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- EpiPen® Auto-Injector
- EpiPen® Jr. Auto-Injector
Epinephrine is a prescription medications used to treat life-threatening allergic reactions in adults and children. Epinephrine belongs to a group of drugs called sympathomimetic agents. They relax muscles in the airways and tighten the blood vessels, reversing severely low blood pressure and symptoms of allergic reaction.
This medication comes in an injectable form and is injected in the thigh during a serious allergic reaction.
Common side effects of epinephrine include fast and irregular heartbeat, sweating, and nausea.
Seek emergency medical attention, even after epinephrine use, to treat severe allergic reactions.
Indications and Usage for Adrenaclick
Adrenaclick® 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.
Adrenaclick 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.
Adrenaclick is intended for immediate administration as emergency supportive therapy only and is not a replacement or substitute for immediate medical care.
Adrenaclick Dosage and Administration
Selection of the appropriate Adrenaclick dosage strength is determined according to patient body weight.
- Patients greater than or equal to 30 kg (approximately 66 pounds or more): Adrenaclick 0.3 mg
- Patients 15 to 30 kg (33 pounds to 66 pounds): Adrenaclick 0.15 mg
Inject Adrenaclick intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary. Instruct caregivers of young children who are prescribed an Adrenaclick and who may be uncooperative and kick or move during an injection to hold the leg firmly in place and limit movement prior to and during an injection [see Warnings and Precautions (5.2)].
Each Adrenaclick contains a single dose of epinephrine for single use injection. Since the doses of epinephrine delivered from Adrenaclick 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 Adrenaclick may be necessary. More than two sequential doses of epinephrine should only be administered under direct medical supervision [see Warnings and Precautions (5.1)].
The epinephrine solution in the viewing window of Adrenaclick 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 [see How Supplied/Storage and Handling (16.2)].
Patients who receive epinephrine while concomitantly taking cardiac glycosides, diuretics, or anti-arrhythmics should be observed carefully for the development of cardiac arrhythmias [see Warnings and Precautions (5.5)].
The effects of epinephrine may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium, and certain antihistamines, notably chlorpheniramine, tripelennamine, and diphenhydramine.
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 also reverse the pressor effects of epinephrine.
Adrenaclick (epinephrine injection, USP) auto-injector 0.3 mg and 0.15 mg is an auto-injector and a combination product containing drug and device components.
Each Adrenaclick 0.3 mg delivers a single dose of 0.3 mg epinephrine from epinephrine injection, USP (0.3 mL) in a sterile solution.
Each Adrenaclick 0.15 mg delivers a single dose of 0.15 mg epinephrine from epinephrine injection, USP (0.15 mL) in a sterile solution.
Adrenaclick 0.3 mg and Adrenaclick 0.15 mg each contain 1.1 mL of epinephrine solution. 0.3 mL and 0.15 mL epinephrine solution are dispensed for Adrenaclick 0.3 mg and Adrenaclick 0.15 mg, respectively, when activated. The solution remaining after activation is not available for future use and should be discarded.
Each 0.3 mL in Adrenaclick 0.3 mg contains 0.3 mg epinephrine, 2.6 mg sodium chloride, not more than 1.5 mg chlorobutanol, 0.45 mg sodium bisulfite, hydrochloric acid and sodium hydroxide to adjust pH, and water for injection. The pH range is 2.2-5.0.
Each 0.15 mL in Adrenaclick 0.15 mg contains 0.15 mg epinephrine, 1.3 mg sodium chloride, not more than 0.75 mg chlorobutanol, 0.225 sodium bisulfite, hydrochloric acid and sodium hydroxide to adjust pH, and water for injection. The pH range is 2.2-5.0.
Epinephrine is a sympathomimetic catecholamine. Chemically, epinephrine is (-)-3,4-Dihydroxy-α-[(methylamino)methyl]benzyl alcohol with the following structure:
Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. Replace Adrenaclick if the epinephrine solution appears discolored (pinkish or brown color), cloudy, or contains particles.
Thoroughly review the patient instructions and operation of Adrenaclick with patients and caregivers prior to use [see Patient Counseling Information (17)].
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies to evaluate the carcinogenic potential of epinephrine have not been conducted.
Epinephrine and other catecholamines have been shown to have mutagenic potential in vitro and to be an oxidative mutagen in a WP2 bacterial reverse mutation assay.
