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Voluven

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Voluven

Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

General Warnings and Precautions

Anaphylactoid reactions (mild influenza-like symptoms, bradycardia, tachycardia, bronchospasm, non-cardiac pulmonary edema) have been reported with solutions containing hydroxyethyl starch. If a hypersensitivity reaction occurs, administration of the drug should be discontinued immediately and the appropriate treatment and supportive measures should be undertaken until symptoms have resolved. [see ADVERSE REACTIONS]

Fluid status and rate of infusion should be assessed regularly during treatment, especially in patients with cardiac insufficiency or severe kidney dysfunction.

In cases of severe dehydration, a crystalloid solution should be given first. Generally, sufficient fluid should be administered in order to avoid dehydration.

Caution should be observed before administering Voluven® (hydroxyethyl starch in sodium chloride injection) to patients with severe liver disease or severe bleeding disorders (e.g., severe cases of von Willebrand´s disease).

Monitoring: Laboratory Tests

Clinical evaluation and periodic laboratory determinations are necessary to monitor fluid balance, electrolyte concentrations, kidney function, acid-base balance, and coagulation parameters during prolonged parenteral therapy or whenever the patient's condition warrants such evaluation.

Interference with Laboratory Tests

Elevated serum amylase levels may be observed temporarily following administration of the product and can interfere with the diagnosis of pancreatitis.

At high dosages the dilutional effects may result in decreased levels of coagulation factors and other plasma proteins and a decrease in hematocrit.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals to evaluate the carcinogenic potential of Voluven® (hydroxyethyl starch in sodium chloride injection) have not been performed. No mutagenic effects were observed with hydroxyethyl starch 130/0.4 10% solution in the following tests on mutagenic activity: Salmonella typhimurium reverse mutation assay (in vitro), mammalian cells in the in vitro gene mutation assay, assessment of the clastogenic activity in cultured human peripheral lymphocytes (in vitro), bone marrow cytogenetic test in Sprague-Dawley rats.

Fertility studies on directly exposed animals have not been performed.

Use In Special Populations

Pregnancy

Pregnancy Category C. Voluven® (hydroxyethyl starch in sodium chloride injection) has been shown to cause embryocidal or other adverse effects in rats and rabbits when given in doses 1.7 times the human dose. There are no adequate and well-controlled studies in pregnant women. Voluven® (hydroxyethyl starch in sodium chloride injection) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

The type of hydroxyethyl starch present in Voluven® (hydroxyethyl starch in sodium chloride injection) had no teratogenic properties in rats or rabbits. At 5 g/kg of body weight per day, administered as a bolus injection, fetal retardations and embryolethal effects were observed in rats and rabbits, respectively. In rats, a bolus injection of this dose during pregnancy and lactation reduced body weight of offspring and induced developmental delays. All adverse effects were seen exclusively at maternal toxic doses due to fluid overload. [see Toxicology]

Fertility studies on directly exposed animals have not been conducted.

Labor and Delivery

Information on the use of Voluven® (hydroxyethyl starch in sodium chloride injection) during labor or delivery is unknown.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Voluven® (hydroxyethyl starch in sodium chloride injection) is administered to a nursing woman.

Pediatric Use

In one trial, children including newborns to infants ( < 2 years) undergoing elective surgery were randomized to receive Voluven® (hydroxyethyl starch in sodium chloride injection) (N=41) or 5% albumin (N=41). The mean dose of Voluven® (hydroxyethyl starch in sodium chloride injection) administered was 16 ± 9 mL/kg3).

Voluven® (hydroxyethyl starch in sodium chloride injection) may be given to premature infants and newborns only after a careful risk/benefit evaluation. The safety and efficacy of Voluven® (hydroxyethyl starch in sodium chloride injection) have not been established in the age group of 2 to 12 years. Use of Voluven® (hydroxyethyl starch in sodium chloride injection) in children > 12 years is supported by evidence from adequate and well-controlled studies of Voluven® (hydroxyethyl starch in sodium chloride injection) in adults and by data from children < 2 years old. Dosage in children should be adapted to individual patient colloid needs, taking into account underlying disease, hemodynamics and hydration status. [see Pediatric Dose]

Geriatric Use

Of the total number of subjects in clinical studies of Voluven® (hydroxyethyl starch in sodium chloride injection) (N= 471), 32% were 65 years old and older while 7% were 75 and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Renal impairment

Voluven® (hydroxyethyl starch in sodium chloride injection) is mainly excreted by the kidneys, and the risk of adverse reactions may be greater in patients with impaired renal function. Volume status, infusion rate, and urine output should be closely monitored. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection. [see Pharmacokinetics]

Drug Abuse And Dependence

Voluven® (hydroxyethyl starch in sodium chloride injection) is not considered to be a drug of abuse potential.

Last reviewed on RxList: 2/1/2008
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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