Albutein 5% Inj, 250ml

Manufacturer GRIFOLS USA Active Ingredient Albumin(al BYOO min) Pronunciation AL-byoo-tin (for Albutein); AL-byoo-min (for Albumin)
It is used to treat or prevent low blood volume.It is used to treat low blood pressure. It is used to replace albumin in people with low blood albumin levels.It is used to treat swelling in certain people.It is used to treat high bilirubin levels in newborns.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Plasma Volume Expanders; Blood Products
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Pharmacologic Class
Colloids
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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?

Albutein 5% Injection is a clear, yellowish liquid given into a vein (intravenously). It contains a natural protein called albumin, which is found in your blood. It's used to help replace lost fluid and protein in your body, especially when you've lost a lot of blood or fluids, or if your body isn't making enough of its own protein.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to follow the instructions carefully. This medication is administered as an infusion into a vein 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 what to do next.
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Lifestyle & Tips

  • This medication is given in a hospital or clinic setting, so no specific lifestyle changes are typically required by the patient related to its administration.
  • Patients should report any discomfort or unusual symptoms during or after the infusion.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable based on indication and patient response. For hypovolemia/shock: 5% solution, initial dose 250-500 mL, may repeat as needed. For hypoalbuminemia: 5% solution, 250-500 mL/day, adjusted based on serum albumin levels and clinical response.
Dose Range: 250 - 1000 mg

Condition-Specific Dosing:

hypovolemicShock: Initial 250-500 mL of 5% solution, infused rapidly; may repeat as needed. Total dose should not exceed 250 g/48 hours.
hypoalbuminemia: 250-500 mL of 5% solution daily or every other day, adjusted to maintain serum albumin levels and clinical status. Infusion rate typically 2-4 mL/min.
burns: Dosing highly individualized based on burn severity, extent, and fluid resuscitation protocols (e.g., Parkland formula). Often 5% solution used after initial crystalloid resuscitation.
acuteRespiratoryDistressSyndrome: Often 25% solution, but 5% may be used in conjunction with diuretics to mobilize fluid.
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Pediatric Dosing

Neonatal: 0.5-1 g/kg (10-20 mL/kg of 5% solution) infused over 5-10 minutes for acute volume expansion; slower for hypoalbuminemia.
Infant: 0.5-1 g/kg (10-20 mL/kg of 5% solution) infused over 5-10 minutes for acute volume expansion; slower for hypoalbuminemia.
Child: 0.5-1 g/kg (10-20 mL/kg of 5% solution) infused over 5-10 minutes for acute volume expansion; slower for hypoalbuminemia.
Adolescent: Similar to adult dosing, 0.5-1 g/kg (10-20 mL/kg of 5% solution) for acute volume expansion; slower for hypoalbuminemia.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed, monitor fluid status.
Moderate: No specific adjustment needed, monitor fluid status closely to avoid fluid overload.
Severe: No specific adjustment needed, monitor fluid status closely to avoid fluid overload. Use with caution.
Dialysis: No specific adjustment needed. May be used to maintain oncotic pressure or replace fluid during dialysis, monitor fluid status.

Hepatic Impairment:

Mild: No specific adjustment needed, monitor fluid status.
Moderate: No specific adjustment needed, monitor fluid status. May be used to manage ascites or spontaneous bacterial peritonitis.
Severe: No specific adjustment needed, monitor fluid status. May be used to manage ascites or spontaneous bacterial peritonitis.

Pharmacology

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Mechanism of Action

Albumin is the most abundant plasma protein, accounting for 70-80% of the colloid oncotic pressure of plasma. It helps maintain plasma volume by drawing fluid from the interstitial space into the intravascular space. It also functions as a transport protein for various endogenous and exogenous substances (e.g., hormones, fatty acids, bilirubin, drugs) and has antioxidant and free radical scavenging properties.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (intravenous administration)
Tmax: Immediate (for volume expansion effect)
FoodEffect: Not applicable (IV administration)

Distribution:

Vd: Approximately 0.08 L/kg (initial plasma volume), expanding to 0.12-0.14 L/kg as it equilibrates between intravascular and extravascular compartments.
ProteinBinding: Albumin itself is a protein, and its primary function is to bind and transport various substances. It is 100% in the plasma.
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 15-20 days (variable depending on patient's clinical condition and albumin turnover rate).
Clearance: Not applicable in the traditional sense; catabolized.
ExcretionRoute: Amino acids are reused for protein synthesis or excreted.
Unchanged: Not applicable (catabolized)
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Pharmacodynamics

OnsetOfAction: Immediate (for volume expansion)
PeakEffect: Within minutes for volume expansion; for hypoalbuminemia, peak effect on serum levels depends on infusion rate and patient's condition.
DurationOfAction: Hours to days, depending on the underlying condition, rate of albumin degradation, and fluid shifts.

