Ligotin

• Type 2 Diabetes Mellitus:
  Approved for improving glycemic control in adults with type 2 diabetes mellitus, as monotherapy when diet and exercise alone are inadequate or in combination with other antidiabetic agents including metformin, sulfonylureas, pioglitazone, or insulin.
• Combination Therapy:
  Used as part of combination regimens for patients inadequately controlled on one or more oral antidiabetic drugs.
• Off-label Uses (Clinically Accepted):
  Occasionally considered adjunctive therapy in patients with cardiovascular risk factors or in those who require renal function preservation during diabetes management. Not indicated for type 1 diabetes or diabetic ketoacidosis.

• Adults:
  Standard oral dose is 25 mg once daily, with or without food.
• Elderly:
  No dose adjustment generally required, but caution advised in patients with reduced renal function.
• Renal Impairment:
• Mild to moderate renal impairment (eGFR ≥30 to <90 mL/min): No dosage adjustment necessary.
• Severe renal impairment or end-stage renal disease (eGFR <30 mL/min): Reduce dose to 12.5 mg once daily.
• Hepatic Impairment:
  No specific dose adjustment recommended in mild or moderate hepatic impairment; use with caution in severe hepatic impairment.
• Pediatrics:
  Safety and efficacy not established; use not recommended in patients under 18 years.
• Route: Oral administration.

Alogliptin is a selective dipeptidyl peptidase-4 (DPP-4) inhibitor. It works by inhibiting the enzyme DPP-4, which degrades incretin hormones such as glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). By preventing their degradation, alogliptin increases endogenous incretin levels, enhancing glucose-dependent insulin secretion and suppressing glucagon release, leading to improved glycemic control. This mechanism helps reduce both fasting and postprandial blood glucose without significant risk of hypoglycemia.

• Absorption:
  Rapidly absorbed after oral administration; peak plasma concentrations (Cmax) achieved within 1–2 hours.
• Bioavailability: Approximately 100%.
• Distribution: Volume of distribution is moderate (~417 L), with low plasma protein binding (~20%).
• Metabolism: Minimal hepatic metabolism; primarily excreted unchanged.
• Half-life: Approximately 21 hours, supporting once-daily dosing.
• Elimination: Mainly eliminated via renal excretion (~60-70%) unchanged; the remainder eliminated in feces.

• Pregnancy:
  FDA Pregnancy Category B — animal studies have not demonstrated risk to the fetus; however, there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed.
• Lactation:
  It is unknown whether alogliptin is excreted in human breast milk. Caution is advised when administered to breastfeeding mothers; breastfeeding is generally not recommended during treatment.

• Primary Class: Antidiabetic Agent
• Subclass: Dipeptidyl Peptidase-4 (DPP-4) Inhibitor (Gliptin)

• Known hypersensitivity to alogliptin or any excipients
• Type 1 diabetes mellitus or diabetic ketoacidosis (due to lack of efficacy and risk)
• Severe hypersensitivity reactions including anaphylaxis, angioedema, or Stevens-Johnson syndrome reported with DPP-4 inhibitors (discontinue immediately if occurs)

• Pancreatitis:
  Cases of acute pancreatitis have been reported; monitor for persistent severe abdominal pain. Discontinue if pancreatitis is suspected.
• Hypersensitivity Reactions:
  Serious allergic reactions including anaphylaxis, angioedema, and Stevens-Johnson syndrome have been reported.
• Heart Failure:
  Increased risk of heart failure hospitalizations noted in some patients; exercise caution especially in patients with pre-existing heart failure.
• Renal Impairment:
  Dose adjustments are necessary; monitor renal function regularly.
• Hypoglycemia:
  Risk increases when used with sulfonylureas or insulin; monitor accordingly.
• Monitoring:
  Regular blood glucose and renal function monitoring are advised.

Common:

• Nasopharyngitis
• Headache
• Upper respiratory tract infection
• Arthralgia

Less Common:

• Hypoglycemia (mainly when combined with insulin or sulfonylureas)
• Gastrointestinal disturbances (nausea, diarrhea)
• Rash or pruritus

Rare/Serious:

• Acute pancreatitis
• Hypersensitivity reactions (anaphylaxis, angioedema, Stevens-Johnson syndrome)
• Heart failure exacerbation

• Major Interactions:
• Increased risk of hypoglycemia with insulin or sulfonylureas.
• No significant CYP450 enzyme interactions; minimal metabolism reduces interaction potential.
• Drug-Food Interactions:
  Food does not significantly affect alogliptin absorption.
• Drug-Alcohol Interactions:
  No known significant interactions, but alcohol may affect glycemic control.

• Current diabetes management guidelines (ADA, EASD) recommend DPP-4 inhibitors including alogliptin as a second-line or adjunctive therapy after metformin in type 2 diabetes.
• Recent safety data emphasizes monitoring for heart failure risk and pancreatitis.
• No major changes in dosing recommendations or approved indications recently reported by FDA or EMA.

• Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C.
• Protect from moisture and light.
• Keep in original packaging until use.
• Do not freeze.