Pregnancy Cat

Pregnancy Category B. No adequate or well-controlled studies in pregnant women have been conducted with Alogliptin. Alogliptin tablets should be used during pregnancy only if clearly needed. It is not known whether Alogliptintin is excreted in human milk. caution should be exercised when Alogliptin is administered to a nursing woman.

Precautions

Acute pancreatitis: If pancreatitis is suspected, promptly Alogliptin should be discontinued.Hypersensitivity: There have been postmarketing reports of serious hypersensitivity reactions in patients treated with Alogliptin such as anaphylaxis, angioedema and severe cutaneous adverse reactions. In such cases, promptly Alogliptin should be discontinued.Hepatic effects: Postmarketing reports of hepatic failure, sometimes fatal. Causality can not be excluded. If liver injury is detected, promptly interrupt Alogliptin and assess patient for probable cause, then treat cause if possible, to resolution or stabilization. Do not restart Alogliptin if liver injury is confirmed and no alternative etiology can be found.Hypoglycemia: When an insulin secretagogue (e.g. sulfonylurea) or insulin is used in combination with Alogliptin, a lower dose of the insulin secretagogue or insulin may be required to minimize the risk of hypoglycaemia.Macrovascular outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Alogliptin or any other antidiabetic drug.

Overdose Effects

The highest doses of Alogliptin administered in clinical trials were single doses of 800 mg to healthy subjects and doses of 400 mg once daily for 14 days to patients with type 2 diabetes (equivalent to 32 times and 16 times the maximum recommended clinical dose of 25 mg, respectively). No serious adverse events 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. Per clinical judgment, it may be reasonable to initiate removal of unabsorbed material from the gastrointestinal tract. Alogliptin is minimally dialyzable; over a 3-hour hemodialysis session, approximately 7% of the drug was removed. Therefore, hemodialysis is unlikely to be beneficial in an overdose situation. It is not known if Alogliptin is dialyzable by peritoneal dialysis.

Drug Classes

Dipeptidyl Peptidase-4 (DPP-4) inhibitor

Storage Conditions

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Composition

n/a

Mode Of Action

Alogliptin is a DPP-4 inhibitor that slows the inactivation of the incretin hormones, thereby increasing their bloodstream concentrations and reducing fasting and postprandial glucose concentrations in a glucose-dependent manner in patients with type 2 diabetes mellitus. Increased concentrations of the incretin hormones such as glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) are released into the bloodstream from the small intestine in response to meals. These hormones cause insulin release from the pancreatic beta cells in a glucose-dependent manner but are inactivated by the DPP-4 enzyme within minutes. GLP-1 also lowers glucagon secretion from pancreatic alpha cells, reducing hepatic glucose production. In patients with type 2 diabetes, concentrations of GLP-1 are reduced but the insulin response to GLP-1 is preserved.

Reconstitution

n/a