Ephedrine Sulfate 50mg/ml Inj, 1ml

Manufacturer XIROMED Active Ingredient Ephedrine Injection(e FED rin) Pronunciation e-FED-rin
It is used to treat low blood pressure. It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Vasopressor; Bronchodilator
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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
Jun 1938
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Ephedrine is a medication given by injection, usually in a hospital setting, to help raise your blood pressure if it drops too low, for example, during surgery. It works by making your heart pump stronger and tightening your blood vessels.
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How to Use This Medicine

To use this medication correctly, follow your doctor's instructions and carefully read all the information provided. Administration of this drug involves intravenous infusion over a specified period.

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the appropriate storage method.

In the event that you miss a dose, contact your doctor for guidance on the next steps to take.
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Lifestyle & Tips

  • Report any unusual symptoms like chest pain, fast heartbeat, or severe headache immediately.
  • Remain in a supervised setting during and after administration.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 5-25 mg IV slow bolus, repeated as needed
Dose Range: 5 - 50 mg

Condition-Specific Dosing:

hypotension_during_anesthesia: 5-10 mg IV slow bolus, may repeat every 3-4 minutes as needed, not to exceed 50 mg in any 10-minute period or 150 mg total daily dose.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: 0.2-0.3 mg/kg IV/IM/SC every 4-6 hours as needed (max 25 mg/dose)
Adolescent: 5-25 mg IV slow bolus, repeated as needed (similar to adult dosing for hypotension)
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, monitor closely.
Moderate: No specific adjustment recommended, monitor closely.
Severe: Use with caution; consider lower initial doses and extended dosing intervals due to renal excretion. Monitor for prolonged effects.
Dialysis: Not well studied; likely removed by dialysis. Monitor closely and adjust dose based on response.

Hepatic Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended.
Severe: No specific adjustment recommended, as hepatic metabolism is minor.

Pharmacology

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Mechanism of Action

Ephedrine is a sympathomimetic amine that acts on alpha- and beta-adrenergic receptors. It has both direct and indirect effects. Directly, it stimulates alpha-1, beta-1, and beta-2 adrenergic receptors. Indirectly, it causes the release of norepinephrine from sympathetic nerve endings. The combined effects lead to increased heart rate, increased cardiac output, peripheral vasoconstriction (alpha-1), and bronchodilation (beta-2).
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV)
Tmax: Rapid (IV)
FoodEffect: Not applicable for IV injection

Distribution:

Vd: Approximately 2.5 L/kg
ProteinBinding: Low (approximately 10-20%)
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 3-6 hours
Clearance: Not precisely quantified, primarily renal
ExcretionRoute: Renal (urine)
Unchanged: Approximately 77-90% (dependent on urine pH)
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Pharmacodynamics

OnsetOfAction: Within 1 minute (IV)
PeakEffect: Within 5 minutes (IV)
DurationOfAction: Approximately 10-60 minutes (IV)

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Attention Immediately

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help 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 high blood pressure, including:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in eyesight
Chest pain or pressure
Abnormal heartbeat (fast, slow, or irregular)
Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred eyesight
Trouble passing urine
Shortness of breath
Seizures

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:

Dizziness
Headache
Feeling nervous and excitable
Trouble sleeping
Upset stomach or vomiting
Decreased appetite
Restlessness
Excessive sweating

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, contact your doctor for medical advice. 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:

  • Severe headache
  • Chest pain or tightness
  • Irregular or very fast heartbeat
  • Difficulty breathing
  • Dizziness or lightheadedness
  • Anxiety or nervousness
  • Tremors
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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, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have taken certain medications for depression or Parkinson's disease within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may increase the risk of very high blood pressure.
If you are currently taking linezolid or methylene blue, as these medications can interact with this drug.
If you are taking any other medications for nasal congestion, weight loss, or attention deficit hyperactivity disorder (ADHD), as these may interact with this medication.

This list is not exhaustive, and it is crucial to disclose all of your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, as well as any health problems you may have. Your doctor and pharmacist need this information to ensure it is safe for you to take this medication. Do not initiate, stop, or modify the dosage 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.

This drug may cause high blood pressure or a rapid heartbeat, which can increase the risk of a heart attack or stroke, potentially leading to fatal outcomes. If you have any concerns or questions, consult your doctor.

Regularly monitor your blood pressure as instructed by your healthcare provider.

There have been instances of severely high blood pressure in postpartum women who received this medication in combination with other drugs, such as ergonovine and methylergonovine, which in some cases resulted in stroke. If you have any questions or concerns, discuss them with your doctor.

