INSTRUCTION ON MEDICAL
APPLICATION
GLUTOXIM
0.5%, 1%, AND 3% SOLUTION OF GLUTOXIM FOR
INJECTIONS
International
unpatented name: Disodium salt of bis-(g -L-glutamyl)-L-cysteinyl-bis-glycine.
Active
principle: glutoxim (Disodium salt of bis-(g
-L-glutamyl)-L-cysteinyl-bis-glycine).
Additional
compounds: isotonic sodium chloride solution.
Colorless
transparent liquid.
"Glutoxim"
is a chemically synthesized biologically active substance - hexapeptide
(disodium salt of bis-(g -L-glutamyl)-L-cysteinyl-bis-glycine) with a sum
formula (C20H32O16N6S2).
"Glutoxim"
injection form is manufactured as a sterile solution for intramuscular,
intravenous and subcutaneous use.
PHARMACOLOGICAL
EFFECTS
"Glutoxim" is related to a new class of
medical agents - thiopoietins, which has a unique biological activity due to a
modulating effect on intracellular processes of thiol metabolism that plays an
important role in a genetic and metabolic processes' regulation in cells and
tissues.
The basic mechanism of the drug biological and
pharmacological efficacy is a regulable escalation of cells' redox state. New
level of redox systems and dynamics of phosphorilating of key proteins of
signal-transducing systems and transcriptional factors (NFkB and AP-1), first
of all, in immunocompetent cells determinates immunomodulating and systemic
cell-protective drug effects.
Glutoxim is capable to perform differentiated impact
on normal (stimulation of differentiation and proliferation) and on transformed
(induction of apoptosis, genetically programmed cell death) cells. Main immune
and physiologic drug features are the following: high drug affinity to cells of
central immunity organs and lymphoid tissue system; enhancement of bone marrow
hemopoiesis - processes of erythropoiesis, lymphopoiesis and
granulocyto-monocytopoiesis; phagocytosis system activation including
immunodeficiency conditions; restoration of neutrophil, monocyte, lymphocyte
counts in peripheral blood and tissue macrophage functional capacities.
Among Glutoxim immune biochemical properties the
following should be underlined: drug stimulating effect on cascade mechanisms
of phosphate modifications of main proteins of the signal-transducing systems;
initiation of cytokine systems including endogenous production of IL-1, IL-6,
TNF, IFN, erythropoietin, and reproduction of IL-2 effects through its receptor
expression induction.
PHARMACOKINETICS
Glutoxim is related to a group of natural metabolites
that determinates its metabolism characteristics by existing cell enzyme
system. Biological availability after intramuscular, intravenous and
subcutaneous injection exceeds 90%. There is a linear dependence between dose
and drug concentration in blood plasma. Maximum drug concentration in plasma after
an intravenous introduction is observed in 2-5 min., after an intramuscular
introduction - in 7-10 min. As a natural compound of peptide origin Glutoxim is
metabolized in organs and tissues being eliminated through kidneys.
INDICATIONS
Glutoxim is administered to adults as an agent for
prophylaxis and treatment of secondary immunodeficient conditions induced by
radiation, chemical and/or infectious factors; to restore inhibited immune
reactions and suppressed bone marrow condition; to enhance body resistance to
multifarious pathologic impacts such as infectious agents, chemical and/or
physical factors (intoxication, radiation, etc.); as a hepatoprotective agent
for acute and chronic viral (B and C) hepatitis eliminating chronic
virus-carriage objective signs; to potentate antibacterial therapy effects for
chronic obstructive lung diseases; to prevent postoperative suppurative
complications.
CONTRAINDICATIONS
Glutoxim introduction is contraindicated only in cases
of individual intolerance.
ADVERSE EFFECTS
Some patients may note an insignificant temperature
raise (to 37.10C - 37.50C) and tenderness in a drug
introduction site. If subjectively such tenderness is tolerated badly it's
recommended administering Glutoxim along with 1-2 ml of 0.5% Novocain solution.
DRUG FORMS
In 1.0-ml and 2.0-ml ampoules.
STORAGE CONDITIONS
Glutoxim should be stored in a dry, shadowed place at
+40 - +60C.
SHELF LIFE
2 years.
PHARMACY
Prescribed by a medical doctor.
MANUFACTURER:
PharmaBAM Ltd., 47, Myasnitskaya str.,
For more
references:
Dr. Giorgio Castello
Via A. Cecchi, 19/9
16129 – Genova (Italy)
Tel:
Mobil
phone:
e-mail:
castello@tiopoietine.info