Epinephrine Inhalation
Drug Details
- Generic Name
- Epinephrine Inhalation
- Brand Names
- Primatene Mist
- Application Number
- NDA205920
- Sponsor
- Armstrong Pharmaceuticals, Inc.
- NDC Codes
- 1
- Dosage Forms
- AEROSOL
- Routes
- RESPIRATORY (INHALATION)
- Active Ingredients
- EPINEPHRINE
Indications and Usage
Uses for temporary relief of mild symptoms of intermittent asthma ■ wheezing ■ tightness of chest ■ shortness of breath
Warnings
Warnings For oral inhalation only Asthma alert: Because asthma may be life threatening, see a doctor if you ■ are not better in 20 minutes ■ get worse ■ need more than 8 inhalations in 24 hours ■ have more than 2 asthma attacks in a week These may be signs that your asthma is getting worse. 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 a pharmacist before taking this product. Ask a doctor before use if you have ■ ever been hospitalized for asthma ■ heart disease ■ high blood pressure ■ diabetes ■ trouble urinating due to an enlarged prostate gland ■ thyroid disease ■ seizures ■ narrow angle glaucoma 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 ■ your blood pressure or heart rate may go up. This could increase your risk of heart attack or stroke, which may cause death. ■ your risk of heart attack or stroke increases if you: ■ have a history of high blood pressure or heart disease ■ take this product more frequently or take more than the recommended dose. ■ avoid foods or beverages that contain caffeine ■ avoid dietary supplements containing ingredients reported or claimed to have a stimulant effect ■ avoid spraying in eyes ■ contents under pressure. Do not puncture or incinerate. ■ do not store near open flame or heat above 120°F (49°C). May cause bursting. Stop use and ask a doctor if ■ your asthma is getting worse (see asthma alert) ■ you have difficulty sleeping ■ you have a rapid heart beat ■ you have tremors, nervousness, or seizure If pregnant or breast-feeding , ask a health care professional before use Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.