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Comet 500 mg Tablet
Comet 500 TabletIndication:Management of type 2 diabetes mellitus.Dosage & Administration:Adults : Starting dose of Comet® (Metformin Hydrochloride Tablet) is 500 mg twice a day or 850 mg once a day, given with meals. Dosage increases should be made in increments of 500 mg weekly or 850 mg every 2 weeks, up to a total of 2000 mg per day, given in divided doses. Starting dose of Comet® XR (Metformin Hydrochloride Extended Release Tablet) is 500 mg once daily with the evening meal. Dosage increases should be made in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal. If glycemic control is not achieved on Comet® XR 2000 mg once daily, a trial of Comet® XR 1000 mg twice daily should be considered. Pediatrics : Starting dose of Comet® is 500 mg twice a day, given with meals. Dosage increases should be made in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses.Show less Preparation:Comet® 500 : Box containing 10 x 10 tablets in blister pack.Comet® 850 : Box containing 5 x 10 tablets in blister pack.Comet® XR 500 : Box containing 5 x 10 tablets in blister pack.Comet® XR 1gm : Box containing 5 x 6 tablets in blister pack...
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Comet 850 mg Tablet
Comet 850 TabletIndication:Management of type 2 diabetes mellitus.Dosage & Administration:Adults : Starting dose of Comet® (Metformin Hydrochloride Tablet) is 500 mg twice a day or 850 mg once a day, given with meals. Dosage increases should be made in increments of 500 mg weekly or 850 mg every 2 weeks, up to a total of 2000 mg per day, given in divided doses. Starting dose of Comet® XR (Metformin Hydrochloride Extended Release Tablet) is 500 mg once daily with the evening meal. Dosage increases should be made in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal. If glycemic control is not achieved on Comet® XR 2000 mg once daily, a trial of Comet® XR 1000 mg twice daily should be considered. Pediatrics : Starting dose of Comet® is 500 mg twice a day, given with meals. Dosage increases should be made in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses.Show less Preparation:Comet® 500 : Box containing 10 x 10 tablets in blister pack.Comet® 850 : Box containing 5 x 10 tablets in blister pack.Comet® XR 500 : Box containing 5 x 10 tablets in blister pack.Comet® XR 1gm : Box containing 5 x 6 tablets in blister pack...
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Comet XR 1 gm Tablet
Indication:Management of type 2 diabetes mellitus.Dosage & Administration:Adults : Starting dose of Comet® (Metformin Hydrochloride Tablet) is 500 mg twice a day or 850 mg once a day, given with meals. Dosage increases should be made in increments of 500 mg weekly or 850 mg every 2 weeks, up to a total of 2000 mg per day, given in divided doses. Starting dose of Comet® XR (Metformin Hydrochloride Extended Release Tablet) is 500 mg once daily with the evening meal. Dosage increases should be made in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal. If glycemic control is not achieved on Comet® XR 2000 mg once daily, a trial of Comet® XR 1000 mg twice daily should be considered. Pediatrics : Starting dose of Comet® is 500 mg twice a day, given with meals. Dosage increases should be made in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses.Show less Preparation:Comet® 500 : Box containing 10 x 10 tablets in blister pack.Comet® 850 : Box containing 5 x 10 tablets in blister pack.Comet® XR 500 : Box containing 5 x 10 tablets in blister pack.Comet® XR 1gm : Box containing 5 x 6 tablets in blister pack...
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Comet XR 500 mg Tablet
Comet XR 500 mg Tablet Indication:Management of type 2 diabetes mellitus.Dosage & Administration:Adults : Starting dose of Comet® (Metformin Hydrochloride Tablet) is 500 mg twice a day or 850 mg once a day, given with meals. Dosage increases should be made in increments of 500 mg weekly or 850 mg every 2 weeks, up to a total of 2000 mg per day, given in divided doses. Starting dose of Comet® XR (Metformin Hydrochloride Extended Release Tablet) is 500 mg once daily with the evening meal. Dosage increases should be made in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal. If glycemic control is not achieved on Comet® XR 2000 mg once daily, a trial of Comet® XR 1000 mg twice daily should be considered. Pediatrics : Starting dose of Comet® is 500 mg twice a day, given with meals. Dosage increases should be made in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses.Show less Preparation:Comet® 500 : Box containing 10 x 10 tablets in blister pack.Comet® 850 : Box containing 5 x 10 tablets in blister pack.Comet® XR 500 : Box containing 5 x 10 tablets in blister pack.Comet® XR 1gm : Box containing 5 x 6 tablets in blister pack...
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Comprid 80 mg Tablet
Comprid 80 mg TabIndication:Comprid™ is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2DM).Dosage & Administration:The usual initial dose of Comprid™ is 40 to 80 mg daily, gradually increased, if necessary up to 320 mg daily until adequate control is achieved. A single dose should not exceed 160 mg. When higher doses are required it should be taken twice daily, according to the main meals of the day. For extended release tablet the initial recommended dose is 30 mg daily, even in elderly patients (>65 years); the daily dose may vary from 30 to 120 mg taken orally, once daily. Comprid™ XR should be taken with food because there is increased risk of hypoglycemia if a meal is taken late. It is recommended that the medication be taken at breakfast time. If a dose is forgotten, the dose taken on the next day should not be increased. Dose titration should be carried out in steps of 30 mg, according to the fasting blood glucose response. Each step should last for at least two weeks. Comprid™ XR is an extended release tablet and therefore, should be neither broken nor chewed. Comprid™ XR 30, can replace Gliclazide 80 mg tablets, tablet for tablet, for doses of 1 to 4 tablets per day.Elderly: Plasma clearance of Gliclazide is not altered in the elderly and steady state plasma levels are similar to those in adults under 65 years. Clinical experience in the elderly shows that it is effective and well tolerated.Children: Gliclazide as with other sulfonylureas is not indicated for the treatment of juvenile onset diabetes mellitus.Preparation:Comprid™ tablet: Each box contains 60's tablets in blister pack.Comprid™ XR 30 tablet: Each box contains 50's tablets in blister pack.Comprid™ XR 60 tablet: Each box contains 30's tablets in blister pack...
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Comprid XR 30 mg Tablet
Comprid XR 30 TabIndication:Comprid™ is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2DM).Dosage & Administration:The usual initial dose of Comprid™ is 40 to 80 mg daily, gradually increased, if necessary up to 320 mg daily until adequate control is achieved. A single dose should not exceed 160 mg. When higher doses are required it should be taken twice daily, according to the main meals of the day. For extended release tablet the initial recommended dose is 30 mg daily, even in elderly patients (>65 years); the daily dose may vary from 30 to 120 mg taken orally, once daily. Comprid™ XR should be taken with food because there is increased risk of hypoglycemia if a meal is taken late. It is recommended that the medication be taken at breakfast time. If a dose is forgotten, the dose taken on the next day should not be increased. Dose titration should be carried out in steps of 30 mg, according to the fasting blood glucose response. Each step should last for at least two weeks. Comprid™ XR is an extended release tablet and therefore, should be neither broken nor chewed. Comprid™ XR 30, can replace Gliclazide 80 mg tablets, tablet for tablet, for doses of 1 to 4 tablets per day.Elderly: Plasma clearance of Gliclazide is not altered in the elderly and steady state plasma levels are similar to those in adults under 65 years. Clinical experience in the elderly shows that it is effective and well tolerated.Children: Gliclazide as with other sulfonylureas is not indicated for the treatment of juvenile onset diabetes mellitus.Preparation:Comprid™ tablet: Each box contains 60's tablets in blister pack.Comprid™ XR 30 tablet: Each box contains 50's tablets in blister pack.Comprid™ XR 60 tablet: Each box contains 30's tablets in blister pack...
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Comprid XR 60 mg Tablet
Comprid XR 60 TabletIndication:Comprid™ is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2DM).Dosage & Administration:The usual initial dose of Comprid™ is 40 to 80 mg daily, gradually increased, if necessary up to 320 mg daily until adequate control is achieved. A single dose should not exceed 160 mg. When higher doses are required it should be taken twice daily, according to the main meals of the day. For extended release tablet the initial recommended dose is 30 mg daily, even in elderly patients (>65 years); the daily dose may vary from 30 to 120 mg taken orally, once daily. Comprid™ XR should be taken with food because there is increased risk of hypoglycemia if a meal is taken late. It is recommended that the medication be taken at breakfast time. If a dose is forgotten, the dose taken on the next day should not be increased. Dose titration should be carried out in steps of 30 mg, according to the fasting blood glucose response. Each step should last for at least two weeks. Comprid™ XR is an extended release tablet and therefore, should be neither broken nor chewed. Comprid™ XR 30, can replace Gliclazide 80 mg tablets, tablet for tablet, for doses of 1 to 4 tablets per day.Elderly: Plasma clearance of Gliclazide is not altered in the elderly and steady state plasma levels are similar to those in adults under 65 years. Clinical experience in the elderly shows that it is effective and well tolerated.Children: Gliclazide as with other sulfonylureas is not indicated for the treatment of juvenile onset diabetes mellitus.Preparation:Comprid™ tablet: Each box contains 60's tablets in blister pack.Comprid™ XR 30 tablet: Each box contains 50's tablets in blister pack.Comprid™ XR 60 tablet: Each box contains 30's tablets in blister pack...
