IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.
PSEUDOEPHEDRINE - ORAL
(sue-doh-eff-ED-rin)
COMMON BRAND NAME(S): Afrinol, Novafed, Sudafed
USES: Pseudoephedrine is used for the temporary relief of nose, sinus, and ear congestion caused by the common cold, allergies, or infection. Pseudoephedrine is called a sympathomimetic and works by decreasing swelling of nose and ear tissues.
Do not use this medication in children younger than 2 years unless specifically directed by the doctor. To decrease the risk for serious side effects, carefully follow all of the doctor's dosage directions. Do not give other cough and cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask your doctor or pharmacist about other ways to relieve cough and cold symptoms (e.g., saline nose drops/spray, using a humidifier or infant nasal suction bulb).
HOW TO USE: If you are using the over-the-counter product to self-treat, read all the directions on the product package before taking this medication. If your doctor has prescribed this medication, follow your doctor's directions and the instructions on your prescription label. If you have any questions, consult your doctor or pharmacist.
Take this medication by mouth with or without food, usually every 4-6 hours, or as directed by your doctor or the product package. Do not take more than 4 doses in a day. Dosage is based on your age, condition, and response to treatment. Do not increase your dose or take this drug more often than directed. Do not take more of this medication than recommended for your age.
If you are using the chewable tablets, chew each tablet well and swallow. If you are using the liquid form of this medication, measure the dose carefully using a special measuring device/cup. Do not use a household spoon because you may not get the correct dose.
If your symptoms do not improve after 7 days, if they worsen, if you develop a fever/chills, or if you think you may have a serious medical problem, seek immediate medical attention.
SIDE EFFECTS: Mild stomach upset, trouble sleeping, dizziness, lightheadedness, headache, nervousness, fast heartbeat, loss of appetite, shaking, or unusual sweating may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
This product may reduce blood flow to your hands and feet, causing them to feel cold. Smoking may worsen this effect. Dress warmly and avoid tobacco use.
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. Many people using this medication do not have serious side effects.
Notify your doctor immediately if any of these unlikely but serious side effects occur: fast irregular heartbeat, severe/uncontrolled shaking, difficulty urinating, decreased sexual ability.
Tell your doctor immediately if any of these rare but very serious side effects occur: seizures, mental/mood changes (e.g., anxiety, panic, unusual thoughts/behavior).
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking pseudoephedrine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. Also tell your doctor if you have had negative reactions to other sympathomimetics (e.g., ephedrine, phenylephrine).
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe high blood pressure, heart disease (e.g., severe coronary artery disease, angina, heart failure), certain types of fast heart rhythm problems (e.g., atrial fibrillation/flutter, paroxysmal supraventricular tachycardia-PSVT), a certain slow heart rhythm problem (sinus bradycardia), closed-angle glaucoma, difficulty urinating (e.g., due to enlarged prostate).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: stroke, high blood pressure, chest pain (angina), heart attack, mental/mood disorders (e.g., anxiety, bipolar disorder, mania), epilepsy/seizure problems, certain blood vessel problems (e.g., Raynaud's disease, peripheral vascular disease), overactive thyroid (hyperthyroidism), low blood flow to the brain (cerebral insufficiency), diabetes, difficulty sleeping.
This drug may make you dizzy or lightheaded; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages.
Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially dizziness and lightheadedness.
Caution is advised when using this product in children because they may be more sensitive to its side effects, especially excitation, agitation, or increased blood pressure.
Some liquid/chewable forms of pseudoephedrine may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to restrict your intake of aspartame (phenylalanine), consult your doctor or pharmacist regarding the safe use of this medicine.
This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.
The medication in this product passes into breast milk. However, the amount in breast milk is small, and there are no reports of serious harm to infants. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.
This drug should not be used with the following medications because very serious interactions may occur: MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, selegiline, tranylcypromine, rasagiline).
Avoid taking MAO inhibitors within 2 weeks before, during, and after treatment with pseudoephedrine. In some cases a serious, possibly fatal drug interaction may occur.
If you are currently using any of these medications, tell your doctor or pharmacist before starting this product.
Before using pseudoephedrine, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other decongestants (taken by mouth or sprayed into the nose), products containing caffeine.
Pseudoephedrine may decrease the effectiveness of some blood pressure medications (e.g., beta blockers, calcium channel blockers, reserpine, guanethidine, methyldopa).
Pseudoephedrine may worsen the serious side effects of some medications used for migraine headaches (e.g., sumatriptan, naratriptan, zolmitriptan, ergotamine). Consult your pharmacist or doctor for more details.
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: severe dizziness/fainting, severe weakness, fast/irregular heartbeat, slow/shallow breathing, hallucinations, seizures.
NOTES: Do not share this medication with others.
This medication is for temporary use only. Do not use for more than 7 days without first consulting your doctor.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Different brands/strengths of this medication may have different storage requirements. Read the package labeling or ask your pharmacist for the storage requirements for the product you are using. Protect from light. Do not store in the bathroom. Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.
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