Glamin

Arginine:

• Glamin (Arginine) reviews

Nutritive Wound - Skin Cream

For Minor Cuts and Wounds

- Eases Discomfort

- Soothing Cream

CONTAINS:

Glamin (Arginine) Aminobenzoate 2.5% Patent # 5734080

In a cream base with Safflower Oil, Apricot Kernel Oil, Mixed Tocopherols, Glycerin, Coconut Oil, Borage Oil, Tea Tree Oil, Camphor, Thymine, Lecithin, Grapefruit Extract, Lemon Oil and Aloe Vera.

DIRECTIONS:

Apply topically as needed to superficial wounds and abrasions.

INDICATIONS FOR USE:

FelineAid can be used on minor cuts, abrasions and irritations as well as superficial wounds and skin lesions on cats.

CAUTIONS:

Avoid contact with eyes. If contact occurs, flush with copious amounts of water. If condition persists or worsens discontinue use.

Shake Well

Store at room temperature.

For Veterinary Use Only

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
• Glamin (Glutamine) reviews

1 INDICATION AND USAGE

Glamin (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) ].

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

The safety and efficacy of Glamin (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

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

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

Glamin (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

Glamin (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

Glamin (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 Glamin (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 Glamin (Glutamine); rhGH + SOD = Human Growth Hormone plus Specialized Oral Diet; rhGH + SOD [GLN] = Human Growth Hormone plus Specialized Oral Diet supplemented with Glamin (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 Glamin (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 Glamin (Glutamine) reported at least one AR, whereas 89% of patients receiving growth hormone placebo with Glamin (Glutamine) reported at least one AR. During weeks 5 to 18, 81% of patients receiving growth hormone with Glamin (Glutamine), 80% of patients receiving growth hormone without Glamin (Glutamine) and 78% of patients receiving growth hormone placebo with Glamin (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 Glamin. It is also not known whether Glamin (Glutamine) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Glamin (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 Glamin 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

Glamin (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 Glamin (Glutamine).

8.7 Renal Impairment

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

10 OVERDOSAGE

Single oral doses of Glamin (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

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

12.2 Pharmacodynamics

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

Elimination

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

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

16 HOW SUPPLIED/STORAGE AND HANDLING

Glamin (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

Glamin (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 Glamin (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

Glamin (Glutamine)^® (NOO-tre-stor)

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

Please read this leaflet carefully before you start to use Glamin (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 Glamin (Glutamine)^®?

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

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

What should I avoid while taking Glamin (Glutamine)^®?

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

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

How should I take Glamin (Glutamine)^®?

Glamin (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 Glamin (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 Glamin (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 Glamin (Glutamine)^®?

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

Storage conditions for Glamin (Glutamine)^®

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

PRINCIPAL DISPLAY PANEL - 84 Packet Carton

Glamin (Glutamine)^®

[L-glutamine powder for oral solution]

Principal Display Panel - 84 Packet Carton

Glycine:

• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Overdosage
• Dosage and administration
• How supplied
• Im-1453
• Glamin (Glycine) reviews

INDICATIONS AND USAGE

1.5% Glamin (Glycine) Irrigation, USP is indicated for use as irrigating fluid during transurethral prostatic resection and other transurethral surgical procedures.

CONTRAINDICATIONS

NOT FOR INJECTION BY USUAL PARENTERAL ROUTES.

Do not use in patients with anuria.

WARNINGS

FOR UROLOGIC IRRIGATION ONLY.

Solutions for urologic irrigation must be used with caution in patients with severe cardiopulmonary or renal dysfunction. Irrigating fluids used during transurethral prostatectomy have been demonstrated to enter the systemic circulation in relatively large volumes. Thus, Glamin (Glycine) irrigating solution must be regarded as a systemic drug. Absorption of large amounts of fluids containing Glamin (Glycine) may significantly alter cardiopulmonary and renal dynamics.

Do not heat container over 66°C (150°F).

PRECAUTIONS

Cardiovascular status, especially of the patient with cardiac disease, should be carefully observed before and during transurethral resection of the prostate when using Glamin (Glycine) irrigating solution, because the quantity of fluid absorbed into the systemic circulation by opened prostatic veins may produce significant expansion of the extracellular fluid and lead to fulminating congestive heart failure. Shift of sodium free intracellular fluid into the extracellular compartment following systemic absorption of solution may lower serum sodium concentration and aggravate pre-existing hyponatremia.

