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Jentadueto

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Overview

What is Jentadueto?

JENTADUETO tablets contain 2 oral antihyperglycemic drugs used in the management of type 2 diabetes mellitus: linagliptin and metformin hydrochloride.

Linagliptin

Linagliptin is described chemically as 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-

The empirical formula is CHNO and the molecular weight is 472.54 g/mol. The structural formula is:

Linagliptin is a white to yellowish, not or only slightly hygroscopic solid substance. It is very slightly soluble in water (0.9 mg/mL). Linagliptin is soluble in methanol (ca. 60 mg/mL), sparingly soluble in ethanol (ca. 10 mg/mL), very slightly soluble in isopropanol (<1 mg/mL), and very slightly soluble in acetone (ca. 1 mg/mL).

Metformin Hydrochloride

N,N

JENTADUETO



What does Jentadueto look like?



What are the available doses of Jentadueto?

Tablets:2.5 mg linagliptin/500 mg metformin hydrochloride2.5 mg linagliptin/850 mg metformin hydrochloride2.5 mg linagliptin/1000 mg metformin hydrochloride

What should I talk to my health care provider before I take Jentadueto?

How should I use Jentadueto?

JENTADUETO 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

The dosage of JENTADUETO should be individualized on the basis of both effectiveness and tolerability, while not exceeding the maximum recommended dose of 2.5 mg linagliptin/1000 mg metformin hydrochloride twice daily. JENTADUETO should be given twice daily with meals. Dose escalation should be gradual to reduce the gastrointestinal (GI) side effects associated with metformin use. For available dosage forms and strengths .

Recommended starting dose:

No studies have been performed specifically examining the safety and efficacy of JENTADUETO in patients previously treated with other oral antihyperglycemic agents and switched to JENTADUETO. Any change in therapy of type 2 diabetes mellitus should be undertaken with care and appropriate monitoring as changes in glycemic control can occur.


What interacts with Jentadueto?

Sorry No Records found


What are the warnings of Jentadueto?

Sorry No Records found


What are the precautions of Jentadueto?

Sorry No Records found


What are the side effects of Jentadueto?

Sorry No records found


What should I look out for while using Jentadueto?

P8

JENTADUETO is contraindicated in patients with:

Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL

Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment.

Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the full prescribing information

If metformin-associated lactic acidosis is suspected, immediately discontinue JENTADUETO and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended


What might happen if I take too much Jentadueto?

In the event of an overdose with JENTADUETO, contact the Poison Control Center. Employ the usual supportive measures (e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive treatment) as dictated by the patient’s clinical status. Removal of linagliptin by hemodialysis or peritoneal dialysis is unlikely. However, metformin is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions. Therefore, hemodialysis may be useful partly for removal of accumulated metformin from patients in whom JENTADUETO overdosage is suspected.

Linagliptin

Metformin

[see Boxed Warning and Warnings and Precautions ()].


How should I store and handle Jentadueto?

