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JANUVIA

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Overview

What is JANUVIA?

JANUVIA Tablets contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme.

Sitagliptin phosphate monohydrate is described chemically as 7-[(3)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-]pyrazine phosphate (1:1) monohydrate.

The empirical formula is CHFNO•HPO•HO and the molecular weight is 523.32. The structural formula is:

Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate.

Each film-coated tablet of JANUVIA contains 32.13, 64.25, or 128.5 mg of sitagliptin phosphate monohydrate, which is equivalent to 25, 50, or 100 mg, respectively, of free base and the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, and sodium stearyl fumarate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, red iron oxide, and yellow iron oxide.



What does JANUVIA look like?



What are the available doses of JANUVIA?

Tablets: 100 mg, 50 mg, and 25 mg ()

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

How should I use JANUVIA?

JANUVIA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

The recommended dose of JANUVIA is 100 mg once daily. JANUVIA can be taken with or without food.


What interacts with JANUVIA?

Sorry No Records found


What are the warnings of JANUVIA?

Sorry No Records found


What are the precautions of JANUVIA?

Sorry No Records found


What are the side effects of JANUVIA?

Sorry No records found


What should I look out for while using JANUVIA?

History of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema.


What might happen if I take too much JANUVIA?

During controlled clinical trials in healthy subjects, single doses of up to 800 mg JANUVIA were administered. Maximal mean increases in QTc of 8.0 msec were observed in one study at a dose of 800 mg JANUVIA, a mean effect that is not considered clinically important . There is no experience with doses above 800 mg in clinical studies. In Phase I multiple-dose studies, there were no dose-related clinical adverse reactions observed with JANUVIA with doses of up to 600 mg per day for periods of up to 10 days and 400 mg per day for up to 28 days.

In the event of an overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring (including obtaining an electrocardiogram), and institute supportive therapy as dictated by the patient's clinical status.

Sitagliptin is modestly dialyzable. In clinical studies, approximately 13.5% of the dose was removed over a 3- to 4-hour hemodialysis session. Prolonged hemodialysis may be considered if clinically appropriate. It is not known if sitagliptin is dialyzable by peritoneal dialysis.


How should I store and handle JANUVIA?

