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

Alogliptin is a DPP-4 inhibitor that slows down the inactivation of incretin hormones. This increases their concentration in the blood and helps reduce both fasting and post-meal blood glucose levels by increasing insulin secretion and decreasing glucagon levels in a glucose-dependent manner.

Apply to the affected area 2–3 times daily or as directed by the physician.

Alogliptin is mainly eliminated through the kidneys, and its metabolism via the cytochrome P450 (CYP) system is minimal. It has not shown any significant interactions with drugs that affect CYP enzymes or with other medications that are primarily excreted by the kidneys.

This medicine should not be used in patients who have a history of severe allergic reactions to alogliptin or similar drugs, including conditions like anaphylaxis, angioedema, or serious skin reactions.

Frequently reported side effects include inflammation of the throat and nasal passages (nasopharyngitis), headache, and infections of the upper respiratory tract.

Alogliptin is classified under Pregnancy Category B. There are no sufficient controlled studies in pregnant women. It should only be used during pregnancy if clearly necessary. It is not known whether the drug passes into breast milk, so caution is advised when used in breastfeeding mothers.

Acute pancreatitis: If pancreatitis is suspected, Alogliptin should be discontinued immediately.

Hypersensitivity: Serious hypersensitivity reactions such as anaphylaxis, angioedema, and severe skin reactions have been reported. Discontinue the drug promptly if such reactions occur.

Hepatic effects: Cases of liver injury, including severe hepatic failure, have been reported. If liver injury is suspected, stop Alogliptin and assess the patient. Do not restart if liver damage is confirmed without another cause.

Hypoglycemia: When used with insulin or insulin secretagogues (e.g., sulfonylureas), dose reduction may be necessary to reduce the risk of hypoglycemia.

Macrovascular outcomes: No conclusive clinical evidence shows that Alogliptin reduces macrovascular (cardiovascular) risks.

Pediatric Use: The safety and effectiveness of Alogliptin in children have not been established.

Geriatric Use: In clinical studies involving 8507 patients, 2064 (24.3%) were aged 65 years or older, and 341 (4%) were 75 years or older. No significant differences in safety or effectiveness were observed between elderly and younger patients. However, increased sensitivity in some older individuals cannot be excluded.

Hepatic Impairment: No dosage adjustment is required for patients with mild to moderate liver impairment (Child-Pugh A and B), as no meaningful changes in drug exposure were observed. Alogliptin has not been studied in severe hepatic impairment (Child-Pugh C), so caution is advised in such patients.

Patients with Renal Impairment:

• No dose adjustment is needed in mild renal impairment (creatinine clearance ≥60 mL/min).
• Recommended dose is 12.5 mg once daily for moderate renal impairment (creatinine clearance ≥30 to <60 mL/min).
• Recommended dose is 6.25 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 dialysis).
• Patients undergoing hemodialysis may take Alogliptin without regard to dialysis timing.

In clinical studies, the maximum doses of Alogliptin given were 800 mg as a single dose in healthy individuals and 400 mg once daily for 14 days in patients with type 2 diabetes. These doses correspond to 32 times and 16 times the recommended maximum daily dose of 25 mg. No serious adverse effects were reported at these levels. If an overdose occurs, appropriate clinical monitoring and supportive care should be provided based on the patient’s condition. Removal of any unabsorbed drug from the gastrointestinal tract may be considered if necessary. Alogliptin is only slightly removed by dialysis; about 7% is eliminated during a 3-hour hemodialysis session. Therefore, hemodialysis is unlikely to be effective in overdose management. It is unknown whether peritoneal dialysis can remove Alogliptin.

Dipeptidyl Peptidase-4 (DPP-4) inhibitor

Store below 30°C in a cool, dry place, protected from light and moisture. Keep out of reach of children.