Store at JENTADUETO (linagliptin and metformin hydrochloride) tablets 2.5 mg/500 mg are supplied as follows: Bottles of 60 (NDC 0597-0146-60) Bottles of 180 (NDC 0597-0146-18) JENTADUETO (linagliptin and metformin hydrochloride) tablets 2.5 mg/850 mg are supplied as follows: Bottles of 60 (NDC 0597-0147-60) Bottles of 180 (NDC 0597-0147-18)JENTADUETO (linagliptin and metformin hydrochloride) tablets 2.5 mg/1000 mg are supplied as follows: Bottles of 60 (NDC 0597-0148-60) Bottles of 180 (NDC 0597-0148-18) StorageStore at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F)JENTADUETO (linagliptin and metformin hydrochloride) tablets 2.5 mg/500 mg are supplied as follows: Bottles of 60 (NDC 0597-0146-60) Bottles of 180 (NDC 0597-0146-18) JENTADUETO (linagliptin and metformin hydrochloride) tablets 2.5 mg/850 mg are supplied as follows: Bottles of 60 (NDC 0597-0147-60) Bottles of 180 (NDC 0597-0147-18)JENTADUETO (linagliptin and metformin hydrochloride) tablets 2.5 mg/1000 mg are supplied as follows: Bottles of 60 (NDC 0597-0148-60) Bottles of 180 (NDC 0597-0148-18) StorageStore at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F)JENTADUETO (linagliptin and metformin hydrochloride) tablets 2.5 mg/500 mg are supplied as follows: Bottles of 60 (NDC 0597-0146-60) Bottles of 180 (NDC 0597-0146-18) JENTADUETO (linagliptin and metformin hydrochloride) tablets 2.5 mg/850 mg are supplied as follows: Bottles of 60 (NDC 0597-0147-60) Bottles of 180 (NDC 0597-0147-18)JENTADUETO (linagliptin and metformin hydrochloride) tablets 2.5 mg/1000 mg are supplied as follows: Bottles of 60 (NDC 0597-0148-60) Bottles of 180 (NDC 0597-0148-18) StorageStore at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F)JENTADUETO (linagliptin and metformin hydrochloride) tablets 2.5 mg/500 mg are supplied as follows: Bottles of 60 (NDC 0597-0146-60) Bottles of 180 (NDC 0597-0146-18) JENTADUETO (linagliptin and metformin hydrochloride) tablets 2.5 mg/850 mg are supplied as follows: Bottles of 60 (NDC 0597-0147-60) Bottles of 180 (NDC 0597-0147-18)JENTADUETO (linagliptin and metformin hydrochloride) tablets 2.5 mg/1000 mg are supplied as follows: Bottles of 60 (NDC 0597-0148-60) Bottles of 180 (NDC 0597-0148-18) StorageStore at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F)JENTADUETO (linagliptin and metformin hydrochloride) tablets 2.5 mg/500 mg are supplied as follows: Bottles of 60 (NDC 0597-0146-60) Bottles of 180 (NDC 0597-0146-18) JENTADUETO (linagliptin and metformin hydrochloride) tablets 2.5 mg/850 mg are supplied as follows: Bottles of 60 (NDC 0597-0147-60) Bottles of 180 (NDC 0597-0147-18)JENTADUETO (linagliptin and metformin hydrochloride) tablets 2.5 mg/1000 mg are supplied as follows: Bottles of 60 (NDC 0597-0148-60) Bottles of 180 (NDC 0597-0148-18) StorageStore at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F)


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

JENTADUETO

Linagliptin

Metformin

[see Warnings and Precautions ()]

Non-Clinical Toxicology
P8

JENTADUETO is contraindicated in patients with:

Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL

Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment.

Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the full prescribing information

If metformin-associated lactic acidosis is suspected, immediately discontinue JENTADUETO and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended

Ketorolac is highly bound to human plasma protein (mean 99.2%). There is no evidence in animal or human studies that ketorolac tromethamine induces or inhibits hepatic enzymes capable of metabolizing itself or other drugs.

Metformin

If metformin-associated lactic acidosis is suspected, general supportive measures should be instituted promptly in a hospital setting, along with immediate discontinuation of JENTADUETO. In JENTADUETO-treated patients with a diagnosis or strong suspicion of lactic acidosis, prompt hemodialysis is recommended to correct the acidosis and remove accumulated metformin (metformin hydrochloride is dialyzable, with clearance of up to 170 mL/min under good hemodynamic conditions). Hemodialysis has often resulted in reversal of symptoms and recovery.

Educate patients and their families about the symptoms of lactic acidosis and if these symptoms occur instruct them to discontinue JENTADUETO and report these symptoms to their healthcare provider.

For each of the known and possible risk factors for metformin-associated lactic acidosis, recommendations to reduce the risk of and manage metformin-associated lactic acidosis are provided below:

Radiological Studies with Contrast:

2

Surgery and Other Procedures:

Hypoxic States:

Excessive Alcohol Intake:

Hepatic Impairment:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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