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Metadoze v pi

Only for the use of a Registered Medical Practitioner or a Hospital or a Laboratory.
Metformin Hydrochloride and Voglibose Tablets METADOZE V- 0.2/0.3
METADOZE V - 0.2
Distribution:
COMPOSITION
After ingestion of voglibose (and other glucosidase inhibitors), the majority of active Each uncoated bi-layered tablet contains unchanged drug remains in the lumen of the gastrointestinal tract to exert its Metabolism
METADOZE V - 0.3
Voglibose is metabolized by intestinal enzymes and by the microbial flora. COMPOSITION
Each uncoated bi-layered tablet contains
Elimination:
Voglibose is excreted in the urine and feces.
In a study in which a single dose of 1 mg/kg of C14-voglibose was administered to rats, the PHARMACEUTICAL FORM
transfer of voglibose to the fetus and to mother’s milk was observed, and the rates of excretion into urine and feces were about 5% and 98%, respectively.
PHARMACOLOGICAL PROPERTIES
Metformin
Absorption:
After an oral dose of metformin, time to peak plasma concentration (Tmax) is reached in
Mechanism of Action
2.5 hours. Absolute bioavailability of a 500 mg or 850 mg metformin tablet is Voglibose
approximately 50% to 60% in healthy subjects. After an oral dose, the non-absorbed Voglibose is an alpha-glucosidase inhibitor which reduces intestinal absorption of starch, fraction recovered in feces was 20% to 30%. After oral administration, metformin dextrin, and disaccharides by inhibiting the action of α-glucosidase in the intestinal brush absorption is saturable and incomplete. It is assumed that the pharmacokinetics of border. Inhibition of this enzyme halts the decomposition of disaccharides into metformin absorption is non-linear. At the usual metformin doses and the dosing monosaccharides and slows the digestion and absorption of carbohydrates; the post- schedules, steady state plasma concentrations are reached within 24 to 48 hours and are prandial rise in plasma glucose is blunted in both normal and diabetic subjects resulting in generally less than 1 µg/ml. In controlled clinical trials, peak plasma concentration (Cmax) improvement of post-prandial hyperglycemia and various disorders caused by of metformin did not exceed 4 µg/ml, even at maximum doses. Food decreases the extent hyperglycemia. α-glucosidase inhibitors do not stimulate insulin release and therefore do of absorption and slightly delays absorption. Following administration of a dose of not result in hypoglycemia. These agents may be considered as monotherapy in elderly 850mg, a 40% lower Cmax, a 25% decrease in area under the curve (AUC) and a 35- patients or in patients with predominantly post prandial hyperglycemia. α-glucosidase minute prolongation of Tmax were observed. The clinical relevance of these findings is inhibitors are typically used in combination with other oral antidiabetic agents and/or insulin. Voglibose should be administered at the start of a meal as it is poorly absorbed. Distribution:
Clinical Efficacy:
Plasma protein binding is negligible. Metformin partitions into erythrocytes. The blood In a randomized double-blind trial comprising 1780 Japanese individuals with impaired peak is lower than the plasma peak and appears approximately the same time. The red glucose tolerance, who were treated for an average of 48.1 weeks (standard deviation, SD blood cells most likely represent a secondary compartment of distribution. The mean Vd =36.3), Ryuzo Kawamori et al reported voglibose to be better than placebo (p=0.0026). It was noted that voglibose, in addition to lifestyle modification, can reduce the development of type 2 diabetes in high risk Japanese individuals with impaired glucose Metabolism
Metformin is excreted unchanged in urine. No metabolites have been identified in humans.
Kazuhisa Takami et al examined the effects of dietary modification/restriction alone and dietary modification/restriction with voglibose or glyburide on abdominal adiposity and Elimination:
metabolic abnormalities in 36 Japanese patients with type 2 diabetes. In newly diagnosed Renal clearance of metformin is >400 ml/min, indicating that metformin is eliminated by patients who were relatively lean but had excess visceral adipose tissue area (VAT), dietary glomerular filtration and tubular secretion. Following an oral dose, the apparent terminal modification/restriction (with or without voglibose or glyburide) effectively reduced VAT. elimination half-life is approximately 6.5 hours.
