Adrenalin

Name: Adrenalin

What other information should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. If you use a pre-filled automatic injection device, be sure to get a replacement right away. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

How supplied

Dosage Forms And Strengths

Adrenalin® 1 mg/mL (1:1000) epinephrine injection, 1 mL solution in a single-use clear glass vial and 30 mL solution in a multiple-dose amber glass vial.

Storage And Handling

Adrenalin® 1 mL Single-Use Vials

Each carton contains 25 single-use vials containing 1 mL Adrenalin® (epinephrine injection, USP) solution 1 mg/mL (1:1000) in a 3 mL clear glass vial.

NDC 42023-159-25 1 mL vial

Adrenalin® 30 mL Multi-Dose Vials

Each carton contains either 1 multiple-dose vial or 10 multiple-dose vials containing 30 mL Adrenalin® (epinephrine injection, USP) solution 1 mg/mL (1:1000) in a 36 mL amber glass vial.

NDC 42023-168-01 30 mL vial, pack of 1
NDC 42023-168-10 30 mL vial, pack of 1

Vial and contents must be discarded 30 days after initial use.

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.

Distributed by: Par Pharmaceutical Companies, Inc. Chestnut Ridge, NY 10977. Revised: May 2016

Patient information

Advise patients or their caregivers about common adverse reactions associated with the use of epinephrine including an increase in heart rate, the sensation of a more forceful heartbeat, palpitations, sweating, nausea and vomiting, difficulty breathing, pallor, dizziness, weakness or shakiness, headache, apprehension, nervousness, or anxiety. These symptoms and signs usually subside rapidly, especially with rest, quiet and recumbent positioning.

Warn patients with a good response to initial treatment about the possibility of recurrence of symptoms and instruct patients to obtain proper medical attention if symptoms return.

Warn patients with diabetes that they may develop increased blood glucose levels following epinephrine administration.

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. 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. [see WARNINGS AND PRECAUTIONS]

What is Adrenalin (epinephrine injection)?

Epinephrine is a chemical that narrows blood vessels and opens airways in the lungs. These effects can reverse severe low blood pressure, wheezing, severe skin itching, hives, and other symptoms of an allergic reaction.

Epinephrine injection is used to treat severe allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs, and other allergens. Epinephrine is also used to treat exercise-induced anaphylaxis.

Epinephrine auto-injectors may be kept on hand for self-injection by a person with a history of an severe allergic reaction.

Epinephrine injection may also be used for purposes not listed in this medication guide.

What happens if I overdose?

Seek emergency medical attention right away after any use of epinephrine injection.

Symptoms of an epinephrine overdose may include worsened breathing trouble, sudden numbness or weakness on one side of the body, slurred speech, problems with vision or balance, or dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

What should I avoid while using Adrenalin (epinephrine injection)?

Do not inject epinephrine into a vein or into the muscles of your buttocks, or it may not work as well. Inject it only into the fleshy outer portion of the thigh.

Accidentally injecting epinephrine into your hands or feet may result in a loss of blood flow to those areas, and resulting numbness.

Adrenalin (epinephrine injection) side effects

Before using epinephrine, tell your doctor if any past use of this medicine caused an allergic reaction to get worse.

Call your doctor at once if you notice pain, swelling, warmth, redness, or other signs of infection around the area where you gave an injection.

Common side effects may include:

  • fast or pounding heartbeats;

  • pale skin, sweating;

  • nausea and vomiting;

  • dizziness;

  • weakness or tremors;

  • throbbing headache; or

  • feeling nervous, anxious, or fearful.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information i should know about epinephrine injection?

Before using this medication, tell your doctor if you have heart disease or high blood pressure, a heart rhythm disorder, coronary artery disease, Parkinson's disease, diabetes, or a thyroid disorder.

Before using epinephrine, tell your doctor about all other medications you use, especially digoxin (digitalis, Lanoxin), heart or blood pressure medicine, heart rhythm medication, an antidepressant, a diuretic (water pill), thyroid medication, migraine headache medicine, cold or sleep medicine that contains an antihistamine, or an MAO inhibitor such as Marplan, Nardil, Azilect, Eldepryl, Emsam, or Parnate.

