[DRUG NAMES]
GENERIC NAME: Reduced Glutathione Sodium for injection
CHINESE PINYIN: Zhusheyong Huanyuanxing Guguanggantaina
[INGREDIENTS]
ACTIVE INGREDIENTS: Reduced Glutathione Sodium
CHEMICAL NAME: N-(N-L-glutamyl-L-cysteinyl)glycine sodium salt
STRUCTURAL FORMULA:
CHEMICAL FORMULA: C10H16N3O6SNa
MOLECULAR WEIGHT: 329.33
[DESCRIPTION] white powder.
Glutathione is an antioxidant formed from the amino acid cysteine, glutamate and glycine. Virtually all your cells have glutathione, but this antioxidant is most highly concentrated in your liver, pancreas, spleen and eyes. Your glutathione levels dwindle as you age. Taking glutathione supplements may offset the reduced glutathione levels caused by age. Glutathione supplements may be administered intramusclely or intravenously. You can also take glutathione supplements in oralform or via nebulizer. No known side effects are associated with injections of glutathione.
Glutathione is primarily responsible for reducing the levels of cysteine on the surface of proteins and helps protect your body from free-radical damage.Recent scientific research has shown that the level of glutathione in your cells has a direct impact on and is an important indicator of the health and appearance of your skin. Your skin all over the body will become white after taking enough doses of glutathione. Glutathione also helps synthesize and repair DNA. Glutathione facilitates the recycling of vitamins C and E. Intravenous glutathione impairs platinum buildup in your kidneys. It helps transport amino acids and plays a vital role in purging your body of toxic compounds such as heavy metals. By helping your body detoxify, glutathione helps reduce your risk of developing cancer. Glutathione is able to fight cancer by causing malignant cells to die but keeping healthy cells alive. This antioxidant also slows your body's aging process.
Your body may develop coordination problems as a result of glutathione deficiency. Deficient glutathione levels can cause red blood cells to rupture and impair the functioning of white blood cells. Your nerve tissue may deteriorate as a result of glutathione deficiency, and you may suffer mental and nervous system disorders such as tremors and twitching.
[INDICATIONS]
1) Adjuvant in intoxications by chemotherapeutic (cisplatin, cyclophosphamide, adriamycin, rubidomycin,bleomycin), lessen the damage caused by chemotherapeutics without influence on therapy, so be able to increase the dose of chemotherapeutics.
2) Adjuvant in prophylaxis and treatment of damages from ionization radiations.
3) Adjuvant in hypoxemia: such as acute anaemia, ARDS (Adult Respiratory Distress Syndrome), septicaemia and so on.
4) Adjuvant in hepatitis caused by virus, pharmaceutical, ethyl alcohol and other chemicals.
5) Adjuvant in intoxications by orgnaophosphorus, amino- or nitro-compounds.
[STRENGTH] 0.6g, 1.2g, 1.8g, 2.4g
[DOSAGE AND ADMINISTRATION]
1. Administration route: (1) intravenous injection: The product is dissolved with Water for Injection and added to 100ml NS (normal saline), administered by intravenous drop infusion . Or dissolve Reduced Glutathione in less than 20ml saline, administer slowly by i.v. (2) intramuscular injection: The product is dissolved with Water for Injection and then injected.
2. Dosage: (1) Chemotherapeutic: In 15 mins before chemotherapeutic, Reduced Glutathione (1500mg/m2) need to be dissolved with 100ml saline. Then complete the administration in 15 mins. During the 2nd -5th day, 600mg, i.m., once daily.
For CTX (cyclophosphamide) treatment, after the injection of CTX, Reduced Glutathione should be immediately administered by i.v. in 15 mins to lessen the damage of urinary system.
For cisplatin treatment, dose of Reduced Glutathione should not be more than 35mg/mg cisplatin to avoid influence on chemotherapy effect.
(2) Liver impairment: intravenous drop infusion or i.m..
(3) Other diseases: Such as treatment of hypoxemia, the product (1500mg/m2) must be dissolved in 100ml saline and initiated by intravenous administration. Until improvement, dosage can reduced to 300-600mg once daily, i.m., for maintenance.
Mild cases: 0.3-0.6g once or twice daily by intravenous drop infusion or i.m..
Severe cases: 0.6-1.2g once or twice daily by intravenous drop infusion or i.m..
Dose can be adjusted according to the age of the patients and conditions of the disease.
3. Medication period: The general medication period for liver diseases is 30 days, and other situations depend on the condition of the disease.
[ADVERSE REACTIONS]
The incidence of adverse reactions is very low even at high doses and long-term use. Rarely paroxysmal rash have been observed.
[CONTRAINDICATIONS]
Hypersensitivity to reduced glutathione.
[PRECAUTIONS AND WARNINGS]
(1)The product must be used under medical supervision in hospital.
(2)The product for injection must be dissolved completely. The solution must be clear and colorless. The dissolved product can be kept for 2 hours at room temperature and for 8 hours at 0-5ºC.
(3)Keep out of reach of children.
[PREGNANCY AND LACTATION USE]
Data are not available.
[PEDIATRIC USE]
Neonatal infants, premature infants, infants and children shall take this product with extra care, especially by i.m..
[GERIATRIC USE]
Elderly patients should reduce the normal dosage properly and monitoring is necessary during the administration.
[INTERACTIONS OF DRUGS]
The product should not be used in combination with Vitamin B12, Vitamin K3, aquinone, calpanate, saratin, antihistamine pharmaceuticals, sulphonamide, and economycin.
[OVERDOSE]
No adverse reaction has been observed in the case of overdose.
[PHARMACOLOGY AND TOXICOLOGY]
Glutathione is a natural tripeptide present in the cells of all the organs and apparatus. Its wide distribution is connected to an extended variety of biological functions and has fundamental importance in numerous biochemical functions. Being the prosthetic group of glyceraldehyde phosphate dehydrognase and coenzyme of glyoxalase and triose dehydroganse ,Glutathione has important role in tricarboxylic acid cycle and glycometabolism .Through activating many enzymes,Glutathione can promote the metabolism of carbohydrate .fat and protein; its free sulfidrilic group represents a powerful acceptor of free radicals and its connection which is created between Glutathione and free radicals determines the formation of acids which are easily metabolized and lessen the damage caused by chemotherapeutics or ionization radiations without influence on therapy, especially in enteritis stimulated by radiations;
Glutathione also can promote restoring ,lessen tissue damage caused by hypoxemia of total or local body which always represents in anaemia,intoxication and tissue inflammation. GSH can protect liver in synthesization, detoxication and inactivating hormone, increase metabolism of cholic acid, and promote assimilation of fat and Vitamin (A,D,E,K) in alimentary tract.
[PHARMACOKINETICS]
The peak time of the reduced glutathione administered i.m. in mice is 5 h, t1/2 about 24 h, and the product most distributed in liver, kidney, and muscle.
[STORAGE] Protect from light and well closed. Kept in cool and dry places(with temperature below 20ºC).
[PACK] Injection vials made of low borosilicate glass, 0.6g in one vial, 1 vial per box.
[SHELF-LIFE] 36 months
Production:
Inspection:
Loading:
Certificates:
Audited Supplier 
){kind=link}