Glipita-M 50/500 Tablet
by Beximco Pharmaceuticals Ltd.
৳16.00
The IBN SINA Pharmaceutical Industry Ltd.
Sitagliptin + Metformin Hydrochloride
When both sitagliptin and metformin medication is appropriate, this is advised as an addition to diet and exercise to enhance glycemic control in persons with type 2 diabetes mellitus. Important usage restrictions:
This pill combines two antihyperglycemic medicines with complimentary modes of action to help patients with type 2 diabetes improve their glycemic control. Metformin HCl, a member of the biguanide class, and Sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor. Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor that is thought to work in type 2 diabetes patients by reducing the inactivation of incretin hormones. The intestine releases incretin hormones throughout the day, including glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), and levels rise in response to a meal. GLP-1 and GIP stimulate insulin production and release from pancreatic beta cells via intracellular signaling pathways including cyclic AMP when blood glucose levels are normal or increased. GLP-1 also inhibits the secretion of glucagon by pancreatic alpha cells, resulting in lower hepatic glucose synthesis. Sitagliptin enhances insulin release and reduces glucagon levels in the circulation in a glucose-dependent manner by boosting and prolonging active incretin levels. Metformin HCl has a different pharmacologic mode of action than other oral antihyperglycemic drugs. Metformin HCl inhibits the synthesis of glucose in the liver.
Dose of film-coated tablet: The dosage of this tablet should be individualized on the basis of the patient's current regimen, efectiveness, 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 efects 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 efects 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 specifcally examining the safety and efcacy 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.
Cationic Drugs: Cationic drugs eliminated by renal tubular secretion: Use with caution.
Phenprocoumon: Metformin may decrease the anticoagulant effect of phenprocoumon. Therefore, close monitoring of the INR is recommended.
Levothyroxine: Levothyroxine can reduce the hypoglycemic effect of metformin. Monitoring of blood glucose levels is recommended, especially when thyroid hormone therapy is initiated or stopped, and the dosage of metformin must be adjusted if necessary.
This tablet is contraindicated in patients with:
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.
The most common adverse reactions reported in ≥5% of patients simultaneously started on sitagliptin and metformin and more commonly than in patients treated with placebo were diarrhea, upper respiratory tract infection, and headache.
Adverse reactions reported in ≥5% of patients treated with sitagliptin in combination with sulfonylurea and metformin and more commonly than in patients treated with placebo in combination with sulfonylurea and metformin were hypoglycemia and headache.
Hypoglycemia was the only adverse reaction reported in ≥5% of patients treated with sitagliptin in combination with insulin and metformin and more commonly than in patients treated with placebo in combination with insulin and metformin.
Nasopharyngitis was the only adverse reaction reported in ≥5% of patients treated with sitagliptin monotherapy and more commonly than in patients given placebo.
Pregnancy Classification B. Because no appropriate and well-controlled trials with Sitagliptin Phosphate Monohydrate INN/Metformin Hydrochloride BP or its individual components have been conducted in pregnant women, the safety of Sitagliptin Phosphate Monohydrate INN/Metformin Hydrochloride BP in pregnant women is unknown. This tablet should only be taken during pregnancy if absolutely necessary.
Lactic Acidosis-
Lactic acidosis can occur due to metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic insufciency, renal impairment, and acute congestive heart failure.
Symptoms include malaise, myalgias, respiratory distress, increasing somnolence, and nonspecifc 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.
Combination Oral hypoglycemic preparations
Store below 25°C in a dry place away from light. Keep the medicines in a safe place, out of the reach of children. Do not use later than the date of expiry. To be dispensed only on the prescription of a registered physician.
Ibn Sina Pharmaceuticals Ltd.