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Drug Catalog - Product Detail

ALOGLIPTIN AND PIOGLITAZONE TB 12.5MG/30MG 30

NDC Mfr Size Str Form
45802-0260-65 PADAGIS 30 12.5-30MG NA
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Generic Name
ALOGLIPTIN BENZOATE AND PIOGLITAZONE HYDROCHLORIDE
Substance Name
ALOGLIPTIN BENZOATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
NDA022426
Description
11 DESCRIPTION Alogliptin and pioglitazone tablets contain two 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-[(3 R )-3-aminopiperidin-1-yl]-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2 H )-yl}methyl)benzonitrile monobenzoate. It has a molecular formula of C 18 H 21 N 5 O 2 ∙C 7 H 6 O 2 and a molecular weight of 461.51 daltons. The structural formula is: 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. Chemical Structure 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 C 19 H 20 N 2 O 3 S∙HCl and a molecular weight of 392.90 daltons. The structural formula is: 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. Alogliptin and pioglitazone tablets are 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) 33.06 mg pioglitazone hydrochloride equivalent to 30 mg pioglitazone (25 mg/30 mg) 49.59 mg pioglitazone hydrochloride equivalent to 45 mg pioglitazone (25 mg/45 mg) Alogliptin and pioglitazone tablets are 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) 33.06 mg pioglitazone hydrochloride equivalent to 30 mg pioglitazone (12.5 mg/30 mg) 49.59 mg pioglitazone hydrochloride equivalent to 45 mg pioglitazone (12.5 mg/45 mg) Alogliptin and pioglitazone 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 and ferric oxide (yellow and/or red) and are marked with printing ink (Red A1 or Gray F1). Chemical Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Alogliptin and pioglitazone tablets are available in the following strengths and packages: 25 mg/15 mg tablet: yellow, round, biconvex and film-coated with both "A/P" and "25/15" printed on one side, available in: NDC 45802-351-65 Bottles of 30 tablets 25 mg/30 mg tablet: peach, round, biconvex and film-coated with both "A/P" and "25/30" printed on one side, available in: NDC 45802-402-65 Bottles of 30 tablets 25 mg/45 mg tablet: red, round, biconvex, film-coated and with both "A/P" and "25/45" printed on one side, available in: NDC 45802-499-65 Bottles of 30 tablets 12.5 mg/15 mg tablet: pale yellow, round, biconvex and film-coated with both "A/P" and "12.5/15" printed on one side, available in: NDC 45802-238-65 Bottles of 30 tablets 12.5 mg/30 mg tablet: pale peach, round, biconvex and film-coated with both "A/P" and "12.5/30" printed on one side, available in: NDC 45802-260-65 Bottles of 30 tablets 12.5 mg/45 mg tablet: pale red, round, biconvex and film-coated with both "A/P" and "12.5/45" printed on one side, available in: NDC 45802-304-65 Bottles of 30 tablets Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed and protect from moisture and humidity.
Indications & Usage
1 INDICATIONS AND USAGE Alogliptin and pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus . Alogliptin and pioglitazone tablets are a combination of alogliptin, a dipeptidyl peptidase-4 inhibitor and pioglitazone, a thiazolidinedione which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use: Should not be used in patients with type 1 diabetes. ( 1 ) Limitations of Use Alogliptin and pioglitazone tablets should not be used in patients with type 1 diabetes mellitus.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Individualize the starting dose of alogliptin and pioglitazone tablets based on the patient's current regimen and concurrent medical condition but do not exceed a daily dose of alogliptin 25 mg and pioglitazone 45 mg. ( 2.1 ) Can be taken with or without food. ( 2.1 ) Limit initial dose of pioglitazone to 15 mg once daily in patients with NYHA Class I or II heart failure. ( 2.1 ) Adjust dose if moderate renal impairment. ( 2.2 ) Degree of Renal Impairment Creatinine Clearance (mL/min) Recommended Dosing Moderate ≥30 to <60 12.5 mg/15 mg, 12.5 mg/30 mg or 12.5 mg/45 mg once daily Alogliptin and pioglitazone tablets are not recommended for patients with severe renal impairment or end-stage renal disease (ESRD) requiring dialysis. ( 2.2 ) The maximum recommended dose of pioglitazone is 15 mg once daily in patients taking strong CYP2C8 inhibitors (e.g., gemfibrozil). ( 2.3 , 7.1 ) 2.1 Recommendations for All Patients Alogliptin and pioglitazone tablets should be taken once daily and can be taken with or without food. Do not split tablets. The recommended starting dose for alogliptin and pioglitazone tablets: for patients inadequately controlled on diet and exercise is 25 mg/15 mg or 25 mg/30 mg, for patients inadequately controlled on metformin monotherapy is 25 mg/15 mg or 25 mg/30 mg, for patients on alogliptin who require additional glycemic control is 25 mg/15 mg or 25 mg/30 mg, for patients on pioglitazone who require additional glycemic control is 25 mg/15 mg, 25 mg/30 mg or 25 mg/45 mg as appropriate based upon current therapy, for patients switching from alogliptin coadministered with pioglitazone, alogliptin and pioglitazone tablets may be initiated at the dose of alogliptin and pioglitazone based upon current therapy, for patients with congestive heart failure (NYHA Class I or II) is 25 mg/15 mg. The alogliptin and pioglitazone tablets dose can be titrated up to a maximum of 25 mg/45 mg once daily based on glycemic response as determined by hemoglobin A1c (A1C). After initiation of alogliptin and pioglitazone tablets or with dose increase, monitor patients carefully for adverse reactions related to fluid retention as has been seen with pioglitazone (e.g., weight gain, edema and signs and symptoms of congestive heart failure) [see Boxed Warning and Warnings and Precautions (5.1) ] . 2.2 Patients with Renal Impairment No dose adjustment of alogliptin and pioglitazone tablets is necessary for patients with mild renal impairment (creatinine clearance [CrCl] ≥60 mL/min). The dose of alogliptin and pioglitazone tablets is 12.5 mg/15 mg, 12.5 mg/30 mg or 12.5 mg/45 mg once daily for patients with moderate renal impairment (CrCl ≥30 to <60 mL/min). Alogliptin and pioglitazone tablets are not recommended for patients with severe renal impairment or ESRD [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ] . Coadministration of pioglitazone and alogliptin 6.25 mg once daily based on individual requirements may be considered in these patients. Because there is a need for dose adjustment based upon renal function, assessment of renal function is recommended prior to initiation of alogliptin and pioglitazone tablets therapy and periodically thereafter. 2.3 Coadministration with Strong CYP2C8 Inhibitors Coadministration of pioglitazone and gemfibrozil, a strong CYP2C8 inhibitor, increases pioglitazone exposure approximately three-fold. Therefore, the maximum recommended dose of alogliptin and pioglitazone tablets is 25 mg/15 mg daily when used in combination with gemfibrozil or other strong CYP2C8 inhibitors [see Drug Interactions (7.1) and Clinical Pharmacology (12.3) ].