VOLTAREN 100MG SUPP

Indications

Approved Uses

Symptomatic treatment of pain and inflammation in rheumatic diseases (e.g., rheumatoid arthritis, osteoarthritis, ankylosing spondylitis) and acute painful/inflammatory conditions where rectal diclofenac is appropriate (e.g., acute gout, post‑operative/post‑traumatic pain).

Dosage & Administration

Dosing by Condition

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 (25 mg four times daily with optional extra 25 mg at bedtime). Maximum recommended daily dose is 200 mg/day. Rectal suppository dosing specifically is not detailed in provided sources; the 100 mg suppository was used as a single dose in clinical studies but routine maintenance dosing is not specified

Initial Dose

100 mg once daily as a single rectal suppository.

Maximum Dose

Rectal: Insert 1 suppository (100 mg) once daily; do not exceed 150 mg/day total diclofenac from all formulations.

Children's Dosage

100mg suppositories are not suitable for children and adolescents. For juvenile rheumatoid arthritis (ages 1-12), the dose is 1-3 mg/kg daily in divided doses, not to exceed 150mg/day.

Dose Adjustment Notes

Use the lowest effective dose for the shortest duration. In older adults or higher-risk patients, start at the lowest dose and monitor closely. Avoid/use with extreme caution in severe renal impairment, severe hepatic impairment, or active GI bleeding/ulcer. Do not exceed a total diclofenac dose of 150 mg/day from all formulations combined (typical adult maximum).

Side Effects

Common Side Effects

GI: dyspepsia/abdominal pain, nausea, diarrhea; CNS: headache, dizziness; local: rectal irritation/burning/itching; labs: possible elevation of liver enzymes with systemic exposure.

Side Effect Frequency

Common: GI symptoms (nausea, dyspepsia/abdominal pain, diarrhea), headache/dizziness, rash, and local rectal irritation; elevated transaminases can occur. Serious GI ulcer/bleeding, severe skin reactions (e.g., SJS/TEN), hepatotoxicity, renal injury, and CV thrombotic events are uncommon/rare but clinically important.

Safety & Warnings

Contraindications

Contraindications: hypersensitivity to diclofenac/other NSAIDs; history of asthma/urticaria/allergic-type reactions after aspirin/NSAIDs (AERD); active GI bleeding or peptic ulcer; peri-operative pain in CABG surgery; proctitis/rectal inflammation or recent rectal bleeding (suppository route). Avoid/contraindicated in 3rd trimester pregnancy.

Warnings & Precautions

Key warnings/precautions: use lowest effective dose for shortest duration; CV risk (avoid in established CVD when possible; monitor BP/edema); GI risk (consider gastroprotection in high-risk patients; watch for bleeding); renal risk (monitor renal function, avoid dehydration and high-risk combinations); hepatic monitoring (stop if LFTs rise or symptoms); hypersensitivity/AERD; severe skin reactions; may mask infection/fever; avoid concomitant NSAIDs.

Drug Interactions

Drug Interactions

Clinically important interactions: anticoagulants (e.g., warfarin) and antiplatelets/SSRIs/SNRIs (↑ bleeding); other NSAIDs/salicylates and corticosteroids (↑ GI toxicity); ACEi/ARB/diuretics (↓ antihypertensive/diuretic effect, ↑ AKI risk-“triple whammy”); lithium (↑ levels); methotrexate (↑ toxicity); cyclosporine/tacrolimus (↑ nephrotoxicity); digoxin (↑ levels).

Interaction Severity

MAJOR: anticoagulants/antiplatelets (e.g., warfarin) and SSRIs/SNRIs (↑ bleeding risk), other NSAIDs (↑ GI/renal risk), methotrexate (↑ toxicity), lithium (↑ levels/toxicity). MODERATE: ACE inhibitors/ARBs and diuretics (↓ antihypertensive/diuretic effect, ↑ AKI risk), cyclosporine/tacrolimus (↑ nephrotoxicity), digoxin (↑ levels).

Food Interaction

Not applicable for rectal administration; food does not meaningfully affect absorption from a suppository.

Special Populations

Breastfeeding

Caution

Children

100mg suppositories are not suitable for children and adolescents. For juvenile rheumatoid arthritis (ages 1-12), the dose is 1-3 mg/kg daily in divided doses, not to exceed 150mg/day.

Elderly

Start at the lower end of the dosing range. Use the lowest effective dose for the shortest duration possible due to increased risk of side effects, particularly GI bleeding.

Kidney Impairment

No adjustment for mild-moderate renal impairment but use with caution and monitor renal function; avoid/contraindicated in advanced/severe renal impairment (commonly CrCl <30 mL/min) or if renal function deteriorates.

Storage & Patient Advice

Missed Dose

Insert/use as soon as remembered unless it is close to the next scheduled dose; if close, skip the missed dose and resume the regular schedule. Do not double doses.

Stopping the Medicine

Can be stopped without tapering; if used chronically, stop and seek medical review if symptoms recur or if adverse effects occur.

Overdose

Overdose may cause nausea/vomiting, epigastric pain, GI bleeding, dizziness/drowsiness, tinnitus; severe cases: hypotension/hypertension, acute kidney injury, metabolic acidosis, respiratory depression, seizures, coma, anaphylactoid reactions. Management is supportive (airway/breathing/circulation, fluids, treat seizures), consider activated charcoal if recent ingestion; no specific antidote-seek urgent medical care/poison center.

Patient Counseling

Rectal use: insert suppository as directed (preferably after bowel movement); use the lowest effective dose for the shortest duration; avoid using with other NSAIDs (including OTC ibuprofen/naproxen; low-dose aspirin only if prescribed); seek urgent care for GI bleeding (black/tarry stools, vomiting blood), chest pain/shortness of breath, stroke symptoms, severe rash, or jaundice; avoid alcohol to reduce GI risk; caution with driving if dizzy; tell your clinician about anticoagulants/antiplatelets, SSRIs/SNRIs, steroids, ACEI/ARB/diuretics, and kidney/liver/heart disease; avoid if proctitis/rectal bleeding unless advised; store below 30°C.

Monitoring Requirements

If prolonged/repeated use: monitor blood pressure, renal function (SCr/BUN ± electrolytes), liver enzymes (AST/ALT), and CBC; monitor for GI bleeding and cardiovascular risk, especially in high-risk patients.

Pharmacology

Mechanism of Action

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

Duration of Effect

Approximately 8-12 hours (clinical analgesic/anti-inflammatory effect), supporting once-daily 100 mg suppository use in many patients.

Metabolism

Extensive hepatic metabolism primarily via CYP2C9 (with minor CYP3A4 contribution) to hydroxylated metabolites (e.g., 4′-hydroxy-diclofenac) followed by glucuronidation/sulfation; metabolites have minimal activity.

Product Information

Available Dosage Forms

For diclofenac (Voltaren brand varies by country): suppository; oral tablets (immediate/enteric‑coated and modified/extended‑release); injectable solution; topical gel; ophthalmic drops (diclofenac ophthalmic products exist).

Composition per Dose

Each suppository: 100 mg diclofenac sodium

Generic Availability

Yes

OTC Alternatives

Paracetamol (acetaminophen) and ibuprofen (if no NSAID contraindications); topical NSAIDs (e.g., diclofenac gel) may be an OTC option depending on local availability.

Pain Type

General, Muscular, Joint

Nsaid

Yes

Opioid

No

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