| PENTASPANŽ |
|DuPont Pharma |
|Plasma Volume Expander |
|Action And Clinical Pharmacology: The colloidal properties of pentastarch render it useful as a plasma volume expander. I.V. infusion of pentastarch results in expansion of the plasma volume in excess of the volume infused. This expansion persists for approximately 18 to 24 hours and is expected to improve the hemodynamic status for 12 to 18 hours.
Pentastarch molecules below 50 000 molecular weight are rapidly eliminated by renal excretion. A single dose of approximately 500 mL of pentastarch results in elimination in the urine of approximately 70% of the dose within 24 hours, and approximately 80% of the dose within 1 week. The remaining percentage of the administered dose is presumed to be eliminated at a slower rate. Although this process is variable, it generally results in an intravascular pentastarch concentration below the level of detection by 1 week. The hydroxyethyl group is not cleaved, but remains intact and attached to glucose units when excreted.
Indications And Clinical Uses: When plasma volume expansion is desired as an adjunct in the management of shock due to hemorrhage, surgery, sepsis, burns or other trauma. It is not a substitute for red blood cells or coagulation factors in plasma.
Contra-Indications: In patients with known hypersensitivity to hydroxyethyl starch, or with bleeding disorders, or with congestive heart failure where volume overload is a potential problem. Pentastarch should not be used in renal disease with oliguria or anuria not related to hypovolemia. tag_WarningWarnings
Manufacturers' Warnings In Clinical States: General: Administration of large volumes of pentastarch will decrease hemoglobin concentration and dilute plasma proteins excessively. Administration should be kept below the recommended ceiling of 2 000 mL in 24 hours (see Dosage).
As with other plasma volume expanders, large volumes of pentastarch will alter the coagulation mechanisms, inasmuch as a prolongation of prothrombin, partial thromboplastin and clotting times will occur. The physician should also be alert to the possibility of transient prolongation of bleeding time.
Hypersensitivity has been seen (wheezing and urticaria and hypotension). Anaphylactic/anaphylactoid reactions have been reported with pentastarch; a causal relationship has not been established. If hypersensitivity effects occur, discontinue the drug and, if necessary, administer appropriate therapy.
Pregnancy: Pentastarch has been shown to be embryocidal in New Zealand rabbits and in Swiss mice when given in doses 5 times the human dose. There are no adequate and well-controlled clinical studies using pentastarch in pregnant women. Pentastarch should not be used during pregnancy unless potential benefits justify the potential risk to the fetus.
Lactation: It is not known whether pentastarch is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when pentastarch is administered to a nursing woman.
Children: The safety and effectiveness of pentastarch in children have not been established.
Precautions: Pentastarch, like all plasma volume expanders, is not a substitute for red blood cells or coagulation factors in plasma.
The possibility of circulatory overload should be kept in mind.
Caution should be used when the risk of pulmonary edema and/or congestive heart failure is increased. Special care should be exercised in patients who have impaired renal clearance since this is the principal route by which pentastarch is eliminated.
The serum chemistries of 16 normal volunteers who were given pentastarch in doses of 500 to 2 000 mL (2´1 000 mL infusions on separate days) were essentially unchanged from pre- to 7 days post infusion, except for dilutional effects. There were no clinically significant abnormal values except for one creatinine phosphokinase level following an episode of venospasm. However, indirect bilirubin levels of 8.3 mg/L (normal 0 to 7 mg/L) have been reported in 2 out of 20 normal subjects who received multiple infusions of a 6% hetastarch product. Total bilirubin was within normal limits at all times; indirect bilirubin returned to normal by 96 hours following the final infusion. The significance, if any, of these elevations is not known; however, caution should be observed before administering pentastarch to patients with a history of liver disease.
Caution should be exercised when administering pentastarch to patients allergic to corn because such patients can also be allergic to pentastarch.
Elevated serum amylase levels may be observed temporarily following administration of pentastarch although no association with pancreatitis has been demonstrated. A 6% hetastarch injection product has not been shown to increase serum lipase. Similar effects may be expected with pentastarch.
Adverse Reactions: Coagulation disorders or hemorrhage have been reported in association with the use of pentastarch as a plasma volume expander. Headache, diarrhea, nausea, weakness, temporary weight gain, insomnia, fatigue, fever, edema, paresthesia, acne, malaise, shakiness, dizziness, chest pain, chills, nasal congestion, anxiety and increased heart rate have also been reported in clinical studies involving pentastarch.
It is uncertain whether any of these adverse experiences are attributable to the drug, medical procedures, concurrent adjunctive medication, or a combination of these factors.
Hypersensitivity has been seen (wheezing, urticaria and hypotension). Anaphylactic/anaphylactoid reactions have been reported with pentastarch (see Warnings).
Symptoms And Treatment Of Overdose: Symptoms and Treatment: The treatment of overdosage would be essentially symptomatic and supportive. tag_DosageDosage
Dosage And Administration: Pentastarch is administered by i.v. infusion only. Total dosage and rate of infusion depend upon the amount of blood or plasma lost. In adults, the amount usually administered is 500 to 2 000 mL. Total dosage does not usually exceed 2 000 mL/day or approximately 28 mL/kg of body weight for the typical 70 kg patient. In acute hemorrhagic shock, an administration rate approaching 20 mL/kg/hour may be used. Use beyond 72 hours has not been studied.
Parenteral drug products should be inspected for particulate matter and discoloration prior to administration whenever solution and container permit.
The solution is intended for i.v. administration using sterile equipment. It is recommended that i.v. administration apparatus be replaced at least once every 24 hours.
Special Instructions: Caution: Before administering to patient, review these directions: Visual Checking: 1. Do not remove the plastic infusion container from its overwrap until immediately before use. 2. While the overwrap is intact, identify the solution (Pentaspan), lot number and expiration date. 3. Check that the solution is clear. 4. Inspect the intact unit for signs of obvious damage. If present, the unit should not be used.
Removal of Overwrap: To open overwrap, tear at any notch located at either end of unit. After removing overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be impaired.
Preparation for Administration (Use aseptic technique): 1. Close flow control clamp of administration set. 2. Twist off plug from port designated "Infusion Set Port". 3. Insert spike of infusion set into port with a twisting motion until the set is firmly sealed. 4. Suspend container from hanger. 5. Follow manufacturer's recommended procedures for the administration set. 6. Discontinue administration and notify physician immediately if patient exhibits signs of adverse reactions.
Availability And Storage: Each 100 mL of sterile, clear, pale yellow to amber-colored, nonpyrogenic solution contains: pentastarch 10 g, sodium chloride USP 0.9 g and water for injection USP qs. pH adjusted with sodium hydroxide to approximately 5.0. Approximate concentration of electrolytes (mEq/L): sodium 154, chloride 154. Calculated Osmolarity: approximately 326 mOsM. Plastic i.v. infusion bags of 250 and 500 mL. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at room temperature (15 to 25°C).