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Januvia

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Januvia

INDICATIONS

Monotherapy and Combination Therapy

JANUVIA® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. [See Clinical Studies]

Important Limitations of Use

JANUVIA 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.

JANUVIA 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 JANUVIA. [See WARNINGS AND PRECAUTIONS]

DOSAGE AND ADMINISTRATION

Recommended Dosing

The recommended dose of JANUVIA is 100 mg once daily. JANUVIA can be taken with or without food.

Patients with Renal Insufficiency

For patients with mild renal insufficiency (creatinine clearance [CrCl] greater than or equal to 50 mL/min, approximately corresponding to serum creatinine levels of less than or equal to 1.7 mg/dL in men and less than or equal to 1.5 mg/dL in women), no dosage adjustment for JANUVIA is required.

For patients with moderate renal insufficiency (CrCl greater than or equal to 30 to less than 50 mL/min, approximately corresponding to serum creatinine levels of greater than 1.7 to less than or equal to 3.0 mg/dL in men and greater than 1.5 to less than or equal to 2.5 mg/dL in women), the dose of JANUVIA is 50 mg once daily.

For patients with severe renal insufficiency (CrCl less than 30 mL/min, approximately corresponding to serum creatinine levels of greater than 3.0 mg/dL in men and greater than 2.5 mg/dL in women) or with end-stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis, the dose of JANUVIA is 25 mg once daily. JANUVIA may be administered without regard to the timing of dialysis.

Because there is a need for dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of JANUVIA and periodically thereafter. Creatinine clearance can be estimated from serum creatinine using the Cockcroft-Gault formula. [See CLINICAL PHARMACOLOGY.] There have been postmarketing reports of worsening renal function in patients with renal insufficiency, some of whom were prescribed inappropriate doses of sitagliptin.

Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin

When JANUVIA 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. [See WARNINGS AND PRECAUTIONS]

HOW SUPPLIED

Dosage Forms And Strengths

  • 100 mg tablets are beige, round, film-coated tablets with “277” on one side.
  • 50 mg tablets are light beige, round, film-coated tablets with “112” on one side.
  • 25 mg tablets are pink, round, film-coated tablets with “221” on one side.

Storage And Handling

No. 6737 — Tablets JANUVIA, 25 mg, are pink, round, film-coated tablets with “221” on one side. They are supplied as follows:

NDC 0006-0221-31 unit-of-use bottles of 30
NDC 0006-0221-54 unit-of-use bottles of 90
NDC
0006-0221-28 unit dose blister packages of 100.

No. 6738 — Tablets JANUVIA, 50 mg, are light beige, round, film-coated tablets with “112” on one side. They are supplied as follows:

NDC 0006-0112-31 unit-of-use bottles of 30
NDC
0006-0112-54 unit-of-use bottles of 90
NDC
0006-0112-28 unit dose blister packages of 100.

No. 6739 — Tablets JANUVIA, 100 mg, are beige, round, film-coated tablets with “277” on one side. They are supplied as follows:

NDC 0006-0277-31 unit-of-use bottles of 30
NDC 0006-0277-54 unit-of-use bottles of 90
NDC
0006-0277-33 unit-of-use blister calendar package of 30
NDC
0006-0277-28 unit dose blister packages of 100
NDC 0006-0277-82 bottles of 1000. Storage

Store at 20-25°C (68-77°F), excursions permitted to 15-30°C (59-86°F), [see USP Controlled Room Temperature].

Manufactured by: Merck Sharp & Dohme (Italia) S.p.A. Via Emilia, 21 27100 – Pavia, Italy or Merck Sharp & Dohme Ltd. Cramlington, Northumberland, UK NE23 3JU. Revised: 02/2013

Last reviewed on RxList: 3/1/2013
This monograph has been modified to include the generic and brand name in many instances.

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