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Consucon 60 mg MR Tab
Consucon 60 mg MR TabDescriptionConsucon (Gliclazide) is a second generation sulfonylurea drug that has hypoglycaemic and potentially useful haemobiological properties. It stimulates the release of insulin from pancreatic beta-cells by facilitating Ca+2 transport across the beta-cell membranes and decreases hepatic glucose output.IndicationsConsucon and Consucon MR is indicated for the treatment of type 2 diabetes mellitus.Dosage & AdministrationConsucon: The usual initial dose is 40 to 80 mg daily. The dose can be increased upto 320 mg daily in divided doses when needed. The drug should be taken before meal.Consucon MR: The usual daily dosage is 1 to 4 tablets per day as a single dose. It is recommended that the drug should be taken at breakfast time. It is preferable to take this drug before breakfast in order to avoid or to minimize the possible onset of digestive disorders.Side EffectsThere may be hypoglycaemia in concurrent conditions such as hepatic and renal disease, malnutrition, alcohol intoxication. Sometimes headache, gastrointestinal upsets, nausea, dizziness, skin reactions including rash, pruritus, erythema may occur.PrecautionsGliclazide should be used carefully in patients with hepatic impairment. If there is definite hepatic disease then gliclazide should not be used. Consucon (Gliclazide) can be used safely in patients with renal insufficiency as it is extensively metabolized. Consucon has less sudden hypoglycaemic episode than other sulfonylurea group of drugs.Use in Pregnancy & LactationPregnant Women: Gliclazide should not be used in pregnant women although animal studies of Gliclazide have not shown any teratogenic effect.Nursing Mothers: This drug is contraindicated when breast feeding.Over DoseIn accidental overdose, at first gastric lavage should be done and at the same time the hypoglycaemia should be corrected. In severe cases I/V infusion of 5% glucose should be started immediately with frequent monitoring of blood glucose and potassium level...
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Consucon 80 mg Tablet
Consucon 80 mg TabletDescriptionConsucon (Gliclazide) is a second generation sulfonylurea drug that has hypoglycaemic and potentially useful haemobiological properties. It stimulates the release of insulin from pancreatic beta-cells by facilitating Ca+2 transport across the beta-cell membranes and decreases hepatic glucose output.IndicationsConsucon and Consucon MR is indicated for the treatment of type 2 diabetes mellitus.Dosage & AdministrationConsucon: The usual initial dose is 40 to 80 mg daily. The dose can be increased upto 320 mg daily in divided doses when needed. The drug should be taken before meal.Consucon MR: The usual daily dosage is 1 to 4 tablets per day as a single dose. It is recommended that the drug should be taken at breakfast time. It is preferable to take this drug before breakfast in order to avoid or to minimize the possible onset of digestive disorders.Side EffectsThere may be hypoglycaemia in concurrent conditions such as hepatic and renal disease, malnutrition, alcohol intoxication. Sometimes headache, gastrointestinal upsets, nausea, dizziness, skin reactions including rash, pruritus, erythema may occur.PrecautionsGliclazide should be used carefully in patients with hepatic impairment. If there is definite hepatic disease then gliclazide should not be used. Consucon (Gliclazide) can be used safely in patients with renal insufficiency as it is extensively metabolized. Consucon has less sudden hypoglycaemic episode than other sulfonylurea group of drugs.Use in Pregnancy & LactationPregnant Women: Gliclazide should not be used in pregnant women although animal studies of Gliclazide have not shown any teratogenic effect.Nursing Mothers: This drug is contraindicated when breast feeding.Over DoseIn accidental overdose, at first gastric lavage should be done and at the same time the hypoglycaemia should be corrected. In severe cases I/V infusion of 5% glucose should be started immediately with frequent monitoring of blood glucose and potassium level...
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Consucon MR 30 mg Tab
Consucon MR 30 mg TabDescriptionConsucon (Gliclazide) is a second generation sulfonylurea drug that has hypoglycaemic and potentially useful haemobiological properties. It stimulates the release of insulin from pancreatic beta-cells by facilitating Ca+2 transport across the beta-cell membranes and decreases hepatic glucose output.IndicationsConsucon and Consucon MR is indicated for the treatment of type 2 diabetes mellitus.Dosage & AdministrationConsucon: The usual initial dose is 40 to 80 mg daily. The dose can be increased upto 320 mg daily in divided doses when needed. The drug should be taken before meal.Consucon MR: The usual daily dosage is 1 to 4 tablets per day as a single dose. It is recommended that the drug should be taken at breakfast time. It is preferable to take this drug before breakfast in order to avoid or to minimize the possible onset of digestive disorders.Side EffectsThere may be hypoglycaemia in concurrent conditions such as hepatic and renal disease, malnutrition, alcohol intoxication. Sometimes headache, gastrointestinal upsets, nausea, dizziness, skin reactions including rash, pruritus, erythema may occur.PrecautionsGliclazide should be used carefully in patients with hepatic impairment. If there is definite hepatic disease then gliclazide should not be used. Consucon (Gliclazide) can be used safely in patients with renal insufficiency as it is extensively metabolized. Consucon has less sudden hypoglycaemic episode than other sulfonylurea group of drugs.Use in Pregnancy & LactationPregnant Women: Gliclazide should not be used in pregnant women although animal studies of Gliclazide have not shown any teratogenic effect.Nursing Mothers: This drug is contraindicated when breast feeding.Over DoseIn accidental overdose, at first gastric lavage should be done and at the same time the hypoglycaemia should be corrected. In severe cases I/V infusion of 5% glucose should be started immediately with frequent monitoring of blood glucose and potassium level...
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Daomin XR 500 mg Tab
Daomin XR 500 TabIndicationsMetformin Hydrochloride, as monotherapy, is indicated as an adjunct to diet to lower blood glucose especially in overweight patients with non-insulin-dependent diabetes mellitus (NIDDM) or type 2 diabetes mellitus whose hyperglycemia cannot be satisfactorily managed on diet alone. Metformin Hydrochloride may be used concomitantly with a sulfonylurea when diet and metformin hydrochloride or sulfonylureas alone do not result in adequate glycemic control.PharmacologyMetformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Metformin reduces hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis, and stimulates intracellular glycogen synthesis by acting on glycogen synthase. In muscle, it increases insulin sensitivity, improving peripheral glucose uptake and utilization. Metformin also delays intestinal glucose absorption. Metformin increases the transport capacity of all types of membrane glucose transporters (GLUTs) known to date.In humans, independently of its action on glycemia, metformin has favorable effects on lipid metabolism. This has been shown at therapeutic doses in controlled, medium-term or long-term clinical studies: Metformin reduces total cholesterol, LDL, cholesterol and triglycerides levels. Unlike sulfonylureas, metformin does not produce hypoglycemia in either patients with type 2 diabetes or normal subjects and does not cause hyperinsulinemia. With metformin therapy, insulin secretion remains unchanged while fasting insulin levels and daylong plasma insulin response may actually decrease.Children and adolescents-Monotherapy and combination with insulinMetformin tablets can be used in children from 10 years of age and adolescents.The usual starting dose is one tablet of 500 mg or 850 mg once daily, given during meals or after meals.After 10 to 15 days the should be adjusted on the basis of blood glucose measurements. A slow increase of dose may improve gastrointestinal tolerability. The maximum recommended dose of metformin is 2 g daily, taken as 2 or 3 divided doses.Combinations requiring precautions for use-Certain drugs tend to produce hyperglycemia and may lead to loss of glycemic control. These drugs include thiazide and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. When such drugs are administered to a patient receiving Metformin HCl, the patient should be closely observed to maintain adequate glycemic control. Inform the patient and perform more frequent blood glucose monitoring, especially at the beginning of treatment. If necessary, adjust the dosage of the antidiabetic drug during therapy with the other drug and upon its discontinuation.Nifedipine appears to enhance the absorption of Metformin. Metformin has minimal effects on nifedipine. 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.ContraindicationsHypersensitivity to metformin hydrochloride or to any of the excipients of the medication.Diabetic ketoacidosis, diabetic pre-coma Renal failure or renal dysfunction (creatinine clearance < 60 mL/min)Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock, intravascular administration of iodinated contrast agents.Acute or chronic disease which may cause tissue hypoxia such as: cardiac or respiratory failure, recent myocardial infarction, shock Hepatic insufficiency, acute alcohol intoxication, alcoholism LactationSide EffectsMetformin may cause gastro-intestinal adverse effects like diarrhoea, anorexia, nausea & vomiting. Lactic acidosis and malabsorption of vitamin B12 may be occurred. Patients may experience a metallic taste and there may be weight loss, which in some diabetics could be an advantage.Overdose EffectsHypoglycemia has not been seen with metformin doses up to 85g, although lactic acidosis has occurred in such circumstances. High overdose or concomitant risks of metformin may lead to lactic acidosis. Lactic acidosis is a medical emergency and must be treated in hospital. The most effective method to remove lactate and metformin is hemodialysis...
