RVP

Drug Catalog - Product Detail

ADRENALIN INJ SOL 1MG/ML 1ML X 25

NDC Mfr Size Str Form
42023-0122-25 PAR STERILE PRODUCTS 1ML 1MG/ML NA
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Description
DESCRIPTION A sterile solution intended for subcutaneous or intramuscular injection. When diluted, it may also be administered intracardially or intravenously. It may also be administered intraspinally by adding to anesthetic spinal fluid mixture. Each milliliter contains 1 mg Adrenalin (EPINEPHrine) as the hydrochloride dissolved in Water for Injection, USP, with sodium chloride added for isotonicity. 1 mL Vial Contains not more than 0.1% sodium bisulfite as an antioxidant, and the air in the vial has been displaced by nitrogen. 30 mL Vial Contains 0.5% Chlorobutanol (chloroform derivative) as a preservative and not more than 0.15% sodium bisulfite as an antioxidant. Epinephrine is the active principle of the adrenal medulla, chemically described as (—)-3,4-Dihydroxy-α-[(methylamino) methyl] benzyl alcohol, and has the following structural formula: Chemical Structure
How Supplied
HOW SUPPLIED NDC 42023-122-25: 1 mL vial supplied in packages of twenty-five Sterile solution containing 1 mg/mL Adrenalin (EPINEPHrine) as the hydrochloride in each 1 mL vial (1:1000). For intramuscular or subcutaneous use. When diluted, it may also be administered intracardially or intravenously. It may also be administered intraspinally by adding to anesthetic spinal fluid mixture. NDC 42023-101-01: 30 mL individual vial NDC 42023-101-10: 30 mL vial supplied in packages of ten Sterile solution containing 1 mg/mL Adrenalin (EPINEPHrine) as the hydrochloride (1:1000) in each 30 mL vial. For intramuscular or subcutaneous use. When diluted, it may also be administered intracardially or intravenously. It may also be administered intraspinally by adding to anesthetic spinal fluid mixture. Store between 20° to 25°C (68° to 77°F). (See USP Controlled Room Temperature.) Protect from light and freezing. Rx Only. Prescribing Information as of January 2013. JHP Pharmaceuticals Manufactured and Distributed by: JHP Pharmaceuticals, LLC. Rochester, MI 48307 3000390F
Indications & Usage
INDICATIONS AND USAGE In general, the most common uses of epinephrine are to relieve respiratory distress due to bronchospasm, to provide rapid relief of hypersensitivity reactions to drugs and other allergens, and to prolong the action of infiltration anesthetics. Its cardiac effects may be of use in restoring cardiac rhythm in cardiac arrest due to various causes, but it is not used in cardiac failure or in hemorrhagic, traumatic, or cardiogenic shock. Epinephrine is used as a hemostatic agent. It is also used in treating mucosal congestion of hay fever, rhinitis, and acute sinusitis; to relieve bronchial asthmatic paroxysms; in syncope due to complete heart block or carotid sinus hypersensitivity; for symptomatic relief of serum sickness, urticaria, angioneurotic edema; for resuscitation in cardiac arrest following anesthetic accidents; in simple (open angle) glaucoma; for relaxation of uterine musculature and to inhibit uterine contractions. Epinephrine injection can be utilized to prolong the action of intraspinal and local anesthetics (see CONTRAINDICATIONS section).
Dosage and Administration
DOSAGE AND ADMINISTRATION Parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit. Vial and contents must be discarded 30 days after initial use. Subcutaneously or intramuscularly—0.2 to 1 mL (mg). Start with a small dose and increase if required. Note: The subcutaneous is the preferred route of administration. If given intramuscularly, injection into the buttocks should be avoided. For bronchial asthma and certain allergic manifestations, e.g., angioedema, urticaria, serum sickness, anaphylactic shock, use epinephrine subcutaneously. For bronchial asthma in pediatric patients, administer 0.01 mg/kg or 0.3 mg/m 2 to a maximum of 0.5 mg subcutaneously, repeated every four hours if required. For cardiac resuscitation—A dose of 0.5 mL (0.5 mg) diluted to 10 mL with sodium chloride injection can be administered intravenously or intracardially to restore myocardial contractility. External cardiac massage should follow intracardial administration to permit the drug to enter coronary circulation. The drug should be used secondarily to unsuccessful attempts with physical or electromechanical methods. Ophthalmologic use (for producing conjunctival decongestion, to control hemorrhage, produce mydriasis and reduce intraocular pressure)—Use a concentration of 1:10,000 (0.1 mg/mL) to 1:1,000 (1 mg/mL). Intraspinal use—Usual dose is 0.2 to 0.4 mL (0.2 to 0.4 mg) added to anesthetic spinal fluid mixture (may prolong anesthetic action by limiting absorption). For use with local anesthetic—Epinephrine 1:100,000 (0.01 mg/mL) to 1:20,000 (0.05 mg/mL) is the usual concentration employed with local anesthetics.