VOLTAREN 12.5/MG SUPP FOR CHILDREN 10/SUPP

Indications

Approved Uses

Short-term symptomatic treatment of pain and/or fever and inflammatory conditions where rectal diclofenac is appropriate (e.g., acute pain including post‑operative pain, musculoskeletal/inflammatory pain); use in children is typically for short-term pain/fever under medical supervision.

Off-Label Uses

Juvenile idiopathic arthritis (JIA) symptom control may be used off-label depending on local labeling and specialist direction.

Dosage & Administration

Dosing by Condition

Children (rectal): 0.5 mg/kg per dose every 6-8 hours as needed; maximum 3 mg/kg/day

Initial Dose

0.5-1 mg/kg per dose rectally

Maintenance Dose

0.5 mg/kg rectally every 6-8 hours as needed

Maximum Dose

Rectal (children): do not exceed a total diclofenac dose of 3 mg/kg/day from all routes (rectal/oral combined).

Children's Dosage

For juvenile idiopathic arthritis (off-label), 2-3 mg/kg/day has been used in children aged 3-16 years. The 12.5mg suppository is intended for children.

Dose Adjustment Notes

Use the lowest effective dose for the shortest duration; avoid in severe renal impairment/advanced renal disease and use caution with renal dysfunction or dehydration; use caution in hepatic impairment and discontinue if significant LFT elevation occurs.

How to Take

For rectal use only. Remove suppository from the blister/foil, insert into the rectum (preferably after a bowel movement); for children, place on the side with knees flexed, insert the pointed end gently, and keep the child lying for a few minutes. Wash hands before and after.

Side Effects

Common Side Effects

Abdominal pain/dyspepsia, nausea/vomiting, diarrhea (or constipation), headache/dizziness; rectal irritation/discomfort may occur with suppositories.

Side Effect Frequency

Common: GI symptoms (abdominal pain, nausea, dyspepsia, diarrhea/constipation), headache/dizziness; rectal irritation can occur with suppositories. Uncommon/rare but serious: GI ulceration/bleeding/perforation (e.g., black stools), hypersensitivity/anaphylaxis, severe cutaneous adverse reactions (SJS/TEN), hepatotoxicity (elevated LFTs/jaundice), and renal impairment.

Safety & Warnings

Contraindications

Hypersensitivity to diclofenac/NSAIDs; history of aspirin/NSAID-induced asthma/urticaria/anaphylactoid reactions; active GI bleeding or peptic ulcer; severe hepatic or severe renal failure; severe heart failure; proctitis/anorectal inflammation (rectal products); third-trimester pregnancy; CABG peri-operative pain.

Warnings & Precautions

Use lowest effective dose for shortest duration; increased CV thrombotic and serious GI risk; avoid concomitant NSAIDs; monitor for GI bleeding, BP/edema/heart failure worsening, renal function (esp. dehydration/CKD/ACEi/ARB/diuretic use), and liver enzymes if prolonged; avoid in proctitis/anorectal disorders (rectal); pregnancy: avoid from 20 weeks onward due to fetal renal dysfunction/oligohydramnios and contraindicated in 3rd trimester (ductus arteriosus closure).

Age Restriction

Pediatric suppository; generally used in children ≥1 year (avoid in infants <1 year unless specialist-directed).

Drug Interactions

Drug Interactions

Clinically important interactions include: anticoagulants/antiplatelets (↑ bleeding), other NSAIDs/aspirin (↑ GI/CV risk), corticosteroids and SSRIs/SNRIs (↑ GI bleeding), 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), other NSAIDs (including high-dose aspirin) due to bleeding/GI risk; Methotrexate and lithium (increased toxicity/levels). MODERATE: ACE inhibitors/ARBs/diuretics (renal risk and reduced antihypertensive/diuretic effect), corticosteroids and SSRIs/SNRIs (increased GI bleeding), cyclosporine/tacrolimus (nephrotoxicity).

Food Interaction

No restriction

Special Populations

Children

For juvenile idiopathic arthritis (off-label), 2-3 mg/kg/day has been used in children aged 3-16 years. The 12.5mg suppository is intended for children.

Kidney Impairment

No formal adjustment for mild-moderate renal impairment but use cautiously with monitoring; avoid in advanced renal disease (eGFR/CrCl <30 mL/min) or if renal function worsens/dehydration is present.

Storage & Patient Advice

Missed Dose

If used on a schedule, give as soon as remembered unless it is close to the next dose; skip the missed dose if close to the next dose and do not double. If used PRN, give the next dose when needed within the prescribed maximum.

Stopping the Medicine

No taper is required; may stop when no longer needed-if used regularly/long-term, stop and seek medical advice if symptoms recur or if adverse effects occur.

Overdose

Possible overdose effects: nausea/vomiting, abdominal pain, GI bleeding, dizziness/drowsiness, headache, hypotension, renal impairment/failure, metabolic acidosis, seizures (rare), and hepatic injury; management is supportive with urgent medical evaluation/poison center contact (activated charcoal only if recent oral ingestion-less relevant for rectal).

Patient Counseling

For rectal use only: insert one suppository gently into the rectum (preferably after a bowel movement); wash hands before/after. Use the lowest effective dose for the shortest duration as prescribed. Do not use with other NSAIDs (e.g., ibuprofen, naproxen) or aspirin unless the prescriber directs. Stop and seek urgent care if signs of GI bleeding (black/tarry stools, blood in stool/vomit), severe abdominal pain, allergic reaction (wheeze, facial swelling, hives), severe skin rash, or unusual bruising occur. Avoid use if the child has rectal/anal inflammation or bleeding unless advised by a clinician. Store below 30°C and keep out of reach of children.

Monitoring Requirements

Monitor for GI bleeding/ulcer symptoms, renal function (especially if dehydrated or on ACEi/ARB/diuretics), liver enzymes with prolonged/repeated use, blood pressure/edema, and hypersensitivity/asthma exacerbation.

Pharmacology

Mechanism of Action

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

Onset of Action

30-60 minutes

Half-Life

1.2-2 hours.

Bioavailability

Rectal bioavailability is higher than oral, approximately 80-100%

Metabolism

Extensive hepatic metabolism primarily via CYP2C9 (major), with minor contributions from other CYPs (e.g., CYP3A4/2C8) and subsequent glucuronidation/sulfation.

Excretion

Elimination is mainly as metabolites: ~65% in urine and ~35% via bile/feces.

Protein Binding

>99% protein bound, mainly to albumin.

Product Information

Available Dosage Forms

For this SFDA-registered product: Suppository (rectal).

Composition per Dose

Each suppository: 12.5 mg diclofenac sodium

Generic Availability

Yes

OTC Alternatives

For pediatric pain/fever: paracetamol (acetaminophen) and ibuprofen (age/weight-appropriate formulations).

Pain Type

General, Muscular, Joint

Nsaid

Yes

Opioid

No

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