Adyphren II Kit Epinephrine and Isopropyl Alcohol ADRENALIN EPINEPHRINE SODIUM CHLORIDE SODIUM METABISULFITE HYDROCHLORIC ACID WATER EPINEPHRINE EPINEPHRINE Isopropyl Alcohol ISOPROPYL ALCOHOL WATER ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL

Adrenalin (epinephrine injection, USP) is a clear, colorless, sterile solution containing 1 mg/mL epinephrine, packaged as 1 mL of solution in a single dose clear glass vial. In the 1 mL vial, each 1 mL of Adrenalin solution contains 1 mg epinephrine, 7.3 mg sodium chloride, 0.457 mg sodium metabisulfite, 1 mg sodium hydroxide, 2.25 mg tartaric acid, 0.20 mg disodium edetate dihydrate, hydrochloric acid to adjust pH, and water for injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine. The chemical name of epinephrine is: 1,2-Benzenediol, 4-[(1R)-1-hydroxy-2-(methylamino)ethyl]-, or (-)-3,4-Dihydroxy-α-[2-(methylamino)ethyl]benzyl alcohol. The chemical structure of epinephrine is: The molecular weight of epinephrine is 183.2. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. image description

Adrenalin ® is available as a single-use 1 mL vial. The 1 mL vial is for intramuscular, subcutaneous, and intraocular use. Adrenalin ® is a non-selective alpha and beta adrenergic agonist indicated for: Emergency treatment of allergic reactions (Type 1), including anaphylaxis (Adrenalin ® 1 mL vials) ( 1.1 ) Induction and maintenance of mydriasis during intraocular surgery (Adrenalin ® 1 mL vial only) ( 1.2 ) 1.1 Anaphylaxis (Adrenalin ® 1 mL single-use) Emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from allergic reactions to insect stings, biting insects, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. The signs and symptoms associated with anaphylaxis include flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with hypotension, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, airway swelling, laryngospasm, bronchospasm, pruritus, urticaria or angioedema, swelling of the eyelids, lips, and tongue. 1.2 Induction and Maintenance of Mydriasis during Intraocular Surgery (Adrenalin ® 1 mL single-use vial only) Induction and maintenance of mydriasis during intraocular surgery. Uses For first aid to decrease germs in minor cuts scrapes burns For preparation of the skin prior to injection

Anaphylaxis (Adrenalin ® 1 mL vials): Adults and Children 30 kg (66 lbs) or more : 0.3 to 0.5 mg (0.3 to 0.5 mL) intramuscularly or subcutaneously into anterolateral aspect of the thigh every 5 to 10 minutes as necessary ( 2.1 ) Children 30 kg (66 lbs) or less : 0.01 mg/kg (0.01 mL/kg), up to 0.3 mg (0.3 mL), intramuscularly or subcutaneously into anterolateral aspect of the thigh every 5 to 10 minutes as necessary ( 2.1 ) Intraocular surgery (Adrenalin ® 1 mL vial only): Dilute 1 mL with 100 to 1000 mL of an ophthalmic irrigation fluid, for ophthalmic irrigation or intracameral injection ( 2.2 ) 2.1 Anaphylaxis (Adrenalin ® 1 mL single-use vials) Inject Adrenalin ® intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary. When administering to a child, to minimize the risk of injection related injury, hold the leg firmly in place and limit movement prior to and during an injection. The injection may be repeated every 5 to 10 minutes as necessary. For intramuscular administration, use a needle long enough (at least 1/2 inch to 5/8 inch) to ensure the injection is administered into the muscle. Monitor the patient clinically for the severity of the allergic reaction and potential cardiac effects of the drug, with repeat doses titrated to effect. Do not administer repeated injections at the same site, as the resulting vasoconstriction may cause tissue necrosis. Inspect visually for particulate matter and discoloration prior to administration. Do not use if the solution is colored or cloudy, or if it contains particulate matter. Adults and Children 30 kg (66 lbs) or more : 0.3 to 0.5 mg (0.3 mL to 0.5 mL) of undiluted Adrenalin ® administered intramuscularly or subcutaneously in the anterolateral aspect of the thigh, up to a maximum of 0.5 mg (0.5 mL) per injection, repeated every 5 to 10 minutes as necessary. Monitor clinically for reaction severity and cardiac effects. Children less than 30 kg (66 lbs) : 0.01 mg/kg (0.01 mL/kg) of undiluted Adrenalin ® administered intramuscularly or subcutaneously in the anterolateral aspect of the thigh, up to a maximum of 0.3 mg (0.3 mL) per injection, repeated every 5 to 10 minutes as necessary. Monitor clinically for reaction severity and cardiac effects. 2.2 Induction and Maintenance of Mydriasis during Intraocular Surgery (Adrenalin ® 1 mL single-use vial only) Adrenalin ® must be diluted prior to intraocular use. Dilute 1 mL of Adrenalin ® 1 mg/mL (1:1000) in 100 to 1000 mL of an ophthalmic irrigation fluid to create an epinephrine concentration of 1:100,000 to 1:1,000,000 (10 mcg/mL to 1 mcg/mL). Use the irrigating solution as needed for the surgical procedure. After dilution in an ophthalmic irrigating fluid, Adrenalin ® may also be injected intracamerally as a bolus dose of 0.1 mL at a dilution of 1:100,000 to 1:400,000 (10 mcg/mL to 2.5 mcg/mL). Inspect visually for particulate matter and discoloration prior to administration. Do not use if the solution is colored or cloudy, or if it contains particulate matter. Note: The Adrenalin ® 30 mL multiple-dose vial is not for ophthalmic use. USE ONLY THE ADRENALIN 1 ML SINGLE-USE VIAL FOR OPHTHALMIC USE. Directions apply to skin as needed discard after single use

