Calcium chloride/dextrose/hetastarch/magnesium chloride/potassium chloride/sodium chloride/sodium lactate (Intravenous)

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

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

It is very important that your doctor monitors your progress closely while you are receiving the medicine to ensure 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, difficulty or pain while urinating, a sudden increase or decrease in the amount of urine, or swelling of the face, feet, or lower legs. These may be signs of a serious kidney problem.

This medicine may cause a serious allergic reaction, called anaphylaxis, which can be life-threatening and needs 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 your 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 you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor will consider the risks of taking the medicine against the benefits it may provide. The following points should be considered for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies on the effects of Hextend® injection in children have not been conducted. Safety and effectiveness have not been proven for this age group.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the use of Hextend® injection. However, older patients may react more strongly to this medicine than younger adults and may have kidney issues related to age, which could require careful monitoring and possible dose adjustments for those receiving this medicine.

Breast Feeding

Research in women indicates that this medicine poses minimal risk to infants while breastfeeding.

There are no sufficient studies in women to determine the risk to infants when using this medicine during breastfeeding. Consider the potential benefits against the risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if there is a chance of interaction. In such cases, your doctor might adjust the dose or take other precautions. When you are receiving this medicine, it is very important for your healthcare professional to know if you are taking any of the following medicines. The following interactions have been highlighted for their potential importance but are not an exhaustive list.

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

• Eplerenone

Using this medicine with any of the following medicines is generally not recommended, but may be necessary in some situations. If both medicines are prescribed, your doctor may adjust the dose or frequency of one or both 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 increase the risk of certain side effects, but using both may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both of the medicines.

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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken when eating food or certain types of food due to potential interactions. Using alcohol or tobacco with some medicines may also cause interactions. Talk to your healthcare professional about using this medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may influence the use of this medicine. Be sure to inform your doctor if you have any other medical issues, 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
• Severe kidney disease—Use with caution. May worsen these conditions.

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

• Severe infection (e.g., sepsis) or
• Surgery or
• Trauma—Use with caution. May increase the risk of serious kidney problems.

• Leukapheresis—Use is not recommended for patients undergoing this procedure.

• Severe liver disease—Use with caution. May increase the risk of serious side effects.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do, 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 sometimes 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 healthcare professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your healthcare 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.

In the U.S.

• Hextend

Available Dosage Forms:

• Solution

Therapeutic Class: Volume Expander

Chemical Class: Hydroxyethyl Starch

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.