Explain the risks, symptoms and appropriate management of hypoglycemia.Inform patients that severe and disabling joint pain may occur with this class of drugs.
Alogliptin tablets should not be restarted in these patients without another explanation for the liver test abnormalities.Insulin and insulin secretagogues, such as sulfonylureas, are known to cause hypoglycemia. It is unclear how these findings relate to changes in overall glycemic control in patients with type 2 diabetes mellitus. No drug-related tumors were observed up to 75 mg/kg or approximately 32 times the maximum recommended clinical dose of 25 mg, based on area under the plasma concentration curve (AUC) exposure. Patients had an overall mean age of 57 years (range 21 to 91 years).In patients with type 2 diabetes, treatment with Alogliptin tablets produced clinically meaningful and statistically significant improvements in hemoglobin A1c (A1C) compared to placebo. No serious adverse reactions were observed at these doses.In the event of an overdose, it is reasonable to institute the necessary clinical monitoring and supportive therapy as dictated by the patient's clinical status. If pancreatitis is suspected, Alogliptin tablets should promptly be discontinued and appropriate management should be initiated.In the EXAMINE trial which enrolled patients with type 2 diabetes and recent acute coronary syndrome, 106 (3.9%) of patients treated with Alogliptin tablets and 89 (3.3%) of patients treated with placebo were hospitalized for congestive heart failure.Consider the risks and benefits of Alogliptin tablets prior to initiating treatment in patients at risk for heart failure, such as those with a prior history of heart failure and a history of renal impairment, and observe these patients for signs and symptoms of heart failure during therapy. tablets can cause rapid release and absorption of a potentially fatal dose) Exjade (deferasirox) Tablet Note: do not give as whole tablet, tablets are meant to be given as oral suspension; see co mpany insert Extendryl JR (combination) Capsule Slow -release Peak and total exposure over 24 hours to active GLP-1 were three to four fold greater with Alogliptin tablets (at doses of 25 to 200 mg) than placebo. The mean duration of diabetes was seven years, the mean body mass index (BMI) was 31 kg/mIn a pooled analysis of these 14 controlled clinical trials, the overall incidence of adverse reactions was 73% in patients treated with Alogliptin tablets 25 mg compared to 75% with placebo and 70% with active comparator. These reactions include anaphylaxis, angioedema and severe cutaneous adverse reactions, including Stevens-Johnson syndrome. If you notice other effects not listed above, contact your doctor or pharmacist.Call your doctor for medical advice about side effects. **Caffeine (1A2 substrate), tolbutamide (2C9 substrate), dextromethorphan (2D6 substrate), midazolam (3A4 substrate) and fexofenadine (P-gp substrate) were administered as a cocktail.There are no clinically meaningful changes in the pharmacokinetics of Alogliptin when Alogliptin tablets are administered concomitantly with the drugs described below Rats were administered oral doses of 75, 400 and 800 mg/kg Alogliptin for two years. Overall discontinuation of therapy due to adverse reactions was 6.8% with Alogliptin tablets 25 mg compared to 8.4% with placebo or 6.2% with active comparator.Adverse reactions reported in ≥4% of patients treated with Alogliptin tablets 25 mg and more frequently than in patients who received placebo are summarized in Hypoglycemic events were documented based upon a blood glucose value and/or clinical signs and symptoms of hypoglycemia.In the monotherapy study, the incidence of hypoglycemia was 1.5% in patients treated with Alogliptin tablets compared to 1.6% with placebo. Alogliptin comes as a tablet to take by mouth. Patients with severe hepatic impairment (Child-Pugh Grade C) have not been studied. DESCRIPTION. If you have any of these health problems: Acidic blood problem or type 1 diabetes. Metformin, one of the medicines in KAZANO, can cause a rare but serious condition called lactic acidosis (a buildup of an acid in the blood) that can cause death.
The most commonly reported adverse reactions were renal impairment (7.7% for Alogliptin tablets and 6.7% for placebo), decreased glomerular filtration rate (4.9% for Alogliptin tablets and 4.3% for placebo) and decreased renal clearance (2.2% for Alogliptin tablets and 1.8% for placebo).
Patients were maintained on their insulin regimen (median dose = 55 IU) upon randomization and those previously treated with insulin in combination with metformin (median dose = 1700 mg) prior to randomization continued on the combination regimen during the treatment period. The magnitude of these reductions is not considered to be clinically meaningful.
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