Glutamine (Endari) is a "conditionally essential" amino acid that is required in times of stress and deficiency. It is especially important for gastrointestinal health and is used to treat patients with short bowel syndrome. It also affects the oxidative pathway and is used in the treatment of acute sickle cell crisis in combination with hydroxyurea and other medicines.

Glutamine Uses:

• Short bowel syndrome (NutreStore):

  • Glutamine is used for the management of short bowel syndrome in patients receiving specialized nutrition. If and when it is used in conjunction with a recombinant growth hormone that is approved for this purpose.

• Sickle cell disease (Endari only):

  • This glutamine can also be used to alleviate acute complications of sickle cell disease in adults and children greater than 5 years of age.
  • In the clinical trial conducted, Endari was used for the prevention of vaso-occlusive pain crisis in patients with more frequent episodes (≥2 in the last year), either as an adjunct to hydroxyurea or as an alternative in patients unable to tolerate hydroxyurea.

• Supplement (nutritional):

  • It can be used as a medical food component to promote Gastrointestinal healing and can be used as nutritional support in patients with AIDS, malignancy, and other critical illnesses.

Note:

• Medical food is made to be administered enterally under the supervision of a physician or a dietician and is intended for the targeted dietary management of a disease or illness for which particular nutritional requirements are established via expert evaluation.
• These are not drugs and, hence, are not subject to any FDA approval that characteristically applies to drugs (eg, the requirement for written/oral prescription prior to dispensing, premarket review or approval, proof of safety and efficacy).

Glutamine (Endari) Dose in Adults

Glutamine (Endari) Dose in the treatment of Short bowel syndrome:

• NutreStore:
  • Orally it can be given as 30 g/day administered as 5 g, 6 times daily for up to 4 months.
  • It can be used in combination with growth hormone and nutritional support in patients.

Glutamine (Endari) Dose in the treatment of Sickle cell disease :

• Endari: Oral:
• Note: In patients with sickle cell disease only the brand name Endari can be used and other products from other brands should be avoided.

Prevention of vaso-occlusive pain in patients with frequent episodes (≥2 in the prior year), either as an adjunct to hydroxyurea or as an alternative in patients unable to tolerate hydroxyurea:

• <30 kg:
  • 5 g (1 packet) twice a day (total dose 10 g/day)
• 30 to 65 kg:
  • 10 g (2 packets) twice a day (total dose 20 g/day)
• >65 kg:
  • 15 g (3 packets) twice a day (total dose 30 g/day)

Supplement (nutritional):

• GlutImmune, GlutaMent, GlutaSolve, Glutapak-10, Sympt-X: Oral:
  • Its average dose is 10 g 3 times/day with a range of 5 to 30 g/day
• Glutamine (capsules):
  • Orally 500 mg daily

Glutamine (Endari) Dose in Childrens

Glutamine (Endari) Dose in the treatment of Sickle cell disease: Endari: Oral:

Note:

• Only the Endari brand/formulation is approved for the management of pain crisis in sickle cell disease (SCD).
• Avoid the use of other glutamine formulations for a pain crisis.

Prevention of vaso-occlusive pain episodes in patients with frequent episodes (≥2 in the prior year), either as an adjunct to hydroxyurea or as an alternative in patients unable to tolerate hydroxyurea:

• <30 kg:
  • 5 g (1 packet) twice a day (max dose 10 g/day)
• 30 to 65 kg:
  • 10 g (2 packets) twice a day (max dose 20 g/day)
• >65 kg:
  • 15 g (3 packets) twice a day (max dose 30 g/day)

Supplement (nutritional):

• Sympt-X:
  • Orally it can be given 0.25 to 0.5 g/kg/day given in 3 divided doses

Pregnancy Risk Factor C

• Animal reproduction studies have not been done yet.
• Endogenous glutamine in cord blood can be detected in lower concentrations in infants born at low birth weights.

Glutamine use during breastfeeding:

• Breastfeeding women should not consume glutamine.
• Breast milk is known to secrete glutamine endogenously.
• During lactation, the amount of breast milk total protein and free amin acids varies. 
• We don't know yet what the effects of the recommended glutamine dose.

Dose in Kidney disease:

No dose adjustments are given in labeling however caution is advised in kidney diseases.

Dose in Liver disease:

Caution is advised in liver disease however no specific adjustments are provided by the manufacturer.

