Albutein 25% Inj , 50ml

Manufacturer GRIFOLS USA Active Ingredient Albumin(al BYOO min) Pronunciation AL-byoo-min
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 expander; Blood product derivative
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Pharmacologic Class
Plasma protein fraction
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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?

Albumin is a natural protein found in your blood. It helps keep fluid in your blood vessels and carries important substances throughout your body. This medication is given through an IV to replace albumin if your body isn't making enough, or to help increase blood volume in certain medical conditions.
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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 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.
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Lifestyle & Tips

  • Report any swelling, difficulty breathing, or allergic reactions immediately.
  • Maintain good hydration as advised by your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly individualized based on clinical condition, fluid status, and albumin levels. For hypovolemia: 25g (100ml of 25% solution) initially, may repeat after 15-30 minutes if response is inadequate. For hypoalbuminemia: 50-75g (200-300ml of 25% solution) daily, adjusted based on patient response and serum albumin levels.
Dose Range: 25 - 100 mg

Condition-Specific Dosing:

hypovolemia: 25g (100ml of 25% solution) initially, may repeat.
hypoalbuminemia: 50-75g (200-300ml of 25% solution) daily.
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Pediatric Dosing

Neonatal: 0.5-1 g/kg (2-4 ml/kg of 25% solution) IV over 5-10 minutes for acute volume expansion; slower infusion for hypoalbuminemia.
Infant: 0.5-1 g/kg (2-4 ml/kg of 25% solution) IV over 5-10 minutes for acute volume expansion; slower infusion for hypoalbuminemia.
Child: 0.5-1 g/kg (2-4 ml/kg of 25% solution) IV over 5-10 minutes for acute volume expansion; slower infusion for hypoalbuminemia.
Adolescent: 0.5-1 g/kg (2-4 ml/kg of 25% solution) IV over 5-10 minutes for acute volume expansion; slower infusion for hypoalbuminemia.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed, monitor fluid balance.
Moderate: No specific adjustment needed, monitor fluid balance closely to avoid fluid overload.
Severe: No specific adjustment needed, monitor fluid balance closely to avoid fluid overload.
Dialysis: No specific adjustment needed, monitor fluid balance closely. May be used to maintain oncotic pressure during dialysis.

Hepatic Impairment:

Mild: No specific adjustment needed, often used in hepatic impairment to manage ascites or spontaneous bacterial peritonitis.
Moderate: No specific adjustment needed, often used in hepatic impairment to manage ascites or spontaneous bacterial peritonitis.
Severe: No specific adjustment needed, often used in hepatic impairment to manage ascites or spontaneous bacterial peritonitis.

Pharmacology

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Mechanism of Action

Albumin is a highly soluble, globular protein that accounts for 50% of the plasma protein content. It is responsible for approximately 80% of the colloid osmotic pressure of plasma. It functions as a transport protein for various endogenous and exogenous substances (e.g., hormones, enzymes, fatty acids, drugs) and plays a crucial role in maintaining plasma volume and tissue fluid balance by exerting oncotic pressure, thereby drawing fluid from the interstitial space into the intravascular space.
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Pharmacokinetics

Absorption:

Bioavailability: 100%
Tmax: Immediate (IV administration)
FoodEffect: Not applicable (IV administration)

Distribution:

Vd: Approximately 0.1 L/kg (initial), expanding to 0.2-0.3 L/kg as it equilibrates between intravascular and extravascular compartments.
ProteinBinding: Not applicable (it is the protein)
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 15-19 days (variable depending on clinical condition)
Clearance: Approximately 10-15% of total body albumin is catabolized and replaced daily.
ExcretionRoute: Metabolites excreted via renal and biliary routes.
Unchanged: Not applicable (catabolized)
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Pharmacodynamics

OnsetOfAction: Immediate (volume expansion)
PeakEffect: Minutes (volume expansion), hours to days (sustained oncotic effect)
DurationOfAction: Hours to days (depending on fluid shifts and underlying condition)
Confidence: High

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 immediately or seek emergency 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 do not experience any side effects or only have mild ones. If you have any side effects that bother you or do not go away, contact your doctor for advice.

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.
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Seek Immediate Medical Attention If You Experience:

  • Shortness of breath
  • Swelling in ankles, feet, or hands
  • Chest pain or tightness
  • Rash or hives
  • Fever or chills
  • Nausea or vomiting
  • Headache
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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 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 with all 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.

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

During treatment, 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 infection, there is a small chance it may still contain viruses that can cause disease. Consult with your doctor to discuss this risk.