No. 6737 — Tablets JANUVIA, 25 mg, are pink, round, film-coated tablets with "221" on one side. They are supplied as follows:NDC 0006-0221-31 unit-of-use bottles of 30NDC 0006-0221-54 unit-of-use bottles of 90NDC 0006-0221-28 unit dose blister packages of 100.No. 6738 — Tablets JANUVIA, 50 mg, are light beige, round, film-coated tablets with "112" on one side. They are supplied as follows:NDC 0006-0112-31 unit-of-use bottles of 30NDC 0006-0112-54 unit-of-use bottles of 90NDC 0006-0112-28 unit dose blister packages of 100.No. 6739 — Tablets JANUVIA, 100 mg, are beige, round, film-coated tablets with "277" on one side. They are supplied as follows:NDC 0006-0277-31 unit-of-use bottles of 30NDC 0006-0277-54 unit-of-use bottles of 90NDC 0006-0277-02 unit-of-use blister calendar package of 30NDC 0006-0277-33 unit-of-use blister calendar package of 30NDC 0006-0277-28 unit dose blister packages of 100NDC 0006-0277-82 bottles of 1000.No. 6737 — Tablets JANUVIA, 25 mg, are pink, round, film-coated tablets with "221" on one side. They are supplied as follows:NDC 0006-0221-31 unit-of-use bottles of 30NDC 0006-0221-54 unit-of-use bottles of 90NDC 0006-0221-28 unit dose blister packages of 100.No. 6738 — Tablets JANUVIA, 50 mg, are light beige, round, film-coated tablets with "112" on one side. They are supplied as follows:NDC 0006-0112-31 unit-of-use bottles of 30NDC 0006-0112-54 unit-of-use bottles of 90NDC 0006-0112-28 unit dose blister packages of 100.No. 6739 — Tablets JANUVIA, 100 mg, are beige, round, film-coated tablets with "277" on one side. They are supplied as follows:NDC 0006-0277-31 unit-of-use bottles of 30NDC 0006-0277-54 unit-of-use bottles of 90NDC 0006-0277-02 unit-of-use blister calendar package of 30NDC 0006-0277-33 unit-of-use blister calendar package of 30NDC 0006-0277-28 unit dose blister packages of 100NDC 0006-0277-82 bottles of 1000.No. 6737 — Tablets JANUVIA, 25 mg, are pink, round, film-coated tablets with "221" on one side. They are supplied as follows:NDC 0006-0221-31 unit-of-use bottles of 30NDC 0006-0221-54 unit-of-use bottles of 90NDC 0006-0221-28 unit dose blister packages of 100.No. 6738 — Tablets JANUVIA, 50 mg, are light beige, round, film-coated tablets with "112" on one side. They are supplied as follows:NDC 0006-0112-31 unit-of-use bottles of 30NDC 0006-0112-54 unit-of-use bottles of 90NDC 0006-0112-28 unit dose blister packages of 100.No. 6739 — Tablets JANUVIA, 100 mg, are beige, round, film-coated tablets with "277" on one side. They are supplied as follows:NDC 0006-0277-31 unit-of-use bottles of 30NDC 0006-0277-54 unit-of-use bottles of 90NDC 0006-0277-02 unit-of-use blister calendar package of 30NDC 0006-0277-33 unit-of-use blister calendar package of 30NDC 0006-0277-28 unit dose blister packages of 100NDC 0006-0277-82 bottles of 1000.No. 6737 — Tablets JANUVIA, 25 mg, are pink, round, film-coated tablets with "221" on one side. They are supplied as follows:NDC 0006-0221-31 unit-of-use bottles of 30NDC 0006-0221-54 unit-of-use bottles of 90NDC 0006-0221-28 unit dose blister packages of 100.No. 6738 — Tablets JANUVIA, 50 mg, are light beige, round, film-coated tablets with "112" on one side. They are supplied as follows:NDC 0006-0112-31 unit-of-use bottles of 30NDC 0006-0112-54 unit-of-use bottles of 90NDC 0006-0112-28 unit dose blister packages of 100.No. 6739 — Tablets JANUVIA, 100 mg, are beige, round, film-coated tablets with "277" on one side. They are supplied as follows:NDC 0006-0277-31 unit-of-use bottles of 30NDC 0006-0277-54 unit-of-use bottles of 90NDC 0006-0277-02 unit-of-use blister calendar package of 30NDC 0006-0277-33 unit-of-use blister calendar package of 30NDC 0006-0277-28 unit dose blister packages of 100NDC 0006-0277-82 bottles of 1000.No. 6737 — Tablets JANUVIA, 25 mg, are pink, round, film-coated tablets with "221" on one side. They are supplied as follows:NDC 0006-0221-31 unit-of-use bottles of 30NDC 0006-0221-54 unit-of-use bottles of 90NDC 0006-0221-28 unit dose blister packages of 100.No. 