DICLOGESIC 12.5/MG CHILDREN 10/SUPP

Indications

Approved Uses

Symptomatic treatment of pain and inflammation (e.g., acute musculoskeletal pain, post‑operative pain, dysmenorrhea, and other inflammatory painful conditions); pediatric use may include short-term treatment of pain/fever where rectal diclofenac is clinically indicated per local labeling.

Off-Label Uses

Renal colic (adjunct/analgesia) and acute migraine treatment are commonly used off-label in some settings; juvenile idiopathic arthritis is generally treated with NSAIDs but diclofenac use depends on local approvals and is not a universal off-label standard for this specific product.

Dosage & Administration

Dosing by Condition

Dosing is indication- and age/weight-dependent; commonly used pediatric rectal dosing is 0.5-1 mg/kg per dose every 8-12 hours (max ~3 mg/kg/day) and should follow local product labeling/prescriber direction for this 12.5 mg suppository.

Initial Dose

12.5mg rectally as a single dose

Maximum Dose

Rectal (suppository): insert 1 suppository per dose; may repeat every 6-8 hours as needed. Maximum 4 suppositories (total 50 mg) in 24 hours.

Children's Dosage

Children 1-12 years: 0.5-1mg/kg/dose rectally every 6-8 hours; maximum 3mg/kg/day. Infants post-immunization: 12.5mg once, may repeat after 6 hours. Not recommended in neonates

Dose Adjustment Notes

Use the lowest effective dose for the shortest duration; use caution in elderly and in renal/hepatic impairment, avoid in severe renal impairment and in severe hepatic impairment, and discontinue if significant liver enzyme elevations or clinical hepatotoxicity occur.

How to Take

For rectal use only: remove the suppository from the foil/blister, insert into the rectum (preferably after a bowel movement) with the pointed end first; if soft, chill briefly before unwrapping; wash hands before and after and remain lying for a few minutes to reduce expulsion.

Side Effects

Common Side Effects

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

Side Effect Frequency

Common: GI upset (nausea, dyspepsia/abdominal pain, diarrhea/constipation), headache/dizziness; rectal irritation/discomfort can occur with suppositories. Uncommon: rash, elevated liver enzymes, fluid retention. Rare/serious: GI ulcer/bleeding/perforation, severe hypersensitivity/bronchospasm/anaphylaxis, severe cutaneous reactions (SJS/TEN), hepatitis, acute kidney injury.

Safety & Warnings

Contraindications

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

Warnings & Precautions

Use the lowest effective dose for the shortest duration; assess CV risk (IHD/stroke risk, hypertension, HF) and GI risk (ulcer history, elderly, anticoagulants/antiplatelets/SSRIs/corticosteroids-consider gastroprotection when indicated); monitor renal function in at-risk patients (CKD, HF, dehydration, diuretics/ACEi/ARB); monitor for hepatotoxicity (LFTs if prolonged use); avoid in aspirin-sensitive asthma; NSAIDs may mask infection; for rectal route avoid use with proctitis/rectal inflammation and avoid prolonged rectal use.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Major/clinically important interactions include: anticoagulants (e.g., warfarin), antiplatelets (aspirin, clopidogrel), other NSAIDs, corticosteroids, SSRIs/SNRIs (↑ bleeding/GI risk); ACE inhibitors/ARBs and diuretics (↓ antihypertensive/diuretic effect, ↑ AKI risk-"triple whammy"); lithium (↑ levels); methotrexate (↑ toxicity); cyclosporine/tacrolimus (↑ nephrotoxicity).

Interaction Severity

MAJOR/clinically significant: anticoagulants/antiplatelets (e.g., warfarin), other NSAIDs (additive GI/renal risk), methotrexate (toxicity), lithium (increased levels). MODERATE: ACE inhibitors/ARBs and diuretics (renal risk/reduced antihypertensive effect), cyclosporine/tacrolimus (nephrotoxicity), corticosteroids and SSRIs/SNRIs (increased GI bleeding risk).

Food Interaction

No food interaction relevant for this rectal suppository; food effects apply to oral diclofenac only.

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Category D (FDA); contraindicated in third trimester.

Children

Children 1-12 years: 0.5-1mg/kg/dose rectally every 6-8 hours; maximum 3mg/kg/day. Infants post-immunization: 12.5mg once, may repeat after 6 hours. Not recommended in neonates

Elderly

Start at the lower end of the dosing range due to a greater frequency of decreased renal, hepatic, and cardiac function. Monitor for GI bleeding.

Kidney Impairment

No formal dose adjustment for mild-moderate impairment, but use caution and monitor renal function; avoid/contraindicated in severe renal impairment or advanced renal disease (often CrCl <30 mL/min) and in dehydration/volume depletion.

Liver Impairment

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

Storage & Patient Advice

Missed Dose

Use as soon as remembered if needed; if it is close to the next scheduled dose, skip the missed dose-do not double doses.

Stopping the Medicine

No taper is required; can stop at any time, but if used chronically, stop/seek review if adverse effects occur or if long-term therapy is being changed.

Overdose

Overdose may cause nausea/vomiting, epigastric pain, GI bleeding, dizziness/drowsiness, headache; severe cases: hypotension, acute kidney injury, metabolic acidosis, respiratory depression, seizures/coma; management is supportive with urgent medical evaluation (activated charcoal may be considered for recent significant oral ingestion).

Patient Counseling

Insert rectally as directed (preferably after bowel movement); use the lowest effective dose for the shortest duration; do not exceed the prescribed daily maximum; avoid concurrent NSAIDs (e.g., ibuprofen/aspirin) unless prescriber advises; seek care urgently for GI bleeding (black/bloody stools, vomiting blood), severe allergy/bronchospasm, severe skin rash, or reduced urine/swelling; avoid use in active proctitis/rectal bleeding; store below 30°C.

Monitoring Requirements

If repeated/prolonged use: monitor blood pressure, renal function (SCr/eGFR), liver enzymes, and for GI bleeding; consider CBC if long-term or if bleeding is suspected.

Pharmacology

Mechanism of Action

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

Onset of Action

Approximately 30-60 minutes (rectal diclofenac suppository).

Duration of Effect

Typically about 6-8 hours (may vary by patient and formulation).

Half-Life

1.2-2 hours.

Bioavailability

Rectal systemic bioavailability is variable; typically about 50-60% relative to oral (reduced by incomplete absorption and first-pass metabolism).

Metabolism

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

Excretion

Eliminated mainly as metabolites: ~60-70% in urine and ~30-40% via bile/feces.

Protein Binding

>99% protein bound (mainly to albumin).

Product Information

Available Dosage Forms

For this PRODUCT (DICLOGESIC): Suppository only (rectal use).

Composition per Dose

Each suppository: 12.5mg diclofenac sodium

Generic Availability

Yes

OTC Alternatives

Paracetamol (acetaminophen) age/weight-appropriate formulations (e.g., oral liquid/tablets; suppositories where available); ibuprofen age/weight-appropriate formulations where OTC and clinically appropriate.

Pain Type

Muscular/Joint

Nsaid

Yes

Opioid

No

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