- 5 Medicine Mistakes You Could Be Making
- Sudafed PSE
- What is Sudafed PSE?
- Important Information
- Before taking this medicine
- How should I take Sudafed PSE?
- What happens if I miss a dose?
- What happens if I overdose?
- What should I avoid while taking Sudafed PSE?
- Sudafed PSE side effects
- What other drugs will affect Sudafed PSE?
- Further information
- More about naproxen / pseudoephedrine
- Don’t let decongestants squeeze your heart
- As many over-the-counter decongestants get a new ingredient, you might want to look for alternatives.
- What Causes Ankle Injuries and How to Contain Them
5 Medicine Mistakes You Could Be Making
Forgetting your multivitamin may not be so bad: One in three Americans puts their health on the line by taking potentially hazardous combinations of prescription medications and dietary supplements, reports a new study from the U.S. Army Research Institute of Environmental Medicine (USARIEM).
“Many people mistakenly believe that because supplements can be obtained without a prescription, they’re safe,” says study author Harris Lieberman, Ph.D. But some herbal ingredients can interfere with enzymes that your body uses to break down medications, affecting the potency or effectiveness of other prescriptions, he explains.
So why didn’t your doctor warn you? Most people don’t think to include fish oil or iron supplements on their “daily medication” list, so your doc may not know the script he’s writing could pose a health issue. “It’s very important to check with your doctor about taking a supplement on top of medication,” Lieberman says.
The combinations to steer clear of (like prescription pills and booze) can be obvious. But others-some seemingly innocent pairings-can be just as hazardous. Here are five.
RELATED: The Diseases Doctors Miss Most
Multivitamins and Most Serious Meds
Multivitamins contain so many ingredients already, and many brands now offer additional support (like One-a-Day plus DHA or plus immune protection). The more nutrients, the higher the chance something interacts with your prescription medications, says Lieberman. Plus, in over 25 percent of bottles, the vitamins and mineral levels on the label don’t match the dosage, according to a 2011 analysis from ConsumerLab. This means you might not be safe from combinations that are only a threat at high doses-like Vitamin K and blood thinners or iron and thyroid medications.
St. John’s Wort and Birth Control
The herb that promises to fight depression can also weaken the effect of serious prescriptions like heart and cancer meds, allergy medications, and birth control pills. In addition to reports of unintentional pregnancies while taking the two, an FDA study found 300 milligrams (mg) of St. John’s Wort three times a day (similar to the recommended dosage for depression) may alter contraceptive’s chemical makeup enough to warrant additional protection.
Vitamin B and Statins
Niacin-better known as vitamin B-is used as a natural remedy for everything from acne to diabetes, but it can harm your muscles if taken with cholesterol-lowering statins. Both vitamin B and statins weaken muscles, which individually just means possible cramps or aches. Together though, the side effect is compounded: One quarter of people taking niacin and statins as part of a 2013 heart study dropped out because of reactions including rashes, indigestion, and muscle problems-29 people developed the muscle fiber condition myopathy.
Decongestants and Blood Pressure Medications
Decongestants, particularly brands with pseudoephedrine (Allegra D and Mucinex D), clear your stuffy nose by constricting blood vessels, lowering the swelling and draining the fluid. But the drugs narrow blood vessels throughout your body too and can raise your blood pressure slightly, which could counteract medication and pose an issue for someone with high blood pressure, says the American Heart Association (AHA). A lot of unsuspecting cold and flu medicines have decongestants in them, the AHA adds, including some favorite brands: Clear Eyes drops, Visine, Afrin, and Sudafed.
Fish Oil and Blood Thinners
Omega-3-packed supplements get (and deserve) praise for heart benefits, but they also thin your blood. While this isn’t a rare or worrisome side effect normally, if you’re also taking blood thinners (like warfarin or aspirin), you could be increasing your risk of excessive bleeding, according to the Cleveland Clinic. The jury’s still out on how much fish oil makes for a harmful combination, but tell your doctor if the supplement is part of your routine. In fact, if you’re on a blood thinner, talk to your M.D. about what nutrients to avoid. Many herbs and minerals have natural coagulant effects-even chamomile tea.
