PROXEN 250/MG FC TAB 20/FC TAB

Indications

Approved Uses

Pain and inflammation in rheumatic/musculoskeletal conditions (e.g., osteoarthritis, rheumatoid arthritis, ankylosing spondylitis), acute pain including primary dysmenorrhea, and acute gout; antipyretic use is also recognized for naproxen as an NSAID.

Dosage & Administration

Dosing by Condition

Mild to moderate pain/dysmenorrhea: Initial 500mg, then 250mg every 6-8 hours; max 1250mg/day. Osteoarthritis/Rheumatoid arthritis/Ankylosing spondylitis: 250-500mg twice daily; max 1000mg/day. Acute gout: Initial 750mg, then 250mg every 8 hours until attack subsides.

Initial Dose

500mg for pain/dysmenorrhea; 250-500mg twice daily for inflammatory conditions

Maintenance Dose

250-500mg twice daily for osteoarthritis/rheumatoid arthritis/ankylosing spondylitis.

Maximum Dose

1250mg on the first day for acute pain, then 1000mg daily. Up to 1500mg daily for short-term use in arthritis.

Children's Dosage

Children (juvenile arthritis): 5mg/kg twice daily (max 10mg/kg/day). Not recommended for children <50kg with tablets.

Dose Adjustment Notes

Use the lowest effective dose for the shortest duration; use caution and consider dose reduction in older adults; avoid use in severe renal impairment (e.g., CrCl <30 mL/min) and use caution in hepatic impairment, heart failure, dehydration, or concomitant nephrotoxic drugs.

How to Take

Swallow the film‑coated tablet whole with a full glass of water; take with food or milk (or just after food) to reduce GI upset; do not crush or chew.

Side Effects

Common Side Effects

Common: dyspepsia/heartburn, nausea, abdominal pain, constipation or diarrhea, headache, dizziness, drowsiness; may also cause peripheral edema and rash/pruritus; tinnitus can occur.

Side Effect Frequency

Common (≥1%): dyspepsia/heartburn, nausea, abdominal pain, constipation or diarrhea, headache, dizziness, drowsiness. Uncommon/rare (<1%): GI ulceration/bleeding/perforation, elevated liver enzymes, renal impairment, hypertension/edema, severe hypersensitivity and severe cutaneous adverse reactions (e.g., SJS/TEN).

Safety & Warnings

Contraindications

Contraindications: hypersensitivity to naproxen/other NSAIDs; history of asthma/urticaria or other allergic-type reactions after aspirin/NSAIDs (AERD); active GI bleeding or active peptic ulcer; use for peri-operative pain in CABG surgery; (commonly also: late pregnancy/third trimester due to fetal ductus arteriosus/renal risks).

Warnings & Precautions

Key warnings/precautions: use lowest effective dose for shortest duration; increased risk of CV thrombotic events and GI bleeding/ulceration/perforation; avoid around CABG; caution in hypertension, heart failure/edema, ischemic heart disease, prior stroke, CKD, hepatic disease, older adults, and history of ulcer/GI bleed; avoid in AERD; monitor for renal function decline and BP elevation; may mask fever/inflammation and signs of infection; avoid combining with other NSAIDs and use gastroprotection when high GI risk.

Age Restriction

OTC: not recommended for children <12 years unless directed by a doctor; prescription use: approved in children ≥2 years for juvenile idiopathic arthritis (JIA) (age limits for other pediatric uses depend on indication/product labeling).

Driving Warning

Safe

Drug Interactions

Interaction Severity

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

Food Interaction

Take with food

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Avoid in late pregnancy (third trimester); no FDA category assigned.

Children

Children (juvenile arthritis): 5mg/kg twice daily (max 10mg/kg/day). Not recommended for children <50kg with tablets.

Elderly

Use lowest effective dose for shortest duration; increased risk of GI bleeding, renal impairment, and cardiovascular events; monitor renal function and blood pressure regularly; consider dose reduction

Kidney Impairment

Avoid in severe renal impairment/advanced renal disease (commonly CrCl <30 mL/min); in mild-moderate impairment use with caution at the lowest effective dose and monitor renal function, especially with ACEi/ARB/diuretic use or dehydration.

Liver Impairment

No specific dose adjustment is defined; use the lowest effective dose with caution in hepatic impairment, and avoid use in severe hepatic failure/active severe liver disease.

Storage & Patient Advice

Missed Dose

Take as soon as remembered; skip if near the time of the next scheduled dose; do not double the dose

Stopping the Medicine

No taper is required; it can be stopped at any time-if used chronically, stop due to adverse effects or lack of benefit should be discussed with a clinician and the underlying condition reassessed.

Overdose

Symptoms may include nausea/vomiting, epigastric pain/dyspepsia, drowsiness, dizziness, tinnitus; severe toxicity can include GI bleeding, metabolic acidosis, seizures, hypotension, acute kidney injury, and respiratory depression. Management: urgent medical evaluation/poison control, activated charcoal if early after ingestion, and supportive care with monitoring (renal function, electrolytes, acid-base, bleeding).

Patient Counseling

Take with food/milk and a full glass of water; do not exceed the labeled dose and use the lowest effective dose for the shortest time; avoid combining with other NSAIDs/aspirin unless advised; limit alcohol (↑ GI bleed risk); stop and seek urgent care for black/tarry stools, vomiting blood, severe abdominal pain, chest pain, shortness of breath, or sudden weakness; consult a clinician before use if history of ulcer/GI bleed, kidney disease, heart disease/heart failure, uncontrolled hypertension, or if taking anticoagulants/antiplatelets/SSRIs; avoid in the 3rd trimester of pregnancy.

Monitoring Requirements

Monitor for GI bleeding/ulcer symptoms; check blood pressure and signs of fluid retention/edema; with prolonged use or in at-risk patients monitor renal function (SCr/eGFR), liver enzymes, and CBC (for anemia/bleeding).

Pharmacology

Mechanism of Action

Reversibly inhibits COX-1 and COX-2, decreasing prostaglandin synthesis and thereby producing anti-inflammatory, analgesic, and antipyretic effects.

Duration of Effect

Approximately 8-12 hours (often up to ~12 hours) for analgesic effect.

Bioavailability

Oral naproxen is well absorbed with high bioavailability (commonly reported ~95% or greater).

Protein Binding

>99% protein bound (primarily to albumin).

Product Information

Available Dosage Forms

Tablet, film-coated tablet.

Composition per Dose

Each film-coated tablet: 250mg naproxen

Generic Availability

Yes

OTC Alternatives

Paracetamol (acetaminophen) and ibuprofen are common OTC alternatives for mild-moderate pain/fever (choice depends on patient risk factors).

Pain Type

General, Migraine, Muscular, Joint

Nsaid

Yes

Opioid

No

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