Naproxen/Pseudoephedrine

DEA Class; OTC,

Common Brand Names; Aleve-D Sinus & Headache

 Cough/Cold, Other Combos; 

Analgesic/Decongestant Combos

Naproxen: Inhibits cyclooxygenase; [at least 2 isoenzymes, cyclooxygenase-1 (COX-1) & -2 (COX-2)], thereby inhibiting prostaglandin synthesis

Pseudoephedrine: Alpha adrenergic agonist

Hypersensitivity

Do not coadministration pseudoephedrine with MAOIs or within 2 weeks after discontinuing MAOIs

Naproxen

• Abdominal pain, constipation, nausea, diarrhea
• GI bleeding, perforation, ulcers
• Dizziness, headache

Pseudoephedrine

• Tremor, restlessness, insomnia
• Nausea, vomiting
• Hypertension
• Atrial fibrillation, premature ventricular beats

NSAIDs may increase risk of serious cardiovascular thrombotic events, myocardial infarction (MI), and stroke, which can be fatal

If taking aspirin for heart attack or stroke, ask healthcare professional before using this drug; NSAIDs may decrease benefits of aspirin

Naproxen may cause hypersensitivity, particularly in individuals allergic to aspirin

Pseudoephedrine may increase blood pressure

Pregnancy

Naproxen

• 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, do not use after 20 weeks of gestation unless directed by a physician

• Data from observational studies regarding other potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive

Pseudoephedrine

• Avoid, during first trimester; may be associated with possible risk of gastroschisis, small intestinal atresia, and hemifacial microsomia due to pseudoephedrine’s vasoconstrictive effects; magnitude of risk unknown

• Fetal tachycardia reported following maternal use of extended release formulation for multiple days

Lactation

Naproxen

• Based on available published clinical data, drug may be present in human milk; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition

Pseudoephedrine

• Excreted in breast milk; irritability reported in nursing infants (limited data); milk production may be decreased in some women

1 caplet PO q12hr

Pediatric

<12 years: Safety and efficacy not established

12 years or older: 1 caplet PO q12hr

caplet

• 200mg/120mg (220mg naproxen sodium equivalent to 200mg naproxen)