VOLTAREN 50/MG ADULTS 10/SUPP

Indications

Approved Uses

Treatment of pain and inflammation in rheumatic diseases (e.g., rheumatoid arthritis, osteoarthritis, ankylosing spondylitis) and acute pain conditions such as primary dysmenorrhea; other acute pain uses may be included per local label (e.g., postoperative pain) but fever and migraine are not core approved indications for this rectal product without label confirmation.

Dosage & Administration

Initial Dose

50-100 mg depending on the condition.

Maximum Dose

Rectal: 50 mg suppository 2-3 times daily as needed; maximum 150 mg/day.

Dose Adjustment Notes

Use the lowest effective dose for the shortest duration; use caution and consider lower doses in older adults and in renal/hepatic impairment, and avoid use in severe renal or severe hepatic failure unless specialist-directed.

How to Take

For rectal use only: remove the suppository from the blister/foil, insert into the rectum (preferably after a bowel movement) and remain lying for a few minutes; wash hands before and after use.

Side Effects

Common Side Effects

Common adverse effects include GI symptoms (abdominal pain, nausea, dyspepsia, diarrhea/constipation), headache/dizziness, and with rectal use: local rectal irritation/discomfort/tenesmus; liver enzyme elevations can occur.

Safety & Warnings

Contraindications

Hypersensitivity to diclofenac/NSAIDs (including aspirin-sensitive asthma/urticaria reactions); active GI ulcer/bleeding; use for peri-operative pain in CABG surgery; third trimester of pregnancy; and (for rectal dosage forms) proctitis/anorectal inflammation or recent rectal bleeding.

Warnings & Precautions

Use the lowest effective dose for the shortest duration; monitor/avoid in patients with cardiovascular disease risk (MI/stroke), heart failure, hypertension; high GI-risk patients (elderly, prior ulcer/GI bleed, concomitant anticoagulants/antiplatelets/SSRIs/steroids) may need gastroprotection; monitor liver enzymes and renal function in at-risk patients; avoid in aspirin-sensitive asthma; may mask infection; for suppositories avoid use with proctitis/anorectal inflammation.

Age Restriction

Generally for adults and adolescents ≥14 years; not recommended in children <14 years unless specifically prescribed by a specialist (pediatric dosing usually uses lower-strength formulations).

Driving Warning

Safe

Drug Interactions

Drug Interactions

Clinically important interactions include: anticoagulants (e.g., warfarin) and antiplatelets (including aspirin) ↑ bleeding; other NSAIDs (including ketorolac) ↑ GI/renal risk; SSRIs/SNRIs and corticosteroids ↑ GI bleeding; ACEi/ARBs and diuretics ↑ renal risk/reduced antihypertensive/diuretic effect; lithium ↑ levels; methotrexate ↑ toxicity; cyclosporine/tacrolimus ↑ nephrotoxicity; digoxin ↑ levels.

Interaction Severity

MAJOR: anticoagulants/antiplatelets (e.g., warfarin), other NSAIDs, high-dose methotrexate; MODERATE: ACE inhibitors/ARBs, diuretics, lithium, cyclosporine/tacrolimus, SSRIs/SNRIs, systemic corticosteroids; MINOR/variable: digoxin (possible level increase).

Food Interaction

Not applicable for rectal administration; no food restrictions specific to this suppository.

Special Populations

Elderly

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

Kidney Impairment

No routine dose adjustment for mild-moderate renal impairment but use with caution and monitor renal function; avoid/contraindicated in severe renal impairment (commonly eGFR/CrCl <30 mL/min) and in patients with advanced renal disease unless benefits clearly outweigh risks.

Storage & Patient Advice

Missed Dose

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

Stopping the Medicine

Can be stopped without tapering; for chronic/long-term use, discontinue under clinician guidance and use the lowest effective dose for the shortest duration.

Overdose

Symptoms may include nausea/vomiting, epigastric pain, dizziness/drowsiness, headache; severe toxicity can include GI bleeding, hypotension, acute kidney injury, metabolic acidosis, seizures, respiratory depression, and hepatic injury; management is supportive with urgent medical evaluation (activated charcoal may be considered for recent oral ingestion, though not applicable to rectal exposure).

Patient Counseling

Rectal use only: insert after bowel movement if possible; do not exceed the prescribed total daily dose (commonly max 150 mg/day for adults); use the lowest effective dose for the shortest duration; avoid combining with other NSAIDs and limit alcohol; seek urgent care for GI bleeding (black stools/vomiting blood), severe abdominal pain, chest pain/shortness of breath/weakness (CV events), or allergic reactions; inform clinician about kidney/liver disease, hypertension/heart disease, anticoagulants, and pregnancy (avoid in 3rd trimester).

Monitoring Requirements

If prolonged/repeated use: monitor blood pressure, renal function (SCr/eGFR), liver function tests, and CBC; counsel/monitor for GI bleeding and cardiovascular thrombotic events.

Pharmacology

Mechanism of Action

Inhibits cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) enzymes, reducing prostaglandin synthesis, thereby decreasing inflammation, pain, and fever

Duration of Effect

Approximately 6-8 hours (may be up to ~8 hours depending on patient and dose).

Half-Life

1.2-2 hours.

Metabolism

Metabolism: extensive hepatic metabolism primarily via CYP2C9 (major), with minor contribution from other CYPs (e.g., CYP3A4) plus conjugation (glucuronidation/sulfation).

Excretion

Excretion: predominantly renal as metabolites (~60-70% in urine) with the remainder via bile/feces (~30-40%).

Protein Binding

>99% protein bound (mainly to albumin).

Product Information

Available Dosage Forms

Diclofenac sodium is available in multiple dosage forms depending on country/brand: rectal suppositories; oral immediate/delayed-release and extended-release tablets/capsules; injectable formulations; topical gel/solution/patch; and ophthalmic drops.

Composition per Dose

Each suppository: 50 mg diclofenac sodium

OTC Alternatives

OTC alternatives for mild-moderate pain include paracetamol (acetaminophen) and ibuprofen; naproxen is OTC in some countries; topical diclofenac gel may be OTC in some markets but is product/country dependent.

Pain Type

Muscular/Joint

Nsaid

Yes

Opioid

No

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