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DRUGS & SUPPLEMENTS
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Milid
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Milid uses
- 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
Milid® [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) ].
Milid 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 Milid and intravenous parenteral nutrition (IPN), particularly in those with renal or hepatic impairment. Milid is metabolized to glutamate and ammonia, which may increase in patients with hepatic dysfunction.
The safety and efficacy of Milid 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
Milid should be administered as a cotherapy with rhGH ] for injection) followed by continued Milid for up to 16 weeks.
The recommended dosage of Milid is 30 g daily in divided doses (5 g taken 6 times each day orally) for up to 16 weeks. Each dose of Milid (5 g) should be reconstituted in 8-oz (250-mL) of water prior to consumption.
Milid 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
Milid 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
Milid 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 Milid, 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 Milid reported at least one AR, whereas 89% of patients receiving growth hormone placebo with Milid reported at least one AR. During weeks 5 to 18, 81% of patients receiving growth hormone with Milid, 80% of patients receiving growth hormone without Milid and 78% of patients receiving growth hormone placebo with Milid 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 Milid. It is also not known whether Milid can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Milid 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 Milid 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
Milid 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 and Milid.
8.7 Renal Impairment
Milid is metabolized to glutamate and ammonia. Routine monitoring of renal function is recommended in patients receiving intravenous parental nutrition (IPN) and Milid.
10 OVERDOSAGE
Single oral doses of Milid 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
Milid (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 Milid contains 5 g of L-glutamine. The amino acid Milid 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 Milid is C5H10N2O3, and the molecular weight is 146.15 d. Milid 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, Milid 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 Milid during catabolic illness, trauma, and infection may differ significantly from the role of and nutritional requirements for Milid in healthy individuals. Milid concentrations decrease and tissue Milid metabolism increases during many catabolic disease states, and thus Milid is often considered a "conditionally essential" amino acid.
12.2 Pharmacodynamics
When Milid 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 Milid 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 Milid 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 Milid at 0.1 g/kg to six subjects, mean peak blood Milid 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 Milid participates in various metabolic activities, including the formation of glutamate, and synthesis of proteins, nucleotides, and amino sugars. Exogenous Milid is anticipated to undergo similar metabolism.
Elimination
Metabolism is the major route of elimination for Milid. Although Milid 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 Milid 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 Milid is mediated via non-CYP enzymes, Milid 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 Milid 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 Milid placebo for 16 weeks, Group B (N=16) received rhGH for four weeks plus oral Milid for 16 weeks, and Group C (N=9), received rhGH placebo for four weeks plus oral Milid for 16 weeks. The efficacy of Milid was assessed by comparing the cotherapy (rhGH and oral Milid) to rhGH alone.
After 4 weeks of treatment with subcutaneous rhGH (0.1 mg/kg/d) and oral Milid (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 Milid (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 Milid beyond 16 weeks of treatment has not been adequately studied.
16 HOW SUPPLIED/STORAGE AND HANDLING
Milid 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
Milid 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 Milid, 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
Milid® (NOO-tre-stor)
[L-glutamine powder for oral solution] (GLOO-tah-min)
Please read this leaflet carefully before you start to use Milid® 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 Milid®?
Milid® is the amino acid L-glutamine, identical to the L-glutamine that your body produces. Milid® 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 Milid®?
Your doctor prescribed Milid® 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 Milid® alone to maintain the treatment effect. During your treatment with Milid® you will be taking up to 6 packets of Milid® 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 Milid®?
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 Milid® passes into your milk and if it can harm your baby. You should talk to your doctor about breastfeeding while taking Milid®.
- have liver or kidney problems. Your doctor may do blood tests to check your liver and kidney function while you are taking Milid®.
- are older than 65 years of age. Your dose of Milid® 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 Milid® and other medicines can affect each other.
What should I avoid while taking Milid®?
- Pregnancy. You should talk to your doctor if you are planning to become pregnant while taking Milid®. It is not known whether Milid® can affect the ability of a woman to become pregnant. It is also not known whether Milid® can cause harm to a fetus when taken by a pregnant woman or if Milid® has an effect on labor and delivery.
- Breastfeeding. You should talk to your doctor before breastfeeding an infant while taking Milid®. It is not known whether the Milid in Milid® 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 Milid®?
Many patients taking Milid® 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 Milid® 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 Milid® 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 Milid®. For more information, ask your doctor or pharmacist.
How should I take Milid®?
Milid® 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 Milid® 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 Milid® 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 Milid®?
Your doctor or dietitian will prescribe for you the types and quantities of foods you should eat during your treatment with Milid®. 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 Milid®. It is important that you carefully follow the eating plan your doctor or dietitian gives you.
Storage conditions for Milid®
Packets of Milid® should be stored at room temperature (25°C / 77°F). Expiration dates are stated on product labels. Do not use any damaged packets of Milid®. Keep Milid® 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 Milid® patient hotline at 1-877-420-6493.
PRINCIPAL DISPLAY PANEL - 84 Packet Carton
Milid®
[L-glutamine powder for oral solution]
Principal Display Panel - 84 Packet Carton
Milid pharmaceutical active ingredients containing related brand and generic drugs:
Milid 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.