Label: SYMJEPI- epinephrine injection

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated February 6, 2019

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use SYMJEPI™ safely and effectively. See full prescribing information for SYMJEPI™. SYMJEPI™ (epinephrine) injection, for intramuscular ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    SYMJEPI 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 ...
  • 2 DOSAGE AND ADMINISTRATION
    This product delivers 0.3 mg epinephrine injection (0.3 mL) and is intended for patients who weigh 30 kg or more (approximately 66 pounds or more). Inject SYMJEPI intramuscularly or subcutaneously ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Injection: Single-dose pre-filled syringe for manual injection, containing 0.3 mg/0.3 mL epinephrine sterile solution for injection, USP
  • 4 CONTRAINDICATIONS
    None.
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Emergency Treatment - SYMJEPI is intended for immediate administration as emergency supportive therapy and is not intended as a substitute for immediate medical care. In conjunction with the ...
  • 6 ADVERSE REACTIONS
    Due to the 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 ...
  • 7 DRUG INTERACTIONS
    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 ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - There are no adequate and well controlled studies of the acute effect of epinephrine in pregnant women. In animal reproductive studies, epinephrine administered by ...
  • 10 OVERDOSAGE
    Overdosage of epinephrine may produce extremely elevated arterial pressure, which may result in cerebrovascular hemorrhage, particularly in elderly patients. Overdosage may also result in ...
  • 11 DESCRIPTION
    Each SYMJEPI pre-filled, syringe delivers a single dose of 0.3 mg of epinephrine from epinephrine injection, USP (0.3mg/0.3 mL). Each SYMJEPI (epinephrine injection, USP) syringe contains 0.8 mL ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Epinephrine acts on both alpha and beta-adrenergic receptors. 12.2 Pharmacodynamics - Through its action on alpha-adrenergic receptors, epinephrine lessens the ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Long-term studies to evaluate the carcinogenic potential of epinephrine have not been conducted. Epinephrine and other catecholamines ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    16.1 How Supplied - SYMJEPI (epinephrine injection, USP) 0.3 mg pre-filled syringes are available as a single pack, NDC 38739-200-01 containing a single pre-filled syringe, and as a two-pack ...
  • 17 PATIENT COUNSELING INFORMATION
    [see FDA-Approved Patient Labeling (Patient Information and Instructions for Use)] A healthcare provider should review the patient instructions and operation of SYMJEPI, in detail, with the ...
  • PATIENT INFORMATION
    SYMJEPI™ (sim-JEP-ee) (epinephrine) injection for intramuscular or subcutaneous use - For allergic emergencies (anaphylaxis) Read this Patient Information leaflet carefully before using SYMJEPI and ...
  • INSTRUCTIONS FOR USE
    Instructions for Use - SYMJEPI (sim-JEP-ee) (epinephrine injection, USP) 0.3 mg prefilled syringe - For Allergic Emergencies (anaphylaxis) Read this Instructions for Use carefully before you use ...
  • PRINCIPAL DISPLAY PANEL
    Syringe Label - SYMJEPI - Epinephrine Injection - 0.3 mg - Lot: Exp: Distributor: Adamis Pharmaceuticals - Replace when discolored or expired - [2] Insert Needle in Thigh - After use Call 911
  • Syringe Case Label
    SYMJEPI - (epinephrine) ​injection 0.3 mg - Prefilled Syringe - Remove Device From Case - 1 Pull off cap - 2 Insert in thigh - 3 Push plunger - Pull latch to open - How to Store - Store SYMJEPI in ...
  • 2-Pack Inner Carton
    NDC #38739-200-02 - RX ONLY - SYMJEPITM - (epinephrine) Injection 0.3 mg - (0.3 mg PRE-FILLED SINGLE DOSE SYRINGE) FOR ALLERGIC EMERGENCIES (ANAPHYLAXIS) Protect from light. Store at room ...
  • 2-Pack Outer Carton
    NDC #38739-200-12 - RX ONLY - Protect from light - SYMJEPITM - (epinephrine) Injection 0.3 mg - (0.3 mg PRE-FILLED SINGLE DOSE SYRINGE) For Allergic Emergencies (Anaphylaxis) USP (0.3mg ...
  • INGREDIENTS AND APPEARANCE
    Product Information