Common Side Effects of Glutamine (Endari):

• Cardiovascular:

  • Chest Pain

• Central Nervous System:

  • Headache

• Gastrointestinal:

  • Flatulence
  • Constipation
  • Nausea
  • Abdominal Pain

• Neuromuscular & Skeletal:

  • Limb Pain
  • Back Pain

• Respiratory:

  • Cough

Glutamine (Endari) Uncommon Side effects:

• Cardiovascular:

  • Peripheral Edema
  • Vascular Disease

• Central Nervous System:

  • Chills
  • Depression
  • Hypoesthesia
  • Insomnia
  • Pain

• Dermatologic:

  • Nail Disease
  • Pruritus
  • Skin Rash

• Endocrine & Metabolic:

  • Dehydration
  • Increased Thirst

• Gastrointestinal:

  • Abdominal Distention
  • Crohn Disease
  • Gastric Ulcer
  • Gastrointestinal Fistula
  • Hemorrhoids
  • Pancreatitis
  • Tenesmus
  • Vomiting
  • Xerostomia

• Genitourinary:

  • Fungal Vaginosis
  • Mastalgia

• Hepatic:

  • Hepatic Insufficiency

• Hypersensitivity:

  • Hypersensitivity Reaction

• Infection:

  • Bacterial Infection
  • Infection
  • Viral Infection

• Local:

  • Injection Site Reaction

• Neuromuscular & Skeletal:

  • Myalgia

• Respiratory:

  • Flu-Like Symptoms
  • Laryngitis
  • Pharyngitis
  • Rhinitis

• Renal:

  • Nephrolithiasis
  • Pyelonephritis

• Miscellaneous:

  • Fever

Contraindications to Glutamine (Endari):

Endari, NutreStore - There are no specific contraindications.

OTC labelingIt is not recommended for severe renal or liver impairment Reye Syndrome, shock, and multiorgan failure.

Warnings and precautions

• Hepatic impairment

  • Patients with hepatic impairment should exercise caution.

• Renal impairment

  • Patients with impaired renal function should exercise caution.

Glutamine (including L-glutamine [pharmaceutical grade] and supplements): Drug Interaction

Monitoring parameters:

Renal function tests and liver function tests.

How to administer Glutamine (Endari)?

Endari:

• It can be given by Mixing each dose with 240 mL of room temperature beverage (eg, water, milk, apple juice) or with 120 to 180 mL of food (eg, applesauce or yogurt).
• A clear solution is not required before administration but should be prepared instantly before giving this to the patient.

GlutaMent:

• Mix each 10 g packet with 120 to 180 mL water. It should be used within 30 minutes of mixing. Do not mix with very hot liquids.
• May also add to pudding, or yogurt. For mucositis, mix each 10 g packet with 120 mL water and administer it using a swish-and-swallow technique.
• If administering via feeding tube, mix with 60 mL water and flush the tubing with 30 mL water before and after administration. Do not mix directly with enteral formula.

Glutapak-10:

• Before administration, mix with 60 to 120 mL liquid or semisolid food.
• If administering via feeding tube, mix each 10 g packet with 60 to 120 mL water, and flush feeding tube before and after administration and should be used immediately after preparation.

GlutaSolve:

• Mix each 15 g packet with 120 mL water. May also be mixed in hot or cold beverages, applesauce, or pudding.
• If administering via feeding tube, mix with 60 to 120 mL warm water.
• The minimum tube size required is 8 Fr. Flush the tube before and after giving the diet.  Do not mix directly with enteral formula.

GlutImmune:

• It can be mixed with cold and hot beverages..

NutreStore:

• Mix each packet (5 g) with ~250 mL water prior to administration. This may vary the volume of water according to the patient's preference.
• Administer with food or snacks every 2 to 3 hours while awake. If transient intolerance to oral intake, the administration can be delayed up to 2 hours.

Sympt-X:

• It should be Mixed as a dose with 180 to 240 mL of water, juice, or another beverage.
• It can also be mixed with semi-solid foods such as yogurt or smoothie. Use immediately after preparation. May administer via a feeding tube.

Mechanism of action of Glutamine (Endari):

• Glutamine is responsible for controlling GI cell function and growth. 
• Glutamine can be considered an "essential" amino acid in times of metabolic stress or injury.
• It is the precursor to nicotinamide dinucleotide. NAD and its reduced version, NADH, play a key role in sickle cell disease.
• The ratio of NADH and total NAD in sickle red blood cells is lower which leads to a decrease in NAD redox potency.
• It can increase NAD redox potency in sickle red cells by increasing the availability and concentration of reduced glutathione.

Metabolism:

• Hepatic metabolism to glutamate and ammonia

Half-life elimination:

• Adults (healthy): IV: ~1 hour

Time to peak, serum:

• Adults (healthy): ~30 minutes

International Brand Names of Glutamine:

• Endari
• GlutaMent
• Glutasolve
• GlutImmune
• NutreStore
• Sympt-X
• Adamin-G
• An Kai Shu
• Convales
• Diamin
• Glutamin
• Glutapak-10
• Glutapure
• Glutaven
• Glutrop
• Pure Warrior Powered By Swisse
• Shi Lin
• Xin Kun Chang
• Xin Mai Lin

Glutamine Brand Names in Pakistan: