OLFEN-50 50/GM GASTRO-R TAB 20/TAB

Indications

Approved Uses

Symptomatic treatment of pain and inflammation in rheumatic diseases (e.g., rheumatoid arthritis, osteoarthritis, ankylosing spondylitis) and other acute painful conditions (e.g., acute musculoskeletal/post-operative/dental pain) and primary dysmenorrhea; acute gout is also an accepted labeled indication in many diclofenac IR products, while “headache” as a general indication and “acute migraine attacks” are not consistently labeled for this specific product.

Dosage & Administration

Dosing by Condition

Adults (diclofenac sodium immediate-release/enteric-coated): typically 50 mg 2-3 times daily (usual max 150 mg/day) for RA/OA/AS; acute pain or primary dysmenorrhea: 50 mg up to 3 times daily (max 150 mg/day) for short-term use. Some references allow RA up to 150 mg/day in divided doses; higher-frequency regimens (e.g., 50 mg 3-4 times daily) are not routinely recommended for this 50 mg tablet because they exceed 150 mg/day.

Initial Dose

50mg two or three times daily for osteoarthritis.

Maintenance Dose

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

Maximum Dose

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

Dose Adjustment Notes

Use the lowest effective dose for the shortest duration; in older adults use caution and consider lower starting doses. Avoid in severe renal impairment and severe hepatic impairment; in hepatic impairment use the lowest dose with close monitoring; monitor renal function in at-risk patients (e.g., CKD, dehydration, HF, diuretics/ACEi/ARB).

How to Take

Swallow the gastro-resistant (enteric-coated) film-coated tablet whole with water; do not crush, chew, or split. Preferably take with or after food (or milk) to reduce GI upset.

Side Effects

Common Side Effects

Common: dyspepsia/indigestion, abdominal pain, nausea (± vomiting), diarrhea, constipation, flatulence; headache, dizziness; edema/fluid retention can occur.

Side Effect Frequency

Common (≥1%): dyspepsia/heartburn, abdominal pain, nausea, diarrhea, constipation, flatulence, headache, dizziness, rash/pruritus, and increased liver enzymes. Serious but less common/rare: GI ulceration/bleeding/perforation (may present as black stools/vomiting blood), hepatitis/jaundice, severe skin reactions (e.g., SJS/TEN), renal impairment, hypersensitivity/bronchospasm, edema/heart failure exacerbation, and thrombotic 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 CABG surgery; third trimester of pregnancy.

Warnings & Precautions

Use lowest effective dose for shortest duration due to CV and GI risks; avoid/use extreme caution in established CVD or risk factors; assess GI risk (history of ulcer/bleed, elderly, concomitant anticoagulants/antiplatelets/SSRIs/steroids) and consider gastroprotection; monitor renal function in CKD, HF, dehydration, or with ACEi/ARB+diuretic; monitor liver enzymes with prolonged use or if symptoms of liver injury; avoid in aspirin-sensitive asthma; watch for edema, hypertension, and HF worsening; discontinue if rash or hypersensitivity occurs.

Drug Interactions

Drug Interactions

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

Interaction Severity

MAJOR/clinically significant: anticoagulants/antiplatelets (e.g., warfarin) and SSRIs/SNRIs (↑ bleeding), other NSAIDs/aspirin (↑ GI/renal toxicity), methotrexate (↑ toxicity, especially with high-dose or impaired clearance). MODERATE: ACE inhibitors/ARBs and diuretics (↓ antihypertensive/diuretic effect; ↑ AKI risk-“triple whammy”), lithium (↑ levels), cyclosporine/tacrolimus (↑ nephrotoxicity), systemic corticosteroids (↑ GI bleeding). MINOR: antacids may delay absorption slightly.

Food Interaction

Take with food

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Contraindicated

Breastfeeding

Caution

Elderly

Start at lowest effective dose (25mg 2-3 times daily), monitor renal function, GI status, and cardiovascular parameters closely; increased risk of adverse effects

Kidney Impairment

No routine dose adjustment for mild-moderate renal impairment, but use with caution and monitor renal function; avoid in advanced/severe renal disease (e.g., eGFR/CrCl <30 mL/min) or if renal function deteriorates.

Liver Impairment

No specific dose adjustment defined for mild-moderate hepatic impairment, but use the lowest effective dose with close monitoring; avoid/contraindicated in severe hepatic impairment or active hepatic disease.

Storage & Patient Advice

Stopping the Medicine

Can be stopped without tapering; for chronic/long-term use, stop and seek medical advice if symptoms recur or if used regularly for ongoing pain/inflammation.

Overdose

Symptoms: nausea, vomiting, epigastric pain, GI bleeding, dizziness, drowsiness; severe cases may include hypotension, metabolic acidosis, acute kidney injury, respiratory depression, and seizures. Management: supportive care; consider activated charcoal if early after ingestion; no specific antidote-seek urgent medical attention/poison center.

Patient Counseling

Take OLFEN-50 (diclofenac sodium 50 mg) by mouth with food or milk and swallow the film‑coated tablet whole (do not crush/chew). Use the lowest effective dose for the shortest duration. Avoid taking other NSAIDs (e.g., ibuprofen, naproxen) and avoid/limit alcohol due to increased GI bleeding risk. Seek urgent care if you develop black/tarry stools, vomiting blood, severe/persistent stomach pain, chest pain, shortness of breath, weakness on one side, or slurred speech. Tell your prescriber before use if you have a history of peptic ulcer/GI bleeding, cardiovascular disease or risk factors, kidney or liver disease, asthma/NSAID allergy, or if you are pregnant (especially ≥20 weeks/3rd trimester). Prescription-only; do not share.

Monitoring Requirements

If used beyond short-term: blood pressure; renal function (SCr/eGFR) especially in at-risk patients; liver enzymes (ALT/AST) with prolonged use; CBC if prolonged therapy or if bleeding/anemia suspected; monitor for GI bleeding and cardiovascular risk.

Pharmacology

Mechanism of Action

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

Half-Life

Terminal plasma half-life is approximately 2.3 hours (not 1-2 hours as commonly cited).

Bioavailability

Approximately 50% due to first-pass metabolism.

Protein Binding

>99%, primarily to albumin.

Product Information

Available Dosage Forms

Diclofenac is available (by product) as immediate-release tablets, enteric-coated/gastro-resistant tablets, prolonged/modified-release tablets/capsules, suppositories, injectable solution (IM/IV depending on product), topical gel/solution/patch, and ophthalmic drops.

Composition per Dose

Each gastro-resistant film-coated tablet: 50mg diclofenac sodium

Generic Availability

Yes

Pain Type

General/Muscular/Joint

Nsaid

Yes

Opioid

No

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