Care should be exercised if impaired liver function is known or suspected. Under such conditions, ammonia resulting from metabolism of Glamin (Glycine) may accumulate in the blood.

Aseptic technique is essential with the use of sterile solutions for irrigation. The administration set should be attached promptly. Unused portions should be discarded and a fresh container of appropriate size used for the start-up of each cycle or repeat procedure.

Do not administer unless solution is clear, seal is intact and container is undamaged. Discard unused portion.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies with Glamin (Glycine) Irrigation, USP have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

Nursing Mothers: Caution should be exercised when Glamin (Glycine) Irrigation, USP is administered to a nursing woman.

Pregnancy: Teratogenic Effects.

Pregnancy Category C. Animal reproduction studies have not been conducted with Glamin (Glycine) Irrigation, USP. It is also not known whether Glamin (Glycine) Irrigation, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Glamin (Glycine) Irrigation, USP should be given to a pregnant woman only if clearly needed.

Pediatric Use: The safety and effectiveness of Glamin (Glycine) Irrigation have not been established. Its limited use in pediatric patients has been inadequate to fully define proper dosage and limitations for use.

ADVERSE REACTIONS

Adverse reactions may result from intravascular absorption of Glamin (Glycine). Large intravenous doses of Glamin (Glycine) are known to cause salivation, nausea and lightheadedness. Other consequences of absorption of urologic irrigating solutions include fluid and electrolyte disturbances such as acidosis, electrolyte loss, marked diuresis, urinary retention, edema, dryness of mouth, thirst, dehydration, coma from hyponatremia, secondary hyponatremia due to fluid overload, and hyper- ammonemia with resultant coma and/or encephalopathy; cardiovascular disorders such as hypotension, tachycardia, angina-like pains; pulmonary disorders such as pulmonary congestion; and other general reactions such as blurred vision, convulsions, nausea, vomiting, rhinitis, chills, vertigo, backache, transient blindness and urticaria. Allergic reactions from Glamin (Glycine) are unknown or exceedingly rare.

Should any adverse reaction occur, discontinue the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

OVERDOSAGE

In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS.

DOSAGE AND ADMINISTRATION

1.5% Glamin (Glycine) Irrigation, USP should be administered only by transurethral instillation with appropriate urologic instrumentation. A disposable irrigation set should be used. The total volume of solution used for irrigation is solely at the discretion of the surgeon.

Height of container(s) above the operating table in excess of 60 cm (approx. 2 ft.) has been reported to increase intravascular absorption of the irrigating fluid.

Drug Interactions

Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution container permits. See PRECAUTIONS.

HOW SUPPLIED

1.5% Glamin (Glycine) Irrigation, USP is supplied in single-dose 3000 mL flexible irrigation container ( List No. 7974).

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20 to 25°C (68 to 77°F).

Revised: October 2004

©Hospira 2004 EN-0577 Printed in USA

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

IM-1453

iv bag ndc 0409-7974-08

2

HDPE

TO OPEN TEAR AT NOTCH

DO NOT REMOVE FROM OVERWRAP UNTIL READY FOR USE. AFTER REMOVING

THE OVERWRAP, CHECK FOR MINUTE LEAKS BY SQUEEZING CONTAINER FIRMLY.

IF LEAKS ARE FOUND, DISCARD SOLUTION AS STERILITY MAY BE IMPAIRED.

RECOMMENDED STORAGE: ROOM TEMPERATURE (25°C). AVOID EXCESSIVE

HEAT. PROTECT FROM FREEZING. SEE INSERT.

98-4321-R14-3/98

Lysine Acetate:

• Boxed warning
• Description
• Clinical pharmacology
• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Overdosage
• Dosage and administration
• How supplied
• Glamin (Lysine Acetate) reviews

BOXED WARNING

Pharmacy Bulk Package

Not For Direct Infusion

DESCRIPTION

Glamin (Lysine Acetate)^® 15% Amino Acids Injection in a Pharmacy Bulk Package is a sterile, clear, nonpyrogenic solution of essential and nonessential amino acids for intravenous infusion in parenteral nutrition following appropriate dilution.

Glamin (Lysine Acetate)^® 15% in a Pharmacy Bulk Package is not for direct infusion. It is a sterile dosage from which contains several single doses for use in a pharmacy admixture program in the preparation of intravenous parenteral fluids.

