac tablets unless specifically prescribed by a specialist with weight-based pediatric dosing.

Drug Interactions

Drug Interactions

Other NSAIDs/aspirin; anticoagulants (e.g., warfarin) and antiplatelets (↑ bleeding); SSRIs/SNRIs (↑ GI bleeding); ACE inhibitors/ARBs and diuretics (↓ antihypertensive/diuretic effect, ↑ AKI risk-‘triple whammy’); lithium (↑ levels); methotrexate (↑ toxicity); cyclosporine/tacrolimus (↑ nephrotoxicity); digoxin (↑ levels).

Interaction Severity

Major/clinically significant: anticoagulants/antiplatelets (e.g., warfarin) and SSRIs/SNRIs (↑ bleeding), other NSAIDs/aspirin (↑ GI/renal toxicity), methotrexate (↑ toxicity), lithium (↑ levels), cyclosporine/tacrolimus (↑ nephrotoxicity). Moderate: ACEi/ARB/diuretics (↓ antihypertensive/diuretic effect; ↑ AKI risk), digoxin (↑ levels).

Food Interaction

Take with food

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Pregnancy Category C (first and second trimesters); Contraindicated (third trimester)

Elderly

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

Kidney Impairment

No formal dose adjustment for mild-moderate renal impairment, but use the lowest effective dose with close renal monitoring; avoid in advanced renal disease/severe impairment (e.g., eGFR/CrCl <30 mL/min) unless benefits outweigh risks.

Liver Impairment

No specific dose adjustment defined for mild-moderate hepatic impairment; use with caution and monitor LFTs; avoid/contraindicated in severe hepatic impairment or active significant liver disease.

Storage & Patient Advice

Patient Counseling

Take with/after food and water; do not combine with other NSAIDs unless directed; limit alcohol; use the lowest effective dose for the shortest time; seek urgent care for black stools/vomiting blood, severe abdominal pain, chest pain/shortness of breath, or signs of allergy; inform clinician about history of ulcer/bleeding, cardiovascular disease, kidney/liver disease, and all anticoagulants/antiplatelets; avoid use in the 3rd trimester of pregnancy; this product is prescription-only (SFDA).

Monitoring Requirements

Monitor blood pressure, renal function (SCr/BUN) and fluid status, and for GI bleeding; check liver enzymes with prolonged use or if symptoms occur; consider CBC if long-term therapy or bleeding is suspected.

Pharmacology

Mechanism of Action

Inhibits COX‑1 and COX‑2, decreasing prostaglandin synthesis and thereby reducing inflammation, pain, and fever.

Half-Life

1.1-2 hours.

Bioavailability

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

Metabolism

Extensive hepatic metabolism; 4'-hydroxy-diclofenac is a major metabolite; minor metabolites include 5-hydroxy- and 3’-hydroxy-diclofenac via CYP3A4.

Product Information

Available Dosage Forms

For diclofenac sodium (general): oral immediate‑release tablets/capsules, enteric‑coated (delayed‑release) tablets, extended‑release tablets, suppositories, injection, topical gel/solution/patch, and ophthalmic drops; for this SFDA product specifically: oral tablet in blister pack (20 tablets).

Composition per Dose

Each tablet: 50 mg diclofenac sodium

Generic Availability

Yes

Pain Type

General/Muscular/Joint

Nsaid

Yes

Opioid

No

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