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 or seek immediate 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
+ 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
* Signs of fluid and electrolyte problems, such as:
+ Mood changes
+ Confusion
+ Muscle pain or weakness
+ Fast or abnormal heartbeat
+ Severe dizziness or fainting
+ Increased thirst
+ Seizures
+ Feeling very tired or weak
+ Decreased appetite
+ Unable to pass urine or changes in urine production
+ Dry mouth
+ Dry eyes
+ Severe stomach upset or vomiting

Other Possible Side Effects

Like all medications, this drug can cause side effects. However, many people experience no side effects or only mild ones. If you have any side effects that bother you or do not go away, contact your doctor for advice.

Reporting Side Effects

If you have questions or concerns about side effects, talk to 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 or shortness of breath
  • Swelling in your ankles, feet, or hands
  • Chest pain or tightness
  • Rash, hives, or itching
  • Fever or chills
  • Nausea or vomiting
  • Headache
  • Flushing (redness and warmth of the skin)
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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.
Certain health conditions, including:
+ Anemia
+ Heart failure (also known as a weak heart)
+ Kidney disease

This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.

To ensure your safety, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your health problems, including any medical conditions or allergies

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe for you to do so.
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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.

Your doctor will require you to undergo regular blood tests, as directed, to monitor your condition. Be sure to discuss any concerns or questions you have with your doctor.

During treatment with this medication, your doctor will closely monitor your blood pressure, heart rate, and oxygen levels. If you have any concerns or questions, discuss them with your doctor.

This medication is derived from human plasma, a component of blood, and although it is thoroughly screened, tested, and treated to minimize the risk of viral transmission, there is still a possibility of infection. Discuss any concerns you may have with your doctor.

If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Signs of fluid overload (e.g., pulmonary edema, increased blood pressure, increased central venous pressure, dyspnea, crackles)
  • Circulatory overload (e.g., headache, flushing, jugular venous distention)

What to Do:

Discontinue infusion immediately. Symptomatic and supportive care, including diuretics to manage fluid overload. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.

Drug Interactions

Monitoring

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Baseline Monitoring

Vital Signs (BP, HR, RR)

Rationale: To assess hemodynamic status and identify signs of fluid overload or allergic reaction.

Timing: Prior to infusion

Fluid Balance (I&O)

Rationale: To monitor for fluid overload or dehydration.

Timing: Prior to infusion

Serum Electrolytes (Na, K, Cl)

Rationale: To detect electrolyte imbalances, especially with large volumes.

Timing: Prior to infusion

Renal Function (BUN, Creatinine)

Rationale: To assess kidney function, especially in patients at risk for fluid overload.

Timing: Prior to infusion

Serum Albumin (if for hypoalbuminemia)

Rationale: To establish baseline and guide therapy.

Timing: Prior to infusion

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Routine Monitoring

Vital Signs (BP, HR, RR)

Frequency: Every 15-30 minutes during infusion, then as clinically indicated.

Target: Within patient's normal limits, stable.

Action Threshold: Significant changes (e.g., sudden increase in BP, dyspnea, tachycardia) warrant immediate assessment and potential cessation of infusion.

Fluid Balance (I&O)

Frequency: Hourly during infusion, then every 4-8 hours.

Target: Appropriate for clinical condition (e.g., positive balance for hypovolemia, neutral/negative for fluid overload).

Action Threshold: Significant positive balance or signs of fluid overload.

Central Venous Pressure (CVP) or Pulmonary Artery Wedge Pressure (PAWP) (if monitored)

Frequency: As per institutional protocol, often hourly during acute resuscitation.

Target: Goal-directed therapy based on clinical guidelines.

Action Threshold: Elevated pressures indicating fluid overload.

