Classes
DEA Class; Rx
Common Brand Names; Aleve PM
Analgesics, Other Combos
Description
Naproxen: Inhibits synthesis of prostaglandins in body tissues by inhibiting at least 2 cyclooxygenase (COX) isoenzymes, COX-1 and COX-2
Diphenhydramine: Histamine H1-receptor antagonist that elicits sedative effects
Indications
Indicated in Sleeplessness due to Pain
Contraindications
Hypersensitivity
Naproxen
Absolute: Aspirin allergy; perioperative pain in setting of coronary artery bypass graft (CABG) surgery
Relative: Bleeding disorders, delayed esophageal transit, hepatic disease, peptic ulcer, renal impairment, stomatitis, late pregnancy (may cause premature closure of ductus arteriosus
Diphenhydramine
Coadministration with MAOIs
Adverse Effects
1-10%
Naproxen
- Abdominal pain
- GI bleeding
- Nausea
- Edema
- Fluid retention
Diphenhydramine
- Sedation
- Anticholinergic effects
- Xerostomia
- Blurred vision
- Palpitations
Warnings
In case of overdose, get medical help or contact a Poison Control Center right away
Not recommmended for patients with likelihood of unrecognized CAD, severe renal impairment (CrCl <30 mL/min), or women who are breast feeding
Use NSAIDs with caution with underlying cardiovascular disease, active/history of peptic ulcer, inflammatory bowel disease, GI disease, bleeding disorder, renal/hepatic impairment, anemia, asthma, heart failure, edema, dehydration, HTN, or seizure disorder
Pregnancy and Lactation
Pregnancy
Use of NSAIDs can cause premature closure of fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment
Because of these risks, limit dose and duration of use between about 20 and 30 weeks of gestation, and avoid use at about 30 weeks of gestation and later in pregnancy
Lactation
Naproxen and diphenhydramine are excreted in human breast milk; effect on infant unknown; not recommended
Maximum Dosage
2 tablets (440mg/50mg) PO at bedtime PRN
Pediatric
<12 years: Safety and efficacy not established
≥12 years: 2 tablets (440mg/50mg) PO at bedtime PRN
How supplied
naproxen/diphenhydramine
Tablet
- 220mg/25mg