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DRUGS & SUPPLEMENTS
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Gluserin B12
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Gluserin B12 uses
Gluserin B12 consists of DL-Phosphoserine, Glutamine, Vitamin B12 (Cyanocobalamin).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
Gluserin B12 (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) ].
Gluserin B12 (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 Gluserin B12 (Glutamine) and intravenous parenteral nutrition (IPN), particularly in those with renal or hepatic impairment. Gluserin B12 (Glutamine) is metabolized to glutamate and ammonia, which may increase in patients with hepatic dysfunction.
The safety and efficacy of Gluserin B12 (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
Gluserin B12 (Glutamine) should be administered as a cotherapy with rhGH ] for injection) followed by continued Gluserin B12 (Glutamine) for up to 16 weeks.
The recommended dosage of Gluserin B12 (Glutamine) is 30 g daily in divided doses (5 g taken 6 times each day orally) for up to 16 weeks. Each dose of Gluserin B12 (Glutamine) (5 g) should be reconstituted in 8-oz (250-mL) of water prior to consumption.
Gluserin B12 (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
Gluserin B12 (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
Gluserin B12 (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 Gluserin B12 (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 Gluserin B12 (Glutamine) reported at least one AR, whereas 89% of patients receiving growth hormone placebo with Gluserin B12 (Glutamine) reported at least one AR. During weeks 5 to 18, 81% of patients receiving growth hormone with Gluserin B12 (Glutamine), 80% of patients receiving growth hormone without Gluserin B12 (Glutamine) and 78% of patients receiving growth hormone placebo with Gluserin B12 (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 Gluserin B12. It is also not known whether Gluserin B12 (Glutamine) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Gluserin B12 (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 Gluserin B12 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
Gluserin B12 (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 Gluserin B12 (Glutamine).
8.7 Renal Impairment
Gluserin B12 (Glutamine) is metabolized to glutamate and ammonia. Routine monitoring of renal function is recommended in patients receiving intravenous parental nutrition (IPN) and Gluserin B12 (Glutamine).
10 OVERDOSAGE
Single oral doses of Gluserin B12 (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
Gluserin B12 (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 Gluserin B12 (Glutamine) contains 5 g of L-glutamine. The amino acid Gluserin B12 (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 Gluserin B12 (Glutamine) is C5H10N2O3, and the molecular weight is 146.15 d. Gluserin B12 (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, Gluserin B12 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 Gluserin B12 (Glutamine) during catabolic illness, trauma, and infection may differ significantly from the role of and nutritional requirements for Gluserin B12 (Glutamine) in healthy individuals. Gluserin B12 (Glutamine) concentrations decrease and tissue Gluserin B12 (Glutamine) metabolism increases during many catabolic disease states, and thus Gluserin B12 (Glutamine) is often considered a "conditionally essential" amino acid.
12.2 Pharmacodynamics
When Gluserin B12 (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 Gluserin B12 (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 Gluserin B12 (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 Gluserin B12 (Glutamine) at 0.1 g/kg to six subjects, mean peak blood Gluserin B12 (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 Gluserin B12 (Glutamine) participates in various metabolic activities, including the formation of glutamate, and synthesis of proteins, nucleotides, and amino sugars. Exogenous Gluserin B12 (Glutamine) is anticipated to undergo similar metabolism.
Elimination
Metabolism is the major route of elimination for Gluserin B12 (Glutamine). Although Gluserin B12 (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 Gluserin B12 (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 Gluserin B12 (Glutamine) is mediated via non-CYP enzymes, Gluserin B12 (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 Gluserin B12 (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 Gluserin B12 (Glutamine) placebo for 16 weeks, Group B (N=16) received rhGH for four weeks plus oral Gluserin B12 (Glutamine) for 16 weeks, and Group C (N=9), received rhGH placebo for four weeks plus oral Gluserin B12 (Glutamine) for 16 weeks. The efficacy of Gluserin B12 (Glutamine) was assessed by comparing the cotherapy (rhGH and oral Gluserin B12 (Glutamine)) to rhGH alone.
After 4 weeks of treatment with subcutaneous rhGH (0.1 mg/kg/d) and oral Gluserin B12 (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 Gluserin B12 (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 Gluserin B12 (Glutamine) beyond 16 weeks of treatment has not been adequately studied.
