July 27, 2016
Recommended Topic Related To:

Nesina

"The U.S. Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called keto"...

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Nesina




Indications
Dosage
How Supplied

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 [see Clinical Studies].

Important Limitations Of Use

NESINA is not indicated for the treatment of type 1 diabetes mellitus or 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 Use in Specific Populations, 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: May 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 6/28/2016

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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