Albutein 5% Inj, 500ml
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
Colloid; 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 through an IV to help increase the amount of fluid in your blood vessels, which can be important if you've lost a lot of blood or fluids, or if your body isn't making enough of its own albumin. It helps keep your blood pressure stable and carries important substances throughout 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 as an intravenous infusion, which means it is given through 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 discomfort or changes during or after the infusion.
- Inform healthcare providers about all medications, supplements, and medical conditions.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Highly variable based on indication and patient response. For hypovolemia: 250-500 ml of 5% solution, may repeat as needed. For hypoalbuminemia: 250-500 ml of 5% solution daily or every other day.
Dose Range:
250 - 1000 mg
Condition-Specific Dosing:
hypovolemia:
250-500 ml of 5% solution, infused at 2-4 ml/min; may repeat after 15-30 min if response is inadequate.
hypoalbuminemia:
250-500 ml of 5% solution daily or every other day, infused at 5-10 ml/min; adjust based on albumin levels and clinical status.
burns:
Initial dose based on estimated fluid loss, then adjusted to maintain adequate plasma volume and urine output. Often 5% albumin is used after initial crystalloid resuscitation.
Pediatric Dosing
Neonatal:
Not established (use with extreme caution, often 5% solution at 10-20 ml/kg over 5-10 minutes for acute volume expansion).
Infant:
10-20 ml/kg of 5% solution for acute volume expansion, infused over 5-10 minutes. For hypoalbuminemia, 0.5-1 g/kg (10-20 ml/kg of 5% solution) over 30-60 minutes.
Child:
10-20 ml/kg of 5% solution for acute volume expansion, infused over 5-10 minutes. For hypoalbuminemia, 0.5-1 g/kg (10-20 ml/kg of 5% solution) over 30-60 minutes.
Adolescent:
Similar to adult dosing, 10-20 ml/kg of 5% solution for acute volume expansion. For hypoalbuminemia, 0.5-1 g/kg (10-20 ml/kg of 5% solution) over 30-60 minutes.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed, monitor fluid status carefully.
Moderate:
No specific adjustment needed, monitor fluid status carefully.
Severe:
No specific adjustment needed, monitor fluid status carefully; risk of fluid overload is higher, especially in anuric patients.
Dialysis:
Administer post-dialysis if needed for volume expansion or hypoalbuminemia; monitor fluid status closely.
Hepatic Impairment:
Mild:
No specific adjustment needed, monitor fluid status carefully.
Moderate:
No specific adjustment needed, monitor fluid status carefully.
Severe:
No specific adjustment needed, monitor fluid status carefully; often used in severe hepatic impairment for volume expansion or to manage ascites/spontaneous bacterial peritonitis.
Pharmacology
Mechanism of Action
Albumin is a natural protein that accounts for 50% of the total protein content in human plasma. It is responsible for approximately 75-80% of the colloid oncotic pressure of plasma. When administered intravenously, it increases plasma volume by drawing interstitial fluid into the intravascular space, thereby expanding circulating blood volume. It also functions as a transport protein for various endogenous and exogenous substances (e.g., hormones, enzymes, drugs, toxins).
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
Immediately upon completion of IV infusion
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 0.07 L/kg (intravascular), with significant distribution into the extravascular space (total body pool ~4-5 g/kg). About 60% of total body albumin is in the extravascular compartment.
ProteinBinding:
Not applicable (it is the protein itself)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 15-20 hours (intravascular half-life), but total body half-life is about 19 days due to slow extravascular-intravascular equilibration.
Clearance:
Variable, depends on catabolic rate.
ExcretionRoute:
Not excreted intact; catabolized to amino acids which are reused or excreted as urea.
Unchanged:
0%
Pharmacodynamics
OnsetOfAction:
Immediate (upon infusion)
PeakEffect:
Within minutes to hours, depending on fluid shifts
DurationOfAction:
Hours to days, depending on clinical condition and rate of catabolism
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when 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
+ Difficulty urinating or changes in urine output
+ 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.
While rare, some people may experience severe and potentially life-threatening side effects when 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
+ Difficulty urinating or changes in urine output
+ 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.
Seek Immediate Medical Attention If You Experience:
- Difficulty breathing or shortness of breath
- Swelling in your ankles, feet, or hands
- Chest pain or tightness
- Headache
- Fever or chills
- Rash or hives
- 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, including any symptoms that occurred.
Certain health conditions, including:
+ Anemia
+ Heart failure (a weakened 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
Natural products and vitamins you are using
* Any health problems you have
It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose 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 weakened 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
Natural products and vitamins you are using
* Any health problems you have
It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose 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. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss any concerns or questions with your doctor.
Your doctor will closely monitor your blood pressure, heart rate, and oxygen levels while you are taking this medication. It is crucial to maintain open communication with your doctor regarding your treatment.
