EPINEPHRINE INJECTION (JR) MYLAN

/ Dexcel

Selection of the appropriate dosage strength (Epinephrine Injection 0.3 mg or Epinephrine Injection Jr 0.15 mg) is determined according to patient body weight.
* Patients greater than or equal to 30 kg: Epinephrine Injection 0.3 mg
* Patients 15 to 30 kg: Epinephrine Injection 0.15 mg
Inject Epinephrine Injection intramuscularly into the anterolateral aspect of the thigh, through clothing if necessary. Instruct caregivers of young children who are prescribed an Epinephrine Injection and who may be uncooperative and kick or move during an injection to hold the leg firmly in place and limit movement prior to and during an injection.
Each Epinephrine Injection contains a single dose of epinephrine for single-use injection. Since the doses of epinephrine delivered from Epinephrine Injection are fixed, consider using other forms of injectable epinephrine if doses lower than 0.15 mg are deemed necessary.
The prescriber should carefully assess each patient to determine the most appropriate dose of epinephrine, recognizing the life-threatening nature of the reactions for which this drug is indicated. With severe persistent anaphylaxis, repeat injections with an additional Epinephrine Injection may be necessary. More than two sequential doses of epinephrine should only be administered under direct medical supervision.

Epinephrine Injection are indicated in the emergency treatment of severe allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.
Epinephrine Injection are intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions.
Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema.
Epinephrine Injection are intended for immediate administration as emergency supportive therapy only and Epinephrine Injection are not a substitute for immediate medical care.

Emergency Treatment
Epinephrine Injection are intended for immediate administration as emergency supportive therapy and are not intended as a substitute for immediate medical care. In conjunction with the administration of epinephrine, the patient should seek immediate medical or hospital care. More than two sequential doses of epinephrine should only be administered under direct medical supervision.
Injection-Related Complications
Epinephrine Injection should only be injected into the anterolateral aspect of the thigh.
Do not inject intravenously– large doses or accidental intravenous injection of epinephrine may result in cerebral hemorrhage due to sharp rise in blood pressure. Rapidly acting vasodilators can counteract the marked pressor effects of epinephrine if there is such inadvertent administration.
Do not inject into buttock- injection into the buttock may not provide effective treatment of anaphylaxis. Advise the patient to go immediately to the nearest emergency room for further treatment of anaphylaxis. Additionally, injection into the buttock has been associated with Clostridial infections (gas gangrene). Cleansing with alcohol does not kill bacterial spores, and therefore, does not lower this risk.
Do not inject into digits, hands or feet– since epinephrine is a strong vasoconstrictor, accidental injection into the digits, hands or feet may result in loss of blood flow to the affected area. Advise the patient to go immediately to the nearest emergency room and to inform the healthcare provider in the emergency room of the location of the accidental injection. Treatment of such inadvertent administration should consist of vasodilation, in addition to further appropriate treatment of anaphylaxis.
Hold leg firmly during injection– lacerations, bent needles, and embedded needles have been reported when Epinephrine Injection have been injected into the thigh of young children who are uncooperative and kick or move during an injection. To minimize the risk of injection related injury when administering Epinephrine Injection to young children, instruct caregivers to hold the child’s leg firmly in place and limit movement prior to and during injection.
It is necessary to hold firmly the injection in place for 3 seconds.
Serious Infections at the Injection Site
Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported at the injection site following epinephrine injection for anaphylaxis. Clostridium spores can be present on the skin and introduced into the deep tissue with subcutaneous or intramuscular injection. While cleansing with alcohol may reduce presence of bacteria on the skin, alcohol cleansing does not kill Clostridium spores. To decrease the risk of Clostridium infection, do not inject Epinephrine Injection into the buttock. Advise patients to seek medical care if they develop signs or symptoms of infection, such as persistent redness, warmth, swelling, or tenderness, at the epinephrine injection site.
Allergic Reactions Associated with Sulfite
The presence of a sulfite in this product should not deter administration of the drug for treatment of serious allergic or other emergency situations even if the patient is sulfite-sensitive.
Epinephrine is the preferred treatment for serious allergic reactions or other emergency situations even though this product contains sodium metabisulfite, 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.
Disease Interactions
Some patients may be at greater risk for developing adverse reactions after epinephrine administration. Despite these concerns, it should be recognized that the presence of these conditions is not a contraindication to epinephrine administration in an acute, life-threatening situation. Therefore, patients with these conditions, and/or any other person who might be in a position to administer Epinephrine Injection Mylan or Epinephrine Injection Mylan Jr to a patient experiencing anaphylaxis
should be carefully instructed in regard to the circumstances under which epinephrine should be used.
Patients with Heart Disease
Epinephrine should be administered with caution to patients who have heart disease, including patients with cardiac arrhythmias, coronary artery or organic heart disease, or hypertension. In such patients, or in patients who are on drugs that may sensitize the heart to arrhythmias, epinephrine may precipitate or aggravate angina pectoris as well as produce ventricular arrhythmias.
Other Patients and Diseases
Epinephrine should be administered with caution to patients with hyperthyroidism, diabetes, elderly individuals, and pregnant women. Patients with Parkinson’s disease may notice a temporary worsening of symptoms.

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 is difficult to determine.
See prescribing information for full details.

Cardiac Glycosides, Diuretics, and Anti-arrhythmics
Patients who receive epinephrine while concomitantly taking cardiac glycosides, diuretics, or anti- arrhythmics should be observed carefully for the development of cardiac arrhythmias.
Antidepressants, Monoamine Oxidase Inhibitors, Levothyroxine, and Antihistamines
The effects of epinephrine may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium, and certain antihistamines, notably chlorpheniramine, tripelennamine, and diphenhydramine.
Beta-Adrenergic Blockers
The cardiostimulating and bronchodilating effects of epinephrine are antagonized by beta- adrenergic blocking drugs, such as propranolol.
Alpha-Adrenergic Blockers
The vasoconstricting and hypertensive effects of epinephrine are antagonized by alpha- adrenergic blocking drugs, such as phentolamine.
Ergot Alkaloids
Ergot alkaloids may also reverse the pressor effects of epinephrine.

Pregnancy: There are no adequate and well controlled studies of the acute effect of epinephrine in pregnant women. Epinephrine is the first -line medication of choice for the treatment of anaphylaxis during pregnancy in humans.
Epinephrine should be used for treatment of anaphylaxis during pregnancy in the same manner as it is used in non- pregnant patients.
Lactation: There is no information on the presence of epinephrine in human milk, the effects on breastfed, infants, or the effects on milk production. Epinephrine is the first line -medication of choice for treatment of anaphylaxis; it should be used in the same manner in breastfeeding and non-breastfeeding patients.
See prescribing information for full details.

Overdosage of epinephrine may produce extremely elevated arterial pressure, which may result in cerebrovascular hemorrhage, particularly in elderly patients. Overdosage may also result in pulmonary edema because of peripheral vascular constriction together with cardiac stimulation. Treatment consists of rapidly acting vasodilators or alpha-adrenergic blocking drugs and/or respiratory support.
Epinephrine overdosage can also cause transient bradycardia followed by tachycardia, and these may be accompanied by potentially fatal cardiac arrhythmias. Premature ventricular contractions may appear within one minute after injection and may be followed by multifocal ventricular tachycardia (prefibrillation rhythm). Subsidence of the ventricular effects may be followed by atrial tachycardia and occasionally by atrioventricular block. Treatment of arrhythmias consists of administration of a beta-adrenergic blocking drug such as propranolol.