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Jentadueto XR

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Overview

What is Jentadueto XR?

JENTADUETO XR 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 XR consists of an extended-release metformin core tablet that is coated with the immediate-release drug substance linagliptin. JENTADUETO XR is available for oral administration as tablets containing 5 mg linagliptin and 1000 mg metformin hydrochloride extended-release (JENTADUETO XR 5 mg/1000 mg) or 2.5 mg linagliptin and 1000 mg metformin hydrochloride extended-release (JENTADUETO XR 2.5 mg/1000 mg). Each coated tablet of JENTADUETO XR contains the following inactive ingredients: Tablet core: polyethylene oxide, hypromellose, and magnesium stearate. Coating: hydroxypropyl cellulose, hypromellose, talc, titanium dioxide, arginine, polyethylene glycol, ferric oxide yellow (2.5 mg/1000 mg), carnauba wax, ferrosoferric oxide, propylene glycol, and isopropyl alcohol.



What does Jentadueto XR look like?



What are the available doses of Jentadueto XR?

Tablets:

5 mg linagliptin/1000 mg metformin hydrochloride extended-release

2.5 mg linagliptin/1000 mg metformin hydrochloride extended-release ()

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

How should I use Jentadueto XR?

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

The dosage of JENTADUETO XR should be individualized on the basis of both effectiveness and tolerability, while not exceeding the maximum recommended total daily dose of linagliptin 5 mg and metformin hydrochloride 2000 mg. JENTADUETO XR should be given once daily with a meal. For available dosage forms and strengths .

Recommended starting dose:

JENTADUETO XR should be swallowed whole. The tablets must not be split, crushed, dissolved, or chewed before swallowing. There have been reports of incompletely dissolved tablets being eliminated in the feces for other tablets containing metformin extended-release. If a patient reports seeing tablets in feces, the healthcare provider should assess adequacy of glycemic control.

JENTADUETO XR 5 mg linagliptin/1000 mg metformin hydrochloride extended-release tablet should be taken as a single tablet once daily. Patients using 2.5 mg linagliptin/1000 mg metformin extended-release tablets should take two tablets together once daily.

No studies have been performed specifically examining the safety and efficacy of JENTADUETO XR in patients previously treated with other oral antihyperglycemic agents and switched to JENTADUETO XR. 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 XR?

Sorry No Records found


What are the warnings of Jentadueto XR?

Sorry No Records found


What are the precautions of Jentadueto XR?

Sorry No Records found


What are the side effects of Jentadueto XR?

Sorry No records found


What should I look out for while using Jentadueto XR?

JENTADUETO XR 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 XR and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended


What might happen if I take too much Jentadueto XR?

In the event of an overdose with JENTADUETO XR, 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 XR overdosage is suspected.

Linagliptin

Metformin

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


How should I store and handle Jentadueto XR?

