DICLOGESIC 100/MG SUPP 5/SUPP

Indications

Approved Uses

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

Off-Label Uses

Off-label examples include acute gout flares and acute pericarditis (as an NSAID option); other pain indications (e.g., dental pain) may be used off-label depending on local practice.

Dosage & Administration

Dosing by Condition

Adults (rectal): typical total diclofenac dose 75-150 mg/day; for suppositories, 100 mg once daily (often at bedtime) is common, and some patients may require up to 150 mg/day total from all diclofenac formulations as directed; do not exceed 150 mg/day total without prescriber direction.

Initial Dose

100mg rectally as a single dose

Maintenance Dose

For rectal suppositories, 100 mg once daily.

Dose Adjustment Notes

Use the lowest effective dose for the shortest duration; use caution in older adults and those with renal/hepatic impairment or cardiovascular risk, and avoid use in severe renal or severe hepatic impairment unless specialist-directed.

How to Take

For rectal use only: remove the suppository from the foil/blister, insert into the rectum (preferably pointed end first) while lying on your side, remain lying for a few minutes to reduce expulsion, and wash hands before and after use.

Side Effects

Common Side Effects

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

Side Effect Frequency

Common (1-10%): GI symptoms (e.g., nausea, abdominal pain, dyspepsia, diarrhea/constipation, flatulence) and CNS symptoms (e.g., headache, dizziness). Uncommon (0.1-1%): transaminase elevations and local rectal irritation (for suppositories). Rare/very rare (<0.1%): GI ulceration/bleeding, severe hypersensitivity (including anaphylaxis), severe cutaneous adverse reactions, clinically significant hepatotoxicity/jaundice, renal impairment, and serious cardiovascular events (e.g., heart failure).

Safety & Warnings

Contraindications

Hypersensitivity to diclofenac/other NSAIDs; history of asthma/urticaria/allergic-type reaction after aspirin/NSAIDs; use in the setting of CABG surgery; active GI ulceration or bleeding; severe hepatic impairment; severe renal impairment/advanced renal disease; severe heart failure; third trimester of pregnancy; and (for suppositories) proctitis or recent rectal bleeding.

Warnings & Precautions

Use the lowest effective dose for the shortest duration; monitor/avoid in patients with cardiovascular disease or risk factors; high risk of GI bleeding/ulceration (higher in elderly, prior ulcer/GI bleed, concomitant anticoagulants/antiplatelets/SSRIs/corticosteroids); monitor BP, edema/heart failure, and renal function in at-risk patients; monitor liver enzymes with prolonged use; avoid use with other NSAIDs; and avoid in rectal inflammation/bleeding (suppository).

Age Restriction

Not generally recommended for children; 100 mg suppository strength is typically for adults/adolescents and is usually not used under 14 years unless specifically prescribed by a specialist.

Driving Warning

Safe

Drug Interactions

Drug Interactions

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

Interaction Severity

MAJOR/clinically significant: anticoagulants/antiplatelets (e.g., warfarin, DOACs, aspirin/clopidogrel) and SSRIs/SNRIs (↑ bleeding), other NSAIDs (↑ GI/renal risk), lithium (↑ levels), methotrexate (↑ toxicity, especially high-dose), cyclosporine/tacrolimus (↑ nephrotoxicity). MODERATE: ACE inhibitors/ARBs and diuretics (↓ antihypertensive/diuretic effect, ↑ AKI risk), digoxin (↑ levels), systemic corticosteroids and alcohol (↑ GI bleeding).

Food Interaction

Not applicable for this product (rectal suppository); for oral diclofenac, taking with food may reduce GI upset but can delay absorption.

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Avoid in third trimester; use in first and second trimesters only if benefit outweighs risk (FDA Pregnancy Category D in third trimester, C earlier).

Breastfeeding

Caution

Elderly

Start at the lowest effective dose and use for the shortest duration possible due to increased risk of side effects, particularly GI bleeding and renal toxicity.

