Jentadueto XR
Pronunciation: Not extracted from the supplied research notes..
- Generic name
- linagliptin and metformin hydrochloride
- Brand names
- Jentadueto XR
- Drug class
- Dipeptidyl peptidase-4 (DPP-4) inhibitor and biguanide combination
- Form
- Film-coated extended-release tablet
- Route
- Oral
- Legal status
- Not extracted from the supplied research notes.
Availability and supply rules vary by country
Trade names by country: United States
Australia: · Full directory
What linagliptin and metformin hydrochloride is and how it works
Jentadueto XR is a combination of linagliptin, a DPP-4 inhibitor, and extended-release metformin hydrochloride. Linagliptin increases incretin hormone levels, stimulating insulin release and reducing hepatic glucose production. Metformin lowers hepatic glucose production and intestinal glucose absorption and improves insulin sensitivity. (1)
The US label states that Jentadueto XR is used with diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both linagliptin and metformin is appropriate. It is not indicated for type 1 diabetes. Country-specific availability and indication verification outside the United States are unresolved.
Mechanism of action: how linagliptin and metformin hydrochloride works
Linagliptin is a DPP-4 inhibitor that increases incretin hormone levels, stimulating insulin release and reducing hepatic glucose production. Metformin lowers hepatic glucose production and intestinal glucose absorption and improves insulin sensitivity. (1)
What linagliptin and metformin hydrochloride is used for
Type 2 diabetes mellitus in adults
Jentadueto XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both linagliptin and metformin is appropriate. (1)
Before taking linagliptin and metformin hydrochloride
Do not take / not appropriate for
- Jentadueto XR is contraindicated when estimated glomerular filtration rate (eGFR) is below 30 mL/min/1.73 m². Anyone with kidney function in this range should ask the prescribing clinician whether treatment can be started or continued. (US label) (1)
- Jentadueto XR is contraindicated in anyone with known hypersensitivity to linagliptin or metformin. Anyone with a known reaction to either ingredient should discuss treatment options with the prescribing clinician. (US label) (1)
- Jentadueto XR is contraindicated in acute or chronic metabolic acidosis, including diabetic ketoacidosis. Anyone with suspected metabolic acidosis or ketoacidosis needs urgent clinical assessment, and the treating clinician will determine whether this medicine can be started or continued. (US label) (1)
Tell your clinician about
- Any kidney problem or previous eGFR result, because renal function affects whether this medicine can be started or continued.
- Any liver impairment, heart failure, planned surgery, hypoxic state, or age-related risk of declining kidney function.
- Any planned iodinated contrast imaging procedure.
- All medicines, including carbonic anhydrase inhibitors, cationic medicines that may reduce metformin clearance, insulin, sulfonylureas, and strong P-glycoprotein or CYP3A4 inducers.
- Alcohol intake, particularly excessive alcohol intake.
- Previous pancreatitis, blistering or erosive skin reactions, or risk factors for heart failure.
- Pregnancy, plans for pregnancy, or breastfeeding.
How to take linagliptin and metformin hydrochloride
- Take Jentadueto XR once daily with a meal, using the dose selected by the prescriber based on effectiveness and tolerability.
- The usual US-label starting dose is 5 mg linagliptin and 1000 mg metformin hydrochloride extended-release once daily for people not already taking metformin or already taking metformin at that dose.
- The maximum recommended US-label daily dose is 5 mg linagliptin and 2000 mg metformin hydrochloride once daily.
- Swallow the tablets whole. Do not cut, crush, or chew extended-release tablets.
- Do not change the dose or dosing schedule without prescriber advice.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1)
Missed dose
Missed-dose instructions were not extracted from the supplied research notes. Contact the prescribing clinician or pharmacist for advice rather than taking an extra dose.
Overdose
Dedicated overdose-management instructions were not extracted from the supplied research notes. Metformin accumulation can cause lactic acidosis, for which the US label describes prompt hemodialysis as recommended when lactic acidosis is suspected. Urgent medical assessment is needed if overdose or lactic-acidosis symptoms are suspected. (1)
Side effects
In clinical trials, the adverse reactions reported in at least 5% of people and more often than with placebo were nasopharyngitis and diarrhea.
Nasopharyngitis
What to notice: Symptoms described as nasopharyngitis.
What to do: Discuss persistent or troublesome symptoms with the prescribing clinician. (1)
Diarrhea
What to notice: Diarrhea.
What to do: Discuss persistent or troublesome symptoms with the prescribing clinician. (1)
Possible pancreatitis
What to notice: The supplied notes identify acute pancreatitis, including fatal pancreatitis, as reported with linagliptin, but do not extract a symptom list.
