Insulin Glargine 100 Units/mL Solution For Injection (SC)

Summary of Product characteristics

                                DESCRIPTION:
Insulin Glargine (Basagine
) is a solution for injection used as antidiabetic
agent. Insulin Glargine (Basagine
) is a biosynthetic long-acting, human
insulin analogue administered subcutaneously to lower the excess
blood-
glucose-level. It is synthesized by using recombinant DNA technology
and a special laboratory strain of non-pathogenic _Escherichia coli_.
Insulin Glargine differs from human insulin in that the amino acid
asparagine
at position A21 is replaced by glycine and two arginines are added to
the
C-terminus of the B-chain. Chemically, it is 21
A
-Gly-30
B
a-L-Arg-30
B
b-
L-Arg-human insulin and has the molecular formula C
267
H
404
N
72
O
78
S
6
.
FORMULATION:
Insulin Glargine (Basagine
) is available as solution for injection for
subcutaneous administration as:
Insulin Glargine (Basagine
) 100Units/ mL:
Each mL contains:
Insulin Glargine (r-DNA origin) ... 100 Units (3.64mg)
Preservative: Metacresol... 0.27% w/v
CLINICAL PHARMACOLOGY
MECHANISM OF ACTIOn
The primary activity of insulin glargine is the regulation of glucose
metabolism. It inhibits hepatic glucose production and lowers blood
glucose level by enhancing peripheral glucose uptake especially by
skeletal muscle and fat. It also inhibits lipolysis in the adipocyte,
inhibits
proteolysis and enhances protein synthesis. Insulin Glargine is a
human
insulin analogue designed to have a low solubility at neutral pH. It
is
completely soluble at the acidic pH of the injection solution (pH 4).
After
injection into the subcutaneous tissue, the acidic solution is
neutralized
leading to formation of micro-precipitates from which small amounts of
insulin glargine are continuously released, providing a smooth,
peakless,
predictable concentration/ time profile with a prolonged duration of
action.
PHARMACOKINETICS
_Absorption and Bioavailability_
Following subcutaneous injection, absorption of insulin glargine is
slower
and more prolonged compared with that of isophane (NPH) human insulin;
the serum concentration-time profile for insulin glargine
                                
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