Naproxen Sodium 250 mg, 375 mg, and 500 mg
Generic Name: Naproxen Sodium
Therapeutic Class: Non-steroidal Anti-inflammatory Drug (NSAID)
Indications
Naproxen is indicated for the rapid relief of mild to moderate pain and inflammation in:
- Rheumatic Disorders: Rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.
- Acute Musculoskeletal Disorders: Tenosynovitis, bursitis, sprains, and strains.
- Acute Gout: Management of pain and inflammation during acute gouty attacks.
- Dysmenorrhea: Relief of primary menstrual cramps and associated pain.
- Juvenile Idiopathic Arthritis: Specifically in children over 2–5 years of age.
Presentation & Strengths
Available in various oral and topical formulations:
- Tablets: 250 mg, 375 mg, and 500 mg.
- SR/CR Tablets (Sustained/Controlled Release): 500 mg.
- Oral Suspension: 125 mg/5 ml.
- Topical Gel: 10% w/w for localized musculoskeletal pain.
- Combination: Often found with Esomeprazole (e.g., 500mg+20mg) to reduce GI risk.
Description
Naproxen Sodium is a propionic acid derivative with analgesic, anti-inflammatory, and antipyretic properties. It works by non-selectively inhibiting **Cyclooxygenase-1 (COX-1)** and **COX-2** enzymes, which leads to a decrease in prostaglandin synthesis. Its primary advantage over other NSAIDs like Ibuprofen is its longer duration of action, typically requiring only twice-daily dosing.
Dosage & Administration
Must be taken with or after food to minimize gastrointestinal irritation.
- Rheumatic Disorders: 500 mg to 1000 mg daily in two divided doses.
- Acute Gout: 750 mg initially, followed by 250 mg every 8 hours until the attack subsides.
- Dysmenorrhea & Acute Pain: 500 mg initially, then 250 mg every 6–8 hours as needed (Max 1250 mg on day one).
- SR/CR Formulations: 500 mg to 1000 mg taken once daily.
- Children (>2 years): 10 mg/kg/day in two divided doses for juvenile arthritis.
Side Effects
Common side effects include:
- Gastrointestinal: Heartburn, dyspepsia, nausea, and abdominal pain.
- CNS: Headache, dizziness, drowsiness, and vertigo.
- Dermatological: Skin rash, pruritus (itching), and bruising.
- Others: Tinnitus (ringing in the ears), visual disturbances, and edema (fluid retention).
Pregnancy & Lactation
Pregnancy: Category C (Category D in the third trimester). Avoid use from 20 weeks onwards as it may cause premature closure of the ductus arteriosus and fetal renal dysfunction.
Lactation: Naproxen is excreted in breast milk; therefore, its use is generally not recommended for nursing mothers.
Lactation: Naproxen is excreted in breast milk; therefore, its use is generally not recommended for nursing mothers.
Precautions & Interactions
Precautions: High risk of GI bleeding/ulceration in the elderly. Use with caution in patients with hypertension, heart failure, or renal impairment.
Interactions:
Interactions:
- Anticoagulants (Warfarin): Increased risk of bleeding.
- Lithium/Methotrexate: May increase toxicity levels of these drugs.
- ACE Inhibitors/Diuretics: May reduce the antihypertensive effect and increase renal risk.
- Aspirin: Displaces naproxen from protein binding, increasing toxicity risk.
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