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Diapro 30 MR
What Diapro® MR is and what it is used for?Gliclazide is a second generation sulfonylurea that has hypoglycemic and potentially useful hemobiological properties. It stimulates the influx of calcium ions into pancreatic beta cells and as a result increases insulin secretion. Moreover, in vivo studies have demonstrated changes in thrombin-induced platelet aggregation in NIDDM patients treated with gliclazide. Non-insulin dependent diabetes mellitus (type-II) when dietary modification has failed.Before you take Diapro® MRHigh Risk GroupsNeonates : The drug is not used in neonatesNursing mothers : The drug should not be used by breast-feeding mothers.Children : Gliclazide is contraindicated in childrenPregnant women : Gliclazide, as other sulfonylurea, is contraindicated for use in pregnant women. No teratological changes have been shown in animals or human, but diabetes can be controlled more tightly in pregnancy by insulin than by oral hypoglycemic agents.Elderly : All sulfonylureas should be used with caution in the elderly because of the greater likelihood of their missing meals and the more severe outcome of significant hypoglycemia.Concurrent disease : Definite hepatic disease should contraindicate the use of Gliclazide, since it is almost completely metabolized in the liver. Renal disease does not appear significantly to alter the pharmacokinetics, although it may be wise to limit the maximum dose when the serum creatinine starts to rise.Drug InteractionsPotentially hazardous interactions - These may be divided into those which will tend to increase the hypoglycemic effect and those tending to oppose it. In the first category come drugs which displace the sulfonylurea from protein binding, such as aspirin, non-steroidal anti-inflammatory drugs, phenylbutazone, clofibrate, sulfonamides and coumarin anticoagulants, or which inhibit, hepatic microsomal enzymes, for example cimetidine, sulfonamides, imidazole antifungal agents and the monoamine oxidase inhibitors (MAOI), which may increase the hypoglycemic effect of Gliclazide. Any effects, which result from protein-binding displacement, are transient, lasting from 12-24 hrs. Regular concomitant doses of these agents together with a constant dose of Gliclazide would not cause problems.The hypoglycemic action of sulfonylureas may be opposed by the induction of hepatic enzymes, which metabolize the drug causing lower plasma concentrations and less hypoglycemic effect. Common inducers include rifampicin, barbiturates, phenytoin and alcohol, or by drugs that inhibit the release or action of insulin, e.g. thiazide diuretics, dizoxide, glucocorticoids, estrogens or sympathomimetic drugs. Early symptoms of hypoglycemia such as tremor, sweating and tachycardia may be masked by beta-adrenoreceptor blocking drugs, such as propranolol allowing severe hypoglycemic episodes without preceding warning symptoms. If beta-adrenoreceptor blocking drugs are required the moreselective types, such as metoprolol or atenolol, are preferred in the diabetic patient.How to take Diapro® MRInitially 40-80 mg daily, adjusted according to response; up to 160 mg as a single dose, with breakfast; higher doses divided; maximum 320 mg daily. Switching from Gliclazide 80 mg tablets to Gliclazide 30 mg modified release tablets. 1 tablet of Gliclazide 80 mg is comparable to 1 tablet of Gliclazide 30 mg modified release tablet. Consequently the switch can be performed provided a careful blood monitoring.Possible side effectsPotentially life-threatening effects - All hypoglycemic agents have the potential to cause severe hypoglycemia and may cause severe brain damage or death. Gliclazide used in standard dose is less likely than glyburide to cause hypoglycemia. Hypoglycemia may be favored by concurrent conditions such as hepatic and renal disease, malnutrition, anorexia, senility, alcohol intoxication or adrenal and pituitary insufficiency.Severe or irreversible adverse effects - Approximately 2% of patients have been withdrawn from therapy because of adverse reactions, namely hypoglycemia (overdose effect), gastrointestinal disturbances and dermatological reactions.Symptomatic adverse effects - Side effects of Gliclazide treatment are similar to those of other sulfonylureas. Headache, gastrointestinal upsets, nausea and dizziness have been reported and skin reactions, including rash, pruritus, erythema and bullous eruptions may occur. Abnormalities of liver function are not uncommon.How to store Diapro® MRKeep in a cool & dry place. Protect from light. Keep out of the reach of children...
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Diapro 60 MR
Diapro 60 MRWhat Diapro® 60 MR is and what it is used for?Diapro® 60 MR is a preparation of Gliclazide which is a second generation sulphonylurea used as a Non-insulin dependent diabetes mellitus (type-II) when dietary modification has failed.Before you take Diapro® 60 MRDo not take the medicine and talk to your doctor ifHypoglycemia (overdose effect), gastrointestinal disturbances and dermatological reactions occur.Take special care withAll sulfonylureas should be used with caution in the elderly because of the greater likelihood of their missing meals and the more severe outcome of significant hypoglycemia.Early symptoms of hypoglycemia such as tremor, sweating and tachycardia may be masked by beta-adrenoreceptor blocking drugs, such as propranolol allowing severe hypoglycemic episodes without preceding warning symptoms.ContraindicationDiapro® 60 MR is contraindicated in patients with definite hepatic disease. Renal disease does not appear significantly to alter the pharmacokinetics, although it may be wise to limit the maximum dose when the serum creatinine starts to rise.Tell your doctor if you are taking other medicinesDrug interactions occur with rifampicin, barbiturates, phenytoin, and alcohol, or drugs that inhibit release of insulin like thiazide diuretics, dioxides, glucocorticoids, estrogens or sympathomimetic drugs.Pregnancy and breast-feedingDiapro® 60 MR should not be used in nursing mothers. It is contraindicated in children and pregnant women.How to take Diapro® 60 MR?Dosage and AdministrationsInitially 40-80 mg daily, adjusted according to response; up to 160 mg as a single dose, with breakfast; higher doses divided; maximum 320 mg daily.Switching from Gliclazide 80 mg tablets to Gliclazide 30 mg & 60 mg modified release tablets:1 tablet of Gliclazide 80 mg is comparable to 1 tablet of Gliclazide 30 mg modified release tablet. Consequently the switch can be performed provided a careful blood monitoring.One Gliclazide 60 mg modified release tablet is equivalent to two Gliclazide 30 mg modified release tablets. Gliclazide 60 mg modified release tablets can be used to replace other oral antidiabetic agents.Possible side effectsPotentially life-threatening effects - All hypoglycemic agents have the potential to cause severe hypoglycemia and may cause severe brain damage or death. Gliclazide used in standard dose is less likely than glyburide to cause hypoglycemia. Hypoglycemia may be favored by concurrent conditions such as hepatic and renal disease, malnutrition, anorexia, senility, alcohol intoxication or adrenal and pituitary insufficiency.Severe or irreversible adverse effects - Approximately 2% of patients have been withdrawn from therapy because of adverse reactions, namely hypoglycemia (overdose effect), gastrointestinal disturbances and dermatological reactions.Symptomatic adverse effects - Side effects of Gliclazide treatment are similar to those of other sulfonylureas. Headache, gastrointestinal upsets, nausea and dizziness have been reported and skin reactions, including rash, pruritus, erythema and bullous eruptions may occur. Abnormalities of liver function are not uncommon.Tell your doctor if any of the side effects gets serious or lasts longer than a few days, or if you notice any side effects not listed in this leafletHow to store Diapro® 60 MR?Keep in a cool & dry place. Protect from light. Keep out of the reach of children.Do not store above 25°C (room temperature). Do not freeze...
