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DRUGS & SUPPLEMENTS
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Esaglut
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Esaglut uses
Esaglut consists of Calcium (Calcium Fructose-1,6-Diphosphate), Glutamine, Vitamin B1 (Thiamine Nitrate), Vitamin B5 (Calcium Pantothenate), Vitamin B6 (Pyridoxine Hydrochloride).Calcium (Calcium Fructose-1,6-Diphosphate):
- Indications and usage
- Dosage and administration
- Dosage forms and strengths
- Contraindications
- Warnings and precautions
- Adverse reactions
- Drug interactions
- Use in specific populations
- Overdosage
- Description
- Clinical pharmacology
- Nonclinical toxicology
- Clinical studies
- How supplied/storage and handling
- Patient counseling information
1 INDICATIONS AND USAGE
Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD).
- Calcium acetate is a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease. (1)
2 DOSAGE AND ADMINISTRATION
The recommended initial dose of Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate for the adult dialysis patient is 2 capsules with each meal. Increase the dose gradually to lower serum phosphorus levels to the target range, as long as hypercalcemia does not develop. Most patients require 3 to 4 capsules with each meal.
- Starting dose is 2 capsules with each meal. (2)
- Titrate the dose every 2 to 3 weeks until acceptable serum phosphorus level is reached. Most patients require 3 to 4 capsules with each meal. (2)
3 DOSAGE FORMS AND STRENGTHS
Capsule: 667 mg Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate capsule.
- Capsule: 667 mg Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate capsule. (3)
4 CONTRAINDICATIONS
Patients with hypercalcemia.
- Hypercalcemia. (4)
5 WARNINGS AND PRECAUTIONS
- Treat mild hypercalcemia by reducing or interrupting Esaglut ) acetate and Vitamin D. Severe hypercalcemia may require hemodialysis and discontinuation of Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate. (5.1)
- Hypercalcemia may aggravate digitalis toxicity. (5.2)
5.1 Hypercalcemia
Patients with end stage renal disease may develop hypercalcemia when treated with Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)), including Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate. Avoid the use of Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) supplements, including Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) based nonprescription antacids, concurrently with Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate.
An overdose of Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate may lead to progressive hypercalcemia, which may require emergency measures. Therefore, early in the treatment phase during the dosage adjustment period, monitor serum Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) levels twice weekly. Should hypercalcemia develop, reduce the Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate dosage, or discontinue the treatment, depending on the severity of hypercalcemia
More severe hypercalcemia (Ca >12 mg/dL) is associated with confusion, delirium, stupor and coma. Severe hypercalcemia can be treated by acute hemodialysis and discontinuing Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate therapy.
Mild hypercalcemia (10.5 to 11.9 mg/dL) may be asymptomatic or manifest as constipation, anorexia, nausea, and vomiting. Mild hypercalcemia is usually controlled by reducing the Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate dose or temporarily discontinuing therapy. Decreasing or discontinuing Vitamin D therapy is recommended as well.
Chronic hypercalcemia may lead to vascular calcification and other soft-tissue calcification. Radiographic evaluation of suspected anatomical regions may be helpful in early detection of soft tissue calcification. The long term effect of Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate on the progression of vascular or soft tissue calcification has not been determined.
Hypercalcemia (>11 mg/dL) was reported in 16% of patients in a 3 month study of solid dose formulation of Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate; all cases resolved upon lowering the dose or discontinuing treatment.
Maintain the serum calcium-phosphorus (Ca x P) product below 55 mg2/dL2.
5.2 Concomitant Use with Medications
Hypercalcemia may aggravate digitalis toxicity.
6 ADVERSE REACTIONS
Hypercalcemia is discussed elsewhere [see Warnings and Precautions ].
- The most common (>10%) adverse reactions are hypercalcemia, nausea and vomiting. (6.1)
- In clinical studies, patients have occasionally experienced nausea during Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate therapy. (6)
To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-800-962-8364 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
6.1 Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In clinical studies, Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate has been generally well tolerated.
Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate was studied in a 3 month, open-label, non-randomized study of 98 enrolled ESRD hemodialysis patients and an alternate liquid formulation of Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate was studied in a two week double-blind, placebo-controlled, cross-over study with 69 enrolled ESRD hemodialysis patients. Adverse reactions (>2% on treatment) from these trials are presented in Table 1.
| Preferred Term | Total adverse reactions reported for Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate N=167 N (%) | 3 month, open label study of Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate N=98 N (%) | Double blind, placebo-controlled, cross-over study of liquid Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate N=69 | |
| Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate N (%) | Placebo N (%) | |||
| Nausea | 6 (3.6) | 6 (6.1) | 0 (0) | 0 (0) |
| Vomiting | 4 (2.4) | 4 (4.1) | 0 (0) | 0 (0) |
| Hypercalcemia | 21 (12.6) | 16 (16.3) | 5 (7.2) | 0 (0) |
Mild hypercalcemia may be asymptomatic or manifest itself as constipation, anorexia, nausea, and vomiting. More severe hypercalcemia is associated with confusion, delirium, stupor, and coma. Decreasing dialysate Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) concentration could reduce the incidence and severity of Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate-induced hypercalcemia. Isolated cases pruritus have been reported, which may represent allergic reactions.
6.2 Postmarketing Experience
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or to establish a causal relationship to drug exposure.
The following additional adverse reactions have been identified during post-approval of Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate: dizziness, edema, and weakness.