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Common adverse reactions to systemically administered epinephrine include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and respiratory difficulties. Arrhythmias, including fatal ventricular fibrillation, rapid rises in blood pressure producing cerebral hemorrhage, and angina have occurred ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Par Pharmaceutical, Inc. at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Adverse Reactions Associated with Intramuscular/Subcutaneous Use (for Anaphylaxis) Common adverse reactions to systemically administered epinephrine include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and respiratory difficulties. These symptoms occur in some persons receiving therapeutic doses of epinephrine, but are more likely to occur in patients with heart disease, hypertension, or hyperthyroidism [ see Warnings and Precautions (5.5) ]. 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. Adverse reactions reported in observational trials, case reports, and studies are listed below by body system: Cardiovascular : angina, arrhythmias, hypertension, pallor, palpitations, tachyarrhythmia, tachycardia, vasoconstriction, and ventricular ectopy. Angina may occur in patients with coronary artery disease [ see Warnings and Precautions (5.5) ]. Arrhythmias, including fatal ventricular fibrillation, have occurred, particularly in patients with underlying organic heart disease or patients receiving drugs that sensitize the heart to arrhythmias [ see Warnings and Precautions (5.5) ]. Rapid rises in blood pressure associated with epinephrine use have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease [ see Warnings and Precautions (5.5) ]. Respiratory : respiratory difficulties. Neurological : dizziness , disorientation , excitability , headache , impaired memory , lightheadedness , nervousness , panic, psychomotor agitation, sleepiness , tingling , tremor, and weakness. Psychiatric : anxiety, apprehensiveness, restlessness. Gastrointestinal : nausea, vomiting. Other : Patients with Parkinson's disease may experience psychomotor agitation or a temporary worsening of symptoms [ see Warnings and Precautions (5.5) ]. Diabetic patients may experience transient increases in blood sugar [ see Warnings and Precautions (5.5) ]. Accidental injection into the digits, hands or feet may result in loss of blood flow to the affected area [ see Warnings and Precautions (5.3) ]. Adverse events experienced as a result of an injection into these areas include increased heart rate, local reactions including injection site pallor, coldness, hypoesthesia, and tissue loss, or injury at the injection site resulting in bruising, bleeding, discoloration, erythema, and skeletal injury. Injection into the buttock has resulted in cases of gas gangrene [ see Warnings and Precautions (5.3) ]. Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported following epinephrine injection in the thigh [see Warnings and Precautions (5.4) ] . Skin : sweating. 6.2 Adverse Reactions Associated with Intraocular Use (for Mydriasis) Epinephrine containing sodium bisulfite has been associated with corneal endothelial damage when used in the eye at undiluted concentrations (1 mg/mL). To report SUSPECTED ADVERSE REACTIONS, contact Par Pharmaceutical, Inc. at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Epinephrine should be administered cautiously to patients taking other sympathomimetic agents because of the possibility of additive effects. Patients who are concomitantly receiving cardiac glycosides, digitalis, diuretics, quinidine, and other antiarrhythmics should be observed carefully for the development of cardiac arrhythmias [ see Warnings and Precautions (5.5) and Adverse Reactions (6.1) ]. Administer epinephrine cautiously to patients receiving halogenated hydrocarbon general anesthetics, such as halothane, as coadministration may result in arrhythmias. The effects of epinephrine may be potentiated by tricyclic antidepressants such as imipramine, monoamine oxidase inhibitors (MAOI), levothyroxine sodium, and certain antihistamines, notably diphenhydramine, tripelannamine, and dexchlorpheniramine. The cardiostimulating and bronchodilating effects of epinephrine are antagonized by beta-adrenergic blocking drugs, such as propranolol. The vasoconstricting and hypertensive effects of epinephrine are antagonized by alpha-adrenergic blocking drugs, such as phentolamine. Ergot alkaloids may reverse the pressor effects of epinephrine. Epinephrine should not be used to counteract circulatory collapse or hypotension caused by phenothiazines, as a reversal of the pressor effects of epinephrine may result in further lowering of blood pressure. Sympathomimetic agents: possible additive effects ( 7 ) Cardiac glycosides, halogenated hydrocarbon anesthetics, or diuretics: observe for development of cardiac arrhythmias ( 7 ) Tricyclic antidepressants, MAO inhibitors, levothyroxine sodium, and certain antihistamines: potentiate effects of epinephrine ( 7 ) Beta-adrenergic blocking drugs: antagonize the cardiostimulating and bronchodilating effects of epinephrine ( 7 ) Alpha-adrenergic blocking drugs: antagonize the vasoconstricting and hypertensive effects of epinephrine ( 7 ) Ergot alkaloids may reverse the pressor response to epinephrine ( 7 )

Purpose Antiseptic

Do not use with electrocautery procedures

When using this product do not get into eyes apply over large areas of the body in case of deep or puncture wounds, animal bites or serious burns consult a doctor

Stop use and ask a doctor if condition persists or gets worse or lasts for more than 72 hours do not use longer than 1 week unless directed by a doctor

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Store between 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] . Epinephrine is light sensitive. Protect from light and freezing. Inspect visually for particulate matter and discoloration prior to administration. Do not use the solution if it is colored or cloudy, or if it contains particulate matter. Other information Protect from freezing and avoid excessive heat