Naproxen and pseudoephedrine

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID). Naproxen works by reducing hormones that cause inflammation and pain in the body.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Naproxen and pseudoephedrine is a combination medicine used to treat stuffy nose, sinus congestion, headache, fever, and minor aches and pains caused by the common cold or flu.

Naproxen and pseudoephedrine may also be used for purposes not listed in this medication guide.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Naproxen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Naproxen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using naproxen, especially in older adults.

Use exactly as directed on the label, or as prescribed by your doctor. Do not take this medicine in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition.

Do not crush, chew, or break the tablet. Swallow it whole.

Take this medicine with a full glass of water.

Take with food or milk if this medicine upsets your stomach.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Call your doctor if you have a fever lasting longer than 3 days, or if your symptoms do not improve after 7 days of taking this medicine.

Store at room temperature away from moisture and heat.

Ask your doctor before using this medicine if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.

Ask a doctor or pharmacist if it is safe for you to use naproxen and pseudoephedrine if you are also using any of the following drugs:

• lithium;

• methotrexate;

• a blood thinner (warfarin, Coumadin, Jantoven);

• heart or blood pressure medication, including a diuretic or "water pill"; or

• steroid medicine (such as prednisone).

This list is not complete. Other drugs may interact with naproxen and pseudoephedrine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Chest pain or pressure.
• Very bad dizziness or passing out.
• Any unexplained bruising or bleeding.
• Very bad belly pain.
• Black, tarry, or bloody stools.
• Throwing up blood or throw up that looks like coffee grounds.

Applies to naproxen / pseudoephedrine: oral tablet extended release

Cardiovascular

Nonsteroidal anti-inflammatory drugs (NSAIDs) may elevate blood pressure and increase the risk of the initiation of antihypertensive therapy. NSAIDs may antagonize the blood-pressure lowering effect of antihypertensive medications in patients already being treated with antihypertensive drugs.

Pseudoephedrine causes vasoconstriction which generally does not produce hypertension, but may be problematic for patients with preexisting hypertension. Arrhythmias may be produced in predisposed patients. Rarely, pseudoephedrine has been reported to cause coronary artery spasm and chest pain.[Ref]

Cardiovascular side effects have included tachycardia and elevation of blood pressure, which may have clinical relevance in patients with comorbid illnesses. Dyspnea has been reported in patients receiving controlled release naproxen. An increased risk of cardiovascular events has been observed in preliminary study results from a clinical trial conducted by the National Institute of Aging evaluating the use of NSAIDs in patients at risk of developing Alzheimer's disease.[Ref]

Gastrointestinal

Gastrointestinal (GI) side effects have been reported the most frequently with the use of naproxen. These have included constipation (3% to 9%), general abdominal discomfort (3% to 9%), nausea (3% to 9%), dyspepsia (3% to 9%), diarrhea, and stomatitis. Serious gastrointestinal side effects include peptic ulcerations, and, in rare cases, gastrointestinal hemorrhage or perforation. Ulcerative esophagitis, eosinophilic colitis, allergic sialadenitis, and pancreatitis have been reported. Heartburn and stomatitis have been reported in patients receiving the controlled release formulation of naproxen. The GI side effects associated with the use of pseudoephedrine have included anorexia and gastric irritation in approximately 5% of patients. Dry mouth, nose, or throat have occurred in up to 15% of patients.[Ref]

Patients with a history of serious gastrointestinal events or alcohol abuse are at increased risk for severe gastrointestinal side effects. Naproxen should be used with caution in these patients.[Ref]

Renal

Renal side effects have included the development of mild renal insufficiency, nephrotic syndrome (with or without renal failure), acute renal failure due to tubulointerstitial nephritis, papillary necrosis, and acute tubular necrosis. Hypersensitivity may play a role in some cases of renal failure.[Ref]

A 52-year-old male developed cutaneous necrotizing vasculitis, renal failure, and nephrotic syndrome following administration of naproxen 250 mg every 12 hours and dicloxacillin 250 mg every six hours for three days for the treatment of a blunt injury to the leg. Renal pathology was suggestive of a hypersensitivity angiitis. Symptoms resolved following discontinuation of naproxen.

Naproxen may impair the ability of the kidney to cope with low renal blood flow states due to inhibition of prostaglandin-dependent afferent arteriolar vasodilation. Renal function may be further compromised in patients with heart failure, hypovolemia, cirrhosis, nephrotic syndrome, or hypoalbuminemia. Additional risk factors for naproxen-induced renal insufficiency are advanced age and concomitant use of diuretics.

A case-control study suggested that patients who consumed 5000 or more pills containing NSAIDs during their lifetime may be at increased risk of end-stage renal disease.[Ref]

Nervous system

Nervous system side effects have included insomnia in up to 30% of patients taking pseudoephedrine. Tremor, anxiety, nervousness, and headache have also been reported. Depression, dream abnormalities, insomnia, malaise, myalgia, muscle weakness, aseptic meningitis, inability to concentrate, and cognitive dysfunction have been reported with the use of naproxen.[Ref]

Dermatologic

Excessive sun exposure may play a role in cases of skin eruptions resembling porphyria cutanea tarda. Biochemical evidence of porphyria, such as elevated serum porphyrins, is lacking in these cases. Photosensitivity reactions have also been associated with lesions resembling those of epidermolysis bullosa.

Although rarely reported with the use of naproxen, a 14-year-old girl is diagnosed with periareolar fixed drug eruption after taking naproxen during menses for dysmenorrhea.[Ref]

Dermatologic side effects have included pruritus, ecchymoses, purpura, rash, and photosensitivity. Rare cases of pseudoporphyria cutanea tarda, toxic epidermal necrolysis, generalized bullous fixed drug eruption, erythema multiforme, and Stevens-Johnson syndrome have also been reported. Skin eruptions have been reported in patients receiving the controlled release formulation of naproxen.[Ref]

Hypersensitivity

Hypersensitivity side effects have been reported rarely. These may result in an erythematous or urticarial rash, angioedema, and bronchospasm, especially in patients with aspirin-sensitive asthma. Anaphylactoid reactions have been reported as well. Hypersensitivity has been implicated in cases of renal failure, pneumonitis, and colitis. Fixed drug eruptions have been reported with the use of pseudoephedrine.[Ref]

Respiratory

Several cases of pulmonary infiltration accompanied by eosinophilia have been reported in the literature. Fever, malaise, and respiratory symptoms are typically present. Discontinuation of naproxen results in resolution of symptoms.[Ref]

Respiratory side effects have included bronchospasm. Rarely, cases of eosinophilic pneumonitis have been reported.[Ref]

Other

Other side effects have included tinnitus, altered hearing, vertigo, visual disturbances, and keratopathy. Increased thirst has been reported in patients receiving the controlled release naproxen.[Ref]

Some side effects of naproxen / pseudoephedrine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.