Decrease in VAT was closely associated with improvement of glycemic control through diet. Additional use of voglibose or low-dose glyburide had no detrimental effects on When renal function is impaired, renal clearance is decreased in proportion to that of abdominal adiposity and had beneficial effects on insulin sensitivity and the acute insulin creatinine and thus the elimination half-life is prolonged, leading to increased levels of In another trial, treatment with voglibose in diabetes mellitus patients demonstrated Children and Adolescents:
improved post prandial blood glucose levels, a significant decline in triglyceride level, and Single-dose study: After single doses of metformin 500 mg, pediatric patients have shown an elevation of high density lipoprotein (HDL) cholesterol and apolipoprotein A-1. As a similar pharmacokinetic profile to that observed in healthy adults.
compared to acarbose, voglibose was more effective and had fewer side effects. Multiple-dose study: Data are restricted to 1 study. After repeated doses of 500 mg BID for 7 days in pediatric patients the Cmax and systemic exposure (AUC0-t) were reduced by In a meta-analysis comparing miglitol and voglibose, no significant differences in post approximately 33% and 40%, respectively, compared to diabetic adults who received prandial glucose were observed between the 2 groups.
repeated doses of 500 mg BID for 14 days. As the dose is individually titrated based on glycemic control, this is of limited clinical relevance.
Metformin
Metformin is a biguanide with antihyperglycemic effects, lowering both basal and post-
Preclinical Safety Data
prandial plasma glucose. It does not stimulate insulin secretion and therefore does not No animal studies have been conducted with the combined products in METADOZE V - 0.2/0.3 mg. The following data are findings in studies performed with metformin individually.
Metformin may act via 3 mechanisms:
1. By reducing hepatic glucose production through inhibition of gluconeogenesis and
Voglibose
No animal studies of safety pharmacology, repeated-dose toxicity, genotoxicity, 2. By increasing insulin sensitivity in muscle, improving peripheral glucose uptake and carcinogenic potential, toxicity to reproduction and development have been conducted 3. By delaying intestinal glucose absorption.
Metformin
Metformin stimulates intracellular glycogen synthesis by acting on glycogen synthase. Preclinical data suggests no special hazards for humans based on conventional studies of Metformin increases the transport capacity of all types of membrane glucose transporters safety pharmacology, repeated-dose toxicity, genotoxicity, carcinogenic potential, and (GLUTs), known till date. In humans, independently of its action on glycemia, metformin has favourable effects on lipid metabolism. This has been shown at therapeutic doses in controlled, medium-term or long term clinical studies: Metformin reduces total CLINICAL PARTICULARS
cholesterol, low density lipoprotein (LDL) cholesterol, and triglycerides levels.
Therapeutic IndicationsAs a second-line treatment of type 2 diabetes mellitus when diet, exercise, and the single Clinical Efficacy:
agent do not result in adequate glycemic control.
The prospective randomized UKPDS trial established long-term benefit of intensive blood glucose control in type 2 diabetes.
Posology and Method of Administration
One tablet, 3 times daily before meals, or as prescribed by the physician
Analysis of the results of overweight patients treated with metformin after failure of diet alone showed: Voglibose
Normal Adult Dose

• A significant reduction of the absolute risk of any diabetes-related complications in Usually, voglibose tablets are orally administered in a single dose of 0.2 mg, 3 times a day, the metformin group (29.8 events/1000 patient-years), the group with diet before each meal. If the effect is not sufficient, the quantity of a single dose may be alone (43.3 events/1000 patient-years, p=0.0023); and the combined sulfonylurea and insulin monotherapy group (40.1 events/1000 patient-years, p=0.0034).
