Albutein 5% Inj, 50ml
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.
Drug Class
Plasma volume expander; Blood product derivative
Pharmacologic Class
Plasma protein fraction
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Albumin is a natural protein found in your blood. It's given to help replace lost fluid and protein, especially when you've had significant blood loss, burns, or certain medical conditions that cause low protein levels. It helps keep fluid in your blood vessels and can carry other substances in your body.
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 via infusion into a vein over a specified period of time.
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.
In the event that you miss a dose, contact your doctor immediately to receive guidance on the appropriate course of action.
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.
In the event that you miss a dose, contact your doctor immediately to receive guidance on the appropriate course of action.
Lifestyle & Tips
- Report any signs of swelling, difficulty breathing, or allergic reactions immediately.
- Maintain good hydration as advised by your healthcare provider.
- Follow all post-infusion instructions from your healthcare team.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Highly variable based on indication and patient's clinical status. For hypovolemia: 25 g (500 mL of 5% solution) initially, may repeat after 15-30 minutes if response is inadequate. For hypoalbuminemia: 50-75 g (1000-1500 mL of 5% solution) daily, adjusted based on albumin levels and clinical response.
Condition-Specific Dosing:
Hypovolemia:
Initial: 25 g (500 mL of 5% solution) IV, may repeat. Max rate: 5% solution up to 2-4 mL/min.
Hypoalbuminemia:
50-75 g/day (1000-1500 mL of 5% solution) IV, adjusted based on clinical response and albumin levels.
Burns (acute phase):
Dose individualized based on fluid requirements and serum albumin levels, often used after 24 hours post-burn.
Acute Respiratory Distress Syndrome (ARDS):
Often 25 g (500 mL of 5% solution) IV over 30 minutes, sometimes combined with a diuretic.
Pediatric Dosing
Neonatal:
Hypovolemia: 0.5-1 g/kg (10-20 mL/kg of 5% solution) IV over 5-10 minutes, may repeat. Max rate: 5% solution up to 5-10 mL/min.
Infant:
Hypovolemia: 0.5-1 g/kg (10-20 mL/kg of 5% solution) IV over 5-10 minutes, may repeat. Max rate: 5% solution up to 5-10 mL/min.
Child:
Hypovolemia: 0.5-1 g/kg (10-20 mL/kg of 5% solution) IV over 5-10 minutes, may repeat. Max rate: 5% solution up to 5-10 mL/min. Hypoalbuminemia: 0.5-1 g/kg/day (10-20 mL/kg/day of 5% solution) IV.
Adolescent:
Dosing similar to adult, adjusted for weight and clinical status.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed, but monitor fluid status closely to avoid volume overload.
Moderate:
No specific adjustment needed, but monitor fluid status closely to avoid volume overload.
Severe:
No specific adjustment needed, but monitor fluid status closely to avoid volume overload. Use with caution in patients with chronic renal failure due to risk of fluid overload.
Dialysis:
May be used to maintain oncotic pressure during or after dialysis, especially in patients with significant fluid removal. Monitor fluid status and electrolytes.
Hepatic Impairment:
Mild:
No specific adjustment needed, but monitor fluid status and albumin levels.
Moderate:
No specific adjustment needed, but monitor fluid status and albumin levels. Patients with severe liver disease may have impaired albumin synthesis, requiring higher doses or more frequent administration.
Severe:
No specific adjustment needed, but monitor fluid status and albumin levels. Patients with severe liver disease may have impaired albumin synthesis, requiring higher doses or more frequent administration. Use with caution to avoid fluid overload.
Pharmacology
Mechanism of Action
Albumin is a highly soluble, globular protein that accounts for 70-80% of the colloid osmotic pressure of plasma. It functions as a transport protein for various endogenous and exogenous substances (e.g., hormones, fatty acids, bilirubin, drugs) and plays a crucial role in maintaining plasma oncotic pressure, thereby regulating fluid distribution between the intravascular and extravascular compartments. Administration of albumin increases plasma volume by drawing interstitial fluid into the vascular space.
Pharmacokinetics
Absorption:
Bioavailability:
100% (intravenous administration)
Tmax:
Immediate (peak plasma concentration achieved rapidly after infusion)
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 0.07 L/kg (intravascular space), with significant distribution to extravascular compartments (e.g., skin, muscle, gut) over several days. Total body albumin is about 4-5 g/kg, with 30-40% in the intravascular space.
ProteinBinding:
Not applicable (Albumin is the protein itself, and it binds to many substances)
CnssPenetration:
Limited (does not readily cross the intact blood-brain barrier)
Elimination:
HalfLife:
Approximately 15-19 days (variable depending on clinical condition)
Clearance:
Not readily quantifiable as it's catabolized rather than excreted unchanged. Catabolic rate is about 4-12% of total body albumin per day.
