DICLOGESIC RETARD 100/MG 12/CAP

Indications

Approved Uses

Relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.

Dosage & Administration

Dosing by Condition

Osteoarthritis / Rheumatoid arthritis / Ankylosing spondylitis (modified/extended‑release): 100 mg orally once daily; some patients may require 150 mg/day total (typically by adding an immediate‑release dose or using an alternative regimen per prescriber).

Initial Dose

100 mg once daily for osteoarthritis or rheumatoid arthritis.

Maintenance Dose

100 mg once daily.

Maximum Dose

150 mg/day (typical maximum for oral diclofenac sodium in adults; extended-release/retard products are commonly 100 mg once daily, sometimes up to 150 mg/day depending on product labeling).

Dose Adjustment Notes

Use the lowest effective dose for the shortest duration. Use with caution in renal or hepatic impairment and monitor renal function, liver enzymes, and blood pressure; avoid in severe renal impairment and in severe hepatic impairment/active hepatic disease.

How to Take

Swallow the modified‑release capsule whole with a full glass of water; do not crush, chew, or open. Preferably take with or after food (or milk) to reduce gastrointestinal irritation.

Side Effects

Common Side Effects

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

Side Effect Frequency

Common (1-10%): GI symptoms (e.g., dyspepsia/indigestion, abdominal pain, nausea, diarrhea), headache, dizziness, rash; Uncommon (0.1-1%): vomiting, gastritis, pruritus/urticaria, elevated transaminases; Rare/very rare (<0.1%): peptic ulcer, GI bleeding/perforation, hepatitis/severe liver injury, severe cutaneous adverse reactions (e.g., SJS/TEN), renal impairment/failure, heart failure/fluid retention.

Safety & Warnings

Contraindications

Contraindicated in: hypersensitivity to diclofenac; history of asthma/urticaria/other allergic-type reactions after aspirin or other NSAIDs (AERD); in the setting of CABG surgery. Also avoid/contraindicate with active GI bleeding or active peptic ulcer. Third trimester pregnancy is contraindicated for systemic NSAIDs.

Warnings & Precautions

Use the lowest effective dose for the shortest duration; assess CV risk (MI/stroke) and avoid in CABG setting; assess GI risk and consider gastroprotection in high-risk patients; monitor BP/edema and heart failure status; monitor renal function in CKD, elderly, dehydration, diuretic/ACEi/ARB use; monitor liver enzymes and stop if persistent elevations or symptoms of liver injury; avoid in aspirin-sensitive asthma/serious NSAID hypersensitivity.

Age Restriction

Not recommended for children; modified/extended-release diclofenac 100 mg is generally for adults/adolescents and is typically not used under 14 years (use pediatric diclofenac formulations/doses if needed).

Driving Warning

Safe

Drug Interactions

Drug Interactions

Major/clinically important interactions include: anticoagulants (e.g., warfarin/DOACs) and antiplatelets (↑ bleeding), SSRIs/SNRIs (↑ GI bleeding), corticosteroids (↑ GI bleeding/ulcer), other NSAIDs/aspirin (↑ GI/renal risk). Other important interactions: ACEi/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, DOACs, clopidogrel) and SSRIs/SNRIs (↑ bleeding), other NSAIDs/aspirin (↑ GI/renal toxicity), methotrexate (↑ toxicity), lithium (↑ levels/toxicity). MODERATE: ACE inhibitors/ARBs and diuretics (↓ antihypertensive effect, ↑ AKI risk-"triple whammy"), cyclosporine/tacrolimus (↑ nephrotoxicity), corticosteroids (↑ GI ulcer/bleed), digoxin (possible ↑ levels).

Food Interaction

Food may delay absorption/onset but can improve GI tolerability; take with or after food if stomach upset occurs (consistent daily administration).

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Contraindicated

Breastfeeding

Caution

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

Avoid/not recommended in advanced renal impairment (e.g., eGFR/CrCl <30 mL/min) and in patients with significant renal disease unless benefits outweigh risks; if used in mild-moderate impairment, use the lowest effective dose with close renal monitoring.

Storage & Patient Advice

Missed Dose

Take as soon as remembered; skip if near the time of the next dose. Do not double the dose

Stopping the Medicine

Can be stopped without tapering; if used chronically, stop and reassess with the prescriber (pain may recur, but there is no physiologic withdrawal requiring taper).

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/coma (rare). Management: urgent medical evaluation, supportive care, consider activated charcoal if early after ingestion; monitor renal/hepatic function and bleeding; no specific antidote.

Patient Counseling

Take with/after food if it upsets your stomach; swallow the capsule whole (do not crush/chew/open). Use the lowest effective dose for the shortest time. Seek urgent care for black/tarry stools, vomiting blood, severe stomach pain, chest pain, shortness of breath, or stroke symptoms. Avoid combining with other NSAIDs (e.g., ibuprofen/naproxen) and limit alcohol. Tell your clinician about blood thinners/antiplatelets, SSRIs, lithium, methotrexate, and kidney disease. Avoid use in the 3rd trimester of pregnancy. Store below 25°C.

Monitoring Requirements

Monitor blood pressure and signs/symptoms of GI bleeding; for prolonged therapy check renal function (SCr/eGFR), hepatic function (ALT/AST), and CBC periodically, and assess cardiovascular risk/edema.

Pharmacology

Mechanism of Action

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

Duration of Effect

Approximately 24 hours for extended-release formulation.

Bioavailability

Approximately 50% due to first-pass metabolism.

Metabolism

Extensive hepatic metabolism, primarily via CYP2C9; minor contribution from other CYPs (e.g., CYP3A4) with subsequent conjugation (glucuronidation/sulfation).

Product Information

Available Dosage Forms

Tablet (immediate-release), modified-release capsule, enteric-coated tablet, suppository, injection (IM/IV), topical gel, eye drops

Composition per Dose

Each modified-release capsule: 100 mg diclofenac sodium

Generic Availability

Yes

OTC Alternatives

Paracetamol (acetaminophen) and ibuprofen are common OTC oral alternatives for mild-moderate pain (subject to local OTC status); topical diclofenac gel may be an OTC alternative in some regions.

Pain Type

General/Muscular/Joint

Nsaid

Yes

Opioid

No

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