FACTS AVAILABLE IN THE LEAFLET:
Presentation and Form
IV vial (sterile, white lyophilized powder) 600mg x 10’s
Each vial contains glutathione sodium 646mg equivalent to glutathione 600mg
Glutathione is a physiologic tripeptide – a chain of three amino acids cystein, glycine and glutamic acid: and is irreversibly consume in the detoxification of electrophilic metabolites and xenobiotics. It is very efficient free radical scavenger and protects cell from noxious effect or reactive oxygen compound.
Enhanced oxidative stress has been implicated in the pathogenesis of several disorders; as made evident by the low glutathione levels found in immune compromised individuals , neuro-degenerative diseases such as multiple scelerosis, ALS, Alzheimer's and Parkinson's disease, artherosclerosos, male infertility, pregnancy complications, cataracts, cancer and HIV-infected patients
Published clinical and scientific research has demonstrated the protective effect of glutathione in several pathologic situation which cause cellular damage, as is the case of intoxications from substances such as ethyl alcohol, paracetamol, salicylates, Phenobarbital, tricyclic antidepressants, organophosphorous insecticides, etc.
The mechanism of neurotoxicity induced by chemotherapeutic agents has been proposed to involved the accumulation of platinum within he peripheral nervous system, especially in the dorsal root ganglia. A strategy optimal for reducing the neurotoxicity associated with platinum drugs may be the use of glutathione, which is able to prevent the initial accumulation of platinum adducts in the dorsal root ganglia.
Posology and mode of administration
Mild: 300-600mg slow IV or IM daily
Severe: 600-1200mg slow IV or IM daily
The dosage however is dependent on age, weight and clinical condition of the patient and should also be related to the dose and administration schedule of the chemotherapeutic agent. In case of simultaneous administration of glutathione and chemotherapeutic agent, the intravenous infusion of glutathione should be 15-30 minutes before the start of chemotheraphy.
Intravenous use: Dissolve 600mg lyophilized powder with 4ml water for injection (reconstituted solution contains 150mg/ml of glutathione)
Products for parenteral use should be visually inspected before administration, when the container or the solution makes it possible, in order to possibly detect the presence of particles or of an abnormal color. Do not use in case of presence of turbidity or precipitates.
Use in pregnancy & lactation
The available data show that Glutathione, being a substance physiologically present in cells, does not cause unwanted effects in women during pregnancy or breast-feeding. Nevertheless, as with all drugs, Glutathione should only be administered to pregnant or lactating mothers on proper medical advice.
Vitamin K3, Vitamin B12, Calcium Pantothenate, orotic acid, antihistamines, sulfanilamides and tetracycline can affect the bioavailability of glutathione. In the absence of compatibility studies, Glutathione should not be mixed with other products.
After intramascular administration, rare of skin rash have been reported which have disappeared after discontinuation of treatment.
No case of overdose has been reported. If needed, symptomatic treatments may be employed.
Store below 30C. Constituted solutions of Glutathione maintain satisfactory potency at room temperature (up to 25C) up to 8hrs.
Two years from date of manufacture.