DRUGS & SUPPLEMENTS

Fosfoglutina B6

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Fosfoglutina B6 uses

Fosfoglutina B6 consists of Calcium Pyrrolidonecarboxylate, Glutamine, Tetraethylammonium Phosphate, Vitamin B6 (Pyridoxine Hydrochloride).

Glutamine:


1 INDICATION AND USAGE

Fosfoglutina B6 (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) ].

Fosfoglutina B6 (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 Fosfoglutina B6 (Glutamine) and intravenous parenteral nutrition (IPN), particularly in those with renal or hepatic impairment. Fosfoglutina B6 (Glutamine) is metabolized to glutamate and ammonia, which may increase in patients with hepatic dysfunction.

The safety and efficacy of Fosfoglutina B6 (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

Fosfoglutina B6 (Glutamine) should be administered as a cotherapy with rhGH ] for injection) followed by continued Fosfoglutina B6 (Glutamine) for up to 16 weeks.

The recommended dosage of Fosfoglutina B6 (Glutamine) is 30 g daily in divided doses (5 g taken 6 times each day orally) for up to 16 weeks. Each dose of Fosfoglutina B6 (Glutamine) (5 g) should be reconstituted in 8-oz (250-mL) of water prior to consumption.

Fosfoglutina B6 (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)
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3 DOSAGE FORMS AND STRENGTHS

Fosfoglutina B6 (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

Fosfoglutina B6 (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 Fosfoglutina B6 (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 Fosfoglutina B6 (Glutamine); rhGH + SOD = Human Growth Hormone plus Specialized Oral Diet; rhGH + SOD [GLN] = Human Growth Hormone plus Specialized Oral Diet supplemented with Fosfoglutina B6 (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 Fosfoglutina B6 (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 Fosfoglutina B6 (Glutamine) reported at least one AR, whereas 89% of patients receiving growth hormone placebo with Fosfoglutina B6 (Glutamine) reported at least one AR. During weeks 5 to 18, 81% of patients receiving growth hormone with Fosfoglutina B6 (Glutamine), 80% of patients receiving growth hormone without Fosfoglutina B6 (Glutamine) and 78% of patients receiving growth hormone placebo with Fosfoglutina B6 (Glutamine) experienced at least one AR. There were no deaths in this study.

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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 Fosfoglutina B6. It is also not known whether Fosfoglutina B6 (Glutamine) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Fosfoglutina B6 (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 Fosfoglutina B6 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

Fosfoglutina B6 (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 Fosfoglutina B6 (Glutamine).

8.7 Renal Impairment

Fosfoglutina B6 (Glutamine) is metabolized to glutamate and ammonia. Routine monitoring of renal function is recommended in patients receiving intravenous parental nutrition (IPN) and Fosfoglutina B6 (Glutamine).

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10 OVERDOSAGE

Single oral doses of Fosfoglutina B6 (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

Fosfoglutina B6 (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 Fosfoglutina B6 (Glutamine) contains 5 g of L-glutamine. The amino acid Fosfoglutina B6 (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 Fosfoglutina B6 (Glutamine) is C5H10N2O3, and the molecular weight is 146.15 d. Fosfoglutina B6 (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, Fosfoglutina B6 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 Fosfoglutina B6 (Glutamine) during catabolic illness, trauma, and infection may differ significantly from the role of and nutritional requirements for Fosfoglutina B6 (Glutamine) in healthy individuals. Fosfoglutina B6 (Glutamine) concentrations decrease and tissue Fosfoglutina B6 (Glutamine) metabolism increases during many catabolic disease states, and thus Fosfoglutina B6 (Glutamine) is often considered a "conditionally essential" amino acid.

12.2 Pharmacodynamics

When Fosfoglutina B6 (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 Fosfoglutina B6 (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 Fosfoglutina B6 (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 Fosfoglutina B6 (Glutamine) at 0.1 g/kg to six subjects, mean peak blood Fosfoglutina B6 (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 Fosfoglutina B6 (Glutamine) participates in various metabolic activities, including the formation of glutamate, and synthesis of proteins, nucleotides, and amino sugars. Exogenous Fosfoglutina B6 (Glutamine) is anticipated to undergo similar metabolism.

Elimination

Metabolism is the major route of elimination for Fosfoglutina B6 (Glutamine). Although Fosfoglutina B6 (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 Fosfoglutina B6 (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 Fosfoglutina B6 (Glutamine) is mediated via non-CYP enzymes, Fosfoglutina B6 (Glutamine) pharmacokinetics are unlikely to be affected by other agents through CYP enzyme inhibition or induction.

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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 Fosfoglutina B6 (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 Fosfoglutina B6 (Glutamine) placebo for 16 weeks, Group B (N=16) received rhGH for four weeks plus oral Fosfoglutina B6 (Glutamine) for 16 weeks, and Group C (N=9), received rhGH placebo for four weeks plus oral Fosfoglutina B6 (Glutamine) for 16 weeks. The efficacy of Fosfoglutina B6 (Glutamine) was assessed by comparing the cotherapy (rhGH and oral Fosfoglutina B6 (Glutamine)) to rhGH alone.

After 4 weeks of treatment with subcutaneous rhGH (0.1 mg/kg/d) and oral Fosfoglutina B6 (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 Fosfoglutina B6 (Glutamine); rhGH + SOD = Human Growth Hormone plus Specialized Oral Diet; rhGH + SOD[GLN] = Human Growth Hormone plus Specialized Oral Diet supplemented with Fosfoglutina B6 (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 Fosfoglutina B6 (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 Fosfoglutina B6 (Glutamine) beyond 16 weeks of treatment has not been adequately studied.

