Ephedrine Sulf 5mg/ml Inj, 10ml

Manufacturer PAR STERILE PRODUCTS 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.
đŸˇī¸
Drug Class
Vasopressor; Bronchodilator
đŸ§Ŧ
Pharmacologic Class
Alpha- and Beta-Adrenergic Agonist (Direct and Indirect)
🤰
Pregnancy Category
Category C
✅
FDA Approved
Jan 1970
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

Ephedrine is a medication given by injection, usually in a hospital or clinic setting, to help raise blood pressure if it drops too low (e.g., during surgery) or to help with breathing problems by opening up airways.
📋

How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. Adhere to the instructions carefully. This medication is administered intravenously over a specified period.

Storing and Disposing of Your Medication

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

Missing a Dose

If you miss a dose, contact your doctor to receive guidance on the next steps to take.
💡

Lifestyle & Tips

  • This medication is typically administered by a healthcare professional in a controlled setting.
  • Report any unusual symptoms or discomfort immediately to your healthcare provider.
💊

Available Forms & Alternatives

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: Hypotension (e.g., during spinal/epidural anesthesia): 5-10 mg IV bolus, repeat as needed every 3-4 minutes. Max single dose: 50 mg. Max total dose: 150 mg/24 hours. IM/SC: 25-50 mg.
Dose Range: 5 - 50 mg

Condition-Specific Dosing:

bronchospasm: 25-50 mg IM/SC, repeat in 4 hours if needed. Max 150 mg/24 hours.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established for routine use; use with extreme caution if at all. Dosing for hypotension is highly individualized and off-label (e.g., 0.1-0.2 mg/kg IV).
Infant: Not established for routine use; use with extreme caution if at all. Dosing for hypotension is highly individualized and off-label (e.g., 0.1-0.2 mg/kg IV).
Child: Hypotension: 0.1-0.2 mg/kg IV, repeat as needed. Bronchospasm (less common now): 0.5-0.75 mg/kg/day divided every 4-6 hours (IM/SC/Oral). Max 50 mg/day.
Adolescent: Follow adult dosing for hypotension. For bronchospasm, follow child dosing or adult dosing if weight/size appropriate.
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, monitor closely.
Moderate: Reduce dose and/or extend dosing interval; monitor closely for adverse effects and efficacy. Ephedrine is primarily renally excreted.
Severe: Significant dose reduction and/or extended dosing interval required; monitor closely. Avoid if possible.
Dialysis: Ephedrine is dialyzable. Administer after dialysis. Monitor closely.

Hepatic Impairment:

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

Pharmacology

đŸ”Ŧ

Mechanism of Action

Ephedrine is a sympathomimetic amine that acts on alpha- and beta-adrenergic receptors. Its primary mechanism involves both direct stimulation of adrenergic receptors and indirect release of norepinephrine from sympathetic nerve endings. This leads to increased heart rate, myocardial contractility, peripheral vasoconstriction, and bronchodilation.
📊

Pharmacokinetics

Absorption:

Bioavailability: 100% (IV); ~85% (Oral)
Tmax: Immediate (IV); 20-30 minutes (IM)
FoodEffect: Not applicable for injection; oral absorption not significantly affected by food.

Distribution:

Vd: Approximately 2.5 L/kg
ProteinBinding: Low (<50%)
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 3-6 hours (pH dependent; shorter in acidic urine)
Clearance: Not readily available as a single rate, primarily renal excretion.
ExcretionRoute: Renal
Unchanged: Approximately 77-90% (in acidic urine); 20-35% (in alkaline urine)
âąī¸

Pharmacodynamics

OnsetOfAction: Immediate (IV); 10-20 minutes (IM/SC)
PeakEffect: 1-2 minutes (IV); 20-60 minutes (IM/SC)
DurationOfAction: 10-60 minutes (IV); 30-90 minutes (IM/SC)

Safety & Warnings

âš ī¸

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 or fainting
+ Changes in eyesight
Chest pain or pressure
Abnormal heart rhythms, such as fast, slow, or irregular heartbeat
Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred eyesight
Difficulty urinating
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, contact your doctor or seek medical help:

Dizziness or headache
Feeling nervous or 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. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
🚨

Seek Immediate Medical Attention If You Experience:

  • Severe headache
  • Chest pain or tightness
  • Fast, pounding, or irregular heartbeat
  • Shortness of breath
  • Dizziness or lightheadedness
  • Nervousness or anxiety
  • Tremors
  • Nausea or vomiting
📋

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.
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 also interact with this medication.

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
âš ī¸

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 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 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.
🆘

Overdose Information

Overdose Symptoms:

  • Severe hypertension (very high blood pressure)
  • Tachycardia (very fast heart rate)
  • Arrhythmias (irregular heartbeats)
  • Palpitations
  • Myocardial infarction (heart attack)
  • Cerebral hemorrhage (bleeding in the brain)
  • Seizures
  • Coma
  • Respiratory depression
  • Hyperthermia

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management is supportive, including alpha-adrenergic blockers for severe hypertension, beta-blockers for tachycardia/arrhythmias, and benzodiazepines for seizures.