What to do: Seek prompt medical assessment if pancreatitis is suspected; the clinician should determine ongoing treatment. (1)
Bullous pemphigoid
What to notice: Blister or erosion formation on the skin.
What to do: Report blister or erosion formation promptly for clinical assessment; the clinician should determine ongoing treatment. (1)
Vitamin B12 deficiency or hematologic abnormality
What to notice: Specific symptoms were not extracted from the supplied research notes.
What to do: Attend recommended annual hematologic-parameter and vitamin B12 monitoring, and discuss any abnormal result with the clinician. (1)
Serious warnings
Lactic acidosis — emergency
Symptoms: Malaise, myalgia, respiratory distress, increasing somnolence, and nonspecific abdominal distress.
Action: Seek emergency medical care immediately if these symptoms occur. Metformin accumulation can cause lactic acidosis, which can be fatal; the clinician managing suspected lactic acidosis should institute supportive measures, and the label recommends prompt hemodialysis. (1)
Acute pancreatitis — urgent
Symptoms: Specific symptoms were not extracted from the supplied research notes. Acute pancreatitis, including fatal pancreatitis, has been reported with linagliptin.
Action: Seek prompt medical assessment if pancreatitis is suspected; the clinician should determine whether treatment should continue. (1)
Hypoglycemia when used with insulin or a sulfonylurea — urgent
Symptoms: Specific symptoms were not extracted from the supplied research notes.
Action: Contact the prescribing clinician promptly about suspected low blood glucose or recurrent episodes. Combining Jentadueto XR with insulin or an insulin secretagogue increases hypoglycemia risk, and the clinician may need to review the other medicine's dose. (1)
Heart failure risk — urgent
Symptoms: Specific symptoms were not extracted from the supplied research notes.
Action: People with known heart-failure risk factors should have benefits and risks considered by the prescriber, as heart failure has been observed with DPP-4-inhibitor-class medicines in cardiovascular outcome trials. (1)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Carbonic anhydrase inhibitors, including topiramate, zonisamide, and acetazolamide | May increase the risk of metabolic acidosis or lactic acidosis. | Ensure the prescriber and pharmacist know about these medicines; close monitoring may be needed. (1) |
| Cationic medicines that reduce metformin renal clearance, including cimetidine, ranolazine, vandetanib, and dolutegravir | May increase metformin exposure through competition for renal tubular transport systems. | The prescriber may need to consider dose adjustment and monitoring. (1) |
| Alcohol | Alcohol potentiates metformin's effect on lactate metabolism and increases the risk of lactic acidosis. | Discuss alcohol intake with the prescriber and avoid excessive alcohol intake. (1) |
| Insulin and insulin secretagogues, including sulfonylureas | Using these medicines with Jentadueto XR increases the risk of hypoglycemia. | The prescriber may need to review the insulin or secretagogue dose. (1) |
| Strong P-glycoprotein or CYP3A4 inducers, including rifampin | May reduce linagliptin exposure and efficacy. | The prescriber should consider an alternative to linagliptin if a strong P-glycoprotein or CYP3A4 inducer must be co-administered. (1) |
Pregnancy, breastfeeding, kidney/liver function, age
Children and adolescents
The supplied US-label notes limit the indication to adults and state that pediatric dosing was not separately confirmed in this research pass. Do not extrapolate adult use or dosing to a child. (1)
Older adults and people with renal impairment
Age 65 years or older and renal impairment increase lactic-acidosis risk. Renal function should be assessed before treatment and periodically thereafter, at least annually and more frequently, such as every 3 to 6 months, for people at increased risk of further decline. (1)
Pregnancy
Data on use in pregnant women are limited. Animal reproduction studies did not show adverse developmental effects at clinically relevant exposures. Published studies of metformin in pregnancy have not established an association with major birth defects, miscarriage, or adverse maternal or fetal outcomes, but data are limited. Discuss treatment decisions with the prescribing clinician. (1)
Breastfeeding
Metformin is present in human milk at low reported levels, approximately 0.11% to 1% of the maternal weight-adjusted dose. Linagliptin was present in milk of lactating rats. A clinician should weigh breastfeeding benefits, the mother's clinical need, and potential effects on the breastfed infant. (1)
Monitoring
Before starting
- Assess renal function before starting treatment.
- Confirm that eGFR is not below 30 mL/min/1.73 m² and that there is no acute or chronic metabolic acidosis, including diabetic ketoacidosis.