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Diapro tab
Diapro tab1. What Diapro® is and what it is used for?Gliclazide is a second generation sulfonylurea that has hypoglycemic and potentially useful hemobiological properties. It stimulates the influx of calcium ions into pancreatic beta cells and as a result, increases insulin secretion. Moreover, in vivo studies have demonstrated changes in thrombin-induced platelet aggregation in NIDDM patients treated with gliclazide. Non-insulin dependent diabetes mellitus (type-II) when dietary modification has failed.2. Before you take Diapro®High Risk GroupsNeonates - The drug is not used in neonatesNursing mothers - The drug should not be used by breast-feeding mothers.Children - Gliclazide is contraindicated in childrenPregnant women - Gliclazide, as other sulfonylurea, is contraindicated for use in pregnant women. No teratological changes have been shown in animals or human, but diabetes can be controlled more tightly in pregnancy by insulin than by oral hypoglycemic agents.Elderly - All sulfonylureas should be used with caution in the elderly because of the greater likelihood of their missing meals and the more severe outcome of significant hypoglycemia.Concurrent diseaseDefinite hepatic disease should contraindicate the use of Gliclazide, since it is almost completely metabolized in the liver. Renal disease does not appear significantly to alter the pharmacokinetics, although it may be wise to limit the maximum dose when the serum creatinine starts to rise.3. How to take Diapro®?Initially 40-80 mg daily, adjusted according to response; up to 160 mg as a single dose, with breakfast; higher doses divided; maximum 320 mg daily.4. Possible side effectsPotentially life-threatening effects – All hypoglycemic agents have the potential to cause severe hypoglycemia and may cause severe brain damage or death. Gliclazide used in standard dose is less likely than glyburide to cause hypoglycemia. Hypoglycemia may be favored by concurrent conditions such as hepatic and renal disease, malnutrition, anorexia, senility, alcohol intoxication or adrenal and pituitary insufficiency.Severe or irreversible adverse effects - Approximately 2% of patients have been withdrawn from therapy because of adverse reactions, namely hypoglycemia (overdose effect), gastrointestinal disturbances and dermatological reactions.Symptomatic adverse effects - Side effects of Gliclazide treatment are similar to those of other sulfonylureas. Headache, gastrointestinal upsets, nausea and dizziness have been reported and skin reactions, including rash, pruritus, erythema and bullous eruptions may occur. Abnormalities of liver function are not uncommon.5. How to store Diapro®?Store below 25° C...
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Gliclid 80 mg Tab
Gliclid 80 mg TabCOMPOSITIONGliclidTM 80: Each tablet contains Gliclazide BP 80 mg.GliclidTM MR: Each modified release tablet contains Gliclazide BP 30 mg.GliclidTM 60 MR: Each modified release tablet contains Gliclazide BP 60 mg.PHARMACOLOGYGliclidTM (Gliclazide) is a second generation oral hypoglycemic sulphonylurea, which stimulates the release of insulin from functioning pancreatic β-cells. This is mediated by an increase in the intracellular ratio of ATP/ADP, which inhibits K+ -ATP channels. Inaddition, there is evidence that Gliclazide has action on peripheral tissues. This has been shown to enhance glycogen synthesis and inhibit glycogenolysis and gluconeogenesis in the liver. This may also improve peripheral glucose uptake by muscles.INDICATIONSGliclazide is indicated in non-insulin dependent diabetes (type II) when dietary modification has failed.DOSAGE AND ADMINISTRATIONRoute of administration : Oral.Adult: The usual initial dose is 40-80 mg (1/2-1 tablet) given orally daily which may if needed gradually increased upto 320 mg daily until adequate control is achieved. A single dose should not exceed 160 mg (2 tablets). When higher doses are required, GliclidTM should be taken twice daily and according to the main meals of the day. For GliclidTM MR tablet the initial recommended dose is 30 mg daily, even in elderly patients (>65 years); the daily dose may vary from 30 mg to 120 mg taken orally. Dose titration should be carried out in steps of 30 mg, according to the fasting blood glucose response. Each step should last for at least two weeks. GliclidTM MR is a Modified release tablet and therefore, should be neither broken nor chewed.Elderly: Plasma clearance of Gliclazide is not altered in the elderly and steady state plasma levels are similar to those in adults under 65 years. Clinical experience in the elderly shows that Gliclazide is effective and well tolerated.Children: Gliclazide, as with other sulphonylureas is not indicated for the treatment of juvenile onset diabetes mellitus. It is recommended that the medication be taken at breakfast time. If a dose is forgotten, the dose taken on the next day should not be increased.OR AS DIRECTED BY THE PHYSICIAN.CONTRAINDICATIONSGliclazide is contraindicated in patients with known hypersensitivity to the drug. It is also contraindicated in patients with juvenile onset diabetes (type-1), diabetes associated with ketosis and acidosis, diabetic patients undergoing surgery, after severe injury or during infection.PRECAUTIONSCare should be exercised in patients with hepatic and renal impairment and a small starting dose should be used with careful patient monitoring. It has been suggested thatGliclazide may be suitable for use in patients with renal impairment, but careful monitoring of blood-sugar concentration is essential.SIDE EFFECTSCommon : As with other sulphonylureas, hypoglycemia will occur if the patients dietary intake is reduced or if they are receiving a larger dose of Gliclazide than required.Rare : Mild gastro-intestinal disturbances including nausea, dyspepsia, diarrhea and constipation have been reported, but these type of adverse reaction can be avoided ifGliclazide is taken during a meal.USE IN PREGNANCY AND LACTATIONPregnancy : Gliclazide, as other sulphonylureas, is contraindicated for use in pregnant women.Lactation : It has not yet been established whether Gliclazide is transferred to human milk. However, other sulphonylureas have been found in milk, there is no evidence to suggest that Gliclazide differs from the group in this respect. Therefore, if use is deemed essential, the patient should stop nursing.DRUG INTERACTIONSWith Medicine : The hypoglycemic effects of Gliclazide may be increased by Aspirin,NSAIDs, Phenylbutazone, Clofibrate, sulfonamide, Cemetidine, Imidazole antifungal agents and Monoamino Oxidase Inhibitors. The hypoglycemic effect of Gliclazide sometimes may be reduced by Rifampin, Barbiturates, Phenytoin, Thiazide diuretics,Diazoxide, Glucocorticoids, Estrogens, Sympathomymetic drugs and occasionally alcohol.With food : There are no established drug-food interaction.OVERDOSEThe administration of an excessive dose results in hypoglycemia (refer to warnings) which should be treated immediately by the administration of sugar. If the patient is unconscious, immediately inform a doctor and call the emergency service.STORAGEKeep all medicines out of reach of children. Store below 300 C and dry place, protected from light.PACKINGGliclidTM 80 : Each box contains 5x10 tablets in blister strips.GliclidTM MR : Each box contains 3x10 tablets in blister strips.GliclidTM 60 MR : Each box contains 3x10 tablets in blister strips...
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Glipita 100 tablet
What is Glipita?Glipita is the preparation of Sitagliptin. Sitagliptin is a new oral agent approved by the USFDA to treat type 2 diabetes with diet & exercise. It belongs to a new class of antihyperglycemic, Dipeptidyl Dipeptidase-4 (DPP-4) inhibitors. This unique class of orally active agent targets the underlying pathophysiologic processes of type 2 diabetic patients and provides an excellent alternative to the traditional agents.How Glipita works in our body?Normally, when glucose appears in blood after meal, Incretin hormones (GLP-1 & GIP) are secreted from gut to stimulate pancreatic β cell for insulin secretion and to act on α cell for glucagon inhibition. Dipeptidyl Peptidase 4 (DPP-4), an enzyme present in plasma, inactivates GLP-1 & GIP to stop insulin secretion from pancreatic β cell and to increase uninterrupted glucagon secretion from pancreatic α cell. Sitagliptin inhibits plasma DPP-4 activity (i.e. inactivation of GLP & GIP) and thus, increases circulating levels of active GLP-1 and GIP by two-to-threefold. This in turn, increases insulin release from pancreatic β cell and decreases glucagon levels from pancreatic α cell in the circulation in a glucose-dependent manner. Therefore, Sitagliptin is the only oral drug that involves both pancreatic α & β cell in a complimentary mode of action and thus ensures effective glycemic control in type 2 diabetes.What is the indications of Glipita?Monotherapy- GLIPITA is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. Combination with Metformin- GLIPITA is indicated in patients with type 2 diabetes mellitus to improve glycemic control in combination with Metformin as initial therapy or when the single agent alone, with diet and exercise, does not provide adequate glycemic control. Combination with a Sulfonylurea- GLIPITA is indicated in patients with type 2 diabetes mellitus to improve glycemic control in combination with a sulfonylurea when treatment with the single agent alone, with diet and exercise, does not provide adequate glycemic control. Combination with a Thiazolidinediones- GLIPITA is indicated in patients with type 2 diabetes mellitus to improve glycemic control in combination with a thiazolidinedione when treatment with the single agent alone, with diet and exercise, does not provide adequate glycemic control. Combination with Metformin and a Sulfonylurea- GLIPITA is indicated in patients with type 2 diabetes mellitus to improve glycemic control in combination with Metformin and a sulfonylurea when dual therapy with these agents, with diet and exercise, does not provide adequate glycemic control.What is the dosage guideline for Glipita?The recommended dose of SITAGLIPTIN is 100 mg once daily as monotherapy or as combination therapy with Metformin, a sulfonylurea, a thiazolidinedione, or Metformin plus a sulfonylurea. SITAGLIPTIN can be taken with or without food. Patients with Renal Insufficiency- For patients with mild renal insufficiency (creatinine clearance [CrCl] ≥50 mL/min, approximately corresponding to serum creatinine levels of ≤1.7 mg/dL in men and ≤1.5 mg/dL in women), no dosage adjustment for SITAGLIPTIN is required. For patients with moderate renal insufficiency (CrCl ≥30 to <50 mL/min, approximately corresponding to serum creatinine levels of >1.7 to ≤3.0 mg/dL in men and >1.5 to ≤2.5 mg/dL in women), the dose of SITAGLIPTIN is 50 mg once daily. For patients with severe renal insufficiency (CrCl <30 mL/min, approximately corresponding to serum creatinine levels of >3.0 mg/dL in men and >2.5 mg/dL in women) or with end -stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis, the dose of SITAGLIPTIN is 25 mg once daily. SITAGLIPTIN may be administered without regard to the timing of hemodialysis. Concomitant Use with a Sulfonylurea- When SITAGLIPTIN is used in combination with a sulfonylurea, a lower dose of sulfonylurea may be required to reduce the risk of hypoglycemia. Patients with Hepatic Insufficiency- No dosage adjustment is necessary for patients with mild to moderate hepatic insufficiency. SITAGLIPTIN has not been studied in patients with severe hepatic insufficiency. Elderly- No dosage adjustment is necessary for elderly patients. Pediatric population- There is no data on the use of SITAGLIPTIN in patients younger than 18 years of age and therefore not recommended.Is there any dosage guideline for special population like renal insufficient patient with type 2 diabetes?Dosage adjustments in patients with moderate, severe, or end-stage renal disease (ESRD)50 mg once daily Moderate25 mg once daily Severe and ESRDCrCl ≥30 to <50 mL/min ˜Serum Cr levels (mg/dL)CrCl <30 mL/min ˜Serum Cr levels (mg/dL)Men: >1.7 – ≤3.0 Women: >1.5 – ≤2.5Men: >3.0 Women: >2.5 or on dialysisWhat are the precautions should I follow?SITAGLIPTIN should not be used in patients with type 1 diabetes or for the trea..