Dosage in Renal Failure
Voglibose is poorly absorbed after oral doses and renal excretion is negligible, suggesting
• A significant reduction of the absolute risk of the diabetes-related mortality: that no dose adjustment is required. However, pharmacokinetic studies in patients with metformin, hydrochloride 7.5 events/1000 patient-years; diet alone, 12.7 renal insufficiency are not available.
Pediatrics
• A significant reduction of the absolute risk of overall mortality: metformin The safety and effectiveness of voglibose in children has not been established. hydrochloride 13.5 events/1000 patient-years; versus diet alone 20.6 events/1000 patient years (p=0.011), and the combined sulfonylurea and insulin Geriatrics
monotherapy group 18.9 events/1000 patient-years (p=0.021).
Since elderly patients generally have a physiological hypofunction, it is desirable that such caution be taken as starting the administration at a low dose (eg, 0.1 mg at a time). • A significant reduction in the absolute risk of myocardial infarction: metformin group, Furthermore, this drug should be carefully administered under close observation through 11 events/1000 patients-years, diet alone 18 events/1000 patients years the course of the disease condition, with careful attention to the blood sugar level and the Pharmacokinetic Properties
Metformin:
Adults:
• The usual starting dose for fixed-dose combination of voglibose 0.2/0.3 mg and
Absorption:
metformin hydrochloride 500 mg is 1 tablet, 2 or 3 times daily, given during or after Voglibose is poorly absorbed after oral dosing. Plasma concentrations after oral doses meals. After 10 to 15 days the dose should be adjusted on the basis of blood glucose have usually been undetectable. After an 80 mg dose (substantially higher than the measurements. A slow increase of dose may improve gastrointestinal tolerability. The recommended dose), peak plasma levels of about 20 ng/mL were observed in 1 to 1.5 maximum recommended dose of metformin is 3 g daily, taken as 3 divided doses. Do not exceed 0.9 mg voglibose and 2500 mg metformin daily.
When voglibose tablets were repeatedly administered to healthy male adults (6 subjects) • If transfer from another oral antidiabetic is intended, discontinue the other agent and in a single dose of 0.2 mg, 3 times a day for 7 consecutive days, voglibose was not initiate metformin at the dose indicated above.
detected in plasma or urine. Similarly, when voglibose was administered to healthy male adults (10 subjects) as a single dose of 2 mg, voglibose was not detected in plasma or Dose in Renal Failure
Metformin has the potential for decreased renal function in elderly subjects, therefore the combination of metformin and voglibose is contraindicated in the presence of renal Only for the use of a Registered Medical Practitioner or a Hospital or a Laboratory.
Metformin Hydrochloride and Voglibose Tablets METADOZE V- 0.2/0.3
dysfunction. Regular assessment of renal function is necessary (for details see “Special When the patient plans pregnancy and during pregnancy, diabetes should not be treated Warnings and Precautions for Use”).
with metformin but insulin should be used to maintain blood glucose levels as close to normal as possible in order to lower the risk of fetal malformations associated with Pediatrics:
Metformin can be used in children from 10 years of age and adolescents. The safety and effectiveness of voglibose and metformin combination has not been established in Metformin is excreted into milk in lactating rats. Similar data is not available in humans and a decision should be made whether to discontinue nursing or to discontinue metformin, taking into account the benefit of using the compound in the mother.
Contraindications
• Hypersensitivity to metformin, voglibose, or to any of the excipients.
Animal studies (rats) have revealed a suppressive action of voglibose on body weight • Diabetic ketoacidosis, diabetic pre-coma.
increase in newborns presumably due to suppression of milk production in mother • Severe infection, before and after operation or with serious trauma.
animals resulting from suppression of carbohydrate absorption. Therefore, it is desirable • Gastrointestinal obstruction or predisposed to it.
not to give voglibose to women during lactation. When the administration is unavoidable, • Renal failure or renal dysfunction (creatinine clearance <60 mL/min) • Acute conditions with the potential to alter renal function such as: Effects on Ability to Drive and Use Machines
Metformin monotherapy does not cause hypoglycemia and therefore has no effect on the ability to drive or to use machines.