- Assess concurrent medicines, alcohol intake, risk factors for lactic acidosis, and risk factors for heart failure.
- Consider whether treatment with both linagliptin and metformin is appropriate for the adult with type 2 diabetes mellitus.
During treatment
- Assess renal function periodically, at least annually, and more frequently, such as every 3 to 6 months, in people at increased risk of further renal decline.
- Measure hematologic parameters and vitamin B12 annually, and evaluate and treat abnormalities.
- Monitor closely when carbonic anhydrase inhibitors are used concurrently.
- Monitor for hypoglycemia when Jentadueto XR is used with insulin or an insulin secretagogue.
- Review for possible pancreatitis, blistering or erosive skin reactions, lactic-acidosis symptoms, and heart-failure risk.
Storage
Storage instructions were not extracted from the supplied research notes. Follow the dispensing label and pharmacist's instructions for the exact product.
Professional information
Clinician-facing context only. Use the current US prescribing information and individual clinical assessment. Country-specific product information outside the United States was not researched.
United States
Indication: Adults with type 2 diabetes mellitus when treatment with both linagliptin and metformin is appropriate
Dose summary: Usual starting dose: linagliptin 5 mg/metformin hydrochloride extended-release 1000 mg once daily with a meal in people not already receiving metformin or already receiving metformin at that dose. Individualize for effectiveness and tolerability. Maximum recommended daily dose: linagliptin 5 mg/metformin hydrochloride 2000 mg once daily. Swallow tablets whole; do not cut, crush, or chew.
Renal context: Assess eGFR before initiation and periodically thereafter. Do not initiate at eGFR 30 to 45 mL/min/1.73 m²; assess benefit versus risk if already established on treatment in this range. Use is contraindicated below eGFR 30 mL/min/1.73 m². Monitor at least annually and more frequently, such as every 3 to 6 months, in people at increased risk of renal decline. (1)
Other countries
Dose summary: Do not extrapolate the US label to another country without current local product information.
Renal context: Not established from the sources reviewed: use current local product information. (1)
Hepatic guidance
Hepatic impairment is a listed risk factor for metformin-associated lactic acidosis. The supplied notes do not provide a hepatic-impairment dosing recommendation.
Overdose note
A dedicated overdosage section was not extracted. In suspected lactic acidosis from metformin accumulation, the label states that prompt hemodialysis is recommended alongside general supportive measures. (1)
Frequently asked questions
What is Jentadueto XR used for?
Under the US label, it is used with diet and exercise to improve glycemic control in adults with type 2 diabetes when treatment with both linagliptin and metformin is appropriate. It is not indicated for type 1 diabetes. (1)
Can I split, crush, or chew a Jentadueto XR tablet?
No. Jentadueto XR is an extended-release tablet and should be swallowed whole. (1)
What should I do if I am scheduled for an iodinated contrast scan?
Tell the imaging team and prescribing clinician. For specified risk groups, the US label requires the clinician to direct a temporary treatment interruption at the time of or before contrast, re-evaluate eGFR 48 hours afterward, and determine whether renal function is stable before restarting. (1)
What is the mechanism of action of linagliptin and metformin hydrochloride?
Linagliptin is a DPP-4 inhibitor that increases incretin hormone levels, stimulating insulin release and reducing hepatic glucose production. Metformin lowers hepatic glucose production and intestinal glucose absorption and improves insulin sensitivity. (1)
What is the generic name of Jentadueto XR?
The generic name is linagliptin and metformin hydrochloride. It is sold under brand names including Jentadueto XR. (1)
What class of drug is linagliptin and metformin hydrochloride?
Jentadueto XR is classed as: Dipeptidyl peptidase-4 (DPP-4) inhibitor and biguanide combination. (1)
References
- JENTADUETO XR (linagliptin and metformin hydrochloride) tablet, film coated, extended release — full prescribing informationU.S. Food and Drug Administration / DailyMed · United States · accessed 2026-08-05 · source 1
- LINAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [NOVADOZ PHARMACEUTICALS LLC] — US prescribing information (DailyMed SPL)U.S. National Library of Medicine (DailyMed) · US · accessed 2026-08-14 · source 2
- Linagliptin — patient drug information (MedlinePlus)U.S. National Library of Medicine (MedlinePlus) · US · accessed 2026-08-14 · source 3
- Jentadueto XR — FDA approval record (Drugs@FDA NDA208026)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 4
- linagliptin and metformin — RxNorm normalized drug concept (RXCUI 1243019)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 5
Brand names by country
Single-ingredient linagliptin and metformin hydrochloride names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- Jentadueto
- Trijardy XR