7 DRUG INTERACTIONS
The drug interaction of Esaglut ) acetate is characterized by the potential of Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) to bind to drugs with anionic functions (e.g., carboxyl, and hydroxyl groups). Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate may decrease the bioavailability of tetracyclines or fluoroquinolones via this mechanism.
There are no empirical data on avoiding drug interactions between Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate and most concomitant drugs. When administering an oral medication with Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy, administer the drug one hour before or three hours after Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate. Monitor blood levels of the concomitant drugs that have a narrow therapeutic range. Patients taking anti-arrhythmic medications for the control of arrhythmias and anti-seizure medications for the control of seizure disorders were excluded from the clinical trials with all forms of Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate.
- Calcium acetate may decrease the bioavailability of tetracyclines or fluoroquinolones. (7)
- When clinically significant drug interactions are expected, administer the drug at least one hour before or at least three hours after Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate or consider monitoring blood levels of the drug. (7)
7.1 Ciprofloxacin
In a study of 15 healthy subjects, a co-administered single dose of 4 Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate tablets, approximately 2.7g, decreased the bioavailability of ciprofloxacin by approximately 50%.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Category C:
Esaglut ) acetate capsules contains Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate. Animal reproduction studies have not been conducted with Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate, and there are no adequate and well controlled studies of Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate use in pregnant women. Patients with end stage renal disease may develop hypercalcemia with Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate treatment [see Warnings and Precautions (5.1 ) ]. Maintenance of normal serum Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) levels is important for maternal and fetal well being. Hypercalcemia during pregnancy may increase the risk for maternal and neonatal complications such as stillbirth, preterm delivery, and neonatal hypocalcemia and hypoparathyroidism. Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate treatment, as recommended, is not expected to harm a fetus if maternal Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) levels are properly monitored during and following treatment.
8.2 Labor and Delivery
The effects of Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate on labor and delivery are unknown.
8.3 Nursing Mothers
Esaglut ) Acetate Capsules contains Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate and is excreted in human milk. Human milk feeding by a mother receiving Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate is not expected to harm an infant, provided maternal serum Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) levels are appropriately monitored.
8.4 Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
8.5 Geriatric Use
Clinical studies of Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
10 OVERDOSAGE
Administration of Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate in excess of the appropriate daily dosage may result in hypercalcemia [see Warnings and Precautions (5.1)].
11 DESCRIPTION
Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate acts as a phosphate binder. Its chemical name is Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate. Its molecular formula is C4H6CaO4, and its molecular weight is 158.17. Its structural formula is:
Each white opaque/blue opaque capsule contains 667 mg of Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate USP (anhydrous; Ca(CH3COO)2; MW=158.17 grams) equal to 169 mg (8.45 mEq) Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)), polyethylene glycol 8000 and magnesium stearate. Each capsule shell contains: black monogramming ink, FD&C Blue #1, FD&C Red #3, gelatin and titanium dioxide. The black monogramming ink contains: ammonium hydroxide, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac glaze.
Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) Acetate Capsules are administered orally for the control of hyperphosphatemia in end-stage renal failure.
12 CLINICAL PHARMACOLOGY
Patients with ESRD retain phosphorus and can develop hyperphosphatemia. High serum phosphorus can precipitate serum Esaglut ) resulting in ectopic calcification. Hyperphosphatemia also plays a role in the development of secondary hyperparathyroidism in patients with ESRD.
12.1 Mechanism of Action
Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate, when taken with meals, combines with dietary phosphate to form an insoluble Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) phosphate complex, which is excreted in the feces, resulting in decreased serum phosphorus concentration.
12.2 Pharmacodynamics
Orally administered Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate from pharmaceutical dosage forms is systemically absorbed up to approximately 40% under fasting conditions and up to approximately 30% under nonfasting conditions. This range represents data from both healthy subjects and renal dialysis patients under various conditions.
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
No carcinogenicity, mutagenicity, or fertility studies have been conducted with Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate.
14 CLINICAL STUDIES
Effectiveness of Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate in decreasing serum phosphorus has been demonstrated in two studies of the Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate solid oral dosage form.
Ninety-one patients with end-stage renal disease who were undergoing hemodialysis and were hyperphosphatemic (serum phosphorus >5.5 mg/dL) following a 1 week phosphate binder washout period contributed efficacy data to an open-label, non-randomized study.
The patients received Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate 667 mg tablets at each meal for a period of 12 weeks. The initial starting dose was 2 tablets per meal for 3 meals a day, and the dose was adjusted as necessary to control serum phosphorus levels. The average final dose after 12 weeks of treatment was 3.4 tablets per meal. Although there was a decrease in serum phosphorus, in the absence of a control group the true magnitude of effect is uncertain.
The data presented in Table 2 demonstrate the efficacy of Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate in the treatment of hyperphosphatemia in end-stage renal disease patients. The effects on serum Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) levels are also presented.
| * Ninety-one patients completed at least 6 weeks of the study. † ANOVA of difference in values at pre-study and study completion. ‡ Values expressed as mean ± SE. | |||||
| Parameter | Pre-Study | Week 4* | Week 8 | Week 12 | p-value† |
| Phosphorus (mg/dL)‡ | 7.4 ± 0.17 | 5.9 ± 0.16 | 5.6 ± 0.17 | 5.2 ± 0.17 | ≤0.01 |
| Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) (mg/dL)‡ | 8.9 ± 0.09 | 9.5 ± 0.10 | 9.7 ± 0.10 | 9.7 ± 0.10 | ≤0.01 |
There was a 30% decrease in serum phosphorus levels during the 12 week study period (p<0.01). Two-thirds of the decline occurred in the first month of the study. Serum Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) increased 9% during the study mostly in the first month of the study.
