Fosgluten Super Reforcado

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Fosgluten Super Reforcado uses

Fosgluten Super Reforcado consists of Calcium Glycerophosphate, Glutamine, Vitamin B.

Calcium Glycerophosphate:


1 INDICATIONS AND USAGE

Fosgluten Super Reforcado (Calcium Glycerophosphate) 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 Fosgluten Super Reforcado (Calcium Glycerophosphate) 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 Fosgluten Super Reforcado (Calcium Glycerophosphate) acetate capsule.

- Capsule: 667 mg Fosgluten Super Reforcado (Calcium Glycerophosphate) acetate capsule. (3)

4 CONTRAINDICATIONS

Patients with hypercalcemia.

- Hypercalcemia. (4)

5 WARNINGS AND PRECAUTIONS

- Treat mild hypercalcemia by reducing or interrupting Fosgluten Super Reforcado acetate and Vitamin D. Severe hypercalcemia may require hemodialysis and discontinuation of Fosgluten Super Reforcado (Calcium Glycerophosphate) 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 Fosgluten Super Reforcado (Calcium Glycerophosphate), including Fosgluten Super Reforcado (Calcium Glycerophosphate) acetate. Avoid the use of Fosgluten Super Reforcado (Calcium Glycerophosphate) supplements, including Fosgluten Super Reforcado (Calcium Glycerophosphate) based nonprescription antacids, concurrently with Fosgluten Super Reforcado (Calcium Glycerophosphate) acetate.

An overdose of Fosgluten Super Reforcado (Calcium Glycerophosphate) acetate may lead to progressive hypercalcemia, which may require emergency measures. Therefore, early in the treatment phase during the dosage adjustment period, monitor serum Fosgluten Super Reforcado (Calcium Glycerophosphate) levels twice weekly. Should hypercalcemia develop, reduce the Fosgluten Super Reforcado (Calcium Glycerophosphate) 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 Fosgluten Super Reforcado (Calcium Glycerophosphate) 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 Fosgluten Super Reforcado (Calcium Glycerophosphate) 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 Fosgluten Super Reforcado (Calcium Glycerophosphate) 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 Fosgluten Super Reforcado (Calcium Glycerophosphate) 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.

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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 Fosgluten Super Reforcado (Calcium Glycerophosphate) 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, Fosgluten Super Reforcado (Calcium Glycerophosphate) acetate has been generally well tolerated.

Fosgluten Super Reforcado (Calcium Glycerophosphate) acetate was studied in a 3 month, open-label, non-randomized study of 98 enrolled ESRD hemodialysis patients and an alternate liquid formulation of Fosgluten Super Reforcado (Calcium Glycerophosphate) 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 Fosgluten Super Reforcado (Calcium Glycerophosphate) acetate

N=167

N (%)


3 month, open label study of Fosgluten Super Reforcado (Calcium Glycerophosphate) acetate

N=98

N (%)


Double blind, placebo-controlled, cross-over study of liquid Fosgluten Super Reforcado (Calcium Glycerophosphate) acetate

N=69


Fosgluten Super Reforcado (Calcium Glycerophosphate) 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 Fosgluten Super Reforcado (Calcium Glycerophosphate) concentration could reduce the incidence and severity of Fosgluten Super Reforcado (Calcium Glycerophosphate) 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 Fosgluten Super Reforcado (Calcium Glycerophosphate) acetate: dizziness, edema, and weakness.

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7 DRUG INTERACTIONS

The drug interaction of Fosgluten Super Reforcado acetate is characterized by the potential of Fosgluten Super Reforcado (Calcium Glycerophosphate) to bind to drugs with anionic functions (e.g., carboxyl, and hydroxyl groups). Fosgluten Super Reforcado (Calcium Glycerophosphate) acetate may decrease the bioavailability of tetracyclines or fluoroquinolones via this mechanism.