• intravascular administration of iodinated contrast agents However, patients should be alerted to the risk of hypoglycemia when metformin is used (see “Special Warnings and Precautions for Use”).
in combination with other antidiabetic agents (sulfonylureas, insulin, repaglinide).
• Acute or chronic disease which may cause tissue hypoxia such as: Undesirable Effects
Gastrointestinal disorders such as diarrhea, loose stools, abdominal pain, constipation, anorexia, nausea, vomiting, diarrhoea, abdominal pain, and loss of appetite may occur • Hepatic insufficiency, acute alcohol intoxication, alcoholism with the combination of voglibose and metformin. These undesirable effects occur most frequently during initiation of therapy and resolve spontaneously in most cases. To prevent them, it is recommended that metformin hydrochloride be taken in 2 or 3 daily doses Special Warnings and Precautions for Use
during or after meals. A slow increase of the dose may also improve gastrointestinal Lactic Acidosis:
Lactic acidosis is a rare, but serious (high mortality in the absence of prompt treatment), metabolic complication that can occur due to metformin accumulation. Reported cases of Skin and subcutaneous tissue disorders: very rarely skin reactions such as erythema, lactic acidosis in patients on metformin have occurred primarily in diabetic patients with pruritus, urticaria have been seen. In such a case, voglibose tablets should be significant renal failure. The incidence of lactic acidosis can and should be reduced by assessing also other associated risk factors such as poorly-controlled diabetes, ketosis, prolonged fasting, excessive alcohol intake, hepatic insufficiency, and any condition Metabolism and nutrition disorders: decrease of vitamin B-12 absorption with decrease in associated with hypoxia. The risk of lactic acidosis must be considered in the event of non- serum levels may occur during long term use of metformin. Consideration of this etiology specific signs, such as muscle cramps with digestive disorders as abdominal pain and is recommended if a patient on metformin presents with megaloblastic anemia.
severe asthenia. Lactic acidosis is characterised by acidotic dyspnea, abdominal pain, and There are isolated reports of liver-function-test abnormalities or hepatitis resolving upon hypothermia followed by coma. Diagnostic laboratory findings are decreased blood pH, metformin discontinuation. Serious hepatic dysfunction accompanied with jaundice, plasma lactate levels above 5 mmol/L, and an increased anion gap and lactate/pyruvate increased AST or ALT may also occur.
ratio. If lactic acidosis is suspected, metformin should be discontinued and patient should be hospitalised immediately (for more details see “Overdose”).
When voglibose is used in combination with other antidiabetic drugs, hypoglycemia may occur (0.1% to <5%). Renal Function:
As metformin is excreted by the kidneys, serum creatinine levels should be determined
Overdose
before initiating treatment and regularly thereafter: Hypoglycemia has not been seen with metformin doses up to 85 g, although lactic • At least annually in patients with normal renal function.
acidosis has occurred in such circumstances. High overdose or concomitant risks of • At least 2 to 4 times a year in patients with serum creatinine levels at the upper limit of metformin may lead to lactic acidosis. Lactic acidosis is a medical emergency and must be treated in a hospital. The most effective method to remove lactate and metformin is hemodialysis.
Decreased renal function in elderly subjects is frequent and asymptomatic. Special caution should be exercised in situations where renal function may become impaired, for example Voglibose competitively and reversibly inhibits the α when initiating antihypertensive therapy or diuretic therapy and when starting therapy sucrase, maltase, and isomaltase) in the brush border of the small intestine, which delays with a non-steroidal anti inflammatory drug (NSAID).
the hydrolysis of complex carbohydrates. The combination is unlikely to produce hypoglycemia in overdose, but abdominal discomfort and diarrhea may occur.
