Primatene Mist 0.125 mg/actuation HFA aerosol inhaler

Generic name:
Epinephrine inhaler - oral inhalation

Pronunciation
(EP-i-NEF-rin)

Brand name(s)
Primatene Mist

Epinephrine is used to treat wheezing and shortness of breath that commonly occur with asthma. Controlling these symptoms can decrease time lost from work or school. Epinephrine belongs to a class of drugs known as bronchodilators. It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Use this medication only if you have been told by your doctor that you have asthma.

Read the Patient Information Leaflet for instructions on proper use of this medication and the proper cleaning of the mouthpiece. Consult your doctor or pharmacist if you have any questions.

Shake the canister well before each inhalation. Follow all directions on the product package. If you have any questions, ask your doctor or pharmacist. If you take other asthma drugs by mouth or with inhaling devices, ask your doctor about how to correctly take this medication with your other asthma medicines.

Use this medication exactly as directed in the product package. Inhale by mouth as needed. Take the cap off the mouthpiece. Place the mouthpiece near your mouth and exhale. Place the mouthpiece fully into your mouth and press the inhaler as you breathe in deeply. Hold your breath for as long as comfortable to allow the drug to be absorbed. If more than one inhalation is needed, wait at least 1 full minute between inhalations. Do not use again for at least 4 hours. If your breathing does not get better within 20 minutes after using this medication, or if your breathing gets worse, get medical help right away.

Rinse your mouth after using this medication to help prevent dryness and throat irritation. Do not use more of this medication or use it more often than recommended by the product package or your doctor.

Clean the mouthpiece after each day of use as directed. The mouthpiece should also be cleaned if it is clogged or not working properly.

Try to keep track of the number of inhalations used from each canister. Discard the canister after you have used the number of inhalations marked on the product package. Do not float the inhaler in water to test if any more drug is left in it.

Headache, nausea, vomiting, nervousness, dizziness, shaking (tremor), trouble sleeping, stomach upset, sweating, dry mouth, bad taste, cough, or sore throat may occur. If any of these effects last or get worse, notify your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that your doctor 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.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including:

• fast/pounding/irregular heartbeat
• muscle cramps
• weakness
• mental/mood changes (such as anxiety, hallucinations)

Get medical help right away if you have any very serious side effects, including:

• chest pain

Rarely, this medication has caused severe (rarely fatal), sudden worsening of breathing problems/asthma (paradoxical bronchospasm). If you experience sudden wheezing, get medical help right away.

A very serious allergic reaction to this drug is rare. However, get medical help right away 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.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking epinephrine, tell your doctor or pharmacist if you are allergic to it; or to similar bronchodilators (such as albuterol, levalbuterol, salmeterol); or to sympathomimetic drugs (such as pseudoephedrine); 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.

If you have any of the following health problems, consult your doctor or pharmacist before using this product:

• heart disease (such as high blood pressure, abnormal heart rhythm, coronary insufficiency)
• seizures
• overactive thyroid (hyperthyroidism)
• diabetes
• low blood potassium level (hypokalemia)
• glaucoma (narrow-angle)
• Parkinson's disease
• urination problems (such as trouble urinating due to enlarged prostate)

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially the effects on the heart.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

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 (such as 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 are:

• some beta blockers (such as propranolol)
• other sympathomimetic drugs (such as ephedrine)

Avoid taking MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) or tricyclic antidepressants (such as amitriptyline, nortriptyline) within 2 weeks before, during, and after treatment with this medication. In some cases a serious, possibly fatal drug interaction may occur.

Caffeine can increase the side effects of this medication. Limit drinking large amounts of beverages containing caffeine (coffee, tea, colas) or eating large amounts of chocolate.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: chest pain, fast/pounding/irregular heartbeat, headache, shaking (tremors), nervousness, weakness, severe dizziness, seizures.

Do not share this medication with others.

Avoid allergens, irritants, smoking, and other factors that make asthma worse.

Lab and/or medical tests (such as blood pressure, heart rate, EKG, blood potassium levels) may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Learn to use a peak flow meter, use it daily, and promptly report worsening asthma (such as readings in the yellow/red range or increased use of quick-relief inhalers).

Not applicable.

Store at room temperature away from direct sunlight. Do not puncture the canister or expose it to high heat or open flame. Do not store in the bathroom. Keep all medications 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.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.