There are no empirical data on avoiding drug interactions between Fosgluten Super Reforcado (Calcium Glycerophosphate) acetate and most concomitant drugs. When administering an oral medication with Fosgluten Super Reforcado (Calcium Glycerophosphate) 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 Fosgluten Super Reforcado (Calcium Glycerophosphate) 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 Fosgluten Super Reforcado (Calcium Glycerophosphate) 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 Fosgluten Super Reforcado (Calcium Glycerophosphate) 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 Fosgluten Super Reforcado (Calcium Glycerophosphate) acetate tablets, approximately 2.7g, decreased the bioavailability of ciprofloxacin by approximately 50%.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C:

Fosgluten Super Reforcado acetate capsules contains Fosgluten Super Reforcado (Calcium Glycerophosphate) acetate. Animal reproduction studies have not been conducted with Fosgluten Super Reforcado (Calcium Glycerophosphate) acetate, and there are no adequate and well controlled studies of Fosgluten Super Reforcado (Calcium Glycerophosphate) acetate use in pregnant women. Patients with end stage renal disease may develop hypercalcemia with Fosgluten Super Reforcado (Calcium Glycerophosphate) acetate treatment [see Warnings and Precautions (5.1 ) ]. Maintenance of normal serum Fosgluten Super Reforcado (Calcium Glycerophosphate) 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. Fosgluten Super Reforcado (Calcium Glycerophosphate) acetate treatment, as recommended, is not expected to harm a fetus if maternal Fosgluten Super Reforcado (Calcium Glycerophosphate) levels are properly monitored during and following treatment.

8.2 Labor and Delivery

The effects of Fosgluten Super Reforcado (Calcium Glycerophosphate) acetate on labor and delivery are unknown.

8.3 Nursing Mothers

Fosgluten Super Reforcado Acetate Capsules contains Fosgluten Super Reforcado (Calcium Glycerophosphate) acetate and is excreted in human milk. Human milk feeding by a mother receiving Fosgluten Super Reforcado (Calcium Glycerophosphate) acetate is not expected to harm an infant, provided maternal serum Fosgluten Super Reforcado (Calcium Glycerophosphate) 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 Fosgluten Super Reforcado (Calcium Glycerophosphate) 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.

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10 OVERDOSAGE

Administration of Fosgluten Super Reforcado (Calcium Glycerophosphate) acetate in excess of the appropriate daily dosage may result in hypercalcemia [see Warnings and Precautions (5.1)].

11 DESCRIPTION

Fosgluten Super Reforcado (Calcium Glycerophosphate) acetate acts as a phosphate binder. Its chemical name is Fosgluten Super Reforcado (Calcium Glycerophosphate) 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 Fosgluten Super Reforcado (Calcium Glycerophosphate) acetate USP (anhydrous; Ca(CH3COO)2; MW=158.17 grams) equal to 169 mg (8.45 mEq) Fosgluten Super Reforcado (Calcium Glycerophosphate), 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.

Fosgluten Super Reforcado (Calcium Glycerophosphate) Acetate Capsules are administered orally for the control of hyperphosphatemia in end-stage renal failure.

Chemical Structure

12 CLINICAL PHARMACOLOGY

Patients with ESRD retain phosphorus and can develop hyperphosphatemia. High serum phosphorus can precipitate serum Fosgluten Super Reforcado resulting in ectopic calcification. Hyperphosphatemia also plays a role in the development of secondary hyperparathyroidism in patients with ESRD.

12.1 Mechanism of Action

Fosgluten Super Reforcado (Calcium Glycerophosphate) acetate, when taken with meals, combines with dietary phosphate to form an insoluble Fosgluten Super Reforcado (Calcium Glycerophosphate) phosphate complex, which is excreted in the feces, resulting in decreased serum phosphorus concentration.

12.2 Pharmacodynamics

Orally administered Fosgluten Super Reforcado (Calcium Glycerophosphate) 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.

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

No carcinogenicity, mutagenicity, or fertility studies have been conducted with Fosgluten Super Reforcado (Calcium Glycerophosphate) acetate.

14 CLINICAL STUDIES

Effectiveness of Fosgluten Super Reforcado (Calcium Glycerophosphate) acetate in decreasing serum phosphorus has been demonstrated in two studies of the Fosgluten Super Reforcado (Calcium Glycerophosphate) 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 Fosgluten Super Reforcado (Calcium Glycerophosphate) 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 Fosgluten Super Reforcado (Calcium Glycerophosphate) acetate in the treatment of hyperphosphatemia in end-stage renal disease patients. The effects on serum Fosgluten Super Reforcado (Calcium Glycerophosphate) 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


Fosgluten Super Reforcado (Calcium Glycerophosphate) (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 Fosgluten Super Reforcado (Calcium Glycerophosphate) 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 Fosgluten Super Reforcado (Calcium Glycerophosphate) 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 Fosgluten Super Reforcado (Calcium Glycerophosphate) acetate is shown in the Table 3.