Each 100 mL contains:

Essential Amino Acids
Glamin (Lysine Acetate) (from Glamin (Lysine Acetate) Acetate, USP)……………………………………...1.18		g
Leucine, USP……………………………………………………………...1.04		g
Phenylalanine, USP……………………………………...1.04		g
Valine, USP……………………………………………………………...960		mg
Isoleucine, USP………………………………………...749		mg
Methionine, USP………………………………………...749		mg
Threonine, USP………………………………………...749		mg
Tryptophan, USP………………………………………...250		mg
Nonessential Amino Acids
Alanine, USP…………………………………………...2.17		g
Arginine, USP…………………………………………...1.47		g
Glycine, USP…………………………………………...1.04		g
Histidine, USP…………………………………………...894		mg
Proline, USP……………………………………………………………...894		mg
Glutamic Acid…………………………………………...749		mg
Serine, USP……………………………………………...592		mg
Aspartic Acid, USP……………………………………...434		mg
Tyrosine, USP…………………………………………...39		mg
Sodium Metabisulfite, NF added……………………………………………...30		mg
Water for Injection, USP……………………………………………………...		qs
Essential Amino Acids………………………………………………………...6.7		g
Nonessential Amino Acids…………………………………………………...8.3		g
Total Amino Acids…………………………………………………………...15.0		g
Total Nitrogen………………………………………………………………...2.37		g
Acetate*……………………………………………………...151		mEq/L
Osmolarity (calculated)……………………………………...1388		mOsmol/L
pH……………………………………………………………………………...5.6(5.2-6.0)
*Acetate from Glamin (Lysine Acetate) Acetate, USP and acetic acid used for pH adjustment.

The formulas for the individual amino acids are as follows:

Formulas for individual amino acids

CLINICAL PHARMACOLOGY

Glamin (Lysine Acetate)^® 15% Amino Acids Injection providesseventeen crystalline amino acids. This completely utilizable substrate promotesprotein synthesis and wound healing and reduces the rate of protein catabolism.

A.Total Parenteral Nutrition (Central Infusion)

When enteralfeeding is inadvisable, Glamin (Lysine Acetate)^® 15% given by central venousinfusion in combination with energy sources, vitamins, trace elements andelectrolytes, will completely satisfy the requirements for weight maintenanceor weight gain, depending upon the dose selected. The energy component inparenteral nutrition by central infusion may be derived solely from dextroseor may be provided by a combination of dextrose and intravenous fat emulsion. The addition of intravenous fat emulsion provides essential fatty acids andpermits a dietary balance of fat and carbohydrate, at the same time offeringthe option of reducing the dextrose load and/or increasing the total caloricinput. An adequate energy supply is essential for optimal utilization of aminoacids.

B. Total Parenteral Nutrition (Peripheral Infusion)

Glamin (Lysine Acetate)^® 15%can also be administered as part of a total parenteral nutrition program byperipheral vein when the enteral route is inadvisable and use of the centralvenous catheter is contraindicated.

Reduction of proteinloss can be achieved by use of diluted Glamin (Lysine Acetate)^® 15% in combinationwith dextrose or with dextrose and intravenous fat emulsion by peripheralinfusion. Complete peripheral intravenous nutrition can be achieved in patientswith low caloric requirements by a Glamin (Lysine Acetate)^®15%-dextrose-fatregimen.

INDICATIONS AND USAGE

Glamin (Lysine Acetate)^® 15% is indicated as an amino acid(nitrogen) source in parenteral nutrition regimens. This use is appropriatewhen the enteral route is inadvisable, inadequate or not possible, as when:

-Gastrointestinal absorption is impaired by obstruction, inflammatory diseaseor its complications, or antineoplastic therapy;

-Bowel rest is needed because of gastrointestinal surgery or its complicationssuch as ileus, fistulae or anastomotic leaks;

-Tube feeding methods alone cannot provide adequate nutrition.

CONTRAINDICATIONS

This solution should not be used in patients in hepatic coma,severe renal failure, metabolic disorders involving impaired nitrogen utilizationor hypersensitivity to one or more amino acids.