Treatment with the phosphate binder was discontinued for patients from the open-label study, and those patients whose serum phosphorus exceeded 5.5 mg/dL were eligible for entry into a double-blind, placebo-controlled, cross-over study. Patients were randomized to receive Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate or placebo, and each continued to receive the same number of tablets as had been individually established during the previous study. Following 2 weeks of treatment, patients switched to the alternative therapy for an additional 2 weeks.
The phosphate binding effect of Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate is shown in the Table 3.
| * ANOVA of Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate vs. placebo after 2 weeks of treatment. † Values expressed as mean ± SEM. | ||||
| Parameter | Pre-Study | Post-Treatment | p-value* | |
| Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) Acetate | Placebo | |||
| Phosphorus (mg/dL)† | 7.3 ± 0.18 | 5.9 ± 0.24 | 7.8 ± 0.22 | <0.01 |
| Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) (mg/dL)† | 8.9 ± 0.11 | 9.5 ± 0.13 | 8.8 ± 0.12 | <0.01 |
Overall, 2 weeks of treatment with Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate statistically significantly (p<0.01) decreased serum phosphorus by a mean of 19% and increased serum Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) by a statistically significant (p<0.01) but clinically unimportant mean of 7%.
16 HOW SUPPLIED/STORAGE AND HANDLING
Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) Acetate Capsules
667 mg capsule is supplied as a white opaque/blue opaque capsule, imprinted with “54 215” on the cap and body.
NDC 0615-2303-39: Blistercards of 30 Capsules
NDC 0615-2303-30: Unit-dose Boxes of 30 Capsules
STORAGE
Store at 20° to 25°C (68° to 77°F).
17 PATIENT COUNSELING INFORMATION
Inform patients to take Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate capsules with meals, adhere to their prescribed diets, and avoid the use of Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) supplements including nonprescription antacids. Inform the patients about the symptoms of hypercalcemia [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ].
Advise patients who are taking an oral medication where reduction in the bioavailability of that medication would have clinically significant effect on its safety or efficacy to take the drug one hour before or three hours after Esaglut (Calcium (Calcium Fructose-1,6-Diphosphate)) acetate capsules.
Distr. by: West-Ward
Pharmaceuticals Corp.
Eatontown, NJ 07724
10003705/05
Revised April 2016
Glutamine:
- Indication and usage
- Dosage and administration
- Dosage forms and strengths
- Contraindications
- Warnings and precautions
- Adverse reactions
- Drug interactions
- Use in specific populations
- Overdosage
- Description
- Clinical pharmacology
- Nonclinical toxicology
- Clinical studies
- How supplied/storage and handling
- Patient counseling information
1 INDICATION AND USAGE
Esaglut (Glutamine)® [L-glutamine powder for oral solution] is indicated for the treatment of Short Bowel Syndrome (SBS) in patients receiving specialized nutritional support when used in conjunction with a recombinant human growth hormone that is approved for this indication [see Dosage and Administration (2) ].
Esaglut (Glutamine) and recombinant human growth hormone (rhGH) therapy should be used in conjunction with optimal management of SBS. Optimal management of SBS may include a specialized oral diet, enteral feedings, parenteral nutrition, fluid and micronutrient supplements. A specialized oral diet may consist of a high carbohydrate, low-fat diet, adjusted for individual patient requirements and preferences.
Routine monitoring of renal and hepatic function is recommended in patients receiving Esaglut (Glutamine) and intravenous parenteral nutrition (IPN), particularly in those with renal or hepatic impairment. Esaglut (Glutamine) is metabolized to glutamate and ammonia, which may increase in patients with hepatic dysfunction.
The safety and efficacy of Esaglut (Glutamine) have not been studied beyond 16 weeks of treatment.
NutreStore® is an amino acid indicated for:
- the treatment of Short Bowel Syndrome in patients receiving specialized nutritional support when used in conjunction with a recombinant human growth hormone that is approved for this indication (1)
2 DOSAGE AND ADMINISTRATION
Esaglut (Glutamine) should be administered as a cotherapy with rhGH ] for injection) followed by continued Esaglut (Glutamine) for up to 16 weeks.
The recommended dosage of Esaglut (Glutamine) is 30 g daily in divided doses (5 g taken 6 times each day orally) for up to 16 weeks. Each dose of Esaglut (Glutamine) (5 g) should be reconstituted in 8-oz (250-mL) of water prior to consumption.
Esaglut (Glutamine) should be taken with meals or snacks at 2- to 3-hour intervals while awake. The volume of water may be varied according to the patient's preference. In the event of a patient's transient intolerance to oral intake, a dose may be delayed for up to 2 hours.
- 30 g daily in divided doses (5 g taken 6 times each day orally) for up to 16 weeks (2)
- Each dose should be reconstituted in 8 oz (250 mL) of water prior to consumption (2)
- Should be taken with meals or snacks at 2- to 3-hour interval while awake (2)
3 DOSAGE FORMS AND STRENGTHS
Esaglut (Glutamine) is supplied in preprinted paper-foil-plastic laminate packets containing 5 g of L-glutamine powder.
- Pre-printed paper-foil-plastic laminate packets: 5 g powder (3)
4 CONTRAINDICATIONS
None.