Epinephrine was positive in the DNA Repair test with B. subtilis (REC) assay, but was not mutagenic in the Salmonella bacterial reverse mutation assay.
The potential for epinephrine to impair fertility has not been evaluated.
This should not prevent the use of epinephrine under the conditions noted under Indications and Usage (1).
(epinephrine injection, USP)
For allergic emergencies (anaphylaxis)
Read this Patient Information Leaflet carefully before you use the Adrenaclick auto-injector, and each time you get a refill. There may be new information. You, your parent, caregiver, or others who may be in a position to administer Adrenaclick auto-injector should know how to use it before you have an allergic emergency.
This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
What is the most important information I should know about Adrenaclick?
1. Adrenaclick contains epinephrine, a medicine used to treat allergic emergencies (anaphylaxis). Anaphylaxis can be life-threatening, can happen within minutes, and can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or other unknown causes. Symptoms of an anaphylaxis may include:
- trouble breathing
- hoarseness (changes in the way your voice sounds)
- hives (raised reddened rash that may itch)
- severe itching
- swelling of your face, lips, mouth, or tongue
- skin rash, redness, or swelling
- fast heartbeat
- weak pulse
- feeling very anxious
- stomach pain
- losing control of urine or bowel movements (incontinence)
- diarrhea or stomach cramps
- dizziness, fainting, or “passing out” (unconsciousness)
2. Always carry your Adrenaclick with you because you may not know when anaphylaxis may happen. Talk to your healthcare provider if you need additional units to keep at work, school, or other locations. Tell your family members, caregivers, and others where you keep your Adrenaclick and how to use it before you need it. You may be unable to speak in an allergic emergency.
3. When you have an allergic emergency (anaphylaxis)
- Use Adrenaclick right away.
- Get emergency medical help right away. You may need further medical attention. You may need to use a second Adrenaclick auto-injector if symptoms continue or recur. Only a healthcare provider should give additional doses of epinephrine if you need more than 2 injections for a single anaphylaxis episode.
What is Adrenaclick?
- Adrenaclick is a disposable, prefilled automatic injection device (auto-injector) used to treat life-threatening, allergic emergencies including anaphylaxis in people who are at risk for or have a history of serious allergic emergencies. Each device contains a single dose of epinephrine.
- Adrenaclick is for immediate self (or caregiver) administration and does not take the place of emergency medical care. You should get emergency medical help right away after using Adrenaclick.
- Adrenaclick is for people who have been prescribed this medicine by their healthcare provider.
- The Adrenaclick 0.3 mg auto-injector is for patients who weigh 66 pounds or more (30 kilograms or more).
- The Adrenaclick 0.15 mg auto-injector is for patients who weigh about 33 to 66 pounds (15 to 30 kilograms).
- It is not known if Adrenaclick is safe and effective in children who weigh less than 33 pounds (15 kilograms).
What should I tell my healthcare provider before using Adrenaclick?
Before you use Adrenaclick, tell your healthcare provider about all your medical conditions, especially if you:
- have heart problems or high blood pressure
- have diabetes
- have thyroid problems
- have asthma
- have a history of depression
- have Parkinson's disease
- have any other medical conditions
- are pregnant or plan to become pregnant. It is not known if epinephrine will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if epinephrine passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Tell your healthcare provider of all known allergies.
Especially tell your healthcare provider if you take certain asthma medicines.
Adrenaclick and other medicines may affect each other, causing side effects. Adrenaclick may affect the way other medicines work, and other medicines may affect how Adrenaclick works.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
Use your Adrenaclick auto-injector for treatment of anaphylaxis as prescribed by your healthcare provider, regardless of your medical conditions or the medicine you take.
How should I use Adrenaclick?
- Each Adrenaclick auto-injector contains only 1 dose of medicine.
- Adrenaclick should only be injected into the middle of the outer thigh (upper leg). It can be injected through clothing, if needed.
- Read the Instructions for Use at the end of this Patient Information Leaflet for information about the right way to use Adrenaclick.
- Your healthcare provider will show you how to safely use the Adrenaclick auto-injector.
- Use Adrenaclick exactly as your healthcare provider tells you to use it. You may need to use a second Adrenaclick auto-injector if symptoms continue or recur. Only a healthcare provider should give additional doses of epinephrine if you need more than 2 injections for a single anaphylaxis episode.