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Glipita 50 tablet
Glipita 50 tabletWhat is Glipita?Glipita is the preparation of Sitagliptin. Sitagliptin is a new oral agent approved by the USFDA to treat type 2 diabetes with diet & exercise. It belongs to a new class of antihyperglycemic, Dipeptidyl Dipeptidase-4 (DPP-4) inhibitors. This unique class of orally active agent targets the underlying pathophysiologic processes of type 2 diabetic patients and provides an excellent alternative to the traditional agents.How Glipita works in our body?Normally, when glucose appears in blood after meal, Incretin hormones (GLP-1 & GIP) are secreted from gut to stimulate pancreatic β cell for insulin secretion and to act on α cell for glucagon inhibition. Dipeptidyl Peptidase 4 (DPP-4), an enzyme present in plasma, inactivates GLP-1 & GIP to stop insulin secretion from pancreatic β cell and to increase uninterrupted glucagon secretion from pancreatic α cell. Sitagliptin inhibits plasma DPP-4 activity (i.e. inactivation of GLP & GIP) and thus, increases circulating levels of active GLP-1 and GIP by two-to-threefold. This in turn, increases insulin release from pancreatic β cell and decreases glucagon levels from pancreatic α cell in the circulation in a glucose-dependent manner. Therefore, Sitagliptin is the only oral drug that involves both pancreatic α & β cell in a complimentary mode of action and thus ensures effective glycemic control in type 2 diabetes.What is the indications of Glipita?Monotherapy- GLIPITA is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. Combination with Metformin- GLIPITA is indicated in patients with type 2 diabetes mellitus to improve glycemic control in combination with Metformin as initial therapy or when the single agent alone, with diet and exercise, does not provide adequate glycemic control. Combination with a Sulfonylurea- GLIPITA is indicated in patients with type 2 diabetes mellitus to improve glycemic control in combination with a sulfonylurea when treatment with the single agent alone, with diet and exercise, does not provide adequate glycemic control. Combination with a Thiazolidinediones- GLIPITA is indicated in patients with type 2 diabetes mellitus to improve glycemic control in combination with a thiazolidinedione when treatment with the single agent alone, with diet and exercise, does not provide adequate glycemic control. Combination with Metformin and a Sulfonylurea- GLIPITA is indicated in patients with type 2 diabetes mellitus to improve glycemic control in combination with Metformin and a sulfonylurea when dual therapy with these agents, with diet and exercise, does not provide adequate glycemic control.What is the dosage guideline for Glipita?The recommended dose of SITAGLIPTIN is 100 mg once daily as monotherapy or as combination therapy with Metformin, a sulfonylurea, a thiazolidinedione, or Metformin plus a sulfonylurea. SITAGLIPTIN can be taken with or without food. Patients with Renal Insufficiency- For patients with mild renal insufficiency (creatinine clearance [CrCl] ≥50 mL/min, approximately corresponding to serum creatinine levels of ≤1.7 mg/dL in men and ≤1.5 mg/dL in women), no dosage adjustment for SITAGLIPTIN is required. For patients with moderate renal insufficiency (CrCl ≥30 to <50 mL/min, approximately corresponding to serum creatinine levels of >1.7 to ≤3.0 mg/dL in men and >1.5 to ≤2.5 mg/dL in women), the dose of SITAGLIPTIN is 50 mg once daily. For patients with severe renal insufficiency (CrCl <30 mL/min, approximately corresponding to serum creatinine levels of >3.0 mg/dL in men and >2.5 mg/dL in women) or with end -stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis, the dose of SITAGLIPTIN is 25 mg once daily. SITAGLIPTIN may be administered without regard to the timing of hemodialysis. Concomitant Use with a Sulfonylurea- When SITAGLIPTIN is used in combination with a sulfonylurea, a lower dose of sulfonylurea may be required to reduce the risk of hypoglycemia. Patients with Hepatic Insufficiency- No dosage adjustment is necessary for patients with mild to moderate hepatic insufficiency. SITAGLIPTIN has not been studied in patients with severe hepatic insufficiency. Elderly- No dosage adjustment is necessary for elderly patients. Pediatric population- There is no data on the use of SITAGLIPTIN in patients younger than 18 years of age and therefore not recommended.Is there any dosage guideline for special population like renal insufficient patient with type 2 diabetes?Dosage adjustments in patients with moderate, severe, or end-stage renal disease (ESRD)50 mg once daily Moderate25 mg once daily Severe and ESRDCrCl ≥30 to <50 mL/min ˜Serum Cr levels (mg/dL)CrCl <30 mL/min ˜Serum Cr levels (mg/dL)Men: >1.7 – ≤3.0 Women: >1.5 – ≤2.5Men: >3.0 Women: >2.5 or on dialysisWhat are the precautions should I follow?SITAGLIPTIN should not be used in patients with type 1 diabete..