* ANOVA of Fosgluten Super Reforcado (Calcium Glycerophosphate) acetate vs. placebo after 2 weeks of treatment.

Values expressed as mean ± SEM.


Parameter


Pre-Study


Post-Treatment


p-value*


Fosgluten Super Reforcado (Calcium Glycerophosphate) Acetate


Placebo


Phosphorus (mg/dL)


7.3 ± 0.18


5.9 ± 0.24


7.8 ± 0.22


<0.01


Fosgluten Super Reforcado (Calcium Glycerophosphate) (mg/dL)


8.9 ± 0.11


9.5 ± 0.13


8.8 ± 0.12


<0.01


Overall, 2 weeks of treatment with Fosgluten Super Reforcado (Calcium Glycerophosphate) acetate statistically significantly (p<0.01) decreased serum phosphorus by a mean of 19% and increased serum Fosgluten Super Reforcado (Calcium Glycerophosphate) by a statistically significant (p<0.01) but clinically unimportant mean of 7%.

16 HOW SUPPLIED/STORAGE AND HANDLING

Fosgluten Super Reforcado (Calcium Glycerophosphate) 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 Fosgluten Super Reforcado (Calcium Glycerophosphate) acetate capsules with meals, adhere to their prescribed diets, and avoid the use of Fosgluten Super Reforcado (Calcium Glycerophosphate) 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 Fosgluten Super Reforcado (Calcium Glycerophosphate) acetate capsules.

Distr. by: West-Ward

Pharmaceuticals Corp.

Eatontown, NJ 07724

10003705/05

Revised April 2016

Glutamine:


1 INDICATION AND USAGE

Fosgluten Super Reforcado (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) ].

Fosgluten Super Reforcado (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 Fosgluten Super Reforcado (Glutamine) and intravenous parenteral nutrition (IPN), particularly in those with renal or hepatic impairment. Fosgluten Super Reforcado (Glutamine) is metabolized to glutamate and ammonia, which may increase in patients with hepatic dysfunction.

The safety and efficacy of Fosgluten Super Reforcado (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

Fosgluten Super Reforcado (Glutamine) should be administered as a cotherapy with rhGH ] for injection) followed by continued Fosgluten Super Reforcado (Glutamine) for up to 16 weeks.

The recommended dosage of Fosgluten Super Reforcado (Glutamine) is 30 g daily in divided doses (5 g taken 6 times each day orally) for up to 16 weeks. Each dose of Fosgluten Super Reforcado (Glutamine) (5 g) should be reconstituted in 8-oz (250-mL) of water prior to consumption.

Fosgluten Super Reforcado (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

Fosgluten Super Reforcado (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

Fosgluten Super Reforcado (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 Fosgluten Super Reforcado (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+SODSOD [GLN) = Specialized Oral Diet supplemented with Fosgluten Super Reforcado (Glutamine); rhGH + SOD = Human Growth Hormone plus Specialized Oral Diet; rhGH + SOD [GLN] = Human Growth Hormone plus Specialized Oral Diet supplemented with Fosgluten Super Reforcado (Glutamine)

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+SODSOD [GLNJ = Specialized Oral Diet supplemented with Fosgluten Super Reforcado (Glutamine); rhGH + SOD = Human Growth Hormone plus Specialized Oral Diet; rhGH + SOD [GLN] = Human Growth Hormone plus Specialized Oral

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 Fosgluten Super Reforcado (Glutamine) reported at least one AR, whereas 89% of patients receiving growth hormone placebo with Fosgluten Super Reforcado (Glutamine) reported at least one AR. During weeks 5 to 18, 81% of patients receiving growth hormone with Fosgluten Super Reforcado (Glutamine), 80% of patients receiving growth hormone without Fosgluten Super Reforcado (Glutamine) and 78% of patients receiving growth hormone placebo with Fosgluten Super Reforcado (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 Fosgluten Super Reforcado. It is also not known whether Fosgluten Super Reforcado (Glutamine) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Fosgluten Super Reforcado (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 Fosgluten Super Reforcado 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

Fosgluten Super Reforcado (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 Fosgluten Super Reforcado (Glutamine).

