Albunorm 0.05

INDICATIONS

Shock: Albumin is indicated in the emergency treatment of shock and in other similar conditions where the restoration of blood volume is urgent. If there has been considerable loss of red blood cells, transfusion with packed red blood cells is indicated.... Read moreShock: Albumin is indicated in the emergency treatment of shock and in other similar conditions where the restoration of blood volume is urgent. If there has been considerable loss of red blood cells, transfusion with packed red blood cells is indicated.Burns: Albumin or Albumin in either normal saline or dextrose is indicated to prevent marked hemoconcentration and to maintain appropriate electrolyte balance.Hypoproteinemia with or without edema: Albumin is indicated in those clinical situations usually associated with a low concentration of plasma protein and a resulting decreased circulating blood volume. Although diuresis may occur soon after albumin administration has been instituted, best results are obtained if albumin is continued until the normal serum protein level is regained.

PHARMACOLOGY

The main function of albumin results from its contribution to plasma colloid oncotic pressure and transport function. Albumin stabilizes circulating blood volume and carries hormones, enzymes, medicines, and toxins. Other physiological functions include antioxidant properties, free radical scavenging, in addition to maintenance capillary membrane integrity. Exogenously administered albumin increases the oncotic pressure of the intravascular system, moving fluids from the interstitial space, thereby decreasing edema and increasing the circulating blood volume. The increase in volume reduces the concentration and viscosity of blood in patients with decreased circulating blood volume while maintaining cardiac output in shock. In dehydrated patients, negligible effects exist on circulating blood volume. In addition to the above albumin replaces protein in patients with hypoproteinemia until the cause of the deficiency can be determined.This drug has thousands of endogenous and exogenous targets. Human albumin also binds and carries a plethora of hydrophobic molecules, such as endogenous (i.e., cholesterol, fatty acids, bilirubin, thyroxine) or exogenous substances (for example, drugs and toxins), transition metal ions, as well as gas (nitric oxide [NO]), with resulting implications for their solubilisation, transport, metabolism, and detoxification.

DOSAGE & ADMINISTRATION

Human albumin 25% is for intravenous administration only. Human albumin may be diluted with 5% glucose or 0.9% sodium chloride. Concentration, dosage, and infusion-rate should be adjusted to the patient’s individual requirements and indication.

Hypovolemia: Initial dose 25 g is suggested.
Hypoalbuminemia: 50-75 gm
Prevention of central volume fluid removed depletion after
paracentesis due to cirrhotic ascites: 6-8 gm for every 1000 mL of ascitic.
OHSS: 50 to 100 gm over 4 hours and repeated at 4-12 hour intervals as necessary. 10-50 gm; single infusion.
ARDS: 25 g over 30 minutes and repeated at 8 hours for 3 days if necessary.
Burns: Determined by direct observation of vital sign or measurement of either plasma oncotic pressure or protein content.

Human albumin 20%: Measures of adequacy of circulating volume and not plasma albumin levels should be used to determine the dose required. If human albumin is to be administered, haemodynamic performance should be monitored regularly; this may include:

arterial blood pressure and pulse rate
central venous pressure
pulmonary artery wedge pressure
urine output
electrolyte
haematocrit / haemoglobin

The solution can be directly administered by the intravenous route, or it can be diluted in an isotonic solution (e.g. 0.9% sodium chloride). In plasma exchange the infusion rate should be adjusted to the rate of removal.Human albumin 5% may be given intravenously without further dilution. This concentration is approximately isotonic and iso-osmotic with citrated plasma. Albumin (Human) in this concentration provides additional fluid for plasma volume expansion. Therefore, when it is administered to patients with normal blood volume, the rate of infusion should be slow enough to prevent too rapid expansion of plasma volume.In the treatment of shock in an adult patient an initial dose of 500 mL of the 5% albumin solution is given as rapidly as tolerated. If response within 30 minutes is inadequate, an additional 500 mL of 5% albumin solution may be given. The 50 mL dosage form would be appropriate for pediatric use, with a dose of 10-20 mL per kg of body weight infused intravenously at a rate up to 5-10 mL per minute. Therapy should be guided by the clinical response, blood pressure and an assessment of relative anemia. If more than 1000 mL are given, or if hemorrhage has occurred, the administration of packed red blood cells may be desirable.In severe burns, immediate therapy should include large volumes of crystalloid with lesser amounts of 5% albumin solution to maintain an adequate plasma volume. After the first 24 hours, the ratio of albumin to crystalloid may be increased to establish and maintain a plasma albumin level of about 2.5 g/100 mL or a total serum protein level of about 5.2 g/100 mL. However, an optimal regimen for the use of colloids, electrolytes and water after severe burns has not been established.The infusion of Albumin (Human) as a nutrient in the treatment of chronic hypoproteinemia is not recommended. In acute hypoproteinemia, 5% albumin may be used in replacing the protein lost in hypoproteinemic conditions. However, if edema is present or if large amounts of albumin are lost, Albumin (Human) 25% is preferred because of the greater amount of protein in the concentrated solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

INTERACTION

Albumin solution should not be mixed by protein hydrolysates or alcoholic solutions. Risk of atypical reactions to ACE inhibitors in patients undergoing therapeutic plasma exchange with albumin human replacement.

SIDE EFFECTS

Allergic or pyrogenic reactions are characterized primarily by fever and chills; rash, nausea, vomiting, tachycardia and hypotension have also been reported. Should an adverse reaction occur, slow or stop the infusion for a period of time which may result in the disappearance of the symptoms. If administration has been stopped and the patient requires additional Albumin (Human), material from a different lot should be used. Albumin (Human), particularly if administered rapidly, may result in vascular overload with resultant pulmonary edema.

PREGNANCY & LACTATION

Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

PRECAUTIONS & WARNINGS

Hypertension or low cardiac reserve; additional fluids for dehydrated patients. Monitor for signs of cardiac overload in injured or postoperative patients. May carry risk of viral transmission. Volume admin and rate of infusion must always be individualised according to situation and response. Pregnancy, lactation.

USE IN SPECIAL POPULATIONS

No clinical studies using Albumin (Human) have been conducted in pediatric patients. Safety and effectiveness in pediatric patients have not been established. However, extensive experience in patients suggests that children respond to Albumin (Human) in the same manner as adults.

THERAPEUTIC CLASS

Plasma expanders

STORAGE CONDITIONS

Store below 30°C. Do not freeze.