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Glipita M 50/1000 tablet
Glipita M 50/1000 tabletWhat is Glipita-M?Glipita-M is the preparation of sitagliptin and metformin. Sitagliptin phosphate, a dipeptidyl peptidase 4(DPP-4) inhibitor and metformin HCI, a member of the biguanide class. Glipita-M is indicated as an adjunct to diet and exercise to treat Type 2 diabetes where metfromin is not enough to improve glycemic control. FDA Approves Glipita-M For Type 2 Diabetes, Offering Powerful Glucose Control Of A DPP-4 Inhibitor And Metformin in a Single Tablet.How Glipita works in our body?Glipita-M (sitagliptin phosphate/metformin HCI) combines 2 antihyperglycemic agents with complementary mechanism of action to improve glycemic control in patients with type 2 diabetes. Sitagliptin increases the levels of 2 known active incretin hormones, glucagon-like peptide-1(GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). When blood glucose concentrations are normal or elevated, GLP-1 and GIP increase insulin synthesis and release from pancreatic β-cells. GLP-1 also lowers glucagon secretion from pancreatic α-cells, leading to reduced hepatic glucose production. Metformin improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. It decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.What is the indications of Glipita-M?As initial therapy in type 2 DM when diet & exercise do not provide adequate glycemic control. As adjunct to diet & exercise to improve glycemic control in type 2 DM inadequately controlled on metformin or sitagliptin alone, or combination sitagliptin & metformin, or triple combination sitagliptin, metformin or a sulfonylurea.What are Dosage of Glipita-M?The dosage of Glipita-M should be individualized on the basis of the patient’s current regimen, effectiveness and tolerabilty while not excceding the maximum recommended daily dose of 100 mg sitagliptin and 2000 mg metformin. Initial combination therapy or maintenance of combination therapy should be individualized and left to the discretion of the health care provider . Glipita-M shoul generally be given twice daily with meals , with gradual dose escalation , to reducethe gasterointestinal side effect due to metformin. The recommended starting dose not currently treated with metformin is 50 mg sitagliptin/500 mg metformin hydrochloride twice daily, with gradual dose escalation recommended to reduce gastrointestinal side effects associated with metformin .The starting dose in patient already treated with metformin should provide sitagliptin dosed as 50 mg twice daily (100 mg toatal daily dose )and the dose of metformin already being taken. For patients taking 850 mg twice daily the recommended starting dose of Glipita-M is 50 mg sitagliptin/1000 mg metformin hydrochloride twice daily.Patients treated with an insulin secrtagauge or insulin co-administration of Glipita-M with an insulin secrtagauge (e.g. sulfonylurea) or insulin may require lower dose of insulin secretagauge or insulin to reduce the risk of hypoglycemia .No studies have been performed specifically examining the safety and efficacy of Glipita-M in patients previously treated with other oral antihyperglycemic agents and switched to Glipita-M.What is the Use of Glipita-M in Specific Populations:Pregnancy: Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women with Sitagliptin/Metformin HCl combination or its individual components; therefore, the safety of Sitagliptin/Metformin HCl combination in pregnant women is not known. Nursing Mothers: No studies in lactating animals have been conducted with the combined components of Sitagliptin/Metformin HCl combination. Pediatric Use: Safety and effectiveness of Sitagliptin/Metformin HCl combination in pediatric patients under 18 years have not been established.Geriatric Use: Because sitagliptin and metformin are substantially excreted by the kidney, and because aging can be associated with reduced renal function, Sitagliptin/Metformin HCl combination should be used with caution as age increases. Care should be taken in dose selection and should be based on careful and regular monitoring of renal function.Selected Important Risk Information:Lactic acidosis is a rare but serious complication that can occur because of metformin accumulation. Glipita M is contraindicated in renal disease or renal dysfunction (serum creatinine levels >1.5 mg/dL in males and >1.4 mg/dL in females) or abnormal creatinine clearance.What are the possible adverse reactions of Glipita-M?Diarrhea, nausea, dyspepsia, flatulence, vomiting, headache, hypoglycaemia; abdominal pain, loss of appetite, metallic taste, hypersensitivity reactions...
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Glipita M 50/500 tablet
What is Glipita-M?Glipita-M is the preparation of sitagliptin and metformin. Sitagliptin phosphate, a dipeptidyl peptidase 4(DPP-4) inhibitor and metformin HCI, a member of the biguanide class. Glipita-M is indicated as an adjunct to diet and exercise to treat Type 2 diabetes where metfromin is not enough to improve glycemic control. FDA Approves Glipita-M For Type 2 Diabetes, Offering Powerful Glucose Control Of A DPP-4 Inhibitor And Metformin in a Single Tablet.How Glipita works in our body?Glipita-M (sitagliptin phosphate/metformin HCI) combines 2 antihyperglycemic agents with complementary mechanism of action to improve glycemic control in patients with type 2 diabetes. Sitagliptin increases the levels of 2 known active incretin hormones, glucagon-like peptide-1(GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). When blood glucose concentrations are normal or elevated, GLP-1 and GIP increase insulin synthesis and release from pancreatic β-cells. GLP-1 also lowers glucagon secretion from pancreatic α-cells, leading to reduced hepatic glucose production. Metformin improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. It decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.What is the indications of Glipita-M?As initial therapy in type 2 DM when diet & exercise do not provide adequate glycemic control. As adjunct to diet & exercise to improve glycemic control in type 2 DM inadequately controlled on metformin or sitagliptin alone, or combination sitagliptin & metformin, or triple combination sitagliptin, metformin or a sulfonylurea.What are Dosage of Glipita-M?The dosage of Glipita-M should be individualized on the basis of the patient’s current regimen, effectiveness and tolerabilty while not excceding the maximum recommended daily dose of 100 mg sitagliptin and 2000 mg metformin. Initial combination therapy or maintenance of combination therapy should be individualized and left to the discretion of the health care provider . Glipita-M shoul generally be given twice daily with meals , with gradual dose escalation , to reducethe gasterointestinal side effect due to metformin. The recommended starting dose not currently treated with metformin is 50 mg sitagliptin/500 mg metformin hydrochloride twice daily, with gradual dose escalation recommended to reduce gastrointestinal side effects associated with metformin .The starting dose in patient already treated with metformin should provide sitagliptin dosed as 50 mg twice daily (100 mg toatal daily dose )and the dose of metformin already being taken. For patients taking 850 mg twice daily the recommended starting dose of Glipita-M is 50 mg sitagliptin/1000 mg metformin hydrochloride twice daily.Patients treated with an insulin secrtagauge or insulin co-administration of Glipita-M with an insulin secrtagauge (e.g. sulfonylurea) or insulin may require lower dose of insulin secretagauge or insulin to reduce the risk of hypoglycemia .No studies have been performed specifically examining the safety and efficacy of Glipita-M in patients previously treated with other oral antihyperglycemic agents and switched to Glipita-M.What is the Use of Glipita-M in Specific Populations:Pregnancy: Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women with Sitagliptin/Metformin HCl combination or its individual components; therefore, the safety of Sitagliptin/Metformin HCl combination in pregnant women is not known. Nursing Mothers: No studies in lactating animals have been conducted with the combined components of Sitagliptin/Metformin HCl combination. Pediatric Use: Safety and effectiveness of Sitagliptin/Metformin HCl combination in pediatric patients under 18 years have not been established.Geriatric Use: Because sitagliptin and metformin are substantially excreted by the kidney, and because aging can be associated with reduced renal function, Sitagliptin/Metformin HCl combination should be used with caution as age increases. Care should be taken in dose selection and should be based on careful and regular monitoring of renal function.Selected Important Risk Information:Lactic acidosis is a rare but serious complication that can occur because of metformin accumulation. Glipita M is contraindicated in renal disease or renal dysfunction (serum creatinine levels >1.5 mg/dL in males and >1.4 mg/dL in females) or abnormal creatinine clearance.What are the possible adverse reactions of Glipita-M?Diarrhea, nausea, dyspepsia, flatulence, vomiting, headache, hypoglycaemia; abdominal pain, loss of appetite, metallic taste, hypersensitivity reactions...
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Janmet 50/1000 mg Tab
Janmet 50/1000 mg TabDescriptionJanmet is an oral anti-diabetic drug that helps control blood sugar levels. Janmet contains a combination of Metformin and Sitagliptin.Metformin and Sitagliptin are oral diabetes medicines that help control blood sugar levels. Janmet is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes (NIDDM).CompositionJanmet 500 : Each film-coated tablet contains Sitagliptin PhosphateMonohydrate INN 64.25 mg equivalent to 50 mg of Sitagliptin and Metformin Hydrochloride BP 500 mg. Janmet 1000 : Each film-coated tablet contains Sitagliptin PhosphateMonohydrate INN 64.25 mg equivalent to 50 mg of Sitagliptin and Metformin Hydrochloride BP 1000 mg.IndicationJanmet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both Sitagliptin and Metformin is appropriate.Dosage and AdministrationJanmet should generally be given twice daily with meals, with gradual dose escalation, to reduce the gastrointestinal (GI) side effects due toMetformin.The recommended starting dose in patients not currently treated withMetformin is 50 mg Sitagliptin/500 mg Metformin hydrochloride twice daily.The starting dose in patients already treated with Metformin should provide Sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and the dose of Metformin already being taken. For patients takingMetformin 850 mg twice daily, the recommended starting dose ofJanmet is 50 mg Sitagliptin/1000 mg Metformin twice daily. Patients treated with an insulin secretagogue or insulinCo-administration of Janmet with an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower doses of the insulin secretagogue or insulin to reduce the risk of hypoglycemia.Use in Specific PopulationsPediatric population- There is no data on the use of Sitagliptin in patients younger than 18 years of age and therefore not recommended.Geriatric Use- Janmet should be used with caution as age increases.Care should be taken in dose selection and should be based on careful and regular monitoring of renal function.Renal Insufficiency- A dosage adjustment is recommended in patientswith moderate or severe renal insufficiency and in patients with ESRD requiring hemodialysis or peritoneal dialysis.Impaired Hepatic Function- Janmet should generally be avoided in patients with clinical or laboratory evidence of hepatic disease.Use in Pancreatitis: Janmet has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk of developing pancreatitis while taking Janmet.OR AS DIRECTED BY THE PHYSICIAN.Side EffectsMost common side effects of Janmet are diarrhea, gas, headache, indigestion, nausea, sore throat, stomach upset, stuffy or runny nose, vomiting, and weakness.Severe allergic reactions (rash; hives; itching; difficulty swallowing or breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); chest pain or discomfort; decreased urination; dizziness or light-headedness; fast or difficult breathing; feeling of being unusually cold; general feeling of being unwell; muscle pain or weakness; red, blistered, swollen, or peelingskin; slow or irregular heartbeat; symptoms of pancreas inflammation (eg, severe stomach or back pain with or without nausea or vomiting); unusual drowsiness; unusual or persistent stomach pain or discomfort; unusual tiredness or weakness.ContraindicationJanmet is contraindicated in patients with hypersensitivity to the active substances or to any of the excipients, diabetic ketoacidosis, diabetic pre-coma, moderate and severe renal impairment [serum creatinine levels 1.5 mg/dL (males), 1.4 mg/dL (Females)].PrecautionJanmet may cause lactic acidosis, low blood sugar, and decreased vitamin B12 levels. Janmet warnings and precautions also extend to those who are allergic to any components of the drug, have metabolic or diabetic ketoacidosis, have kidney disease, or are about to have an x-ray procedure with contrast dye.Use in Pregnancy and LactationPregnancyPregnancy Category : B. Animal studies have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy.Sitagliptin-Metformin is only recommended for use during pregnancy when benefit outweighs risk.LactationThere are no data on the excretion of Sitagliptin-Metformin into human milk. It is recommended that caution should be used when administering Sitagliptin-Metformin to nursing women.Drug InteractionCationic agents that are eliminated by renal tubular secretion (e.g. cimetidine) may interact with Metformin by competing for common renal tubular transport systems. So, close monitoring of glycaemic control, dose adjustment within the recommended posology and changes in diabetic treatment should be considered when cationic agents that are eliminated by renal tubular secretion are co-administered. ..
