DICLOGESIC 50/MG 10/SUPP

Indications

Approved Uses

Symptomatic treatment of pain and inflammation in rheumatic disorders (e.g., rheumatoid arthritis, osteoarthritis, ankylosing spondylitis) and for acute pain conditions such as dysmenorrhea and post‑operative/post‑traumatic pain and inflammation.

Off-Label Uses

Common off‑label/variable-label uses include acute migraine treatment, acute gout flares, biliary/renal colic analgesia, and antipyresis (fever) in some settings.

Dosage & Administration

Dosing by Condition

Adults (rectal): typical total diclofenac dose 75-150 mg/day in divided doses; maximum combined daily dose from all routes is 150 mg/day. Suppositories are often used as part of the daily total (e.g., 50 mg 2-3 times daily or 100 mg at night), individualized to indication and tolerability.

Initial Dose

50mg rectally

Maintenance Dose

Adults (rectal): typical total diclofenac dose 75-150 mg/day in divided doses; maximum combined daily dose from all routes is 150 mg/day. Suppositories are often used as part of the daily total (e.g., 50 mg 2-3 times daily or 100 mg at night), individualized to indication and tolerability.

Maximum Dose

Rectal: 50 mg (1 suppository) per administration; usual maximum 150 mg/day (e.g., 1 suppository up to 3 times daily) unless otherwise prescribed.

Children's Dosage

For juvenile chronic arthritis (ages 1-12): 12.5mg and 25mg suppositories are used. For post-operative pain (ages over 6): can be used alone or with other painkillers. The 50mg strength is not typically recommended for children.

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 failure or severe hepatic impairment and in active GI bleeding/ulceration; monitor renal function, BP, and GI risk when clinically indicated.

How to Take

For rectal use only. Remove from blister/unwrap. Insert one suppository into the rectum (preferably after a bowel movement) and push it in far enough to stay in place; remain lying for a few minutes. Wash hands before and after use.

Side Effects

Common Side Effects

Common: dyspepsia/abdominal pain, nausea, diarrhea or constipation, headache, dizziness; with rectal use: local rectal irritation/discomfort/tenesmus may occur; rash can occur.

Side Effect Frequency

Common (≥1% to <10%): GI upset (nausea, dyspepsia, abdominal pain, diarrhea), headache, dizziness; Uncommon/Rare: GI ulceration/bleeding, hypersensitivity reactions, renal impairment, hepatotoxicity, severe skin reactions; Rectal irritation is possible with suppositories but is not consistently “very common” across references.

Safety & Warnings

Contraindications

Hypersensitivity to diclofenac/other NSAIDs (including aspirin triad); active GI ulceration or GI bleeding; use in the setting of CABG surgery; third-trimester pregnancy; and (for suppository) proctitis/rectal inflammation/rectal bleeding.

Warnings & Precautions

Key warnings/precautions: CV thrombotic risk (use lowest effective dose/shortest duration; caution in CVD risk); GI bleeding risk (higher in elderly, prior ulcer/bleed, with anticoagulants/antiplatelets/SSRIs/steroids); renal risk (avoid dehydration; monitor in CKD, HF, diuretics/ACEi/ARB use); hepatotoxicity (periodic LFTs); hypersensitivity/aspirin-exacerbated respiratory disease; severe skin reactions; avoid concomitant NSAIDs; and for rectal route avoid use with proctitis/rectal inflammation.

Driving Warning

Caution advised; diclofenac may cause dizziness, drowsiness, blurred vision, and neurologic effects that may impair physical and mental abilities, potentially affecting driving safety.

Drug Interactions

Drug Interactions

Clinically important interactions include: anticoagulants (e.g., warfarin), antiplatelets (e.g., aspirin/clopidogrel), SSRIs/SNRIs, corticosteroids (↑ bleeding); other NSAIDs (↑ toxicity); ACEi/ARBs and diuretics (↓ antihypertensive/diuretic effect, ↑ AKI risk-“triple whammy”); lithium (↑ levels); methotrexate (↑ toxicity); cyclosporine/tacrolimus (↑ nephrotoxicity); and quinolones (rare ↑ seizure risk).

Interaction Severity

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

Food Interaction

Not applicable for rectal administration; for oral diclofenac, taking with food may reduce GI upset but can delay absorption/onset.

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Category D (contraindicated in third trimester)

Children

For juvenile chronic arthritis (ages 1-12): 12.5mg and 25mg suppositories are used. For post-operative pain (ages over 6): can be used alone or with other painkillers. The 50mg strength is not typically recommended for children.

Elderly

Start at the lower end of the dosing range. Use with caution due to a higher risk of adverse effects, particularly GI bleeding and cardiovascular events.

Liver Impairment

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

Storage & Patient Advice

Overdose

Symptoms: nausea/vomiting, epigastric pain, drowsiness/dizziness, GI bleeding; severe cases may include hypotension, acute kidney injury, metabolic acidosis, respiratory depression, and seizures. Management: urgent medical evaluation, supportive care, monitor renal/hepatic function; activated charcoal may be considered for recent significant ingestion (not typically relevant to suppository exposure).

Patient Counseling

Insert rectally as directed (preferably after a bowel movement), remain lying briefly after insertion; use the lowest effective dose for the shortest duration; avoid using with other NSAIDs (including OTC ibuprofen/naproxen) or aspirin unless prescriber directs; seek urgent care for GI bleeding (black/tarry stools, vomiting blood) or serious CV symptoms (chest pain, shortness of breath, sudden weakness/slurred speech); avoid alcohol to reduce GI risk; tell your clinician if you have history of ulcer/GI bleed, heart disease, kidney/liver disease, asthma/NSAID allergy; avoid use in active proctitis/rectal bleeding; store at ≤30°C.

Monitoring Requirements

For long-term use, periodic monitoring of blood pressure, renal function (BUN, creatinine), liver function tests (ALT, AST), and complete blood count is recommended.

Pharmacology

Mechanism of Action

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

Half-Life

About 1-2 hours (terminal plasma half-life).

Excretion

Approximately 65% is excreted in urine and about 35% via bile/feces, predominantly as metabolites (minimal unchanged drug).

Protein Binding

>99%, primarily to albumin.

Product Information

Available Dosage Forms

For diclofenac sodium in general: gastro‑resistant/immediate‑release oral tablets, prolonged/modified‑release tablets, capsules, rectal suppositories, injectable solution, topical preparations (gel/solution/patch in some markets), and ophthalmic drops.

Composition per Dose

Each suppository: 50mg diclofenac sodium

Generic Availability

Yes

Pain Type

General, Muscular, Joint

Nsaid

Yes

Opioid

No

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