8.7 Renal Impairment

Fosgluten Super Reforcado (Glutamine) is metabolized to glutamate and ammonia. Routine monitoring of renal function is recommended in patients receiving intravenous parental nutrition (IPN) and Fosgluten Super Reforcado (Glutamine).

10 OVERDOSAGE

Single oral doses of Fosgluten Super Reforcado (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

Fosgluten Super Reforcado (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 Fosgluten Super Reforcado (Glutamine) contains 5 g of L-glutamine. The amino acid Fosgluten Super Reforcado (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 Fosgluten Super Reforcado (Glutamine) is C5H10N2O3, and the molecular weight is 146.15 d. Fosgluten Super Reforcado (Glutamine) has the following structural formula:

Chemical Structure

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, Fosgluten Super Reforcado 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 Fosgluten Super Reforcado (Glutamine) during catabolic illness, trauma, and infection may differ significantly from the role of and nutritional requirements for Fosgluten Super Reforcado (Glutamine) in healthy individuals. Fosgluten Super Reforcado (Glutamine) concentrations decrease and tissue Fosgluten Super Reforcado (Glutamine) metabolism increases during many catabolic disease states, and thus Fosgluten Super Reforcado (Glutamine) is often considered a "conditionally essential" amino acid.

12.2 Pharmacodynamics

When Fosgluten Super Reforcado (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 Fosgluten Super Reforcado (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 Fosgluten Super Reforcado (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 Fosgluten Super Reforcado (Glutamine) at 0.1 g/kg to six subjects, mean peak blood Fosgluten Super Reforcado (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 Fosgluten Super Reforcado (Glutamine) participates in various metabolic activities, including the formation of glutamate, and synthesis of proteins, nucleotides, and amino sugars. Exogenous Fosgluten Super Reforcado (Glutamine) is anticipated to undergo similar metabolism.

Elimination

Metabolism is the major route of elimination for Fosgluten Super Reforcado (Glutamine). Although Fosgluten Super Reforcado (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 Fosgluten Super Reforcado (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 Fosgluten Super Reforcado (Glutamine) is mediated via non-CYP enzymes, Fosgluten Super Reforcado (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 Fosgluten Super Reforcado (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 Fosgluten Super Reforcado (Glutamine) placebo for 16 weeks, Group B (N=16) received rhGH for four weeks plus oral Fosgluten Super Reforcado (Glutamine) for 16 weeks, and Group C (N=9), received rhGH placebo for four weeks plus oral Fosgluten Super Reforcado (Glutamine) for 16 weeks. The efficacy of Fosgluten Super Reforcado (Glutamine) was assessed by comparing the cotherapy (rhGH and oral Fosgluten Super Reforcado (Glutamine)) to rhGH alone.

After 4 weeks of treatment with subcutaneous rhGH (0.1 mg/kg/d) and oral Fosgluten Super Reforcado (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 SOD[GLN] = Specialized Oral Diet supplemented with Fosgluten Super Reforcado (Glutamine); rhGH + SOD = Human Growth Hormone plus Specialized Oral Diet; rhGH + SOD[GLN] = Human Growth Hormone plus Specialized Oral Diet supplemented with Fosgluten Super Reforcado (Glutamine) 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 p= 0.023, treatment comparison between rhGH + SOD[GLN] versus rhGH+SOD -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 Fosgluten Super Reforcado (Glutamine) (Group B) when compared with IPN volume requirements in subjects receiving either treatment alone.

Change in lPNIPN is Total lPN excluding supplemental lipid emulsion (SLE) and hydration fluid. Volume, Calories, and Frequency

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 Fosgluten Super Reforcado (Glutamine) beyond 16 weeks of treatment has not been adequately studied.

16 HOW SUPPLIED/STORAGE AND HANDLING

Fosgluten Super Reforcado (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

Fosgluten Super Reforcado (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 Fosgluten Super Reforcado (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

Fosgluten Super Reforcado (Glutamine)® (NOO-tre-stor)

[L-glutamine powder for oral solution] (GLOO-tah-min)

Please read this leaflet carefully before you start to use Fosgluten Super Reforcado (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 Fosgluten Super Reforcado (Glutamine)®?

