Epinephrine 0.15mg 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, Vasopressor, Bronchodilator
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Pharmacologic Class
Alpha- and Beta-adrenergic Agonist
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Pregnancy Category
C
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Epinephrine is an emergency medicine used to treat severe allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs, or other allergens. It works quickly to open airways, raise blood pressure, and reduce swelling.
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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 part 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 devices at work, school, and home in case of an emergency. Inform others about the location and proper use of this medication, as they may need to administer it if necessary.

Pre-Use Checks

Before using the device, ensure the safety release is in place and 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 by your doctor. 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, request a refill before the next 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 your epinephrine auto-injector with you, especially if you have a history of severe allergic reactions.
  • Avoid known allergens.
  • Learn how to properly use the auto-injector and teach family members or caregivers how to use it.
  • Check the expiration date regularly and replace expired devices.
  • Store at room temperature, away from light and extreme heat or cold.

Dosing & Administration

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Adult Dosing

Standard Dose: For patients weighing 15-30 kg (33-66 lbs): 0.15 mg intramuscularly (IM) into the anterolateral aspect of the thigh. May repeat every 5-15 minutes if symptoms persist or recur.
Dose Range: 0.15 - 0.15 mg

Condition-Specific Dosing:

anaphylaxis: 0.15 mg IM for patients 15-30 kg. For patients >30 kg, 0.3 mg IM is typically used.
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Pediatric Dosing

Neonatal: Not established for 0.15mg auto-injector. Dosing typically 0.01 mg/kg IM/SC for severe reactions.
Infant: Not established for 0.15mg auto-injector. Dosing typically 0.01 mg/kg IM/SC for severe reactions.
Child: For children weighing 15-30 kg (33-66 lbs): 0.15 mg intramuscularly (IM) into the anterolateral aspect of the thigh. May repeat every 5-15 minutes if symptoms persist or recur.
Adolescent: For adolescents weighing 15-30 kg (33-66 lbs): 0.15 mg intramuscularly (IM) into the anterolateral aspect of the thigh. For adolescents >30 kg, 0.3 mg IM is typically used.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed for acute, emergency use.
Moderate: No specific adjustment needed for acute, emergency use.
Severe: No specific adjustment needed for acute, emergency use.
Dialysis: No specific considerations for acute, emergency use.

Hepatic Impairment:

Mild: No specific adjustment needed for acute, emergency use.
Moderate: No specific adjustment needed for acute, emergency use.
Severe: No specific adjustment needed for acute, emergency use.

Pharmacology

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Mechanism of Action

Epinephrine is a sympathomimetic catecholamine that acts on alpha-1, beta-1, and beta-2 adrenergic receptors. Its alpha-1 adrenergic effects cause vasoconstriction, increasing peripheral vascular resistance and blood pressure, and decreasing mucosal edema. Its beta-1 adrenergic effects increase heart rate and myocardial contractility. Its beta-2 adrenergic effects cause bronchodilation and decrease the release of mediators from mast cells and basophils.
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Pharmacokinetics

Absorption:

Bioavailability: Variable (rapid after IM/SC injection)
Tmax: Approximately 5-10 minutes (IM)
FoodEffect: Not applicable (parenteral administration)

Distribution:

Vd: Not precisely quantified, rapidly distributed to tissues.
ProteinBinding: Approximately 50%
CnssPenetration: Limited (does not readily cross the blood-brain barrier)

Elimination:

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

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

Safety & Warnings

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Side Effects

Important Side Effects to Report to Your Doctor Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, seek medical attention right away:

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
+ Trouble 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
+ An irregular heartbeat
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
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, changes in balance, 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

Most people experience few or no side effects while taking this medication. However, if you experience any of the following side effects, contact your doctor if they bother you or don't go away:

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, shortness of breath, gasping)
  • Swelling of the face, lips, tongue, or throat
  • Hives, itching, or skin rash
  • Dizziness, lightheadedness, or fainting
  • Rapid or weak pulse
  • Nausea, vomiting, or diarrhea
  • Feeling of impending doom
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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 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) drugs, natural products, and vitamins. This is not an exhaustive list, and it is crucial to discuss all your medications and health conditions with your doctor.
* Any health problems you have, as they may interact with this medication.

To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is your responsibility to verify that it is safe to take this medication with all your other medications and health conditions. Your doctor and pharmacist will work together to help you make informed decisions about your treatment.
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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 known allergy to sulfites, 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 of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe hypertension (high blood pressure)
  • Tachycardia (rapid heart rate)
  • Cardiac arrhythmias (irregular heartbeats)
  • Palpitations
  • Headache
  • Tremor
  • Anxiety
  • Pulmonary edema (fluid in the lungs)
  • Cerebral hemorrhage (bleeding in the brain)

What to Do:

Seek immediate medical attention. Call 911 or Poison Control (1-800-222-1222). Treatment is supportive, including alpha-blockers for severe hypertension and beta-blockers for arrhythmias, if appropriate.

