Epipen (Epinephrine)

EPIPEN® EPIPEN® JR.

Allerex

Epinephrine

Allergy Therapy Auto-Injector

Action And Clinical Pharmacology: Epinephrine is a sympathomimetic drug, acting on both alpha and beta receptors. It is the drug of choice for the emergency treatment of severe allergic reactions to insect bites, insect stings, food, medication and other allergens. It is also indicated for the temporary emergency treatment of severe, life-threatening asthma attacks. The strong vasoconstrictor action of epinephrine acts quickly to counter vasodilation and resulting increased capillary permeability. By its effect on smooth muscle, epinephrine relaxes the bronchioles, relieving wheezing and dyspnea. Its action also relieves angioedema or hives.

Indications And Clinical Uses: In the emergency treatment of anaphylactic reactions. The auto-injectors are intended for immediate self-administration by individuals with a history of hypersensitivity to insect stings or bites, foods, drugs and other allergens as well as idiopathic or exercise-induced anaphylaxis. They are also intended for self-administration of asthmatics presenting a risk of severe, life-threatening asthma attacks. They are designed as emergency supportive therapy only and not as a replacement or substitute for subsequent medical or hospital care, nor are they intended to supplant insect venom hyposensitization.

Contra-Indications: In individuals with organic brain damage.

Manufacturers’ Warnings In Clinical States: Epinephrine is light sensitive and should be stored in the tube provided. Store at room temperature (15 to 30°C). Do not refrigerate. Before using, check to make sure solution in auto-injector is not brown in color. If it is discolored or contains a precipitate, do not use.

Accidental injection into the hands or feet may result in loss of blood flow to the affected areas and should be avoided. If there is an accidental injection into these areas, go immediately to the nearest emergency room for treatment. Epinephrine should only be injected into the thigh. Every effort should be made to avoid possible inadvertent intravascular administration through appropriate selection of an injection site such as the thigh. Do not inject into buttock. Large doses or accidental i.v. 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. Epinephrine should be administered with extreme caution to patients who have developed degenerative heart disease. Use of epinephrine with drugs that sensitize the heart to arrhythmias is not recommended. Anginal pain may be induced by epinephrine in patients with coronary insufficiency.

Precautions: The effects of epinephrine may be potentiated by tricyclic antidepressants; certain antihistamines, e.g., diphenhydramine, tripelennamine, d-chlorpheniramine, and sodium levothyroxine. Administer with caution to hyperthyroid individuals, individuals with cardiovascular disease, hypertension, or diabetes, elderly individuals, psychoneurotic individuals, pregnant women, and children under 30 kg body weight.

Adverse Reactions: Transient and minor side effects of epinephrine include palpitation, respiratory difficulty, pallor, dizziness, weakness, tremor, headache, throbbing, restlessness, tenseness, anxiety and fear. Ventricular arrhythmias may follow administration of epinephrine.

Dosage And Administration: Dosage in any specific patient should be based on body weight in addition to the patient’s risk of anaphylaxis and ability to tolerate epinephrine. Usual epinephrine adult dose for allergic adult emergencies is 0.3 mg. Usual pediatric dose is 0.01 mg/kg body weight. A physician who prescribes EpiPen or EpiPen Jr. should take appropriate steps to insure that the patient understands the indications and use of the device thoroughly. The physician should review with the patient, in detail, the package insert and operation of the auto-injector. Inject the delivered dose of the auto-injector i.m. into the anteriolateral aspect of the thigh. See package insert.

EpiPen and EpiPen Jr. contain 2 mL but deliver a single dose of 0.3 mL only , with 1.7 mL remaining in the unit after use.

Availability And Storage: The EpiPen device provides epinephrine for i.m. auto-injection in a sterile solution prepared from epinephrine with the aid of hydrochloric acid in pyrogen-free water.

EpiPen: Each auto-injector contains: 2 mL epinephrine injection 1:1 000 and is designed to deliver a single dose of epinephrine 0.3 mg. Each mL contains: epinephrine 1 mg. Also contains sodium chloride 6 mg, sodium metabisulfite 1.67 mg and hydrochloric acid to adjust pH.

EpiPen Jr.: Each auto-injector contains: 2 mL epinephrine injection 1: 2 000 and is designed to deliver a single dose of epinephrine 0.15 mg. Each mL contains: epinephrine 0.5 mg. Also contains sodium chloride 6 mg, sodium metabisulfite 1.67 mg and hydrochloric acid to adjust pH.

Packages of 1 auto-injector and packages of 6 units. Training device for patient instruction purposes also available.

EPIPEN® EPIPEN® JR. Allerex Epinephrine Allergy Therapy Auto-Injector

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