Sitagliptin 50 mg and metformin 500 mg

Boxed Warning Lactic acidosis: 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/L), 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 (eg, carbonic anhydrase inhibitors such as topiramate), age ≥65 years, having a radiological study with contrast, surgery and other procedures, hypoxic states (eg, 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 sitagliptin/metformin and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended. Dosage Forms Excipient information presented when available (limited, particularly for generics); consult specific product labeling. Tablet, oral: Janumet 50/500: Sitagli...

Rarely, too much metformin can build up in the body and cause a serious (sometimes fatal) condition called lactic acidosis. Lactic acidosis is more likely if you are an older adult, if you have kidney or liver disease, dehydration, heart failure, heavy alcohol use, if you have surgery, if you have X-ray or scanning procedures that use iodinated contrast, or if you are using certain drugs. For some conditions, your doctor may tell you to stop taking this medication for a short time. Ask your doctor or pharmacist for more details. Stop taking this medication and get medical help right away if you have any symptoms of lactic acidosis, such as unusual tiredness, dizziness, severe drowsiness, chills, blue/cold skin, muscle pain, fast/difficult breathing, slow/irregular heartbeat, or stomach pain with nausea/vomiting/diarrhea. Uses This combination medication is used with a proper diet and exercise program and possibly with other medications to control high blood sugar. It is used in patients with type 2 diabetes. This product contains 2 medications. Sitagliptin works by increasing levels of natural substances called incretins. Incretins help to control blood sugar by increasing insulin release, especially after a meal. They also decrease the amount of sugar your liver makes. Metformin works by helping to restore your body's proper response to the insulin you naturally produce. It also decreases the amount of sugar that your liver makes and that your stomach/intestines absorb. C...

Janumet and Janumet XR are brand-name prescription drugs. They’re FDA-approved for use in adults with Janumet and Janumet XR have limitations of use. For more information, see the “ Drug details Janumet and Janumet XR contain the active ingredients Janumet vs. Janumet XR Janumet and Janumet XR come as oral tablets. They differ in the way they release the active drug: • Janumet is an immediate-release (IR) medication. This means the tablet is fast-acting and releases the drug into your body right away. • Janumet XR is an extended-release (ER) medication. This means the tablet is long-acting and releases the drug slowly into your body over time. Janumet is usually taken twice daily, while Janumet XR is typically taken once daily. Each drug is available in different strengths. Janumet comes in two strengths: • 50 milligrams (mg) sitagliptin/500 mg metformin • 50 mg sitagliptin/1,000 mg metformin Janumet XR is available in three strengths: • 50 mg sitagliptin/500 mg metformin • 50 mg sitagliptin/1,000 mg metformin • 100 mg sitagliptin/1,000 mg metformin Effectiveness For information about the effectiveness of Janumet and Janumet XR, see the “ Janumet and Janumet XR contain the active ingredients Sitagliptin and metformin are available separately as generic medications. However, they aren’t available together as a combination generic drug. A generic drug is an exact copy of the active ingredient in a brand-name medication. Generics usually cost less than brand-name drugs. Janum...

What Is Januvia? Januvia ( What Are Side Effects of Januvia? Many people using Januvia do not have serious side effects. Side effects that may occur with Januvia include: • runny or • • headache, • • joint or muscle pain, • nausea, • stomach pain, • diarrhea, or • constipation. Although Januvia by itself usually does not cause low blood sugar ( Tell your doctor if you have serious side effects of Januvia including Seek medical care or call 911 at once if you have the following serious side effects: • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights; • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out; • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors. This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects. Dosage for Januvia The recommended dose of Januvia is 100 mg once daily. What Drugs, Substances, or Supplements Interact with Januvia? Januvia may interact with Januvia During Pregnancy and Breastfeeding During pregnancy Januvia should be used only when prescribed. Pregnancy may cause or worsen diabetes. Your doctor may change your diabetes ...

Tablets not shown at actual size. JANUMET XR is also available as 50/500 mg, 2 tablets once daily. Recommended Dosing • Take JANUMET XR orally once daily with a meal. Patients taking two JANUMET XR tablets should take the two tablets together once daily. • Individualize the dosage of JANUMET XR on the basis of the patient’s current regimen, effectiveness, and tolerability. • The maximum recommended daily dose is 100 mg of sitagliptin and 2000 mg of metformin hydrochloride (HCl) extended-release. • The recommended starting dose in patients not currently treated with metformin is 100 mg sitagliptin and 1000 mg metformin HCl extended-release once 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 100 mg sitagliptin and the previously prescribed dose of metformin. • For patients taking metformin HCl immediate-release 850 mg twice daily or 1000 mg twice daily, the recommended starting dose of JANUMET XR is two 50 mg sitagliptin and 1000 mg metformin HCl extended-release tablets taken together once daily. • Maintain the same total daily dose of sitagliptin and metformin when changing between JANUMET (sitagliptin and metformin HCl immediate-release) and JANUMET XR. • Do not split, crush or chew JANUMET XR tablets. Recommendations for Use in Renal Impairment • Assess renal function prior to initiation of JANUMET XR and periodically thereafte...

