1 What is Sudafed?

Brand: Biofed, Cenafed, Chlor Trimeton Nasal Decongestant, Contac Cold, Contac 12-Hour, Dimetapp Decongestant, Drixoral Decongestant Non-Drowsy, Efidac 24 Pseudoephedrine, ElixSure Decongestant, Entex, Genaphed, Kid Kare Drops, Nasofed, Pediacare Decongestant Infants, Seudotabs, Silfedrine, Simply Stuffy, Sudafed, Sudafed 12-Hour, Sudafed 24-Hour, Sudafed Children's Nasal Decongestant, Sudodrin, SudoGest, SudoGest 12 Hour, Suphedrin, Triaminic Softchews Allergy Congestion, Unifed

Generic: Pseudoephedrine

Sudafed or pseudoephedrine is a nasal decongestant that works by shrinking the dilated blood vessels in the nasal passages. Dilated blood vessels are responsible for stuffy nose, or nasal congestion both mild and severe. Sudafed decongestant acts as both an alpha- and beta-adrenergic receptor agonist. It causes vasoconstriction via direct stimulation of alpha-adrenergic receptors of the respiratory mucosa. It also directly stimulates beta-adrenergic receptors causing bronchial relaxation, increased heart rate and contractility.

Pseudoephedrine or Sudafed is used to treat nasal congestion due to the common cold, hay fever, or any other upper respiratory allergies. For any more serious conditions, Sudafed use must be discussed with your doctor. Also, Sudafed relieves sinus congestion and pressure, or congestion of the tubes that drain fluid from your inner ears, called the Eustachian tubes. Such congestion is caused by inflammation or infection of both nose and ear. This drug may also be used for purposes not listed in the medication guide.

Taking certain products together with Sudafed or pseudoephedrine can affect the beneficial effects of both medicines. It may also become a cause of marked deterioration of certain medical conditions. There is increased risk of hypertension and arrhythmias if this drug is taken with cardiac glycosides, quinidine, or tricyclic antidepressants (TCAs). Concurrent administration with monoamine oxidase inhibitors (MAOIs) may cause hypertensive crisis. Also, there is increased risk of vasoconstrictor effects if given with ergot alkaloids or oxytocin.

Anesthetics (e.g., cyclopropane, halothane, and other halogenated anesthetics) as well as antihypertensive agents should be avoided when you are following a Sudafed regimen. You must check with your doctor and/or read the label carefully before using a medicine that contains pseudoephedrine or a decongestant. It will help you to know the proper usages, contraindications, drug interactions, precautions, and adverse effects of this medicine that would ensure the most possible outcome of this medicine.

Do not give Sudafed to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Using these medicines in very young children might cause serious or possibly life-threatening side effects. Regarding this matter, the US FDA strongly recommends that over-the-counter (OTC) cough and cold products not be used in children younger than 2 years of age because serious and potentially life-threatening side effects can occur including death, convulsions, rapid heart rates, and decreased levels of consciousness. OTC cough and cold products include decongestants, expectorants, antihistamines, and antitussives.

Pseudoephedrine or other decongestants are contained in many combination medicines. Some of these preparations are available only with your doctor's prescription.

This medication is intended for administration to the patients by mouth with a full glass of water (8 ounces or 240 milliliters) or as directed by your doctor. This medication may be taken with or without food. It can be taken with a glass of milk if stomach upset occurs.

This product is available in the following dosage forms:

  • Capsule
  • Capsule, Liquid Filled
  • Capsule, Extended Release
  • Tablet
  • Tablet, Chewable
  • Tablet, Extended Release
  • Syrup
  • Liquid
  • Solution
  • Suspension

2 What to Know Before Using

If you are about to start using Sudafed treatment as recommended by your doctor, the risk-benefit ratio of taking the drug should be considered carefully. The suitable drug therapy is usually chosen by a doctor with active participation of the patient. There are some important factors such as drug interactions, presence of any metabolic impairment, history of hypersensitivity reaction, pregnancy, lactation etc. that may alter the desired therapeutic effects of a medicine.

Sometimes the presence of other preexisting and underlying health disorders, diseases, and conditions affects the beneficial effects of this medicine and even may cause serious side effects. If you have had any allergic reactions to any medicine then you must tell your doctor. The use of Sudafed is contraindicated in pregnancy and in those who are allergic to pseudoephedrine or to other decongestants, diet pills, stimulants, or ADHD medications.

