epinephrine

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

Injection solution: 10 mL multiple-dose amber glass vial containing 10 mg/10 mL (1 mg/mL) epinephrine as a sterile, nonpyrogenic, clear and colorless solution. Injection solution: 30 mL multiple-dose amber glass vial containing 30 mg/30 mL (1 mg/mL) epinephrine as a sterile, nonpyrogenic, clear and colorless solution.

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

None.

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

7 DRUG INTERACTIONS

DRUG INTERACTIONS SECTION

Drugs antagonizing pressor effects of epinephrine α-blockers, such as phentolamine Vasodilators, such as nitrates Diuretics Antihypertensives Ergot alkaloids Drugs potentiating pressor effects of epinephrine Sympathomimetics β-blockers, such as propranolol Tricyclic anti-depressants Monoamine oxidase (MAO) inhibitors Catechol-O-methyl transferase (COMT) inhibitors, such as entacapone Clonidine Doxapram Oxytocin Drugs potentiating arrhythmogenic effects of epinephrine Patients who are concomitantly receiving any of the following drugs should be observed carefully for the development of cardiac arrhythmias [see Warnings and Precautions (5.6) and Adverse Reactions (6) ]. β-blockers, such as propranolol Cyclopropane or halogenated hydrocarbon anesthetics, such as halothane Antihistamines Thyroid hormones Diuretics Cardiac glycosides, such as digitalis glycosides Quinidine Drugs potentiating hypokalemic effects of epinephrine Potassium depleting diuretics Corticosteroids Theophylline Epinephrine should not be used to counteract circulatory collapse or hypotension caused by phenothiazines, as a reversal of the pressor effects of epinephrine may result in further lowering of blood pressure. Epinephrine may antagonize the neuronal blockade produced by guanethidine resulting in decreased antihypertensive effect and requiring increased dosage of the latter.

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

10 OVERDOSAGE

OVERDOSAGE SECTION

Overdosage of epinephrine may produce extremely elevated arterial pressure, which may result in cerebrovascular hemorrhage, particularly in elderly patients. Overdosage may also result in pulmonary edema because of peripheral vascular constriction together with cardiac stimulation. Epinephrine overdosage may also cause transient bradycardia followed by tachycardia and these may be accompanied by potentially fatal cardiac arrhythmias. Premature ventricular contractions may appear within one minute after injection and may be followed by multifocal ventricular tachycardia (prefibrillation rhythm). Subsidence of the ventricular effects may be followed by atrial tachycardia and occasionally by atrioventricular block. Myocardial ischemia and infarction, cardiomyopathy, extreme pallor and coldness of the skin, metabolic acidosis due to elevated blood lactic acid levels, and renal insufficiency and failure have also been reported. Epinephrine is rapidly inactivated in the body and treatment following overdose is primarily supportive. Treatment of pulmonary edema consists of a rapidly acting alpha-adrenergic blocking drug (such as phentolamine mesylate) and respiratory support. Treatment of arrhythmias consists of administration of a beta-adrenergic blocking drug (such as propranolol). If necessary, pressor effects may be counteracted by rapidly acting vasodilators (such as nitrites) or alpha-adrenergic blocking drugs. If prolonged hypotension follows such measures, it may be necessary to administer another pressor drug.

11 DESCRIPTION

DESCRIPTION SECTION

Epinephrine Injection, USP is a clear, colorless, sterile solution containing 1 mg/mL epinephrine. 10 mL Multiple Dose Vial: 10 mL multiple dose amber glass vial containing 10 mg/10 mL (1 mg/mL) epinephrine as a sterile, nonpyrogenic, clear and colorless solution. In the 10 mL vial, each 1 mL of Epinephrine Injection, USP solution contains 1 mg epinephrine, 5.25 mg chlorobutanol hemihydrate as preservative, 7.5 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid for pH adjustment and water for injection. The pH range is 2.2 to 5.0. 30 mL Multiple Dose Vial: 30 mL multiple dose amber glass vial containing 30 mg/30 mL epinephrine as a sterile, nonpyrogenic, clear and colorless solution. In the 30 mL vial, each 1 mL of Epinephrine Injection USP solution contains 1 mg epinephrine, 5.25 mg chlorobutanol hemihydrate as preservative, 7.5 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid for pH adjustment and water for injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine. The chemical name of epinephrine is: 1,2-Benzenediol, 4-[(1R)-1-hydroxy-2-(methylamino)ethyl]-, or (-)-3,4-Dihydroxy-α-[2- (methylamino)ethyl]benzyl alcohol. The chemical structure of epinephrine is: The molecular weight of epinephrine is 183.2. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin.

