GLUCOVANCE TABLET 500 mg5 mg

देश: सिंगापुर

भाषा: अंग्रेज़ी

स्रोत: HSA (Health Sciences Authority)

सक्रिय संघटक:

GLIBENCLAMIDE; METFORMIN HCl

थमां उपलब्ध:

MERCK PTE. LTD.

ए.टी.सी कोड:

A10BD02

डोज़:

5 mg

फार्मास्यूटिकल फॉर्म:

TABLET, FILM COATED

रचना:

GLIBENCLAMIDE 5 mg; METFORMIN HCl 500 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

Prescription Only

द्वारा बनाया गया:

MERCK SANTE SAS

प्राधिकरण का दर्जा:

ACTIVE

प्राधिकरण की तारीख:

2003-06-23

सूचना पत्रक

5
2
2
140
140
5
5
5
2
2
10
MC-1528-2014
M
C-
152
8-
20
14
M
C-
152
8-
20
14
_Other precautions_
_Because this medicinal product contains lactose, it is
contraindicated in case of _
_congenital galactosemia, glucose and galactose malabsorption syndrome
or in _
_case of lactase deficiency._
_Hypoxic states--_-Cardiovascular collapse (shock) from whatever
cause, acute 
congestive heart failure, acute myocardial infarction, and other
conditions 
characterized by hypoxemia have been associated with lactic
acidosis and 
may also cause prerenal azotemia. When such events occur in patients
on 
GLUCOVANCE therapy, the drug should be promptly discontinued.
_Alcohol intake_---Alcohol is known to
potentiate the effect of metformin on 
lactate metabolism. Patients, therefore, should be warned against
excessive 
alcohol intake, acute or chronic, while receiving GLUCOVANCE. Due to
its effect 
on the gluconeogenic capacity of the liver, alcohol may also increase
the risk of 
hypoglycemia.
_Impaired hepatic function_--Since impaired hepatic function has
been associated 
with some cases of lactic acidosis, GLUCOVANCE should generally be
avoided in 
patients with clinical or laboratory evidence of hepatic disease.
_Vitamin B_
_12_
_ levels_---In controlled clinical trials with metformin of 29
weeks 
duration, a decrease to subnormal levels of previously normal serum
Vitamin B
12

without clinical manifestations, was observed in approximately 7%
of patients. 
Such decrease, possibly due to interference with B
12
 absorption from the 
B
12
-intrinsic factor complex, is, however, very rarely associated with anemia (see 
ADVERSE REACTIONS) and appears to be rapidly reversible with discontinuation 
of metformin or Vitamin B
12
 supplementation. Measurement of hematologic 
parameters on an annual basis is advised in patients on metformin and
any 
apparent abnormalities should be appropriately investigated and
managed (see 
PRECAUTIONS: Laboratory Tests)

उत्पाद विशेषताएं

MERCK
GLUCOVANCE

(METFORMIN HCL AND GLIBENCLAMIDE TABLETS)
DESCRIPTION
GLUCOVANCE

(Metformin HCI and Glibenclamide Tablets) contains two oral
antihyperglycemic drugs used in the management of
type 2 diabetes, metformin hydrochloride and glibenclamide.
GLUCOVANCE is available for oral administration in tablets containing
500 mg metformin hydrochloride with 5 mg glibenclamide
In addition, each tablet contains the following inactive ingredients:
microcrystalline cellulose, povidone, croscarmellose sodium,
magnesium stearate, lactose monohydrate, hypromellose 15cP, titanium
dioxide (E171) and macrogol 4000. The tablets are film
coated, which provides color differentiation.
PHARMACOLOGY
PHARMACODYNAMIC
GLUCOVANCE combines metformin hydrochloride and glibenclamide, two
antihyperglycemic agents with complementary mechanisms
of action, to improve glycemic control in patients with type 2
diabetes.
Metformin hydrochloride is an antihyperglycemic agent that improves
glucose tolerance in patients with type 2 diabetes, lowering both
basal and postprandial plasma glucose. Metformin hydrochloride
decreases hepatic glucose production, decreases intestinal absorption
of glucose, and improves insulin sensitivity by increasing peripheral
glucose uptake and utilization.
Glibenclamide is a second generation sulphonylurea which appears to
lower blood glucose acutely by stimulating the release of insulin
from the pancreas, an effect dependent upon functioning beta cells in
the pancreatic islets.
Results from controlled, double blind clinical trials versus reference
products in the treatment of type 2 diabetes inadequately controlled
by monotherapy with metformin or glibenclamide combined with diet and
exercise, have demonstrated that the combination had an
additive effect on glucose regulation.
PHARMACOKINETICS
_ABSORPTION AND BIOAVAILABILITY _
_Related to GLUCOVANCE _
In bioavailability studies of GLUCOVANCE 500 mg/5 mg, the mean area
under the plasma concentration versus time curve (AUC) for
the glibenclamide component was 18