Drug Facts

Active ingredient (in each inhalation)

Epinephrine 0.22 mg with the purpose of being a Bronchodilator.

Inactive Ingredients

ascorbic acid, dehydrated alcohol (34%), dichlorodifluoromethane (CFC 12), dichlorotetrafluoroethane (CFC 114), hydrochloric acid, nitric acid, purified water

Last updated on RxList: 11/6/2008

Uses

• for temporary relief of occasional symptoms of mild asthma
• wheezing, tightness of chest, shortness of breath

DIRECTIONS

• do not exceed dosage
• supervise children using this product
• adults and children 4 years and over: start with one inhalation, then wait at least 1 minute. If not relieved, use once more. Do not use again for at least 3 hours.
• children under 4 years of age: ask a doctor

For Inhalation Only

• store at room temperature, between 20-25°C (68-77°F)
• contains no sulfites
• see insert for mouthpiece use and care instructions

© Armstrong Pharmaceuticals, Inc.

Questions or Comments? Call 1-8 PRIMATENE or 1-877-462-8363. www.primatene.com

Last updated on RxList: 11/6/2008

When using this product
- increased blood pressure or heart rate can occur, which could lead to more serious problems such as heart attack and stroke. Your risk may increase if you take more frequently or more than the recommended dose.
- nervousness, sleeplessness, rapid heart beat, tremor, and seizure may occur. If these symptoms persist or get worse, consult a doctor right away.

Ask a doctor or pharmacist before use if you are
- taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions
- taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain)

Last updated on RxList: 11/6/2008

Asthma alert: Because asthma can be life threatening, see a doctor if you

• are not better in 20 minutes
• get worse
• need 12 inhalations in any day
• use more than 9 inhalations a day for more than 3 days a week
• have more than 2 asthma attacks in a week

For Inhalation only

Do not use

• unless a doctor said you have asthma
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs taken for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• ever been hospitalized for asthma heart disease
• high blood pressure diabetes thyroid disease seizures
• narrow angle glaucoma a psychiatric or emotional condition
• trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

• taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions
• taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain)

When using this product

• increased blood pressure or heart rate can occur, which could lead to more serious problems such as heart attack and stroke. Your risk may increase if you take more frequently or more than the recommended dose.
• nervousness, sleeplessness, rapid heart beat, tremor, and seizure may occur. If these symptoms persist or get worse, consult a doctor right away.
• avoid caffeine-containing foods or beverages.
• avoid dietary supplements containing ingredients reported or claimed to have a stimulant effect.
• do not puncture or throw into incinerator. Contents under pressure.
• do not use or store near open flame or heat above 120°F (49°C). May cause bursting.

Contains CFC 12, 114, substances which harm public health and environment by destroying ozone in the upper atmosphere.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Last updated on RxList: 11/6/2008

No Information Provided.

Do not use

• unless a doctor said you have asthma
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs taken for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Last updated on RxList: 11/6/2008

No Information Provided.

Last updated on RxList: 11/6/2008

Directions for use of Mouthpiece:

The Primatene® Mist mouthpiece, which is enclosed in the Primatene® Mist 15 mL size (not the refill size), should be used for inhalation only with Primatene® Mist.

	Take plastic cap off mouthpiece. (For refills, use mouthpiece from previous purchase.)
	Take plastic mouthpiece off bottle.
	Place short end of mouthpiece on bottle.
	Turn bottle upside down. Place thumb on bottom of mouthpiece over circular button and forefinger on top of vial. Empty the lungs as completely as possible by exhaling.
	Place mouthpiece in mouth with lips closed around opening. Inhale deeply while squeezing mouthpiece and bottle together. Release immediately and remove unit from mouth, then complete taking the deep breath, drawing medication into your lungs, holding breath as long as comfortable.
	Exhale slowly keeping lips nearly closed. This helps distribute the medication in the lungs.
	For storage, place long end of mouthpiece back on bottle and cover with plastic cap.

Care of Mouthpiece: The Primatene® Mist mouthpiece should be washed after each use with hot, soapy water, rinsed thoroughly, and dried with a clean, lint-free cloth.

If the unit becomes clogged and fails to spray, please write and send the clogged unit to: Armstrong Pharmaceuticals, Inc., 423 LaGrange St., West Roxbury, MA 02132.

© 2008 Armstrong Pharmaceuticals, Inc.

Last updated on RxList: 11/6/2008

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.

EPINEPHRINE INHALER - ORAL

(ep-in-EFF-rin)

COMMON BRAND NAME(S): Primatene Mist

USES: 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 is a bronchodilator that works by opening breathing passages to make breathing easier. Use this medication only if you have been told by your doctor that you have asthma.

HOW TO USE: 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 are uncertain about any of the information, consult 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 three hours. If your breathing does not get better in 20 minutes after using this medication, or if your breathing worsens, seek immediate medical attention.

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

Clean the mouthpiece after each use as directed in the Patient Information Leaflet. It should also be cleaned at any time that it appears to be clogged or is not working correctly.

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.

SIDE EFFECTS: 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 persist or worsen, notify your doctor or pharmacist promptly.

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.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fast/pounding/irregular heartbeat, muscle cramps, weakness, mental/mood changes (e.g., anxiety, hallucinations).

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain.

Rarely, this medication has caused severe (rarely fatal), sudden worsening of breathing problems/asthma (paradoxical bronchospasm). If you experience sudden wheezing, seek immediate medical attention.

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, 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 epinephrine, tell your doctor or pharmacist if you are allergic to it; or to similar bronchodilators (e.g., albuterol, levalbuterol, salmeterol); or to sympathomimetic drugs (e.g., pseudoephedrine); or if you have any other allergies.

If you have any of the following health problems, consult your doctor or pharmacist before using this product: heart disease (e.g., 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 (e.g., trouble urinating due to enlarged prostate).

This drug may make you dizzy. Use caution while driving, using machinery, or doing any activity that requires alertness. Limit alcoholic beverages.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the 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 not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: If you are taking this product under your doctor's direction, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

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

Before using this product, tell your doctor or pharmacist if you use any of the following: other asthma drugs (e.g., levalbuterol, salmeterol), beta blockers (e.g., atenolol, propranolol), inhaled anesthetics (e.g., halothane, isoflurane), other sympathomimetic drugs (e.g., ephedrine), certain "water pills" (diuretics that cause potassium loss such as furosemide, hydrochlorothiazide).

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.

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. Canada residents can call a provincial poison control center. Symptoms of overdose may include: chest pain, fast/pounding/irregular heartbeat, headache, shaking (tremors), nervousness, weakness, severe dizziness, seizures.

NOTES: Do not share this medication with others.

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

Keep all regular medical and laboratory appointments. Laboratory and/or medical tests (e.g., blood pressure, heart rate, EKG, blood potassium levels) may be performed from time to time to monitor your progress or check for side effects. 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).

MISSED DOSE: Not applicable.

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) 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 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.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.