Adrenaclick

Name: Adrenaclick

How should this medicine be used?

Epinephrine injection comes as a pre-filled automatic injection device containing a solution (liquid) and in vials to inject subcutaneously (under the skin) or intramuscularly (into the muscle). It is usually injected as needed at the first sign of a serious allergic reaction. Use epinephrine injection exactly as directed; do not inject it more often or inject more or less of it than prescribed by your doctor.

Ask your doctor or pharmacist to show you and any of your caregivers who could be injecting the medication how to use the pre-filled automatic injection device. Training devices are available to practice how to use the automatic injection device during an emergency. Training devices do not contain medication and do not have a needle. Before you use epinephrine injection for the first time, read the patient information that comes with it. This information includes directions for how to use the pre-filled automatic injection device. Be sure to ask your pharmacist or doctor if you or your caregivers have any questions about how to inject this medication.

You should inject epinephrine injection as soon as you suspect that you may be experiencing a serious allergic reaction. Signs of a serious allergic reaction include closing of the airways, wheezing, sneezing, hoarseness, hives, itching, swelling, skin redness, fast heartbeat, weak pulse, anxiety, confusion, stomach pain, losing control of urine or bowel movements, faintness, or loss of consciousness. Talk to your doctor about these symptoms and be sure you understand how to tell when you are having a serious allergic reaction and should inject epinephrine.

Keep your automatic injection device with you or available at all times so that you will be able to inject epinephrine quickly when an allergic reaction begins. Be aware of the expiration date stamped on the device and replace the device when this date passes. Look at the solution in the device from time to time. If the solution is discolored or contains particles, call your doctor to get a new injection device.

Epinephrine injection helps to treat serious allergic reactions, but does not take the place of medical treatment. Get emergency medical treatment immediately after you inject epinephrine. Rest quietly while you wait for emergency medical treatment.

Most automatic injection devices contain enough solution for one dose of epinephrine. If your symptoms continue or return after the first injection, your doctor may tell you to use a second dose of epinephrine injection with a new injection device. Be sure that you know how to inject the second dose and how to tell whether you should inject a second dose. Only a healthcare provider should give more than 2 injections for a single allergic episode.

Epinephrine should be injected only in the middle of the outer side of the thigh, and can be injected through clothing if necessary in an emergency. If you are injecting epinephrine to a young child who may move during the injection, hold their leg firmly in place and limit the child's movement before and during the injection. Do not inject epinephrine into the buttocks or any other part of your body such as fingers, hands, or feet or into a vein. Do not put your thumb, fingers, or hand over the needle area of the automatic injection device. If epinephrine is accidently injected into these areas, get emergency medical treatment immediately.

After you inject a dose of epinephrine injection, some solution will remain in the injection device. This is normal and does not mean that you did not receive the full dose. Do not use the extra liquid; dispose of the remaining liquid and device properly. Take the used device with you to the emergency room or ask your doctor, pharmacist, or health care provider how to dispose of used injection devices safely.

Adrenaclick Drug Class

Adrenaclick is part of the drug classes:

  • Adrenergic and dopaminergic agents

  • Inhaled alpha and beta adrenoreceptor agonists

  • Local hemostatics

  • Other agents for local oral treatment

  • Sympathomimetics in glaucoma therapy

  • Sympathomimetics, plain

Proper Use of epinephrine

This section provides information on the proper use of a number of products that contain epinephrine. It may not be specific to Adrenaclick. Please read with care.

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

If you are using this medicine at home, make sure you or any of your family members understand exactly how to give them. Also, tell your doctor if you or your caregiver has severe arthritis of the hands. If you have any questions about this, check with your doctor.

This medicine is injected into the muscle of your outer thigh only. Do not inject this medicine into a vein, into the muscle of your buttocks, or into your fingers, toes, hands, or feet. To do so, may increase the chance of having serious side effects.

This medicine comes with patient information and instructions leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

This medicine comes in 2 forms:an autoinjector syringe and needle kit or a prefilled syringe. This contains the correct dose of medicine your doctor has prescribed.

This medicine comes with an autoinjector trainer and a separate trainer instructions for use. Be sure to practice first with your autoinjector trainer before an allergy emergency happens to make sure you are ready to use the real Adrenaclick®, EpiPen®, or EpiPen Jr® autoinjector in an actual emergency. The autoinjector trainer has a grey color (for EpiPen® or EpiPen Jr®) or beige color (for Adrenaclick®) and does not contain any medicine or needle.

