Janvia 50 mg Tab

Janvia (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).

Composition

Janvia 50: Each film-coated tablet contains Sitagliptin Phosphate Monohydrate INN 64.25 mg equivalent to 50 mg of Sitagliptin

Janvia 100: Each film-coated tablet contains Sitagliptin Phosphate Monohydrate INN 128.50 mg equivalent to 100 mg of Sitagliptin

Indication

Janvia (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 Administration

The recommended dose of Janvia (Sitagliptin) is 100 mg once daily. Janvia can be taken with or without food.

Patients with Renal Insufficiency

For 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 Use

Safety and effectiveness of Sitagliptin in pediatric patients under 18 years of age have not been established.

Geriatric Use

No 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 Effects

The 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.

Contraindication

History of a serious hypersensitivity reaction to Sitagliptin, such as anaphylaxis or angioedema and exfoliative skin conditions including

Stevens-Johnson syndrome.

Precaution

If 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 function

should recommend prior to initiating Janvia (Sitagliptin). When Janvia is used in combination with 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 Lactation

Pregnancy

Pregnancy 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 to the fetus.

Nursing mother

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.

Drug Interaction

Co-administration of Digoxin and Sitagliptin may slightly increase the mean peak drug concentration of Digoxin. But no dosage adjustment of

Digoxin or Sitagliptin is recommended.

Supply

Janvia 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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