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Invokamet (Canagliflozin / Metformin Hydrochloride) - Summary

 
 



WARNING: LACTIC ACIDOSIS

  • Lactic acidosis is a rare but serious complication that can occur due to metformin accumulation. The risk increases with conditions such as renal impairment, sepsis, dehydration, excess alcohol intake, hepatic impairment, and acute congestive heart failure.
  • The onset is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress.
  • Laboratory abnormalities include low pH, increased anion gap, and elevated blood lactate.
  • If lactic acidosis is suspected, INVOKAMETâ„¢ should be discontinued and the patient hospitalized immediately [see Warnings and Precautions].
 

INVOKAMET SUMMARY

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

INVOKAMET (canagliflozin and metformin hydrochloride) 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 metformin or canagliflozin, or in patients who are already treated with both canagliflozin and metformin [see Clinical Studies].

Limitations of Use

INVOKAMET is not recommended in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.


See all Invokamet indications & dosage >>

NEWS HIGHLIGHTS

Clinical Trials Related to Invokamet (Canagliflozin / Metformin)

A Study to Assess the Bioequivalence of Fixed Dose Combination (FDC) Tablets of Canagliflozin and Metformin Immediate Release (IR) With Respect to the Individual Components of Canagliflozin and Metformin IR Tablets in Healthy Volunteers [Completed]
The purpose of this study is to evaluate the bioequivalence of a fixed dose combination (FDC) tablet of canagliflozin and metformin immediate release (IR) in comparison with the individual components of canagliflozin and metformin IR.

A Study to Assess the Bioequivalence of 2 Fixed Dose Combination (FDC) Tablets of Canagliflozin and Metformin Immediate Release (IR) (150 mg/850 mg) With Respect to the Individual Components of Canagliflozin (1 x 300 mg) and Metformin IR Tablets (2 x 850 mg) in Healthy Volunteers [Completed]
The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC) tablets of canagliflozin and metformin immediate release (IR) in comparison with the individual components of canagliflozin and metformin IR.

A Study to Assess the Bioequivalence of 2 Fixed Dose Combination (FDC) Tablets of Canagliflozin and Metformin Immediate Release (IR) (50 mg/1,000 mg) With Respect to the Individual Components of Canagliflozin (1 x 100 mg) and Metformin IR Tablets (2 x 1,000 mg) in Healthy Volunteers [Completed]
The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC) tablets of canagliflozin and metformin immediate release (IR) in comparison with the individual components of canagliflozin and metformin IR.

Bioequivalence Study of Metformin Component of Canagliflozin and Metformin Fixed Dose Combination Immediate Release (IR) Tablet Comparing With Metformin IR Tablet Co-administered With Canagliflozin Tablet in Healthy Fed and Fasted Participants [Completed]
The purpose of this study to evaluate the bioequivalence (is the amount same in both the pills) of metformin component of the canagliflozin and metformin immediate release (IR) fixed dose combination (FDC) tablet compared with the metformin IR tablet co-administered with canagliflozin tablet in healthy fed and fasted participants.

Bioequivalence Study of Metformin Component of Fixed Dose Combination (FDC) Immediate Release (IR) Tablet of Canagliflozin and Metformin Compared to Metformin IR Tablet Co-administered With Canagliflozin in Healthy Fed and Fasted Participants [Completed]
The purpose of this study is to evaluate the bioequivalence of metformin component of the canagliflozin and metformin immediate release (IR) fixed dose combination (FDC) tablet compared with the metformin IR tablet co-administered with canagliflozin in healthy fed and fasted participants.

more trials >>


Page last updated: 2014-08-08

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