Emerphed 50mg/10ml Pf Syr Inj 10ml

Manufacturer NEXUS PHARMA 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
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Pharmacologic Class
Sympathomimetic (alpha and beta adrenergic agonist)
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Pregnancy Category
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?

Ephedrine is a medication given by injection, usually in a hospital setting, to quickly raise blood pressure if it drops too low, for example, during surgery or certain medical procedures. 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 accompanying information. Take this medication exactly as directed, and adhere to all guidelines provided. This drug is administered intravenously over a specified period.

For storage and disposal, consult with your doctor, nurse, or pharmacist to determine the best approach if you need to keep this medication at home.

If you miss a dose, contact your doctor promptly to receive guidance on the appropriate course of action.
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Lifestyle & Tips

  • This medication is typically administered in an acute care setting, so lifestyle modifications are not directly applicable during administration.
  • Patients should inform their healthcare provider about all medications, supplements, and medical conditions, especially heart problems, high blood pressure, or thyroid issues.

Dosing & Administration

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Adult Dosing

Standard Dose: 5-10 mg IV, administered slowly
Dose Range: 5 - 25 mg

Condition-Specific Dosing:

hypotension_during_anesthesia: 5-10 mg IV bolus, repeated as needed every 3-4 minutes, not to exceed 50 mg in 10 minutes or 150 mg in 24 hours.
bronchodilator: Not recommended for this indication via injection due to safer alternatives.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: 0.2-0.3 mg/kg IV, not to exceed 25 mg/dose, repeated every 4-6 hours as needed. (Use with extreme caution and only if other vasopressors are unavailable or contraindicated).
Adolescent: Similar to adult dosing, 5-10 mg IV, repeated as needed.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, monitor closely.
Moderate: Consider lower initial doses and extend dosing intervals; monitor closely.
Severe: Consider lower initial doses and extend dosing intervals; monitor closely. Ephedrine is primarily renally excreted.
Dialysis: Not well studied; use with caution, monitor hemodynamics closely.

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

Ephedrine is a sympathomimetic amine that acts both directly and indirectly on adrenergic receptors. It directly stimulates alpha- and beta-adrenergic receptors, leading to vasoconstriction (alpha-1), increased heart rate and contractility (beta-1), and bronchodilation (beta-2). Its indirect action involves promoting the release of norepinephrine from sympathetic nerve endings, which further contributes to its adrenergic effects.
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Pharmacokinetics

Absorption:

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

Distribution:

Vd: Not precisely quantified, but widely distributed.
ProteinBinding: Not extensively protein bound.
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 3-6 hours (variable, pH-dependent)
Clearance: Primarily renal
ExcretionRoute: Renal
Unchanged: Approximately 77% (dependent on urine pH; increased excretion with acidic urine)
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Pharmacodynamics

OnsetOfAction: Within 1 minute (IV)
PeakEffect: Within 2-5 minutes (IV)
DurationOfAction: Approximately 10-15 minutes (IV)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately

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 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
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 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. 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe headache
  • Chest pain or tightness
  • Irregular heartbeat (palpitations)
  • Shortness of breath
  • Severe dizziness or lightheadedness
  • Confusion
  • Difficulty urinating
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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.
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 lead to very high blood pressure.
If you are currently taking linezolid or methylene blue, as these medications may interact with this drug.
If you are taking any other medications for conditions such as nose stuffiness, weight loss, or attention deficit hyperactivity disorder (ADHD).

This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter 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 with 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.

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.

As directed, regularly monitor your blood pressure to ensure it remains within a safe range.

In some cases, individuals who received this medication in combination with other drugs, such as ergonovine and methylergonovine, after delivering a baby have experienced severely high blood pressure, which has led to strokes in some instances. 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 to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Severe hypertension
  • Tachycardia
  • Arrhythmias (e.g., ventricular fibrillation)
  • Myocardial infarction
  • Cerebral hemorrhage
  • Seizures
  • Coma
  • Respiratory depression
  • Hyperpyrexia

What to Do:

Seek immediate medical attention. Management is supportive and symptomatic, including alpha-blockers for severe hypertension, beta-blockers for arrhythmias, and benzodiazepines for seizures. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs): Risk of hypertensive crisis.
  • Cyclopropane, Halothane, or other halogenated anesthetics: Risk of cardiac arrhythmias.
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Major Interactions