Seek emergency medical attention even after you use epinephrine to treat a severe allergic reaction. The effects of epinephrine may wear off after 10 or 20 minutes. You will need to receive further treatment and observation.

Before using epinephrine a second time, tell your doctor if your first injection caused a serious side effect such as increased breathing difficulty, or dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Side effects

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].

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].

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].

Rapid rises in blood pressure associated with epinephrine use have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease [see WARNINGS AND PRECAUTIONS].

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].

Diabetic patients may experience transient increases in blood sugar [see WARNINGS AND PRECAUTIONS].

Accidental injection into the digits, hands or feet may result in loss of blood flow to the affected area [see WARNINGS AND PRECAUTIONS]. 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].

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].

Skin: sweating.

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.

Read the entire FDA prescribing information for Adrenalin (Epinephrine)

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For Healthcare Professionals

Applies to epinephrine: compounding powder, inhalation aerosol, inhalation solution, injectable kit, injectable solution, intravenous solution, subcutaneous suspension

General

Due to the lack of randomized, controlled clinical trials for the treatment of anaphylaxis, the true incidence of adverse reactions associated with the systemic use of this drug is difficult to determine. The most commonly reported adverse reactions include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and/or respiratory difficulties.[Ref]

Cardiovascular

Frequency not reported: Tachycardia, supraventricular tachycardia, ventricular arrhythmias, myocardial ischemia, myocardial infarction, limb/peripheral ischemia, palpitations, angina, arrhythmias, hypertension, vasoconstriction, ventricular ectopy, ventricular fibrillation, cold extremities, electrocardiogram changes, stress cardiomyopathy[Ref]

Nervous system

Frequency not reported: Headache, paresthesia, tremor, stroke, central nervous system bleeding, dizziness, cerebral hemorrhage, memory impaired, lightheadedness, psychomotor agitation, tingling, Parkinsonism aggravated, syncope, convulsions, subarachnoid hemorrhage, hemiplegia[Ref]

Psychiatric

Frequency not reported: Nervousness, excitability, anxiety, apprehension, restlessness, disorientation, panic, hallucinations, psychosis, fear, sleeplessness/insomnia, tenseness, confusion, irritability[Ref]

Local

Frequency not reported: Extravasation, injection site pallor, coldness at injection site, hypoesthesia at injection site, injury at injection site, local ischemic necrosis[Ref]

Dermatologic

Frequency not reported: Diaphoresis, pallor, piloerection, skin blanching, skin necrosis with extravasation, necrotizing fasciitis, flushing/redness of skin and face, hyperhidrosis[Ref]

Metabolic

Frequency not reported: Hypoglycemia, hyperglycemia, insulin resistance, hypokalemia, lactic acidosis, insulin secretion inhibited, metabolic acidosis, anorexia[Ref]

Respiratory

Frequency not reported: Pulmonary edema, rales, respiratory difficulty, dyspnea, bronchospasm, hypoxia of mucosa[Ref]

Renal

Frequency not reported: Renal insufficiency[Ref]

Hypersensitivity

Hypersensitivity side effects have been extremely unusual. Contact dermatitis has been associated with ocularly applied epinephrine (the active ingredient contained in Adrenalin) These reactions have typically presented with lid edema and a thick yellow discharge.

Gastrointestinal

Frequency not reported: Nausea, vomiting, bowel necrosis, hypersalivation[Ref]

Genitourinary

Frequency not reported: Urinary retention, difficult micturition[Ref]

Hematologic

Frequency not reported: Thrombocytosis[Ref]

Musculoskeletal

Frequency not reported: Myonecrosis[Ref]

Other

Frequency not reported: Chest pain, weakness, gas gangrene, asthenia[Ref]

Ocular

Frequency not reported: Corneal endothelial damage[Ref]

Endocrine

Frequency not reported: Growth hormone secretion stimulated[Ref]

Some side effects of Adrenalin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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