WARNINGS

Administration of amino acids solutions at excessive ratesor to patients with hepatic insufficiency may result in plasma amino acidimbalances, hyperammonemia, prerenal azotemia, stupor and coma. Conservativedoses of amino acids should be given to these patients, dictated by the nutritionalstatus of the patient. Should symptoms of hyperammonemia develop, amino acidadministration should be discontinued and the patient’s clinical statusre-evaluated.

Contains sodium metabisulfite, a sulfitethat may cause allergic-type reactions including anaphylactic symptoms andlife-threatening or less severe asthmatic episodes in certain susceptiblepeople. The overall prevalence of sulfite sensitivity in the general populationis unknown and probably low.

Sulfite sensitivity isseen more frequently in asthmatic than in nonasthmatic people.

WARNING: This product contains aluminum that maybe toxic. Aluminum may reach toxic levels with prolonged parenteral administrationif kidney function is impaired. Premature neonates are particularly at riskbecause their kidneys are immature, and they require large amounts of calciumand phosphate solutions, which contain aluminum.

Researchindicates that patients with impaired kidney function, including prematureneonates, who receive parenteral levels of aluminum at greater than 4 to 5mcg/kg/day accumulate aluminum at levels associated with central nervous systemand bone toxicity. Tissue loading may occur at even lower rates of administration.

PRECAUTIONS

A. GENERAL

It is essential to provide adequate calories concurrently if parenterally administered amino acids are to be retained by the body and utilized for protein synthesis.

The administration of Glamin (Lysine Acetate)^® 15% Amino Acids Injection as part of total parenteral nutrition (TPN) with large volumes of hyperosmotic fluids requires periodic monitoring of the patient for signs of hyperosmolarity, hyperglycemia, glycosuria and hypertriglyceridemia.

During parenteral nutrition with concentrated dextrose and amino acids solutions, essential fatty acid deficiency syndrome may develop but may not be clinically apparent. Early demonstration of this condition can only be accomplished by gas liquid chromatographic analysis of plasma lipids. The syndrome may be prevented or corrected by appropriate treatment with intravenous fat emulsions.

For complete nutritional support, TPN regimens must also include multiple vitamins and trace elements. Potentially incompatible ions such as calcium and phosphate may be added to alternate infusate bottles to avoid precipitation. Although the metabolizable acetate ion in Glamin (Lysine Acetate)^® 15% diminishes the risk of acidosis, the physician must be alert to the potential appearance of this disorder.

Initiation and termination of infusions of TPN fluids must be gradual to permit adjustment of endogenous insulin release.

Undiluted Glamin (Lysine Acetate)^® 15% should not be administered peripherally. When administered centrally, it should be diluted with appropriate diluents, e.g., dextrose, electrolytes and other nutrient components, to at least half strength. See DOSAGE AND ADMINISTRATION.

Caution against volume overload should be exercised.

Drug product contains no more than 25 mcg/L of aluminum.

B. Laboratory Tests

Infusion of Glamin (Lysine Acetate)^® 15% without concomitant infusion of an adequate number of non-protein calories may result in elevated BUN. Monitoring of BUN is required and the balance between Glamin (Lysine Acetate)^® 15% and the calorie source may require adjustment. Frequent clinical evaluations and laboratory determinations are required to prevent the complications which may occur during the administration of solutions used in TPN. Laboratory tests should include blood glucose, serum electrolytes, liver and kidney function, serum osmolarity, blood ammonia, serum protein, pH, hematocrit, WBC and urinary glucose. When Glamin (Lysine Acetate)^® 15% is combined with electrolytes, care should be used in administering this solution to patients with congestive heart failure, renal failure, edema, adrenal hyperactivity, acid-base imbalance and those receiving diuretics or antihypertensive therapy. Total volume infused should be closely monitored. Serum electrolytes should be monitored daily in these patients.

C. Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies with Glamin (Lysine Acetate)^® 15% have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

D. Pregnancy Category C

Animal reproduction studies have not been conducted with Glamin (Lysine Acetate)^® 15%. It is also not known whether Glamin (Lysine Acetate)^® 15% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Glamin (Lysine Acetate)^® 15% should be given to a pregnant woman only if clearly needed.

E. Nursing Mothers

Caution should be exercised when Glamin (Lysine Acetate)^® 15% is administered to a nursing woman.

F. Pediatric Use

Safety and effectiveness of Glamin (Lysine Acetate)^® 15% Amino Acids Injection in pediatric patients have not been established by adequate and well-controlled studies. However, the use of amino acids injections in pediatric patients as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance is referenced in the medical literature.