- None (4)
5 WARNINGS AND PRECAUTIONS
- Routine monitoring of renal and hepatic function is recommended in patients receiving lPN, particularly in those with renal or hepatic impairment
5.1 Increased Serum Ammonia and Glutamate
Esaglut (Glutamine) is metabolized to glutamate and ammonia, which may increase in patients with hepatic dysfunction. Therefore, routine monitoring of renal and hepatic function is recommended in patients receiving intravenous parenteral nutrition (IPN) and Esaglut (Glutamine), particularly in those with renal or hepatic impairment.
6 ADVERSE REACTIONS
Most common adverse reactions are :
- In initial four (4) weeks (incidence >10%): flatulence, abdominal pain, nausea, tenesmus, vomiting, hemorrhoids, mouth dry.
- In weeks 5-18 (incidence >10%): nausea, vomiting, tenesmus, pancreatitis, constipation, Crohn's disease aggravated, gastric ulcer, gastrointestinal fistula.
To report SUSPECTED ADVERSE REACTIONS, contact Emmaus Medical, Inc. at 1-877-420-6493 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice
Table 1 provides the number of subjects by system-organ class experiencing at least one adverse reaction during the 4-week treatment period of the SBS study. To be listed in Table 1, an adverse reaction must have occurred in more than 10% of subjects in any treatment group.
| Adverse Reactions | Group A | Group B | Group C |
|---|---|---|---|
| rhGH+SOD N=16 n (%) | rhGH+SOD[GLN] N=16 n (%) | SOD[GLN] N=9 n (%) | |
| GROUP A: rhGH + SOD for 4 weeks followed by SOD for 12 weeks. | |||
| GROUP B: rhGH + SOD [GLN] for 4 weeks followed by SOD [GLN] for 12 weeks. | |||
| GROUP C: rhGH placebo + SOD [GLN] for 4 weeks followed by SOD [GLN) for 12 weeks. | |||
| Total Number of Subjects with At Least One Adverse Reaction | 16 (100) | 16 (100) | 8 (89) |
| Body as a Whole: General Disorders | 15 (94) | 15 (94) | 4 (44) |
| Edema, Peripheral | 11 (69) | 13 (81) | 1 (11) |
| Edema, Facial | 8 (50) | 7 (44) | 0(0) |
| Pain | 3 (19) | 1 (6) | 1 (11) |
| Chest Pain | 3 (19) | 0 (0) | 0 (0) |
| Fever | 0 (0) | 1 (6) | 2 (22) |
| Back Pain | 1 (6) | 0 (0) | 1 (11) |
| Flu-like Disorder | 0 (0) | 1 (6) | 1 (11) |
| Malaise | 2 (13) | 0 (0) | 0 (0) |
| Edema, Generalized | 2 (13) | 0 (0) | 0 (0) |
| Abdomen Enlarged | 0 (0) | 0 (0) | 1 (11) |
| Allergic Reaction | 0 (0) | 0 (0) | 1 (11) |
| Rigors (Chills) | 0 (0) | 0 (0) | 1 (11) |
| Gastrointestinal System Disorders | 12 (75) | 12 (75) | 6 (67) |
| Flatulence | 4 (25) | 4 (25) | 2 (22) |
| Abdominal Pain | 4 (25) | 2 (13) | 1 (11) |
| Nausea | 2 (13) | 5 (31) | 0 (0) |
| Tenesmus | 1 (6) | 3 (19) | 3 (33) |
| Vomiting | 3 (19) | 3 (19) | 1 (11) |
| Hemorrhoids | 1 (6) | 0 (0) | 1 (11) |
| Mouth Dry | 1 (6) | 0 (0) | 1(11) |
| Musculoskeletal System Disorders | 7 (44) | 7 (44) | 1 (11) |
| Arthralgia | 7(44) | 5 (31) | 0 (0) |
| Myalgia | 2 (13) | 0 (0) | 1 (11) |
| Resistance Mechanism Disorders | 6 (38) | 3 (19) | 4 (44) |
| Infection | 0 (0) | 1 (6) | 3 (33) |
| Infection Bacterial | 3 (19) | 0 (0) | 1 (11) |
| Infection Viral | 1 (6) | 2 (13) | 0 (0) |
| Moniliasis | 2 (13) | 0 (0) | 0 (0) |
| Application Site Disorders | 5 (31) | 4 (25) | 1 (11) |
| Injection Site Reaction | 3 (19) | 4 (25) | 1 (11) |
| Injection Site Pain | 5 (31) | 0 (0) | 0 (0) |
| Central and Peripheral Nervous System Disorders | 4 (25) | 4 (25) | 2 (22) |
| Dizziness | 1 (6) | 2 (13) | 0 (0) |
| Headache | 1 (6) | 1 (6) | 1 (11) |
| Hypoasthesia | 1 (6) | 1 (6) | 1 (11) |
| Skin and Appendages Disorders | 4 (25) | 4 (25) | 2 (22) |
| Rash | 1 (6) | 2 (13) | 0 (0) |
| Pruritis | 0 (0) | 1 (6) | 1 (11) |
| Sweating Increased | 2 (13) | 0 (0) | 0 (0) |
| Nail Disorder | 0 (0) | 0 (0) | 1 (11) |
| Respiratory System Disorders | 1 (6) | 5 (31) | 1 (11) |
| Rhinitis | 0 (0) | 3 (19) | 1 (11) |
| Metabolic and Nutritional Disorders | 3 (19) | 1 (6) | 1 (11) |
| Dehydration | 3 (19) | 0 (0) | 1 (11) |
| Thirst | 0 (0) | 0 (0) | 1 (11) |
| Urinary System Disorders | 2 (13) | 1 (16) | 1 (11) |
| Pyelonephritis | 0 (0) | 0 (0) | 1 (11) |
| Psychiatric Disorders | 1 (6) | 0 (0) | 2 (22) |
| Depression | 0 (0) | 0 (0) | 2 (22) |
| Reproductive Disorders, Female | 2 (13) | 0 (0) | 1 (11) |
| Breast Pain Female | 1 (6) | 0 (0) | 1 (11) |
| Hearing and Vestibular Disorders | 0 (0) | 2 (13) | 0 (0) |
| Ear or Hearing Symptoms | 0 (0) | 2 (13) | 0 (0) |
Table 2 summarizes the number of subjects by system-organ class who experienced an AR during weeks 5 to 18 of the randomized, controlled SBS study. To be listed in Table 2, an AR must have occurred in more than 10% of subjects in any treatment group.