16 HOW SUPPLIED/STORAGE AND HANDLING
Gluserin B12 (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
Gluserin B12 (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 Gluserin B12 (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
Gluserin B12 (Glutamine)® (NOO-tre-stor)
[L-glutamine powder for oral solution] (GLOO-tah-min)
Please read this leaflet carefully before you start to use Gluserin B12 (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 Gluserin B12 (Glutamine)®?
Gluserin B12 (Glutamine)® is the amino acid L-glutamine, identical to the L-glutamine that your body produces. Gluserin B12 (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 Gluserin B12 (Glutamine)®?
Your doctor prescribed Gluserin B12 (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 Gluserin B12 (Glutamine)® alone to maintain the treatment effect. During your treatment with Gluserin B12 (Glutamine)® you will be taking up to 6 packets of Gluserin B12 (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 Gluserin B12 (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 Gluserin B12 (Glutamine)® passes into your milk and if it can harm your baby. You should talk to your doctor about breastfeeding while taking Gluserin B12 (Glutamine)®.
- have liver or kidney problems. Your doctor may do blood tests to check your liver and kidney function while you are taking Gluserin B12 (Glutamine)®.
- are older than 65 years of age. Your dose of Gluserin B12 (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 Gluserin B12 (Glutamine)® and other medicines can affect each other.
What should I avoid while taking Gluserin B12 (Glutamine)®?
- Pregnancy. You should talk to your doctor if you are planning to become pregnant while taking Gluserin B12 (Glutamine)®. It is not known whether Gluserin B12 (Glutamine)® can affect the ability of a woman to become pregnant. It is also not known whether Gluserin B12 (Glutamine)® can cause harm to a fetus when taken by a pregnant woman or if Gluserin B12 (Glutamine)® has an effect on labor and delivery.
- Breastfeeding. You should talk to your doctor before breastfeeding an infant while taking Gluserin B12 (Glutamine)®. It is not known whether the Gluserin B12 (Glutamine) in Gluserin B12 (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 Gluserin B12 (Glutamine)®?
Many patients taking Gluserin B12 (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 Gluserin B12 (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 Gluserin B12 (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 Gluserin B12 (Glutamine)®. For more information, ask your doctor or pharmacist.
How should I take Gluserin B12 (Glutamine)®?
Gluserin B12 (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 Gluserin B12 (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 Gluserin B12 (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 Gluserin B12 (Glutamine)®?
Your doctor or dietitian will prescribe for you the types and quantities of foods you should eat during your treatment with Gluserin B12 (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 Gluserin B12 (Glutamine)®. It is important that you carefully follow the eating plan your doctor or dietitian gives you.
Storage conditions for Gluserin B12 (Glutamine)®
Packets of Gluserin B12 (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 Gluserin B12 (Glutamine)®. Keep Gluserin B12 (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 Gluserin B12 (Glutamine)® patient hotline at 1-877-420-6493.
PRINCIPAL DISPLAY PANEL - 84 Packet Carton
Gluserin B12 (Glutamine)®
[L-glutamine powder for oral solution]
Principal Display Panel - 84 Packet Carton
Vitamin B12 (Cyanocobalamin):
Pharmacological action
Gluserin B12 ) refers to a group of water-soluble vitamins. It has high biological activity. Gluserin B12 (Vitamin B12 (Cyanocobalamin)) is necessary for normal hematopoiesis (promotes maturation of erythrocytes). Involved in the processes of transmethylation, hydrogen transport, synthesis of methionine, nucleic acids, choline, creatine. Contributes to the accumulation in erythrocytes of compounds containing sulfhydryl groups. Has a beneficial effect on liver function and the nervous system. Activates the coagulation of blood in high doses causes an increase in the activity of thromboplastin and prothrombin.
Pharmacokinetics
After oral administration Gluserin B12 (Vitamin B12 (Cyanocobalamin)) absorbed from the gastrointestinal tract. Metabolized in the tissues, becoming a co-enzyme form - adenosylcobalamin which is the active form of cyanocobalamin. Excreted in bile and urine.
Why is Gluserin B12 ) prescribed?
