Sudafed PE

Generic Name: phenylephrine (FEN il EFF rin)
Brand Names: Dimetapp Cold Drops, Lusonal, Nasop, Sudafed PE

What is Sudafed PE?

Sudafed PE contains phenylephrine, a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Sudafed PE is used to treat nasal congestion and sinus pressure caused by allergies, the common cold, or the flu. Sudafed PE may be used to treat congestion of the tubes that drain fluid from your inner ears, called the eustachian (yoo-STAY-shun) tubes.

Sudafed PE may also be used for other purposes not listed in this medication guide.

Important information about Sudafed PE

Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children.

You should not use Sudafed PE if you are allergic to phenylephrine.

Do not use Sudafed PE if you have taken a monoamine oxidase inhibitor (MAOI) such as furazolidone (Furoxone), isocarboxazid (Marplan), linezolid (Zyvox), phenelzine (Nardil), procarbazine (Matulane), or tranylcypromine (Parnate) in the last 14 days. Serious, life-threatening side effects can occur if you take Sudafed PE before the MAO inhibitor has cleared from your body.

Before you take Sudafed PE, tell your doctor if you are allergic to any decongestants, or if you have heart disease, heart rhythm disorder, high blood pressure, circulation problems, diabetes, glaucoma, a thyroid disorder, kidney disease, an enlarged prostate or urination problems, anxiety, sleep problems, bipolar disorder or other mental illness.

Sudafed PE may interact with heart or blood pressure medications, antidepressants, diabetes medications, migraine headache medications, and other decongestants.

Never take more of the medicine than directed on the label or prescribed by your doctor.

Call your doctor if your symptoms do not improve after 7 days of using Sudafed PE, or if they get worse and your also have a fever.

What should I discuss with my healthcare provider before taking Sudafed PE?

You should not use Sudafed PE if you are allergic to phenylephrine.

Do not use Sudafed PE if you have taken a monoamine oxidase inhibitor (MAOI) such as furazolidone (Furoxone), isocarboxazid (Marplan), linezolid (Zyvox), phenelzine (Nardil), procarbazine (Matulane), or tranylcypromine (Parnate) in the last 14 days. Serious, life-threatening side effects can occur if you take Sudafed PE before the MAO inhibitor has cleared from your body.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take Sudafed PE, tell your doctor if you are allergic to any decongestants, or if you have:

• heart disease, heart rhythm disorder;

• high blood pressure;

• circulation problems (such as Raynaud's syndrome);

• diabetes;

• glaucoma;

• a thyroid disorder;

• kidney disease;

• an enlarged prostate or urination problems;

• sleep problems, anxiety; or

• mental illness such as bipolar disorder.

FDA pregnancy category C. Is not known whether this medication will harm an unborn baby. Before you take Sudafed PE, tell doctor if you are pregnant. Phenylephrine may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults may be more likely to have side effects from Sudafed PE.

How should I use Sudafed PE?

Use Sudafed PE exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children. You may take Sudafed PE with food if it upsets your stomach. Take the Sudafed PE tablet with a full glass of water.

Sudafed PE is usually taken every 4 hours. Follow the directions on the medicine label. Never take more of the medicine than directed on the label or prescribed by your doctor.

Call your doctor if your symptoms do not improve after 7 days of using Sudafed PE, or if they get worse and your also have a fever.

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.

Store Sudafed PE at room temperature away from moisture and heat.

Throw away any unused Sudafed PE after the expiration date on the label has passed. Do not flush this medication down a toilet. Ask your pharmacist about the safest way to dispose of unused medicines.

What happens if I miss a dose?

Sudafed PE is usually taken only as needed, so you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include feeling restless or nervous, severe dizziness, sweating, vomiting, hallucinations, fast or uneven heart rate, fainting, seizure (convulsions), and weak or shallow breathing.

What should I avoid while using Sudafed PE?

Do not use any other over-the-counter cold, allergy, or cough medication without first asking your doctor or pharmacist. Phenylephrine is contained in many medicines available over the counter. If you take certain products together you may accidentally take too much phenylephrine. Read the label of any other medicine you are using to see if it contains phenylephrine or another decongestant.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Avoid smoking. It can add to the effects of Sudafed PE in decreasing blood flow, which can lead to uncomfortable symptoms. Avoid drinking alcohol while you are taking Sudafed PE.

Sudafed PE side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Sudafed PE and call your doctor at once if you have a serious side effect such as:

• severe dizziness, restless feeling, nervousness, or insomnia;

• unusual thoughts or behavior;

• feeling like you might pass out;

• fast, pounding, or uneven heartbeat;

• tremors or shaking;

• numbness, tingling, or cold feeling in your hands or feet; or

• urinating less than usual or not at all.

Less serious Sudafed PE side effects may include:

• headache, dizziness;

• feeling excited or restless (especially in children);

• upset stomach; or

• mild sleep problems.

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 PE?

Tell your doctor about all other medications you use, especially:

• other decongestants, including nasal sprays;

• digoxin (digitalis, Lanoxin);

• medicine to treat diabetes;

• medicines to treat high blood pressure such as reserpine, guanethidine (Ismelin), methyldopa (Aldomet), and others;

• migraine headache medicine such as ergotamine (Ergomar), naratriptan (Amerge), sumatriptan (Imitrex) or zolmitriptan (Zomig);

• an antidepressant such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others;

• a beta-blocker such as atenolol (Tenormin), carvedilol (Coreg), metoprolol (Lopressor, Toprol), propranolol (Inderal), sotalol (Betapace), and others; or

• a calcium channel blocker such as amlodipine (Norvasc), diltiazem (Tiazac, Cartia, Cardizem), felodipine (Plendil), nifedipine (Procardia, Adalat), verapamil (Calan, Covera, Isoptin, Verelan), and others.

This list is not complete and there may be other drugs that can interact with Sudafed PE. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about Sudafed PE.

• 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.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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