Adyphren Amp

Adyphren Amp® is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which includes bees, wasps, hornets, yellow jackets and fire ants), and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media), and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.

Adyphren Amp is intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions.

Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria, or angioedema.

Adyphren Amp is intended for immediate administration as emergency supportive therapy only and is not a replacement or substitute for immediate medical care.

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.

Adyphren Amp is used to treat severe allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs, and other allergens.

Epinephrine auto-injectors may be kept on hand for self-injection by a person with a history of severe allergic reaction. Adyphren Amp is for use in adults and children who weigh at least 16.5 pounds (7.5 kilograms).

Epinephrine is also used to treat exercise-induced anaphylaxis, or to treat low blood pressure that is caused by septic shock.

Adyphren Amp may also be used for purposes not listed in this medication guide.

Selection of the appropriate dosage strength (Adyphren Amp 0.3 mg or Adyphren Amp 0.15 mg) is determined according to patient body weight.

• Patients greater than or equal to 30 kg (approximately 66 pounds or more): Adyphren Amp 0.3 mg
• Patients 15 to 30 kg (33 pounds to 66 pounds): Adyphren Amp 0.15 mg

Inject Adyphren Amp intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary. Instruct caregivers of young children who are prescribed Adyphren Amp and who may be uncooperative and kick or move during an injection to hold the child's leg firmly in place and limit movement prior to and during an injection.

Each Adyphren Amp contains a single dose of epinephrine for single-use injection. Since the doses of epinephrine delivered from Adyphren Amp are fixed, consider using other forms of injectable epinephrine if doses lower than 0.15 mg are deemed necessary.

The prescriber should carefully assess each patient to determine the most appropriate dose of epinephrine, recognizing the life-threatening nature of the reactions for which this drug is indicated. With severe persistent anaphylaxis, repeat injections with an additional Adyphren Amp may be necessary. More than two sequential doses of epinephrine should only be administered under direct medical supervision.

The epinephrine solution in the viewing window of Adyphren Amp should be inspected visually for particulate matter and discoloration. Epinephrine is light sensitive and should be stored in the outer case provided to protect it from light.

How supplied

Dosage Forms And Strengths

• Injection, 0.3 mg/0.3 mL epinephrine injection, USP, pre-filled auto-injector
• Injection, 0.15 mg/0.15 mL epinephrine injection, USP, pre-filled auto-injector

Carton containing two Adyphren Amp (epinephrine injection, USP) 0.3 mg auto-injectors and a single Adyphren Amp Trainer -NDC 60842-023-01

Carton containing two Adyphren Amp (epinephrine injection, USP) 0.15 mg auto-injectors and a single Adyphren Amp Trainer -NDC 60842-022-01

Storage And Handling

Epinephrine is light sensitive and should be stored in the outer case provided to protect it from light. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). Do not refrigerate. Before using, check to make sure the solution in the auto-injector is clear and colorless. Replace the auto-injector if the solution is discolored, cloudy, or contains particles.

Manufactured for: Kaleo, Inc. Richmond, VA 23219 USA. Revised: May 2016

See also:
What is the most important information I should know about Adyphren Amp?

Epinephrine is contraindicated in patients with known hypersensitivity to sympathomimetic amines, in patients with angle closure glaucoma, and patients in shock (nonanaphylactic). It should not be used in patients anesthetized with agents such as cyclopropane or halothane as these may sensitize the heart to the arrhythmic action of sympathomimetic drugs.

Addition of epinephrine to local anesthetics for injection of certain areas (e.g., fingers, toes, ears, etc.) is contraindicated because of danger that vasoconstriction may result in sloughing of tissue.

Except as diluted for admixture with local anesthetics to reduce absorption and prolong action, epinephrine should not ordinarily be used in those cases where vasopressor drugs may be contraindicated, e.g., in thyrotoxicosis, diabetes, in obstetrics when maternal blood pressure is in excess of 130/80 and in hypertension and other cardiovascular disorders.

• Each Adyphren Amp contains only one dose of medicine.
• Adyphren Amp should only be injected into the muscle of your outer thigh. It can be injected through your clothing, if needed
• Read the Instructions for Use included with Adyphren Amp for information about the right way to use Adyphren Amp.
• Use Adyphren Amp exactly as your healthcare provider tells you to use it.
• An Adyphren Amp Trainer with a separate Trainer Instructions for Use leaflet is included with Adyphren Amp. Additional training resources are available at www.Adyphren Amp.com.
  • Practice with the Adyphren Amp Trainer before an allergic emergency happens to make sure you are able to safely use the real Adyphren Amp in an emergency.
  • The Adyphren Amp Trainer does not contain a needle or medicine and can be reused to practice your injection.

