XINMAILIN®（Glutamin Granules）
XINMAILIN®（Glutamin Granules）
XINMAILIN®（Glutamin Granules）
XINMAILIN®（Glutamin Granules）
【Ingredients】
1, The main ingredient of this product: glutamine
Chemical name: L-2-amino-glutaramic acid
Chemical structural formula:
Molecular formula:C5H10203
Molecular weight: 146.15
2、Excipients:dextrin
【Description】
This product is white or off-white granules.
【Indications】
This product is an amino acid drug. And it is indicated for the treatment of chronic gastritis.
【Specifications】
1.0g
【Dosage and administration】
Administration: oral administration prior to a meal
Dosage: 1g each time (one bag each time), and twice or three times a day Or otherwise as directed by your physician.
【Adverse reactions】
Digestive system: incidental upper abdominal pain, stomach upset, vomiting, nausea, diarrhea, constipation, and so forth.
Others: incidental thirst, erythematous malar rash, facial flushing, etc.
【Contraindications】
Persons who are hypersensitive to this product.
【Precautions】
1, This product is an amino acid drug. For the patients with chronic kidney failure,overdose can cause damage to the kidneys, and therefore in a case like this, glutamine must be administered under the close supervision by a physician.
Glutamine can increase intestinal absorption of chlorine and sodium, and thus increase intestinal absorption of water, which is beneficial for diarrhea patients,but may cause the stool to become hard,leading to constipation, in the case of patients without diarrhea. Patients who are on this drug for a long period of time must increase the intake of fiber-rich foods and drink a large amount of water.
3, This product is not indicated for the patients with severe liver diseases. For the patients with severe cirrhosis and other metabolic diseases, an elevated blood ammonia level may predispose to hepatic encephalopathy and even hepatic coma.
This product will be destroyed by hydrolysis at a high temperature, and therefore it must be taken at ambient temperature or with cold food or drinks, and cannot be taken with heated food or acid-rich foods.
【Use in pregnant and lactating women】
This product is a conditionally essential amino acid to the human body, with certain benefits for the pregnant women.Whether it may affect the fetus remains unknown. However,it was demonstrated in some reports that there is a high level of glutamine in the amniotic fluid, and any adverse reaction was not observed following intravenous administration of glutamine in premature infants.
【Pediatric use】
Unknown
【Geriatric use】
In general, It should be cautioned to reduce dose in the geriatric patients when the physiological functions in them are low.
【Drug interactions】
This product will not affect the metabolism of other drugs.
【Pharmacology and Toxicology】
Pharmacological effects: It is demonstrated in in vitro experiments that glutamine has a protective and repairing effect on gastro-intestinal mucosal damage, which is due to the reason that glutamine plays a promoting role in the biochemical synthesis of gastrointestinal mucosal epithelial components, hexosamine as well as glucosamine. In an experiment using a pylorus-ligated rat model, it is demonstrated that after being given orally,glutamine can inhibit the ulcers induced by aspirin and indomethacin.
Toxicology study: the results remain unknown.
【Pharmacokinetics】
As reported in literatures, after oral administration of L-Gln in healthy volunteers,the whole blood L-G1n concentration increased in proportion to the amount of L-G1n taken orally. The blood L-Gln level peaks at 30 to 45 minutes, and then slowly declines to a normal level at 90 to 120 minutes (low dose of 0.1g Gln/kg) or 180 to 240 minutes (high dose of 0.3g Gln/kg). The Vd of L-Gln after oral administration (512±63ml/kg at a low dose of 0.1k/kg, and 1254±84ml/kg at a high dose of 0.3g/kg) is significantly greater than that of 210±20ml/kg after intravenous injection, with the Gln T1/2being 106±11min and 117±17min, respectively. The absorption rate calculated after oral administration of Gln is approximately 84% （in subjects receiving the high dose of 0.3g/kg) and 57% (in subjects receiving the low dose of 0.1g/kg). The elimination half-life of L-glutamine after oral administration is longer than that following intravenous injection, with greater apparent volume of distribution compared to that after intravenous injection, which results from incomplete absorption after oral administration or absorption of amino acid by the viscera.
【Storage】
This product should be stored sealed in a light-proof,shaded and cool place (at a temperature not exceeding 20℃) This product should be used within the validity period.
【Packaging】
Aluminum-plastic composite film packaging, 1.0g per bag, 10 bags per box, 12 bags per box and 18 bags per box.
