Albutein 25% Inj, 20ml

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
Colloid; Plasma protein
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Pregnancy Category
Not assigned (Risk Summary available)
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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 intravenously (into a vein) to replace albumin if your body isn't making enough, or to help increase your blood volume if you've lost a lot of fluid, for example, after surgery or injury.
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How to Use This Medicine

Taking Your Medication Correctly
To ensure safe and effective use, take this medication exactly as directed by your doctor. Carefully read all the information provided to you and follow the instructions precisely. This medication is administered as an intravenous infusion, which means it is given slowly into a vein over a specified period of time.

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 immediately to receive guidance on what to do next.
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Lifestyle & Tips

  • Report any unusual symptoms immediately during or after infusion.
  • Maintain adequate hydration as advised by your doctor.
  • Follow all post-infusion instructions from your healthcare provider.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable based on indication and patient's clinical status. Typically 25-100g/day for hypoalbuminemia or 25-50g for hypovolemia/shock.

Condition-Specific Dosing:

Hypovolemic Shock: 25 g (500 mL of 5% or 100 mL of 25%) initially, repeat as needed based on clinical response. Rapid infusion (1-2 mL/min for 25% solution).
Hypoalbuminemia: 50-75 g/day (200-300 mL of 25% solution) for 1-2 days, then adjust based on albumin levels and clinical response. Slower infusion (0.05-0.1 mL/min for 25% solution).
Burns (after 24 hours): Dose adjusted to maintain plasma albumin levels and colloid oncotic pressure.
Acute Liver Failure: Often used with diuretics for paracentesis or hepatorenal syndrome, dose varies.
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Pediatric Dosing

Neonatal: 0.5-1 g/kg (2-4 mL/kg of 25% solution) IV over 5-10 minutes, repeat as needed. Max 25% solution: 6 g/kg/day.
Infant: 0.5-1 g/kg (2-4 mL/kg of 25% solution) IV over 5-10 minutes, repeat as needed. Max 25% solution: 6 g/kg/day.
Child: 0.5-1 g/kg (2-4 mL/kg of 25% solution) IV over 5-10 minutes, repeat as needed. Max 25% solution: 6 g/kg/day.
Adolescent: Similar to adult dosing, adjusted for weight and clinical status.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed, but monitor for fluid overload, especially in anuric patients.
Dialysis: No specific adjustment needed. May be used to maintain intravascular volume during dialysis.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed. Often used in severe hepatic impairment (e.g., spontaneous bacterial peritonitis, hepatorenal syndrome) to maintain oncotic pressure and support renal function.

Pharmacology

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Mechanism of Action

Albumin is a natural protein that accounts for 70-80% of the colloid oncotic pressure of plasma. It functions as a transport protein for various endogenous and exogenous substances (e.g., hormones, enzymes, drugs, toxins). When administered intravenously, it increases plasma volume by drawing interstitial fluid into the intravascular space, thereby increasing cardiac output and maintaining blood pressure. It also helps in maintaining fluid balance and transporting substances.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (intravenous administration)
Tmax: Immediate (upon completion of infusion)
FoodEffect: Not applicable (IV administration)

Distribution:

Vd: Approximately 4-5 L (initial intravascular volume), then equilibrates with extravascular space over several days, leading to a larger apparent Vd of 10-12 L.
ProteinBinding: Albumin itself is a protein; it binds to and transports various substances.
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 15-20 days (variable depending on patient's condition and albumin turnover rate).
Clearance: Not typically expressed as a fixed clearance rate due to its catabolic elimination and dynamic distribution.
ExcretionRoute: Amino acids are reused or excreted via renal/fecal routes after catabolism.
Unchanged: Not applicable (catabolized)
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Pharmacodynamics

OnsetOfAction: Immediate (upon infusion)
PeakEffect: Within minutes to hours, depending on fluid shifts and underlying condition.
DurationOfAction: Hours to days, depending on the patient's clinical condition, rate of albumin loss, and catabolism.

Safety & Warnings

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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: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision
Signs of fluid and electrolyte problems: mood changes, confusion, muscle pain or weakness, fast or abnormal heartbeat, severe dizziness or fainting, increased thirst, seizures, feeling extremely tired or weak, decreased appetite, difficulty urinating or changes in urine output, dry mouth, dry eyes, or severe stomach upset or vomiting
Headache
* Shortness of breath, significant weight gain, or swelling in the arms or legs

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 have side effects that bother you or persist, contact your doctor for guidance.

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, consult 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
  • Sudden weight gain
  • Chest pain or tightness
  • Rash, hives, or itching
  • Fever or chills
  • Nausea or vomiting
  • Headache or flushing
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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 and its symptoms.
Certain health conditions, including:
+ Anemia
+ Heart failure (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
Natural products
Vitamins
Health problems

Carefully review your medications and health conditions with your doctor to confirm that it is safe to take this medication. 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.

Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss any concerns or questions you have with your doctor.

Your doctor will closely monitor your blood pressure, heart rate, and oxygen levels while you are taking this drug. It is crucial to maintain open communication with your doctor regarding your condition.

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 crucial to notify your doctor. You and your doctor will need to carefully weigh the benefits and risks of taking this medication to ensure the best possible outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Signs of fluid overload (e.g., dyspnea, crackles in lungs, elevated blood pressure, jugular venous distension, peripheral edema)
  • Headache
  • Flushing
  • Nausea
  • Vomiting
  • Tachycardia

What to Do:

Stop infusion immediately. Administer diuretics as needed. Provide supportive care. Call 1-800-222-1222 (Poison Control) or seek emergency medical attention.