6738 — Tablets JANUVIA, 50 mg, are light beige, round, film-coated tablets with "112" on one side. They are supplied as follows:NDC 0006-0112-31 unit-of-use bottles of 30NDC 0006-0112-54 unit-of-use bottles of 90NDC 0006-0112-28 unit dose blister packages of 100.No. 6739 — Tablets JANUVIA, 100 mg, are beige, round, film-coated tablets with "277" on one side. They are supplied as follows:NDC 0006-0277-31 unit-of-use bottles of 30NDC 0006-0277-54 unit-of-use bottles of 90NDC 0006-0277-02 unit-of-use blister calendar package of 30NDC 0006-0277-33 unit-of-use blister calendar package of 30NDC 0006-0277-28 unit dose blister packages of 100NDC 0006-0277-82 bottles of 1000.No. 6737 — Tablets JANUVIA, 25 mg, are pink, round, film-coated tablets with "221" on one side. They are supplied as follows:NDC 0006-0221-31 unit-of-use bottles of 30NDC 0006-0221-54 unit-of-use bottles of 90NDC 0006-0221-28 unit dose blister packages of 100.No. 6738 — Tablets JANUVIA, 50 mg, are light beige, round, film-coated tablets with "112" on one side. They are supplied as follows:NDC 0006-0112-31 unit-of-use bottles of 30NDC 0006-0112-54 unit-of-use bottles of 90NDC 0006-0112-28 unit dose blister packages of 100.No. 6739 — Tablets JANUVIA, 100 mg, are beige, round, film-coated tablets with "277" on one side. They are supplied as follows:NDC 0006-0277-31 unit-of-use bottles of 30NDC 0006-0277-54 unit-of-use bottles of 90NDC 0006-0277-02 unit-of-use blister calendar package of 30NDC 0006-0277-33 unit-of-use blister calendar package of 30NDC 0006-0277-28 unit dose blister packages of 100NDC 0006-0277-82 bottles of 1000.No. 6737 — Tablets JANUVIA, 25 mg, are pink, round, film-coated tablets with "221" on one side. They are supplied as follows:NDC 0006-0221-31 unit-of-use bottles of 30NDC 0006-0221-54 unit-of-use bottles of 90NDC 0006-0221-28 unit dose blister packages of 100.No. 6738 — Tablets JANUVIA, 50 mg, are light beige, round, film-coated tablets with "112" on one side. They are supplied as follows:NDC 0006-0112-31 unit-of-use bottles of 30NDC 0006-0112-54 unit-of-use bottles of 90NDC 0006-0112-28 unit dose blister packages of 100.No. 6739 — Tablets JANUVIA, 100 mg, are beige, round, film-coated tablets with "277" on one side. They are supplied as follows:NDC 0006-0277-31 unit-of-use bottles of 30NDC 0006-0277-54 unit-of-use bottles of 90NDC 0006-0277-02 unit-of-use blister calendar package of 30NDC 0006-0277-33 unit-of-use blister calendar package of 30NDC 0006-0277-28 unit dose blister packages of 100NDC 0006-0277-82 bottles of 1000.No. 6737 — Tablets JANUVIA, 25 mg, are pink, round, film-coated tablets with "221" on one side. They are supplied as follows:NDC 0006-0221-31 unit-of-use bottles of 30NDC 0006-0221-54 unit-of-use bottles of 90NDC 0006-0221-28 unit dose blister packages of 100.No. 6738 — Tablets JANUVIA, 50 mg, are light beige, round, film-coated tablets with "112" on one side. They are supplied as follows:NDC 0006-0112-31 unit-of-use bottles of 30NDC 0006-0112-54 unit-of-use bottles of 90NDC 0006-0112-28 unit dose blister packages of 100.No. 6739 — Tablets JANUVIA, 100 mg, are beige, round, film-coated tablets with "277" on one side. They are supplied as follows:NDC 0006-0277-31 unit-of-use bottles of 30NDC 0006-0277-54 unit-of-use bottles of 90NDC 0006-0277-02 unit-of-use blister calendar package of 30NDC 0006-0277-33 unit-of-use blister calendar package of 30NDC 0006-0277-28 unit dose blister packages of 100NDC 0006-0277-82 bottles of 1000.No. 6737 — Tablets JANUVIA, 25 mg, are pink, round, film-coated tablets with "221" on one side. They are supplied as follows:NDC 0006-0221-31 unit-of-use bottles of 30NDC 0006-0221-54 unit-of-use bottles of 90NDC 0006-0221-28 unit dose blister packages of 100.No. 6738 — Tablets JANUVIA, 50 mg, are light beige, round, film-coated tablets with "112" on one side. They are supplied as follows:NDC 0006-0112-31 unit-of-use bottles of 30NDC 0006-0112-54 unit-of-use bottles of 90NDC 0006-0112-28 unit dose blister packages of 100.No. 