ROFENAC 25/MG SUPP FOR CHILDREN 10/SUPP

Indications

Approved Uses

Symptomatic short-term treatment of pain and inflammation and as an antipyretic (fever) where rectal diclofenac is clinically appropriate; specific adult chronic arthritis indications (e.g., OA/RA/AS), dysmenorrhea, and migraine are not assumed for this pediatric 25 mg suppository without the local label.

Off-Label Uses

Off-label examples: acute renal colic analgesia; closure of patent ductus arteriosus (PDA) in neonates (diclofenac is not standard-ibuprofen/indomethacin are preferred); juvenile idiopathic arthritis is generally managed with other NSAIDs and specialist-directed regimens rather than rectal diclofenac.

Dosage & Administration

Dosing by Condition

Children (typically 1-12 years) for pain/fever: 0.5-1 mg/kg per dose rectally every 8-12 hours as needed; usual maximum 3 mg/kg/day (do not exceed adult maximums).

Initial Dose

0.5-1mg/kg per dose rectally

Maintenance Dose

0.5-1mg/kg every 8 hours as needed

Maximum Dose

Children (rectal): Max 3 mg/kg/day (as diclofenac sodium) in 2-3 divided doses; do not exceed 150 mg/day.

Children's Dosage

Children 1-12 years: 0.5-1mg/kg/dose rectally every 8 hours; maximum 3mg/kg/day. The 25mg suppository is appropriate for children approximately 15-25kg

Dose Adjustment Notes

Use the lowest effective dose for the shortest duration; avoid in severe renal impairment/advanced renal disease and use caution in hepatic impairment (consider dose reduction/monitoring); avoid in significant dehydration; pediatric use is generally for children ≥1 year (per many rectal diclofenac labels) and dosing should be weight-based.

How to Take

For rectal use only: remove from blister/unwrap, if soft chill briefly, place child on side with knees flexed, gently insert the suppository into the rectum (preferably pointed end first) until past the sphincter, then keep the child lying for a few minutes to reduce expulsion; wash hands before/after.

Side Effects

Common Side Effects

Common: gastrointestinal upset (abdominal pain, nausea, dyspepsia, diarrhea or constipation), headache/dizziness; rectal irritation/discomfort can occur with suppositories.

Side Effect Frequency

Common: GI symptoms (abdominal pain, nausea, dyspepsia, diarrhea/constipation), headache/dizziness; with rectal use, local rectal irritation can occur. Uncommon: rash/urticaria, vomiting, elevated liver enzymes, edema/fluid retention. Rare/serious: peptic ulcer/GI bleeding or perforation, severe skin reactions (e.g., SJS/TEN), anaphylaxis/bronchospasm, hepatitis, renal impairment, and thrombotic cardiovascular events.

Safety & Warnings

Contraindications

Hypersensitivity to diclofenac/other NSAIDs; history of NSAID/aspirin-induced asthma/urticaria/anaphylactoid reactions; active GI ulcer or bleeding; severe hepatic impairment; severe renal impairment/advanced renal disease; severe heart failure; peri-operative pain in CABG surgery; third trimester of pregnancy; proctitis/rectal inflammation (for rectal dosage forms).

Warnings & Precautions

Use the lowest effective dose for the shortest duration; assess CV risk (MI/stroke) and avoid in established significant CV disease when possible; monitor/avoid in heart failure, hypertension, and fluid retention; high GI risk-consider gastroprotection in high-risk patients and avoid with active ulcer/bleed; monitor renal function in at-risk patients (elderly, dehydration, CKD, ACEi/ARB+diuretic); monitor liver enzymes with prolonged use; discontinue for rash/hypersensitivity; NSAIDs may mask fever/inflammation; avoid rectal use in proctitis/rectal inflammation.

Age Restriction

Not recommended in children <6 months; used in children ≥6 months.

Drug Interactions

Drug Interactions

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

Food Interaction

No restriction

Special Populations

Children

Children 1-12 years: 0.5-1mg/kg/dose rectally every 8 hours; maximum 3mg/kg/day. The 25mg suppository is appropriate for children approximately 15-25kg

Storage & Patient Advice

Missed Dose

If a dose is missed, administer when remembered unless it is close to the next scheduled dose; skip the missed dose if close to the next dose and do not double doses.

Stopping the Medicine

Safe to stop anytime; no tapering required for short-term use

Patient Counseling

Insert one suppository into the rectum as prescribed (preferably after a bowel movement); if soft, chill briefly before unwrapping, then insert pointed end and keep the child lying for a few minutes. Use the lowest effective dose for the shortest duration; do not exceed the prescribed dose and do not combine with other NSAIDs (e.g., ibuprofen) or aspirin unless directed. Seek urgent care for signs of GI bleeding (black/tarry stools, blood in vomit), severe allergic/skin reactions, breathing difficulty, or unusual bruising/bleeding; stop and contact the prescriber if significant rectal pain/bleeding occurs. Store below 25°C in the original blister.

Monitoring Requirements

If used beyond short-term: monitor blood pressure, renal function (SCr/eGFR), liver enzymes, and CBC; monitor for GI bleeding/ulcer symptoms and signs of fluid retention.

Pharmacology

Mechanism of Action

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

Onset of Action

30-60 minutes

Duration of Effect

Approximately 6-8 hours (typical dosing interval every 8-12 hours depending on clinical need and tolerability).

Half-Life

Terminal plasma half-life is about 1-2 hours (often cited ~2 hours).

Bioavailability

Rectal diclofenac has variable systemic bioavailability, typically about 50-60% relative to parenteral dosing (and similar order of magnitude to oral, which is ~50-60% due to first-pass metabolism).

Excretion

Excretion is mainly as metabolites: ~60-70% in urine and ~30-40% via bile/feces; unchanged diclofenac is minimal.

Protein Binding

>99%, primarily to albumin.

Product Information

Available Dosage Forms

For this product: suppository (rectal) only.

Composition per Dose

Each suppository: 25mg diclofenac sodium

Generic Availability

Yes

OTC Alternatives

For children: paracetamol (acetaminophen) is the preferred OTC alternative for fever/mild pain; ibuprofen may be an OTC alternative where age/weight-appropriate and not contraindicated; naproxen and topical diclofenac are generally not appropriate substitutes for a pediatric rectal product without clinician advice.

Pain Type

General/Muscular/Joint

Nsaid

Yes

Opioid

No

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