If you are pregnant, planning to become pregnant, or are breastfeeding, 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.
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Overdose Information

Overdose Symptoms:

  • Signs of fluid overload (e.g., pulmonary edema, hypertension, increased CVP)
  • Cardiac failure
  • Electrolyte disturbances

What to Do:

Discontinue infusion immediately. Manage symptoms of fluid overload (e.g., diuretics, oxygen). Call 1-800-222-1222 (Poison Control) or seek emergency medical attention.

Drug Interactions

Monitoring

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Baseline Monitoring

Vital Signs (BP, HR, RR)

Rationale: To assess hemodynamic stability and identify signs of fluid overload or hypovolemia.

Timing: Prior to infusion

Fluid Status (I&O, CVP if available)

Rationale: To guide dosing and prevent fluid overload or dehydration.

Timing: Prior to infusion

Serum Electrolytes (Na, K, Cl)

Rationale: To assess baseline electrolyte balance, as rapid infusion can affect levels.

Timing: Prior to infusion

Serum Albumin Level

Rationale: To confirm hypoalbuminemia and guide replacement therapy.

Timing: Prior to infusion (for hypoalbuminemia)

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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, improving towards target.

Action Threshold: Significant changes (e.g., hypertension, tachycardia, dyspnea) warrant slowing/stopping infusion and assessment.

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 for stable).

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

Central Venous Pressure (CVP) / Pulmonary Artery Wedge Pressure (PAWP)

Frequency: As clinically indicated, especially in critically ill patients.

Target: Improving towards target (e.g., CVP 8-12 mmHg for volume expansion).

Action Threshold: Rapid increase indicating fluid overload.

Serum Albumin Level

Frequency: Daily or every 2-3 days, as clinically indicated (for hypoalbuminemia).

Target: Improving towards normal range (e.g., >3.0 g/dL).

Action Threshold: Persistent low levels despite adequate dosing.

Renal Function (BUN, Creatinine)

Frequency: Daily or as clinically indicated.

Target: Stable or improving.

Action Threshold: Worsening renal function, especially with signs of fluid overload.

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Symptom Monitoring

  • Signs of fluid overload (e.g., dyspnea, crackles, peripheral edema, jugular venous distension)
  • Signs of allergic reaction (e.g., rash, urticaria, fever, chills, nausea, vomiting, hypotension, bronchospasm)
  • Headache
  • Flushing

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 safe when clinically indicated, as it is a physiological substance. Use only if clearly needed.

Trimester-Specific Risks:

First Trimester: No known specific risks, but use only if clearly indicated.
Second Trimester: No known specific risks, but use only if clearly indicated.
Third Trimester: No known specific risks, but use only if clearly indicated.
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Lactation

Albumin is a normal component of human milk. Exogenous administration is unlikely to cause adverse effects in a breastfed infant. Considered compatible with breastfeeding.

Infant Risk: Low risk
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Pediatric Use

Dosing is weight-based (g/kg). Close monitoring of fluid status and vital signs is crucial due to the risk of fluid overload, especially in neonates and infants.

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Geriatric Use

Use with caution in elderly patients, particularly those with compromised cardiac or renal function, due to increased risk of circulatory overload. Monitor fluid status and vital signs closely.

Clinical Information

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Clinical Pearls

  • Albumin 25% is hyperoncotic and will draw fluid from the interstitial space into the intravascular space, leading to volume expansion. Monitor for signs of fluid overload.
  • Rapid infusion can lead to circulatory overload, especially in patients with cardiac or renal impairment. Infuse slowly.
  • Albumin solutions do not contain clotting factors or antibodies, so they are not a substitute for whole blood or plasma when these components are needed.
  • Electrolyte disturbances (e.g., hypernatremia) can occur, especially with large volumes or rapid infusions.
  • Consider the patient's overall fluid balance and electrolyte status when administering albumin.
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Alternative Therapies

  • Crystalloids (e.g., Normal Saline, Lactated Ringer's) for volume expansion
  • Synthetic colloids (e.g., starches, dextrans) - generally less preferred due to safety concerns and limited indications
  • Blood products (e.g., Fresh Frozen Plasma) when clotting factors or other plasma proteins are needed
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Cost & Coverage

Average Cost: Not available per 50ml vial
Generic Available: Yes
Insurance Coverage: Tier 3 or 4 (Specialty/Non-preferred Brand), often covered under medical benefit for approved indications.
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General Drug Facts

If your symptoms or health issues 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 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, 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.