Anemia due to B12-deficiency conditions; in the complex therapy for iron and posthemorrhagic anemia; aplastic anemia caused by toxic substances and drugs; liver disease (hepatitis, cirrhosis); funicular myelosis; polyneuritis, radiculitis, neuralgia, amyotrophic lateral sclerosis; children cerebral palsy, Down syndrome, peripheral nerve injury; skin diseases (psoriasis, photodermatosis, herpetiformis dermatitis, neurodermatitis); to prevent and treat symptoms of deficiency of Gluserin B12 (Vitamin B12 (Cyanocobalamin)) (including the application of biguanide, PASA, vitamin C in high doses); radiation sickness.
Dosage and administration
Gluserin B12 ) is used as injections SC, IV, IM, intralumbar, and also oral. With anemia associated with Gluserin B12 (Vitamin B12 (Cyanocobalamin)) deficiency is introduced on 100-200 mcg in 2 days. In anemia with symptoms of funicular myelosis and megalocytic anemia with diseases of the nervous system - 400-500 micrograms in the first 7 days daily, then 1 time every 5-7 days. In the period of remission in the absence of events funicular myelosis maintenance dose - 100 mcg 2 times a month, in the presence of neurological symptoms - at 200-400 mcg 2-4 times a month. In acute post-hemorrhagic anemia and iron anemia by 30-100 mcg 2-3 times a week. When aplastic anemia (especially in children) - 100 micrograms before clinical improvement. When nutritional anemia in infants and preterm - 30 mcg / day during 15 days.
In diseases of the central and peripheral nervous system and neurological diseases with a pain syndrome is administered in increasing doses - 200-500 mcg, with the improvement in the state - 100 mcg / day. The course of treatment with Gluserin B12 (Vitamin B12 (Cyanocobalamin)) is 2 weeks. In traumatic lesions of peripheral nervous system - at 200-400 mcg every other day for 40-45 days.
When hepatitis and cirrhosis - 30-60 mcg / day or 100 mg every other day for 25-40 days.
Dystrophy in young children, Down syndrome and cerebral palsy - by 15-30 mcg every other day.
When funicular myelosis, amyotrophic lateral sclerosis can be introduced into the spinal canal at 15-30 mcg, gradually increasing the dose of 200-250 micrograms.
In radiation sickness, diabetic neuropathy, sprue - by 60-100 mcg daily for 20-30 days.
When deficiency of Gluserin B12 (Vitamin B12 (Cyanocobalamin)) to prevent - IV or IM for 1 mg 1 time a month; for treatment - IV or IM for 1 mg daily for 1-2 weeks, the maintenance dose is 1-2 mg IV or IM from 1 per week, up to 1 per month. Duration of treatment is determined individually.
Gluserin B12 (Vitamin B12 (Cyanocobalamin)) side effects, adverse reactions
CNS: rarely - a state of arousal.
Cardiovascular system: rarely - pain in the heart, tachycardia.
Allergic reactions: rarely - urticaria.
Gluserin B12 ) contraindications
Thromboembolism, erythremia, erythrocytosis, increased sensitivity to cyanocobalamin.
Gluserin B12 ) using during pregnancy and breastfeeding
Cyanocobalamin can be used in pregnancy according to prescriptions.
Special instructions
When stenocardia should be used with caution in a single dose of Gluserin B12 ) 100 mcg. During treatment should regularly monitor the blood picture and coagulation. It is unacceptable to enter in the same syringe with cyanocobalamin solutions of thiamine and pyridoxine.
Gluserin B12 (Vitamin B12 (Cyanocobalamin)) drug interactions
In an application of Gluserin B12 (Vitamin B12 (Cyanocobalamin)) with hormonal contraceptives for oral administration may decrease the concentration of cyanocobalamin in plasma.
In an application with anticonvulsant drugs decreased cyanocobalamin absorption from the gut.
In an Gluserin B12 (Vitamin B12 (Cyanocobalamin)) application with neomycin, aminosalicylic acid, colchicine, cimetidine, ranitidine, drugs potassium decreased cyanocobalamin absorption from the gut.
Cyanocobalamin may exacerbate allergic reactions caused by thiamine.
When parenteral application of chloramphenicol may decrease the hematopoietic effects of cyanocobalamin with anemia.
Pharmaceutical incompatibility
Contained in the molecule of cyanocobalamin cobalt ion contributes to the destruction of ascorbic acid, thiamine bromide, riboflavin in one solution.
Gluserin B12 pharmaceutical active ingredients containing related brand and generic drugs:
Gluserin B12 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.