| Adverse Reactions | Group A | Group B | Group C |
|---|---|---|---|
| rhGH+SOD N=15 n (%) | rhGH+SOD[GLN] N=16 n (%) | SOD[GLN] N=9 n (%) | |
| GROUP A: rhCH + SOD for 4 weeks followed by SOD for 12 weeks. | |||
| GROUP B: rhGH + SOD [GLN] for 4 weeks followed by SOD [GLN] for 12 weeks. | |||
| GROUP C: rhGH placebo + SOD [GLN] for 4 weeks followed by SOD [GLN] for 12 weeks. | |||
| Total Number of Subjects with At Least One Adverse Reaction | 12 (80) | 13 (81) | 7 (78) |
| Gastrointestinal System Disorders | 7 (47) | 7 (44) | 3 (33) |
| Nausea | 3 (20) | 0 (0) | 2 (22) |
| Vomiting | 2 (13) | 3 (19) | 0 (0) |
| Abdominal Pain | 3 (20) | 1 (6) | 0 (0) |
| Tenesmus | 0 (0) | 3 (19) | 1 (11) |
| Pancreatitis | 0 (0) | 1 (6) | 1 (11) |
| Constipation | 0 (0) | 0 (0) | 1 (11) |
| Crohn's Disease Aggravated | 0 (0) | 0 (0) | 1 (11) |
| Gastric Ulcer | 0 (0) | 0 (0) | 1 (11) |
| Gastrointestinal FistuIa | 0 (0) | 0 (0) | 1 (11) |
| Resistance Mechanism Disorders | 6 (40) | 5 (31) | 5 (56) |
| Infection Bacterial | 0 (0) | 2 (13) | 3 (33) |
| Infection Viral | 3 (20) | 1 (6) | 1 (11) |
| Infection | 1 (7) | 2 (13) | 1 (11) |
| Sepsis | 3 (20) | 1 (6) | 0 (0) |
| Body as a Whole: General Disorders | 4 (27) | 2 (13) | 1 (11) |
| Fever | 2 (13) | 1 (6) | 1 (11) |
| Fatigue | 2 (13) | 0 (0) | 0 (0) |
| Respiratory System Disorders | 2 (13) | 4 (25) | 1 (11) |
| Rhinitis | 1 (7) | 3 (19) | 0 (0) |
| Laryngitis | 0 (0) | 0 (0) | 1 (11) |
| Pharyngitis | 0 (0) | 0 (0) | 1 (11) |
| Reproductive Disorders, Female | 0 (0) | 4 (25) | 1 (11) |
| Vaginal Fungal Infection | 0 (0) | 0 (0) | 1 (11) |
| Skin and Appendages Disorders | 2 (13) | 2 (13) | 1 (11) |
| Rash | 1 (7) | 0 (0) | 1 (11) |
| Musculoskeletal System Disorders | 2 (13) | 2 (13) | 0 (0) |
| Arthralgia | 2 (13) | 2 (13) | 0 (0) |
| Psychiatric Disorders | 0 (0) | 1 (6) | 1 (11) |
| Depression | 0 (0) | 0 (0) | 1 (11) |
| Insomnia | 0 (0) | 0 (0) | 1 (11) |
| Urinary System Disorders | 0 (0) | 0 (0) | 2 (22) |
| Pyelonephritis | 0 (0) | 0 (0) | 1 (11) |
| Renal Calculus | 0 (0) | 0 (0) | 1 (11) |
| Application Site Disorders | 0 (0) | 0 (0) | 1 (11) |
| Injection Site Reaction | 0 (0) | 0 (0) | 1 (11) |
| Liver and Biliary System Disorders | 0 (0) | 0 (0) | 1 (11) |
| Hepatic Function Abnormal | 0 (0) | 0 (0) | 1 (11) |
| Vascular Extracardiac Disorders | 0 (0) | 0 (0) | 1 (11) |
| Vascular Disorder | 0 (0) | 0 (0) | 1 (11) |
During the initial 4-week treatment period, 100% of patients receiving growth hormone with and without Esaglut (Glutamine) reported at least one AR, whereas 89% of patients receiving growth hormone placebo with Esaglut (Glutamine) reported at least one AR. During weeks 5 to 18, 81% of patients receiving growth hormone with Esaglut (Glutamine), 80% of patients receiving growth hormone without Esaglut (Glutamine) and 78% of patients receiving growth hormone placebo with Esaglut (Glutamine) experienced at least one AR. There were no deaths in this study.
