Pronunciation:

GLOO-ta-meen

Brand Names:

• Endari
• Enterex Glutapak-10
• Resource Glutasolve
• Sympt-X
• Sympt-X G.I.

Dosage Forms:

• Tablet
• Powder
• Capsule
• Powder for Solution
• Packet
• Powder for Suspension

Classifications:

Therapeutic—

Amino Acid Supplement

Uses of This Medicine:

Glutamine is a substance naturally produced in the body to help regulate cell growth and function. There may also be man-made versions of these substances. Glutamine is used together with human growth hormone and a specialized diet to treat short bowel syndrome.

Glutamine is also used to reduce the acute complications of sickle cell disease (blood disorder) in adults and children.

This medicine is available only with your doctor's prescription.

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—

Safety and efficacy of glutamine to treat short bowel syndrome in children has not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of glutamine to reduce acute complications of sickle cell disease in children 5 years of age and older. Safety and efficacy of glutamine to reduce acute complications of sickle cell anemia in children younger than 5 years of age has not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of glutamine 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:

• Liver disease—May make this condition worse.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

For patients using the oral powder for solution:

• Mix a packet of this medicine with water just before using it.
• Take it with a meal or snack every 2 to 3 hours while you are awake. Be sure to drink all of the mixture.
• Do not use the medicine during the night unless your doctor tells you to.

For patients using the oral powder:

• Mix the oral powder with 4 to 6 ounces (oz) of food (eg, applesauce, yogurt) or 8 oz of cold or room temperature beverage (eg, water, milk, or apple juice). Complete dissolution of the mixture is not required.
• Be sure to drink or swallow all of the mixture.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (powder for oral solution):
  • For short bowel syndrome:
    • Adults—30 grams (g) per day in divided doses (5 g taken 6 times a day) for up to 16 weeks. Taken with meals or snacks, 2 to 3 hours apart while awake.
    • Children—Use and dose must be determined by your doctor.
• For oral dosage form (oral powder):
  • For sickle cell disease:
    • Adults and children 5 years of age and older and weighs greater than 65 kilograms (kg)—15 grams (g) per dose (3 packets per dose) 2 times a day or 30 g per day (6 packets per day).
    • Adults and children 5 years of age and older and weighs 30 to 65 kg—10 g per dose (2 packets per dose) 2 times a day or 20 g per day (4 packets per day).
    • Children 5 years of age and older and weighs less than 30 kg—5 g per dose (1 packet per dose) 2 times a day or 10 g per day (2 packets per day).
    • Children younger than 5 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

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. These could be symptoms of a serious liver problem.

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 immediately if any of the following side effects occur:

Less common

Blood in urine

changes in skin color

chills

cold hands and feet

confusion

cough

difficulty swallowing

dizziness

fainting

fast heartbeat

fever

frequent and painful urination

headache

hives, itching, skin rash

lightheadedness

lower back or side pain

pain, redness, or swelling in the arm or leg

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

rapid, shallow breathing

stomach pain

sudden decrease in amount of urine

tightness in the chest

unusual tiredness or weakness

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:

More common

Cough or hoarseness

frequent urge to have a bowel movement

straining while passing stool

Less common

Abnormal or decreased touch sensation

back pain

bacterial infection

bleeding after having a bowel movement

body aches or pain

breast pain in females

chest pain

change in the color, amount, or odor of vaginal discharge

congestion

constipation

dark urine

decreased urination

diarrhea

difficulty having a bowel movement

difficulty in moving

discoloration of the fingernails or toenails

discouragement

dry mouth

dryness or soreness of the throat

ear or hearing symptoms

excess air or gas in the stomach or intestines

feeling sad or empty

feeling unusually cold, shivering

full or bloated feeling

general feeling of discomfort or illness

increased heart rate

indigestion

irritability

joint pain

lack of appetite

light-colored stools

loss of appetite

loss of interest or pleasure

muscle aches and pains

muscle pain or stiffness

nausea

pain or burning feeling while urinating

pains in the stomach, side, or abdomen, possibly radiating to the back

passing gas

pressure in the stomach

rectal bleeding

runny nose

sneezing

stomach bloating, burning, cramping, or pain

stuffy nose

sunken eyes

sweating

swelling of the face

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

swelling of the stomach area

swollen joints

tender, swollen glands in the neck

thirst

trouble concentrating

trouble sleeping

trouble in swallowing

uncomfortable swelling around the anus

unpleasant breath odor

unusual tiredness or weakness

voice changes

vomiting

vomiting of blood

weight loss

wrinkled skin

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.