Epinephrine Injection Ampule 1mg/mL

NDC: 54288-103-10

Epinephrine 1 mg/mL (1:1000) Injection, 1 mL Ampule — BPI Labs

Active ingredients	Epinephrine 1 mg/mL (1:1000)
Dosage form	Injection, solution
Route	Intravenous, intramuscular, subcutaneous, and intraocular
Size	1 mL ampule
Manufacturer	BPI Labs
NDC	54288-103-10

Indications and Usage

Indicated to increase mean arterial blood pressure in adults with hypotension associated with septic shock, for emergency treatment of allergic reactions including anaphylaxis, and to induce and maintain mydriasis during intraocular surgery.

Dosage and Administration

For anaphylaxis, inject 0.3 to 0.5 mg intramuscularly or subcutaneously into the anterolateral thigh in adults and children over 30 kg, repeating every 5 to 10 minutes as needed. For septic shock, dilute and infuse intravenously at 0.05 to 2 mcg/kg/min titrated to blood pressure. For intraocular use, dilute prior to administration in irrigation fluid.

Warnings and Precautions

• May cause severe or extreme rises in blood pressure resulting in cerebral hemorrhage
• Risk of tissue extravasation and necrosis; do not inject into the buttocks, digits, hands, or feet
• May cause potentially fatal cardiac arrhythmias, especially in patients with underlying cardiac disease
• May precipitate pulmonary edema and renal vascular constriction

Contraindications

None.

Adverse Reactions

Common adverse reactions include headache, anxiety, tremor, dizziness, sweating, palpitations, and nausea. Serious reactions include cardiac arrhythmias, including fatal ventricular fibrillation, and rapid rises in blood pressure that can cause stroke.

Storage and Handling

Store at room temperature, 20°C to 25°C (68°F to 77°F). Protect from light. Do not refrigerate or freeze.

How Supplied

Sterile solution supplied in single-dose glass ampules.

Professional use only. Clinical information summarized from FDA-approved prescribing information (Structured Product Labeling); refer to the full prescribing information via DailyMed for complete details.

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