Sitagil M 50/500 ER

Indications

This can be shown as an aide to eat less and work out to move forward glycemic control in grown-ups with sort 2 diabetes mellitus when treatment with both sitagliptin and metformin is fitting.

Critical impediments of use: This ought to not be utilized in patients with sort 1 diabetes or for the treatment of diabetic ketoacidosis, because it would not be effective in these settings. This has not been considered in patients with a history of pancreatitis. It is obscure whether patients with a history of pancreatitis are at expanded hazard for the improvement of pancreatitis whereas utilizing This.

Pharmaceutical Name

Incepta Pharmaceuticals Ltd.

Pharmacology

This tablet combines two antihyperglycemic operators with complementary instruments of activity to move forward glycemic control in patients with sort 2 diabetes. Sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and Metformin HCl, a part of the biguanide lesson. Sitagliptin may be a dipeptidyl peptidase-4 (DPP-4) inhibitor, which is accepted to apply its activities in patients with sort 2 diabetes by abating the inactivation of incretin hormones. Incretin hormones, counting glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), are discharged by the digestive tract all through the day, and levels are expanded in reaction to a dinner. These hormones are quickly inactivated by the chemical, DPP-4. The incretins are part of an endogenous framework included within the physiologic direction of glucose homeostasis.

Dosage & Administration

Dose of film-coated tablet: The dosage of this tablet should be individualized on the basis of the patient's current regimen, effectiveness, and tolerability while not exceeding 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.

This tablet should generally be given twice daily with meals, with gradual dose escalation, to reduce the gastrointestinal (GI) side effects due to metformin.

The starting dose of this tablet should be based on the patient’s current regimen. This tablet should be given twice daily with meals.

The recommended starting dose in patients 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 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 taking metformin 850 mg twice daily, the recommended starting dose of this tablet is 50 mg sitagliptin/1000 mg metformin hydrochloride twice daily.

No studies have been performed specifically examining the safety and efficacy of Sitagliptin Phosphate Monohydrate INN/Metformin Hydrochloride BP in patients previously treated with other oral antihyperglycemic agents and switched to Sitagliptin Phosphate Monohydrate INN/Metformin Hydrochloride BP. Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring as changes in glycemic control can occur.

Dose of extended-release tablet: Administer once daily with a meal preferably in the evening. Gradually escalate the dose to reduce the gastrointestinal side effects due to Metformin. May adjust the dosing based on effectiveness and tolerability while not exceeding the maximum recommended daily dose of 100 mg Sitagliptin and 2000 mg Metformin extended-release. Maintain the same total daily dose of Sitagliptin and Metformin when changing between film-coated tablet and extended-release tablet, without exceeding the maximum recommended daily dose of 2000 mg Metformin extended-release.

Patients using two extended-release tablets (such as two 50/500 or two 50/1000 tablets) should take the two tablets together once daily. The 100 mg Sitagliptin/1000 mg Metformin HCI extended-release tablet should be taken as a single tablet once daily.

Patients treated with an insulin secretagogue or insulin: Co-administration of the combination 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.

Interaction

Cationic Drugs: Cationic drugs dispensed with by renal tubular discharge: Utilize with caution.

Preprohormone: Metformin may diminish the anticoagulant impact of preprohormone. In this manner, near observing of the INR is recommended.

Levothyroxine: Levothyroxine can diminish the hypoglycemic impact of metformin. Observing of blood glucose levels is suggested, particularly when thyroid hormone treatment is started or ceased, and the dose of metformin must be balanced in case essential.

Contraindications

This tablet is contraindicated in patients with:

• Renal disease or renal dysfunction, e.g., as suggested by serum creatinine levels ≥1.5 mg/dL [males], ≥1.4 mg/dL [females] or abnormal creatinine clearance which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia
• Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
• History of a serious hypersensitivity reaction to this tablet or sitagliptin, such as anaphylaxis or angioedema.

This tablet should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function.

Side Effects

The foremost common unfavorable responses detailed in ≥5% of patients at the same time begun on sitagliptin and metformin and more commonly than in patients treated with fake treatment were the runs, upper respiratory tract contamination, and headache. Adverse responses detailed in ≥5% of patients treated with sitagliptin in combination with sulfonylurea and metformin and more commonly than in patients treated with fake treatment in combination with sulfonylurea and metformin were hypoglycemia and headache. Hypoglycemia was the as it were antagonistic response detailed in ≥5% of patients treated with sitagliptin in combination with affront and metformin and more commonly than in patients treated with fake treatment in combination with affront and metformin. Nasopharyngitis was the as it were antagonistic response detailed in ≥5% of patients treated with sitagliptin monotherapy and more commonly than in patients given a placebo.

Pregnancy & Lactation

Pregnancy Category B. There are no satisfactory and well-controlled thinks about in pregnant ladies with Sitagliptin Phosphate Monohydrate INN/Metformin Hydrochloride BP or its person components; subsequently, the security of Sitagliptin Phosphate Monohydrate INN/Metformin Hydrochloride BP in pregnant ladies isn't known. This tablet ought to be utilized amid pregnancy as it were if clearly needed. It isn't known whether sitagliptin is excreted in the human brain. Since numerous drugs are excreted in the human drain, caution ought to be worked out when this tablet is managed by a nursing lady.

Precautions & Warnings

Lactic Acidosis-

• Lactic acidosis can occur due to metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic insufficiency, renal impairment, and acute congestive heart failure.
• Symptoms include malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. Laboratory abnormalities include low pH, increased anion gap and elevated blood lactate.
• If acidosis is suspected, discontinue this tablet and hospitalize the patient immediately.
• Regular monitoring of thyroid-stimulating hormone (TSH) levels is recommended in patients with hypothyroidism.
• Long-term treatment with metformin has been associated with a decrease in vitamin B12 serum levels which may cause peripheral neuropathy. Monitoring of the vitamin B12 level is recommended.

Others-

• Do not use this tablet in patients with hepatic disease.
• There have been post-marketing reports of acute renal failure, sometimes requiring dialysis. Before initiating this tablet and at least annually thereafter, assess renal function and verify as normal.
• There have been post-marketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. If pancreatitis is suspected, promptly discontinue this tablet.
• Measure hematologic parameters annually.
• Warn patients against excessive alcohol intake.
• May need to discontinue this tablet and temporarily use insulin during periods of stress and decreased intake of fluids and food as may occur with fever, trauma, infection or surgery.
• Promptly evaluate patients previously controlled on this tablet who develop laboratory abnormalities or clinical illness for evidence of ketoacidosis or lactic acidosis.
• When used with an insulin secretagogue (e.g., sulfonylurea) or with insulin, a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia.
• There have been post-marketing reports of serious allergic and hypersensitivity reactions in patients treated with sitagliptin (one of the components of this tablet ), such as anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. In such cases, promptly stop this tablet, assess for other potential causes, and institute appropriate monitoring and treatment, and initiate alternative treatment for diabetes.
• There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Sitagliptin Phosphate Monohydrate INN/Metformin Hydrochloride BP or any other anti-diabetic drug.

Therapeutic Class

Combination Oral hypoglycemic preparations

Storage Conditions

Keep away from light and moisture in a cool, dry location (below 30° C). Keep out of children's reach.

Generic

Sitagliptin + Metformin Hydrochloride

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