General Adrenaclick is not intended as a substitute for immediate medical care. In conjunction with the administration of epinephrine, the patient should seek appropriate medical care. More than two sequential doses of epinephrine should only be administered under direct medical supervision. Epinephrine is essential for the treatment of anaphylaxis. Patients with a history of severe allergic reactions should be instructed about the circumstances under which epinephrine should be used (See INDICATIONS AND USAGE Section). It should be determined that the patient is at risk of future anaphylaxis, since there are some concerns in specific patients with epinephrine administration, (a) Epinephrine should be used with caution in patients with cardiac arrhythmias, coronary artery or organic heart disease, hypertension, or in patients who are on medications that may sensitize the heart to arrhythmias, e.g., digitalis, diuretics, or anti-arrhythmics. In such patients, epinephrine may precipitate or aggravate angina pectoris as well as produce ventricular arrhythmias. (b) The effects of epinephrine may be potentiated by tricyclic antidepressants and monoamine oxidase inhibitors, (c) Some patients may be at greater risk of developing adverse reactions after epinephrine administration. These include patients with hyperthyroidism, cardiovascular disease, hypertension, diabetes, and elderly individuals, and pregnant women. It must be noted that, despite these concerns, epinephrine is essential for the treatment of anaphylaxis. Therefore, patients with these conditions, or any other person who might be in a position to administer epinephrine to a patient with these conditions experiencing anaphylaxis, should be instructed about the circumstances under which epinephrine should be used. Information for Patients Complete patient information, including dosage, directions for proper administration, and precautions, can be found inside each Adrenaclick package within the PATIENT INFORMATION Leaflet. Epinephrine may produce symptoms and signs that include an increase in pulse rate, the sensation of a more forceful heartbeat, palpitations, a throbbing headache, pallor, feelings of overstimulation, anxiety, weakness, shakiness, dizziness, or nausea. These signs and symptoms usually subside rapidly, especially with rest, quiet, and recumbency. Patients with hypertension or hyperthyroidism may develop more severe or persistent effects, and patients with coronary artery disease could experience angina. Patients with diabetes may develop increased blood glucose levels following epinephrine administration. Patients with Parkinson's disease may notice a temporary worsening of symptoms. Carcinogenesis, Mutagenesis, Impairment of Fertility There are no data from either animal or human studies regarding the carcinogenicity or mutagenicity of epinephrine, and no studies have been conducted to determine its potential for the impairment of fertility. This should not prevent the use of epinephrine under the conditions noted under INDICATIONS AND USAGE section. Pregnancy Pregnancy Category C Epinephrine has been shown to have developmental effects in rabbits at a subcutaneous dose of 1.2 mg/kg (approximately 30 times the maximum recommended daily subcutaneous or intramuscular dose on a mg/m² basis), in mice at a subcutaneous dose of 1 mg/kg (approximately 7 times the maximum recommended daily subcutaneous or intramuscular dose on a mg/m² basis), and in hamsters at a subcutaneous dose of 0.5 mg/kg (approximately 5 times the maximum recommended daily subcutaneous or intramuscular dose on a mg/m² basis). These effects were not seen in mice at a subcutaneous dose of 0.5 mg/kg (approximately 3 times the maximum recommended daily subcutaneous or intramuscular dose on a mg/m² basis). Although there are no adequate and well-controlled studies in pregnant women, epinephrine crosses the placenta and could lead to fetal anoxia, spontaneous abortion or both. Therefore, epinephrine should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Last reviewed on RxList: 9/20/2013
This monograph has been modified to include the generic and brand name in many instances.