ExcretionRoute:
Not excreted unchanged; catabolized into amino acids.
Unchanged:
0%
Pharmacodynamics
OnsetOfAction:
Immediate (volume expansion occurs as soon as infusion begins)
PeakEffect:
Within minutes to hours, depending on infusion rate and patient's fluid status.
DurationOfAction:
Variable, depending on the patient's underlying condition, fluid shifts, and albumin catabolism. Oncotic effect can last for several hours to days.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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 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. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor if you have any symptoms that bother you or persist.
Common side effects may include:
Headache
Shortness of breath
Sudden weight gain
* Swelling in the arms or legs
Reporting 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.
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 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. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor if you have any symptoms that bother you or persist.
Common side effects may include:
Headache
Shortness of breath
Sudden weight gain
* Swelling in the arms or legs
Reporting 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.
Seek Immediate Medical Attention If You Experience:
- Shortness of breath or difficulty breathing
- Swelling in your ankles, feet, or hands
- Chest pain or tightness
- Headache
- Flushing or rash
- Fever or chills
- Nausea or vomiting
- Unusual tiredness or weakness
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 (a condition where the heart is not pumping efficiently)
+ Kidney disease
This list is not exhaustive, and it is crucial to discuss all your health problems with your doctor.
Additionally, provide your doctor and pharmacist with a comprehensive list of all the medications you are taking, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins
It is vital to verify that it is safe to take this medication in conjunction with all your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting 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 (a condition where the heart is not pumping efficiently)
+ Kidney disease
This list is not exhaustive, and it is crucial to discuss all your health problems with your doctor.
Additionally, provide your doctor and pharmacist with a comprehensive list of all the medications you are taking, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins
It is vital to verify that it is safe to take this medication in conjunction with all your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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 monitor your condition by ordering regular blood tests, as previously discussed. Be sure to follow their instructions and discuss any concerns with them.
During treatment, your doctor will closely monitor your blood pressure, heart rate, and oxygen levels. If you have any questions or concerns, do not hesitate to discuss them with your doctor.
As this medication is derived from human plasma, a component of blood, there is a small risk of transmitting viruses that can cause disease. However, the medication undergoes rigorous screening, testing, and treatment to minimize this risk. If you have concerns, consult with your doctor.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to inform your doctor. They will help you weigh the benefits and risks of taking this medication to ensure the best possible outcome for you and your baby.
Your doctor will monitor your condition by ordering regular blood tests, as previously discussed. Be sure to follow their instructions and discuss any concerns with them.
During treatment, your doctor will closely monitor your blood pressure, heart rate, and oxygen levels. If you have any questions or concerns, do not hesitate to discuss them with your doctor.
As this medication is derived from human plasma, a component of blood, there is a small risk of transmitting viruses that can cause disease. However, the medication undergoes rigorous screening, testing, and treatment to minimize this risk. If you have concerns, consult with your doctor.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to inform your doctor. They will help you weigh the benefits and risks of taking this medication to ensure the best possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Signs of circulatory overload (e.g., headache, flushing, increased venous pressure, dyspnea, pulmonary edema)
- Hypertension
- Tachycardia
What to Do:
Discontinue infusion immediately. Administer diuretics as needed to manage fluid overload. Provide supportive care. Call 1-800-222-1222 (Poison Control) for further guidance if severe symptoms occur.
Drug Interactions
Moderate Interactions
- ACE inhibitors (e.g., enalapril, lisinopril): May increase risk of hypotension when co-administered with albumin in patients undergoing plasmapheresis or large volume paracentesis due to potential for exaggerated bradykinin effects. Monitor blood pressure.
Monitoring
Baseline Monitoring
Fluid status (e.g., vital signs, CVP, urine output)
Rationale: To assess baseline hydration and guide initial dosing, and to prevent fluid overload.
Timing: Prior to initiation of therapy
Serum electrolytes (Na, K, Cl)
Rationale: To identify pre-existing imbalances and monitor for changes during therapy, especially with large volumes.
Timing: Prior to initiation of therapy
Renal function (BUN, creatinine)
Rationale: To assess kidney function and risk of fluid overload.
Timing: Prior to initiation of therapy
Serum albumin levels
Rationale: To confirm hypoalbuminemia and guide replacement therapy.
Timing: Prior to initiation of therapy (if indicated for hypoalbuminemia)
Hemoglobin and Hematocrit
Rationale: To assess for anemia and guide need for blood products if significant blood loss is present.
