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Oseni

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Oseni

OSENI
(alogliptin and pioglitazone) Tablets

WARNING

CONGESTIVE HEART FAILURE

  • Thiazolidinediones, including pioglitazone, which is a component of OSENI, cause or exacerbate congestive heart failure in some patients [see WARNINGS AND PRECAUTIONS].
  • After initiation of OSENI, and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea, and/or edema). If heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of pioglitazone in OSENI must be considered.
  • OSENI is not recommended in patients with symptomatic heart failure.
  • Initiation of OSENI in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

OSENI tablets contain 2 oral antihyperglycemic drugs used in the management of type 2 diabetes: alogliptin and pioglitazone.

Alogliptin

Alogliptin is a selective, orally bioavailable inhibitor of the enzymatic activity of dipeptidyl peptidase-4 (DPP-4). Chemically, alogliptin is prepared as a benzoate salt, which is identified as 2-({6-[(3R)-3-aminopiperidin-1-yl]-3-methyl-2,4-dioxo-3,4-dihydropyrimidin- 1(2H)-yl}methyl)benzonitrile monobenzoate. It has a molecular formula of C18H21N5O2•C7H6O2 and a molecular weight of 461.51 daltons. The structural formula is:

Alogliptin Structural Formula Illustration

Alogliptin benzoate is a white to off-white, crystalline powder, containing one asymmetric carbon in the aminopiperidine moiety. It is soluble in dimethylsulfoxide, sparingly soluble in water and methanol, slightly soluble in ethanol, and very slightly soluble in octanol and isopropyl acetate.

Pioglitazone

Pioglitazone is an oral antihyperglycemic agent that acts primarily by decreasing insulin resistance. Chemically, pioglitazone is prepared as hydrochloride salt, which is identified as (±)-5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-thiazolidinedione monohydrochloride. It has a molecular formula of C19H20N2O3SHCl and a molecular weight of 392.90 daltons; the structural formula is:

Pioglitazone Structural Formula Illustration

Pioglitazone hydrochloride is an odorless white crystalline powder that contains one asymmetric carbon in the thiazolidinedione moiety. The synthetic compound is a racemate and the two enantiomers of pioglitazone interconvert in vivo. It is soluble in N,N dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether.

OSENI is available as a fixed dose combination tablet for oral administration containing 34 mg alogliptin benzoate equivalent to 25 mg alogliptin and any of the following strengths of pioglitazone hydrochloride:

  • 16.53 mg pioglitazone hydrochloride equivalent to 15 mg pioglitazone (25 mg/15 mg) or
  • 33.06 mg pioglitazone hydrochloride equivalent to 30 mg pioglitazone (25 mg/30 mg) or
  • 49.59 mg pioglitazone hydrochloride equivalent to 45 mg pioglitazone (25 mg/45 mg).

OSENI is also available as a fixed dose combination tablet for oral administration containing 17 mg alogliptin benzoate equivalent to 12.5 mg alogliptin and any of the following strengths of pioglitazone hydrochloride:

  • 16.53 mg pioglitazone hydrochloride equivalent to 15 mg pioglitazone (12.5 mg/15 mg) or
  • 33.06 mg pioglitazone hydrochloride equivalent to 30 mg pioglitazone (12.5 mg/30 mg) or
  • 49.59 mg pioglitazone hydrochloride equivalent to 45 mg pioglitazone (12.5 mg/45 mg).

OSENI tablets contain the following inactive ingredients: mannitol, microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, magnesium stearate, and lactose monohydrate; the tablets are film-coated with hypromellose, polyethylene glycol, titanium dioxide, talc, ferric oxide (yellow and/or red), and are marked with printing ink (Red A1 or Gray F1).

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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