As this medication is derived from human plasma, a component of blood, there is a slight risk of transmitting viruses that could cause disease. However, the medication undergoes rigorous screening, testing, and treatment to minimize this risk. Discuss any concerns you may have with your doctor.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is vital to inform your doctor. You and your doctor will need to carefully weigh the benefits and risks of this medication to both you and your baby.
Your doctor will closely monitor your blood pressure, heart rate, and oxygen levels while you are taking this medication. It is crucial to maintain open communication with your doctor regarding your treatment.
As this medication is derived from human plasma, a component of blood, there is a slight risk of transmitting viruses that could cause disease. However, the medication undergoes rigorous screening, testing, and treatment to minimize this risk. Discuss any concerns you may have with your doctor.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is vital to inform your doctor. You and your doctor will need to carefully weigh the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Signs of fluid overload (e.g., pulmonary edema, dyspnea, crackles, jugular venous distension, elevated blood pressure)
- Headache
- Nausea
- Chills
- Fever
What to Do:
Discontinue infusion immediately. Administer diuretics if indicated. Monitor vital signs, fluid balance, and CVP. Provide supportive care. Call 1-800-222-1222 (Poison Control) for further guidance if needed.
Drug Interactions
Moderate Interactions
- ACE inhibitors (potential for hypotension, though rare with albumin)
- Loop diuretics (may enhance diuresis when given sequentially for fluid overload)
Monitoring
Baseline Monitoring
Fluid status (vital signs, CVP, urine output)
Rationale: To assess baseline hydration and guide initial dosing.
Timing: Prior to initiation of therapy
Serum electrolytes (Na, K, Cl)
Rationale: To identify pre-existing imbalances and monitor for changes.
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)
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., hypotension, tachycardia, dyspnea) warrant immediate assessment and potential cessation of infusion.
Fluid balance (I&O, daily weights)
Frequency: Continuously during infusion, then daily
Target: Appropriate for clinical condition (e.g., positive balance for hypovolemia, neutral for stable patients)
Action Threshold: Significant positive fluid balance or rapid weight gain may indicate fluid overload.
Central Venous Pressure (CVP) or Pulmonary Capillary Wedge Pressure (PCWP)
Frequency: As clinically indicated, especially in critically ill patients
Target: Within therapeutic goals
Action Threshold: Rapid increase may indicate fluid overload.
Serum albumin levels
Frequency: Daily or every other day, as clinically indicated
Target: Dependent on indication (e.g., >2.5-3.0 g/dL for hypoalbuminemia)
Action Threshold: Failure to rise or persistent low levels may indicate ongoing loss or inadequate dosing.
Symptom Monitoring
- Signs of fluid overload (dyspnea, crackles, peripheral edema, jugular venous distension)
- Signs of allergic reaction (rash, urticaria, fever, chills, nausea, vomiting, flushing, headache, hypotension, tachycardia, dyspnea)
- Signs of circulatory overload (headache, dyspnea, jugular venous distension, elevated blood 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, it is a naturally occurring plasma protein and is often used in critical situations where the benefit outweighs potential unknown risks.
Trimester-Specific Risks:
First Trimester:
Risk unknown, use only if clearly indicated.
Second Trimester:
Risk unknown, use only if clearly indicated.
Third Trimester:
Risk unknown, use only if clearly indicated.
Lactation
L3 (Moderately safe). Human albumin is a normal component of human milk. No adverse effects on the breastfed infant are expected. Use is generally considered compatible with breastfeeding when clinically indicated.
Infant Risk:
Low
Pediatric Use
Dosing is weight-based. Careful monitoring of fluid status is crucial due to smaller circulating blood volume and potential for rapid fluid shifts. Risk of circulatory overload is higher in neonates and infants.
Geriatric Use
No specific dose adjustment needed, but elderly patients may be more susceptible to circulatory overload due to age-related cardiovascular changes. Monitor fluid status, vital signs, and renal function closely.
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 interstitial to intravascular 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 are rare but can occur.
- Albumin is a blood product; ensure proper patient identification and blood product administration protocols are followed.
- Do not dilute 25% albumin with sterile water for injection as it can cause hemolysis; use 0.9% NaCl or 5% Dextrose.
- Albumin solutions should not be mixed with protein hydrolysates or alcohol-containing solutions as this may cause protein precipitation.
Alternative Therapies
- Crystalloids (e.g., Normal Saline, Lactated Ringer's) for volume expansion
- Other colloids (e.g., Dextran, Hydroxyethyl starch - though use of HES is limited due to safety concerns)
- Blood products (e.g., whole blood, packed red blood cells) for volume expansion with oxygen-carrying capacity
Cost & Coverage
Average Cost:
Highly variable, typically $50-$200 per 500ml of 5% solution per 500ml
Generic Available:
Yes
Insurance Coverage:
Tier 3 or 4 (Specialty/Non-Preferred Brand), often covered by medical benefit for approved indications rather than pharmacy benefit.
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 the 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 correct 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 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 timely and effective treatment.