Timing: Prior to initiation of therapy (especially in hypovolemia)
Routine Monitoring
Vital signs (BP, HR, RR)
Frequency: Every 15-30 minutes during infusion, then as clinically indicated
Target: Within patient's normal limits
Action Threshold: Significant changes (e.g., hypertension, tachycardia, dyspnea) indicating fluid overload or allergic reaction.
Fluid balance (intake/output, daily weight)
Frequency: Continuously during infusion, then daily
Target: Appropriate for clinical condition (e.g., net even or slightly negative in fluid overload)
Action Threshold: Positive fluid balance, rapid weight gain, or decreased urine output indicating fluid retention.
Central Venous Pressure (CVP) or Pulmonary Artery Wedge Pressure (PAWP)
Frequency: As clinically indicated, especially in critically ill patients
Target: Within desired therapeutic range (e.g., CVP 8-12 mmHg in sepsis)
Action Threshold: Elevated pressures indicating fluid overload.
Serum electrolytes
Frequency: Daily or as clinically indicated, especially with large volumes
Target: Within normal limits
Action Threshold: Significant deviations (e.g., hypernatremia, hypokalemia).
Serum albumin levels
Frequency: Every 1-3 days or as clinically indicated (for hypoalbuminemia)
Target: Target level based on indication (e.g., >2.5-3.0 g/dL)
Action Threshold: Failure to rise or persistent low levels despite adequate dosing.
Symptom Monitoring
- Signs of fluid overload (e.g., dyspnea, orthopnea, peripheral edema, crackles on lung auscultation, elevated blood pressure, jugular venous distension)
- Signs of allergic reaction (e.g., rash, urticaria, pruritus, fever, chills, nausea, vomiting, flushing, hypotension, bronchospasm)
- Signs of circulatory overload (e.g., headache, flushing, increased venous pressure)
Special Patient Groups
Pregnancy
Category C. Animal reproduction studies have not been conducted. It is not known whether albumin can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Albumin should be given to a pregnant woman only if clearly needed. However, albumin is a natural component of human plasma and is often used in critical situations where the benefit outweighs potential risks.
Trimester-Specific Risks:
First Trimester:
No specific data on first trimester risks, but generally used only if critically indicated.
Second Trimester:
No specific data on second trimester risks, but generally used only if critically indicated.
Third Trimester:
No specific data on third trimester risks, but generally used only if critically indicated. Monitor for fluid overload in both mother and fetus.
Lactation
L3 (Moderately Safe). Human albumin is a natural component of breast milk. Exogenous administration is unlikely to cause adverse effects in a breastfed infant due to its large molecular weight and poor oral absorption. Use with caution and monitor infant for any unusual symptoms, though unlikely.
Infant Risk:
Low risk of adverse effects to the infant.
Pediatric Use
Use with caution, especially in neonates and infants, due to immature renal function and potential for fluid overload. Dosing is weight-based. Monitor fluid status, electrolytes, and vital signs closely.
Geriatric Use
Use with caution due to increased susceptibility to fluid overload and cardiac decompensation. Start with lower infusion rates and monitor fluid status, vital signs, and cardiac function closely. No specific dose adjustment based on age alone, but individualize based on comorbidities.
Clinical Information
Clinical Pearls
- Albumin 5% is iso-oncotic with plasma and is primarily used for volume expansion, whereas 25% albumin is hyper-oncotic and used for fluid mobilization from the interstitial space.
- Rapid infusion of albumin can lead to circulatory overload, especially in patients with cardiac or renal impairment.
- Monitor for signs of allergic reactions, which can range from mild skin reactions to severe anaphylaxis.
- Albumin is a blood product; standard precautions for blood product administration should be followed.
- Do not dilute 25% albumin with sterile water for injection as it can cause hemolysis; use 0.9% Sodium Chloride or 5% Dextrose in Water.
- Albumin solutions should not be mixed with protein hydrolysates or alcohol-containing solutions, as this may cause protein precipitation.
Alternative Therapies
- Crystalloids (e.g., 0.9% Sodium Chloride, Lactated Ringer's solution) for volume expansion.
- Other colloids (e.g., Dextran, Hydroxyethyl starch - though use of HES is restricted due to safety concerns).
- Fresh Frozen Plasma (FFP) for volume expansion with coagulation factors.
Cost & Coverage
Average Cost:
Variable per 50 mL (5% solution)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generally covered by most medical insurance plans as it's a medically necessary blood product)
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, do not share your medication with others, and never take someone else's medication. 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, do not flush medications down the toilet or pour them down the drain. If you are unsure about the proper disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. 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 medical attention. Be prepared to provide information about the medication taken, the quantity, and the time of ingestion.