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JANUMET

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Overview

What is JANUMET?

JANUMET (sitagliptin and metformin HCl) tablets contain two oral antihyperglycemic drugs used in the management of type 2 diabetes: sitagliptin and metformin hydrochloride.



What does JANUMET look like?



What are the available doses of JANUMET?

Tablets: 50 mg sitagliptin/500 mg metformin HCl and 50 mg sitagliptin/1000 mg metformin HCl ()

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

How should I use JANUMET?

JANUMET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate.

Important Limitations of Use

JANUMET should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

JANUMET has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using JANUMET.

The dosage of JANUMET should be individualized on the basis of the patient's current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100 mg sitagliptin and 2000 mg metformin. Initial combination therapy or maintenance of combination therapy should be individualized and left to the discretion of the health care provider.

JANUMET should generally be given twice daily with meals, with gradual dose escalation, to reduce the gastrointestinal (GI) side effects due to metformin. JANUMET must not be split or divided before swallowing.

The starting dose of JANUMET should be based on the patient's current regimen. JANUMET should be given twice daily with meals. The following doses are available:

50 mg sitagliptin/500 mg metformin hydrochloride

50 mg sitagliptin/1000 mg metformin hydrochloride.

The recommended starting dose in patients not currently treated with metformin is 50 mg sitagliptin/500 mg metformin hydrochloride twice daily, with gradual dose escalation recommended to reduce gastrointestinal side effects associated with metformin.

The starting dose in patients already treated with metformin should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and the dose of metformin already being taken. For patients taking metformin 850 mg twice daily, the recommended starting dose of JANUMET is 50 mg sitagliptin/1000 mg metformin hydrochloride twice daily.

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


What interacts with JANUMET?

Sorry No Records found


What are the warnings of JANUMET?

Sorry No Records found


What are the precautions of JANUMET?

Sorry No Records found


What are the side effects of JANUMET?

Sorry No records found


What should I look out for while using JANUMET?

JANUMET (sitagliptin and metformin HCl) 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 JANUMET and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended.


What might happen if I take too much JANUMET?


How should I store and handle JANUMET?

