Pro Alb Human Albumin IP, 20%/100 ml

Pro Alb 20% Injection: Comprehensive Overview
Brand Name: Pro Alb 20% Injection
Generic Name: Human Albumin
Concentration: 20%
Formulation: Injection (Intravenous)
Manufacturer: Varies by region (often produced by various pharmaceutical companies)
Dosage Form: 50 mL, 100 mL, or 200 mL vials, based on product packaging.

1. Introduction to Pro Alb 20% Injection
Pro Alb 20% Injection is a solution of human albumin, a protein that is an essential component of plasma. Albumin plays a critical role in maintaining the colloidal osmotic pressure of the blood, which helps in regulating the movement of fluids between blood vessels and tissues. Pro Alb 20% Injection contains 20% albumin concentration and is typically administered through intravenous (IV) injection or infusion to treat or prevent low blood volume (hypovolemia) and low albumin levels, a condition called hypoalbuminemia.

2. Pharmacology and Mechanism of Action
Albumin is a large globular protein that is synthesized primarily in the liver. It accounts for about 60% of the total protein content in plasma. Pro Alb 20% Injection contains highly purified human albumin that is extracted from donated human blood plasma. It functions as a plasma expander, which means it helps to increase the volume of circulating blood. It also maintains the oncotic pressure in the blood vessels, preventing fluid from leaking into the tissues and causing edema.

Albumin binds and carries various substances in the bloodstream, such as hormones, fatty acids, and drugs. It plays an essential role in:

Maintaining blood volume: By exerting oncotic pressure, albumin helps in retaining water within the vascular system, preventing edema.
Transport of molecules: Albumin carries various molecules like fatty acids, calcium, bilirubin, and other small molecules in the bloodstream.
Acid-base balance: It helps in buffering blood pH, acting as a buffer to stabilize pH levels within a narrow range.
Nutritional support: Due to its role in the transport of fatty acids and vitamins, albumin also contributes to the nutritional status of the body.
3. Indications
Pro Alb 20% Injection is used in the following clinical conditions:

Hypoalbuminemia: Low levels of albumin in the blood, often caused by liver disease, kidney disease, or malnutrition.
Shock: Severe shock or trauma, where rapid volume expansion is needed to restore circulatory function.
Burns: Severe burns may result in plasma protein loss, and albumin infusion helps in maintaining blood volume and pressure.
Neonatal Conditions: In preterm infants, albumin is used to treat conditions like hyponatremia (low sodium) or edema.
Cirrhosis: Liver disease, especially cirrhosis, often leads to hypoalbuminemia, and albumin infusion may be used as part of treatment.
Nephrotic Syndrome: A kidney condition where protein is lost in the urine, leading to low albumin levels in the blood.
Post-surgery or trauma recovery: To support blood volume following major surgery or injury.
Chronic conditions associated with low protein levels: Such as malnutrition, liver cirrhosis, or kidney disease.
4. Dosage and Administration
The dosage of Pro Alb 20% Injection will depend on the clinical condition being treated, the severity of the condition, the patient’s body weight, and their overall medical status.

Hypovolemia or Shock: A typical initial dose may range from 25-50 mL per patient, infused slowly over 30-60 minutes. This can be adjusted based on response.
Hypoalbuminemia: The usual dose is typically between 100-200 mL, depending on the severity of the albumin deficiency.
Burns or Major Trauma: The dosage might vary from 200-400 mL, depending on the volume lost and the need for plasma expansion.
The infusion rate and amount should always be determined by a healthcare professional, as the volume required can vary greatly depending on the patient’s condition.

Administration Notes:

Route: Administered intravenously.
Dilution: Depending on the condition, it may be diluted with sterile saline or a suitable infusion solution, but this is decided by the treating healthcare provider.
Infusion Rate: The infusion should generally be slow, especially in critically ill patients or those with heart or kidney disease, to avoid complications such as fluid overload.
Monitoring: Close monitoring is required, particularly for patients with heart disease, kidney disease, or fluid imbalances, to avoid circulatory overload or allergic reactions.
5. Contraindications
Pro Alb 20% Injection is contraindicated in the following conditions:

Hypersensitivity: Individuals with known hypersensitivity or allergy to albumin or any of the components of the injection.
Severe Anemia: In patients with severe anemia, where the red blood cell count is significantly low, as albumin does not carry oxygen.
Severe Heart Failure: In cases of heart failure where additional fluid may exacerbate the condition.
Dehydration: For patients with dehydration or those who have a loss of body fluids, as this may lead to circulatory overload when large volumes are infused.
6. Precautions and Warnings
Fluid Overload: Care should be taken when administering albumin to patients who are at risk for fluid overload, such as those with heart failure, kidney disease, or pulmonary edema.
Monitoring: Regular monitoring of vital signs, particularly blood pressure, heart rate, and respiratory rate, is essential during the infusion process. Monitoring for signs of fluid overload, such as edema, breathing difficulties, or weight gain, is also important.
Electrolyte Imbalance: Albumin infusion can lead to shifts in the electrolyte balance, particularly sodium and potassium. Patients receiving albumin should be monitored for signs of imbalances and managed accordingly.
Allergic Reactions: Although rare, some patients may experience allergic reactions to albumin, such as rashes, fever, or anaphylaxis. Immediate discontinuation and appropriate medical intervention are required in case of severe reactions.
7. Side Effects
Common side effects of Pro Alb 20% Injection are usually mild, but they can include:

Allergic Reactions: Mild reactions such as rash, hives, or fever.
Headache or Dizziness: Some patients may experience mild headaches or dizziness during the infusion.
Nausea or Vomiting: These symptoms may occur, although they are rare.
Tachycardia (Increased Heart Rate): May occur during rapid infusion or if the patient is sensitive to volume changes.
Injection Site Reactions: Redness, swelling, or pain at the site of injection.
Fluid Overload Symptoms: If too much albumin is infused too quickly, symptoms like swelling, difficulty breathing, or elevated blood pressure may occur.
In very rare cases, more severe side effects like anaphylactic shock or severe fluid overload may occur, necessitating immediate medical intervention.

8. Drug Interactions
Antihypertensives: Care should be taken when combining albumin with drugs that lower blood pressure, as it may exacerbate hypotension (low blood pressure) during infusion.
Diuretics: The use of diuretics may affect the fluid balance in patients receiving albumin, and doses may need to be adjusted.
Corticosteroids: When used alongside corticosteroids, there is a potential risk for electrolyte imbalances.
It is always essential to inform the prescribing healthcare provider of any medications or health conditions prior to starting albumin therapy.

9. Special Populations
Pregnancy: Pro Alb 20% Injection should only be used during pregnancy if clearly needed. While albumin is not known to be harmful to the fetus, its use should be monitored closely.
Lactation: It is unknown whether albumin is excreted in breast milk, so it should be used with caution during breastfeeding.
Pediatric Use: Albumin can be used in neonates and children when indicated, especially in the treatment of hypoalbuminemia or fluid imbalance. However, the dose and administration must be carefully adjusted by the healthcare provider based on age, weight, and clinical condition.
10. Storage and Handling
Storage: Pro Alb 20% Injection should be stored in a cool, dry place at room temperature, away from direct light. It should not be frozen.
Shelf Life: Typically, the product is stable for up to 36 months from the manufacturing date. Expiry dates are marked on the packaging.
Handling: Before use, the vial should be checked for any particulate matter or discoloration. It should only be used if the solution is clear and free of debris.