Tell your doctor if you have any other medical problems, especially:

  • Enlarged prostate (e.g., benign enlargement of prostate) or
  • Glaucoma, or a predisposition to glaucoma or
  • Heart disease or blood vessel disease or
  • High blood pressure or
  • Type 2 diabetes mellitus or
  • Overactive thyroid—Use of pseudoephedrine may make these conditions worse.

Because of drug-drug interactions, certain medicines should not be used along with Sudafed. It is recommended to keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your physician. You should consult with your physician if you are in need of some other medications or even any over-the-counter medicine for another health problem in order to avoid unwanted toxic effects.

When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below:

  • Dihydroergotamine
  • Furazolidone
  • Guanethidine
  • Iproniazid
  • Isocarboxazid
  • Linezolid
  • Methylene Blue
  • Methyldopa
  • Midodrine
  • Moclobemide
  • Nialamide
  • Phenelzine
  • Procarbazine
  • Rasagiline
  • Safinamide
  • Selegiline
  • Tranylcypromine

In addition, tell your doctor about all other medicines you use, especially:

  • A beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others; or
  • An antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan), nortriptyline (Pamelor), and others.

These drug interactions are possible, but do not always occur. Sometimes your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Using Sudafed with any of the listed medicines is usually not recommended, but may be required in some cases. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

3 Proper Usage

The dosage schedule and the duration of your Sudafed treatment should be individualized and determined based on your physician’s advice. The dose may also vary with the patient’s condition or requirement and the strength of the medicine as well. This medicine comes with patient information. You should read the instructions carefully before using this medicine.

The dosages and administrations of different medicinal preparations to treat nasal and sinus congestion are described below:

For regular (short-acting) oral dosage form (capsules, oral solution, syrup, or tablets):

  • Adults and children 12 years of age and older—60 milligrams (mg) every four to six hours. Do not take more than 240 mg in twenty-four hours.
  • Children 6 to 12 years of age—30 mg every four to six hours. Do not take more than 120 mg in twenty-four hours.
  • Children 4 to 6 years of age—15 mg every four to six hours. Do not take more than 60 mg in twenty-four hours.
  • Children and infants up to 4 years of age—Use is not recommended.

For long-acting oral dosage form (extended-release capsules or extended-release tablets):

  • Adults and children 12 years of age and older—120 mg every 12 hours, or 240 mg every 24 hours. Do not take more than 240 mg in 24 hours.
  • Infants and children up to 12 years of age—Use is not recommended.

Important guidelines for patients taking pseudoephedrine

  • If you are using extended-release capsules, swallow the capsule whole. However, if the capsule is too large to swallow, you may mix the contents of the capsule with jam or jelly and swallow without chewing. Do not crush or chew before swallowing.
  • If you are using extended-release tablets, swallow the tablet whole. Do not break, crush, or chew before swallowing. Doing so can release the entire drug at once, increasing the risk of side effects.
  • If you are using the liquid form, use a medication measuring device to carefully measure the prescribed dose. Do not use a household spoon. If your liquid form is a suspension, shake the bottle well before each dose.
  • Chewable forms of this medication should be chewed thoroughly before swallowing.
  • If you are taking the powder, mix it thoroughly in the proper amount of liquid and stir well. Drink all of the liquid right away. Do not prepare a supply for future use.
  • To help prevent trouble in sleeping, take the last dose of pseudoephedrine for each day a few hours before bedtime. If you have any questions about this, check with your doctor.

You should use Sudafed following all the directions given by your doctor. If you miss a dose of this medicine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. You must not double the dose to catch up. Besides, you are advised not to use this drug in larger amounts, more often, or for a longer time than your doctor ordered.

Further, it is advised to store the medicine in a closed container at room temperature between 68-77 degrees F (20-25 degrees C) away from heat, moisture, and direct light. You should not store medicines in the bathroom. All kinds of medicines should be kept out of the reach of children and pets. However, outdated medicines should be disposed by an appropriate way.

You must not flush medications down the toilet or pour them into a drain unless instructed to do so. You may consult your pharmacist or local waste disposal company for more details about how to safely discard medicinal products.