Do not remove the blue safety release (EpiPen® or EpiPen Jr®) or the gray end caps (Adrenaclick®) on the autoinjector until you are ready to use it. Do not put your thumb, fingers, or hand over the orange (EpiPen® or EpiPen Jr®) or red (Adrenaclick®) tip of the autoinjector or over the needle of the Symjepi® prefilled syringe. This is to avoid an accidental injection.

If you use the Symjepi® prefilled syringe:

  • Do not remove the needle cap until you are ready to use it.
  • Slowly inject the syringe into the thigh while sitting down.
  • Push the plunger all the way down until you hear a "clicking" sound. Hold it for 2 seconds.
  • Remove the syringe and massage the area for 10 seconds.
  • Call your medical provider right away after injection.

You may need to use more than one injection if your allergic reaction does not get better after the first shot. If more than 2 injections are needed for 1 reaction, however, those should be given only under medical supervision.

If you are using the epinephrine injection in a child, make sure to hold his leg firmly in place and limit movement before and during an injection.

Carry this medicine with you at all times for emergency use in case you have a severe allergic reaction.

Check the injection kits regularly to make sure that the liquid has not changed its color. It should be clear and colorless. Do not use this medicine if the liquid has changed its color (pinkish or brown in color), has become cloudy, or if there are particles in it.

Do not reuse the remaining portion of the medicine that is left in the autoinjector or prefilled syringe. Throw away the autoinjector or prefilled syringe after you have used it.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For injection dosage form:
    • For allergic reactions:
      • Adults and children weighing more than 30 kilograms (kg)—0.3 milligram (mg) injected under the skin or into the muscle of your thigh.
      • Children weighing 15 to 30 kg—0.15 mg injected under the skin or into the muscle of your thigh.
      • Children weighing less than 15 kg—Use and dose must be determined by your doctor.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the injection kits at room temperature, away from heat, moisture, and direct light. Do not store the medicine in the refrigerator or freezer, or into your vehicle's glove box.

Keep the autoinjector or prefilled syringe in its carrier tube or case to protect from damage. However, this tube or case is not waterproof. If you accidentally drop it, check for damage or leakage.

Warnings and Precautions

Emergency Treatment

Adrenaclick is intended for immediate administration as emergency supportive therapy and is not intended as a substitute for immediate medical care. In conjunction with the administration of epinephrine, the patient should seek immediate medical or hospital care. More than two sequential doses of epinephrine should only be administered under direct medical supervision [see Indications and Usage (1), Dosage and Administration (2) and Patient Counseling Information (17)].

Injection-Related Complications

Adrenaclick should only be injected into the anterolateral aspect of the thigh [see Dosage and Administration (2) and Patient Counseling Information (17)].

Do not inject intravenously.

  • Large doses or accidental intravenous injection of epinephrine may result in cerebral hemorrhage due to a sharp rise in blood pressure. Rapidly acting vasodilators can counteract the marked pressor effects of epinephrine if there is such inadvertent administration.

Do not inject into buttock.

  • Injection into the buttock may not provide effective treatment of anaphylaxis. Advise the patient to go immediately to the nearest emergency room for further treatment of anaphylaxis. Additionally, injection into the buttock has been associated with the development of Clostridial infections (gas gangrene). Cleansing with alcohol does not kill bacterial spores, and therefore, does not lower the risk.

Do not inject into digits, hands or feet.

  • Since epinephrine is a strong vasoconstrictor, accidental injection into the digits, hands or feet may result in loss of blood flow to the affected area. Advise the patient to go immediately to the nearest emergency room and to inform the healthcare provider in the emergency room of the location of the accidental injection. Treatment of such inadvertent administration should consist of vasodilation, in addition to further appropriate treatment of anaphylaxis [see Adverse Reactions (6)].

Hold leg firmly during injection.

  • Lacerations, bent needles, and embedded needles have been reported when epinephrine has been injected into the thigh of young children who are uncooperative and kick or move during an injection. To minimize the risk of injection related injury when administering Adrenaclick to young children, instruct caregivers to hold the child’s leg firmly in place and limit movement prior to and during injection.

