Pronunciation:

a-MEE-noe AS-ids, SOE-dee-um AS-e-tate, SOE-dee-um KLOR-ide

Classifications:

Chemical—

Amino Acid

Uses of This Medicine:

Amino acids injection is used for nutritional support of newborn babies (including babies with low birth weight) and children requiring total parenteral nutrition (TPN). It may also be used to treat negative nitrogen balance in the blood. This medicine may be also used together with dextrose to provide a more complete profile of amino acids for protein synthesis.

This medicine is to be given only by or under the direct 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 injection in children. However, children are more likely to have kidney problems, infections, or low birth weight, which may require caution in patients receiving this medicine.

Older adults—

Appropriate studies on the relationship of age to the effects of amino acids injection have not been performed in the geriatric population. However, elderly patients are more likely to have electrolyte imbalance, which may require caution in 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.

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:

• Acid-base imbalance or
• Electrolyte imbalance or
• Ketonemia (ketones in the blood)—Should be corrected first before receiving this medicine.

• Anuria (unable to pass urine), untreated or
• Coma caused by severe liver disease or
• Errors of amino acid metabolism, inborn—Should not be used in patients with these conditions.

• Diabetes or
• Heart disease or
• Hyperammonemia (high ammonia levels in the blood) or
• Liver disease or
• Stomach or bowel problems—Use with caution. May make these conditions worse.

• Kidney disease—Giving this medicine for a long time in preterm babies may increase risk for aluminum toxicity.

Proper Use of This Medicine:

A nurse or other trained health professional will give you or your child this medicine in a medical facility. Trophamine® is added to your or your baby's TPN bag. After mixing, it is given through a needle placed in one of your or your baby's veins.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly. Blood and urine tests will be needed to check for unwanted effects.

Tell your doctor if you or your child develop pain, tenderness, changes in skin color, or swelling of foot or leg after receiving this medicine. These could be symptoms of a vein damage or thrombophlebitis.

This medicine may cause electrolyte imbalance, fluid overload, aluminum toxicity (too much aluminum in the blood), ketonemia (too much ketones in the blood), metabolic acidosis (too much acid in your blood), and hyperammonemia (too much ammonia in your blood), which may damage the brain and can be life-threatening. 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

Bloating or swelling of the face, arms, hands, lower legs, or feet

blue lips and fingernails

blurred vision

chest pain

confusion

cough or hoarseness

coughing that sometimes produces a pink frothy sputum

drowsiness

dry mouth

fever or chills

flushed, dry skin

fruit-like breath odor

increased hunger

increased sweating

increased thirst

increased urination

irregular heartbeat

loss of appetite

loss of consciousness

lower back or side pain

muscle cramps, pain, or tremors

nausea or vomiting

numbness, tingling, pain, or weakness in the hands or feet

painful or difficult urination

pale skin

rapid, deep breathing

restlessness

seizures

stomach cramps or pain

trouble breathing

unusual tiredness or weakness

unusual weight gain or loss

weakness and heaviness of the legs

yellow eyes or skin

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

Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

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.