- By Rachael Schultz
Generic Name: naproxen and pseudoephedrine (na PROX en and soo doe e FED rin)
Brand Name: Aleve Cold and Sinus, Aleve Sinus & Headache, Aleve-D Sinus & Cold, Sudafed PSE
Medically reviewed by Drugs.com on Oct 31, 2018 – Written by Cerner Multum
- Side Effects
What is Sudafed PSE?
Naproxen is a nonsteroidal anti-inflammatory drug (NSAID). Pseudoephedrine is a decongestant.
Sudafed PSE 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.
Sudafed PSE may also be used for purposes not listed in this medication guide.
Do not use Sudafed PSE if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.
Sudafed PSE can increase your risk of fatal heart attack or stroke, even if you don’t have any risk factors. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).
Sudafed PSE may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.
Before taking this medicine
Sudafed PSE can increase your risk of fatal heart attack or stroke, even if you don’t have any risk factors. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).
Sudafed PSE may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.
You should not use this medicine if you are allergic to naproxen or pseudoephedrine, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.
Ask a doctor or pharmacist if this medicine is safe to use if you have:
heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
a history of heart attack, stroke, or blood clot;
a history of stomach ulcers or bleeding;
a thyroid disorder;
enlarged prostate, urination problems;
liver or kidney disease; or
Taking naproxen during the last 3 months of pregnancy may harm the unborn baby. Do not use Sudafed PSE without a doctor’s advice if you are pregnant.
Ask a doctor before using this medicine if you are breast-feeding.
Sudafed PSE is not approved for use by anyone younger than 12 years old.
How should I take Sudafed PSE?
Use exactly as directed on the label, or as prescribed by your doctor. Use the lowest dose that is effective in treating your condition.
Swallow the tablet whole and do not crush, chew, or break it.
Take Sudafed PSE 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.
What happens if I miss a dose?
Since cold medicine is used when needed, you may not be on a dosing schedule. Skip any missed dose if it’s almost time for your next dose. Do not use two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking Sudafed PSE?
Avoid drinking alcohol. It may increase your risk of stomach bleeding.
Avoid taking aspirin while you are taking Sudafed PSE.
Ask a doctor or pharmacist before using other cough or cold medicines that may contain similar ingredients.
Sudafed PSE side effects
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).
Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.
Stop using Sudafed PSE and call your doctor at once if you have:
severe dizziness, anxiety, or nervousness;
shortness of breath (even with mild exertion);
swelling or rapid weight gain;
the first sign of any skin rash, no matter how mild;
signs of stomach bleeding–bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
liver problems–loss of appetite, upper stomach pain, tiredness, easy bruising or bleeding, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
kidney problems–little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or
low red blood cells (anemia)–pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating.
Common side effects may include:
indigestion, heartburn, stomach pain, nausea;
warmth, tingling, or redness under your skin;
sleep problems (insomnia); or
feeling restless or excited.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Sudafed PSE?
Ask your doctor before using Sudafed PSE if you take an antidepressant. Taking certain antidepressants with an NSAID may cause you to bruise or bleed easily.
Ask a doctor or pharmacist before using Sudafed PSE with any other medications, especially:
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 affect Sudafed PSE, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Copyright 1996-2018 Cerner Multum, Inc. Version: 3.02.
More about naproxen / pseudoephedrine
- Side Effects
- During Pregnancy
- Dosage Information
- Drug Interactions
- 3 Reviews
- Drug class: upper respiratory combinations
- FDA Alerts (1)
- Naproxen and pseudoephedrine
Other brands: Aleve-D Sinus & Cold, Aleve-D Sinus & Headache, Sudafed 12 Hour Pressure+Pain
Related treatment guides
- Nasal Congestion
- Sinus Symptoms
Don’t let decongestants squeeze your heart
As many over-the-counter decongestants get a new ingredient, you might want to look for alternatives.
Updated: April 3, 2019Published: March, 2014
For nasal congestion due to colds and allergies, millions of Americans reach for an over-the-counter decongestant to clear a stuffy nose. Some read the warning label: “Do not use this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.” Few heed it.
