(ep'' i nef' rin)

Brand Name(s): Primatene Mist^®

WHY is this medicine prescribed?

Epinephrine oral inhalation is used to relieve symptoms of asthma that occur from time to time, including wheezing, chest tightness, and shortness of breath in adults and children 12 years of age and older. Epinephrine oral inhalation is in a class of medications called alpha- and beta-adrenergic agonists (sympathomimetic agents). It works by relaxing and opening air passages to the lungs to make breathing easier.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Epinephrine oral inhalation comes as an aerosol (liquid) to inhale by mouth. It is used as needed to control your asthma symptoms. Follow the directions on the product label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use epinephrine oral inhalation exactly as directed. Do not use more or less of it or use it more often than directed.

Epinephrine oral inhalation is available without a prescription (over the counter). This medication should only be used if a doctor has told you that you have asthma.

If your symptoms do not improve within 20 minutes of use, if your asthma becomes worse, if you need more than 8 inhalations in a 24-hour period, or if you have more than 2 asthma attacks in a week, see a doctor right away. These may be signs that your asthma is getting worse and that you need a different treatment.

To inhale the aerosol using an inhaler, follow these steps:

1. Remove the cap.
2. If you are using the inhaler for the first time, you will need to prime it. To prime the inhaler, shake it well and then press down on the canister to release a spray into the air, away from your face. Repeat this for a total of 4 times (e.g., shake and then spray).
3. Every time you use your inhaler after the first time, shake it and then spray into the air 1 time before each use.
4. When you are ready to use the medication, place inhaler in mouth; inhale deeply while pressing down on top of inhaler and continue the breath as long as possible.
5. Exhale and wait 1 minute.
6. If your symptoms do not improve, use a second inhalation by repeating steps 3-5.
7. If you have used up to 2 sprays (1 dose); wait at least 4 hours between another dose. Do not use more than 8 inhalations in 24 hours.
8. Clean your inhaler daily after use by running water through the mouthpiece for 30 seconds. Follow the manufacturer's directions carefully and ask your doctor or pharmacist if you have any questions about cleaning your inhaler.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before using epinephrine oral inhalation,

• tell your doctor and pharmacist if you are allergic to epinephrine, any other medications, or any of the ingredients in epinephrine oral inhalation. Ask your pharmacist for a list of the ingredients.

• do not use epinephrine oral inhalation if you are taking a monoamine oxidase (MAO) inhibitor including isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), and tranylcypromine (Parnate) or have stopped taking any of these medications within the past 2 weeks.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, dietary or nutritional supplements, you are taking or plan to take. Be sure to mention any of the following: other asthma medications; caffeine; medications for depression, psychiatric, or emotional conditions; medications for obesity or weight control; phenylephrine (Sudafed PE); or pseudoephedrine (Sudafed, in Clarinex-D).

• tell your doctor what herbal products you are taking, especially those used for tiredness or to increase energy.

• tell your doctor if you have ever been hospitalized for treatment of asthma. Also, tell your doctor if you have or have ever had high blood pressure, diabetes, difficulty urinating due to an enlarged prostate, seizures, narrow angle glaucoma (a serious eye condition that may cause loss of vision), or thyroid or heart disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using epinephrine oral inhalation, call your doctor.

What SPECIAL DIETARY instructions should I follow?

Talk to your doctor about drinking or eating caffeine-containing beverages or foods while using this medicine.

What SIDE EFFECTS can this medicine cause?

Some side effects can be serious. If you experience any of these symptoms, stop using your inhaler and call your doctor immediately:

• fast, pounding, or irregular heartbeat
• tremors
• nervousness
• seizure
• difficulty fallling asleep or staying asleep

Epinephrine oral inhalation may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat (>120° F [49° C] and open flame. Do not puncture or incinerate the container.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Ask your pharmacist any questions you have about epinephrine oral inhalation.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: January 15, 2019.