Cetapin

For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory

Abridged Prescribing Information
Cetapin V
Metformin Hydrochloride Sustained Release and Voglibose Tablet
COMPOSITION
Cetapin V 0.2mg: Metformin hydrochloride IP (as sustained release) 500mg & Voglibose 0.2 mg.
Cetapin V 0.3mg: Metformin hydrochloride IP (as sustained release) 500mg & Voglibose 0.3 mg.
THERAPEUTIC INDICATIONS
2nd line treatment for type II diabetes mellitus when diet, exercise, single agent do not result in adequate glycemic
control.
DOSAGE AND ADMINISTRATION
Adults - 1 tablet to be given 2-3 times daily with heavy meals. Safety and efficacy not established in children.
Initiation at lower dose and close observation in case of elderly. Monitoring of renal function is necessary in elderly.
Avoid in patients of hepatic insufficiency. Contraindicated in case of renal dysfunction.
CONTRAINDICATIONS: Known hypersensitivity to metformin hydrochloride, voglibose or another component of
this product ; renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥ 1.5mg/dL (males), ≥
1.4 mg/dL (females) or abnormal creatinine clearance) which may also result from conditions such as cardiovascular
collapse, acute myocardial infarction and septicaemia; acute or chronic metabolic acidosis including diabetic
ketoacidosis with or without coma. Cetapin V should be temporarily discontinued in patients undergoing radiologic
studies. Not to be used in patients with severe ketosis or in a state of diabetic coma or precoma, severe infections
before or after operation or with severe trauma.
WARNINGS: Lactic acidosis is a medical emergency that must be treated in hospital setting. Cetapin V must be
discontinued immediately and general supportive measures promptly instituted. For patients undergoing basic
treatment for diabetes mellitus, voglibose should be given when 2-hr post prandial blood sugar is 200mg/dl or more.
For patients on oral hypoglycemic drugs or insulin preparations, in addition to dietary treatment and/or exercise
therapy, voglibose is to be given when the fasting blood sugar is about 140mg / dl or more. Closely monitor blood
sugar at regular intervals.
PRECAUTIONS : No clinical studies establishing conclusive evidence of macrovascular risk reduction with
metformin or any other anti-diabetic drug. Before initiation of Cetapin V therapy and annually while on Cetapin V
therapy renal function should be assessed and verified as being within normal range. Concomitant medication that
may affect renal function or result in significant hemodynamic change or may interfere with disposition of metformin
should be used with caution. Intravascular contrast studies with iodinated material can lead to acute alteration of renal
function, hence metformin should be temporarily discontinued in whom such studies are planned. Drug should be
promptly discontinued in case of cardiovascular collapse, acute congestive heart failure, acute myocardial infarction
and other conditions characterized by hypoxemia (may be associated with lactic acidosis). Cetapin V must be
temporarily suspended before surgical intervention. Alcohol potentiates effect of metformin on lactate metabolism
therefore patients should be warned against excessive alcohol intake. Cetapin V is to be avoided in patients with
clinical or laboratory evidence of hepatic disease. Measurement of serum vitamin B12 levels every two to three years
is recommended. Patient with Type II diabetes, previously well controlled on metformin, who develops laboratory
abnormality or clinical illness should be promptly evaluated for lactic acidosis or ketoacidosis. Hypoglycemia could
occur when caloric intake is deficient or strenuous exercise is not compensated. Withhold Cetapin V and temporarily
administer insulin in case of temporary loss of glycemic control due to fever, trauma, infection or surgery. Periodic
measurements of fasting blood glucose and glycosylated haemoglobin levels are required. Initial and periodic
monitoring of hematologic parameters and renal function should be performed on annual basis. Administer carefully
in patients receiving other antidiabetic drugs or with a history of laparotomy or ileus or with chronic intestinal disease
accompanied by a disturbance in digestion and absorption or with Roemheld's syndrome, severe hernia or stenosis or
ulceration of the large intestine or with serious hepatic dysfunction or with serious renal dysfunction.
PREGNANCY & LACTATION: Should not be used in pregnancy unless clearly needed. Avoid administration of
voglibose in lactation, however, if the administration is indispensable, nursing should be discontinued. Safety and
efficacy in paediatric patients has not been established.
ADVERSE REACTIONS: Voglibose : Gastrointestinal adverse effects like diarrhea, loose stools, abdominal pain,
constipation, anorexia, nausea, vomiting and heartburn, abdominal swelling, increased flatus may occur. Serious
hepatic dysfunction accompanied with jaundice, increased AST, ALT may occur. When administered to patients with
serious liver cirrhosis, hyperammonemia may worsen with the development of constipation, etc, followed by
disturbance of consciousness. Hypoglycemia may occur. Metformin : Commonly reported adverse events include
diarrhoea, nausea, vomiting.

For full prescribing information please write to : Aventis Pharma Ltd., 54/A Sir Mathuradas Vasanji Road, Andheri
(E), Mumbai - 400 093. Tel : 022 – 28 27 8000

Created : Jan 2012

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