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SEGLUROMET

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Overview

What is SEGLUROMET?

SEGLUROMET (ertugliflozin and metformin hydrochloride) tablet for oral use contains ertugliflozin L-pyroglutamic acid, a SGLT2 inhibitor, and metformin hydrochloride, a member of the biguanide class.



What does SEGLUROMET look like?



What are the available doses of SEGLUROMET?

Tablets:

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

How should I use SEGLUROMET?

SEGLUROMET™ is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled on a regimen containing ertugliflozin or metformin, or in patients who are already treated with both ertugliflozin and metformin.

Individualize the starting dose based on the patient's current regimen. ()

Maximum recommended dose is 7.5 mg ertugliflozin/1,000 mg metformin twice daily. ()

Take twice daily with meals, with gradual dose escalation. ()

Assess renal function before initiating SEGLUROMET ():

SEGLUROMET may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures. ()


What interacts with SEGLUROMET?

Sorry No Records found


What are the warnings of SEGLUROMET?

Sorry No Records found


What are the precautions of SEGLUROMET?

Sorry No Records found


What are the side effects of SEGLUROMET?

Sorry No records found


What should I look out for while using SEGLUROMET?

Severe renal impairment, end stage renal disease, or dialysis. (,,)

Metabolic acidosis, including diabetic ketoacidosis. (,)

History of serious hypersensitivity reaction to ertugliflozin or metformin. ()

Post-marketing 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 SEGLUROMET and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended.


What might happen if I take too much SEGLUROMET?


How should I store and handle SEGLUROMET?

