Drugplain

Auvi-Q .3 mg/.3mL

epinephrine · INJECTION, SOLUTION · Medical Purchasing Solutions, LLC

2 Recalls on RecordCurrently in Shortage
Plain English

Auvi-Q is a injection, solution containing epinephrine at .3 mg/.3mL, taken intramuscular. Manufactured by Medical Purchasing Solutions, LLC.

Key Facts

Brand Name
Auvi-Q
Generic Name
epinephrine
NDC Code (Product)
71872-7173
Manufacturer
Medical Purchasing Solutions, LLC
Strength
.3 mg/.3mL
Dosage Form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Marketing Status
Application #
NDA201739
Drug Class
alpha-Adrenergic Agonist [EPC]; beta-Adrenergic Agonist [EPC]
Marketing Start
11/15/2012

Recall History

2 Recalls on Record
Class I10/28/2015

Sanofi-Aventis U.S. LLC

Defective Delivery System; potential to have inaccurate dosage delivery

TerminatedVoluntary: Firm initiated
Class I10/28/2015

Sanofi-Aventis U.S. LLC

Defective Delivery System; potential to have inaccurate dosage delivery

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective4,398 reports
headache2,956 reports
sinusitis2,863 reports
product dose omission issue2,723 reports
fatigue2,667 reports
covid-192,407 reports
pain2,407 reports
dyspnoea2,149 reports
nausea2,131 reports
pneumonia2,009 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE AUVI-Q® is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. AUVI-Q is intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema. AUVI-Q is intended for immediate self-administration as emergency supportive therapy only and is not a substitute for immediate medical care.

Dosage & Administration

2 DOSAGE & ADMINISTRATION Selection of the appropriate dosage strength (AUVI-Q 0.3 mg, AUVI-Q 0.15 mg or AUVI-Q 0.1 mg) is determined according to patient body weight. Patients greater than or equal to 30 kg (approximately 66 pounds or more): AUVI-Q 0.3 mg Patients 15 to 30 kg (33 to 66 pounds): AUVI-Q 0.15 mg Patients 7.5 to 15 kg (16.5 to 33 pounds): AUVI-Q 0.1 mg Inject AUVI-Q intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary. Instruct caregivers of young children and infants who are prescribed AUVI-Q and who may be uncooperative and kick or move during an injection to hold the child’s leg firmly in place and limit movement prior to and during an injection [see Warnings and Precautions (5.2)]. Each AUVI-Q contains a single dose of epinephrine for single-dose injection. Since the doses of epinephrine delivered from AUVI-Q are fixed, consider using other forms of injectable epinephrine if doses lower than 0.1 mg are deemed necessary. The prescriber should carefully assess each patient to determine the most appropriate dose of epinephrine, recognizing the life-threatening nature of the reactions for which this drug is indica…

Contraindications

4 CONTRAINDICATIONS NONE

Drug Interactions

7 DRUG INTERACTIONS 7.1 Drugs Increasing Risk of Cardiac Arrhythmias Patients who receive epinephrine while concomitantly taking cardiac glycosides, diuretics, or anti-arrhythmics should be observed carefully for the development of cardiac arrhythmias [see Warnings and Precautions (5.5)]. 7.2 Drugs Potentiating Effects of Epinephrine The effects of epinephrine may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium, and certain antihistamines, notably chlorpheniramine, tripelennamine, and diphenhydramine. 7.3 Drugs Antagonizing Effects of Epinephrine The cardiostimulating and bronchodilating effects of epinephrine are antagonized by beta-adrenergic blocking drugs, such as propranolol. The vasoconstricting and hypertensive effects of epinephrine are antagonized by alpha-adrenergic blocking drugs, such as phentolamine. Ergot alkaloids may also reverse the pressor effects of epinephrine.

Adverse Reactions

6 ADVERSE REACTIONS Due to lack of randomized, controlled clinical trials of epinephrine for the treatment of anaphylaxis, the true incidence of adverse reactions associated with the systemic use of epinephrine is difficult to determine. Adverse reactions reported in observational trials, case reports, and studies are listed below. Common adverse reactions to systemically administered epinephrine include anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; nausea and vomiting; headache; and/or respiratory difficulties. These symptoms occur in some persons receiving therapeutic doses of epinephrine, but are more likely to occur in patients with hypertension or hyperthyroidism [see Warnings and Precautions (5.5)]. Arrhythmias, including fatal ventricular fibrillation, have been reported, particularly in patients with underlying cardiac disease or those receiving certain drugs [see Warnings and Precautions (5.5) and Drug Interactions (7)]. Rapid rises in blood pressure have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease [see Warnings and Precautions (5.5)]. Angina may occur in patients with co…

Frequently Asked Questions

What is Auvi-Q used for?

Auvi-Q contains epinephrine. It is a injection, solution taken intramuscular. Consult your doctor for specific uses.

Is Auvi-Q a controlled substance?

Auvi-Q is not classified as a controlled substance by the DEA.

What is the generic name for Auvi-Q?

The generic name for Auvi-Q is epinephrine. There are 10 other brand versions of epinephrine.

What is the NDC code for Auvi-Q .3 mg/.3mL?

The NDC (National Drug Code) for Auvi-Q .3 mg/.3mL is 71872-7173, listed by Medical Purchasing Solutions, LLC.

Product NDC

71872-7173

Package NDC

71872-7173-1

Other Epinephrine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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