Alogliptin
Alogliptin and metformin HCl tablets are a combination medication used to improve blood sugar control in adults with type 2 diabetes mellitus by inhibiting the DPP-4 enzyme.
A combination antihyperglycemic medication for type 2 diabetes that combines a DPP-4 inhibitor (alogliptin) with a biguanide (metformin) to improve blood sugar control.
This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.
Key facts at a glance
- ATC
- A10BH04
- RxNorm
- 1368001
- Generic
- Alogliptin
- Class
- atc-a10
- Brands
- Nesina, Kazano, Oseni
- Availability
- rx
- Lactation
- unknown
- Routes
- oral
- Forms
- tablet
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 500mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 250mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 400mg daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
11 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks
regular fetal monitoring and maternal blood glucose control
Use with caution and monitor for adverse effects.
pregnancy
second trimesteravoid if possible
discontinue if pregnancy occurs, consider insulin alternative
fetal growth monitoring
Use with caution and monitor for adverse effects.
pregnancy
third trimesterdiscontinue before delivery
switch to insulin for glycemic control
fetal wellbeing monitoring
Use with caution and monitor for adverse effects.
lactation
breastfeedingnot recommended
do not breastfeed during treatment, consider infant formula feeding
monitor infant for hypoglycemia if breastfeeding continues
geriatric
elderly 65 years and olderno specific dose adjustment
use with caution due to age-related decline in renal function
monitor renal function regularly
Use with caution and monitor for adverse effects.
pediatric_age
children and adolescents under 18not recommended
not approved for use in pediatric populations
not applicable
Use of this medication in this population requires careful consideration of risks and benefits.
renal_impairment
mild renal impairmentno dose adjustment required
monitor renal function periodically
check creatinine clearance every 6-12 months
Use with caution and monitor for adverse effects.
renal_impairment
moderate renal impairmentreduce dose to 12.5 mg once daily
use reduced dose and monitor renal function closely
monitor renal function every 3-6 months
Use with caution and monitor for adverse effects.
renal_impairment
severe renal impairmentnot recommended
do not use in patients with end-stage renal disease on dialysis
not applicable
Use of this medication in this population requires careful consideration of risks and benefits.
hepatic_impairment
mild hepatic impairmentno dose adjustment required
use with caution, no specific dose adjustment needed
monitor liver function tests periodically
Use with caution and monitor for adverse effects.
hepatic_impairment
moderate to severe hepatic impairmentuse with caution
not recommended in severe hepatic impairment
monitor liver function tests more frequently
Use with caution and monitor for adverse effects.
Statistics and clinical data
FDA Approval Year
FDA approval date for alogliptin (Nesina)
Drug class
DPP-4 inhibitor antidiabetic medication
Common uses
Indicated as an adjunct to diet and exercise to improve glycemic control
Mechanism of action
Increases insulin secretion by preventing DPP-4 from breaking down incretin hormones
Alogliptin and metformin HCl tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when dual therapy with alogliptin and metformin is appropriate.
Alogliptin selectively inhibits dipeptidyl peptidase-4 (DPP-4), an enzyme that breaks down incretin hormones, leading to increased insulin secretion and decreased glucagon release in a glucose-dependent manner. Metformin is a biguanide that decreases hepatic glucose production, reduces intestinal glucose absorption, and improves insulin sensitivity in peripheral tissues.
Not indicated for type 1 diabetes or diabetic ketoacidosis. Contraindicated in patients with severe renal impairment, metabolic acidosis, or conditions that may cause tissue hypoxia. Should be temporarily discontinued in patients undergoing radiographic contrast procedures or surgery. Common side effects may include gastrointestinal symptoms such as diarrhea, nausea, and abdominal pain. Lactic acidosis is a rare but serious risk, particularly in patients with renal impairment. Regular monitoring of renal function is recommended during treatment.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy