Epinephrine 0.3mg Inj 2 Pack

Manufacturer MYLAN SPECIALTY L.P. Active Ingredient Epinephrine Auto-Injector and Prefilled Syringe(ep i NEF rin) Pronunciation ep i NEF rin
It is used to treat an allergic reaction.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antiallergic agent; Vasopressor
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Pharmacologic Class
Alpha- and Beta-Adrenergic Agonist
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Pregnancy Category
Category C
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FDA Approved
Jan 1939
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Epinephrine is a life-saving medication used to treat severe allergic reactions (anaphylaxis) caused by things like insect stings, foods, medications, or latex. It works quickly to open up airways, raise blood pressure, and reduce swelling. It comes in an auto-injector that you can use yourself or have someone else use on you in an emergency.
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How to Use This Medicine

Proper Use of This Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into a muscle or the fatty layer of the skin. It's essential to understand how to use it before an emergency situation arises. Carefully review the package insert and instructions for use that come with this medication. If you have any questions, consult your doctor or pharmacist.

Availability and Accessibility

Keep this medication with you at all times, and consider storing extra doses at work, school, and home in case someone else needs to administer it. Ensure that others know where the medication is stored and how to administer it if necessary.

Pre-Use Checks

Before using the device, verify that the safety release is in place and that the device can be removed from its case. Do not remove the safety release until you are ready to use the medication.

Administration Technique

To administer the medication:

1. Remove the pen from its case.
2. Hold the pen with the tip facing down.
3. Make a fist around the pen.
4. Remove the safety release and discard it immediately after use, as it may pose a choking hazard if accidentally swallowed by a child or pet.
5. Inject the medication straight into the outer thigh, as instructed. If necessary, the medication can be administered through clothing.
6. Hold the injection site for the recommended duration.

Important Administration Considerations

Do not inject the medication into the buttocks.
When administering the medication to a child, hold their leg still to prevent injury and try to limit their movement before and during the injection.

Post-Use Procedures

After using the medication:

1. Seek medical help immediately.
2. Return the device to its storage case.
3. Bring the device with you to the hospital.

Inspection and Replacement

Do not use the medication if the solution has changed color, is cloudy, or contains particles. Obtain a new device in such cases. If the device has expired, get a refill before a dose is needed. If the device has been accidentally activated, do not use it for an emergency; instead, replace it with a new one.

Storage and Disposal

Store the medication at room temperature, avoiding refrigeration or freezing.

Missed Dose

If you miss a dose, seek medical help immediately.
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Lifestyle & Tips

  • Always carry two auto-injectors with you at all times.
  • Know how to use your auto-injector and practice with a trainer device.
  • Educate family, friends, and caregivers on how to use it.
  • Seek immediate medical attention (call 911) after using epinephrine, even if symptoms improve, as a second reaction can occur.
  • Avoid known allergens.
  • Check the expiration date regularly and replace expired devices.

Dosing & Administration

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Adult Dosing

Standard Dose: 0.3 mg intramuscularly (IM) into the anterolateral aspect of the thigh, may repeat every 5-15 minutes if needed for persistent or worsening symptoms.
Dose Range: 0.3 - 0.3 mg

Condition-Specific Dosing:

anaphylaxis: 0.3 mg IM, repeat every 5-15 minutes as needed.
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Pediatric Dosing

Neonatal: Not established for anaphylaxis auto-injector use. IV/IO dosing for cardiac arrest is different.
Infant: Not established for anaphylaxis auto-injector use. IV/IO dosing for cardiac arrest is different.
Child: For children weighing 15 kg to 30 kg (33 lbs to 66 lbs): 0.15 mg IM (Epinephrine 0.15 mg auto-injector). For children weighing >30 kg (66 lbs): 0.3 mg IM (Epinephrine 0.3 mg auto-injector). May repeat every 5-15 minutes if needed.
Adolescent: For adolescents weighing >30 kg (66 lbs): 0.3 mg IM. May repeat every 5-15 minutes if needed.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended.
Severe: No specific adjustment recommended.
Dialysis: No specific considerations for acute anaphylaxis use.

Hepatic Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended.
Severe: No specific adjustment recommended.

