Kazano
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
KAZANO is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings when treatment with both alogliptin and metformin is appropriate [see Clinical Studies (14)].
KAZANO 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.
History
There is currently no drug history available for this drug.
Other Information
KAZANO tablets contain two oral antihyperglycemic drugs used in the management of type 2 diabetes: alogliptin and metformin hydrochloride.
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 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.
Metformin Hydrochloride
Metformin hydrochloride (N,N -dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5•HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is as shown:
KAZANO is available as a tablet for oral administration containing 17 mg alogliptin benzoate equivalent to 12.5 mg alogliptin and:
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- 500 mg metformin hydrochloride (12.5 mg/500 mg) or
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- 1000 mg metformin hydrochloride (12.5 mg/1000 mg).
KAZANO tablets contain the following inactive ingredients: mannitol, microcrystalline cellulose, povidone, crospovidone, and magnesium stearate; the tablets are film-coated with hypromellose 2910, talc, titanium dioxide and ferric oxide yellow.
Sources
Kazano Manufacturers
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Takeda Pharmaceuticals America, Inc.
![Kazano (Alogliptin And Metformin Hydrochloride) Tablet, Film Coated [Takeda Pharmaceuticals America, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Kazano | Actavis Pharma, Inc.
Verify dose using body surface area prior to dispensing. Recommended dosage should generally not exceed 4 mg intravenously [see Overdosage (10)].
2.1 Ovarian CancerRecommended Dose and Schedule
The recommended dose of Topotecan Hydrochloride for Injection is 1.5 mg/m2 by intravenous infusion over 30 minutes daily for 5 consecutive days, starting on Day 1 of a 21-day course.
2.2 Small Cell Lung CancerRecommended Dose and Schedule
The recommended dose of Topotecan Hydrochloride for Injection is 1.5 mg/m2 by intravenous infusion over 30 minutes daily for 5 consecutive days, starting on Day 1 of a 21-day course.
2.3 Cervical CancerRecommended Dose and Schedule
The recommended dose of Topotecan Hydrochloride for Injection is 0.75 mg/m2 by intravenous infusion over 30 minutes daily on Days 1, 2, and 3 in combination with cisplatin 50 mg/m2 on Day 1, repeated every 21 days.
2.4 Dose ModificationsHematologic Toxicities
For single-agent use, dose reduce Topotecan Hydrochloride for Injection to 1.25 mg/m2 for:
neutrophil counts of less than 500 cells/mm3, or administer granulocyte-colony stimulating factor (G-CSF) starting no sooner than 24 hours following the last dose of Topotecan Hydrochloride for Injection. platelet counts less than 25,000 cells/mm3 during previous cycle.For combination use with cisplatin, dose reduce Topotecan Hydrochloride for Injection to 0.60 mg/m2 (and further to 0.45 mg/m2 if necessary) for:
febrile neutropenia (defined as neutrophil counts less than 1,000 cells/mm3 with temperature of greater than or equal to 38.0°C (100.4°F), or administer G-CSF starting no sooner than 24 hours following the last dose of Topotecan Hydrochloride for Injection. platelet counts less than 25,000 cells/mm3 during previous cycle.Renal Impairment
For single-agent use, dose reduce Topotecan Hydrochloride for Injection to 0.75 mg/m2 in patients with moderate renal impairment (creatinine clearance [Clcr] = 20 to 39 mL/min). Insufficient data are available in patients with severe renal impairment (Clcr less than 20 mL/min) to provide a dosage recommendation for Topotecan Hydrochloride for Injection [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].
2.5 Preparation and Intravenous AdministrationTopotecan Hydrochloride for Injection is a cytotoxic drug. Follow applicable special handling and disposable procedures.1
Preparation and Administration
Reconstitute each 4-mg vial of Topotecan Hydrochloride for Injection with 4 mL Sterile Water for Injection, USP. Dilute the appropriate volume of the reconstituted solution in either 0.9% Sodium Chloride Intravenous Infusion, USP or 5% Dextrose in Water Injection, USP prior to administration.
Stability
Unopened vials of Topotecan Hydrochloride for Injection are stable until the date indicated on the package when stored between 20°C and 25°C (68°F and 77°F) [see USP] and protected from light in the original carton. Because the vials contain no preservative, contents should be used immediately after reconstitution.
Reconstituted vials of Topotecan Hydrochloride for Injection diluted for infusion are stable at approximately 20°C to 25°C (68°F to 77°F) and ambient lighting conditions for 24 hours.
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