6739 — Tablets JANUVIA, 100 mg, are beige, round, film-coated tablets with "277" on one side. They are supplied as follows:NDC 0006-0277-31 unit-of-use bottles of 30NDC 0006-0277-54 unit-of-use bottles of 90NDC 0006-0277-02 unit-of-use blister calendar package of 30NDC 0006-0277-33 unit-of-use blister calendar package of 30NDC 0006-0277-28 unit dose blister packages of 100NDC 0006-0277-82 bottles of 1000.No. 6737 — Tablets JANUVIA, 25 mg, are pink, round, film-coated tablets with "221" on one side. They are supplied as follows:NDC 0006-0221-31 unit-of-use bottles of 30NDC 0006-0221-54 unit-of-use bottles of 90NDC 0006-0221-28 unit dose blister packages of 100.No. 6738 — Tablets JANUVIA, 50 mg, are light beige, round, film-coated tablets with "112" on one side. They are supplied as follows:NDC 0006-0112-31 unit-of-use bottles of 30NDC 0006-0112-54 unit-of-use bottles of 90NDC 0006-0112-28 unit dose blister packages of 100.No. 6739 — Tablets JANUVIA, 100 mg, are beige, round, film-coated tablets with "277" on one side. They are supplied as follows:NDC 0006-0277-31 unit-of-use bottles of 30NDC 0006-0277-54 unit-of-use bottles of 90NDC 0006-0277-02 unit-of-use blister calendar package of 30NDC 0006-0277-33 unit-of-use blister calendar package of 30NDC 0006-0277-28 unit dose blister packages of 100NDC 0006-0277-82 bottles of 1000.No. 6737 — Tablets JANUVIA, 25 mg, are pink, round, film-coated tablets with "221" on one side. They are supplied as follows:NDC 0006-0221-31 unit-of-use bottles of 30NDC 0006-0221-54 unit-of-use bottles of 90NDC 0006-0221-28 unit dose blister packages of 100.No. 6738 — Tablets JANUVIA, 50 mg, are light beige, round, film-coated tablets with "112" on one side. They are supplied as follows:NDC 0006-0112-31 unit-of-use bottles of 30NDC 0006-0112-54 unit-of-use bottles of 90NDC 0006-0112-28 unit dose blister packages of 100.No. 6739 — Tablets JANUVIA, 100 mg, are beige, round, film-coated tablets with "277" on one side. They are supplied as follows:NDC 0006-0277-31 unit-of-use bottles of 30NDC 0006-0277-54 unit-of-use bottles of 90NDC 0006-0277-02 unit-of-use blister calendar package of 30NDC 0006-0277-33 unit-of-use blister calendar package of 30NDC 0006-0277-28 unit dose blister packages of 100NDC 0006-0277-82 bottles of 1000.No. 6737 — Tablets JANUVIA, 25 mg, are pink, round, film-coated tablets with "221" on one side. They are supplied as follows:NDC 0006-0221-31 unit-of-use bottles of 30NDC 0006-0221-54 unit-of-use bottles of 90NDC 0006-0221-28 unit dose blister packages of 100.No. 6738 — Tablets JANUVIA, 50 mg, are light beige, round, film-coated tablets with "112" on one side. They are supplied as follows:NDC 0006-0112-31 unit-of-use bottles of 30NDC 0006-0112-54 unit-of-use bottles of 90NDC 0006-0112-28 unit dose blister packages of 100.No. 6739 — Tablets JANUVIA, 100 mg, are beige, round, film-coated tablets with "277" on one side. They are supplied as follows:NDC 0006-0277-31 unit-of-use bottles of 30NDC 0006-0277-54 unit-of-use bottles of 90NDC 0006-0277-02 unit-of-use blister calendar package of 30NDC 0006-0277-33 unit-of-use blister calendar package of 30NDC 0006-0277-28 unit dose blister packages of 100NDC 0006-0277-82 bottles of 1000.No. 6737 — Tablets JANUVIA, 25 mg, are pink, round, film-coated tablets with "221" on one side. They are supplied as follows:NDC 0006-0221-31 unit-of-use bottles of 30NDC 0006-0221-54 unit-of-use bottles of 90NDC 0006-0221-28 unit dose blister packages of 100.No. 6738 — Tablets JANUVIA, 50 mg, are light beige, round, film-coated tablets with "112" on one side. They are supplied as follows:NDC 0006-0112-31 unit-of-use bottles of 30NDC 0006-0112-54 unit-of-use bottles of 90NDC 0006-0112-28 unit dose blister packages of 100.No. 6739 — Tablets JANUVIA, 100 mg, are beige, round, film-coated tablets with "277" on one side. They are supplied as follows:NDC 0006-0277-31 unit-of-use bottles of 30NDC 0006-0277-54 unit-of-use bottles of 90NDC 0006-0277-02 unit-of-use blister calendar package of 