Product Name

Silo
Tablets 50 & 100mg


Composition

Each film coated tablet contains:
Sitagliptin as phosphate monohydrate..........50 mg
Sitagliptin as phosphate monohydrate..........100 mg

Pack
14's Alu Alu Blister

Prescribing Information

INDICATIONS
Sitagliptin indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Important Limitations of Use:

  • Sitagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
  • Sitagliptin 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 for the development of pancreatitis while using sitagliptin.

DOSAGE AND ADMINISTRATION

Recommended Dosing
The recommended dose of Sitagliptin is 100 mg once daily. 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. Because there is a need for dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of Sitagliptin and periodically thereafter. Creatinine clearance can be estimated from serum creatinine using the Cockcroft-Gault formula.

Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin When Sitagliptin is used in combination 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.

CONTRAINDICATIONS
History of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema.

ADVERSE EFFECTS
Hypoglycemia, nasopharyngitis, upper respiratory tract infection, headache, hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, cutaneous vasculitis, exfoliative skin conditions including Stevens-Johnson syndrome, hepatic enzyme elevations, acute pancreatitis, including fatal and non-fatal hemorrhagic and necrotizing pancreatitis

WARNINGS AND SPECIAL PRECAUTIONS
Pancreatitis
There are chances for acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, in patients taking sitagliptin. After initiation of sitagliptin, patients should be observed carefully for signs and symptoms of pancreatitis. If pancreatitis is suspected, sitagliptin should promptly be discontinued and appropriate management should be initiated. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using sitagliptin.
Use in Patients with Renal Insufficiency
A dosage adjustment is recommended in patients with moderate or severe renal insufficiency and in patients with ESRD requiring hemodialysis or peritoneal dialysis. Use with Medications Known to Cause Hypoglycemia When sitagliptin was used in combination with a sulfonylurea or with insulin, medications known to cause hypoglycemia, the incidence of hypoglycemia was increased over that of placebo used in combination with a sulfonylurea or with insulin. Therefore, a lower dose of sulfonylurea or insulin may be required to reduce the risk of hypoglycemia.
Hypersensitivity Reactions
Sitagliptin may cause serious hypersensitivity reactions in patients treated with it. These reactions include anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Onset of these reactions occurred within the first 3 months after initiation of treatment with sitagliptin, with some reports occurring after the first dose. If a hypersensitivity reaction is suspected, discontinue sitagliptin, assess for other potential causes for the event, and institute alternative treatment for diabetes
Macrovascular Outcomes
There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with sitagliptin or any other anti-diabetic drug.
Pregnancy category B
There are no adequate and well-controlled studies in pregnant women.
Nursing mothers
It 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.
Pediatric Use
Safety and effectiveness of sitagliptin in pediatric patients under 18 years of age have not been established.

DRUG INTERACTIONS
Digoxin
There was a slight increase in the area under the curve (AUC, 11%) and mean peak drug concentration (Cmax, 18%) of digoxin with the co-administration of 100 mg sitagliptin for 10 days. Patients receiving digoxin should be monitored appropriately. No dosage adjustment of digoxin or Sitagliptin is recommended.

OVERDOSAGE
In the event of an overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring (including obtaining an electrocardiogram), and institute supportive therapy as dictated by the patient's clinical status.

Sitagliptin is modestly dialyzable. Prolonged hemodialysis may be considered if clinically appropriate. It is not known if sitagliptin is dialyzable by peritoneal dialysis.

STORAGE
Store at 20-25C.
Protect from light, heat and moisture.
Keep all medicines out of the reach of children.

PRESENTATION
Silo 50 mg Tabs, pack of 14s.
Silo 100 mg Tabs, pack of 14s.

 
 
 
 
 
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