Serum Albumin (if for hypoalbuminemia)

Frequency: Every 1-3 days or as clinically indicated.

Target: Goal-directed (e.g., >2.5-3.0 g/dL).

Action Threshold: Failure to increase or persistent low levels may require dose adjustment.

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Symptom Monitoring

  • Signs of fluid overload (dyspnea, crackles, peripheral edema, elevated JVP)
  • Signs of allergic reaction (rash, urticaria, fever, chills, nausea, vomiting, hypotension, tachycardia)
  • Signs of circulatory overload (headache, flushing, dyspnea, jugular venous distention)
  • Hypotension (if infusion too rapid or in patients with severe heart failure)

Special Patient Groups

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Pregnancy

Albumin is a natural component of human plasma. While animal reproduction studies have not been conducted, its use in pregnant women is generally considered acceptable when clinically indicated, particularly in critical situations where the benefits outweigh potential risks. It is often used to manage hypovolemia or hypoalbuminemia in pregnant patients.

Trimester-Specific Risks:

First Trimester: No specific risks identified beyond general considerations for critical illness.
Second Trimester: No specific risks identified beyond general considerations for critical illness.
Third Trimester: No specific risks identified beyond general considerations for critical illness.
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Lactation

Albumin is a normal component of human milk. It is generally considered compatible with breastfeeding. The amount transferred to breast milk is unlikely to cause harm to the infant.

Infant Risk: Low risk to infant.
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Pediatric Use

Dosing is weight-based (g/kg or mL/kg). Careful monitoring of fluid status, vital signs, and electrolytes is crucial due to the higher risk of fluid overload in infants and young children. Infusion rates should be carefully controlled.

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Geriatric Use

Use with caution in elderly patients, especially those with compromised cardiac or renal function, due to increased risk of circulatory overload. Monitor fluid status, vital signs, and renal function closely. Lower initial doses and slower infusion rates may be appropriate.

Clinical Information

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Clinical Pearls

  • Albumin 5% is isotonic with plasma and primarily used for volume expansion, whereas 25% albumin is hyperoncotic and used for fluid mobilization (e.g., in ascites, edema) or severe hypoalbuminemia.
  • Rapid infusion of albumin can lead to circulatory overload, especially in patients with cardiac or renal impairment. Monitor vital signs and fluid status closely.
  • Albumin solutions should not be diluted with sterile water for injection as this can cause hemolysis in recipients. Use 0.9% Sodium Chloride or 5% Dextrose in Water if dilution is necessary.
  • Do not mix albumin with protein hydrolysates or amino acid solutions, as this may cause precipitation.
  • Albumin is a plasma-derived product; while manufacturing processes include viral inactivation steps, the theoretical risk of pathogen transmission cannot be completely eliminated.
  • The therapeutic effect of albumin in critically ill patients (e.g., sepsis, ARDS) is a subject of ongoing debate and research; use should be guided by specific indications and clinical guidelines.
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Alternative Therapies

  • Crystalloids (e.g., 0.9% Sodium Chloride, Lactated Ringer's solution) for initial volume resuscitation.
  • Other colloids (e.g., synthetic colloids like starches, dextrans - though their use is declining due to safety concerns) for volume expansion.
  • Blood products (e.g., packed red blood cells, fresh frozen plasma) if specific blood component deficiencies are present.
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Cost & Coverage

Average Cost: Highly variable, typically $100-$300+ per 250mL of 5% solution per 250mL vial/bag
Generic Available: Yes
Insurance Coverage: Tier 3 or 4 (Specialty/Non-Preferred Brand), often requires prior authorization due to high cost and specific indications.
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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 your safety and the safety of others, never share your prescription medications with anyone, and do not take medications that have been prescribed to someone else.

All medications should be stored in a secure location, out of the reach of children and pets, to prevent accidental ingestion or exposure.

When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless specifically instructed to do so by your pharmacist or healthcare provider. Instead, consult with your pharmacist to determine the best method for disposal, as some communities may have designated drug take-back programs.

Some medications may come with an additional patient information leaflet; if you have questions or concerns, consult with your pharmacist.

If you have any questions or concerns about your medication, it is crucial 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 information about the medication taken, the amount, and the time it was taken, as this will aid in providing prompt and effective treatment.