Storage and StabilitySIMPONI ARIA must be refrigerated at 2º C to 8º C (36º F to 46º F) and protected from light. Keep the product in the original carton to protect from light until the time of use. Do not freeze. Do not shake.Storage and StabilitySIMPONI ARIA must be refrigerated at 2º C to 8º C (36º F to 46º F) and protected from light. Keep the product in the original carton to protect from light until the time of use. Do not freeze. Do not shake.No. 6747 — Tablets JANUMET, 50 mg/500 mg, are light pink, capsule-shaped, film-coated tablets with "575" debossed on one side. They are supplied as follows:NDC 0006-0575-61 unit-of-use bottles of 60NDC 0006-0575-62 unit-of-use bottles of 180NDC 0006-0575-82 bulk bottles of 1000.No. 6749 — Tablets JANUMET, 50 mg/1000 mg, are red, capsule-shaped, film-coated tablets with "577" debossed on one side. They are supplied as follows:NDC 0006-0577-61 unit-of-use bottles of 60NDC 0006-0577-62 unit-of-use bottles of 180NDC 0006-0577-82 bulk bottles of 1000.No. 6747 — Tablets JANUMET, 50 mg/500 mg, are light pink, capsule-shaped, film-coated tablets with "575" debossed on one side. They are supplied as follows:NDC 0006-0575-61 unit-of-use bottles of 60NDC 0006-0575-62 unit-of-use bottles of 180NDC 0006-0575-82 bulk bottles of 1000.No. 6749 — Tablets JANUMET, 50 mg/1000 mg, are red, capsule-shaped, film-coated tablets with "577" debossed on one side. They are supplied as follows:NDC 0006-0577-61 unit-of-use bottles of 60NDC 0006-0577-62 unit-of-use bottles of 180NDC 0006-0577-82 bulk bottles of 1000.No. 6747 — Tablets JANUMET, 50 mg/500 mg, are light pink, capsule-shaped, film-coated tablets with "575" debossed on one side. They are supplied as follows:NDC 0006-0575-61 unit-of-use bottles of 60NDC 0006-0575-62 unit-of-use bottles of 180NDC 0006-0575-82 bulk bottles of 1000.No. 6749 — Tablets JANUMET, 50 mg/1000 mg, are red, capsule-shaped, film-coated tablets with "577" debossed on one side. They are supplied as follows:NDC 0006-0577-61 unit-of-use bottles of 60NDC 0006-0577-62 unit-of-use bottles of 180NDC 0006-0577-82 bulk bottles of 1000.No. 6747 — Tablets JANUMET, 50 mg/500 mg, are light pink, capsule-shaped, film-coated tablets with "575" debossed on one side. They are supplied as follows:NDC 0006-0575-61 unit-of-use bottles of 60NDC 0006-0575-62 unit-of-use bottles of 180NDC 0006-0575-82 bulk bottles of 1000.No. 6749 — Tablets JANUMET, 50 mg/1000 mg, are red, capsule-shaped, film-coated tablets with "577" debossed on one side. They are supplied as follows:NDC 0006-0577-61 unit-of-use bottles of 60NDC 0006-0577-62 unit-of-use bottles of 180NDC 0006-0577-82 bulk bottles of 1000.No. 6747 — Tablets JANUMET, 50 mg/500 mg, are light pink, capsule-shaped, film-coated tablets with "575" debossed on one side. They are supplied as follows:NDC 0006-0575-61 unit-of-use bottles of 60NDC 0006-0575-62 unit-of-use bottles of 180NDC 0006-0575-82 bulk bottles of 1000.No. 6749 — Tablets JANUMET, 50 mg/1000 mg, are red, capsule-shaped, film-coated tablets with "577" debossed on one side. They are supplied as follows:NDC 0006-0577-61 unit-of-use bottles of 60NDC 0006-0577-62 unit-of-use bottles of 180NDC 0006-0577-82 bulk bottles of 1000.No. 6747 — Tablets JANUMET, 50 mg/500 mg, are light pink, capsule-shaped, film-coated tablets with "575" debossed on one side. They are supplied as follows:NDC 0006-0575-61 unit-of-use bottles of 60NDC 0006-0575-62 unit-of-use bottles of 180NDC 0006-0575-82 bulk bottles of 1000.No. 6749 — Tablets JANUMET, 50 mg/1000 mg, are red, capsule-shaped, film-coated tablets with "577" debossed on one side. They are supplied as follows:NDC 0006-0577-61 unit-of-use bottles of 60NDC 0006-0577-62 unit-of-use bottles of 180NDC 0006-0577-82 bulk bottles of 1000.No. 6747 — Tablets JANUMET, 50 mg/500 mg, are light pink, capsule-shaped, film-coated tablets with "575" debossed on one side. They are supplied as follows:NDC 0006-0575-61 unit-of-use bottles of 60NDC 0006-0575-62 unit-of-use bottles of 180NDC 0006-0575-82 bulk bottles of 1000.No. 6749 — Tablets JANUMET, 50 mg/1000 mg, are red, capsule-shaped, film-coated tablets with "577" debossed on one side. They are supplied as follows:NDC 0006-0577-61 unit-of-use bottles of 60NDC 0006-0577-62 unit-of-use bottles of 180NDC 0006-0577-82 bulk bottles of 1000.No. 6747 — Tablets JANUMET, 50 mg/500 mg, are light pink, capsule-shaped, film-coated tablets with "575" debossed on one side. They are supplied as follows:NDC 0006-0575-61 unit-of-use bottles of 60NDC 0006-0575-62 unit-of-use bottles of 180NDC 0006-0575-82 bulk bottles of 1000.No. 6749 — Tablets JANUMET, 50 mg/1000 mg, are red, capsule-shaped, film-coated tablets with "577" debossed on one side. They are supplied as follows:NDC 0006-0577-61 unit-of-use bottles of 60NDC 0006-0577-62 unit-of-use bottles of 180NDC 0006-0577-82 bulk bottles of 1000.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Non-Clinical Toxicology
JANUMET (sitagliptin and metformin HCl) 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 JANUMET and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended.

Nifedipine is mainly eliminated by metabolism and is a substrate of CYP3A. Inhibitors and inducers of CYP3A can impact the exposure to nifedipine and consequently its desirable and undesirable effects. and data indicate that nifedipine can inhibit the metabolism of drugs that are substrates of CYP3A, thereby increasing the exposure to other drugs. Nifedipine is a vasodilator, and coadministration of other drugs affecting blood pressure may result in pharmacodynamic interactions.

Lactic acidosis: See. ()

There have been postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. If pancreatitis is suspected, promptly discontinue JANUMET. ()

Heart failure has been observed with two other members of the DPP-4 inhibitor class. Consider risks and benefits of JANUMET in patients who have known risk factors for heart failure. Monitor patients for signs and symptoms. ()

There have been postmarketing reports of acute renal failure, sometimes requiring dialysis. Before initiating JANUMET and at least annually thereafter, assess renal function. ()

Vitamin Bdeficiency: Metformin may lower Vitamin Blevels. Measure hematologic parameters annually. ()

When used with an insulin secretagogue (e.g., sulfonylurea) or with insulin, a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia. ()

There have been postmarketing reports of serious allergic and hypersensitivity reactions in patients treated with sitagliptin (one of the components of JANUMET), such as anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. In such cases, promptly stop JANUMET, assess for other potential causes, institute appropriate monitoring and treatment, and initiate alternative treatment for diabetes. ()

Severe and disabling arthralgia has been reported in patients taking DPP-4 inhibitors. Consider as a possible cause for severe joint pain and discontinue drug if appropriate. ()

There have been postmarketing reports of bullous pemphigoid requiring hospitalization in patients taking DPP-4 inhibitors. Tell patients to report development of blisters or erosions. If bullous pemphigoid is suspected, discontinue JANUMET. ()

There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with JANUMET. ()

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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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