12 CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

13 NONCLINICAL TOXICOLOGY

NONCLINICAL TOXICOLOGY SECTION

14 CLINICAL STUDIES

CLINICAL STUDIES SECTION

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

Epinephrine injection, 1 mg/mL is a clear, colorless solution available as follows: 10 mL Multiple-Dose Vial: Each carton contains 1 multiple-dose vial containing 10 mg/10 mL (1 mg/mL) epinephrine injection, USP solution in an amber glass vial. NDC 68083-633-01 10 mL Multiple-Dose Vial 30 mL Multiple-Dose Vial: Each carton contains 1 multiple-dose vial containing 30 mg/30 mL (1 mg/mL) epinephrine injection, USP solution in an amber glass vial. NDC 68083-685-01 30 mL Multiple-Dose Vial Epinephrine is light sensitive. Protect from light until ready to use. Do not refrigerate. Protect from freezing. Vial and contents must be discarded 30 days after initial use. Store at room temperature, between 20° to 25°C (68° to 77°F). (See USP Controlled Room Temperature.) Protect from alkalis and oxidizing agents.

17 PATIENT COUNSELING INFORMATION

INFORMATION FOR PATIENTS SECTION

Advise patients or their caregivers about common adverse reactions associated with the use of epinephrine, including an increase in heart rate, the sensation of a more forceful heartbeat, palpitations, sweating, nausea and vomiting, difficulty breathing, pallor, dizziness, weakness or shakiness, headache, apprehension, nervousness, or anxiety. These symptoms and signs usually subside rapidly, especially with rest, quiet and recumbent positioning. Warn patients with a good response to initial treatment about the possibility of recurrence of anaphylaxis symptoms and instruct patients to obtain medical attention if symptoms return. Advise patients with diabetes that they may develop increased blood glucose levels following epinephrine administration. Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported at the injection site following epinephrine injection for anaphylaxis. Advise patients to seek medical care if they develop signs or symptoms of infection, such as persistent redness, warmth, swelling, or tenderness, at the epinephrine injection site [see Warnings and Precautions (5.7) ] . Manufactured by: Gland Pharma Limited Pashamylaram, Patancheru, Hyderabad 502307, India ML No: 2/MD/TS/2015/F/G Revised: March 2025

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container Label : NDC 68083- 633 -01 Rx Only Epinephrine Injection, USP 10 mg/10 mL (1 mg/mL) For Intravenous Infusion, Intramuscular and Subcutaneous Use Only NOT for Ophthalmic Use Dilute Before Intravenous Infusion 10 mL Multiple-Dose Vial Container Label : NDC 68083- 685 -01 Rx Only Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) For Intravenous Infusion, Intramuscular and Subcutaneous Use Only NOT for Ophthalmic Use Dilute Before Intravenous Infusion 30 mL Multiple-Dose Vial Carton Label : NDC 68083- 633 -01 Rx Only Epinephrine Injection, USP 10 mg/10 mL (1 mg/mL) For Intravenous Infusion, Intramuscular and Subcutaneous Use Only NOT for Ophthalmic Use Dilute Before Intravenous Infusion Discard 30 days after initial use: Discard on: ___/___/____ 1 x 10 mL Multiple-Dose Vial Carton Label : NDC 68083- 685 -01 Rx Only Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) For Intravenous Infusion, Intramuscular and Subcutaneous Use Only NOT for Ophthalmic Use Dilute Before Intravenous Infusion Discard 30 days after initial use: Discard on: ___/___/____ 1 x 30 mL Multiple-Dose Vial