Kidney Impairment

Mild-moderate renal impairment: no formal dose adjustment but use with caution and monitor renal function; severe renal impairment (e.g., CrCl <30 mL/min) or advanced renal disease: avoid/not recommended.

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

Take as soon as remembered; skip if near the time of the next dose. Do not double the dose

Stopping the Medicine

No taper is required; it can be stopped at any time, but if used chronically or for inflammatory disease, reassess with a clinician to avoid symptom rebound and to manage underlying condition.

Overdose

Overdose may cause nausea/vomiting, epigastric pain, GI bleeding, dizziness/drowsiness, headache; severe cases can cause hypotension, acute renal failure, metabolic acidosis, seizures, respiratory depression/coma; management is supportive (airway/breathing/circulation, fluids, labs/renal-hepatic monitoring) and urgent medical evaluation-no specific antidote.

Patient Counseling

Rectal use only; insert one suppository as directed (do not exceed prescribed total daily dose). Use the lowest effective dose for the shortest time. Avoid combining with other NSAIDs and limit alcohol. Seek urgent care for signs of GI bleeding (black stools/vomiting blood), severe abdominal pain, allergic reaction, or chest pain/shortness of breath/one-sided weakness. Use caution with blood thinners and in heart, kidney, or liver disease. Avoid use in the 3rd trimester of pregnancy. Store below 30°C in original packaging.

Monitoring Requirements

If used beyond short-term: monitor blood pressure, renal function (SCr/eGFR), hepatic function (LFTs), and CBC periodically; monitor for GI bleeding and cardiovascular symptoms throughout therapy.

Pharmacology

Mechanism of Action

Inhibits cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) enzymes, which results in decreased synthesis of prostaglandins, thereby reducing inflammation, pain, and fever.

Onset of Action

30-60 minutes.

Half-Life

1.2-2 hours.

Bioavailability

Rectal diclofenac has variable systemic bioavailability and is generally lower than 100% due to first-pass metabolism; typical relative bioavailability is roughly ~50-70% versus IM, with substantial interpatient variability.

Metabolism

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

Excretion

Primarily renal excretion as metabolites (~60-65%) with the remainder excreted via bile/feces (~35-40%).

Protein Binding

>99%.

Product Information

Available Dosage Forms

Diclofenac is available in multiple dosage forms depending on country/brand, commonly including oral tablets/capsules (immediate-, enteric/delayed-, and modified/extended-release), rectal suppositories, injectable forms, and topical formulations (gel/solution); ophthalmic forms also exist for diclofenac in some markets.

Composition per Dose

Each suppository: 100mg diclofenac sodium

Generic Availability

Yes

OTC Alternatives

OTC alternatives for mild pain (where available) include ibuprofen and naproxen; topical diclofenac may be OTC in some countries but is not a direct substitute for a prescription 100 mg rectal suppository.

Pain Type

General/Muscular/Joint

Nsaid

Yes

Opioid

No

Legal Disclaimer - Al Mujtama Pharmacy

The product information provided is derived from verified pharmaceutical references and is intended for general health education only. It is not a substitute for professional medical advice, diagnosis, or treatment.

Al Mujtama Pharmacy assumes no legal or medical liability for:

• Any therapeutic decision made based on the information displayed without consulting a licensed physician or pharmacist
• Any discrepancy between the information provided and the product's package insert or SFDA guidelines
• Any misuse of medication resulting from personal interpretation of the content displayed

Important notice: Drug formulations and instructions may vary between production batches. Always rely on the leaflet included inside the product packaging you have, and consult your pharmacist or physician before starting, adjusting, or discontinuing any medication.

By using this content, you acknowledge that you have read this disclaimer and agree that Al Mujtama Pharmacy bears no liability arising from reliance on this information as a substitute for direct medical consultation.

Your health is a trust - always consult your doctor first.