16 HOW SUPPLIED/STORAGE AND HANDLING

Fosfoglutina B6 (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

Fosfoglutina B6 (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 Fosfoglutina B6 (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

Fosfoglutina B6 (Glutamine)® (NOO-tre-stor)

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

Please read this leaflet carefully before you start to use Fosfoglutina B6 (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 Fosfoglutina B6 (Glutamine)®?

Fosfoglutina B6 (Glutamine)® is the amino acid L-glutamine, identical to the L-glutamine that your body produces. Fosfoglutina B6 (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 Fosfoglutina B6 (Glutamine)®?

Your doctor prescribed Fosfoglutina B6 (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 Fosfoglutina B6 (Glutamine)® alone to maintain the treatment effect. During your treatment with Fosfoglutina B6 (Glutamine)® you will be taking up to 6 packets of Fosfoglutina B6 (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 Fosfoglutina B6 (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 Fosfoglutina B6 (Glutamine)® passes into your milk and if it can harm your baby. You should talk to your doctor about breastfeeding while taking Fosfoglutina B6 (Glutamine)®.
  • have liver or kidney problems. Your doctor may do blood tests to check your liver and kidney function while you are taking Fosfoglutina B6 (Glutamine)®.
  • are older than 65 years of age. Your dose of Fosfoglutina B6 (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 Fosfoglutina B6 (Glutamine)® and other medicines can affect each other.

What should I avoid while taking Fosfoglutina B6 (Glutamine)®?

  • Pregnancy. You should talk to your doctor if you are planning to become pregnant while taking Fosfoglutina B6 (Glutamine)®. It is not known whether Fosfoglutina B6 (Glutamine)® can affect the ability of a woman to become pregnant. It is also not known whether Fosfoglutina B6 (Glutamine)® can cause harm to a fetus when taken by a pregnant woman or if Fosfoglutina B6 (Glutamine)® has an effect on labor and delivery.
  • Breastfeeding. You should talk to your doctor before breastfeeding an infant while taking Fosfoglutina B6 (Glutamine)®. It is not known whether the Fosfoglutina B6 (Glutamine) in Fosfoglutina B6 (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 Fosfoglutina B6 (Glutamine)®?

Many patients taking Fosfoglutina B6 (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 Fosfoglutina B6 (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 Fosfoglutina B6 (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 Fosfoglutina B6 (Glutamine)®. For more information, ask your doctor or pharmacist.

How should I take Fosfoglutina B6 (Glutamine)®?

Fosfoglutina B6 (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 Fosfoglutina B6 (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 Fosfoglutina B6 (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 Fosfoglutina B6 (Glutamine)®?

Your doctor or dietitian will prescribe for you the types and quantities of foods you should eat during your treatment with Fosfoglutina B6 (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 Fosfoglutina B6 (Glutamine)®. It is important that you carefully follow the eating plan your doctor or dietitian gives you.

Storage conditions for Fosfoglutina B6 (Glutamine)®

Packets of Fosfoglutina B6 (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 Fosfoglutina B6 (Glutamine)®. Keep Fosfoglutina B6 (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 Fosfoglutina B6 (Glutamine)® patient hotline at 1-877-420-6493.

PRINCIPAL DISPLAY PANEL - 84 Packet Carton

Fosfoglutina B6 (Glutamine)®

[L-glutamine powder for oral solution]

Principal Display Panel - 84 Packet Carton

Fosfoglutina B6 pharmaceutical active ingredients containing related brand and generic drugs:

infoActive ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Fosfoglutina B6 available forms, composition, doses:

infoForm of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
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.


Fosfoglutina B6 destination | category:

infoDestination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Fosfoglutina B6 Anatomical Therapeutic Chemical codes:

infoA medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Fosfoglutina B6 pharmaceutical companies:

infoPharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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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. "Tetraethylammonium". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
  3. "Tetraethylammonium". http://www.drugbank.ca/drugs/DB0883... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Fosfoglutina B6?

Depending on the reaction of the Fosfoglutina B6 after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Fosfoglutina B6 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 Fosfoglutina B6 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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Review

sDrugs.com conducted a study on Fosfoglutina B6, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Fosfoglutina B6 consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

One visitor reported useful

How is the drug Fosfoglutina B6 useful in reducing or relieving the symptoms? How useful is it?
According to the survey conducted by the website sDrugs.com, there are variable results and below are the percentages of the users that say the medicine is useful to them and that say it is not helping them much. It is not ideal to continue taking the medication if you feel it is not helping you much. Contact your healthcare provider to check if there is a need to change the medicine or if there is a need to re-evaluate your condition. The usefulness of the medicine may vary from patient to patient, depending on the other diseases he is suffering from and slightly depends on the brand name.
Visitors%
Useful1
100.0%

One visitor reported frequency of use

How often in a day do you take the medicine?
Are you taking the Fosfoglutina B6 drug as prescribed by the doctor?

Few medications can be taken Twice in a day more than prescribed when the doctor's advice mentions the medicine can be taken according to frequency or severity of symptoms. Most times, be very careful and clear about the number of times you are taking the medication. The report of sDrugs.com website users about the frequency of taking the drug Fosfoglutina B6 is mentioned below.
Visitors%
Twice in a day1
100.0%

One visitor reported doses

What is the dose of Fosfoglutina B6 drug you are taking?
According to the survey conducted among sDrugs.com website users, the maximum number of people are using the following dose 6-10mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
Visitors%
6-10mg1
100.0%

One visitor reported age

Visitors%
46-601
100.0%

Visitor reviews


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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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