Pseudoephedrine

Pseudoephedrine is an oral nasal decongestant used to treat a stuffy nose, sinus pressure, and ear congestion caused by colds, flu, or allergies.

Pseudoephedrine works by narrowing blood vessels in the nasal passages, reducing nasal congestion, and improving symptoms. Pseudoephedrine is a sympathomimetic amine.

Pseudoephedrine products may be single ingredients or combinations with other medications, including antihistamines (cetirizine, fexofenadine, brompheniramine, triprolidine, chlorpheniramine), pain relief or fever reducer (ibuprofen), cough suppressants (dextromethorphan), or guaifenesin (expectorant).

Pseudoephedrine is available as regular tablets, 12-hour release tablets, 24-hour release tablets, and oral syrups.

Yes, you can buy pseudoephedrine OTC (over the counter) without a prescription, but due to its ability to be converted into methamphetamine, it is more highly regulated under the Combat Methamphetamine Epidemic Act of 2005. To purchase pseudoephedrine OTC, you must speak to a pharmacist, provide photo ID, have your purchase logged electronically, and it is only sold in limited quantities.

Use of pseudoephedrine in some states may be subject to additional controls. Where such state laws are more stringent than the provisions of CMEA, state requirements also must be followed.

Pseudoephedrine is also available on prescription.

When you have a congested or blocked nose and sinus, it is caused by blood vessels in your nasal cavities (sinuses) becoming swollen. Pseudoephedrine works by constricting blood vessels, which reduces swelling in the nasal cavity, improving airflow through the nose.

Pseudoephedrine's mechanism of action is as a sympathomimetic amine that acts mainly as an agonist of alpha adrenergic receptors to produce vasoconstriction. This action may increase the mean arterial blood pressure and heart rate, and cause other side effects.

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

Do not give pseudoephedrine to a child younger than 4 years old. 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 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. Measure the liquid with a special dose measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose measuring device, ask your pharmacist for one.

Do not take pseudoephedrine for longer than 7 days in a row. 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 surgery, tell the surgeon ahead of time that you are using pseudoephedrine. You may need to stop using the medicine for a short time.

Store pseudoephedrine at room temperature away from moisture and heat.

Do not give pseudoephedrine to a child younger than 4 years old. 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.

Ask a doctor or pharmacist before using any other cough or cold medicine. Pseudoephedrine or other decongestants are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains pseudoephedrine or a decongestant. Do not use pseudoephedrine if you have used a 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.

Ask a doctor or pharmacist if it is safe for you to take pseudoephedrine if you have:

• Heart disease or high blood pressure;
• Diabetes; or
• Thyroid disorder
• Glaucoma (increased pressure of the eye)
• Enlarged prostate
• Liver or kidney problems

Do 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. Do not use this medication if you are allergic to pseudoephedrine or to other decongestants, diet pills, stimulants, or ADHD medications.

FDA pregnancy category C. It is not known whether pseudoephedrine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Pseudoephedrine can pass into breast milk and may harm a nursing baby. Do not use pseudoephedrine without telling your doctor if you are breastfeeding a baby.

Artificially sweetened liquid cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

Common pseudoephedrine side effects are sleep problems (insomnia), heart palpitations, nervousness, restlessness, shakiness, elevated blood pressure, and skin rash or itching.

Pseudoephedrine may cause serious side effects.

Get emergency medical help if you have any of these signs of an allergic reaction to pseudoephedrine: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using pseudoephedrine and call your doctor at once if you have other serious side effects such as:

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

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 the FDA at 1-800-FDA-1088.

Usual Adult Dose of Pseudoephedrine for Nasal Congestion

Immediate release: 30 to 60 mg orally every 4 to 6 hours as needed.Sustained release: 120 mg orally every 12 hours as needed.Sustained release suspension: 45 to 100 mg orally every 12 hours as needed.Maximum daily dose: 240 mg/day.

Usual Pediatric Dose of Pseudoephedrine for Nasal Congestion

4 years to 5 years:Immediate release: 15 mg every 6 hours.Maximum daily dose: 60 mg/day.6 years to 12 years:Immediate release: 30 mg every 4 to 6 hours.Maximum daily dose: 120 mg in 24 hours.Over 12 years:Immediate release: 30 to 60 mg orally every 4 to 6 hours as needed12-hour extended- release: 120 mg orally every 12 hours as needed24-hour extended-release: 240 mg orally every 24 hours as neededMaximum dose: 240 mg in 24 hours.

Dose modifications

Severe renal impairment: Use caution, especially in patients with concurrent cardiovascular disease.

Severe hepatic impairment: Use caution, especially in patients with concurrent cardiovascular disease.

General advice

• Recommended doses should not be exceeded.
• Taking more than 1 cough and cold medicine could result in overdose; there are many products that have similar names and it is critical to identify the active ingredients in the product to ensure the correct dosage is being used.

Since pseudoephedrine is taken 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. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include feeling restless or nervous.

Avoid taking pseudoephedrine if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Ask a doctor or pharmacist before using any other cough or cold medicine. Pseudoephedrine or other decongestants are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains pseudoephedrine or a decongestant.

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

• blood pressure medications;
• digoxin
• 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.
• Ergotamine for migraines

This list is not complete and other drugs may interact with pseudoephedrine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.