7 DRUG INTERACTIONS
Formal drug interaction studies have not been conducted.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Teratogenic Effects: Pregnancy Category C
Animal reproduction studies have not been conducted with Esaglut. It is also not known whether Esaglut (Glutamine) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Esaglut (Glutamine) should be given to a pregnant woman only if clearly needed.
8.2 Labor and Delivery
The effect of L-glutamine on labor and delivery is unknown.
8.3 Nursing Mothers
It is not known whether L-glutamine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when L-glutamine is administered to a nursing woman.
8.4 Pediatric Use
The safety and effectiveness of L-glutamine in pediatric patients have not been established.
8.5 Geriatric Use
The clinical trial enrolled SBS patients between the ages of ZO and 75 years. Only 8 of the 41 subjects evaluated were ≥65 years of age. The clinical trial of oral Esaglut did not include sufficient numbers of subjects aged 65 years and over to determine if they respond differently than younger subjects. In general, dose selection for an elderly patient should be individualized, because of the greater frequency of decreased hepatic, renal, or cardiac function, as well as concomitant disease in this population.
8.6 Hepatic Impairment
Esaglut (Glutamine) is metabolized to glutamate and ammonia, which may increase in patients with hepatic dysfunction. Therefore, routine monitoring of hepatic function is recommended in patients receiving intravenous parental nutrition (IPN) and Esaglut (Glutamine).
8.7 Renal Impairment
Esaglut (Glutamine) is metabolized to glutamate and ammonia. Routine monitoring of renal function is recommended in patients receiving intravenous parental nutrition (IPN) and Esaglut (Glutamine).
10 OVERDOSAGE
Single oral doses of Esaglut (Glutamine) at about 20 to 22 g/kg, 8 to 11 g/kg, and 19 g/kg were lethal in mice, rats, and rabbits, respectively.
11 DESCRIPTION
Esaglut (Glutamine) (L-glutamine powder for oral solution) for oral administration is formulated as a white crystalline powder in a paper-foil-plastic laminate packet. Each packet of Esaglut (Glutamine) contains 5 g of L-glutamine. The amino acid Esaglut (Glutamine) is also known as (S)-2-aminoglutaramic acid, L-glutamic acid 5-amide, (S)-2,5-diamino-5-oxopentanoic acid, or L-glutamine. The molecular formula of Esaglut (Glutamine) is C5H10N2O3, and the molecular weight is 146.15 d. Esaglut (Glutamine) has the following structural formula:
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
L-glutamine has important functions in regulation of gastrointestinal cell growth, function, and regeneration. Under normal conditions, Esaglut concentration is maintained in the body by dietary intake and synthesis from endogenous glutamate. Data from clinical studies indicate that the role of and nutritional requirements for Esaglut (Glutamine) during catabolic illness, trauma, and infection may differ significantly from the role of and nutritional requirements for Esaglut (Glutamine) in healthy individuals. Esaglut (Glutamine) concentrations decrease and tissue Esaglut (Glutamine) metabolism increases during many catabolic disease states, and thus Esaglut (Glutamine) is often considered a "conditionally essential" amino acid.
12.2 Pharmacodynamics
When Esaglut (Glutamine) was administered in combination with rhGH to rats, villous height, bowel growth, plasma insulin-like growth factor I, and body weight were significantly higher than in rats treated with either Esaglut (Glutamine) or rhGH alone.
12.3 Pharmacokinetics
The pharmacokinetics of L-glutamine as described below are based on literature data in healthy subjects. The pharmacokinetics in patients with SBS have not been determined. The plasma Esaglut (Glutamine) concentrations in these patients following oral administration are expected to be highly variable depending on the length, segment, and presence/ absence of ileal-cecal valve for the remnant bowel.
Absorption
Following single dose oral administration of Esaglut (Glutamine) at 0.1 g/kg to six subjects, mean peak blood Esaglut (Glutamine) concentration was 1028 µM (or 150 mcg/mL) occurring approximately 30 minutes after administration. The pharmacokinetics following multiple oral doses have not been adequately characterized.
Distribution
After an intravenous bolus dose in three subjects, the volume of distribution was estimated to be approximately 200 mL/kg.
Metabolism
Endogenous Esaglut (Glutamine) participates in various metabolic activities, including the formation of glutamate, and synthesis of proteins, nucleotides, and amino sugars. Exogenous Esaglut (Glutamine) is anticipated to undergo similar metabolism.
Elimination
Metabolism is the major route of elimination for Esaglut (Glutamine). Although Esaglut (Glutamine) is eliminated by glomerular filtration, it is almost completely reabsorbed by the renal tubules. After an IV bolus dose in three subjects, the terminal half-life of Esaglut (Glutamine) was approximately 1 hour.
Specific Populations
There are no studies to determine the effect of race, age, or gender on the pharmacokinetics of L-glutamine.
Drug-Drug Interactions
No drug-drug interaction studies have been conducted. Because metabolism of Esaglut (Glutamine) is mediated via non-CYP enzymes, Esaglut (Glutamine) pharmacokinetics are unlikely to be affected by other agents through CYP enzyme inhibition or induction.
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals have not been performed to evaluate the carcinogenic potential of L-glutamine. Studies to evaluate its potential for impairment of fertility or its mutagenic potential have not been conducted.