Serious Infections at the Injection Site

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. Clostridium spores can be present on the skin and introduced into the deep tissue with subcutaneous or intramuscular injection. While cleansing with alcohol may reduce presence of bacteria on the skin, alcohol cleansing does not kill Clostridium spores. To decrease the risk of Clostridium infection, do not inject Adrenaclick into the buttock [see Warnings and Precautions (5.2)]. 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.

Allergic Reactions Associated with Sulfite

The presence of a sulfite in this product should not deter administration of the drug for treatment of serious allergic or other emergency situations even if the patient is sulfite-sensitive.

Epinephrine is the preferred treatment for serious allergic reactions or other emergency situations even though this product contains sodium bisulfite, a sulfite that may, in other products, cause allergic-type reactions including anaphylactic symptoms or life-threatening or less severe asthmatic episodes in certain susceptible persons.

The alternatives to using epinephrine in a life-threatening situation may not be satisfactory.

Disease Interactions

Some patients may be at greater risk for developing adverse reactions after epinephrine administration. Despite these concerns, it should be recognized that the presence of these conditions is not a contraindication to epinephrine administration in an acute, life-threatening situation. Therefore, patients with these conditions, and/or any other person who might be in a position to administer Adrenaclick to a patient experiencing anaphylaxis should be carefully instructed in regard to the circumstances under which epinephrine should be used.


  • Patients with Heart Disease

    Epinephrine should be administered with caution to patients who have heart disease, including patients with cardiac arrhythmias, coronary artery or organic heart disease, or hypertension. In such patients, or in patients who are on drugs that may sensitize the heart to arrhythmias, epinephrine may precipitate or aggravate angina pectoris as well as produce ventricular arrhythmias [see Drug Interactions (7) and Adverse Reactions (6)].

  • Other Patients and Diseases

    Epinephrine should be administered with caution to patients with hyperthyroidism, diabetes, elderly individuals, and pregnant women. Patients with Parkinson's disease may notice a temporary worsening of symptoms.

Overdosage

Overdosage of epinephrine may produce extremely elevated arterial pressure, which may result in cerebrovascular hemorrhage, particularly in elderly patients. Overdosage may also result in pulmonary edema because of peripheral vascular constriction together with cardiac stimulation. Treatment consists of a rapidly acting vasodilators or alpha-adrenergic blocking drugs and/or respiratory support.

Epinephrine overdosage can also cause transient bradycardia followed by tachycardia, and these may be accompanied by potentially fatal cardiac arrhythmias. Premature ventricular contractions may appear within one minute after injection and may be followed by multifocal ventricular tachycardia (prefibrillation rhythm). Subsidence of the ventricular effects may be followed by atrial tachycardia and occasionally by atrioventricular block. Treatment of arrhythmias consists of administration of a beta-adrenergic blocking drug such as propranolol.

Overdosage sometimes results in extreme pallor and coldness of the skin, metabolic acidosis, and kidney failure. Suitable corrective measures must be taken in such situations.

Adrenaclick - Clinical Pharmacology

Mechanism of Action

Epinephrine acts on both alpha- and beta-adrenergic receptors.

Pharmacodynamics

Through its action on alpha-adrenergic receptors, epinephrine lessens the vasodilation and increased vascular permeability that occurs during anaphylaxis, which can lead to loss of intravascular fluid volume and hypotension.

Through its action on beta-adrenergic receptors, epinephrine causes bronchial smooth muscle relaxation and helps alleviate bronchospasm, wheezing, and dyspnea that may occur during anaphylaxis.

Epinephrine also alleviates pruritus, urticaria, and angioedema, and may relieve gastrointestinal and genitourinary symptoms associated with anaphylaxis because of its relaxer effects on the smooth muscle of the stomach, intestine, uterus and urinary bladder.

When given intramuscularly or subcutaneously, epinephrine has a rapid onset and short duration of action.

How Supplied/Storage and Handling

How Supplied

Carton containing two Adrenaclick (epinephrine injection, USP) 0.3 mg auto-injectors: NDC 52054-804-02.

Carton containing two Adrenaclick (epinephrine injection, USP) 0.15 mg auto-injectors: NDC 52054-803-02.

Rx only

Storage and Handling

Protect from light. Epinephrine is light sensitive and should be stored in the carrying-case provided to protect it from light. Store at room temperature (20° to 25°C (68° to 77°F)); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. 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 (pinkish or brown color), cloudy, or contains particles.

