Drugplain

Jentadueto 2.5 mg/1

linagliptin and metformin hydrochloride · TABLET, FILM COATED · Boehringer Ingelheim Pharmaceuticals, Inc.

1 Recall on Record
Plain English

Jentadueto is a prescription tablet that combines linagliptin and metformin hydrochloride to help manage type 2 diabetes. It works by using a dipeptidyl peptidase 4 inhibitor combined with metformin to help control blood sugar levels.

Key Facts

Brand Name
Jentadueto
Generic Name
linagliptin and metformin hydrochloride
NDC Code (Product)
0597-0147
Manufacturer
Boehringer Ingelheim Pharmaceuticals, Inc.
Strength
2.5 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
HUMAN PRESCRIPTION DRUG
Application #
NDA201281
Drug Class
Biguanide [EPC]; Biguanides [CS]
Marketing Start
02/13/2012

Recall History

1 Recall on Record
Class II03/15/2021

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

blood glucose increased100 reports
diarrhoea89 reports
nausea68 reports
vomiting58 reports
drug ineffective55 reports
off label use47 reports
fatigue44 reports
dizziness43 reports
arthralgia41 reports
pain41 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE JENTADUETO XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus . JENTADUETO XR is a combination of linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus ( 1 ) Limitations of Use Not recommended in patients with type 1 diabetes mellitus ( 1 ) Has not been studied in patients with a history of pancreatitis ( 1 ) Limitations of Use JENTADUETO XR is not recommended in patients with type 1 diabetes mellitus. JENTADUETO XR has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using JENTADUETO XR [see Warnings and Precautions (5.2) ].

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Individualize the starting dosage of JENTADUETO XR based on the patient's current regimen ( 2.1 ) The maximum recommended dosage is 5 mg linagliptin/2,000 mg metformin HCl once daily ( 2.1 ) Take orally once daily with a meal, with gradual dose escalation to reduce the gastrointestinal effects due to metformin ( 2.1 ) Swallow whole; do not split, crush, dissolve, or chew ( 2.1 ) Prior to initiation, assess renal function with estimated glomerular filtration rate (eGFR) ( 2.2 ) Do not use in patients with eGFR below 30 mL/min/1.73 m 2 Initiation is not recommended in patients with eGFR between 30 - 45 mL/min/1.73 m 2 Assess risk/benefit of continuing if eGFR falls below 45 mL/min/1.73 m 2 Discontinue if eGFR falls below 30 mL/min/1.73 m 2 JENTADUETO XR may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures ( 2.3 ) 2.1 Recommended Dosage and Administration The dosage of JENTADUETO XR should be individualized on the basis of both effectiveness and tolerability, while not exceeding the maximum recommended total daily dosage of linagliptin 5 mg and metformin hydrochloride (HCl) 2,000 mg. JENTADUETO XR should be given orally…

Contraindications

4 CONTRAINDICATIONS JENTADUETO XR is contraindicated in patients with: severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) [see Warnings and Precautions (5.1) ]. acute or chronic metabolic acidosis, including diabetic ketoacidosis [see Warnings and Precautions (5.1) ]. hypersensitivity to linagliptin, metformin, or any of the excipients in JENTADUETO XR, reactions such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity have occurred with linagliptin [see Warnings and Precautions (5.4) and Adverse Reactions (6.1) ]. Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) ( 4 ) Metabolic acidosis, including diabetic ketoacidosis ( 4 ) Hypersensitivity to linagliptin, metformin, or any of the excipients in JENTADUETO XR ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Table 2 describes clinically relevant interactions with JENTADUETO XR. Table 2 Clinically Relevant Interactions with JENTADUETO XR Carbonic Anhydrase Inhibitors Clinical Impact Topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide) frequently cause a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. Concomitant use of these drugs with JENTADUETO XR may increase the risk of lactic acidosis. Intervention Consider more frequent monitoring of these patients. Drugs that Reduce Metformin Clearance Clinical Impact Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2] / multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase systemic exposure to metformin and may increase the risk for lactic acidosis [see Clinical Pharmacology (12.3) ] . Intervention Consider the benefits and risks of concomitant use. Alcohol Clinical Impact Alcohol is known to potentiate the effect of metformin on lactate meta…

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are described below or elsewhere in the prescribing information: Lactic Acidosis [see Warnings and Precautions (5.1) ] Pancreatitis [see Warnings and Precautions (5.2) ] Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues [see Warnings and Precautions (5.3) ] Hypersensitivity Reactions [see Warnings and Precautions (5.4) ] Vitamin B 12 Deficiency [see Warnings and Precautions (5.5) ] Severe and Disabling Arthralgia [see Warnings and Precautions (5.6) ] Bullous Pemphigoid [see Warnings and Precautions (5.7) ] Heart Failure [see Warnings and Precautions (5.8) ] Most common adverse reactions (incidence ≥5% and more often than placebo) were nasopharyngitis and diarrhea ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates obser…

Frequently Asked Questions

What is Jentadueto used for?

Jentadueto is a prescription tablet that combines linagliptin and metformin hydrochloride to help manage type 2 diabetes. It works by using a dipeptidyl peptidase 4 inhibitor combined with metformin to help control blood sugar levels.

Is Jentadueto a controlled substance?

Jentadueto is not classified as a controlled substance by the DEA.

What is the generic name for Jentadueto?

The generic name for Jentadueto is linagliptin and metformin hydrochloride. There are 9 other brand versions of linagliptin and metformin hydrochloride.

What is the NDC code for Jentadueto 2.5 mg/1?

The NDC (National Drug Code) for Jentadueto 2.5 mg/1 is 0597-0147, listed by Boehringer Ingelheim Pharmaceuticals, Inc..

Product NDC

0597-0147

Package NDC

0597-0147-18

Other Linagliptin Brands

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