ADRENALIN- epinephrine injection

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)

Disponibil de la:

Par Pharmaceutical, Inc.

INN (nume internaţional):

EPINEPHRINE

Compoziție:

EPINEPHRINE 1 mg in 1 mL

Calea de administrare:

INTRAMUSCULAR

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.  Adrenalinis indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. None. Risk Summary Prolonged experience with epinephrine use in pregnant women over several decades, based on published literature, do not identify a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.  However, there are risks to the mother and fetus associated with epinephrine use during labor or delivery (see Clinical Considerations) .  In animal reproduction studies, epinephrine administered by the subcutaneous route to pregnant rabbits, mice, and hamsters, during the period of organogenesis, resulted in adverse developmental effects (including gastroschisis, and embryonic lethalit

Rezumat produs:

Adrenalin 1 mg/mL Single Dose Vials: Each carton contains 25 single dose vials containing 1 mg/mL Adrenalin (epinephrine injection, USP) solution in a 3 mL clear glass vial. NDC 42023-159-01          1 mL Single Dose Vial NDC 42023-159-25          25 Single Dose Vials x 1 mL each Discard unused portion. Adrenalin 30 mg/30 mL (1 mg/mL) Multiple Dose Vials: Each carton contains 1 multiple dose vial containing 30 mg/30 mL (1 mg/mL) Adrenalin (epinephrine injection, USP) solution in a 36 mL amber glass vial. NDC 42023-168-01          30 mL Multiple Dose Vial Vial and contents must be discarded 30 days after initial use.  Store between 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] . Epinephrine is light sensitive.  Protect from light and freezing.  Inspect visually for particulate matter and discoloration prior to administration.  Do not use the solution if it is colored or cloudy, or if it contains particulate matter. 

Statutul autorizaţiei:

New Drug Application

Caracteristicilor produsului

ADRENALIN- EPINEPHRINE INJECTION
PAR PHARMACEUTICAL, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ADRENALIN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ADRENALIN.
ADRENALIN (EPINEPHRINE INJECTION) 1 MG/ML, FOR
INTRAMUSCULAR, SUBCUTANEOUS, AND INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1939
RECENT MAJOR CHANGES
Indications and Usage (1.2) 01/2019
Dosage and Administration (2.3) 01/2019
Warnings and Precautions (5.3, 5.4, 5.5, 5.6, 5.7) 01/2019
INDICATIONS AND USAGE
Adrenalin is a non-selective alpha and beta adrenergic agonist
indicated for:
Emergency treatment of allergic reactions (Type 1), including
anaphylaxis (1.1)
To increase mean arterial blood pressure in adult patients with
hypotension associated with septic
shock (1.2)
DOSAGE AND ADMINISTRATION
Anaphylaxis:
_Adults and Children 30 kg (66 lbs) or more: _0.3 mg to 0.5 mg (0.3 mL
to 0.5 mL) intramuscularly or
subcutaneously into anterolateral aspect of the thigh every 5 to 10
minutes as necessary (2.2)
_Children 30 kg (66 lbs) or less_: 0.01 mg/kg (0.01 mL/kg), up to 0.3
mg (0.3 mL), intramuscularly or
subcutaneously into anterolateral aspect of the thigh every 5 to 10
minutes as necessary (2.2)
Hypotension associated with septic shock:
Dilute epinephrine in dextrose solution prior to infusion (2.3)
Infuse epinephrine into a large vein (2.3)
Intravenous infusion rate of 0.05 mcg/kg/min to 2 mcg/kg/min, titrated
to achieve desired mean
arterial pressure (2.3)
Wean gradually (2.3)
See Full Prescribing Information for instructions on dilution and
administration of the injection.
DOSAGE FORMS AND STRENGTHS
Injection: 1 mg/mL single dose vial and 30 mg/30 mL (1 mg/mL) multiple
dose vial (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Do not inject into buttocks, digits, hands, or feet (5.1)
Avoid extravasation into tissues, which can cause local necrosis (5.3)
May aggravate angina pectoris or produce ventricular arrhythmias (5.7)
ADVERSE REACTIONS
Common adverse react