DICLAC ID 75/MG TAB 20/TAB

Indications

Approved Uses

Symptomatic treatment of pain and inflammation in rheumatic diseases such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis; and other painful inflammatory conditions where oral diclofenac is indicated per local product labeling.

Dosage & Administration

Dosing by Condition

Adults (prolonged-release 75 mg): typically 75 mg once daily; may increase to 75 mg twice daily if needed; maximum 150 mg/day. (Condition-specific titration is individualized; PR tablets are generally used for chronic inflammatory conditions such as OA/RA/AS.)

Initial Dose

For osteoarthritis: 100-150 mg/day in divided doses (50 mg twice or three times daily, or 75 mg twice daily). For rheumatoid arthritis: 150-200 mg/day in divided doses. For ankylosing spondylitis: 100-125 mg/day. The 75 mg prolonged-release tablet is typically dosed as 75 mg twice daily, not 75 mg once daily.

Maintenance Dose

75mg once to twice daily

Dose Adjustment Notes

Use the lowest effective dose for the shortest duration. Elderly: start at the lowest effective dose and monitor closely. Renal impairment: use with caution; avoid in severe renal impairment/advanced renal disease. Hepatic impairment: use caution and monitor; avoid in severe hepatic impairment.

How to Take

Swallow the prolonged-release tablet whole with water; do not crush, chew, or split. Preferably take with/after food to reduce gastrointestinal irritation.

Side Effects

Common Side Effects

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

Safety & Warnings

Contraindications

Hypersensitivity to diclofenac/excipients; history of asthma/urticaria/other allergic-type reactions after aspirin or other NSAIDs (AERD); active peptic ulcer or GI bleeding; severe hepatic impairment; severe renal impairment/advanced renal disease; severe heart failure; third trimester of pregnancy; peri‑operative pain in CABG surgery.

Warnings & Precautions

Use the lowest effective dose for the shortest duration; monitor/avoid in patients with CV disease or risk factors (MI/stroke risk), hypertension, heart failure/edema; high GI risk (elderly, prior ulcer/GI bleed, concomitant anticoagulants/antiplatelets/SSRIs/corticosteroids) and consider gastroprotection; monitor renal function in CKD, dehydration, diuretic/ACEi/ARB use; monitor liver enzymes and stop if significant elevation or symptoms; caution in asthma/AERD; discontinue if rash or hypersensitivity occurs.

Drug Interactions

Drug Interactions

Major/clinically important interactions include: anticoagulants (e.g., warfarin/DOACs) and antiplatelets (e.g., aspirin, clopidogrel) ↑ bleeding; SSRIs/SNRIs ↑ GI bleeding; other NSAIDs/corticosteroids ↑ GI toxicity; ACEi/ARBs and diuretics ↑ AKI risk and may blunt antihypertensive/diuretic effect; lithium ↑ levels; methotrexate ↑ toxicity; cyclosporine/tacrolimus ↑ nephrotoxicity; digoxin ↑ levels.

Food Interaction

Take with food.

Special Populations

Pregnancy

Avoid in third trimester; use with caution in first and second trimesters

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.

Liver Impairment

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

Storage & Patient Advice

Patient Counseling

Swallow whole with water; do not crush/chew/split; take with/after food. Use the lowest effective dose for the shortest time. Avoid combining with other NSAIDs (including OTC ibuprofen/naproxen) unless advised. Seek urgent care for black/tarry stools, vomiting blood, severe abdominal pain, chest pain, shortness of breath, sudden weakness/slurred speech. Report swelling, reduced urine, or rash. Limit/avoid alcohol to reduce GI bleeding risk and inform the prescriber about heart, kidney, liver disease and all anticoagulants/antiplatelets.

Monitoring Requirements

Monitor blood pressure, renal function (serum creatinine/eGFR), and liver enzymes (ALT/AST) at baseline and periodically during ongoing therapy; assess for GI bleeding/ulcer symptoms; consider CBC if long-term use or if bleeding is suspected.

Pharmacology

Mechanism of Action

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

Half-Life

1-2 hours

Protein Binding

>99% protein bound (primarily to albumin).

Product Information

Available Dosage Forms

For this product: oral prolonged-release tablet 75 mg (blister pack of 20).

Composition per Dose

Each prolonged-release tablet: 75mg diclofenac sodium

Generic Availability

Yes

Pain Type

General, Muscular, Joint, Migraine

Nsaid

Yes

Opioid

No

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