This medication is used in emergencies to treat very serious allergic reactions to insect stings/bites, foods, drugs, or other substances. Epinephrine acts quickly to improve breathing, stimulate the heart, raise a dropping blood pressure, reverse hives, and reduce swelling of the face, lips, and throat.

How to use Adyphren Amp injection

Keep this product near you at all times..

Different brands of this medication have different directions for preparing and using the injector. Learn how to properly inject this medication in advance so you will be prepared when you actually need to use it. Also teach a family member or caregiver what to do if you cannot inject the medication yourself. For children, make sure to hold their leg in place before and during the injection of the medication to prevent injuries from occurring. Read the Patient Information Leaflet provided by your pharmacist before you have to use epinephrine and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

The effects of this medication are rapid but not long-lasting. After injecting epinephrine, get medical help right away. Tell the healthcare professional that you have given yourself an injection of epinephrine. Avoid injecting this medication into your hands, feet, buttocks, or areas of your body other than the thigh. If this occurs, tell the healthcare professional right away. Discard the injector properly.

The solution in this product should be clear. Check this product visually for particles or discoloration from time to time. If it has turned cloudy or pink/brown in color, do not use the product. Obtain a new supply.

See also:
What other drugs will affect Adyphren Amp?

Alpha-adrenergic blocking agents (eg, phentolamine), ergot derivative (eg, ergotamine), nitrites, phenothiazines (eg, chlorpromazine)

May counteract the epinephrine pressor effects.

Antihistamines (eg, chlorpheniramine, diphenhydramine), COMT inhibitors (eg, entacapone, tolcapone), levothyroxine, linezolid, MAOIs (eg, phenelzine), tricyclic antidepressants (amitriptyline)

Epinephrine effects may be potentiated.

Beta-adrenergic blockers (eg, propranolol)

Beta-adrenergic effects of epinephrine may be blocked, resulting in hypertension.

Diuretics

May decrease vascular response to epinephrine.

Drugs that sensitize the heart to arrhythmias (eg, antiarrhythmics, digitalis, diuretics, quinidine)

Epinephrine may precipitate or aggravate angina pectoris or produce ventricular arrhythmias.

Furazolidone, methyldopa, rauwolfia alkaloids (eg, alseroxylon, rauwolfia)

Risk of hypertension may be increased.

General anesthetics (eg, cyclopropane, halothane)

Coadministration is contraindicated; may induce cardiac arrhythmias.

Guanethidine

Neuronal blockade may be antagonized by epinephrine, resulting in decreased antihypertensive effect and requiring subsequent dosage adjustments.

Oxytocic drugs

Severe persistent hypertension may occur; rupture of a cerebral blood vessel may occur during the postpartum period.

Sympathomimetic agents (eg, isoproterenol)

Possible additive effects and increased toxicity (eg, serious cardiac arrhythmias); administer alternatively when the preceding effect of the other drug has subsided, not concurrently.

See also:
What are the possible side effects of Adyphren Amp?

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.

Common adverse reactions to systemically administered epinephrine include anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; nausea and vomiting; headache, and/or respiratory difficulties. These symptoms occur in some persons receiving therapeutic doses of epinephrine, but are more likely to occur in patients with hypertension or hyperthyroidism.

Arrhythmias, including fatal ventricular fibrillation, have been reported, particularly in patients with underlying cardiac disease or those receiving certain drugs.

Rapid rises in blood pressure have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease.

Angina may occur in patients with coronary artery disease.

Accidental injection into the digits, hands or feet may result in loss of blood flow to the affected area.

Adverse events experienced as a result of accidental injections may include increased heart rate, local reactions including injection site pallor, coldness and hypoesthesia or injury at the injection site resulting in bruising, bleeding, discoloration, erythema or skeletal injury.

Lacerations, bent needles, and embedded needles have been reported when Adyphren Amp has been injected into the thigh of young children who are uncooperative and kick or move during an injection.

Injection into the buttock has resulted in cases of gas gangrene.

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.

Precursor of an alkylating nitrogen mustard antineoplastic and immunosuppressive agent that must be activated in the liver to form the active aldophosphamide. It has been used in the treatment of lymphoma and leukemia. Its side effect, alopecia, has been used for defleecing sheep. Adyphren Amp may also cause sterility, birth defects, mutations, and cancer.