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Piompride

Anti-diabetics
Product

Piompride 30 mg /4 mg

Active

30 mg pioglitazone plus 4 mg glimepiride tablet

Category
Anti-diabetics
Indication

Piompride is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a thiazolidinedione and sulfonylurea or who have inadequate glycemic control on a thiazolidinedione alone or a sulfonylurea alone.

Important Limitations of Use

Pioglitazone exerts its antihyperglycemic effect only in the presence of endogenous insulin. Piompride should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings.

Use caution in patients with liver disease.

Dose
Posology and method of administration
Recommendations for All Patients

Piompride should be taken once daily with the first main meal.

Piompride tablets are available as a 30 mg pioglitazone plus 4 mg glimepiride tablet. If therapy with a combination tablet containing pioglitazone and glimepiride is considered appropriate the recommended starting dose is:

30mg/4 mg once daily and gradually titrated, as needed, after assessing adequacy of therapeutic response and tolerability,

For patients inadequately controlled on glimepiride monotherapy: 30 mg/4 mg once daily and gradually titrated, as needed, after assessing adequacy of therapeutic response and tolerability,

for patients who are changing from combination therapy of pioglitazone plus glimepiride as separate tablets: Piompride should be taken at doses that are as close as possible to the dose of pioglitazone and glimepiride already being taken,

for patients currently on a different sulfonylurea monotherapy or switching from combination therapy of pioglitazone plus a different sulfonylurea (e.g., glyburide, glipizide, chlorpropamide, tolbutamide, acetohexamide): 30 mg/2 mg once daily and adjusted after assessing adequacy of therapeutic response. Observe for hypoglycemia for one to two weeks due to the potential overlapping drug effect.

for patients with systolic dysfunction, the lowest approved dose of Piompride should be prescribed only after titration from 15 mg to 30 mg of pioglitazone has been safely tolerated.

After initiation of Piompride or with dose increase, monitor patients carefully for hypoglycemia and adverse reactions related to fluid retention such as weight gain, edema, and signs and symptoms of congestive heart failure

Liver tests (serum alanine and aspartate aminotransferases, alkaline phosphatase, and total bilirubin) should be obtained prior to initiating Piompride. Routine periodic monitoring of liver tests during treatment with Piompride is not recommended in patients without liver disease. Patients who have liver test abnormalities prior to initiation of Piompride or who are found to have abnormal liver tests while taking Piompride should be managed as described under Warnings and Precautions

2- Concomitant Use with an Insulin Secretagogue or Insulin

If hypoglycemia occurs in a patient coadministered Piompride and an insulin secretagogue, the dose of the insulin secretagogue should be reduced.

If hypoglycemia occurs in a patient coadministered Piompride and insulin, the dose of insulin should be decreased by 10% to 25%. Further adjustments to the insulin dose should be individualized based on glycemic response.

3- Concomitant Use with Strong CYP2C8 Inhibitors

Coadministration of pioglitazone and gemfibrozil, a strong CYP2C8 inhibitor, increases pioglitazone exposure approximately 3-fold. Therefore, the maximum recommended dose of pioglitazone is 15 mg daily when used in combination with gemfibrozil or other strong CYP2C8 inhibitors. If gemfibrozil or other CYP2C8 inhibitors need to co-administered, patients should switch to individual components of Piompride because the minimum dose of pioglitazone in Piompride exceeds 15 mg

4-Concomitant Use with Colesevelam

When colesevelam is coadministered with glimepiride, maximum plasma concentration and total exposure to glimepiride is reduced. Therefore, Piompride should be administered at least four hours prior to colesevelam