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Nesina

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Nesina

INDICATIONS

Monotherapy and Combination Therapy

NESINA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies].

Limitation of Use

NESINA should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.

DOSAGE AND ADMINISTRATION

Recommended Dosing

The recommended dose of NESINA is 25 mg once daily.

NESINA may be taken with or without food.

Patients with Renal Impairment

No dose adjustment of NESiNa is necessary for patients with mild renal impairment (creatinine clearance [CrCl] ≥ 60 mL/min).

The dose of NESINA is 12.5 mg once daily for patients with moderate renal impairment (CrCl ≥ 30 to < 60 mL/min).

The dose of NESINA is 6.25 mg once daily for patients with severe renal impairment (CrCl ≥ 15 to < 30 mL/min) or with end-stage renal disease (ESRD) (CrCl < 15 mL/min or requiring hemodialysis). NESINA may be administered without regard to the timing of dialysis. NESINA has not been studied in patients undergoing peritoneal dialysis [see CLINICAL PHARMACOLOGY].

Because there is a need for dose adjustment based upon renal function, assessment of renal function is recommended prior to initiation of NESINA therapy and periodically thereafter.

HOW SUPPLIED

Dosage Forms And Strengths

  • 25 mg tablets are light red, oval, biconvex, film-coated, with “TAK ALG-25” printed on one side.
  • 12.5 mg tablets are yellow, oval, biconvex, film-coated, with “TAK ALG-12.5” printed on one side.
  • 6.25 mg tablets are light pink, oval, biconvex, film-coated, with “TAK ALG-6.25” printed on one side.

Storage And Handling

NESINA tablets are available as film-coated tablets containing 25 mg, 12.5 mg or 6.25 mg of alogliptin as follows:

25 mg tablet: light red, oval, biconvex, film-coated, with “TAK ALG-25” printed on one side, available in:

NDC 64764-250-30 Bottles of 30 tablets
NDC
64764-250-90 Bottles of 90 tablets
NDC 64764-250-50 Bottles of 500 tablets

12.5 mg tablet: yellow, oval, biconvex, film-coated, with “TAK ALG-12.5” printed on one side, available in:

NDC 64764-125-30 Bottles of 30 tablets
NDC
64764-125-90 Bottles of 90 tablets
NDC 64764-125-50 Bottles of 500 tablets

6.25 mg tablet: light pink, oval, biconvex, film-coated, with “TAK ALG-6.25” printed on one side, available in:

NDC 64764-625-30 Bottles of 30 tablets
NDC
64764-625-90 Bottles of 90 tablets

Storage

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

Distributed by: Takeda Pharmaceuticals America, Inc., Deerfield, IL 60015. Revised: January 2013

Last reviewed on RxList: 2/11/2013
This monograph has been modified to include the generic and brand name in many instances.

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