VOLTAREN RETARD 100/MG TAB 30/TAB

Indications

Approved Uses

Symptomatic treatment of inflammatory and degenerative rheumatic diseases (e.g., rheumatoid arthritis, osteoarthritis, ankylosing spondylitis) and acute pain/inflammation (e.g., acute musculoskeletal pain, post‑operative/dental pain, primary dysmenorrhea); acute gout may be included depending on local label, while migraine is not a standard approved indication for this MR tablet.

Dosage & Administration

Dosing by Condition

For this product (diclofenac sodium modified-release 100 mg): typical adult dosing is 100 mg once daily; some patients may require up to 150 mg/day total using appropriate formulations (often split dosing with IR/EC products), but routine 100 mg MR twice daily is generally not standard and increases risk.

Initial Dose

100 mg once daily.

Maintenance Dose

100 mg once daily.

Maximum Dose

150 mg per day for most indications.

Children's Dosage

Not approved for children under 14 years for this formulation

Dose Adjustment Notes

Use the lowest effective dose for the shortest duration; use caution and consider lower doses in the elderly; avoid in severe renal impairment and in severe hepatic impairment, and monitor closely/consider dose reduction in hepatic dysfunction.

How to Take

Swallow the modified-release tablet whole with a full glass of water, preferably with or after food; do not crush, chew, or split.

Side Effects

Common Side Effects

Dyspepsia/indigestion, abdominal pain, nausea (± vomiting), diarrhea or constipation, flatulence, headache, dizziness, rash, and possible elevations in liver enzymes.

Side Effect Frequency

Common (1-10%): GI symptoms (dyspepsia, abdominal pain, nausea, diarrhea), headache, dizziness, rash/pruritus, and edema. Uncommon (0.1-1%): GI ulceration/bleeding, elevated liver enzymes/hepatitis, renal impairment, urticaria. Rare/very rare (<0.1% to <0.01%): severe cutaneous adverse reactions (e.g., Stevens-Johnson syndrome/TEN), anaphylaxis, severe hepatic failure, severe renal failure, and serious thrombotic cardiovascular events.

Safety & Warnings

Contraindications

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

Warnings & Precautions

Key warnings/precautions: increased risk of CV thrombotic events (use lowest effective dose/shortest duration; caution in CVD/risk factors); serious GI bleeding/ulceration/perforation (higher risk in elderly/prior ulcer/GI bleed; consider gastroprotection when indicated); hepatotoxicity (monitor LFTs; stop if liver injury suspected); renal toxicity/AKI risk (avoid in severe renal disease; monitor in at-risk patients, dehydration, HF, diuretics/ACEI/ARB use); fluid retention/edema and worsening HF/HTN; serious skin reactions; anaphylaxis/AERD; may mask infection signs; avoid concomitant NSAIDs.

Drug Interactions

Drug Interactions

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

Interaction Severity

MAJOR: anticoagulants/antiplatelets (e.g., warfarin), other NSAIDs (including high-dose aspirin), and methotrexate (especially high-dose); MODERATE: ACE inhibitors/ARBs and diuretics (renal risk/attenuated BP control), lithium (increased levels), SSRIs/SNRIs (GI bleeding risk), cyclosporine/tacrolimus (nephrotoxicity), digoxin (increased levels); MINOR: antacids may alter absorption rate without major clinical impact.

Food Interaction

Take with food

Alcohol Interaction

Avoid

Special Populations

Pregnancy

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

Children

Not approved for children under 14 years for this formulation

Elderly

Use the lowest effective dose; monitor renal function, hepatic function, and cardiovascular status closely; increased risk of GI bleeding and renal impairment

Liver Impairment

Mild-moderate hepatic impairment: use with caution at the lowest effective dose and monitor LFTs; severe hepatic impairment: contraindicated/avoid.

Storage & Patient Advice

Missed Dose

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

Overdose

Symptoms: nausea, vomiting, epigastric pain, GI bleeding, dizziness/drowsiness, headache; severe toxicity may include hypotension, acute renal failure, metabolic acidosis, respiratory depression, coma, and seizures. Management: no specific antidote-supportive care; consider activated charcoal if recent ingestion; treat complications and seek urgent medical attention/poison center guidance.

Patient Counseling

Swallow the modified‑release tablet whole with water (do not crush/chew/split); preferably take with or after food to reduce GI upset and take at the same time each day as prescribed. Use the lowest effective dose for the shortest duration; do not exceed the prescribed dose and do not share (prescription-only). Avoid taking other NSAIDs (e.g., ibuprofen/naproxen) and avoid aspirin for pain unless your prescriber advises; check with a clinician before combining with anticoagulants/antiplatelets, corticosteroids, SSRIs/SNRIs, or alcohol due to increased bleeding risk. Seek urgent care for signs of GI bleeding (black/tarry stools, vomiting blood), severe abdominal pain, allergic reaction (wheeze, facial swelling), severe skin rash/blistering, or symptoms of heart attack/stroke (chest pain, shortness of breath, sudden weakness/slurred speech). Tell your doctor if you have a history of ulcer/bleeding, heart disease, kidney/liver disease, asthma, or if you are pregnant/trying to conceive; avoid in 3rd trimester and use in early pregnancy only if clearly needed. If used long term, periodic monitoring of blood pressure, renal function and liver enzymes is recommended.

Monitoring Requirements

If used beyond short courses: monitor blood pressure, renal function (SCr/BUN), liver function tests, and CBC; assess for GI bleeding and cardiovascular risk.

Pharmacology

Mechanism of Action

Reversibly inhibits COX-1 and COX-2, decreasing prostaglandin synthesis to reduce inflammation, pain, and fever.

Onset of Action

Analgesic onset is typically within ~1-2 hours, with peak effect later than immediate-release due to modified-release design.

Duration of Effect

Approximately 24 hours.

Half-Life

1.2-2 hours (elimination half-life).

Bioavailability

Approximately 50% systemic bioavailability (range ~50-60%) due to significant first‑pass metabolism; the modified‑release formulation slows absorption but does not materially increase bioavailability.

Metabolism

Extensive hepatic metabolism primarily via CYP2C9 (major) with minor contribution from CYP3A4/other CYPs, followed by conjugation (glucuronidation and sulfation).

Excretion

Predominantly renal excretion as metabolites (~65%) with the remainder via bile/feces (~35%).

Protein Binding

>99%

Product Information

Available Dosage Forms

Across diclofenac products: immediate-release tablets/capsules, enteric-coated (delayed-release) tablets, modified/extended-release tablets, suppositories, injection, topical gel/solution/patch, and ophthalmic drops (availability varies by country/brand).

Composition per Dose

Each modified-release tablet: 100mg diclofenac sodium

Generic Availability

Yes

OTC Alternatives

Paracetamol (acetaminophen) and ibuprofen are common OTC alternatives; naproxen may be OTC in some countries but is prescription-only in others.

Pain Type

General, Muscular, Joint, Migraine

Nsaid

Yes

Opioid

No

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