naproxen and misoprostol

M01AE56

Forms & Strengths

Adult Dosing

Osteoarthritis, rheumatoid arthritis, ankylosing spondylitis: One tablet (naproxen 375 mg or 500 mg with misoprostol 200 mcg) orally twice daily
Maximum daily dose: 1000 mg naproxen / 400 mcg misoprostol

Pediatric Dosing

Indications

Relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis
Patients at high risk for developing NSAID-induced gastric and duodenal ulcers

Mechanism of Action

Naproxen: Nonsteroidal anti-inflammatory drug (NSAID) that inhibits prostaglandin synthesis by non-selectively blocking cyclooxygenase (COX-1 and COX-2)
Misoprostol: Synthetic prostaglandin E1 analog that replaces endogenous prostaglandins to inhibit gastric acid secretion and protect the mucosal lining

Contraindications

Known hypersensitivity to naproxen, misoprostol, or other NSAIDs/prostaglandins
History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
Use in the setting of coronary artery bypass graft (CABG) surgery
Pregnancy (misoprostol induces uterine contractions, causes partial or complete abortion, and birth defects)

Adverse Reactions

Diarrhea
Abdominal pain
Nausea and dyspepsia
Headache
Dizziness
Edema and hypertension
Increased risk of serious cardiovascular thrombotic events and gastrointestinal bleeding/ulceration

Drug Interactions

Anticoagulants (e.g., warfarin) and antiplatelet agents (e.g., aspirin): Increased risk of severe gastrointestinal bleeding
ACE inhibitors, angiotensin receptor blockers (ARBs), and diuretics: Decreased antihypertensive efficacy and increased risk of renal impairment
Lithium: Decreased renal clearance, leading to elevated lithium toxicity
Methotrexate: Increased risk of severe methotrexate toxicity due to reduced clearance
Magnesium- or aluminum-containing antacids: May exacerbate misoprostol-associated diarrhea

Curated Content: Needs Vetting Before Put to Clinical Use