Consumer Information

Sudafed

Generic Name: pseudoephedrine (SOO doe ee FED rin)
Brand Names: Sudafed, Sudafed 12-Hour, Sudafed 24-Hour, Sudafed Children's Nasal Decongestant

What is Sudafed?

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

Sudafed is used to treat nasal and sinus congestion, or congestion of the tubes that drain fluid from your inner ears, called the eustachian (yoo-STAY-shun) tubes.

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

Important information about Sudafed

Always ask a doctor before giving a cough or cold medicine such as Sudafed to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use any other over-the-counter cough or cold medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it also contains pseudoephedrine, the active ingredient of Sudafed. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Before taking Sudafed

Do not use Sudafed if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Do not use Sudafed if you are allergic to pseudoephedrine or to other decongestants, diet pills, stimulants, or ADHD medications.

Before taking Sudafed, tell your doctor if you are allergic to any drugs, or if you have:

  • heart disease or high blood pressure;

  • diabetes; or

  • a thyroid disorder.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take Sudafed.

FDA pregnancy category C. Sudafed may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Pseudoephedrine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.



How should I take Sudafed?

Use Sudafed exactly as directed on the label, or as it has been prescribed by your doctor. Do not use Sudafed 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 a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Take this medicine with a full glass of water. Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

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 at room temperature away from moisture and heat.

What happens if I miss a dose?

Since cold medicine is usually taken only as needed, 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.

Symptoms of a Sudafed overdose may include feeling restless or nervous.

What should I avoid while taking Sudafed?

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

Do not use any other over-the-counter cough or cold medication without first asking your doctor or pharmacist. Pseudoephedrine is contained in many over-the-counter medications. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains pseudoephedrine.

Sudafed 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 and call your doctor at once if you have any of these serious side effects:

  • fast, pounding, or uneven heartbeat;

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

  • easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or

  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).

Less serious Sudafed sucha side effects may include:

  • mild loss of appetite;

  • warmth, tingling, or redness under your skin;

  • feeling excited or restless;

  • sleep problems (insomnia); or

  • skin rash or itching.

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?

Before taking Sudafed, tell your doctor if you are using any of the following drugs:

  • medicines to treat high blood pressure;

  • a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or

  • antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.

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

Where can I get more information?

  • Your pharmacist can provide more information about Sudafed.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Sudafed only for the indication prescribed.
  • Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. 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. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.

Copyright 1996-2009 Cerner Multum, Inc. Version: 5.08. Revision Date: 4/12/2009 4:38:10 PM.




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