Glimepiride 3mg Tablet
Country: Philippines
Language: English
Source: FDA (Food And Drug Administration)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
Getryl
Available from:
N/A; Importer: Getz Pharma (Phils.), Inc.; Distributor: N/A
INN (International Name):
Getryl
Dosage:
3mg
Pharmaceutical form:
Tablet
Units in package:
Alu-Alu Blister x 10's (Box of 20's), Alu-Alu Blister Pack x 10's (box of 20's)
Manufactured by:
Getz Pharma (Pvt.) Ltd., Pakistan
Therapeutic area:
Anti-Diabetic
Therapeutic indications:
As an adjunct to diet and exercise to lower blood glucose in patients with non-insulin-dependent (type 2) diabetes mellitus.
Authorization date:
2021-05-17
Summary of Product characteristics
DESCRIPTION
Glimepiride (Getryl
®
) is an oral blood glucose lowering drug of the
sulfonylurea class. Chemically glimepiride is
1-[[p-[2-(3-Ethyl-4-methyl-
2-oxo-3-pyrroline-1-carboxamido) ethyl]phe nyl]-sulphonyl]-3-(trans-4-
methylcyclohexyl)urea. The molecular formula is C
24
H
34
N
4
O
5
S and the
structural formula is:
FORMULATION
Glimepiride (Getryl
®
) is available for oral administration as:
1. Glimepiride (Getryl
®
) Tablets 1mg
Each tablet contains:
Glimepiride…1mg
2. Glimepiride (Getryl
®
) Tablets 2mg
Each tablet contains:
Glimepiride…2mg
3. Glimepiride (Getryl
®
) Tablets 3mg
Each tablet contains:
Glimepiride…3mg
4. Glimepiride (Getryl
®
) Tablets 4mg
Each tablet contains:
Glimepiride…4mg
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
The primary mechanism of action of glimepiride appears to be dependent
on stimulating the release of insulin from functioning pancreatic beta
cells. In addition, extra-pancreatic effects (e.g. reduction of basal
hepatic
glucose production and increased peripheral tissue sensitivity to
insulin
and glucose uptake) may also play a role in the activity of
glimepiride.
However, as with other sulfonylureas, the mechanism by which
glimepiride
lowers blood glucose during long-term administration has not been
clearly established.
PHARMACOKINETICS
After oral administration glimepiride is completely absorbed from the
GI
tract. The oral bioavailability is approximately 100%. Peak plasma
concentrations occur in 2-3 hours. More than 99% of the drug is bound
to plasma proteins. Glimepiride is completely metabolized by oxidative
biotransformation into two main metabolites, a hydroxy derivative and
a carboxy derivative.
The elimination half-life (t
1
/
2
)
after multiple doses is about 5-8 hours.
Approximately 60% of dose is eliminated in the urine and 40% in the
feces.
SPECIAL POPULATIONS
_Renal Insufficiency_
A single-dose clinical study glimepiride showed that glimepiride serum
levels decreased as renal function decreased. However, metabolite
serum levels (mean AUC values) i
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