14 CLINICAL STUDIES
14.1 Short Bowel Syndrome
A randomized, controlled, 3-arm, double-blind, parallel-group clinical study evaluated the efficacy and safety of oral Esaglut (Glutamine) as a cotherapy with rhGH in subjects with SBS who were dependent on intravenous parenteral nutrition (IPN) for nutritional support. The primary endpoint was the change in weekly total IPN volume defined as the sum of the volumes of lPN, supplemental lipid emulsion (SLE), and intravenous hydration fluid. The secondary endpoints were the change in weekly IPN caloric content and the change in the frequency of IPN administration per week.
All subjects received a specialized oral diet (SOD) for the duration of the study. Following a two-week equilibration period, treatment was administered in a double blind manner. Group A (N=16) received rhGH for four weeks plus oral Esaglut (Glutamine) placebo for 16 weeks, Group B (N=16) received rhGH for four weeks plus oral Esaglut (Glutamine) for 16 weeks, and Group C (N=9), received rhGH placebo for four weeks plus oral Esaglut (Glutamine) for 16 weeks. The efficacy of Esaglut (Glutamine) was assessed by comparing the cotherapy (rhGH and oral Esaglut (Glutamine)) to rhGH alone.
After 4 weeks of treatment with subcutaneous rhGH (0.1 mg/kg/d) and oral Esaglut (Glutamine) (30 g/ d) (Group B), subjects with SBS reduced their requirement for IPN volume (-7.7 L/wk), IPN caloric content (-5751 kcal/wk), and weekly frequency of IPN administration (-4.2 d/wk).
| Group A | Group B | Group C | |
|---|---|---|---|
| rhGH + SOD | rhGH + SOD[GLN] | SOD[GLN] | |
| GROUP A: rhGH + SOD for 4 weeks followed by SOD for 12 weeks. | |||
| GROUP B: rhGH + SOD [GLN] for 4 weeks followed by SOD [GLN] for 12 weeks. | |||
| GROUP C: rhGH placebo + SOD[GLN] for 4 weeks followed by SOD[GLN] for 12 weeks | |||
| Total IPN volume (L/wk) | |||
| Mean at Baseline | 10.3 | 10.5 | 13.5 |
| Mean Change | -5.9 | -7.7 | -3.8 |
| Total IPN Calories (kcal/wk) | |||
| Mean at Baseline | 7634.7 | 7895.0 | 8570.4 |
| Mean Change | -4338.3 | -5751.2 | -2633.3 |
| Frequency of IPN or SLE (days/week) | |||
| Mean at Baseline | 5.1 | 5.4 | 5.9 |
| Mean Change | -3.0 | -4.2 | -2.0 |
IPN volume requirements were Significantly reduced in subjects receiving subcutaneous rhGH and oral Esaglut (Glutamine) (Group B) when compared with IPN volume requirements in subjects receiving either treatment alone.
| Change in lPN Week 2 to Week 18 lTT Population | |||
|---|---|---|---|
| Endpoint | Group A [n = 16] | Group B [n = 16] | Group C [n = 9] |
| GROUP A: rhGH + SOD for 4 weeks followed by SOD for 12 weeks. | |||
| GROUP B: rhGH + SOD [GLN] for 4 weeks followed by SOD [GLN] for 12 weeks. | |||
| GROUP C: rhGH placebo + SOD[GLN] for 4 weeks followed yv SOD[GLN] for 12 weeks. | |||
| Change in weekly IPN Volume (L/wk) | -5.9 | -7.2 | -4.7 |
| Change in weekly IPN Calories (kcal/wk) | -3522.2 | -5347.3 | -2254.0 |
| Change in weekly IPN frequency (days/wk) | -2.9 | -3.9 | -1.9 |
The change in weekly IPN volume, calories and frequency was assessed from Week 2 to Week 18. The data support that the treatment effect is maintained for 16 weeks. The efficacy of oral Esaglut (Glutamine) beyond 16 weeks of treatment has not been adequately studied.
16 HOW SUPPLIED/STORAGE AND HANDLING
Esaglut (Glutamine) is supplied in preprinted paper-foil-plastic laminate packets containing 5 g of L-glutamine powder and is supplied as follows:
- Carton of 84 packets (NDC 42457-001-84)
Store at 25°C (77°F) with excursions allowed to 15°-30°C (59°-86°F).
17 PATIENT COUNSELING INFORMATION
17.1 Dosing Instructions
Esaglut (Glutamine) should be taken with meals or snacks at 2- to 3-hour intervals while awake. The volume of water may be varied according to the patient's preference. In the event of a patient's transient intolerance to oral intake, a dose may be delayed for up to 2 hours.
For additional information concerning Esaglut (Glutamine), contact:
Manufactured for:
Emmaus
MEDICAL, INC.
20725 S. Western Ave., Suite 136
Torrance, CA 90501-1884
Tel: 1-877-420-6493
www.nutrestore.com
© 2013 Emmaus Medical, Inc.
FDA-Approved Patient Labeling
Patient Information
Esaglut (Glutamine)® (NOO-tre-stor)
[L-glutamine powder for oral solution] (GLOO-tah-min)
Please read this leaflet carefully before you start to use Esaglut (Glutamine)® and each time your prescription is refilled since there may be new information. The information in this leaflet does not take the place of regularly talking with your doctor or health care professional.
What is Esaglut (Glutamine)®?
Esaglut (Glutamine)® is the amino acid L-glutamine, identical to the L-glutamine that your body produces. Esaglut (Glutamine)® is used together with a human growth hormone, approved for treating short bowel syndrome [SBS], in patients receiving a specialized diet tailored to meet their individual needs.
Why has my doctor prescribed Esaglut (Glutamine)®?