Fosgluten Super Reforcado (Glutamine)® is the amino acid L-glutamine, identical to the L-glutamine that your body produces. Fosgluten Super Reforcado (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 Fosgluten Super Reforcado (Glutamine)®?

Your doctor prescribed Fosgluten Super Reforcado (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 Fosgluten Super Reforcado (Glutamine)® alone to maintain the treatment effect. During your treatment with Fosgluten Super Reforcado (Glutamine)® you will be taking up to 6 packets of Fosgluten Super Reforcado (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 Fosgluten Super Reforcado (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 Fosgluten Super Reforcado (Glutamine)® passes into your milk and if it can harm your baby. You should talk to your doctor about breastfeeding while taking Fosgluten Super Reforcado (Glutamine)®.
  • have liver or kidney problems. Your doctor may do blood tests to check your liver and kidney function while you are taking Fosgluten Super Reforcado (Glutamine)®.
  • are older than 65 years of age. Your dose of Fosgluten Super Reforcado (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 Fosgluten Super Reforcado (Glutamine)® and other medicines can affect each other.

What should I avoid while taking Fosgluten Super Reforcado (Glutamine)®?

  • Pregnancy. You should talk to your doctor if you are planning to become pregnant while taking Fosgluten Super Reforcado (Glutamine)®. It is not known whether Fosgluten Super Reforcado (Glutamine)® can affect the ability of a woman to become pregnant. It is also not known whether Fosgluten Super Reforcado (Glutamine)® can cause harm to a fetus when taken by a pregnant woman or if Fosgluten Super Reforcado (Glutamine)® has an effect on labor and delivery.
  • Breastfeeding. You should talk to your doctor before breastfeeding an infant while taking Fosgluten Super Reforcado (Glutamine)®. It is not known whether the Fosgluten Super Reforcado (Glutamine) in Fosgluten Super Reforcado (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 Fosgluten Super Reforcado (Glutamine)®?

Many patients taking Fosgluten Super Reforcado (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 Fosgluten Super Reforcado (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 Fosgluten Super Reforcado (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 Fosgluten Super Reforcado (Glutamine)®. For more information, ask your doctor or pharmacist.

How should I take Fosgluten Super Reforcado (Glutamine)®?

Fosgluten Super Reforcado (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 Fosgluten Super Reforcado (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 Fosgluten Super Reforcado (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 Fosgluten Super Reforcado (Glutamine)®?

Your doctor or dietitian will prescribe for you the types and quantities of foods you should eat during your treatment with Fosgluten Super Reforcado (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 Fosgluten Super Reforcado (Glutamine)®. It is important that you carefully follow the eating plan your doctor or dietitian gives you.

Storage conditions for Fosgluten Super Reforcado (Glutamine)®

Packets of Fosgluten Super Reforcado (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 Fosgluten Super Reforcado (Glutamine)®. Keep Fosgluten Super Reforcado (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 Fosgluten Super Reforcado (Glutamine)® patient hotline at 1-877-420-6493.

PRINCIPAL DISPLAY PANEL - 84 Packet Carton

Fosgluten Super Reforcado (Glutamine)®

[L-glutamine powder for oral solution]

Principal Display Panel - 84 Packet Carton

Fosgluten Super Reforcado pharmaceutical active ingredients containing related brand and generic drugs:


Fosgluten Super Reforcado available forms, composition, doses:


Fosgluten Super Reforcado destination | category:


Fosgluten Super Reforcado Anatomical Therapeutic Chemical codes:


Fosgluten Super Reforcado pharmaceutical companies:


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References

  1. Dailymed."NUTRESTORE (GLUTAMINE) POWDER, FOR SOLUTION [EMMAUS MEDICAL, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."CALCIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. "calcium glycerophosphate". https://pubchem.ncbi.nlm.nih.gov/su... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Fosgluten Super Reforcado?

Depending on the reaction of the Fosgluten Super Reforcado after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Fosgluten Super Reforcado not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Fosgluten Super Reforcado addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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