But it might be good to pay attention to the decongestant’s warning. Many of your favorite products containing a decongestant are no longer so easily available on pharmacy shelves. Others are getting an ingredient makeover.
These changes were part of a national effort to close down home-based “meth labs” that churn out methamphetamine, a highly addictive street drug that is easily made from pseudoephedrine, the active ingredient in Sudafed and many other non-prescription decongestants. Products containing pseudoephedrine now are purchased “behind the counter.” You don’t need a prescription, but you do have to ask a pharmacist or clerk for them and show an ID or sign a log.
Fearing that customers will shy away from asking a pharmacist or clerk for these products, some drug companies are replacing pseudoephedrine with a another over-the-counter decongestant called phenylephrine that can’t be made into methamphetamine.
Is phenylephrine just like pseudoephedrine? Regarding its effectiveness as a treatment for nasal congestion, the answer is no. In fact, some research has found that at the current recommended doses of phenylephrine it offers minimal symptom improvement. It probably is safer for people with high blood pressure and heart disease, but there is not enough research to be certain.
Decongestant effects beyond the nose
A stuffy nose is a hallmark of the common cold and allergic rhinitis. Chalk this symptom up to the body’s immune response.
When you have a cold, virus-infected cells in the nose, sinuses, and throat attract a flood of white blood cells. These infection fighters churn out substances that kill the cold virus but also swell nasal membranes and make the body produce extra mucus.
In allergic rhinitis, the immune cells trigger the same type of response in the nose, sinuses and throat.
Pseudoephedrine constricts blood vessels in the nose and sinuses. This shrinks swelling and drains fluids, letting you breathe easier again. Unfortunately, the drug doesn’t affect only the head — it tightens blood vessels throughout the body.
One effect is a possible increase in blood pressure. In general, this increase is minimal, even in people with controlled high blood pressure, according to a review of 24 trials of pseudoephedrine and blood pressure published in the August 8/22, 2005, Archives of Internal Medicine.
Not everyone is average. Among the people who took part in these studies, about 3% had marked increases in blood pressure.
The FDA says that pseudoephedrine is safe when taken as directed. Indeed, millions of people use it each year without any dire consequences. That doesn’t mean it’s risk free. Over the years, there have been reports of heart attacks, strokes, disturbed heart rhythms, and other cardiovascular problems linked with use of pseudoephedrine.
Alternatives to decongestants
Alternatives to oral decongestants are available. In the drug realm, antihistamines such as diphenhydramine (Benadryl), chlorpheniramine (Chlor-Trimeton), cetirizine (Zyrtec), and loratadine (Claritin) can help with a stuffy nose are safe for the heart.
Nasal sprays deliver a decongestant right where you need it. In theory, this should minimize cardiovascular effects. However, nasal decongestant sprays should be used only for several days because it can lead to rebound nasal congestion..
If you want to avoid medications altogether, you can try a variety of things to clear your head. Breathe Right nasal strips may help you breathe better at night. A steamy shower or a hot towel wrapped around the face can relieve congestion. Drinking plenty of fluids, especially hot beverages, keeps mucus moist and flowing. Some people swear by spicy foods, and we would be remiss if we did not mention chicken soup.
Photo: spukkato/iStock/Getty images Plus
As a service to our readers, Harvard Health Publishing provides access to our library of archived content. Please note the date of last review on all articles. No content on this site, regardless of date, should ever be used as a substitute for direct medical advice from your doctor or other qualified clinician.
Pseudoephedrine is a drug found in numerous prescription and behind-the-counter medications, including Sudafed Congestion (but not Sudafed PE), Zyrtec-D, and Claritin-D.
It’s used to temporarily relieve nasal congestion from colds, allergies, and hay fever, and temporarily relieve sinus congestion and pressure. Though it can relieve symptoms, pseudoephedrine doesn’t treat or speed the recovery of the underlying health condition.