Drug Interactions

đŸšĢ

Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI discontinuation (risk of hypertensive crisis)
🔴

Major Interactions

  • Tricyclic Antidepressants (TCAs) - may potentiate pressor effects
  • Other Sympathomimetics (e.g., pseudoephedrine, phenylephrine, amphetamines) - additive effects, increased risk of cardiovascular adverse events
  • Alpha-adrenergic blockers (e.g., phentolamine) - may antagonize pressor effects
  • Beta-adrenergic blockers (e.g., propranolol) - may antagonize bronchodilator effects and leave alpha-adrenergic effects unopposed, leading to hypertension
  • Cardiac Glycosides (e.g., digoxin) - increased risk of arrhythmias
  • Ergot Alkaloids (e.g., ergonovine, methylergonovine) - increased risk of severe hypertension
🟡

Moderate Interactions

  • General Anesthetics (e.g., halothane, cyclopropane) - increased risk of ventricular arrhythmias
  • Oxytocin - increased risk of severe hypertension and stroke
  • Diuretics (e.g., loop diuretics, thiazide diuretics) - may reduce pressor response to ephedrine
  • Antihypertensives - may reduce the hypotensive effect of these agents
đŸŸĸ

Minor Interactions

  • Not readily available

Monitoring

đŸ”Ŧ

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/arrhythmias.

Timing: Prior to administration

Electrocardiogram (ECG)

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

Timing: Prior to administration, if clinically indicated

📊

Routine Monitoring

Blood Pressure (BP)

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

Target: Maintain within desired therapeutic range (e.g., within 20% of baseline or >90 mmHg systolic).

Action Threshold: Hypotension or hypertension outside target range; adjust dose or consider alternative.

Heart Rate (HR)

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

Target: Maintain within acceptable physiological limits.

Action Threshold: Significant tachycardia or bradycardia; adjust dose or consider intervention.

Electrocardiogram (ECG)

Frequency: Continuous monitoring during acute administration.

Target: Normal sinus rhythm, absence of significant arrhythmias.

Action Threshold: Development of arrhythmias (e.g., ventricular ectopy, tachycardia); adjust dose or consider antiarrhythmic.

Urine Output

Frequency: Hourly during acute administration, especially in hypotensive states.

Target: >0.5 mL/kg/hr

Action Threshold: Oliguria; assess hydration status, renal perfusion.

đŸ‘ī¸

Symptom Monitoring

  • Headache
  • Palpitations
  • Nervousness
  • Anxiety
  • Tremor
  • Dizziness
  • Nausea
  • Vomiting
  • Chest pain
  • Dyspnea

Special Patient Groups

🤰

Pregnancy

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Ephedrine crosses the placenta and can cause fetal tachycardia and arrhythmias. It has been used to treat maternal hypotension during anesthesia, but fetal monitoring is essential.

Trimester-Specific Risks:

First Trimester: Limited data, but generally avoided unless clearly indicated due to potential for cardiovascular effects.
Second Trimester: Can cause fetal tachycardia and arrhythmias. Monitor fetal heart rate closely if used.
Third Trimester: Can cause fetal tachycardia and arrhythmias. May affect uterine blood flow. Used cautiously for maternal hypotension during delivery.
🤱

Lactation

L3 (Moderately Safe). Ephedrine is excreted into breast milk. Monitor breastfed infant for signs of irritability, sleep disturbances, or changes in feeding patterns. Use with caution, especially in neonates or preterm infants.

Infant Risk: Low to moderate risk of irritability, sleep disturbances, or feeding issues. Monitor infant closely.
đŸ‘ļ

Pediatric Use

Use with caution. Dosing must be carefully calculated based on weight. Neonates and infants may be more susceptible to adverse effects, particularly cardiovascular and CNS effects. Not routinely recommended for hypotension in very young children; alternative vasopressors may be preferred.

👴

Geriatric Use

Use with caution. Elderly patients may be more sensitive to the pressor and CNS effects of ephedrine, increasing the risk of hypertension, arrhythmias, and anxiety. Start with lower doses and titrate slowly, monitoring closely for adverse effects.

Clinical Information

💎

Clinical Pearls

  • Ephedrine has both direct and indirect sympathomimetic effects, meaning it directly stimulates adrenergic receptors and also causes the release of norepinephrine.
  • Tachyphylaxis (rapidly diminishing response to successive doses) can occur with repeated administration due to depletion of norepinephrine stores.
  • Often used in the operating room to treat hypotension, particularly post-spinal or epidural anesthesia.
  • Caution is advised in patients with cardiovascular disease (e.g., hypertension, coronary artery disease, arrhythmias), hyperthyroidism, diabetes mellitus, or prostatic hypertrophy.
  • The pressor effect of ephedrine is less potent but generally longer-lasting than that of epinephrine or norepinephrine.
🔄

Alternative Therapies

  • Phenylephrine (direct alpha-1 agonist, pure vasoconstrictor, less cardiac stimulation)
  • Norepinephrine (potent alpha-1 and beta-1 agonist, for severe hypotension/shock)
  • Dopamine (dose-dependent effects, for hypotension/shock)
  • Epinephrine (potent alpha and beta agonist, for anaphylaxis, cardiac arrest, severe bronchospasm)
  • Albuterol (selective beta-2 agonist, for bronchospasm, oral/inhaled forms)
💰

Cost & Coverage

Average Cost: Not readily available for specific injection product, highly variable. per 10ml vial
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
📚

General Drug Facts

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe use, never share your prescription medications with others, and do not take medications that have been prescribed to someone else.

Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. Proper disposal of unused or expired medications is crucial. Do not dispose of medications by flushing them down the toilet or pouring them down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. If you are unsure about the correct disposal method, consult with your pharmacist, who can provide guidance on safe disposal practices and inform you about potential drug take-back programs in your area.

Some medications may have additional patient information leaflets available. Your pharmacist can provide you with this information upon request. If you have any questions or concerns about your medication, it is important to discuss them with your doctor, nurse, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide critical information, including the name of the medication taken, the amount, and the time it was taken, to ensure prompt and effective treatment.