Aloglip 12.5 mg

INDICATIONS

Alogliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type-2 diabetes mellitus.

PHARMACOLOGY

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.

DOSAGE & ADMINISTRATION

The recommended dose in patients with normal renal function or mild renal impairment is 25 mg once daily or as directed by the physicians.

INTERACTION

Alogliptin is primarily renally excreted. Cytochrome (CYP) P450-related metabolism is negligible. No significant drug-drug interactions are observed with the CYP-substrates or inhibitors tested or with renally excreted drugs.

SIDE EFFECTS

Common side effects are nasopharyngitis, headache and upper respiratory tract infection.

PREGNANCY & LACTATION

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 & WARNINGS

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.

USE IN SPECIAL POPULATIONS

Pediatric Use: Safety and effectiveness of Alogliptin in pediatric patients have not been established.Geriatric Use: Of the total number of patients (N=8507) in clinical safety and efficacy studies treated with Alogliptin, 2064 (24.3%) patients were 65 years and older and 341 (4%) patients were 75 years and older. No overall differences in safety or effectiveness were observed between patients 65 years and over and younger patients. While this clinical experience has not identified differences in responses between the elderly and younger patients, greater sensitivity of some older individuals cannot be ruled out.Hepatic Impairment: No dose adjustments are required in patients with mild to moderate hepatic impairment (Child-Pugh Grade A and B) based on insignificant change in systemic exposures (e.g., AUC) compared to subjects with normal hepatic function in a pharmacokinetic study. Alogliptin has not been studied in patients with severe hepatic impairment (Child-Pugh Grade C). Use caution when administering Alogliptin to patients with liver disease.Patients with Renal Impairment:

No dose adjustment of Alogliptin is necessary for patients with mild renal impairment (creatinine clearance ≥60 mL/min).
The dose of Alogliptin is 12.5 mg once daily for patients with moderate renal impairment (creatinine clearance ≥30 to <60 mL/min).
The dose of Alogliptin is 6.25 mg once daily for patients with severe renal impairment (creatinine clearance ≥15 to <30 mL/min) or with end-stage renal disease (ESRD) (creatinine clearance <15 mL/min or requiring hemodialysis).
Patients requiring hemodialysis can receive their dose of alogliptin without regard to the timing of the dialysis.

THERAPEUTIC CLASS

Dipeptidyl Peptidase-4 (DPP-4) inhibitor

STORAGE CONDITIONS

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