- Caution: Never put your thumb, fingers, or hand over the red tip. Never press or push the red tip with your thumb, fingers, or hand. The needle comes out of the red tip. Accidental injection into finger, hands, or feet may cause a loss of blood flow to those areas. If this happens, go immediately to the nearest emergency room. Tell the healthcare provider where on your body you received the accidental injection.
- Your Adrenaclick auto-injector comes packaged in a carton containing 2 Adrenaclick auto-injectors.
- You may request a separate Trainer, that comes packaged with instructions. Additional video instructions on the use of Adrenaclick are available from www.Adrenaclick.com. The Adrenaclick Trainer has a beige color. The beige Adrenaclick Trainer contains no medicine and no needle. Practice with your Adrenaclick Trainer before an allergic emergency happens to make sure you are able to safely use the real Adrenaclick auto-injector in an emergency. Always carry your real Adrenaclick auto-injector with you in case of an allergic emergency.
- Do not drop the carrying case or Adrenaclick auto-injector. If the carrying case or Adrenaclick auto-injector is dropped, check for damage and leakage. Dispose of the auto-injector and carrying case, and replace if damage or leakage is noticed or suspected.
What are the possible side effects of Adrenaclick?
Adrenaclick may cause serious side effects.
- Adrenaclick should only be injected into the middle of your outer thigh (upper leg). Do not inject Adrenaclick into your:
- fingers, toes, hands or feet.
If you accidently inject Adrenaclick into any other part of your body, go to the nearest emergency room right away. Tell the healthcare provider where on your body you received the accidental injection.
Rarely, patients who use Adrenaclick may develop infections at the injection site within a few days of an injection. Some of these infections can be serious. Call your healthcare provider right away if you have any of the following at an injection site:
- redness that does not go away
- the area feels warm to the touch
Cuts on the skin, bent needles, and needles that remain in the skin after the injection, have happened in young children who do not cooperate and kick or move during an injection. If you inject a young child with Adrenaclick, hold their leg firmly in place before and during the injection to prevent injuries. Ask your healthcare provider to show you how to properly hold the leg of a young child during an injection.
If you have certain medical conditions, or take certain medicines, your condition may get worse or you may have more or longer lasting side effects when you use Adrenaclick. Talk to your healthcare provider about all your medical conditions.
Common side effects of Adrenaclick include:
- faster, irregular or “pounding” heartbeat
- feelings of over excitement, nervousness, or anxiety
- nausea or vomiting
- breathing problems
These side effects may go away with rest. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Adrenaclick. For more information, ask your healthcare provider or pharmacist.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Adrenaclick?
- Store Adrenaclick at room temperature between 68° to 77° F (20° to 25° C).
- Protect from light.
- Do not expose to extreme heat or cold. For example, do not store in your vehicle’s glove box and do not store in the refrigerator or freezer.
- Examine the contents in the clear viewing window of your auto-injector periodically. The solution should be clear. If the solution is discolored (pinkish or brown), cloudy or contains solid particles, replace the unit.
- Always keep your Adrenaclick auto-injector in the carrying case to protect it from damage; however, the carrying case is not waterproof.
- The two blue end caps help to prevent accidental injection. Do not remove the blue end caps until you are ready to use Adrenaclick.
- Your Adrenaclick has an expiration date. Replace it before the expiration date.
Keep Adrenaclick and all medicines out of the reach of children.
General information about the safe and effective use of Adrenaclick:
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use Adrenaclick for a condition for which it was not prescribed. Do not give Adrenaclick to other people.
This Patient Information Leaflet summarizes the most important information about Adrenaclick. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about Adrenaclick that is written for health professionals.
For more information and video instructions on the use of Adrenaclick, go to www.Adrenaclick.com or call 1-888-894-6528.
What are the ingredients in Adrenaclick?
Active Ingredient: epinephrine
Inactive Ingredients: sodium chloride, chlorobutanol, sodium bisulfite, hydrochloric acid and sodium hydroxide, and water.
- The Adrenaclick 0.3 mg auto-injector has a yellow colored label.
- The Adrenaclick 0.15 mg auto-injector has an orange colored label.
- The Adrenaclick Trainer has a beige color, and contains no medicine and no needle.
- Your auto-injector is designed to work through clothing.