StorageStore Pantoprazole Sodium Delayed-Release Tablets, USP at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) []. StorageStore Pantoprazole Sodium Delayed-Release Tablets, USP at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) []. SEGLUROMET (ertugliflozin and metformin hydrochloride) tablets are available in the strengths listed below:ertugliflozin 2.5 mg and metformin hydrochloride 500 mg tablets are pink, oval, debossed with "2.5/500" on one side and plain on the other side. They are supplied as follows:NDC 0006-5369-03 unit-of-use bottles of 60NDC 0006-5369-06 unit-of-use bottles of 180NDC 0006-5369-07 bulk bottles of 500ertugliflozin 2.5 mg and metformin hydrochloride 1000 mg tablets are pink, oval, debossed with "2.5/1000" on one side and plain on the other side. They are supplied as follows:NDC 0006-5373-03 unit-of-use bottles of 60NDC 0006-5373-06 unit-of-use bottles of 180NDC 0006-5373-07 bulk bottles of 500ertugliflozin 7.5 mg and metformin hydrochloride 500 mg tablets are red, oval, debossed with "7.5/500" on one side and plain on the other side. They are supplied as follows:NDC 0006-5370-03 unit-of-use bottles of 60NDC 0006-5370-06 unit-of-use bottles of 180NDC 0006-5370-07 bulk bottles of 500ertugliflozin 7.5 mg and metformin hydrochloride 1000 mg tablets are red, oval, debossed with "7.5/1000" on one side and plain on the other side. They are supplied as follows:NDC 0006-5374-03 unit-of-use bottles of 60NDC 0006-5374-06 unit-of-use bottles of 180NDC 0006-5374-07 bulk bottles of 500SEGLUROMET (ertugliflozin and metformin hydrochloride) tablets are available in the strengths listed below:ertugliflozin 2.5 mg and metformin hydrochloride 500 mg tablets are pink, oval, debossed with "2.5/500" on one side and plain on the other side. They are supplied as follows:NDC 0006-5369-03 unit-of-use bottles of 60NDC 0006-5369-06 unit-of-use bottles of 180NDC 0006-5369-07 bulk bottles of 500ertugliflozin 2.5 mg and metformin hydrochloride 1000 mg tablets are pink, oval, debossed with "2.5/1000" on one side and plain on the other side. They are supplied as follows:NDC 0006-5373-03 unit-of-use bottles of 60NDC 0006-5373-06 unit-of-use bottles of 180NDC 0006-5373-07 bulk bottles of 500ertugliflozin 7.5 mg and metformin hydrochloride 500 mg tablets are red, oval, debossed with "7.5/500" on one side and plain on the other side. They are supplied as follows:NDC 0006-5370-03 unit-of-use bottles of 60NDC 0006-5370-06 unit-of-use bottles of 180NDC 0006-5370-07 bulk bottles of 500ertugliflozin 7.5 mg and metformin hydrochloride 1000 mg tablets are red, oval, debossed with "7.5/1000" on one side and plain on the other side. They are supplied as follows:NDC 0006-5374-03 unit-of-use bottles of 60NDC 0006-5374-06 unit-of-use bottles of 180NDC 0006-5374-07 bulk bottles of 500SEGLUROMET (ertugliflozin and metformin hydrochloride) tablets are available in the strengths listed below:ertugliflozin 2.5 mg and metformin hydrochloride 500 mg tablets are pink, oval, debossed with "2.5/500" on one side and plain on the other side. They are supplied as follows:NDC 0006-5369-03 unit-of-use bottles of 60NDC 0006-5369-06 unit-of-use bottles of 180NDC 0006-5369-07 bulk bottles of 500ertugliflozin 2.5 mg and metformin hydrochloride 1000 mg tablets are pink, oval, debossed with "2.5/1000" on one side and plain on the other side. They are supplied as follows:NDC 0006-5373-03 unit-of-use bottles of 60NDC 0006-5373-06 unit-of-use bottles of 180NDC 0006-5373-07 bulk bottles of 500ertugliflozin 7.5 mg and metformin hydrochloride 500 mg tablets are red, oval, debossed with "7.5/500" on one side and plain on the other side. They are supplied as follows:NDC 0006-5370-03 unit-of-use bottles of 60NDC 0006-5370-06 unit-of-use bottles of 180NDC 0006-5370-07 bulk bottles of 500ertugliflozin 7.5 mg and metformin hydrochloride 1000 mg tablets are red, oval, debossed with "7.5/1000" on one side and plain on the other side. They are supplied as follows:NDC 0006-5374-03 unit-of-use bottles of 60NDC 0006-5374-06 unit-of-use bottles of 180NDC 0006-5374-07 bulk bottles of 500SEGLUROMET (ertugliflozin and metformin hydrochloride) tablets are available in the strengths listed below:ertugliflozin 2.5 mg and metformin hydrochloride 500 mg tablets are pink, oval, debossed with "2.5/500" on one side and plain on the other side. They are supplied as follows:NDC 0006-5369-03 unit-of-use bottles of 60NDC 0006-5369-06 unit-of-use bottles of 180NDC 0006-5369-07 bulk bottles of 500ertugliflozin 2.5 mg and metformin hydrochloride 1000 mg tablets are pink, oval, debossed with "2.5/1000" on one side and plain on the other side. They are supplied as follows:NDC 0006-5373-03 unit-of-use bottles of 60NDC 0006-5373-06 unit-of-use bottles of 180NDC 0006-5373-07 bulk bottles of 500ertugliflozin 7.5 mg and metformin hydrochloride 500 mg tablets are red, oval, debossed with "7.5/500" on one side and plain on the other side. They are supplied as follows:NDC 0006-5370-03 unit-of-use bottles of 60NDC 0006-5370-06 unit-of-use bottles of 180NDC 0006-5370-07 bulk bottles of 500ertugliflozin 7.5 mg and metformin hydrochloride 1000 mg tablets are red, oval, debossed with "7.5/1000" on one side and plain on the other side. They are supplied as follows:NDC 0006-5374-03 unit-of-use bottles of 60NDC 0006-5374-06 unit-of-use bottles of 180NDC 0006-5374-07 bulk bottles of 500SEGLUROMET (ertugliflozin and metformin hydrochloride) tablets are available in the strengths listed below:ertugliflozin 2.5 mg and metformin hydrochloride 500 mg tablets are pink, oval, debossed with "2.5/500" on one side and plain on the other side. They are supplied as follows:NDC 0006-5369-03 unit-of-use bottles of 60NDC 0006-5369-06 unit-of-use bottles of 180NDC 0006-5369-07 bulk bottles of 500ertugliflozin 2.5 mg and metformin hydrochloride 1000 mg tablets are pink, oval, debossed with "2.5/1000" on one side and plain on the other side. They are supplied as follows:NDC 0006-5373-03 unit-of-use bottles of 60NDC 0006-5373-06 unit-of-use bottles of 180NDC 0006-5373-07 bulk bottles of 500ertugliflozin 7.5 mg and metformin hydrochloride 500 mg tablets are red, oval, debossed with "7.5/500" on one side and plain on the other side. They are supplied as follows:NDC 0006-5370-03 unit-of-use bottles of 60NDC 0006-5370-06 unit-of-use bottles of 180NDC 0006-5370-07 bulk bottles of 500ertugliflozin 7.5 mg and metformin hydrochloride 1000 mg tablets are red, oval, debossed with "7.5/1000" on one side and plain on the other side. They are supplied as follows:NDC 0006-5374-03 unit-of-use bottles of 60NDC 0006-5374-06 unit-of-use bottles of 180NDC 0006-5374-07 bulk bottles of 500


