This drug should not be used in combination with other stimulant products (e.g., caffeine) or other cough-and-cold products. Also, it should not be used as a dietary supplement for weight loss, body building, or increasing energy/alertness. Doing so may increase your risk of unlikely but possibly fatal side effects, including stroke, heart attack, seizures, or severe mental disorders (see Side Effects and Precautions sections).
Prolonged use, doses that are higher than recommended, and heavy exercise increase your risk of very serious side effects while using this product. Serious side effects have been reported in young people who used this drug for a short time at doses as low as 20 milligrams a day. Doses greater than 32 milligrams a day may triple your risk of bleeding in the brain.
Because it may be harmful to combine different products that contain this drug, check all product labels carefully to see if they contain any type of this product (ephedrine or ephedra, also known as ma huang). All 3 of these products are very similar, so they work the same way. There is no difference in the risk or effectiveness of these products at equal doses. For more information, consult your pharmacist.Who should not take Ephedrine No.4?
Ephedrine is available in the US as a nonprescription medication for relief of breathing problems. It is rarely used because there are safer and more effective medications (e.g., albuterol, pseudoephedrine). Ma huang/ephedra is an herbal/dietary supplement that was banned by the US FDA in 2004 because it has an unreasonable risk with little proven benefit. Consult your doctor or pharmacist for more details.
Ephedrine is the active ingredient in ephedra/ma huang. It belongs to a class of medications called sympathomimetics. It works like a naturally occurring substance (adrenaline) that your body makes when it thinks it is in danger. It is a central nervous system stimulant that increases your heart rate/blood pressure, narrows your blood vessels (vasoconstriction), and opens up the lungs (bronchodilation).
Some herbal/diet supplement products have been found to contain possibly harmful impurities/additives. The amount of medication may be very different between products. Check with your pharmacist for more details about the particular brand you use.
If you are using the nonprescription product/supplement, read all directions on the product package before taking this medication. Take this product by mouth as directed. If you are uncertain about any of the information, consult your doctor or pharmacist. If your doctor has prescribed this medication, take it exactly as directed.
When used in high doses, this medication may cause serious side effects, including heart attack, seizure, and stroke. Do not take more than the recommended dose, and do not use this product for longer than 7 days in a row unless directed by your doctor.
Rarely, abnormal drug-seeking behavior (addiction) is possible with this medication. Do not increase your dose, take it more frequently, or use it for a longer time than directed. Properly stop the medication when so directed.
When used for an extended time, this medication may not work as well. Talk with your doctor if this medication stops working well.
If you are using this medication for breathing problems and your condition does not improve in 1 hour or worsens, or if you think you may have a serious medical problem, seek immediate medical attention. If you have a cough that returns or lasts more than 7 days, or if you have a fever, rash, or severe headache, seek immediate medical attention. These could be signs of a serious medical condition.
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.
Many people have had serious (sometimes fatal) side effects with this medication. Discuss the risks and benefits of this medication with your doctor or pharmacist.
Tell your doctor immediately if any of these serious side effects occur: mental/mood changes (e.g., anxiety, difficulty concentrating, irritability), dry mouth, increased thirst, muscle pain, flushing/tingling, difficult/painful urination.
Seek immediate medical attention if any of these very serious side effects occur: chest pain, dizziness/fainting, fast/irregular/pounding heartbeat, severe/pounding headache, severe mental/mood changes (e.g., confusion, hallucinations), seizure, swelling ankles/feet, tiredness, slurred speech, change in amount of urine, weakness on one side of the body.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), 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.
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Before using this medication, tell your doctor if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: heart problems (e.g., chest pain, irregular heartbeat, heart attack).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, stroke, certain adrenal gland problem (pheochromocytoma), mental/mood disorders (e.g., anxiety, bipolar disorder, schizophrenia), circulation problems, diabetes, high blood pressure, a certain movement problem (essential tremor), kidney disease, seizures, overactive thyroid (hyperthyroidism), glaucoma (narrow-angle), prostate problems.
This product may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.
The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using this product, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).
Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using this product safely.
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.
Before having surgery, tell your doctor or dentist that you are taking this medication.
This product may rarely make your blood sugar level rise, causing or worsening diabetes. Tell your doctor immediately if you develop symptoms of high blood sugar such as unusual increased thirst/urination or vision changes. Some forms of this product may contain sugar. Caution is advised if you have diabetes. Ask your doctor or pharmacist about using this product safely.
Do not use in children less than 12 years unless directed by the doctor. For use in older children and adolescents, consult the package label for any age warnings.
Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
This medication passes into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Some products that may interact with this drug include: alpha blockers (e.g., prazosin, terazosin), digoxin, drugs for diabetes, drugs for seizures (e.g., carbamazepine, phenytoin), dexamethasone, ergot medications (e.g., ergotamine, bromocriptine), ginseng, MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine), medication for blood pressure (e.g., clonidine, guanethidine, methyldopa, reserpine, beta blockers such as propranolol and metoprolol), adrenaline-like drugs (e.g., epinephrine, norepinephrine, pseudoephedrine), caffeine/other stimulants (e.g., amphetamine, methylphenidate), drugs that change the amount of acid in the urine (e.g., acetazolamide, citrates, sodium bicarbonate).
Many drugs besides this product may affect the heart rhythm (QT prolongation), including dofetilide, pimozide, procainamide, amiodarone, quinidine, sotalol, macrolide antibiotics (such as erythromycin), among others. Therefore, before using this product, report all medications you are currently using to your doctor or pharmacist.
Also report the use of drugs that might increase seizure risk when combined with this medication such as isoniazid (INH), phenothiazines (e.g., thioridazine), theophylline, or tricyclic antidepressants (e.g., amitriptyline), among others. Consult your doctor or pharmacist for details.
Check the labels of all nonprescription cough, cold, or allergy products because they may contain adrenaline-like drugs such as pseudoephedrine or phenylpropanolamine. Using this product with products that contain pseudoephedrine or phenylpropanolamine may increase the likelihood of serious side effects. Consult your doctor or pharmacist for more information.
Avoid caffeine because it may increase your blood pressure. Caffeine can be found in nonprescription diet medications, soft drinks, coffee, and tea.
This medication can interfere with certain lab tests (e.g., urine tests for stimulants). Make sure that all your doctors and lab personnel know that you are using this product.
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: very rapid heartbeat, fever, loss of consciousness, coma.
If your doctor has prescribed this medication, do not share it with others.
If your doctor has prescribed this medication and 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.
Refer to storage information printed on the package. If you have any questions about storage, ask your pharmacist.
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 March 2013. Copyright(c) 2013 First Databank, Inc.
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