30NDC 0006-0277-33 unit-of-use blister calendar package of 30NDC 0006-0277-28 unit dose blister packages of 100NDC 0006-0277-82 bottles of 1000.No. 6737 — Tablets JANUVIA, 25 mg, are pink, round, film-coated tablets with "221" on one side. They are supplied as follows:NDC 0006-0221-31 unit-of-use bottles of 30NDC 0006-0221-54 unit-of-use bottles of 90NDC 0006-0221-28 unit dose blister packages of 100.No. 6738 — Tablets JANUVIA, 50 mg, are light beige, round, film-coated tablets with "112" on one side. They are supplied as follows:NDC 0006-0112-31 unit-of-use bottles of 30NDC 0006-0112-54 unit-of-use bottles of 90NDC 0006-0112-28 unit dose blister packages of 100.No. 6739 — Tablets JANUVIA, 100 mg, are beige, round, film-coated tablets with "277" on one side. They are supplied as follows:NDC 0006-0277-31 unit-of-use bottles of 30NDC 0006-0277-54 unit-of-use bottles of 90NDC 0006-0277-02 unit-of-use blister calendar package of 30NDC 0006-0277-33 unit-of-use blister calendar package of 30NDC 0006-0277-28 unit dose blister packages of 100NDC 0006-0277-82 bottles of 1000.No. 6737 — Tablets JANUVIA, 25 mg, are pink, round, film-coated tablets with "221" on one side. They are supplied as follows:NDC 0006-0221-31 unit-of-use bottles of 30NDC 0006-0221-54 unit-of-use bottles of 90NDC 0006-0221-28 unit dose blister packages of 100.No. 6738 — Tablets JANUVIA, 50 mg, are light beige, round, film-coated tablets with "112" on one side. They are supplied as follows:NDC 0006-0112-31 unit-of-use bottles of 30NDC 0006-0112-54 unit-of-use bottles of 90NDC 0006-0112-28 unit dose blister packages of 100.No. 6739 — Tablets JANUVIA, 100 mg, are beige, round, film-coated tablets with "277" on one side. They are supplied as follows:NDC 0006-0277-31 unit-of-use bottles of 30NDC 0006-0277-54 unit-of-use bottles of 90NDC 0006-0277-02 unit-of-use blister calendar package of 30NDC 0006-0277-33 unit-of-use blister calendar package of 30NDC 0006-0277-28 unit dose blister packages of 100NDC 0006-0277-82 bottles of 1000.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Sitagliptin is a DPP-4 inhibitor, which is believed to exert its actions in patients with type 2 diabetes mellitus by slowing the inactivation of incretin hormones. Concentrations of the active intact hormones are increased by sitagliptin, thereby increasing and prolonging the action of these hormones. Incretin hormones, including glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), are released by the intestine throughout the day, and levels are increased in response to a meal. These hormones are rapidly inactivated by the enzyme, DPP-4. The incretins are part of an endogenous system involved in the physiologic regulation of glucose homeostasis. When blood glucose concentrations are normal or elevated, GLP-1 and GIP increase insulin synthesis and release from pancreatic beta cells by intracellular signaling pathways involving cyclic AMP. GLP-1 also lowers glucagon secretion from pancreatic alpha cells, leading to reduced hepatic glucose production. By increasing and prolonging active incretin levels, sitagliptin increases insulin release and decreases glucagon levels in the circulation in a glucose-dependent manner. Sitagliptin demonstrates selectivity for DPP-4 and does not inhibit DPP-8 or DPP-9 activity at concentrations approximating those from therapeutic doses.

Non-Clinical Toxicology
History of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema.

There have been postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, in patients taking JANUVIA. After initiation of JANUVIA, patients should be observed carefully for signs and symptoms of pancreatitis. If pancreatitis is suspected, JANUVIA should promptly be discontinued and appropriate management should be initiated. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using JANUVIA.

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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

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).