Alodia

Alogliptin is a DPP-4 inhibitor. It slows down the breakdown of the incretin hormones, so their levels in the blood go up. In people with type 2 diabetes mellitus, this lowers both fasting and after-meal glucose, and it does so only in a glucose-dependent way.

The incretin hormones include glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). The small intestine releases them into the bloodstream in response to meals. They make the pancreatic beta cells release insulin, again depending on glucose levels, but the DPP-4 enzyme inactivates them within minutes. GLP-1 also lowers glucagon secretion from the pancreatic alpha cells, and this reduces the glucose the liver produces. In patients with type 2 diabetes, GLP-1 concentrations are reduced, but the insulin response to GLP-1 is preserved.

Alogliptin is Pregnancy Category B. No adequate or well-controlled studies have been done in pregnant women, so Alogliptin tablets should be used in pregnancy only if clearly needed.

It isn't known whether Alogliptintin is excreted in human milk. Caution should be exercised when Alogliptin is given to a nursing woman.

Safety and effectiveness of Alogliptin Benzoate in children have not been established.

Geriatric Use: Clinical safety and efficacy studies included 8507 patients treated with Alogliptin Benzoate. Of these, 2064 (24.3%) were 65 years and older and 341 (4%) were 75 years and older. No overall differences in safety or effectiveness were seen between patients aged 65 and over and younger patients. This experience has not shown differences in response between elderly and younger patients, but some older people may still be more sensitive to the medicine, and this cannot be ruled out.

Hepatic Impairment: No dose adjustment is needed in patients with mild to moderate hepatic impairment (Child-Pugh Grade A and B). A pharmacokinetic study found an insignificant change in systemic exposure (e.g., AUC) compared with subjects who had normal liver function. Alogliptin Benzoate has not been studied in patients with severe hepatic impairment (Child-Pugh Grade C). Use caution when giving it to patients with liver disease.

Patients with Renal Impairment: Patients with mild renal impairment (creatinine clearance ≥60 mL/min) need no dose adjustment. For moderate renal impairment (creatinine clearance ≥30 to <60 mL/min), the dose is 12.5 mg once daily. For severe renal impairment (creatinine clearance ≥15 to <30 mL/min) or end-stage renal disease (ESRD) (creatinine clearance <15 mL/min or requiring hemodialysis), the dose is 6.25 mg once daily. Patients on hemodialysis can take their dose of alogliptin without regard to the timing of the dialysis.

In clinical trials, the highest doses of Alogliptin Benzoate were a single 800 mg dose given to healthy subjects and 400 mg once daily for 14 days given to patients with type 2 diabetes. These are equal to 32 times and 16 times the maximum recommended clinical dose of 25 mg, respectively. No serious adverse events were seen at these doses.

If an overdose happens, it is reasonable to start the necessary clinical monitoring and supportive therapy, based on the patient's clinical status. The doctor may also decide, using clinical judgment, to start removing unabsorbed material from the gastrointestinal tract.

Alogliptin Benzoate is only minimally dialyzable. Over a 3-hour hemodialysis session, approximately 7% of the drug was removed, so hemodialysis is unlikely to help in an overdose. It is not known whether Alogliptin Benzoate can be removed by peritoneal dialysis.

Store Alogliptin Benzoate below 30°C and keep it away from light and moisture. Always keep it out of the reach of children.