Schedule H

Oral

Formulation Strengths Available

Tablets 6.25 mg, 12.5 mg, 25 mg

FDC with Metformin Alogliptin 12.5 mg/25 mg + Metformin 500 mg/1000 mg

FDC with Pioglitazone Alogliptin 12.5 mg/25 mg + Pioglitazone 15 mg/30 mg

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

✔ Type 2 Diabetes Mellitus (T2DM)

As monotherapy or in combination with metformin, sulfonylureas, thiazolidinediones, or insulin

Parameter Dosing Details

Starting dose 25 mg once daily orally (with or without food)

Titration Not required

Usual maintenance dose 25 mg once daily

Maximum dose 25 mg/day

Clinical Notes:

• Suitable as initial monotherapy when metformin is contraindicated or not tolerated

• May be added to existing antidiabetic therapy for additional glycaemic control

• Low intrinsic hypoglycaemia risk; consider reducing sulfonylurea/insulin dose when combined

• Weight-neutral agent

Fixed-Dose Combination Dosing:

FDC Recommended Use

Alogliptin + Metformin Individualise based on current therapy; take with meals to reduce GI effects

Alogliptin + Pioglitazone Use when dual therapy with thiazolidinedione is clinically appropriate; monitor for fluid retention

Secondary Indications — Adults (Off-label)

Not applicable. No established off-label indications in Indian clinical practice.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

Not applicable. Alogliptin is NOT approved for use in children and adolescents below 18 years of age.

Secondary Indications — Paediatrics (Off-label)

Not applicable. Safety and efficacy data in paediatric population are insufficient.

Minimum Age: Not recommended below 18 years under any circumstances.

ESRD on haemodialysis 6.25 mg once daily; may administer without regard to dialysis timing

Peritoneal dialysis 6.25 mg once daily; limited data available

• Hypersensitivity to alogliptin or any excipient

• History of serious hypersensitivity reaction to any DPP-4 inhibitor (anaphylaxis, angioedema, severe cutaneous reactions)

• Type 1 Diabetes Mellitus

• Diabetic ketoacidosis

• History of pancreatitis or risk factors for pancreatitis (gallstones, alcoholism, hypertriglyceridaemia)

• Heart failure (NYHA Class III–IV) — use with caution, especially in combination with pioglitazone

• Concurrent use with sulfonylureas or insulin — increased hypoglycaemia risk; dose reduction of secretagogue may be required

• History of angioedema with ACE inhibitors — may have increased risk with DPP-4 inhibitors

• Bullous pemphigoid — monitor for skin symptoms, particularly in elderly

Parameter Details

Risk category No formal Indian category; equivalent to Category B (animal studies show no harm; limited human data)

Use in pregnancy Avoid unless clearly necessary; benefit must outweigh potential risk

Preferred alternatives Insulin is the preferred agent for glycaemic control during pregnancy

Monitoring Maternal blood glucose, fetal growth parameters

Parameter Details

Compatible with breastfeeding Unknown; excretion in human milk not established

Preferred alternatives Insulin, metformin (if appropriate)

Milk levels Not determined

Infant monitoring Feeding pattern, weight gain, hypoglycaemia signs if used

Parameter Recommendation

Starting dose 25 mg once daily (if eGFR ≥60 mL/min)

Titration Not applicable; adjust dose based on renal function

Extra risks Age-related renal decline (assess eGFR before prescribing and periodically); increased susceptibility to bullous pemphigoid; hypoglycaemia risk if on combination therapy

Drug/Class Interaction Recommendation

Sulfonylureas Additive hypoglycaemic effect Reduce sulfonylurea dose by 50% when initiating alogliptin

Insulin Increased hypoglycaemia risk Consider reducing insulin dose; intensify glucose monitoring

Pioglitazone (in FDC or combination) Increased risk of heart failure and fluid retention Avoid in NYHA Class III–IV heart failure; monitor for oedema

Drug/Class Interaction Recommendation

ACE inhibitors/ARBs Potential increased risk of angioedema Monitor for facial/lip swelling; educate patient

Diuretics Risk of volume depletion affecting renal function Monitor eGFR periodically, especially in elderly

Beta-blockers May mask hypoglycaemia symptoms Patient education regarding atypical hypoglycaemia presentations

Digoxin Minor increase in digoxin exposure reported Generally safe; monitor if symptoms of toxicity occur

Rifampicin Potential minor reduction in alogliptin exposure Monitor glycaemic response; clinical significance unclear

• Headache

• Nasopharyngitis

• Upper respiratory tract infection

• Arthralgia/myalgia

• Nausea

• Diarrhoea

Adverse Effect Action Required

Acute pancreatitis Discontinue immediately; do not rechallenge

Severe hypersensitivity reactions (anaphylaxis, angioedema, Stevens-Johnson syndrome) Discontinue permanently; emergency management

Bullous pemphigoid Discontinue; refer to dermatology

Severe arthralgia Consider discontinuation if disabling

Hepatotoxicity (rare) Monitor LFTs; discontinue if significant elevation

Phase Parameters

Baseline HbA1c, fasting/postprandial glucose, eGFR, LFTs, lipid profile

After initiation Blood glucose monitoring; watch for hypoglycaemia symptoms if on combination therapy

Long-term HbA1c every 3 months until stable, then every 6 months; annual eGFR; periodic LFTs; clinical assessment for pancreatitis symptoms and skin changes

Brand Name Composition Manufacturer

Nesina Alogliptin 25 mg Takeda

Alopride Alogliptin 25 mg Zydus

• Not included in NLEM 2022

• Not under NPPA price control

• Available primarily through private retail pharmacies

1. Weight neutrality: Alogliptin does not cause weight gain, making it suitable for overweight/obese T2DM patients who cannot tolerate SGLT2 inhibitors or GLP-1 agonists

1. Renal safety: Unlike metformin, alogliptin can be used across all stages of CKD with appropriate dose adjustment — useful in elderly diabetics with declining renal function

1. Low hypoglycaemia risk: Intrinsically low risk makes it suitable for patients with erratic meal patterns; however, always reduce sulfonylurea dose when combining

1. Pancreatitis vigilance: Educate patients to report persistent severe abdominal pain; discontinue immediately if pancreatitis is suspected

1. Heart failure consideration: Exercise caution in patients with known heart failure, especially when using pioglitazone-containing FDCs

1. Once-daily convenience: No requirement for timing with meals; supports adherence in polypharmacy situations

alogliptin; type 2 diabetes; DPP-4 inhibitor; gliptin; weight-neutral; low hypoglycaemia risk; renal-safe; oral antidiabetic; Schedule H

RxIndia v1.0 — 07 Jun 2025

• CDSCO approved product inserts

• Indian Pharmacopoeia

• API Textbook of Medicine, 11th Edition

• ICMR Guidelines for Management of Type 2 Diabetes

• AIIMS Endocrinology Department protocols

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• Manufacturer prescribing information (Takeda, Zydus)