Pharmacology

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Mechanism of Action

Epinephrine is a sympathomimetic agent acting on alpha- and beta-adrenergic receptors. Through its action on alpha-1 receptors, it causes vasoconstriction, increasing peripheral vascular resistance and blood pressure, and decreasing mucosal edema. Through its action on beta-1 receptors, it increases heart rate and myocardial contractility. Through its action on beta-2 receptors, it causes bronchodilation and decreases the release of mediators from mast cells and basophils, thereby alleviating bronchospasm, wheezing, and urticaria.
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Pharmacokinetics

Absorption:

Bioavailability: Rapid and complete after IM injection.
Tmax: Approximately 5-10 minutes after IM injection.
FoodEffect: Not applicable for IM injection.

Distribution:

Vd: Not readily quantifiable due to rapid metabolism.
ProteinBinding: Approximately 50%
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 2-3 minutes (plasma half-life)
Clearance: Very rapid
ExcretionRoute: Renal (as inactive metabolites)
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: Rapid (within minutes)
PeakEffect: 5-10 minutes
DurationOfAction: Short (5-30 minutes)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low potassium levels, including:
+ Muscle pain or weakness
+ Muscle cramps
+ Abnormal heartbeat
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Fainting or loss of consciousness
+ Changes in vision
Chest pain or pressure
Rapid heartbeat
Shortness of breath
Difficulty urinating or changes in urine output
Unusual burning, numbness, or tingling sensations
Weakness on one side of the body, trouble speaking or thinking, balance problems, drooping on one side of the face, or blurred vision
Abnormal heartbeat (which can be life-threatening, especially if you have pre-existing heart problems or take certain medications)
Signs of infection at the injection site, such as:
+ Redness that doesn't go away
+ Warmth
+ Swelling
+ Tenderness

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people experience no side effects or only mild ones, others may have more bothersome symptoms. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:

Feeling anxious, nervous, excitable, shaky, or restless
Upset stomach or vomiting
Excessive sweating
Pale skin
Headache
Dizziness, tiredness, or weakness
Goosebumps

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Difficulty breathing (wheezing, gasping, shortness of breath)
  • Swelling of the face, lips, tongue, or throat
  • Hives or rash all over the body
  • Sudden feeling of weakness, dizziness, or fainting
  • Rapid heart rate or weak pulse
  • Severe stomach pain, vomiting, or diarrhea
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or other drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) medications, natural products, and vitamins. This is not an exhaustive list, and it is crucial to disclose all your medications and health conditions to your doctor and pharmacist.
* Any health problems you have, as they may interact with this medication. Your doctor and pharmacist need to be aware of your complete medical profile to ensure safe treatment.

Remember, it is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

When administering this drug, avoid injecting it into the fingers, hands, or feet, as this may cause reduced blood flow to these areas. If accidental injection occurs, seek immediate medical attention.

If you have a sulfite allergy, consult your doctor before taking this medication, as some products may contain sulfites.

Patients with high blood sugar (diabetes) should closely monitor their blood sugar levels while taking this drug.

Individuals 65 years or older should exercise caution when using this medication, as they may be more susceptible to side effects.

If you are pregnant, planning to become pregnant, or are breast-feeding, inform your doctor to discuss the potential benefits and risks to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe hypertension (very high blood pressure)
  • Tachycardia (very fast heart rate)
  • Arrhythmias (irregular heartbeats)
  • Cerebral hemorrhage (bleeding in the brain)
  • Pulmonary edema (fluid in the lungs)
  • Angina (chest pain)
  • Anxiety, restlessness, tremor

What to Do:

Call 911 immediately. Treatment is supportive, including alpha-adrenergic blockers for severe hypertension and beta-blockers for arrhythmias. Call 1-800-222-1222 for Poison Control advice.

Drug Interactions

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Major Interactions

  • Beta-adrenergic blockers (non-selective): May antagonize the cardiac and bronchodilatory effects of epinephrine, leading to severe hypertension and reflex bradycardia.
  • Alpha-adrenergic blockers: May reverse the pressor effect of epinephrine, leading to hypotension.
  • Cocaine: Potentiates the effects of epinephrine, increasing risk of arrhythmias and hypertension.
  • Tricyclic antidepressants (TCAs): May potentiate the pressor effects of epinephrine, leading to severe hypertension and arrhythmias.
  • Monoamine oxidase inhibitors (MAOIs): May potentiate the pressor effects of epinephrine, leading to hypertensive crisis.
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Moderate Interactions

  • Cardiac glycosides (e.g., Digoxin): Increased risk of arrhythmias.
  • Diuretics (e.g., Loop, Thiazide): May reduce arterial responsiveness to pressor agents.
  • Antihistamines (e.g., Diphenhydramine): May potentiate the effects of epinephrine.
  • Thyroid hormones: Increased risk of arrhythmias and coronary insufficiency.
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Confidence Interactions

Monitoring

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Baseline Monitoring

Allergy history

Rationale: To confirm indication for anaphylaxis treatment.