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Janmet 50/500 mg Tab
Janmet 50/500 mg TabDescriptionJanmet is an oral anti-diabetic drug that helps control blood sugar levels. Janmet contains a combination of Metformin and Sitagliptin.Metformin and Sitagliptin are oral diabetes medicines that help control blood sugar levels. Janmet is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes (NIDDM).CompositionJanmet 500 : Each film-coated tablet contains Sitagliptin PhosphateMonohydrate INN 64.25 mg equivalent to 50 mg of Sitagliptin and Metformin Hydrochloride BP 500 mg. Janmet 1000 : Each film-coated tablet contains Sitagliptin PhosphateMonohydrate INN 64.25 mg equivalent to 50 mg of Sitagliptin and Metformin Hydrochloride BP 1000 mg.IndicationJanmet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both Sitagliptin and Metformin is appropriate.Dosage and AdministrationJanmet should generally be given twice daily with meals, with gradual dose escalation, to reduce the gastrointestinal (GI) side effects due toMetformin.The recommended starting dose in patients not currently treated withMetformin is 50 mg Sitagliptin/500 mg Metformin hydrochloride twice daily.The starting dose in patients already treated with Metformin should provide Sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and the dose of Metformin already being taken. For patients takingMetformin 850 mg twice daily, the recommended starting dose ofJanmet is 50 mg Sitagliptin/1000 mg Metformin twice daily. Patients treated with an insulin secretagogue or insulinCo-administration of Janmet with an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower doses of the insulin secretagogue or insulin to reduce the risk of hypoglycemia.Use in Specific PopulationsPediatric population- There is no data on the use of Sitagliptin in patients younger than 18 years of age and therefore not recommended.Geriatric Use- Janmet should be used with caution as age increases.Care should be taken in dose selection and should be based on careful and regular monitoring of renal function.Renal Insufficiency- A dosage adjustment is recommended in patientswith moderate or severe renal insufficiency and in patients with ESRD requiring hemodialysis or peritoneal dialysis.Impaired Hepatic Function- Janmet should generally be avoided in patients with clinical or laboratory evidence of hepatic disease.Use in Pancreatitis: Janmet has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk of developing pancreatitis while taking Janmet.OR AS DIRECTED BY THE PHYSICIAN.Side EffectsMost common side effects of Janmet are diarrhea, gas, headache, indigestion, nausea, sore throat, stomach upset, stuffy or runny nose, vomiting, and weakness.Severe allergic reactions (rash; hives; itching; difficulty swallowing or breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); chest pain or discomfort; decreased urination; dizziness or light-headedness; fast or difficult breathing; feeling of being unusually cold; general feeling of being unwell; muscle pain or weakness; red, blistered, swollen, or peelingskin; slow or irregular heartbeat; symptoms of pancreas inflammation (eg, severe stomach or back pain with or without nausea or vomiting); unusual drowsiness; unusual or persistent stomach pain or discomfort; unusual tiredness or weakness.ContraindicationJanmet is contraindicated in patients with hypersensitivity to the active substances or to any of the excipients, diabetic ketoacidosis, diabetic pre-coma, moderate and severe renal impairment [serum creatinine levels 1.5 mg/dL (males), 1.4 mg/dL (Females)].PrecautionJanmet may cause lactic acidosis, low blood sugar, and decreased vitamin B12 levels. Janmet warnings and precautions also extend to those who are allergic to any components of the drug, have metabolic or diabetic ketoacidosis, have kidney disease, or are about to have an x-ray procedure with contrast dye.Use in Pregnancy and LactationPregnancyPregnancy Category : B. Animal studies have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy.Sitagliptin-Metformin is only recommended for use during pregnancy when benefit outweighs risk.LactationThere are no data on the excretion of Sitagliptin-Metformin into human milk. It is recommended that caution should be used when administering Sitagliptin-Metformin to nursing women.Drug InteractionCationic agents that are eliminated by renal tubular secretion (e.g. cimetidine) may interact with Metformin by competing for common renal tubular transport systems. So, close monitoring of glycaemic control, dose adjustment within the recommended posology and changes in diabetic treatment should be considered when cationic agents that are eliminated by renal tubular secretion are co-administered. J..
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Janvia 100 mg Tab
Janvia 100 mg TabDescriptionJanvia (Sitagliptin) is an oral diabetes medicine that helps control blood sugar levels. Janvia (Sitagliptin) tablets contain the active ingredient Sitagliptin, which is a type of medicine called dipeptidyl peptidase 4 (DPP-4) inhibitor. It is used to treat people with type 2 or non-insulin dependent diabetes mellitus (NIDDM).CompositionJanvia 50: Each film-coated tablet contains Sitagliptin Phosphate Monohydrate INN 64.25 mg equivalent to 50 mg of SitagliptinJanvia 100: Each film-coated tablet contains Sitagliptin Phosphate Monohydrate INN 128.50 mg equivalent to 100 mg of SitagliptinIndicationJanvia (Sitagliptin) is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is also indicated for use in combination with Metformin, Sulfonylurea or Thiazolidinediones when diet and exercise plus the single agent does not provide adequate glycemic control.Dosage and AdministrationThe recommended dose of Janvia (Sitagliptin) is 100 mg once daily. Janvia can be taken with or without food.Patients with Renal InsufficiencyFor patients with mild renal insufficiency, no dosage adjustment for Janvia (Sitagliptin) is required. For patients with moderate renal insufficiencey, the dose of Janvia (Sitagliptin) is 50 mg once daily. For patients with severe renal insufficiency or with end-stage renal disease(ESRD) requiring hemodialysis or peritoneal dialysis, the dose of Janvia (Sitagliptin) is 25 mg once daily.Pediatric UseSafety and effectiveness of Sitagliptin in pediatric patients under 18 years of age have not been established.Geriatric UseNo dosage adjustment is required based solely on age. The drug is excreted by the kidney. As elderly patients are more likely to have decreased renal function, caution should be taken in dose selection in the elderly.OR AS DIRECTED BY THE PHYSICIAN.Side EffectsThe most common adverse reactions are; upper respiratory tract infection, nasopharyngitis and headache. Hypoglycemia may occur in patients treated with the combination of Sitagliptin and sulfonylurea and add-on to insulin.ContraindicationHistory of a serious hypersensitivity reaction to Sitagliptin, such as anaphylaxis or angioedema and exfoliative skin conditions includingStevens-Johnson syndrome.PrecautionIf pancreatitis is suspected, Janvia should promptly be discontinued and appropriate management should be initiated. Dosage adjustment should recommended in patients with moderate or severe renal insufficiency and in patients with ESRD. Assessment of renal functionshould recommend prior to initiating Janvia (Sitagliptin). When Janvia is used in combination with a sulfonylurea or with insulin, medications known to cause hypoglycemia, a lower dose of sulfonylurea or insulin may be required to reduce the risk of hypoglycemia. If a hypersensitivity reaction is suspected, Janvia should discontinued.Use in Pregnancy and LactationPregnancyPregnancy Category: B. Safety of Sitagliptin in pregnant women has not been established. Sitagliptin should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus.Nursing motherIt is not known whether Sitagliptin is excreted in human milk, because many drugs are excreted in human milk, caution should be exercised when Sitagliptin is administered to a nursing woman.Drug InteractionCo-administration of Digoxin and Sitagliptin may slightly increase the mean peak drug concentration of Digoxin. But no dosage adjustment ofDigoxin or Sitagliptin is recommended.SupplyJanvia 50 : Each box contains 1x10 tablets in Alu-Alu blister strip.Janvia 100 : Each box contains 1x10 tablets in Alu-Alu blister strip...
