Epinephrine (aerosol)

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Epinephrine (aerosol)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Adeel Jamil, M.D. [2]

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Overview

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Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

  • For temporary relief of shortness of breath, tightness of chest and wheezing due to bronchial asthma. Eases breathing for asthma patients by reducing spasms of bronchial muscles. For the symptomatic control of bronchial asthma.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Epinephrine (aerosol) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Epinephrine (aerosol) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Epinephrine (aerosol) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Epinephrine (aerosol) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Epinephrine (aerosol) in pediatric patients.

Contraindications

There is limited information regarding Epinephrine (aerosol) Contraindications in the drug label.

Warnings

  • Contains dichlorodifluoromethane, dichlorotetrafluoroethane and trichloromonofluoromethane, substances which harm public health and environment by destroying ozone in the upper atmosphere.
  • FOR ORAL INHALATION THERAPY ONLY
  • Do not use this product unless a diagnosis of asthma has been made by a physician. Do not use this product if you have heart disease, high blood pressure, thyroid disease, diabetes or difficulty in urination due to enlargement of the prostate gland, unless directed by a physician. Do not use this product if you have ever been hospitalized for asthma or if you are taking any prescription drug for asthma unless directed by a physician.
  • MEDIHALER-EPI is intended for oral inhalation only. Do not use this product more frequently or at higher doses than recommended unless directed by a physician. Excessive use may cause nervousness and rapid heartbeat, and, possibly adverse effects on the heart. Do not continue to use this product, but seek medical assistance immediately if symptoms are not relieved within 20 minutes or become worse.
  • As with any drug, if you are pregnant or nursing a baby, seek the advise of a health professional before using this product. Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Epinephrine (aerosol) Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Epinephrine (aerosol) Postmarketing Experience in the drug label.

Drug Interactions

  • Do not use this product if you are presently taking a prescription drug for high blood pressure or depression without first consulting your physician.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Epinephrine (aerosol) in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Epinephrine (aerosol) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Epinephrine (aerosol) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Epinephrine (aerosol) in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Epinephrine (aerosol) in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Epinephrine (aerosol) in geriatric settings.

Gender

There is no FDA guidance on the use of Epinephrine (aerosol) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Epinephrine (aerosol) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Epinephrine (aerosol) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Epinephrine (aerosol) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Epinephrine (aerosol) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Epinephrine (aerosol) in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Epinephrine (aerosol) Administration in the drug label.

Monitoring

There is limited information regarding Epinephrine (aerosol) Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Epinephrine (aerosol) and IV administrations.

Overdosage

There is limited information regarding Epinephrine (aerosol) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Epinephrine (aerosol) Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Epinephrine (aerosol) Mechanism of Action in the drug label.

Structure

There is limited information regarding Epinephrine (aerosol) Structure in the drug label.

Pharmacodynamics

There is limited information regarding Epinephrine (aerosol) Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Epinephrine (aerosol) Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Epinephrine (aerosol) Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Epinephrine (aerosol) Clinical Studies in the drug label.

How Supplied

There is limited information regarding Epinephrine (aerosol) How Supplied in the drug label.

Storage

There is limited information regarding Epinephrine (aerosol) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Epinephrine (aerosol) Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Epinephrine (aerosol) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Epinephrine (aerosol) Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Epinephrine (aerosol) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.