Timing: Prior to prescription/use.

Patient/caregiver training on auto-injector use

Rationale: Ensures proper and timely administration during an emergency.

Timing: At time of prescription and periodically.

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Routine Monitoring

Blood pressure

Frequency: Immediately after administration and periodically thereafter

Target: Maintain within normal limits or improve from hypotensive state

Action Threshold: Persistent hypotension or severe hypertension requires further medical intervention.

Heart rate

Frequency: Immediately after administration and periodically thereafter

Target: Improve from bradycardia or maintain within acceptable limits

Action Threshold: Persistent bradycardia, severe tachycardia, or arrhythmias require further medical intervention.

Respiratory status (e.g., wheezing, stridor, dyspnea)

Frequency: Continuously

Target: Improvement of respiratory distress

Action Threshold: Worsening or persistent respiratory symptoms indicate need for repeat dose or additional therapy.

Skin manifestations (e.g., urticaria, angioedema)

Frequency: Continuously

Target: Resolution of skin symptoms

Action Threshold: Worsening or persistent skin symptoms indicate need for repeat dose or additional therapy.

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Symptom Monitoring

  • Difficulty breathing (wheezing, shortness of breath, stridor)
  • Swelling of face, lips, tongue, or throat (angioedema)
  • Hives or rash (urticaria)
  • Dizziness or fainting (hypotension)
  • Rapid or weak pulse
  • Nausea, vomiting, diarrhea, abdominal pain
  • Sense of impending doom

Special Patient Groups

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Pregnancy

Epinephrine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Anaphylaxis is a life-threatening condition for both mother and fetus, and prompt treatment with epinephrine is critical. Animal studies have shown adverse effects, but human data are limited.

Trimester-Specific Risks:

First Trimester: Limited data, but untreated anaphylaxis poses significant risk to fetus.
Second Trimester: Limited data, but untreated anaphylaxis poses significant risk to fetus.
Third Trimester: May cause uterine contractions and fetal anoxia, but the benefits of treating anaphylaxis outweigh these risks.
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Lactation

Epinephrine is naturally occurring in the body and is rapidly metabolized. It is considered compatible with breastfeeding when used for acute anaphylaxis. The amount transferred into breast milk is expected to be minimal and rapidly inactivated orally.

Infant Risk: Low risk to breastfed infant.
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Pediatric Use

Dosing is weight-based. For children weighing 15-30 kg, a 0.15 mg auto-injector is used. For children >30 kg, a 0.3 mg auto-injector is used. Proper training for parents/caregivers is crucial. Safety and efficacy in infants weighing less than 15 kg have not been established for auto-injector use.

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Geriatric Use

Use with caution in elderly patients, especially those with pre-existing cardiovascular disease (e.g., coronary artery disease, hypertension, arrhythmias), as they may be more susceptible to adverse effects like increased blood pressure, heart rate, and arrhythmias. Dosage adjustment is generally not needed for anaphylaxis, but close monitoring is advised.

Clinical Information

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Clinical Pearls

  • Epinephrine is the first-line treatment for anaphylaxis; do not delay administration.
  • Administer IM into the anterolateral aspect of the thigh, through clothing if necessary.
  • Always call 911 or seek immediate medical attention after administering epinephrine, even if symptoms improve, as biphasic reactions can occur.
  • Patients should carry two auto-injectors at all times due to the possibility of needing a second dose or device malfunction.
  • Proper training on auto-injector use is critical for patients and caregivers.
  • Check expiration dates regularly and replace expired devices.
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Alternative Therapies

  • Antihistamines (e.g., diphenhydramine, cetirizine) - for mild allergic reactions, not a substitute for epinephrine in anaphylaxis.
  • Corticosteroids (e.g., prednisone) - for delayed or prolonged allergic reactions, not for acute anaphylaxis.
  • Albuterol (inhaled) - for bronchospasm, but does not address other systemic manifestations of anaphylaxis.
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Cost & Coverage

Average Cost: $300 - $700 per 2-pack auto-injector
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (often preferred brand or generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.