Description
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:
- Tablet
- Powder
- Capsule
- Powder for Solution
- Packet
- 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.
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 short bowel syndrome:
- 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.
- For sickle cell disease:
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
- 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.
DRG-20064099
