DICLOGESIC RETARD 100MG 10 TAB

Indications

Approved Uses

Symptomatic treatment of inflammatory and degenerative rheumatic diseases such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis; and short-term treatment of pain and inflammation (e.g., acute musculoskeletal pain, postoperative/dental pain, primary dysmenorrhea).

Dosage & Administration

Dosing by Condition

Osteoarthritis/Rheumatoid arthritis/Ankylosing spondylitis: diclofenac ER 100 mg orally once daily; if inadequate, some patients may require up to 150 mg/day total (using appropriate formulations), but routine 100 mg twice daily ER is generally not recommended. Acute pain/primary dysmenorrhea: immediate-release diclofenac regimens are preferred; ER/retard 100 mg once daily may be used only if specifically labeled/clinically appropriate, keeping total daily dose ≤150 mg.

Initial Dose

100 mg orally once daily.

Maintenance Dose

100 mg orally once daily.

Maximum Dose

150 mg/day (typical maximum for oral diclofenac in adults; for modified/extended-release products, usual max is 100 mg once daily, may be increased to 150 mg/day in selected patients depending on product labeling).

Children's Dosage

Not approved for children under 14 years for this formulation; for children ≥1 year (other formulations): 0.5-3mg/kg/day in divided doses

Dose Adjustment Notes

Use the lowest effective dose for the shortest duration. Use caution in hepatic impairment (consider dose reduction/monitor LFTs); avoid in severe hepatic impairment. In renal impairment, avoid in advanced renal disease and monitor renal function/volume status; elderly should start at the lowest effective dose.

Side Effects

Common Side Effects

Common adverse effects: dyspepsia/indigestion, abdominal pain, nausea, vomiting, diarrhea or constipation, flatulence, headache, dizziness; rash and elevated liver enzymes can occur.

Side Effect Frequency

Common (1-10%): GI upset (nausea, dyspepsia, abdominal pain, diarrhea/constipation, flatulence), headache, dizziness, rash/pruritus, and edema. Uncommon/Rare (<1%): peptic ulceration, GI bleeding/perforation, hepatitis/hepatotoxicity (including marked transaminase elevations), renal impairment, hypertension/heart failure exacerbation, serious skin reactions (e.g., SJS/TEN), and thrombotic cardiovascular events (MI/stroke).

Safety & Warnings

Contraindications

Hypersensitivity to diclofenac or excipients; history of asthma/urticaria/other allergic-type reactions after aspirin or other NSAIDs (AERD); active GI bleeding or active peptic ulcer; perioperative pain in the setting of CABG surgery; third trimester of pregnancy.

Warnings & Precautions

Use the lowest effective dose for the shortest duration; increased risk of CV thrombotic events-caution in CVD/risk factors; increased risk of GI bleeding/ulcer/perforation-consider gastroprotection in high-risk patients; monitor BP, renal function, and for fluid retention/HF; monitor liver enzymes and stop if hepatotoxicity suspected; avoid in aspirin-sensitive asthma/AERD; serious skin reactions and anaphylaxis can occur; may mask fever/inflammation and increase infection risk.

Drug Interactions

Drug Interactions

Other NSAIDs/salicylates; anticoagulants (e.g., warfarin) and antiplatelets (e.g., aspirin, clopidogrel); SSRIs/SNRIs; systemic corticosteroids; ACE inhibitors/ARBs; diuretics; lithium; methotrexate; cyclosporine/tacrolimus; digoxin.

Food Interaction

Take with food

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Avoid in third trimester; use with caution in first and second trimesters.

Children

Not approved for children under 14 years for this formulation; for children ≥1 year (other formulations): 0.5-3mg/kg/day in divided doses

Elderly

Use the lowest effective dose; monitor renal function, blood pressure, and GI tolerance closely; increased risk of adverse events

Liver Impairment

No specific dose adjustment defined; use with caution in hepatic impairment with close monitoring of liver enzymes and discontinue if persistent LFT elevation or clinical hepatotoxicity occurs; avoid use in severe hepatic impairment.

Storage & Patient Advice

Patient Counseling

Swallow whole (retard/modified-release) with food or milk; do not crush/chew. Use the lowest effective dose for the shortest duration and do not exceed the prescribed dose. Avoid taking with other NSAIDs (e.g., ibuprofen/naproxen) and use caution/seek advice before combining with aspirin, anticoagulants/antiplatelets, SSRIs/SNRIs, corticosteroids, ACEI/ARB/diuretics, or methotrexate. Seek urgent care for signs of GI bleeding (black/tarry stools, vomiting blood), severe abdominal pain, chest pain/shortness of breath, one-sided weakness/slurred speech, or facial/leg swelling. Avoid in the 3rd trimester of pregnancy; discuss use in earlier pregnancy/breastfeeding with prescriber. If used longer term, periodic monitoring of blood pressure, renal function, and liver enzymes is recommended; limit alcohol to reduce GI risk.

Monitoring Requirements

Blood pressure monitoring. For long-term use, periodic monitoring of renal function, liver function, and complete blood count.

Pharmacology

Mechanism of Action

Reversibly inhibits COX-1 and COX-2, decreasing prostaglandin synthesis, leading to reduced inflammation, pain, and fever.

Onset of Action

Analgesic onset is typically within ~1-2 hours, but the extended-release (retard) formulation may have a slower onset than immediate-release while providing sustained effect over ~24 hours.

Half-Life

2.3 hours (terminal half-life for extended-release).

Bioavailability

Approximately 50-60% (reduced by first-pass metabolism).

Protein Binding

>99% protein bound (primarily to albumin).

Product Information

Available Dosage Forms

Diclofenac is available (market-dependent) as oral immediate-release tablets/capsules, enteric-coated/delayed-release tablets, extended-release tablets, oral powder/sachets, rectal suppositories, injectable forms, topical gel/solution/patch, and ophthalmic drops.

Composition per Dose

Each extended-release film-coated tablet: 100mg diclofenac sodium

Generic Availability

Yes

Pain Type

Joint/Muscular

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.