Drug Interactions

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Moderate Interactions

  • ACE inhibitors (potential for hypotension, especially in patients undergoing rapid volume expansion)
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Unknown Interactions

  • No significant drug-drug interactions are typically reported for human albumin. The primary concerns are related to fluid balance and electrolyte disturbances.

Monitoring

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Baseline Monitoring

Vital Signs (BP, HR, RR)

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

Timing: Prior to infusion

Fluid Status (I&O, edema, lung sounds)

Rationale: To assess baseline hydration and risk of fluid overload.

Timing: Prior to infusion

Serum Electrolytes (Na, K, Cl, Ca)

Rationale: To assess baseline electrolyte balance, especially sodium due to albumin's content, and calcium if large volumes are anticipated.

Timing: Prior to infusion

Serum Albumin (if indicated)

Rationale: To confirm hypoalbuminemia and guide dosing.

Timing: Prior to infusion

Renal Function (BUN, Creatinine)

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

Timing: Prior to infusion

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Routine Monitoring

Vital Signs (BP, HR, RR)

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

Target: Within patient's normal limits or improving towards target.

Action Threshold: Significant changes (e.g., sudden increase in BP, dyspnea, tachycardia) indicating fluid overload or allergic reaction.

Fluid Balance (I&O)

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

Target: Appropriate balance based on clinical goals.

Action Threshold: Positive fluid balance exceeding clinical goals, oliguria, or anuria.

Lung Sounds

Frequency: Before, during, and after infusion, or as clinically indicated.

Target: Clear, no crackles or wheezes.

Action Threshold: New onset crackles, wheezes, or dyspnea.

Serum Electrolytes (Na, K)

Frequency: Daily or as clinically indicated, especially with large volumes.

Target: Within normal limits.

Action Threshold: Significant deviations (e.g., hypernatremia, hypokalemia).

Serum Albumin (if indicated)

Frequency: Every 1-2 days or as clinically indicated to guide further dosing.

Target: Improving towards target (e.g., >2.5-3 g/dL).

Action Threshold: Persistent low levels despite adequate dosing.

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Symptom Monitoring

  • Signs of fluid overload (dyspnea, orthopnea, peripheral edema, jugular venous distension, crackles on lung auscultation)
  • Signs of allergic reaction (rash, urticaria, fever, chills, nausea, vomiting, flushing, headache, hypotension, tachycardia, dyspnea, bronchospasm)
  • Signs of circulatory overload (headache, flushing, increased blood pressure, tachycardia, dyspnea)

Special Patient Groups

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Pregnancy

Albumin is a natural component of human plasma. Its use in pregnancy is generally considered safe when clinically indicated, as the benefits typically outweigh the potential risks. It is often used in conditions like severe preeclampsia, ovarian hyperstimulation syndrome, or hypovolemia.

Trimester-Specific Risks:

First Trimester: No known specific risks. Use only if clearly needed.
Second Trimester: No known specific risks. Use only if clearly needed.
Third Trimester: No known specific risks. Use only if clearly needed. Monitor for fluid overload.
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Lactation

Albumin is a natural component of human milk and is not expected to cause harm to a breastfed infant. It is considered compatible with breastfeeding.

Infant Risk: Low risk (L1)
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Pediatric Use

Dosing is weight-based and adjusted according to the specific indication and clinical response. Careful monitoring for fluid overload is crucial, especially in neonates and infants due to their immature renal function and smaller circulating blood volume.

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Geriatric Use

No specific dose adjustment is typically required based solely on age. However, elderly patients may be more susceptible to fluid overload due to age-related decreases in cardiac and renal function. Close monitoring of fluid status, vital signs, and renal function is essential.

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. Use with caution in patients at risk for fluid overload (e.g., heart failure, renal failure).
  • Rapid infusion of 25% albumin can lead to circulatory overload. Infusion rates should be carefully controlled based on the patient's condition and indication.
  • Monitor for signs of allergic reactions, especially during the initial phase of infusion.
  • Albumin is not a nutritional supplement. While it contributes to plasma protein, it should not be used solely for nutritional support.
  • Electrolyte disturbances, particularly hypernatremia, can occur with large volumes of albumin due to its sodium content. Monitor serum electrolytes.
  • 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.
  • Do not dilute 25% albumin with sterile water for injection, as this can cause hemolysis. If dilution is necessary, use 0.9% Sodium Chloride or 5% Dextrose in Water.
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Alternative Therapies

  • Crystalloids (e.g., 0.9% Sodium Chloride, Lactated Ringer's solution) for volume expansion, especially in initial resuscitation.
  • Other colloids (e.g., Dextran, Hydroxyethyl starch - though HES use is restricted due to safety concerns) for volume expansion.
  • Blood products (e.g., packed red blood cells, fresh frozen plasma) when specific blood components are needed.
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Cost & Coverage

Average Cost: Highly variable, typically $50-$200+ per 50 mL (12.5g) or 100 mL (25g) vial of 25% solution
Generic Available: Yes
Insurance Coverage: Typically covered by most medical insurance plans (Part B for Medicare) when medically necessary, often Tier 4 (Specialty) or covered under medical benefit.
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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 reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly; do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional. 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 emergency medical attention. Be prepared to provide information about the medication taken, the quantity, and the time of ingestion to facilitate prompt and effective treatment.