  • Alpha-adrenergic blockers (e.g., phentolamine): May antagonize vasopressor effects.
  • Beta-adrenergic blockers (non-selective): May lead to unopposed alpha-adrenergic effects (hypertension, bradycardia).
  • Cardiac glycosides (e.g., digoxin): Increased risk of arrhythmias.
  • Ergot alkaloids (e.g., ergotamine): Increased vasoconstrictor effects.
  • Oxytocic drugs (e.g., oxytocin): Potentiation of vasopressor effects, severe hypertension.
  • Tricyclic Antidepressants (TCAs): Potentiation of pressor effects.
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Moderate Interactions

  • Antihypertensives: May reduce antihypertensive effects.
  • Diuretics: May reduce antihypertensive effects.
  • Other sympathomimetics (e.g., pseudoephedrine, phenylephrine): Additive pressor effects, increased risk of adverse cardiovascular events.
  • Thyroid hormones: Increased cardiovascular 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 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 or during anesthesia.

Timing: Prior to administration (if clinically indicated)

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Routine Monitoring

Blood Pressure (BP)

Frequency: Continuously or every 1-2 minutes initially, then every 5-15 minutes once stable.

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

Action Threshold: Hypotension persists or excessive hypertension develops; adjust dose or consider alternative.

Heart Rate (HR)

Frequency: Continuously or every 1-2 minutes initially, then every 5-15 minutes once stable.

Target: Maintain within acceptable physiological limits.

Action Threshold: Significant tachycardia, bradycardia, or arrhythmias; adjust dose or intervene.

Cardiac Rhythm (ECG)

Frequency: Continuous monitoring during administration and for duration of effect.

Target: Normal sinus rhythm, absence of significant arrhythmias.

Action Threshold: Development of new arrhythmias (e.g., ventricular ectopy, tachycardia); intervene as appropriate.

Urine Output

Frequency: Hourly (in critically ill patients)

Target: >0.5 mL/kg/hr

Action Threshold: Oliguria; may indicate inadequate perfusion or renal effects.

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Symptom Monitoring

  • Headache
  • Palpitations
  • Nervousness
  • Anxiety
  • Tremor
  • Dizziness
  • Nausea
  • Vomiting
  • Urinary retention (especially in men with prostatic hypertrophy)

Special Patient Groups

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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, potential for cardiovascular effects on fetus.
Second Trimester: Potential for fetal tachycardia and arrhythmias.
Third Trimester: May cause fetal tachycardia, arrhythmias, and neonatal depression. Use with caution during labor and delivery due to potential for uterine vasoconstriction and fetal distress.
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Lactation

Ephedrine is excreted into breast milk. Caution is advised. Monitor breastfed infant for irritability, sleep disturbances, and feeding difficulties.

Infant Risk: Low to moderate risk. Potential for irritability, sleep disturbances, and feeding issues in the infant. Consider alternative or temporary interruption of breastfeeding.
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Pediatric Use

Use with extreme caution. Dosing is not well-established for all pediatric age groups, especially neonates and infants. Close monitoring of vital signs is essential due to increased sensitivity to sympathomimetic effects.

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Geriatric Use

Use with caution. Elderly patients may be more sensitive to the pressor and cardiac effects of ephedrine, and may have underlying cardiovascular disease. Start with lower doses and titrate slowly, monitoring closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Ephedrine is a mixed-acting sympathomimetic, providing both direct and indirect adrenergic effects, making it useful for acute hypotension.
  • Administer IV slowly to minimize the risk of sudden hypertension or tachycardia.
  • Often preferred for hypotension during spinal or epidural anesthesia due to its balanced alpha and beta effects and lower incidence of reflex bradycardia compared to pure alpha-agonists.
  • Tolerance (tachyphylaxis) can develop with repeated doses, requiring increased doses or consideration of alternative vasopressors.
  • Careful monitoring of blood pressure and heart rate is crucial due to its potent cardiovascular effects.
  • Avoid use in patients with pheochromocytoma, angle-closure glaucoma, or those on MAOIs.
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Alternative Therapies

  • Phenylephrine (pure alpha-1 agonist, often used for hypotension without significant cardiac stimulation)
  • Norepinephrine (potent alpha-1 and beta-1 agonist, used for severe hypotension/shock)
  • Dopamine (dose-dependent effects, used for hypotension/shock)
  • Vasopressin (non-adrenergic vasopressor)
  • Mephentermine (another indirect sympathomimetic, less common)
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Cost & Coverage

Average Cost: Varies widely by supplier and formulation per 10ml vial
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (hospital formulary)
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General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. 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 to do so by a healthcare professional, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the correct disposal method, consult your pharmacist for advice. 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 contact 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.