Primatene

What is Primatene and how is it used?

Primatene is a prescription medicine used to treat the symptoms of Asthma. Primatene may be used alone or with other medications.

Primatene belongs to a class of drugs called Decongestant/Expectorant Combos.

It is not known if Primatene is safe and effective in children younger than 12 years of age.

What are the possible side effects of Primatene?

Primatene may cause serious side effects including:

• hives,
• difficulty breathing,
• swelling of your face, lips, tongue, or throat,
• severe dizziness,
• fast, pounding or irregular heartbeat,
• muscle cramps,
• weakness,
• mood changes,
• anxiety,
• hallucinations,
• chest pain,
• worsening breathing problems, and
• wheezing

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Primatene include:

• headache,
• nausea,
• vomiting,
• nervousness,
• dizziness,
• shaking,
• trouble sleeping,
• stomach upset,
• sweating,
• dry mouth,
• bad taste,
• cough, and
• sore throat

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Primatene. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This product available OTC

DESCRIPTION

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

INDICATIONS

Uses

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

DOSAGE AND ADMINISTRATION

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

HOW SUPPLIED

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

SIDE EFFECTS

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.

DRUG INTERACTIONS

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)

WARNINGS

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

PRECAUTIONS

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.

OVERDOSE

No Information Provided.

CONTRAINDICATIONS

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.

CLINICAL PHARMACOLOGY

No Information Provided.

PATIENT INFORMATION

Directions for use of Mouthpiece:

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

	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 (epinephrine for inhalation) 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.