Adrenalin Chloride Solution (EPINEPHrine injection, USP)

 

Adrenalin® Chloride Solution (EPINEPHrine injection, USP), 1:1000 Adrenalin® Chloride Solution (EPINEPHrine nasal solution, USP) for topical use

Product Summary


Therapeutic Class: Sympathomimetic Agents This product is manufactured and distributed by MCP Pharmaceuticals, LLC

Product Profile:

  • Latex Free
  • Bar Coded
  • Preservative Status 1 mL Vial – No Antimicrobial Preservative Contains not more than 0.1% sodium bisulfite as an antioxidant 30 mL Vial Contains 0.5% Chlorobutanol (chloroform derivative) as a preservative and not more than 0.15% sodium bisulfite as an antioxidant.

 

Adrenalin Chloride Solution (EPINEPHrine injection, USP)

 

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.

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 of Prescribing Information).

Contraindications

Epinephrine is contraindicated in narrow angle (congestive) glaucoma, shock, during general anesthesia with halogenated hydrocarbons or cyclopropane and in individuals with organic brain damage. Epinephrine is also contraindicated with local anesthesia of certain areas, e.g., fingers, toes, because of the danger of vasoconstriction producing sloughing of tissue; in labor because it may delay the second stage; in cardiac dilatation and coronary insufficiency.

Warnings

Administer with caution to elderly people; to those with cardiovascular disease, hypertension, diabetes, or hyperthyroidism; in psychoneurotic individuals; and in pregnancy.

Patients with long-standing bronchial asthma and emphysema who have developed degenerative heart disease should be administered the drug with extreme caution.

Overdosage or inadvertent intravenous injection of epinephrine may cause cerebrovascular hemorrhage resulting from the sharp rise in blood pressure.

Fatalities may also result from pulmonary edema because of the peripheral constriction and cardiac stimulation produced. Rapidly acting vasodilators, such as nitrites, or alpha blocking agents may counteract the marked pressor effects of epinephrine.

Epinephrine is the preferred treatment for serious allergic or other emergency situations even though this product contains sodium bisulfite, a sulfite that may in other products cause allergic-type reactions including anaphylactic symptoms or life-threatening or less severe asthmatic episodes in certain susceptible persons. The alternatives to using epinephrine in a life-threatening situation may not be satisfactory. The presence of a sulfite in this product should not deter administration of the drug for treatment of serious allergic or other emergency situations.

Adverse Events

Transient and minor side effects of anxiety, headache, fear, and palpitations often occur with therapeutic doses, especially in hyperthyroid individuals. Repeated local injections can result in necrosis at sites of injection from vascular constriction. “Epinephrine-fastness” can occur with prolonged use.

Adrenalin ® Chloride Solution (EPINEPHrine nasal solution, USP), for topical use
  • Vasoconstrictor, for topical use only
  • For additional information please see Package Labeling

 

Please see the full prescribing information link above for additional information.

MK104D

 


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