- The two blue end caps on the Adrenaclick auto-injector help to prevent accidental injection of the device. Do not remove the blue end caps until you are ready to use it.
- Only inject into the middle of the outer thigh (upper leg). Never inject into any other part of the body.
- Never put your thumb, fingers, or your hand over the red tip. The needle comes out of the red tip.
- If an accidental injection happens, get medical help right away.
- Do not place patient information or any other foreign objects in carrier with the auto-injector, as this may prevent you from removing the auto-injector for use.
Mechanism of Action
Strong alpha-adrenergic effects, which cause an increase in cardio output and HR, a decrease in renal perfusion and PVR, and a variable effect on BP, resulting in systemic vasoconstriction and increased vascular permeability
Strong beta1- and moderate beta2-adrenergic effects, resulting in bronchial smooth muscle relaxation
Secondary relaxation effect on smooth muscle of stomach, intestine, uterus, and urinary bladder
Onset: 5-10 min (SC); 1 min (inhalation)
Duration: 4 hr
Metabolized by MAO and COMT in adrenergic neuron
Metabolites: Metadrenaline, sulfate conjugates, and hydroxy derivatives of mandelic acid (inactive)
Epinephrine Levels and Effects while Breastfeeding
Summary of Use during Lactation
No information is available on the use of epinephrine during breastfeeding. Because of its poor oral bioavailability and short half-life, any epinephrine in milk is unlikely to affect the infant. High intravenous doses of epinephrine might reduce milk production or milk letdown. Low-dose epidural, topical, inhaled or ophthalmic epinephrine are unlikely to interfere with breastfeeding. To substantially diminish the effect of the drug after using eye drops, place pressure over the tear duct by the corner of the eye for 1 minute or more, then remove the excess solution with an absorbent tissue.
Maternal Levels. Relevant published information was not found as of the revision date.
Infant Levels. Relevant published information was not found as of the revision date.
Effects in Breastfed Infants
Relevant published information was not found as of the revision date.
Effects on Lactation and Breastmilk
Relevant published information in nursing mothers was not found as of the revision date. Intravenous epinephrine infusion in nonnursing subjects and in women with hyperprolactinemia decreases serum prolactin concentrations. Animal data indicate that intraarterial epinephrine can decrease serum oxytocin and inhibit milk ejection. However, low-dose infusion of epinephrine as part of epidural analgesia does not impair breastfeeding in nursing mothers. The prolactin level in a mother with established lactation may not affect her ability to breastfeed.
An Egyptian study compared lidocaine 2% (n = 75) to lidocaine 2% plus epinephrine 1:200,000 (n = 70) as a wound infiltration following cesarean section. Patients who received epinephrine in combination with lidocaine began breastfeeding at 89 minutes following surgery compared to 132 minutes for those receiving lidocaine alone. The difference was statistically significant.
1. Nicoletti I, Filipponi P, Sfrappini M et al. Catecholamines and pituitary function. I. Effects of catecholamine synthesis inhibition and subsequent catecholamine infusion on gonadotropin and prolactin serum levels in normal cycling women and in women with hyperprolactinemic amenorrhea. Horm Res. 1984;19:158-70. PMID: 6425187
2. Gorewit RC, Aromando MC. Mechanisms involved in the adrenalin-induced blockade of milk ejection in dairy cattle. Proc Soc Exp Biol Med. 1985;180:340-7. PMID: 4048172
3. Song SL, Crowley WR, Grosvenor CE. Evidence for involvement of an adrenal catecholamine in the beta-adrenergic inhibition of oxytocin release in lactating rats. Brain Res. 1988;457:303-9. PMID: 2851365
4. Radzyminski S. The effect of ultra low dose epidural analgesia on newborn breastfeeding behaviors. J Obstet Gynecol Neonatal Nurs. 2003;32:322-31. PMID: 12774874
5. Chang ZM, Heaman MI. Epidural analgesia during labor and delivery: effects on the initiation and continuation of effective breastfeeding. J Hum Lact. 2005;21:305-14. PMID: 16113019
6. Tharwat AA, Yehia AH, Wahba KA et al. Efficacy and safety of post-cesarean section incisional infiltration with lidocaine and epinephrine versus lidocaine alone in reducing postoperative pain: A randomized controlled double-blinded clinical trial. J Turk Ger Gynecol Assoc. 2016;17:1-5. PMID: 27026771