Other Precautions:
• In patients who are being managed with lifestyle modifications (diet and/or exercise),
PHARMACEUTICAL PARTICULARS
this drug must be given only when the 2-hour post prandial blood glucose levels are • Voglibose tablets should be administered with caution to the following patients: patients with history of laparotomy or ileus; patients with chronic intestinal disease accompanied by disturbance in digestion and absorption; patients with aggravating symptoms due to increased generation of intestinal gas (eg, Roemheld syndrome, severe hernia, and stenosis and ulcer of the large intestine) and patients with serious • All patients should continue their dietary restriction with a regular distribution of carbohydrate intake during the day. Overweight patients should continue their • The usual laboratory tests for diabetes monitoring should be performed regularly.
• Metformin alone never causes hypoglycemia, although caution is advised when it is used in combination with insulin and sulfonylureas.
Incompatibilities : None reported.
• Patients should be instructed and explained to recognize hypoglycemic symptoms Shelf Life : 24 months.
• When patients with diabetes are exposed to unusual stress such as fever, trauma, infection, or surgery, a temporary loss of control of blood glucose may occur. At such Storage and Precautions
times insulin therapy may be necessary for some time.
Store in a cool, dry place. Protect from light. Keep the medicine out of reach of children.
Drug Interactions
Special Precautions for Disposal and Other Handling
Voglibose
When voglibose is used in combination with derivative(s) of sulfonylamide, sulfonylurea or biguanide, or with insulin, hypoglycemic symptoms may occur. Therefore, when used in THE TABLET SHOULD E SWALLOWED AS A WHOLE AND NOT TO BE CRUSHED OR
combination with any of these drugs, care should be taken, such as starting the Nature and Contents of Container
When voglibose is administered concomitantly with drugs that enhance or diminish the Aluminium blister pack of 3x10 tablets in a carton hypoglycemic action of antidiabetic drugs, caution should be taken as this might additionally delay the action of voglibose on the absorption of carbohydrates. Examples of MANUFACTURED BY: Biocon Limited
drugs enhancing the hypoglycemic action of antidiabetic drugs: β preparations, monoamine oxidase inhibitors and fibrate derivatives. Examples of drugs Jharmajri, Baddi, Tehsil Nalagarh, Dist. Solan, Himachal Pradesh – 173205.
diminishing the hypoglycemic action of antidiabetic drugs: epinephrine, adrenocortical hormone, and thyroid hormone.
MARKETED BY: Biocon Limited
20th KM Hosur Road, Electronics City, Bangalore – 560100.
Voglibose does not affect the pharmacokinetics of warfarin, hence it can be safely administered along with warfarin.
For further details, please contact: Medical Advisor
Biocon Limited, Semicon Park, Tower II, Electronics City Phase II, Bangalore – 560100.
Metformin
Concomitant use with alcohol is not recommended. Increased risk of lactic acidosis in
acute intoxication, particularly in case of: ® - Registered Trade Mark of Biocon Limited • fasting or malnutrition• hepatic insufficiency To report adverse events and/or product complaints visit our website www.biocon.com
Concomitant consumption of alcohol-containing medications should be avoided.
or call the Toll Free Number: 1800 102 9465 or e-mail us at drugsafety@biocon.com
Combinations Requiring Precautions for Use
Glucocorticoids (systemic and local routes), beta-2-agonists, and diuretics have intrinsic
hyperglycemic activity. Inform the patient and perform more frequent blood glucose
monitoring, especially at the beginning of the treatment. If necessary, adjust the dosage of
the antidiabetic drug during therapy with the other drug and upon its discontinuation.
ACE-inhibitors may decrease the blood glucose levels. If necessary, adjust the dosage of the antidiabetic drug during therapy with the other drug and upon its discontinuation.
BF/LL/0107/01
Pregnancy and Lactation
To date, no relevant epidemiological data are available. Animal studies do not indicate
harmful effects with respect to pregnancy, embryonal or fetal development, parturition or
post natal development, therefore the drug should be given to pregnant women or
women suspected of being pregnant only when the potential benefits outweigh the
possible hazards.

Source: http://www.biocon.com/docs/prescribing_information/diabetology/metadozev_pi.pdf

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