4 Precautions to Take

There are several precautions to take when taking Sudafed. Firstly, regular visits to your doctor are recommended to check that this medicine is working properly or not. Additionally, the following guidelines should be followed strictly to prevent unwanted complications as well as for the better prognosis of the patients:

  • Before using this medicine, check with your doctor or pharmacist if you are allergic to this drug or if you have any other medicine as well as food allergies.
  • Further, this product may contain certain inactive ingredients which can cause allergic reactions or other problems. If you have any questions regarding this matter, contact your doctor or pharmacist.
  • You should not take Sudafed for longer than 7 days in a row. Check with your doctor without making any delay if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash because these signs may mean that you have other medical problems.
  • You should take this medicine with a full glass of water. You must not crush, chew, or break an extended-release tablet. It is advised to swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time. You may need to shake the oral suspension (liquid) well just before you measure a dose. You should measure the liquid with a special dose measuring spoon or medicine cup, not with a regular table spoon.
  • Patients should be instructed to pay close attention to drugs labels, particularly to the active ingredients section to ensure they are not receiving duplicate therapy.
  • Patients should check with their health care provider if they are receiving concomitant medications. They should understand that over the counter cough and cold medications do not cure or shorten the duration of the common cold, these products are for the management of symptoms.
  • Although pseudoephedrine has virtually no pressor effects in normotensive patients, it should be used with caution in patients suffering from mild to moderate hypertension.
  • As with other sympathomimetic agents, this drug should be used with caution in patients with heart disease, diabetes, hyperthyroidism, elevated intraocular pressure, and prostatic enlargement.
  • Caution should be exercised when using this product in the presence of severe hepatic impairment or moderate to severe renal impairment.
  • It is advised not to use this dug in children of less than 4 years old because safety and efficacy have not been established in patients younger than 2 years. Moreover, adult cough and cold products should not be used for children; appropriate measuring devices should be used with liquid products.
  • You must not use pseudoephedrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.
  • Also, you should avoid taking this decongestant if you are taking caffeine pills, diet pills, or other stimulants (e.g., ADHD medications). Taking a stimulant together with a decongestant may increase the risk of unwanted toxic effects.

Additionally, you should not use any prescription or nonprescription medicines, herbal preparations, or dietary supplements without checking with your doctor.

5 Potential Side Effects

Along with the beneficial effects, Sudafed may cause some unwanted effects that may not need any medical attention. These side effects usually go away during the treatment episode as your body adjusts to the medicine. Your healthcare professional may advise you about the ways how to prevent or reduce those unwanted side effects. Sometimes you may need to consult with the doctor if you notice any of the following toxic effects.

Serious side effects of pseudoephedrine may include:

  • Dangerously high blood pressure (severe headache, blurred vision, ringing in your ears, anxiety, confusion, chest pain, trouble breathing, uneven heart rate, seizure);
  • Easy bruising or bleeding, unusual weakness;
  • Fast, pounding, or uneven heartbeat;
  • Fever, chills, body aches, flu symptoms;
  • Severe anxiety; or
  • Severe dizziness.

Less serious side effects may include:

  • Constipation;
  • Dry mouth, nose, or throat;
  • Insomnia;
  • Loss of appetite;
  • Feeling restless or excited (especially in children);
  • Ringing in the ears;
  • Skin rash with or without itching;
  • Shaking i.e. tremors;
  • Stomach cramps; or
  • Warmth, tingling, or redness under your skin.

Miscellaneous side effects may include:

Other side effects not listed may also occur in some patients. Symptoms of a serious allergic reaction to this medicine are unlikely but may occur in certain individuals manifesting as rash, itching, swelling, severe dizziness, or troubled breathing. If you notice any other effects including symptoms like these, check with your healthcare professional right away.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Most people using this medication do not have serious side effects.

You may call your doctor for medical advice about side effects. In the US, you may report side effects to the FDA at 1-800-FDA-1088. In Canada, you may report side effects to Health Canada at 1-866-234-2345.

If overdose is suspected, you need to get an emergency medical help right away. You may contact a Poison Control Center right away. US residents can call their local poison control center at 1-800-222-1222.

Symptoms of Sudafed overdose may include:

  • Agitation;
  • Confusion;
  • Convulsions (seizures);
  • Fast breathing;
  • Flushing;
  • Hallucinations (seeing, hearing, or feeling things that are not there);
  • Increase in blood pressure;
  • Irregular or slow heartbeat (continuing);
  • Large or dilated pupil;
  • Loss of consciousness;
  • Loss of coordination of movements;
  • Muscle twitching;
  • Shortness of breath or troubled breathing (severe or continuing);
  • Slow or fast heartbeat (severe or continuing); or
  • Unusual nervousness, restlessness, or excitement.