Patient counseling information

[see FDA-Approved Patient Labeling (Patient Information and Instructions for Use)]

A healthcare provider should review the patient instructions and operation of Adrenaclick, in detail, with the patient or caregiver.

Epinephrine is essential for the treatment of anaphylaxis. Carefully instruct patients who are at risk of or with a history of severe allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs, and other allergens, as well as idiopathic and exercise-induced anaphylaxis, about the circumstances under which epinephrine should be used.

Administration and Training

Instruct patients and/or caregivers in the appropriate use of Adrenaclick. Adrenaclick should be injected into the middle of the outer thigh (through clothing if necessary).

Instruct caregivers to hold the leg of young children firmly in place and limit movement prior to and during injection. Lacerations, bent needles, and embedded needles have been reported when Adrenaclick has been injected into the thigh of young children who are uncooperative and kick during an injection [see Warnings and Precautions (5.2)].

Each Adrenaclick is a single-use injection. Advise patients to seek immediate medical care in conjunction with administration of Adrenaclick.

Complete patient information, including dosage, directions for proper administration and precautions can be found inside each Adrenaclick carton. A printed label on the surface of Adrenaclick shows instructions for use and a diagram depicting the injection process.

Instruct patients and/or caregivers to use the Trainer to familiarize themselves with the use of Adrenaclick in an allergic emergency. The Trainer may be used multiple times.

Adverse Reactions

Epinephrine may produce symptoms and signs that include 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 signs and symptoms usually subside rapidly, especially with rest, quiet, and recumbency. Patients with hypertension or hyperthyroidism may develop more severe or persistent effects, and patients with coronary artery disease could experience angina. Patients with diabetes may develop increased blood glucose levels following epinephrine administration. Patients with Parkinson's disease may notice a temporary worsening of symptoms [see Warnings and Precautions (5.5)].

Accidental Injection

Advise patients to seek immediate medical care in the case of accidental injection. Since epinephrine is a strong vasoconstrictor when injected into the digits, hands or feet, treatment should be directed at vasodilation if there is such an accidental injection to these areas [see Warnings and Precautions (5.2)].

Serious Infections at the Injection Site

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 (5.3)].

Storage and Handling

Instruct patients to inspect the epinephrine solution visually through the viewing window periodically. Replace Adrenaclick if the epinephrine solution appears discolored (pinkish or brown), cloudy, or contains particles. Epinephrine is light sensitive, store in the outer case provided to protect it from light. Instruct patients that Adrenaclick must be properly disposed of once the blue caps have been removed or after use [see How Supplied/Storage and Handling (16.2)].

Complete patient information, including dosage, directions for proper administration and precautions are provided inside each Adrenaclick auto-injector carton.


Manufactured for and Distributed by: Amedra Pharmaceuticals LLC, Horsham, PA 19044

© 2014 Amedra Pharmaceuticals LLC, Horsham, PA. All rights reserved.

For inquiries call 1-888-894-6528

51006-07

For the Consumer

Applies to epinephrine: injection injectable, injection solution

Along with its needed effects, epinephrine (the active ingredient contained in Adrenaclick) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking epinephrine:

Incidence not known
  • Abnormal or decreased touch sensation
  • anxiety
  • arm, back, or jaw pain
  • bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • blurred vision
  • chest pain or discomfort
  • chest tightness or heaviness
  • cold, pale, or bluish color of the skin of the fingers or toes
  • dizziness
  • fainting
  • fast, slow, irregular, pounding, or racing heartbeat or pulse
  • fear or nervousness
  • headache
  • nausea or vomiting
  • numbness, tingling, or pain in the fingers
  • paleness of the skin
  • pounding in the ears
  • restlessness
  • shakiness in the legs, arms, hands, or feet
  • stroke
  • sweating
  • trembling or shaking of the hands or feet
  • troubled breathing
  • unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur while taking epinephrine:

Symptoms of overdose
  • Agitation
  • coldness of the skin
  • coma
  • confusion
  • decreased awareness or responsiveness
  • decreased urine output
  • depression
  • drowsiness
  • hostility
  • irritability
  • lightheadedness, dizziness, fainting
  • muscle twitching
  • rapid weight gain
  • rapid, deep breathing
  • seizures
  • severe sleepiness
  • stomach cramps
  • swelling of the face, ankles, or hands
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Administrative Information

LactMed Record Number

742

Last Revision Date

20170808

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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