Pronunciation:

KAL-see-um KLOR-ide, DEX-trose, HET-a-starch, mag-NEE-zee-um KLOR-ide, poe-TAS-ee-um KLOR-ide, SOE-dee-um KLOR-ide, SOE-dee-um LAK-tate

Brand Names:

• Hextend

Dosage Forms:

• Solution

Warnings:

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

Classifications:

Therapeutic—

Volume Expander

Chemical—

Hydroxyethyl Starch

Uses of This Medicine:

Hextend® injection is used to treat low blood volume (hypovolemia) when other treatment is not available.

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 Hextend® injection have not been performed in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Hextend® injection in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults and are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Breast-feeding—

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

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while 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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Eplerenone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alacepril
• Amiloride
• Baloxavir Marboxil
• Benazepril
• Bictegravir
• Canrenoate
• Captopril
• Cilazapril
• Delapril
• Digoxin
• Eltrombopag
• Erdafitinib
• Fosinopril
• Imidapril
• Indomethacin
• Lisinopril
• Moexipril
• Pentopril
• Perindopril
• Quinapril
• Raltegravir
• Ramipril
• Sparsentan
• Spirapril
• Spironolactone
• Temocapril
• Trandolapril
• Triamterene
• Zofenopril

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Chlorothiazide
• Delafloxacin
• Felodipine
• Isradipine
• Licorice
• Nicardipine
• Strontium Ranelate

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:

• Alkalosis (high pH levels in the blood) or
• Allergy to corn or
• Diabetes or
• Heart or blood vessel disease or
• Hyperkalemia (high potassium levels in the blood) or
• Kidney disease, severe—Use with caution. May make these conditions worse.

• Heart bypass—May increase the risk for bleeding in patients undergoing this surgery.

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

• Leukapheresis—Use in not recommended in patients undergoing this procedure.

• Liver disease, severe—Use with caution. May increase the risk for serious side effects.

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.

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.

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.

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

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.