Description and Brand Names

Drug information provided by: IBM Micromedex

US Brand Name

  1. Enterex Glutapak-10
  2. Resource Glutasolve
  3. Sympt-X
  4. Sympt-X GI

Descriptions


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.

This product is available in the following dosage forms:

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

Before Using

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.

Pediatric

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.

Geriatric

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.

Pregnancy

Information about this glutamine-oral-route
Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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.

Drug Interactions

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

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

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

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

  1. Blood in urine
  2. changes in skin color
  3. chills
  4. cold hands and feet
  5. confusion
  6. cough
  7. difficulty swallowing
  8. dizziness
  9. fainting
  10. fast heartbeat
  11. fever
  12. frequent and painful urination
  13. headache
  14. hives, itching, skin rash
  15. lightheadedness
  16. lower back or side pain
  17. pain, redness, or swelling in the arm or leg
  18. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  19. rapid, shallow breathing
  20. stomach pain
  21. sudden decrease in amount of urine
  22. tightness in the chest
  23. 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

  1. Cough or hoarseness
  2. frequent urge to have a bowel movement
  3. straining while passing stool

Less common

  1. Abnormal or decreased touch sensation
  2. back pain
  3. bacterial infection
  4. bleeding after having a bowel movement
  5. body aches or pain
  6. breast pain in females
  7. chest pain
  8. change in the color, amount, or odor of vaginal discharge
  9. congestion
  10. constipation
  11. dark urine
  12. decreased urination
  13. diarrhea
  14. difficulty having a bowel movement
  15. difficulty in moving
  16. discoloration of the fingernails or toenails
  17. discouragement
  18. dry mouth
  19. dryness or soreness of the throat
  20. ear or hearing symptoms
  21. excess air or gas in the stomach or intestines
  22. feeling sad or empty
  23. feeling unusually cold, shivering
  24. full or bloated feeling
  25. general feeling of discomfort or illness
  26. increased heart rate
  27. indigestion
  28. irritability
  29. joint pain
  30. lack of appetite
  31. light-colored stools
  32. loss of appetite
  33. loss of interest or pleasure
  34. muscle aches and pains
  35. muscle pain or stiffness
  36. nausea
  37. pain or burning feeling while urinating
  38. pains in the stomach, side, or abdomen, possibly radiating to the back
  39. passing gas
  40. pressure in the stomach
  41. rectal bleeding
  42. runny nose
  43. sneezing
  44. stomach bloating, burning, cramping, or pain
  45. stuffy nose
  46. sunken eyes
  47. sweating
  48. swelling of the face
  49. swelling of the hands, ankles, feet, or lower legs
  50. swelling of the stomach area
  51. swollen joints
  52. tender, swollen glands in the neck
  53. thirst
  54. trouble concentrating
  55. trouble sleeping
  56. trouble in swallowing
  57. uncomfortable swelling around the anus
  58. unpleasant breath odor
  59. unusual tiredness or weakness
  60. voice changes
  61. vomiting
  62. vomiting of blood
  63. weight loss
  64. wrinkled skin
  65. 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.