G. Special Precautions for Central Infusion

TPN delivered by indwelling catheter through a central or large peripheral vein is a special technique requiring a team effort by physician, nurse and pharmacist. The responsibility for administering this therapy should be confined to those trained in the procedures and alert to signs of complications. Complications known to occur from the placement of central venous catheter are pneumothorax, hemothorax, hydrothorax, artery puncture and transection, injury to the brachial plexus, malposition of the catheter, formation of arteriovenous fistula, phlebitis, thrombosis, and air/catheter emboli. The risk of sepsis is present during intravenous therapy, especially when using central venous catheters for prolonged periods. It is imperative that the preparation of admixtures and the placement and care of the catheters be accomplished under controlled aseptic conditions.

H. Admixtures

Admixtures should be prepared under a laminar flow hood using aseptic technique.

Admixtures should be stored under refrigeration and must be administered within 24 hours after removal from refrigerator.

Filters of less than 1.2 micron pore size must not be used with admixtures containing fat emulsion.

I. Do not administer unless solution is clear and the seal is intact.

IT IS ESSENTIAL THAT A CAREFULLY PREPARED PROTOCOL, BASED ON CURRENT MEDICAL PRACTICES, BE FOLLOWED, PREFERABLY BY AN EXPERIENCED TEAM.

ADVERSE REACTIONS

OVERDOSAGE

In the event of overhydration or solute overload, re-evaluatethe patient and institute appropriate corrective measures. See WARNINGS andPRECAUTIONS.

DOSAGE AND ADMINISTRATION

The appropriate daily dose of amino acids to be used withdextrose or with dextrose and intravenous fat emulsion will depend upon themetabolic status and clinical response of the patient as therapy proceeds. Doses which achieve nitrogen equilibrium or positive balance are the mostdesirable. The dosage on the first day should be approximately half the anticipatedoptimal dosage and should be increased gradually to minimize glycosuria; similarly,withdrawal should be accomplished gradually to avoid rebound hypoglycemia.

Fatemulsion coadministration should be considered when prolonged (more than 5days) parenteral nutrition is required in order to prevent essential fattyacid deficiency (EFAD). Serum lipids should be monitored for evidence of EFADin patients maintained on fat free TPN.

The amount administeredis dosed on the basis of amino acids/kg of body weight/day. In general, twoto three g/kg of body weight for neonates and infants with adequate caloriesare sufficient to satisfy protein needs and promote positive nitrogen balance. In pediatric patients, the final solution should not exceed twice normal serumosmolarity (718 mOsmol/L).

DIRECTIONSFOR PROPER USE OF PHARMACY BULK PACKAGE

Glamin (Lysine Acetate)^® 15%in a Pharmacy Bulk Package is not intended for direct infusion. The containerclosure may be penetrated only once using a suitable sterile transfer deviceor dispensing set which allows measured dispensing of the contents. The PharmacyBulk Package is to be used only in a suitable work area such as a laminarflow hood (or an equivalent clean air compounding area). Once the closureis penetrated, the contents should be dispensed as soon as possible; the transferof contents must be completed within 4 hours of closure entry. The bottlemay be stored at room temperature (25°C) after the closure has been entered. Date and time of container entry should be noted in the area designated onthe container label.

When using Glamin (Lysine Acetate)^® 15%in patients with a need for fluid volume restriction, it can be diluted asfollows:

	Volume	Amount	FinalConcentration
Glamin (Lysine Acetate)® 15%	500 mL	75 g	7.5%
Dextrose 70%	250 mL	175 g	17.5%
Intralipid® 20%	250 mL	50 g	5.0%

This will provide 1395 kilocalories (kcal) per 1000 mLof admixture with a ratio of 118 non-protein calories per gram of nitrogenand an osmolarity of 1561 mOsmol/L.

In patients wherethe need for fluid restriction is not so marked, either of the following regimensmay be used dependent upon the energy needs of the patient.

	Volume	Amount	FinalConcentration
Glamin (Lysine Acetate)® 15%	500 mL	75 g	3.75%
Dextrose 50%	1000 mL	500 g	25%
Intralipid® 20%	500 mL	100 g	5%

This will provide 1500 kcal per 1000 mL of admixture witha ratio of 228 non-protein calories per gram of nitrogen and an osmolarityof 1633 mOsmol/L.

