Naproxen Oral Suspension

Warning

Risk of serious cardiovascular and gastrointestinal events

Contraindications

• Known hypersensitivity to naproxen or any components of the drug product
• History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
• In the setting of coronary artery bypass graft (CABG) surgery

Adverse Reactions

• Cardiovascular thrombotic events
• Gastrointestinal bleeding, ulceration, and perforation
• Hepatotoxicity
• Hypertension
• Heart failure and edema
• Renal toxicity and hyperkalemia
• Anaphylactic reactions
• Serious skin reactions
• Hematologic toxicity

General Guidance

Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals

Pregnancy

• Use of NSAIDs, including naproxen oral suspension, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment
• Limit dose and duration of naproxen oral suspension use between about 20 and 30 weeks of gestation, and avoid naproxen oral suspension use at about 30 weeks of gestation and later in pregnancy

Nursing Mothers

• Naproxen is excreted in human milk
• Caution should be exercised when naproxen oral suspension is administered to a nursing woman

Pediatric Use

• Safety and effectiveness in pediatric patients below the age of 2 years have not been established
• Pediatric dosing recommendations for polyarticular juvenile idiopathic arthritis are based on well-controlled studies

Geriatric Use

• Elderly patients, compared to younger patients, are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions
• Start dosing at the low end of the dosing range, and monitor patients for adverse effects