Pseudoephedrine is in a class of medications called nasal decongestants, which cause smooth muscles around the airway and nasal cavity to relax, allowing more air to flow through. It also causes blood vessels to contract.
Pseudoephedrine is also sometimes used “off label” to treat urinary or stress incontinence, and to prevent ear pain and blockage from pressure changes due to elevation or scuba diving.
Depending on the medication, pseudoephedrine may be paired with other drugs. For instance, the active components of the allergy medication Zyrtec-D are pseudoephedrine and the antihistamine cetirizine hydrochloride. Advil Cold and Sinus contains pseudoephedrine and ibuprofen, a non-steroidal anti-inflammatory drug (NSAID) for pain and swelling.
Numerous drug manufacturers make medicines containing pseudoephedrine, including Pfizer, Acura Pharmaceuticals, and Bayer Healthcare.
Pseudoephedrine “High” and Abuse
Pseudoephedrine is sometimes abused, or used for non-medical purposes, because of its stimulant effects – it can give an excitable, hyperactive feeling and increase heart rate and blood pressure.
The drug has a low risk of dependence, however, and withdrawal symptoms are unlikely to develop after stopping the drug.
Pseudoephedrine has had a controversial history in sports, as some athletes have used it as a performance-enhancing drug – it’s on the World Anti-Doping Agency’s list of substances prohibited during competition.
Pseudoephedrine can be used to make methamphetamine, or meth, a powerful and highly addictive stimulant. For many years, the drug was available over-the-counter (OTC) without prescription or restrictions.
But under the Combat Methamphetamine Epidemic Act of 2005, which was incorporated into the Patriot Act in 2006, pseudoephedrine can now only be sold from locked cabinets or behind the counter – a photo ID is required when purchasing products containing pseudoephedrine, and people are only allowed to purchase a limited quantity of the drug each month.
In 2013, Westport Pharmaceuticals began selling its cold and allergy decongestant Zephrex-D over-the-counter in Missouri pharmacies, because the pseudoephedrine-based medicine had a special formulation that didn’t allow for the easy manufacture of meth.
The Drug Enforcement Administration (DEA), however, quickly released a statement saying the drug could still be used to manufacture meth, and therefore must remain behind the counter with other pseudoephedrine medicines.
You shouldn’t use pseudoephedrine if you are currently taking or have taken within the past two weeks monoamine oxidase inhibitors (MAOIs), a class of antidepressant medications that includes furazolidone (Furoxone), isocarboxazid (Marplan), and phenelzine (Nardil), among other drugs.
Tell your doctor before taking pseudoephedrine if you have or have ever had:
- High blood pressure
- Difficulty urinating, such as from an enlarged prostate
- Thyroid disease
- Heart disease
- Kidney impairment
Also talk to your doctor if you have ever had a narrowing or blockage of your digestive system and plan to take 24-hour extended-release pseudoephedrine tablets.
Don’t give nonprescription products containing pseudoephedrine to children younger than 4 years old, as they may suffer serious side effects, including death. Children under 12 years old shouldn’t be given extended-release pseudoephedrine capsules.
Pregnancy and Pseudoephedrine
Pseudoephedrine is in FDA Pregnancy Category C, which means the risks to the fetus cannot be ruled out, and the benefits of the drug must be weighed against the risks.
Some research suggests that pseudoephedrine use during the first trimester could increase the risk of birth defects. One study, published 2002 in the American Journal of Epidemiology, found that infants had a higher risk of gastroschisis, an abdominal wall defect in which the intestines poke outside the body, if their mothers used pseudoephedrine during pregnancy.
A more recent study published 2013 in the same journal linked pseudoephedrine use during the first trimester to an increased risk of limb-reduction birth defects.
In both studies, however, the overall risks to the unborn child were still very low.
Breastfeeding and Pseudoephedrine
Small amounts of pseudoephedrine are excreted in breast milk, though it’s unclear what effects this has on breastfeeding infants.
A 2003 study in the British Journal of Clinical Pharmacology suggested the drug was unlikely to harm breastfeeding infants. Nonetheless, you should talk to your doctor about taking pseudoephedrine while pregnant or breastfeeding.
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