EMIFENAC DT 50/MG DISP TAB 20/TAB

Indications

Approved Uses

Symptomatic treatment of pain and inflammation in rheumatic diseases (e.g., osteoarthritis, rheumatoid arthritis, ankylosing spondylitis) and short-term treatment of acute pain conditions such as primary dysmenorrhea and acute migraine attacks.

Dosage & Administration

Dosing by Condition

Adults (immediate-release/dispersible diclofenac): Osteoarthritis/Rheumatoid arthritis/Ankylosing spondylitis: typically 100-150 mg/day in 2-3 divided doses (max usually 150 mg/day for IR). Acute pain/primary dysmenorrhea: 50 mg up to 3 times daily (max 150 mg/day). Acute migraine: 50 mg at onset; may repeat once if needed per local labeling, keeping within the daily maximum for the formulation.

Initial Dose

50 mg two to three times daily.

Maintenance Dose

100-150 mg/day in divided doses for osteoarthritis; 150-200 mg/day in divided doses for rheumatoid arthritis.

Maximum Dose

150 mg/day for osteoarthritis; 200 mg/day for rheumatoid arthritis.

Children's Dosage

For children aged 1-12 years, the recommended oral dose is 1 mg/kg, up to three times daily, with a maximum daily dose of 3 mg/kg or 150mg. Not recommended for children under 1 year.

Dose Adjustment Notes

Use the lowest effective dose for the shortest duration; use caution and consider lower starting doses in older adults and in renal/hepatic impairment; avoid use in severe renal or severe hepatic impairment and in advanced heart failure unless clearly necessary.

How to Take

Disperse the 50 mg dispersible tablet in a small glass of water, stir, and drink immediately; rinse the glass with a little water and drink to ensure the full dose. Preferably take with or after food to reduce gastrointestinal irritation.

How to Prepare

Disperse the tablet in water, stir until dispersed, and take immediately after dispersion (then rinse the glass with a little water and drink to ensure full dose).

Side Effects

Common Side Effects

Nausea, vomiting, dyspepsia, abdominal pain, diarrhea, headache, dizziness, elevated liver enzymes, flatulence

Safety & Warnings

Contraindications

Contraindicated in: hypersensitivity to diclofenac/other NSAIDs; history of asthma/urticaria/allergic-type reactions after aspirin/NSAIDs (AERD); active GI bleeding/peptic ulcer; peri-operative pain in CABG surgery; and use in the third trimester of pregnancy.

Warnings & Precautions

Warnings/precautions: CV thrombotic risk (use lowest effective dose/shortest duration; caution in CV disease/risk factors); serious GI events (higher risk in elderly, prior ulcer/GI bleed, concomitant anticoagulants/antiplatelets/SSRIs); renal toxicity and hyperkalemia risk (caution with CKD, dehydration, ACEi/ARB/diuretics); hepatotoxicity (monitor LFTs, stop if injury suspected); fluid retention/HTN/heart failure worsening; severe skin reactions; may mask infection; avoid in aspirin-sensitive asthma.

Age Restriction

Not recommended for children <14 years for this 50 mg oral diclofenac dispersible tablet (use only if specifically prescribed; pediatric use generally requires weight-based dosing and appropriate formulations).

Drug Interactions

Drug Interactions

Key interactions: anticoagulants/antiplatelets/SSRIs (↑ bleeding); other NSAIDs (↑ GI/CV toxicity); ACEi/ARB/diuretics (↓ antihypertensive/diuretic effect, ↑ AKI risk); lithium (↑ levels); methotrexate (↑ toxicity); cyclosporine/tacrolimus (↑ nephrotoxicity); digoxin (↑ levels).

Interaction Severity

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

Food Interaction

Take with food

Special Populations

Pregnancy

Avoid in third trimester; use with caution earlier.

Breastfeeding

Caution

Children

For children aged 1-12 years, the recommended oral dose is 1 mg/kg, up to three times daily, with a maximum daily dose of 3 mg/kg or 150mg. Not recommended for children under 1 year.

Elderly

Start at the lower end of the dosing range. Use the lowest effective dose for the shortest duration possible due to increased risk of adverse events.

Kidney Impairment

Avoid in advanced renal impairment (e.g., CrCl <30 mL/min) and in patients with active/progressive renal disease; if mild-moderate impairment, use the lowest effective dose with renal function monitoring (no fixed adjustment).

Liver Impairment

No specific dose adjustment for mild-moderate hepatic impairment but use with caution and monitor LFTs; avoid/contraindicated in severe hepatic impairment or active hepatic disease.

Storage & Patient Advice

Preparation Instructions

Disperse the tablet in water, stir until dispersed, and take immediately after dispersion (then rinse the glass with a little water and drink to ensure full dose).

Missed Dose

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

Stopping the Medicine

Can be stopped without tapering.

Overdose

Symptoms: nausea/vomiting, epigastric pain, GI bleeding, dizziness/drowsiness; severe cases: hypotension/hypertension, acute kidney injury, metabolic acidosis, seizures, respiratory depression, hepatic injury. Management: supportive care, consider activated charcoal if early after ingestion; no specific antidote; urgent medical evaluation required.

Patient Counseling

Disperse in water and take with/after food; use the lowest effective dose for the shortest time and do not combine with other NSAIDs unless advised. Seek urgent care for black/tarry stools, vomiting blood, severe abdominal pain, chest pain/shortness of breath, sudden weakness/slurred speech, or swelling/rapid weight gain; avoid in the 3rd trimester of pregnancy and inform the prescriber about ulcer history, kidney/liver disease, hypertension/heart disease, and all anticoagulant/antiplatelet or SSRI/SNRI use.

Monitoring Requirements

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

Pharmacology

Mechanism of Action

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

Onset of Action

Approximately 30-60 minutes for analgesic effect with immediate-release/dispersible diclofenac.

Duration of Effect

Approximately 6-8 hours for immediate-release/dispersible diclofenac.

Half-Life

1.2-2 hours.

Bioavailability

Oral systemic bioavailability ~50% (range ~40-60%) due to first-pass metabolism; absorption from the GI tract is essentially complete.

Protein Binding

>99%, primarily to albumin.

Product Information

Available Dosage Forms

For diclofenac sodium (general): oral immediate-release tablets (including dispersible), enteric-coated/delayed-release tablets, extended/modified-release tablets, capsules (some markets), suppositories, injection, topical gel/solution, and ophthalmic solution; availability varies by country/brand.

Composition per Dose

Each dispersible tablet: 50 mg diclofenac sodium

Generic Availability

Yes

OTC Alternatives

Paracetamol (acetaminophen) and ibuprofen are common OTC alternatives for mild-to-moderate pain; naproxen may be OTC in some countries but is prescription-only in others.

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.