Janumet Generic name: met-FOR-min-and-SI-ta-glip-tin] Brand names: Janumet, Drug class: Medically reviewed by • • • • • • • What is Janumet? Janumet contains a combination of metformin and sitagliptin. Metformin and sitagliptin are Metformin works by decreasing glucose (sugar) production in the liver and decreasing absorption of glucose by the intestines. Sitagliptin works by regulating the levels of insulin your body produces after eating. Janumet is used together with diet and exercise to improve blood sugar control in adults with Janumet is not used to treat type 1 diabetes. Warnings You should not use Janumet if you have severe kidney disease or diabetic ketoacidosis (call your doctor for treatment with insulin). Janumet may cause a serious condition called lactic acidosis. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired. Janumet may also lead to a serious condition called pancreatitis. Call your doctor right away if you have severe stomach pains with or without vomiting. Before taking this medicine You should not use Janumet if you are allergic to metformin or sitagliptin (Januvia), or if you have severe kidney disease. To make sure Janumet is safe for you, tell your doctor if you have ever had: • kidney disease (your kidney function may need to be checked befo...

Janumet and Janumet XR are brand-name prescription drugs. They’re FDA-approved for use in adults with Janumet and Janumet XR have limitations of use. For more information, see the “ Drug details Janumet and Janumet XR contain the active ingredients Janumet vs. Janumet XR Janumet and Janumet XR come as oral tablets. They differ in the way they release the active drug: • Janumet is an immediate-release (IR) medication. This means the tablet is fast-acting and releases the drug into your body right away. • Janumet XR is an extended-release (ER) medication. This means the tablet is long-acting and releases the drug slowly into your body over time. Janumet is usually taken twice daily, while Janumet XR is typically taken once daily. Each drug is available in different strengths. Janumet comes in two strengths: • 50 milligrams (mg) sitagliptin/500 mg metformin • 50 mg sitagliptin/1,000 mg metformin Janumet XR is available in three strengths: • 50 mg sitagliptin/500 mg metformin • 50 mg sitagliptin/1,000 mg metformin • 100 mg sitagliptin/1,000 mg metformin Effectiveness For information about the effectiveness of Janumet and Janumet XR, see the “ Janumet and Janumet XR contain the active ingredients Sitagliptin and metformin are available separately as generic medications. However, they aren’t available together as a combination generic drug. A generic drug is an exact copy of the active ingredient in a brand-name medication. Generics usually cost less than brand-name drugs. Janum...

Janumet Generic name: met-FOR-min-and-SI-ta-glip-tin] Brand names: Janumet, Drug class: Medically reviewed by • • • • • • • What is Janumet? Janumet contains a combination of metformin and sitagliptin. Metformin and sitagliptin are Metformin works by decreasing glucose (sugar) production in the liver and decreasing absorption of glucose by the intestines. Sitagliptin works by regulating the levels of insulin your body produces after eating. Janumet is used together with diet and exercise to improve blood sugar control in adults with Janumet is not used to treat type 1 diabetes. Warnings You should not use Janumet if you have severe kidney disease or diabetic ketoacidosis (call your doctor for treatment with insulin). Janumet may cause a serious condition called lactic acidosis. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired. Janumet may also lead to a serious condition called pancreatitis. Call your doctor right away if you have severe stomach pains with or without vomiting. Before taking this medicine You should not use Janumet if you are allergic to metformin or sitagliptin (Januvia), or if you have severe kidney disease. To make sure Janumet is safe for you, tell your doctor if you have ever had: • kidney disease (your kidney function may need to be checked befo...

Tablets not shown at actual size. JANUMET XR is also available as 50/500 mg, 2 tablets once daily. Recommended Dosing • Take JANUMET XR orally once daily with a meal. Patients taking two JANUMET XR tablets should take the two tablets together once daily. • Individualize the dosage of JANUMET XR on the basis of the patient’s current regimen, effectiveness, and tolerability. • The maximum recommended daily dose is 100 mg of sitagliptin and 2000 mg of metformin hydrochloride (HCl) extended-release. • The recommended starting dose in patients not currently treated with metformin is 100 mg sitagliptin and 1000 mg metformin HCl extended-release once 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 100 mg sitagliptin and the previously prescribed dose of metformin. • For patients taking metformin HCl immediate-release 850 mg twice daily or 1000 mg twice daily, the recommended starting dose of JANUMET XR is two 50 mg sitagliptin and 1000 mg metformin HCl extended-release tablets taken together once daily. • Maintain the same total daily dose of sitagliptin and metformin when changing between JANUMET (sitagliptin and metformin HCl immediate-release) and JANUMET XR. • Do not split, crush or chew JANUMET XR tablets. Recommendations for Use in Renal Impairment • Assess renal function prior to initiation of JANUMET XR and periodically thereafte...

Boxed Warning Lactic acidosis: 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/L), 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 (eg, carbonic anhydrase inhibitors such as topiramate), age ≥65 years, having a radiological study with contrast, surgery and other procedures, hypoxic states (eg, 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 sitagliptin/metformin and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended. Dosage Forms Excipient information presented when available (limited, particularly for generics); consult specific product labeling. Tablet, oral: Janumet 50/500: Sitagli...