[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.
[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
[SPECIFICAITON APPROVAL NO.] WS1-(X-009)-2006Z
[DRUG LICENSE NO.] H20030427