	Volume	Amount	FinalConcentration
Glamin (Lysine Acetate)® 15%	500 mL	75 g	3.75%
Dextrose 30%	1000 mL	300 g	15%
Intralipid® 10%	500 mL	50 g	2.5%

This will provide 935 kcal per 1000 mL of admixture witha ratio of 158 non-protein calories per gram of nitrogen and an osmolarityof 1128.5 mOsmol/L.

A. Total Parenteral Nutrition (CentralInfusion)

In unstressed adult patients with no unusualnitrogen losses, a minimum dosage of 0.1 gram nitrogen (4.2 mL of Glamin (Lysine Acetate)^® 15%)plus 4.4 grams (15 calories) of dextrose per kilogram of body weight per dayare required to achieve nitrogen balance and weight stability. Intravenousfat emulsion may be used as a partial substitute for dextrose. This regimenprovides a ratio of 150 non-protein calories per gram of nitrogen.

Forpatients stressed by surgery, trauma or sepsis, and those with unusual nitrogenlosses, the dosage required for maintenance may be as high as 0.3 to 0.4 gramsof nitrogen (13 to 17 mL Glamin (Lysine Acetate)^® 15%) per kilogram of bodyweight per day, with proportionate increases in non-protein calories. Periodicassessment of nitrogen balance of the individual patient is the best indicatorof proper dosage. Volume overload and glycosuria may be encountered at highdosage, and nitrogen balance may not be achieved in extremely hypermetabolicpatients under these constraints. Concomitant insulin administration may berequired to minimize glycosuria. Daily laboratory monitoring is essential.

Useof an infusion pump is advisable to maintain a steady infusion rate duringcentral venous infusion.

B. Peripheral Nutrition

Inpatients for whom central venous catheterization is not advisable, proteincatabolism can be reduced by peripheral use of diluted Glamin (Lysine Acetate)^® 15%plus non-protein calorie sources. Dilution of 250 mL Glamin (Lysine Acetate)^® 15%in 750 mL of 10% dextrose will reduce the osmolarity to a level (724 mOsmol/L)which is more favorable to the maintenance of the integrity of the walls ofthe veins. Intravenous fat emulsion can be infused separately or simultaneously;if infused simultaneously the fat emulsion will provide a dilution effectupon the osmolarity while increasing the energy supply.

Parenteraldrug products should be inspected visually for particulate matter and discolorationprior to administration, whenever solution and container permit.

Toreduce the risk of bacterial contamination, all intravenous administrationsets should be replaced at least every 24 hours. Usage of admixtures mustbe initiated within 24 hours after mixing. If storage is necessary duringthis 24 hour period, admixtures must be refrigerated and completely used within24 hours of beginning administration.

HOW SUPPLIED

Glamin (Lysine Acetate)^® 15% Amino Acids Injection is suppliedas a Pharmacy Bulk Package in 500 mL containers.

500mL NDC 0409-0468-05

STORAGE

Store inthe closed carton; do not expose solution to light until ready for use. Exposureof pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended that the product be stored at 20 to 25°C (68 to 77°F). Brief exposure to temperatures above25°C during transport and storage will not adversely affect the product. Solution that has been frozen must not be used.

©Hospira 2005	EN-1010

Hospira, Inc., Lake Forest, IL 60045 USA

RL-1450

Tryptophan:

• Glamin (Tryptophan) reviews

In Canada, Glamin (Tryptophan) is sold as a prescription drug to treat mood disorders (such as bipolar disorder, depression ). It is usually used with other medicines. It works to make the mood more stable and reduce extremes in behavior by restoring the balance of certain natural substances (serotonin, melatonin ) in the brain. Glamin (Tryptophan) is a natural substance (amino acid) found in high-protein foods and milk. In the US, Glamin (Tryptophan) is sold as a dietary supplement. It has been used to support mood, relaxation, and restful sleep. If you are taking other medications that may affect serotonin (such as many antidepressants ), do not take Glamin (Tryptophan) without talking with your doctor first. A very serious (possibly fatal) drug interaction may occur. Your doctor should closely monitor you. See also Side Effects section. Some supplement products have been found to contain possibly harmful impurities/additives. Check with your pharmacist for more details about the brand you use. The US FDA has not reviewed this product for safety or effectiveness. Consult your doctor or pharmacist for more details.