Your doctor prescribed Esaglut (Glutamine)® initially in combination with human growth hormone to help decrease your need for intravenous feedings. After treatment in combination with human growth hormone, you will continue to take Esaglut (Glutamine)® alone to maintain the treatment effect. During your treatment with Esaglut (Glutamine)® you will be taking up to 6 packets of Esaglut (Glutamine)® a day. You will also receive instructions from your doctor or a dietitian on the proper diet you should follow during this treatment period as well as after your treatment is over. Please refer to the patient package leaflet available for human growth hormone for more information on how to take human growth hormone.
What should I tell my doctor before taking Esaglut (Glutamine)®?
Tell your doctor about all of your conditions including if you:
- are pregnant or planning to become pregnant. It is not known if NutreStore® can harm your unborn baby.
- are breast feeding. It is not known if Esaglut (Glutamine)® passes into your milk and if it can harm your baby. You should talk to your doctor about breastfeeding while taking Esaglut (Glutamine)®.
- have liver or kidney problems. Your doctor may do blood tests to check your liver and kidney function while you are taking Esaglut (Glutamine)®.
- are older than 65 years of age. Your dose of Esaglut (Glutamine)® may need to be adjusted.
Tell your doctor about all the medicines you take including prescription medicines, non-prescription medicines, vitamins, or herbal supplements. It is not known if Esaglut (Glutamine)® and other medicines can affect each other.
What should I avoid while taking Esaglut (Glutamine)®?
- Pregnancy. You should talk to your doctor if you are planning to become pregnant while taking Esaglut (Glutamine)®. It is not known whether Esaglut (Glutamine)® can affect the ability of a woman to become pregnant. It is also not known whether Esaglut (Glutamine)® can cause harm to a fetus when taken by a pregnant woman or if Esaglut (Glutamine)® has an effect on labor and delivery.
- Breastfeeding. You should talk to your doctor before breastfeeding an infant while taking Esaglut (Glutamine)®. It is not known whether the Esaglut (Glutamine) in Esaglut (Glutamine)® can be passed to an infant in mother's milk, and it is not clear whether the drug could harm the infant if it is passed in mother's milk.
What are the possible side effects of Esaglut (Glutamine)®?
Many patients taking Esaglut (Glutamine)® and human growth hormone for the treatment of SBS experience side effects.
Whether or not you experience side effects, you and your doctor should periodically talk about your general health.
- Your doctor may want to monitor you more closely and ask you to have blood tests done more frequently.
Digestive system.
The possible side effects you may experience while taking Esaglut (Glutamine)® include vomiting, hemorrhoids, pancreatitis, aggravation of Crohn's disease, gastric ulcer, and gastrointestinal fistula (opening between stomach and intestine).
The possible related symptoms you may experience while taking Esaglut (Glutamine)® include urge to empty bowel, gas, abdominal pain, nausea, dry mouth and constipation.
These side effects and related symptoms may be similar to those you have experienced while being treated for SBS. You should talk to your doctor about these problems before starting an over-the-counter medication to treat these symptoms. It is important for you to follow your doctor's or dietitian's instructions on the type of diet best for you.
Please refer also to the patient package leaflet available for human growth hormone for more information on the possible benefits and side effects of human growth hormone.
Tell your doctor about any side effects that bother you or that do not go away.
These are not all the side effects with Esaglut (Glutamine)®. For more information, ask your doctor or pharmacist.
How should I take Esaglut (Glutamine)®?
Esaglut (Glutamine)® should be taken up to 6 times a day (every 2 to 3 hours during the day) with a meal or snack. This should be continued every day for as long as your doctor prescribes. Each dose of Esaglut (Glutamine)® should be prepared by pouring the contents of one packet into an 8-oz glass of water and stirring for approximately 1 minute. After stirring, you should drink the Esaglut (Glutamine)® within 2 hours. If you miss a dose, you should take your next dose as soon as you remember or are able to take it. Do not take more than 6 packets each day.
What kind of food should I eat during my treatment with Esaglut (Glutamine)®?
Your doctor or dietitian will prescribe for you the types and quantities of foods you should eat during your treatment with Esaglut (Glutamine)®. These foods are not special and can be purchased from your local market. Your likes and dislikes should be taken into consideration when your meal plan is created.
Your doctor or dietitian will advise you on how many times a day you should eat. Your doctor or dietitian will adjust your diet as needed during your treatment with Esaglut (Glutamine)®. It is important that you carefully follow the eating plan your doctor or dietitian gives you.
Storage conditions for Esaglut (Glutamine)®
Packets of Esaglut (Glutamine)® should be stored at room temperature (25°C / 77°F). Expiration dates are stated on product labels. Do not use any damaged packets of Esaglut (Glutamine)®. Keep Esaglut (Glutamine)® and all medicines out of the reach of children.
General information about prescription medicines
This medication has been prescribed for a particular medical condition. Do not use it for another condition or give this drug to anyone else. If you have any questions, you should speak with your doctor or health care professional. You may also ask your doctor or pharmacist for a copy of the information provided to them with the product. Keep this and all drugs out of the reach of children.
For additional information, you may call the Esaglut (Glutamine)® patient hotline at 1-877-420-6493.
PRINCIPAL DISPLAY PANEL - 84 Packet Carton
Esaglut (Glutamine)®
[L-glutamine powder for oral solution]
Principal Display Panel - 84 Packet Carton
Esaglut pharmaceutical active ingredients containing related brand and generic drugs:
Esaglut available forms, composition, doses:
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.