Epinephrine, .1 mg/mL — 10 mL Syringe, Pack of 1

EPINEPHRINE INJECTION USP, 1 mg/10 mL (0.1 mg/mL)

PRODUCT OVERVIEW

Epinephrine Injection USP is a prescription vasopressor indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. Epinephrine is a nonselective alpha- and beta-adrenergic agonist. This product is intended for use by trained healthcare professionals.

PRESENTATION

This item is supplied as a shrink-wrapped bundle of 10 individual cartons. Each carton contains one single-dose 10 mL Luer-Jet Luer-Lock prefilled syringe containing 1 mg of epinephrine in 10 mL (0.1 mg/mL). The solution is sterile, clear, colorless, and nonpyrogenic. Discard unused portion; do not reuse or resterilize.

PREPARATION AND ADMINISTRATION

For intravenous use after dilution. The solution must be diluted before intravenous administration. Inspect the syringe for particulate matter, discoloration, and damage before use; do not use colored, cloudy, or particulate-containing solution. Refer to the current full prescribing information for dilution, infusion, titration, and monitoring instructions.

IMPORTANT SAFETY INFORMATION

The label lists no contraindications. Monitor blood pressure frequently and titrate to avoid excessive hypertension. Epinephrine may cause pulmonary edema, cardiac arrhythmias, myocardial ischemia, oliguria or renal impairment, and tissue necrosis following extravasation. This formulation contains sodium metabisulfite, which may cause allergic-type reactions in susceptible patients. Elderly patients and pregnant women may be at greater risk of adverse reactions with parenteral epinephrine.

STORAGE AND HANDLING

Store at controlled room temperature, 68°F to 77°F (20°C to 25°C). Protect from light until ready to use. Do not refrigerate and protect from freezing. Protect from alkalis and oxidizing agents. Epinephrine solutions can deteriorate with exposure to air or light; do not use if the solution is pink, brown, cloudy, or contains particles.

PRODUCT DETAILS

• Generic name: Epinephrine Injection USP

• Manufacturer: International Medication Systems, Limited (IMS), an Amphastar company

• NDC: 76329-3318-01 (76329331801)

• Form: Single-dose Luer-Lock prefilled syringe

• Strength: 1 mg/10 mL (0.1 mg/mL)

• Syringe volume: 10 mL

• Package size: 10 syringes

• Route: Intravenous after dilution

• GTIN: 00376329331812

This summary does not replace the full prescribing information. Current label: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3b1ac82f-6920-4e40-a77e-598398679f2d