Enterex Glutapak-10 (Oral)

Glutamine is a substance that the body makes naturally to help control cell growth and function. There are also synthetic versions of this substance. Glutamine is used with human growth hormone and a special diet to treat short bowel syndrome.

Glutamine is also used to lessen the severe complications of sickle cell disease (a blood disorder) in both adults and children.

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

It is very important that your doctor checks your progress at regular visits to ensure that this medicine is working correctly. Blood tests may be needed to look for unwanted effects.

Contact your doctor immediately if you experience pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellowing of the eyes or skin. These could be signs of a serious liver problem.

Do not take any other medicines unless you have talked about them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks of the medicine compared to the benefits it may provide. Here are some important points to think about for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare provider know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

The safety and effectiveness of glutamine for treating short bowel syndrome in children has not been established.

Current studies have not shown any specific problems in children that would limit the usefulness of glutamine for reducing acute complications of sickle cell disease in children 5 years of age and older. The safety and effectiveness of glutamine for reducing acute complications of sickle cell anemia in children younger than 5 years of age has not been established.

Geriatric

Current studies have not shown any specific problems in elderly patients that would limit the usefulness of glutamine. However, older adults are more likely to have age-related issues with their liver, kidneys, or heart, which may require careful consideration and possible dose adjustments for patients taking this medicine.

Breast Feeding

There are no sufficient studies in nursing women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medicine during breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if an interaction could happen. In these cases, your doctor may need to adjust the dose or take other precautions. Inform your healthcare provider if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken with food or specific types of food, as interactions may happen. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare provider about how to take your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Make sure to inform your doctor if you have any other medical issues, especially:

• Liver disease—May worsen this condition.

Along with its necessary effects, a medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor right away 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 require medical attention. These side effects may go away as your body adjusts to the medicine. Also, your healthcare professional may be able to tell you how to prevent or lessen some of these side effects. Check with your healthcare professional if any of the following side effects continue, 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 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 can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

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

Available Dosage Forms:

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

Therapeutic Class: Amino Acid Supplement

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.

• Do athletes need glutamine?