【Validity period】
1, The main ingredient of this product: glutamine
Chemical name: L-2-amino-glutaramic acid
Chemical structural formula:
Molecular formula:C5H10203
Molecular weight: 146.15
2、Excipients:dextrin
【Description】
This product is white or off-white granules.
【Indications】
This product is an amino acid drug. And it is indicated for the treatment of chronic gastritis.
【Specifications】
1.0g
【Dosage and administration】
Administration: oral administration prior to a meal
Dosage: 1g each time (one bag each time), and twice or three times a day Or otherwise as directed by your physician.
【Adverse reactions】
Digestive system: incidental upper abdominal pain, stomach upset, vomiting, nausea, diarrhea, constipation, and so forth.
Others: incidental thirst, erythematous malar rash, facial flushing, etc.
【Contraindications】
Persons who are hypersensitive to this product.
【Precautions】
1, This product is an amino acid drug. For the patients with chronic kidney failure,overdose can cause damage to the kidneys, and therefore in a case like this, glutamine must be administered under the close supervision by a physician.
Glutamine can increase intestinal absorption of chlorine and sodium, and thus increase intestinal absorption of water, which is beneficial for diarrhea patients,but may cause the stool to become hard,leading to constipation, in the case of patients without diarrhea. Patients who are on this drug for a long period of time must increase the intake of fiber-rich foods and drink a large amount of water.
3, This product is not indicated for the patients with severe liver diseases. For the patients with severe cirrhosis and other metabolic diseases, an elevated blood ammonia level may predispose to hepatic encephalopathy and even hepatic coma.
This product will be destroyed by hydrolysis at a high temperature, and therefore it must be taken at ambient temperature or with cold food or drinks, and cannot be taken with heated food or acid-rich foods.
【Use in pregnant and lactating women】
This product is a conditionally essential amino acid to the human body, with certain benefits for the pregnant women.Whether it may affect the fetus remains unknown. However,it was demonstrated in some reports that there is a high level of glutamine in the amniotic fluid, and any adverse reaction was not observed following intravenous administration of glutamine in premature infants.
【Pediatric use】
Unknown
【Geriatric use】
In general, It should be cautioned to reduce dose in the geriatric patients when the physiological functions in them are low.
【Drug interactions】
This product will not affect the metabolism of other drugs.
【Pharmacology and Toxicology】
Pharmacological effects: It is demonstrated in in vitro experiments that glutamine has a protective and repairing effect on gastro-intestinal mucosal damage, which is due to the reason that glutamine plays a promoting role in the biochemical synthesis of gastrointestinal mucosal epithelial components, hexosamine as well as glucosamine. In an experiment using a pylorus-ligated rat model, it is demonstrated that after being given orally,glutamine can inhibit the ulcers induced by aspirin and indomethacin.
Toxicology study: the results remain unknown.
【Pharmacokinetics】
As reported in literatures, after oral administration of L-Gln in healthy volunteers,the whole blood L-G1n concentration increased in proportion to the amount of L-G1n taken orally. The blood L-Gln level peaks at 30 to 45 minutes, and then slowly declines to a normal level at 90 to 120 minutes (low dose of 0.1g Gln/kg) or 180 to 240 minutes (high dose of 0.3g Gln/kg). The Vd of L-Gln after oral administration (512±63ml/kg at a low dose of 0.1k/kg, and 1254±84ml/kg at a high dose of 0.3g/kg) is significantly greater than that of 210±20ml/kg after intravenous injection, with the Gln T1/2being 106±11min and 117±17min, respectively. The absorption rate calculated after oral administration of Gln is approximately 84% （in subjects receiving the high dose of 0.3g/kg) and 57% (in subjects receiving the low dose of 0.1g/kg). The elimination half-life of L-glutamine after oral administration is longer than that following intravenous injection, with greater apparent volume of distribution compared to that after intravenous injection, which results from incomplete absorption after oral administration or absorption of amino acid by the viscera.
【Storage】
This product should be stored sealed in a light-proof,shaded and cool place (at a temperature not exceeding 20℃) This product should be used within the validity period.
【Packaging】
Aluminum-plastic composite film packaging, 1.0g per bag, 10 bags per box, 12 bags per box and 18 bags per box.
【Validity period】
36 months
【Performance standards】
【Performance standards】
Chinese Pharmacopoeia 2015 edition Part 2
【Approval number】
【Approval number】
SFDA Approval Number H20040245