naproxen and diphenhydramine

M01AE57

Forms & Strengths

Adult Dosing

1 caplet by mouth 30 minutes before bedtime for the short-term management of occasional sleeplessness associated with minor aches and pains
Maximum 1 caplet in a 24-hour period
Not recommended for use for more than 7 consecutive days for sleep or 10 days for pain unless directed by a physician

Pediatric Dosing

Children under 12 years: Safety and efficacy not established; use not recommended

Indications

Short-term management of occasional sleeplessness associated with minor aches and pains

Mechanism of Action

Naproxen: Nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX-1 and COX-2), leading to a decrease in prostaglandin synthesis, providing analgesic, antipyretic, and anti-inflammatory effects
Diphenhydramine: First-generation antihistamine that crosses the blood-brain barrier and competitively blocks central histamine H1 receptors, producing sedative effects

Contraindications

Known hypersensitivity to naproxen, diphenhydramine, or any component of the formulation
History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
Setting of coronary artery bypass graft (CABG) surgery
Nursing mothers
Concurrent use with other products containing diphenhydramine, even those used topically

Adverse Reactions

Central nervous system: Drowsiness, dizziness, sedation, fatigue, headache
Gastrointestinal: Dyspepsia, abdominal pain, nausea, heartburn, GI ulceration or bleeding
Anticholinergic effects: Dry mouth, blurred vision, urinary retention, constipation
Cardiovascular: Edema, hypertension, increased risk of thrombotic events

Drug Interactions

Anticoagulants and antiplatelet agents (e.g., warfarin, aspirin): Increased risk of severe gastrointestinal bleeding
ACE inhibitors, angiotensin receptor blockers, and diuretics: Decreased antihypertensive efficacy and increased risk of renal impairment
CNS depressants (e.g., alcohol, sedatives, tranquilizers, hypnotics): Potentiation of sedative effects
Lithium and methotrexate: Decreased renal clearance, leading to potential toxicity of these agents

Curated Content: Needs Vetting Before Put to Clinical Use