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Non-Clinical Toxicology
Severe renal impairment, end stage renal disease, or dialysis. (,,)

Metabolic acidosis, including diabetic ketoacidosis. (,)

History of serious hypersensitivity reaction to ertugliflozin or metformin. ()

Post-marketing 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 SEGLUROMET and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended.

Drug Interactions:

Drugs possessing beta-blocking properties can blunt the bronchodilator effect of beta-receptor agonist drugs in patients with bronchospasm; therefore, doses greater than the normal antiasthmatic dose of beta-agonist bronchodilator drugs may be required.

Cimetidine has been shown to increase the bioavailability of labetalol HCl. Since this could be explained either by enhanced absorption or by an alteration of hepatic metabolism of labetalol HCl, special care should be used in establishing the dose required for blood pressure control in such patients.

Synergism has been shown between halothane anesthesia and intravenously administered labetalol HCl. During controlled hypotensive anesthesia using labetalol HCl in association with halothane, high concentrations (3% or above) of halothane should not be used because the degree of hypotension will be increased and because of the possibility of a large reduction in cardiac output and an increase in central venous pressure. The anesthesiologist should be informed when a patient is receiving labetalol HCl.

Labetalol HCl blunts the reflex tachycardia produced by nitroglycerin without preventing its hypotensive effect. If labetalol HCl is used with nitroglycerin in patients with angina pectoris, additional antihypertensive effects may occur.

Care should be taken if labetalol is used concomitantly with calcium antagonists of the verapamil type.

Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.





There have been post-marketing cases of metformin-associated lactic acidosis, including fatal cases. These cases had a subtle onset and were accompanied by nonspecific symptoms such as malaise, myalgias, abdominal pain, respiratory distress, or increased somnolence; however, hypothermia, hypotension and resistant bradyarrhythmias have occurred with severe acidosis. Metformin-associated lactic acidosis was characterized by elevated blood lactate concentrations (>5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), and an increased lactate:pyruvate ratio; metformin plasma levels were generally >5 mcg/mL. Metformin decreases liver uptake of lactate increasing lactate blood levels which may increase the risk of lactic acidosis, especially in patients at risk.

If metformin-associated lactic acidosis is suspected, general supportive measures should be instituted promptly in a hospital setting, along with immediate discontinuation of SEGLUROMET. In SEGLUROMET-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 a clearance of up to 170 mL/minute 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 SEGLUROMET 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:

The following important adverse reactions are described elsewhere in the labeling:

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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

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Tips

Tips

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Interactions

Interactions

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