Nesina. Alogliptin is an oral diabetes drug that helps control blood sugar levels. It works by regulating the level of insulin produced by the body after eating. Alogliptin used in combination with diet and exercise can improve blood sugar control in adults with type 2 diabetes.
DISCRIPTION
NESINA tablets contain the active ingredient alogliptin, which is a selective, oral bioavailable inhibitor of the enzymatic activity of dipeptidyl peptidase-4 (DPP-4).
Chemically, alogliptin was prepared as a benzoate salt, which was identified as 2-({6-[(3R) -3aminopiperidin-1-yl] -3-methyl-2,4-di Oxo-3,4-dihydropyrimidine-1 (2H) -yl} methyl) benzonitrile monobenzoate. Its molecular formula is C18H21N5O2 • C7H6O2, and its molecular weight is 461.51 Daltons.
Indications and dosage
INDICATION
Monotherapy and combination therapy
NESINA can be used as an aid to diet and exercise to improve blood sugar control in adults with type 2 diabetes
Important use restrictions
NESINA is not suitable for the treatment of type 1 diabetes or diabetic ketoacidosis because it is not effective in these cases.
Dosage
Recommended dose
The recommended dose of NESINA is 25 mg per day. NESINA can be taken with or without food.
Patients with renal insufficiency
For patients with mild renal insufficiency (creatinine clearance [CrCl] ≥60 mL / min), there is no need to adjust the dose of NESINA.
For patients with moderate renal insufficiency (CrCl ≥30 to <60 mL / min), the dose of NESINA is 12.5 mg once daily.
For patients with severe renal insufficiency (CrCl ≥ 15 to <30 mL / min) or end-stage renal disease (ESRD) (CrCl <15 mL / min or requiring hemodialysis), the dose of NESINA is 6.25 mg once daily. NESINA can be used regardless of dialysis time. NESINA has not been studied in patients undergoing peritoneal dialysis [see "For Specific Populations, Clinical Pharmacology".
Due to the need to adjust the dose according to renal function, it is recommended to regularly assess renal function before and after starting NESINA treatment.
Supply method
Formulations and advantages
The 25 mg tablet is light red, oval, biconvex, film-coated and has "TAK ALG-25" printed on one side.
The 12.5 mg tablet is 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, which contain 25 mg, 12.5 mg or 6.25 mg alogliptin, as follows:
25 mg tablet: light red, oval, biconvex, film-coated, with "TAK ALG-25" printed on one side,
Side effect
The following serious adverse reactions will be described below or in the prescription information:
- pancreatitis
- heart failure
- Allergic reaction
- liver function
- Serious and Disable joint pain
- Bullous pemphigoid
Precaution
Pancreatitis
Acute pancreatitis has been reported in both post-marketing and randomized clinical trials. In the glycemic control trial in patients with type 2 diabetes, 6 patients (0.2%) of NESINA 25 mg patients and 2 patients (<0.1%) of active comparator or placebo reported acute pancreatitis. In the EXAMINE trial (a cardiovascular outcome trial for patients with a high risk of type 2 diabetes and high cardiovascular (CV)), 10 (0.4%) of patients treated with NESINA and 7 (0.3%) were reported Acute pancreatitis occurred in patients treated with NESINA. Placebo.
Heart failure
In the EXAMINE trial, which enrolled patients with type 2 diabetes and recent acute coronary syndrome, 106 patients (3.9%) treated with NESINA and 89 patients (3.3%) treated with placebo were hospitalized for congestive heart failure .
If you want to know more about Nesina Click Here
No comments:
Post a Comment