Silinor-M 50/1000

Generic

Sitagliptin + Metformin Hydrochloride

 

Indications

This is indicated along with diet and exercise to improve glycemic control in adults with type 2 diabetes when treatment with both sitagliptin and metformin is appropriate.

Important Use Restrictions:

• This drug should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.
• This has not been studied in patients with a history of pancreatitis. It is not known whether patients with a history of pancreatitis have an increased risk of developing pancreatitis while using this.

 

Pharmacology

This tablet combines two antihyperglycemic agents with complementary mechanisms of action to improve glycemic control in patients with type 2 diabetes. Sitagliptin, a dipeptidyl peptidase4 (DPP4) inhibitor, and metformin HCl, a member of the biguanid group. Sitagliptin is a dipeptidyl peptidase4 (DPP4) inhibitor, which is believed to work in type 2 diabetes by slowing the inactivation of incretin hormones. Tinnitus hormones, including glucagon1-like peptide (GLP1) and non-glandular polypeptide (GIP), are secreted by the intestine throughout the day and levels rise in response to meals. These hormones are quickly inactivated by the DPP4 enzyme. The increments are part of an endogenous system involved in the physiological regulation of glucose homeostasis. When blood sugar levels are normal or elevated, GLP1 and GIP increase insulin synthesis and release from pancreatic beta cells via intracellular signaling pathways involving cyclic AMP. GLP1 also reduces the secretion of glucagon by alpha cells in the pancreas, resulting in decreased hepatic glucose production. By increasing and prolonging active incretin levels, sitagliptin increases insulin release and decreases circulating glucose-dependent glucagon levels. The pharmacological mechanism of action of Metformin HCl differs from other classes of oral hypoglycemic agents. Metformin HCl reduces hepatic glucose production, decreases intestinal glucose absorption, and increases peripheral glucose absorption and utilization.

 

Dosage & Administration

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.

 

Interaction

Cationic drug: cationic castle drugs eliminated by renal tubular fields: pay attention.

PhenProcoumon: Metformon can reduce the effect of phenProcoumon anticoagulant. As a result, close surveillance of INR is recommended.

Levothyroxine: Lavothyroxine can reduce the effect of hypoglycemic permeability of metramine. If the thyroid hormonal treatment is started or interrupted, the monitoring of the blood glucose level is recommended and the amount of metramine should be adjusted if necessary. 

 

Contraindications

This tablet is contraindicated in patients with:

Kidney disease or renal dysfunction, eg. conditions such as cardiovascular collapse (shock), acute myocardial infarction and sepsis

• Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
• History of serious hypersensitivity reactions to this tablet or to sitagliptin, such as anaphylaxis or angioedema.

The use of this tablet should be temporarily discontinued in patients undergoing radiological studies involving the use of iodinated intravascular contrast agents, as their use may lead to acute changes in renal function.

 

Side Effects

The most common side effects indicated above 5% of patients by 5% of patients were more often diarrhea, upper respiratory infection and headaches that patients treated with placebo.

Patients with sulfonylurea and metformin were more than 5% of patients treated with Sittagliptin, were more than 5% of patients treated with sulfonylurea and meformine and were generally hypoglycemia and headaches in patients treated with nyllyuruor and sulfurized meherphoric.

Hypoglycemia has been reported at 5% or more than 5% of patients associated with insulin and mephilia that patients treated with insulin and metramine.

NasopharynNntintite was more than 5% of patients in patients treated with Sittagliptitin therapy and have generally been reported that patients with placebo patients.

The most common side effects (> 5%) due at the beginning of metformin treatment are diarrhea, nausea / vomiting, the restaurant, abdominal disadvantages, digestives, hydraulics and headaches. 

 

Pregnancy & Lactation

Pregnancy Categories B. Sittagliptin Phosphate Mono High Date / Blucted Metaphos BP or for pregnant women with its individual components has no suitable and well-controlled search. Therefore, the safety of phosphate phosphate of the pregnant phosphate phosphate chloride / metaphor phosphate chloride is not known. This tablet should be used during pregnancy if it is clearly necessary.

Sittagliptin It is unclear whether or not to be excreted towards breast milk. Be careful when this tablet is administered to a nursing woman because many drugs are excreted with breast milk. 

 

Precautions & Warnings

Lactic Acidosis

• Lactic acidosis may occur due to the accumulation of metformin. The risk is increased with conditions such as sepsis, dehydration, excessive alcohol consumption, liver failure, kidney failure, and acute congestive heart failure.
• Symptoms include malaise, myalgia, respiratory distress, increasing somnolence, and nonspecific abdominal distress. Laboratory abnormalities include low pH, increased anion gap, and high blood lactate levels.
• If acidosis is suspected, stop taking this tablet and go to the hospital immediately.
• Thyroid stimulating hormone (TSH) levels should be monitored regularly in patients with hypothyroidism.
• Long-term treatment with metformin has been associated with decreased serum vitamin B12 levels, which can cause peripheral neuropathy. It is recommended to monitor vitamin B12 levels.

 Other

• Do not use this tablet in patients with liver disease.
• There have been postmarketing reports of acute renal failure, sometimes requiring dialysis. Before starting to use this tablet and at least once a year thereafter, evaluate your kidney function and check that it is normal.
• There have been post-marketing reports of acute pancreatitis, including fatal and nonfatal acute pancreatitis or hemorrhagic necrosis. If pancreatitis is suspected, stop this pill quickly.
• Measure hematological parameters annually.
• Warn the patient against excessive alcohol intake.
• It may be necessary to stop this tablet and temporarily use insulin during times of stress and reduced fluid and food intake, which may occur with fever, injury, infection, or surgery.
• Promptly evaluate patients previously monitored with this tablet who present with laboratory abnormalities or clinical disease for signs of ketoacidosis or lactic acidosis.
• When used with an insulin secretagogue (eg, a sulfonylurea) or with insulin, lower doses of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia.
• Serious allergic and hypersensitivity reactions have been reported in patients treated with sitagliptin (one of the ingredients in this tablet), such as anaphylaxis, angioedema, and exfoliative skin conditions. scabs, including post-marketing experiences, including StevensJohnson syndrome. In such cases, immediately stop this tablet, investigate other potential causes, conduct appropriate monitoring and treatment, and initiate alternative treatment for diabetes.
• No clinical studies have provided conclusive evidence of macrovascular risk reduction with sitagliptin phosphate monohydrate INN/metformin hydrochloride BP or any other antidiabetic drug.

 

Therapeutic Class

Combination Oral hypoglycemic preparations

 

Storage Conditions

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.

 

Pharmaceutical Name

Healthcare Pharmaceuticals Ltd.