Epinephrine Auto-Injectors (Epi-Pen) 0.3mg 2/Pack

NDC: 0115-1694-49

Epinephrine Injection, USP 0.3 mg Auto-Injector, 2-Pack — Amneal (Authorized Generic of Adrenaclick)

Active ingredient	Epinephrine 0.3 mg/0.3 mL
Dosage form	Single-dose pre-filled auto-injector
Route	Intramuscular, Subcutaneous
Size	Carton of 2 auto-injectors, each in an individual carrier tube
Manufacturer	Amneal Pharmaceuticals LLC
NDC	0115-1694-49

Indications and Usage

Indicated for the emergency treatment of Type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 30 kg (66 lbs) or greater.

Dosage and Administration

Inject 0.3 mg intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary, for patients weighing 30 kg (66 lbs) or greater. A second dose may be administered with a new auto-injector starting 5 minutes after the first dose if symptoms do not improve or worsen. Patients should be prescribed and have immediate access to two auto-injector devices at all times.

Warnings and Precautions

• Do not inject intravenously, into the buttock, or into digits, hands, or feet — risk of tissue necrosis or Clostridial infection (gas gangrene)
• Hold the leg firmly in place when administering to young children or infants to minimize injection-related injury
• Rare cases of serious skin and soft tissue infections have been reported following injection; advise patients to seek medical care for signs of infection at the injection site
• Administer with caution in patients with heart disease; may aggravate angina pectoris or produce ventricular arrhythmias
• May aggravate certain coexisting conditions, including hyperthyroidism, Parkinson's disease, diabetes, and renal impairment
• Contains sodium bisulfite, which may cause allergic-type reactions in susceptible individuals; however, presence of sulfite should not deter use in a serious allergic emergency

Contraindications

None.

Adverse Reactions

Adverse reactions include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea, vomiting, headache, and respiratory difficulties.

Storage and Handling

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light; keep in the individual carrier tube provided. Do not refrigerate or freeze.

How Supplied

Supplied as a carton containing 2 single-dose pre-filled auto-injectors, each in an individual carrier tube.

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.