Pronunciation:

HET-a-starch, SOE-dee-um KLOR-ide

Brand Names:

• Hespan

Dosage Forms:

• Solution

Warnings:

Warning: Mortality; Kidney Injury; CoagulopathyUse of hydroxyethylstarch (HES) products, including hetastarch/sodium chloride, increases risk of mortality, kidney injury, and coagulopathy. Do not use hydroxyethylstarch (HES) products, including hetastarch/sodium chloride, unless adequate alternative treatment is unavailable .

Classifications:

Therapeutic—

Volume Expander

Chemical—

Hydroxyethyl Starch

Uses of This Medicine:

Hespan® injection is used to treat low blood volume (hypovolemia) when other treatment is not available. It is also used in a procedure called leukapheresis.

This medicine is to be given only by or under the supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies on the relationship of age to the effects of Hespan® injection have not been performed in the pediatric population. Safety and efficacy have not been established.

Older adults—

No information is available on the relationship of age to the effects of Hespan® injection in geriatric patients.

Breast-feeding—

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to corn starch or
• Heart or blood vessel disease or
• Kidney disease or
• Liver disease—Use with caution. May make these conditions worse.

• Heart bypass—Use in not recommended in patients undergoing this surgery.

• Infection (eg, sepsis), severe or
• Surgery or
• Trauma—Use with caution. May increase the risk for serious kidney problems.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is given as a needle placed into one of your veins.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely while receiving the medicine to make sure it is working properly. Blood and urine tests are needed to check for unwanted effects.

Call your doctor right away if you have bloody or cloudy urine, difficult or painful urination, sudden increase or decrease in the amount of urine, or swelling of the face, feet, or lower legs. These may be symptoms of a serious kidney problem.

Check with your doctor right away if you have black, tarry stools, blood in the urine or stools, headache, dizziness, or weakness, pain, swelling, or discomfort in a joint, pinpoint red spots on your skin, unusual nosebleeds, or any unusual bleeding or bruising.

This medicine may cause a serious allergic reaction, called anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing or swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Incidence not known

Bloody or cloudy urine

blue lips and fingernails

blurred vision

chest pain, discomfort, or tightness

confusion

cough

coughing that sometime produces a pink frothy sputum

decreased urine output

difficult or painful urination

difficulty swallowing

dilated neck veins

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

drowsiness

fainting

fast, slow, or irregular heartbeat or pulse

fever

hives, itching, skin rash

increased sweating

large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

muscle tremors

nausea

noisy breathing

no blood pressure or pulse

pale skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

rapid shallow breathing

restlessness

sneezing

stomach cramps

stopping of the heart

sudden increase or decrease in the amount of urine

sweating

swelling around the eyes

swelling in the legs and ankles

swelling of the face, fingers, feet, or lower legs

unconsciousness

unusual bleeding or bruising

unusual tiredness or weakness

weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

Chills

diarrhea

general feeling of discomfort or illness

headache

joint pain

muscle aches and pains

runny nose

shivering

sore throat

tingling of the feet

trouble sleeping

unusual weight gain or loss

vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.