Pronunciation:

a-MEE-noe AS-ids, DEX-trose

Brand Names:

• Clinimix

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Parenteral Amino Acids

Chemical—

Amino Acid

Uses of This Medicine:

Amino acids in dextrose injection is used as dietary supplement for patients who are unable to get enough calorie and protein in their diet, usually because of certain illnesses or a recent surgery. It may also be used to treat negative nitrogen balance in the blood.

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of amino acids in dextrose injection in the pediatric population. However, infants and children receiving this medicine are more likely to have serious unwanted effects (including low or high blood sugar, aluminum toxicity, liver problems, or excess ammonia in the blood). 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 amino acids in dextrose injection in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Breast-feeding—

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. 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:

• Acidosis (too much acid in the blood) or
• Errors in amino acid metabolism, inborn or
• Pulmonary edema (fluid in the lungs)—Should not be used in patients with these conditions.

• Diabetes or
• Heart disease or
• Kidney disease—Use with caution. May make these conditions worse.

• Electrolyte imbalance or
• Metabolic disorders, severe—Should be corrected first before using this medicine.

• Hyperglycemia (high blood sugar) worsened by dextrose or
• Weak immune system caused by poor nutrition or other medicines—May increase the risk for infections.

• Undernourished patients, severely—May cause refeeding syndrome. Monitor and increase nutrient intake slowly for the patients.

Proper Use of This Medicine:

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

Precautions While Using This Medicine:

It is very important that your doctor check you or your child closely to make sure that this medicine is working properly. Blood and urine tests are needed to check for unwanted effects.

This medicine may increase your risk for blood clots forming in the lungs or veins. This can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have a cough, chest pain, fast heartbeat, troubled breathing, dizziness, lightheadedness, or fainting, or tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area.

Serious allergic reactions may occur while you are using this medicine. Tell your doctor right away if you have the following symptoms: rapid, shallow breathing, trouble breathing, fast heartbeat, lightheadedness, dizziness, or fainting, nausea or vomiting, rash or itching skin, or a fever or chills.

This medicine may increase your risk of developing infections. Call your doctor right away if you start to have a cough that won't go away, weight loss, night sweats, fever, chills, flu-like symptoms (such as a runny or stuffy nose, headache, blurred vision, or feeling generally ill), painful or difficult urination, or sores, ulcers, or white spots in the mouth or on the lips.

This medicine may affect your blood sugar levels. Check with your doctor right away if you have increased thirst or increased urination. If you notice a change in the results of your urine or blood sugar tests, or if you have any questions, talk with your doctor.

Call your doctor if you have redness, swelling, pain, or infection at the injection site.

This medicine may cause liver problems, including parenteral nutrition associated liver disease (PNALD). This usually occurs in patients who have been receiving parenteral nutrition for a long time, especially preterm infants. Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin.

This medicine may cause electrolyte imbalance, fluid overload, and aluminum toxicity (too much aluminum in the blood). Talk to your doctor if you have concerns.

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

Anxiety

bloating

blurred vision

chest pain

chills

confusion

cough or hoarseness

dark urine

decrease in the amount of urine

dizziness or lightheadedness

dry mouth

extreme thirst

fainting

fast heartbeat

fatigue

fever

flushed, dry skin

fruit-like breath odor

increased hunger

increased thirst

increased urination

light-colored stools

lower back or side pain

nausea

noisy, rattling breathing

pain or redness at the injection site

painful or difficult urination

pale skin at the injection site

seizure

stomach pain

sugar in the urine

sweating

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

tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area

troubled breathing

troubled breathing at rest

unexplained weight loss

urinating large amounts or very little

vomiting

weakness

weight gain

yellow eyes or skin

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.