If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. It is crucial 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)
  • Palpitations
  • Arrhythmias (irregular heartbeats)
  • Myocardial infarction (heart attack)
  • Cerebral hemorrhage (bleeding in the brain)
  • Seizures
  • Respiratory depression
  • Coma
  • Hyperthermia

What to Do:

Call 1-800-222-1222 (Poison Control). Treatment is supportive and symptomatic, including alpha-blockers for severe hypertension, beta-blockers for tachycardia/arrhythmias, and benzodiazepines for seizures.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) - risk of hypertensive crisis
  • Linezolid (has MAOI activity)
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Major Interactions

  • General Anesthetics (e.g., Halothane, Cyclopropane) - increased risk of ventricular arrhythmias
  • Other Sympathomimetics (e.g., pseudoephedrine, phenylephrine) - additive pressor effects, increased toxicity
  • Tricyclic Antidepressants (TCAs) - potentiate pressor effects
  • Ergot Alkaloids (e.g., Ergotamine) - increased vasoconstriction
  • Oxytocic Drugs (e.g., Oxytocin) - severe persistent hypertension
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Moderate Interactions

  • Beta-blockers (non-selective) - may antagonize bronchodilator effects, risk of hypertension and bradycardia
  • Alpha-blockers - may reduce pressor response
  • Cardiac Glycosides (e.g., Digoxin) - increased risk of arrhythmias
  • Diuretics (e.g., Furosemide) - may reduce pressor response
  • Antihypertensives - may antagonize hypotensive effects
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and guide initial dosing for hypotension.

Timing: Prior to administration

Heart Rate (HR)

Rationale: To establish baseline and monitor for tachycardia/bradycardia.

Timing: Prior to administration

Electrocardiogram (ECG)

Rationale: To assess cardiac rhythm, especially in patients with pre-existing cardiac conditions or during anesthesia.

Timing: Prior to administration, continuous during infusion

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Routine Monitoring

Blood Pressure (BP)

Frequency: Continuously or every 1-5 minutes during acute use, then as clinically indicated.

Target: Individualized, typically aiming for normotension or target MAP.

Action Threshold: Hypotension requiring further dosing, or hypertension requiring intervention.

Heart Rate (HR)

Frequency: Continuously or every 1-5 minutes during acute use, then as clinically indicated.

Target: Individualized, typically within normal limits or patient's baseline.

Action Threshold: Significant tachycardia or bradycardia.

Cardiac Rhythm (ECG)

Frequency: Continuous during acute use.

Target: Normal sinus rhythm.

Action Threshold: Development of arrhythmias (e.g., ventricular ectopy, tachycardia).

Urine Output

Frequency: Hourly during acute use.

Target: >0.5 mL/kg/hr

Action Threshold: Oliguria or anuria, indicating inadequate renal perfusion.

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Symptom Monitoring

  • Chest pain
  • Palpitations
  • Headache
  • Dizziness
  • Anxiety
  • Tremor
  • Nausea/Vomiting
  • Difficulty breathing

Special Patient Groups

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Pregnancy

Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. Ephedrine crosses the placenta. May cause fetal tachycardia and arrhythmias. Prolonged use during pregnancy may lead to fetal growth restriction.

Trimester-Specific Risks:

First Trimester: Limited data, theoretical risk of teratogenicity with sympathomimetics.
Second Trimester: May cause fetal tachycardia and arrhythmias.
Third Trimester: May cause fetal tachycardia, arrhythmias, and potential for neonatal withdrawal symptoms if used chronically. Can also cause maternal hypertension and reduced uterine blood flow.
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Lactation

Lactation Risk L3 (Moderate Risk). Ephedrine is excreted into breast milk. Monitor breastfed infants for irritability, sleep disturbances, and changes in feeding patterns. Use with caution, or consider alternative agents.

Infant Risk: Irritability, sleep disturbances, poor feeding, tachycardia.
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Pediatric Use

Use with caution. Dosing is weight-based and less established for IV use in neonates and infants. Children may be more susceptible to CNS stimulant effects. Close monitoring of vital signs is essential.

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Geriatric Use

Use with caution. Elderly patients may be more sensitive to the pressor and CNS stimulant effects of ephedrine, and may have underlying cardiovascular disease. Start with lower doses and titrate slowly. Monitor closely for hypertension, tachycardia, and arrhythmias.

Clinical Information

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Clinical Pearls

  • Ephedrine has both direct and indirect sympathomimetic effects, making its response less predictable than pure direct-acting agents like phenylephrine.
  • Often preferred over pure alpha-agonists in obstetric anesthesia for hypotension due to less reduction in uterine blood flow.
  • Tolerance (tachyphylaxis) can develop with repeated doses, requiring higher doses or a switch to another vasopressor.
  • Monitor for CNS stimulation (anxiety, tremor, insomnia) even with IV use, especially in sensitive patients.
  • Urine pH significantly affects ephedrine elimination; acidic urine increases excretion, alkaline urine decreases it.
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Alternative Therapies

  • Phenylephrine (pure alpha-1 agonist, direct acting)
  • Norepinephrine (alpha-1, beta-1 agonist, direct acting)
  • Dopamine (dose-dependent effects, direct and indirect)
  • Mephentermine (indirect sympathomimetic)
  • Caffeine (for bronchodilation, not hypotension)
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Cost & Coverage

Average Cost: Varies widely per 1ml vial
Generic Available: Yes
Insurance Coverage: Typically covered by most insurance plans when administered in a hospital or clinic setting for approved indications.
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General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed otherwise, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the proper disposal method, consult your pharmacist for guidance. Many communities offer drug take-back programs, which your pharmacist can help you locate. Some medications may come with an additional patient information leaflet; check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, discuss them with 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. Be prepared to provide information about the medication taken, the amount, and the time it was taken to ensure prompt and effective treatment.