EPINEPHRINE

Overdosage or accidental intravenous administration of conventional subcutaneous doses may induce severe or fatal hypertension, or cerebrovascular hemorrhage. Fatalities may also occur from pulmonary edema resulting from peripheral constriction and cardiac stimulation. The marked pressor effects may be counteracted by use of rapidly acting vasodilators, such as the nitrites and alpha-adrenergic blockers.

Deaths have been reported in asthmatics treated with epinephrine following the use of isoproterenol or orciprenaline. 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(s) in this product should not deter administration of the drug for treatment of serious allergic or other emergency situations.

Epinephrine must be administered with great caution, if at all, in patients with cardiac arrhythmias, coronary artery or organic heart disease, and hypertension. In patients with coronary insufficiency or ischemic heart disease, epinephrine may precipitate or aggravate angina pectoris as well as produce potentially fatal ventricular arrhythmias. Epinephrine should be administered only with great caution to elderly patients, those with diabetes mellitus, hyperthyroidism, or psychoneurotic disorders; also to those with long-standing bronchial asthma or emphysema if such individuals may also have degenerative heart disease, and to pregnant women (see PRECAUTIONS: Pregnancy).

CHLO-AMINE®

Chlorpheniramine maleate should be used with extreme caution in patients with stenosing peptic ulcer, pyloroduodenal obstruction, prostatic hypertrophy, or bladder neck obstruction. These compounds have an atropine-like action and therefore should be used with caution in patients with a history of increased intraocular pressure, cardiovascular disease, or hypertension. The asthmatic patient should take the chlorpheniramine maleate tablets with caution.

General

Ana-Kit® is not intended to be a substitute for medical attention or hospital care. The kit is designed to be compact and easy to carry, and to provide emergency treatment when medical care is not immediately available. Highly sensitive individuals should have the kit readily available at all times. Because of its small size it can be carried by outdoor sportsmen, golfers, gardeners, or any sensitive individual who may be exposed to stinging insects (wasps, hornets, yellow jackets, fire ants or bees) or other potentially life-threatening allergens. The drugs in the Ana-Kit®; when used as directed immediately following exposure to an allergen, may prove life-saving. Certain changes in the emergency instructions and in the kit itself may be made by the doctor according to the needs of the patient. IN ALL CASES THE PHYSICIAN SHOULD INSTRUCT THE PATIENT, AND/OR ANY OTHER PERSON WHO MIGHT BE IN A POSITION TO ADMINISTER THE EPINEPHRINE, IN THE PROPER USE OF THE SYRINGE AND THE OTHER COMPONENTS OF THIS KIT.

Information for Patients

See PATIENT INFORMATION section.

Drug Interactions

See DRUG INTERACTIONS section.

Carcinogenesis, Mutagenesis, Impairment of Fertility

There are no data from either animal or human studies regarding the carcinogenicity or mutagenicity of epinephrine or Chlo-Amine®, and no studies have been conducted to determine their potential for the impairment of fertility.

Pregnancy

Teratogenic Effects. Pregnancy Category C - Epinephrine has been shown to be teratogenic in rats and hamsters at dose levels hundreds of times as high as the maximal human dose. Although there are no adequate or well-controlled studies in pregnant women, epinephrine crosses the placenta and its use during pregnancy may cause anoxia in the fetus. Epinephrine should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Pediatric Use

Administer Epinephrine or Chlo-Amine® with caution to infants and children (see DOSAGE AND ADMINISTRATION). Syncope has occurred following the administration of epinephrine to asthmatic children.

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