Drug Interactions

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Contraindicated Interactions

  • No absolute contraindications in a life-threatening allergic reaction (anaphylaxis) where the potential benefits outweigh the risks.
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Major Interactions

  • Beta-adrenergic blockers (e.g., Propranolol): May antagonize the cardiac and bronchodilatory effects of epinephrine, leading to severe hypertension followed by bradycardia. May also increase risk of anaphylaxis.
  • Alpha-adrenergic blockers (e.g., Phentolamine): May antagonize the pressor effects of epinephrine.
  • Tricyclic antidepressants (TCAs) and Monoamine Oxidase Inhibitors (MAOIs): May potentiate the cardiovascular effects of epinephrine, leading to severe hypertension and arrhythmias.
  • Cocaine, Amphetamines, other sympathomimetics: Additive cardiovascular effects, increased risk of arrhythmias and hypertension.
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Moderate Interactions

  • Cardiac glycosides (e.g., Digoxin): Increased risk of cardiac arrhythmias.
  • Diuretics (e.g., Loop diuretics, Thiazide diuretics): May reduce arterial responsiveness to pressor agents like epinephrine.
  • Antihistamines (e.g., Diphenhydramine, Chlorpheniramine): May potentiate the effects of epinephrine (less common, but possible with older antihistamines).
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Minor Interactions

  • Not typically classified for emergency use.

Monitoring

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Baseline Monitoring

Not applicable for emergency, acute administration.

Rationale: Epinephrine auto-injector is for immediate, life-threatening allergic reactions.

Timing: Prior to administration

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Routine Monitoring

Resolution of anaphylaxis symptoms (e.g., breathing difficulty, hives, swelling, dizziness)

Frequency: Continuously after administration

Target: Improvement or resolution

Action Threshold: If symptoms persist or recur, administer a second dose and seek immediate medical attention.

Vital Signs (Heart Rate, Blood Pressure, Respiratory Rate)

Frequency: Continuously after administration until medical help arrives

Target: Stabilization towards normal

Action Threshold: Significant deviations or worsening indicate need for further medical intervention.

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Symptom Monitoring

  • Difficulty breathing (wheezing, shortness of breath)
  • Swelling of face, lips, tongue, or throat
  • Hives or rash
  • Dizziness or fainting
  • Rapid or weak pulse
  • Nausea, vomiting, diarrhea
  • Feeling 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. In a life-threatening situation like anaphylaxis, the benefits of treating the mother outweigh the potential risks to the fetus.

Trimester-Specific Risks:

First Trimester: Limited data, but life-threatening anaphylaxis requires immediate treatment.
Second Trimester: Limited data, but life-threatening anaphylaxis requires immediate treatment.
Third Trimester: May cause uterine contractions and fetal anoxia due to vasoconstriction. However, untreated anaphylaxis poses a greater risk to both mother and fetus.
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Lactation

Epinephrine is rapidly metabolized and has a very short half-life. It is considered compatible with breastfeeding, and adverse effects on the infant are unlikely.

Infant Risk: Low risk
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Pediatric Use

Dosing is weight-based. The 0.15 mg auto-injector is specifically designed for pediatric patients weighing 15-30 kg (33-66 lbs). For children weighing less than 15 kg, a lower dose (e.g., 0.01 mg/kg) administered via syringe may be necessary. For children over 30 kg, the 0.3 mg auto-injector is typically used.

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Geriatric Use

Use with caution in elderly patients due to increased sensitivity to the pressor and cardiac effects of epinephrine. Pre-existing cardiovascular disease (e.g., coronary artery disease, hypertension) may increase the risk of adverse effects such as angina, myocardial infarction, or arrhythmias. Monitor closely.

Clinical Information

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Clinical Pearls

  • Epinephrine is the first-line treatment for anaphylaxis and should be administered immediately upon recognition of a severe allergic reaction.
  • Always carry two auto-injectors, as a second dose may be needed if symptoms persist or recur.
  • Administer into the anterolateral aspect of the thigh, through clothing if necessary. Do not inject into a vein, buttocks, fingers, or toes.
  • After administering epinephrine, always seek immediate medical attention, even if symptoms improve, as biphasic reactions can occur.
  • Proper training on how to use the auto-injector is crucial for patients and caregivers.
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Alternative Therapies

  • While other medications (e.g., antihistamines, corticosteroids, bronchodilators) may be used as adjunctive therapy for anaphylaxis, none are a substitute for epinephrine as the primary, life-saving treatment for acute anaphylaxis.
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Cost & Coverage

Average Cost: Varies widely, typically $200-$700+ per 2-pack auto-injector
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (varies by insurance plan)
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General Drug Facts

If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication. It's also important to note that some medications may have additional patient information leaflets, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for clarification. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information about the medication taken, including the dosage, timing, and any other relevant factors.