Hydroxyethyl starch: Difference between revisions

Hydroxyethyl starch
	Black Box Warning
	Adult Indications & Dosage
	Pediatric Indications & Dosage
	Contraindications
	Warnings & Precautions
	Adverse Reactions
	Drug Interactions
	Use in Specific Populations
	Administration & Monitoring
	Overdosage
	Pharmacology
	Clinical Studies
	How Supplied
	Images
	Patient Counseling Information
	Precautions with Alcohol
	Brand Names
	Look-Alike Names

VisualWikitext

Revision as of 14:52, 23 April 2015

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

Disclaimer

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Black Box Warning

WARNING:

See full prescribing information for complete Boxed Warning.

MORTALITY RENAL REPLACEMENT THERAPY:

In critically ill adult patients, including patients with sepsis, use of hydroxyethyl starch (HES) products, including Voluven®, increases risk of

Mortality Renal replacement therapy

Do not use HES products, including Voluven®, in critically ill adult patients, including patients with sepsis.

Overview

Hydroxyethyl starch is a plasma volume substitute that is FDA approved for the treatment of hypovolemia in adults and children. There is a Black Box Warning for this drug as shown here. Common adverse reactions include pruritus, elevated serum amylase, hemodilution.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Voluven® (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection) is indicated for the treatment and prophylaxis of hypovolemia in adults and children. It is not a substitute for red blood cells or coagulation factors in plasma.

Dosage

Voluven® is administered by intravenous infusion only. The daily dose and rate of infusion depend on the patient’s blood loss, on the maintenance or restoration of hemodynamics and on the hemodilution (dilution effect). Voluven® can be administered repetitively over several days. [see WARNINGS AND PRECAUTIONS (5)]

The initial 10 to 20 mL should be infused slowly, keeping the patient under close observation due to possible anaphylactoid reactions. [see GENERAL WARNINGS AND PRECAUTIONS (5.1)]

2.1 Adult Dose Up to 50 mL of Voluven® per kg of body weight per day (equivalent to 3 g hydroxyethyl starch and 7.7 mEq sodium per kg of body weight). This dose is equivalent to 3500 mL of Voluven® for a 70 kg patient.

Directions for Use of Voluven

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Hydroxyethyl starch in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Hydroxyethyl starch in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Indications

Voluven® (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection) is indicated for the treatment and prophylaxis of hypovolemia in adults and children. It is not a substitute for red blood cells or coagulation factors in plasma.

Dosage

The dosage in children should be adapted to the individual patient colloid needs, taking into account the disease state, as well as the hemodynamic and hydration status.

In 41 newborns to infants (< 2 years), a mean dose of 16 ± 9 mL/kg was administered. In 31 children from 2 to 12 years of age a mean dose of 36 ± 11 mL/kg was administered. The dose in adolescents > 12 is the same as the adult dose.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Hydroxyethyl starch in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Hydroxyethyl starch in pediatric patients.

Contraindications

Condition1

Warnings

WARNING:

See full prescribing information for complete Boxed Warning.

MORTALITY RENAL REPLACEMENT THERAPY:

In critically ill adult patients, including patients with sepsis, use of hydroxyethyl starch (HES) products, including Voluven®, increases risk of

Mortality Renal replacement therapy

Do not use HES products, including Voluven®, in critically ill adult patients, including patients with sepsis.

Description

Precautions

Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Hydroxyethyl starch in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Hydroxyethyl starch in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

Drug

Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

Pregnancy Category

Pregnancy Category (AUS):

Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Hydroxyethyl starch in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Hydroxyethyl starch during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Hydroxyethyl starch with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Hydroxyethyl starch with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Hydroxyethyl starch with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Hydroxyethyl starch with respect to specific gender populations.

Race

There is no FDA guidance on the use of Hydroxyethyl starch with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Hydroxyethyl starch in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Hydroxyethyl starch in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Hydroxyethyl starch in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Hydroxyethyl starch in patients who are immunocompromised.

Administration and Monitoring

Administration

Oral

Intravenous

Monitoring

There is limited information regarding Monitoring of Hydroxyethyl starch in the drug label.

Description

IV Compatibility

There is limited information regarding IV Compatibility of Hydroxyethyl starch in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

Description

Management

Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Hydroxyethyl starch in the drug label.

Pharmacology

There is limited information regarding Hydroxyethyl starch Pharmacology in the drug label.

Mechanism of Action

Structure

File:Hydroxyethyl starch01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Hydroxyethyl starch in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Hydroxyethyl starch in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Hydroxyethyl starch in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Hydroxyethyl starch in the drug label.

How Supplied

Storage

There is limited information regarding Hydroxyethyl starch Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Hydroxyethyl starch |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Hydroxyethyl starch |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Hydroxyethyl starch in the drug label.

Precautions with Alcohol

Alcohol-Hydroxyethyl starch interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

®^[1]

Look-Alike Drug Names

A® — B®^[2]

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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[1] Empty citation (help)

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[1]

[2]

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+*  In critically ill adult patients, including patients with sepsis, use of hydroxyethyl starch (HES) products, including Voluven®, increases risk of
+Mortality
+Renal replacement therapy
+Do not use HES products, including Voluven®, in critically ill adult patients, including patients with sepsis.
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+Voluven® (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection) is indicated for the treatment and prophylaxis of hypovolemia in adults and children. It is not a substitute for red blood cells or coagulation factors in plasma.
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+Voluven® is administered by intravenous infusion only.  The daily dose and rate of infusion depend on the patient’s blood loss, on the maintenance or restoration of hemodynamics and on the hemodilution (dilution effect). Voluven® can be administered repetitively over several days. [see WARNINGS AND PRECAUTIONS (5)]
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+The initial 10 to 20 mL should be infused slowly, keeping the patient under close observation due to possible anaphylactoid reactions. [see GENERAL WARNINGS AND PRECAUTIONS (5.1)]
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+Up to 50 mL of Voluven® per kg of body weight per day (equivalent to 3 g hydroxyethyl starch and 7.7 mEq sodium per kg of body weight). This dose is equivalent to 3500 mL of Voluven® for a 70 kg patient.
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+Voluven® (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection) is indicated for the treatment and prophylaxis of hypovolemia in adults and children. It is not a substitute for red blood cells or coagulation factors in plasma.
-* Dosing Information
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-* Developed by:
-* Class of Recommendation:
+====Dosage====
+The dosage in children should be adapted to the individual patient colloid needs, taking into account the disease state, as well as the hemodynamic and hydration status.
-* Strength of Evidence:
+In 41 newborns to infants (< 2 years), a mean dose of 16 ± 9 mL/kg was administered.  In 31 children from 2 to 12 years of age a mean dose of 36 ± 11 mL/kg was administered.  The dose in adolescents  > 12 is the same as the adult dose.
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