Store at JENTADUETO XR (linagliptin and metformin hydrochloride extended-release) tablets 5 mg/1000 mg, white, oval-shaped coated tablets with one side printed in black ink with the Boehringer Ingelheim logo and “D5” on the top line and “1000M” on the bottom line, are supplied as follows:Bottles of 30 (NDC 0597-0275-33)Bottles of 90 (NDC 0597-0275-81)JENTADUETO XR (linagliptin and metformin hydrochloride extended-release) tablets 2.5 mg/1000 mg, yellow, oval-shaped coated tablets with one side printed in black ink with the Boehringer Ingelheim logo and “D2” on the top line and “1000M” on the bottom line, are supplied as follows:Bottles of 60 (NDC 0597-0270-73)Bottles of 180 (NDC 0597-0270-94)StorageStore at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F)JENTADUETO XR (linagliptin and metformin hydrochloride extended-release) tablets 5 mg/1000 mg, white, oval-shaped coated tablets with one side printed in black ink with the Boehringer Ingelheim logo and “D5” on the top line and “1000M” on the bottom line, are supplied as follows:Bottles of 30 (NDC 0597-0275-33)Bottles of 90 (NDC 0597-0275-81)JENTADUETO XR (linagliptin and metformin hydrochloride extended-release) tablets 2.5 mg/1000 mg, yellow, oval-shaped coated tablets with one side printed in black ink with the Boehringer Ingelheim logo and “D2” on the top line and “1000M” on the bottom line, are supplied as follows:Bottles of 60 (NDC 0597-0270-73)Bottles of 180 (NDC 0597-0270-94)StorageStore at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F)JENTADUETO XR (linagliptin and metformin hydrochloride extended-release) tablets 5 mg/1000 mg, white, oval-shaped coated tablets with one side printed in black ink with the Boehringer Ingelheim logo and “D5” on the top line and “1000M” on the bottom line, are supplied as follows:Bottles of 30 (NDC 0597-0275-33)Bottles of 90 (NDC 0597-0275-81)JENTADUETO XR (linagliptin and metformin hydrochloride extended-release) tablets 2.5 mg/1000 mg, yellow, oval-shaped coated tablets with one side printed in black ink with the Boehringer Ingelheim logo and “D2” on the top line and “1000M” on the bottom line, are supplied as follows:Bottles of 60 (NDC 0597-0270-73)Bottles of 180 (NDC 0597-0270-94)StorageStore at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F)JENTADUETO XR (linagliptin and metformin hydrochloride extended-release) tablets 5 mg/1000 mg, white, oval-shaped coated tablets with one side printed in black ink with the Boehringer Ingelheim logo and “D5” on the top line and “1000M” on the bottom line, are supplied as follows:Bottles of 30 (NDC 0597-0275-33)Bottles of 90 (NDC 0597-0275-81)JENTADUETO XR (linagliptin and metformin hydrochloride extended-release) tablets 2.5 mg/1000 mg, yellow, oval-shaped coated tablets with one side printed in black ink with the Boehringer Ingelheim logo and “D2” on the top line and “1000M” on the bottom line, are supplied as follows:Bottles of 60 (NDC 0597-0270-73)Bottles of 180 (NDC 0597-0270-94)StorageStore at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F)JENTADUETO XR (linagliptin and metformin hydrochloride extended-release) tablets 5 mg/1000 mg, white, oval-shaped coated tablets with one side printed in black ink with the Boehringer Ingelheim logo and “D5” on the top line and “1000M” on the bottom line, are supplied as follows:Bottles of 30 (NDC 0597-0275-33)Bottles of 90 (NDC 0597-0275-81)JENTADUETO XR (linagliptin and metformin hydrochloride extended-release) tablets 2.5 mg/1000 mg, yellow, oval-shaped coated tablets with one side printed in black ink with the Boehringer Ingelheim logo and “D2” on the top line and “1000M” on the bottom line, are supplied as follows:Bottles of 60 (NDC 0597-0270-73)Bottles of 180 (NDC 0597-0270-94)StorageStore at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F)JENTADUETO XR (linagliptin and metformin hydrochloride extended-release) tablets 5 mg/1000 mg, white, oval-shaped coated tablets with one side printed in black ink with the Boehringer Ingelheim logo and “D5” on the top line and “1000M” on the bottom line, are supplied as follows:Bottles of 30 (NDC 0597-0275-33)Bottles of 90 (NDC 0597-0275-81)JENTADUETO XR (linagliptin and metformin hydrochloride extended-release) tablets 2.5 mg/1000 mg, yellow, oval-shaped coated tablets with one side printed in black ink with the Boehringer Ingelheim logo and “D2” on the top line and “1000M” on the bottom line, are supplied as follows:Bottles of 60 (NDC 0597-0270-73)Bottles of 180 (NDC 0597-0270-94)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 XR

Linagliptin

Metformin

[see Warnings and Precautions ()]

Non-Clinical Toxicology
JENTADUETO XR 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 XR and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended

Interactions between ethinyl estradiol and other substances may lead to decreased or increased serum ethinyl estradiol concentrations. Decreased ethinyl estradiol plasma concentrations may cause an increased incidence of breakthrough bleeding and menstrual irregularities and may possibly reduce efficacy of the combination oral contraceptive. Combined hormonal contraceptives have been shown to significantly decrease plasma concentrations of lamotrigine when co-administered, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary. Consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. Reduced ethinyl estradiol concentrations have been associated with concomitant use of substances that induce hepatic microsomal enzymes, such as rifampin, rifabutin, barbiturates, phenylbutazone, phenytoin sodium, griseofulvin, topiramate, some protease inhibitors, modafinil, and possibly St. John’s wort. Do not co-administer Ayuna with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations (see ). Substances that may decrease plasma ethinyl estradiol concentrations by other mechanisms include any substance that reduces gut transit time and certain antibiotics (e.g., ampicillin and other penicillins, tetracyclines) by a decrease of enterohepatic circulation of estrogens. During concomitant use of ethinyl estradiol containing products and substances that may lead to decreased plasma steroid hormone concentrations, it is recommended that a nonhormonal back-up method of birth control be used in addition to the regular intake of Ayuna (levonorgestrel and ethinyl estradiol tablets). If the use of a substance which leads to decreased ethinyl estradiol plasma concentrations is required for a prolonged period of time, combination oral contraceptives should not be considered the primary contraceptive. After discontinuation of substances that may lead to decreased ethinyl estradiol plasma concentrations, use of a nonhormonal back-up method of birth control is recommended for 7 days. Longer use of a back-up method is advisable after discontinuation of substances that have led to induction of hepatic microsomal enzymes, resulting in decreased ethinyl estradiol concentrations. It may take several weeks until enzyme induction has completely subsided, depending on dosage, duration of use, and rate of elimination of the inducing substance. Some substances may increase plasma ethinyl estradiol concentrations. These include:

Ethinyl estradiol may interfere with the mechanism of other drugs by inhibiting hepatic microsomal enzymes or by inducing hepatic drug conjugation, particularly glucuronidation. Accordingly, tissue concentrations may be either increased (e.g., cyclosporine, theophylline, corticosteroids) or decreased. The prescribing information of concomitant medications should be consulted to identify potential interactions.

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 XR. In JENTADUETO XR-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 XR 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:

Renal Impairment:

[see Dosage and Administration (), Clinical Pharmacology ()]:

Drug Interactions:

[see Drug Interactions ()]

Age 65 or Greater:

[see Use in Specific Populations ()].

Radiological Studies with Contrast:

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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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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