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Janvia 50 mg Tab
Janvia 50 mg TabDescriptionJanvia (Sitagliptin) is an oral diabetes medicine that helps control blood sugar levels. Janvia (Sitagliptin) tablets contain the active ingredient Sitagliptin, which is a type of medicine called dipeptidyl peptidase 4 (DPP-4) inhibitor. It is used to treat people with type 2 or non-insulin dependent diabetes mellitus (NIDDM).CompositionJanvia 50: Each film-coated tablet contains Sitagliptin Phosphate Monohydrate INN 64.25 mg equivalent to 50 mg of SitagliptinJanvia 100: Each film-coated tablet contains Sitagliptin Phosphate Monohydrate INN 128.50 mg equivalent to 100 mg of SitagliptinIndicationJanvia (Sitagliptin) is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is also indicated for use in combination with Metformin, Sulfonylurea or Thiazolidinediones when diet and exercise plus the single agent does not provide adequate glycemic control.Dosage and AdministrationThe recommended dose of Janvia (Sitagliptin) is 100 mg once daily. Janvia can be taken with or without food.Patients with Renal InsufficiencyFor patients with mild renal insufficiency, no dosage adjustment for Janvia (Sitagliptin) is required. For patients with moderate renal insufficiencey, the dose of Janvia (Sitagliptin) is 50 mg once daily. For patients with severe renal insufficiency or with end-stage renal disease(ESRD) requiring hemodialysis or peritoneal dialysis, the dose of Janvia (Sitagliptin) is 25 mg once daily.Pediatric UseSafety and effectiveness of Sitagliptin in pediatric patients under 18 years of age have not been established.Geriatric UseNo dosage adjustment is required based solely on age. The drug is excreted by the kidney. As elderly patients are more likely to have decreased renal function, caution should be taken in dose selection in the elderly.OR AS DIRECTED BY THE PHYSICIAN.Side EffectsThe most common adverse reactions are; upper respiratory tract infection, nasopharyngitis and headache. Hypoglycemia may occur in patients treated with the combination of Sitagliptin and sulfonylurea and add-on to insulin.ContraindicationHistory of a serious hypersensitivity reaction to Sitagliptin, such as anaphylaxis or angioedema and exfoliative skin conditions includingStevens-Johnson syndrome.PrecautionIf pancreatitis is suspected, Janvia should promptly be discontinued and appropriate management should be initiated. Dosage adjustment should recommended in patients with moderate or severe renal insufficiency and in patients with ESRD. Assessment of renal functionshould recommend prior to initiating Janvia (Sitagliptin). When Janvia is used in combination with a sulfonylurea or with insulin, medications known to cause hypoglycemia, a lower dose of sulfonylurea or insulin may be required to reduce the risk of hypoglycemia. If a hypersensitivity reaction is suspected, Janvia should discontinued.Use in Pregnancy and LactationPregnancyPregnancy Category: B. Safety of Sitagliptin in pregnant women has not been established. Sitagliptin should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus.Nursing motherIt is not known whether Sitagliptin is excreted in human milk, because many drugs are excreted in human milk, caution should be exercised when Sitagliptin is administered to a nursing woman.Drug InteractionCo-administration of Digoxin and Sitagliptin may slightly increase the mean peak drug concentration of Digoxin. But no dosage adjustment ofDigoxin or Sitagliptin is recommended.SupplyJanvia 50 : Each box contains 1x10 tablets in Alu-Alu blister strip.Janvia 100 : Each box contains 1x10 tablets in Alu-Alu blister strip...
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Lijenta 5 Tab, 1 strip
Lijenta 5 Tab, 1 stripDescription:Lijenta 5 is an inhibitor of DPP-4 , an enzyme that degrades the incretin hormones GLP-1 and GIP. Thus, Linagliptin increases the concentratins of active incretin hormones, stimulating the release of insulin from pancreatic beta cells in a glucose-dependent manner and decreasing the secretion of glucangon from pancreatic alpha cells in the circulation.Thus it improves glycemic control in patients with type 2 diabetes mellitus.IndicationLijenta 5 is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults. As monotherapy-in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance or contraindicated due to renal impairment. As combination therapy-in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control-in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.Dosage & Administration5 mg once daily. If added to metformin, the dose of metformin should be maintained and linagliptin administered concomitantly. When used in combination with a sulfonylurea, a lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycaemia.Patients with renal impairment: no dose adjustment required. Linagliptin can be taken with or without a meal at any time of the day.ContraindicationHypersensitivity to the active substance or to any of the excipients.PrecautionLinagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.Side EffectsThere may be hypoglycaemia, nasopharyngitis, cough and pancreatitis in combination with metformin and sulfonylurea.Drug InteractionLinagliptin is a weak competitive and a weak to moderate mechanism-based inhibitor of CYP isozyme CYP3A4, but does not inhibit other CYP isozymes. The risk for clinically meaningful interactions by other medicinal products on linagliptin is low and in clinical studies linagliptin had no clinically relevant effect on the pharmacokinetics of metformin, glyburide, simvastatin, warfarin, digoxin or oral contraceptives.Pregnancy & LactationAvoid use during pregnancy. A risk to the breast-fed child cannot be excluded.Storage ConditionKeep in a dry place away from light and heat. Keep out of the reach of children...
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Lijenta-M 500 Tab, 1 strip
Lijenta-M 500 Tab, 1 stripDescription:Lijenta-M is a combination of linagliptin and Metformin Hydrochloride with complementary mechanism of action to improve glycemic control in patients with type 2 diabetes mellitus. Linagliptin is an inhibitor of DPP-4 (dipeptidyl peptidase-4), an enzyme that degrades the incretin hormones GLP-1 (glucagon like peptide-1) and GIP (glucose dependent insulinotropic polypeptide). Thus, Linagliptin increases the concentrations of active incretin hormones, stimulating the release of insulin from pancreatic beta cells in a glucose-dependent manner and decreasing the secretion of glucagon from pancreatic alpha cells in the circulation.Metformin Hydrochloride is a biguanide type oral antihyperglycemic drug used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. Its mechanism of action is different from those of sulfonylureas and it does not produce hypoglycemia. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.IndicationLijenta-M is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both linagliptin and metformin is appropriate.Dosage & AdministrationThe dosage of Lijenta-M should be individualized on the basis of both effectiveness and tolerability. Maximum recommended dose of 2.5 mg Linagliptin and 1000 mg Metformin Hydrochloride twice daily with meals. Dose escalation should be gradual to reduce the gastrointestinal (GI) side effects associated with Metformin use.Recommended starting dose: In patients currently not treated with Metformin, initiate treatment with 2.5 mg Linagliptin and 500 mg Metformin Hydrochloride twice daily.In patients already treated with Metformin, start with 2.5 mg Linagliptin and the current dose of Metformin Hydrochloride twice daily.Patients already treated with linagliptin and metformin, individual components may be switched to this combination containing the same doses of each component.ContraindicationAlthough Linagliptin undergoes minimal renal excretion, Metformin is known to be substantially excreted by the kidney. The risk of Metformin accumulation and lactic acidosis increases with the degree of renal impairment. Therefore, this combination is contraindicated in patients with renal impairment. It is also contraindicated in acute or chronic metabolic acidosis (diabetic ketoacidosis) and in hypersensitivity to Linagliptin or Metformin.PrecautionIn a patient with lactic acidosis who is taking Metformin, the drug should be discontinued immediately and supportive therapy promptly instituted. There have been postmarketing reports of acute pancreatitis. If pancreatitis is suspected, promptly discontinue Lijenta-M. Temporarily discontinue Lijenta-M in patients undergoing radiologic studies with intravascular administration of iodinated contrast materials or any surgical procedures necessitating restricted intake of food and fluids. Metformin may lower Vitamin B12 levels; so hematologic parameters shoud be monitored annually.Side EffectsMost common side effects are nasopharyngitis and diarrhea. Hypoglycemia is more common in patients treated with this combination and sulfonylureas.Drug InteractionCationic drugs (amiloride, digoxin, morphine, ranitidine, trimethoprim etc.): May reduce metformin elimination. P-glycoprotien/CYP3A4 inducer (i.e. rifampin): The efficacy of Lijenta-M may be reduced when administered in combination.Pregnancy & LactationPregnancy category B. There are no adequate and well-controlled studies in pregnant women with this combination or its individual component; so it should be used during pregnancy only if clearly needed. Caution should also be excercised when it is administered to a lactating mother.Storage ConditionKeep in a dry place away from light and heat. Keep out of the reach of children...
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