Naproxen-pseudoephedrine

Naproxen-Pseudoephedrine is an over-the-counter (OTC) medication used for the treatment of sinus headache, cold and flu. 

• Naproxen-Pseudoephedrine is available under the following different brand names: Aleve-D Sinus & Headache

Common side effects of Naproxen-Pseudoephedrine include:

• Water retention
• Ringing in the ears
• Hives
• A skin rash
• Abnormal liver function tests
• Difficulty Sleeping
• Headache
• Constipation
• Drowsiness
• Dizziness
• Nausea
• Heartburn

Serious side effects of Naproxen-Pseudoephedrine include:

• Large purple or brown skin blotches
• Blurred vision.
• A change in vision
• Bleeding
• Bruising under the skin
• Excessive thirst
• Bruising
• Drowsiness
• Dizziness
• Muscle tremors
• Loss of skin color
• Decreased appetite.
• Nausea
• Difficult or painful urination
• Nervousness
• Generalized weakness.
• Fast heartbeat
• Indigestion
• Sensation of spinning or whirling
• Excessive sweating
• Heart throbbing or pounding
• Diarrheal

Rare side effects of Naproxen-Pseudoephedrine include:

• None 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Caplet

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

Sinus Headache/Cold/Flu

Adult dosage

• 1 caplet orally every 12 hours

Pediatric dosage

• Below 12 years: Safety and efficacy not established.
• 12 years or older: 1 caplet orally every 12 hours

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Naproxen-Pseudoephedrine has severe interactions with the following drugs.
  • dihydroergotamine
  • dihydroergotamine inhaled.
  • dihydroergotamine intranasal
  • ergoloid mesylates
  • ergonovine
  • ergotamine
  • isocarboxazid
  • linezolid
  • methylergonovine
  • phenelzine
  • procarbazine
  • rasagiline
  • selegiline
  • selegiline transdermal
  • tranylcypromine
• Naproxen-Pseudoephedrine has serious interactions with at least 45 other drugs.
• Naproxen-Pseudoephedrine has moderate interactions with at least 289 other drugs.
• Naproxen-Pseudoephedrine has minor interactions with at least 27 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

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

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Naproxen-Pseudoephedrine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Naproxen-Pseudoephedrine?”

Cautions

• NSAIDs may increase the risk of serious cardiovascular thrombotic events, myocardial infarction (MI), and stroke, which can be fatal.
• If taking aspirin for heart attack or stroke, ask a healthcare professional before using this drug; NSAIDs may decrease the benefits of aspirin.
• Naproxen may cause hypersensitivity, particularly in individuals allergic to aspirin
• Pseudoephedrine may increase blood pressure.

Pregnancy and Lactation

• 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 embryofoetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive
• Pseudoephedrine
  • Avoid, during the first trimester; may be associated with a possible risk of gastroschisis, small intestinal atresia, and hemifacial microsomia due to pseudoephedrine’s vasoconstrictive effects; the magnitude of risk is unknown.
  • Fetal tachycardia was reported following maternal use of an extended-release formulation for multiple days
• Lactation
  • Naproxen
    • Based on available published clinical data, the drug may be present in human milk; developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed infant from the drug or underlying maternal condition
  • Pseudoephedrine
    • Excreted in breast milk; irritability reported in nursing infants (limited data); milk production may be decreased in some women.