Glimepiride + Pioglitazone

Introduction: Glimepiride + Pioglitazone is a combination medicine used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

How it works: Pioglitazone, a thiazolidinedione, reduces blood glucose by improving target cell response to insulin without increasing pancreatic insulin secretion. Glimepiride, a sulfonylurea, stimulates insulin release from the pancreatic beta-cells and increases insulin sensitivity at peripheral target sites.

Important Information: Take with food. Take it regularly at the same time each day. Do not stop without consulting your doctor. Regular blood sugar and liver function tests are recommended.

• Type 2 diabetes mellitus - as an adjunct to diet and exercise
• Patients already treated with a combination of Pioglitazone and a sulfonylurea
• Patients whose diabetes is not adequately controlled with a sulfonylurea alone
• Patients who have initially responded to Pioglitazone alone and require additional glycemic control

Combination Oral hypoglycemic preparations

Sulfonylurea + Thiazolidinedione

Pioglitazone & Glimepiride combines two antihyperglycemic agents with different mechanisms of action to improve glycemic control in patients with type 2 diabetes. Pioglitazone, a member of the thiazolidinedione class, is an insulin-sensitizing agent that acts primarily by enhancing peripheral glucose utilization. It depends on the presence of insulin for its mechanism of action. The primary mechanism of action of Glimepiride in lowering blood glucose appears to be dependent on stimulating the release of insulin from functioning pancreatic beta cells.

Pioglitazone increases insulin sensitivity and Glimepiride stimulates insulin secretion to lower blood sugar levels.

Adult Dose:

• 30 mg/2 mg OR 30 mg/4 mg: 1 tab once daily, titrate gradually as needed
• Elderly: Start with glimepiride 1 mg/day prior to initiating combination
• Hepatic Impairment: ALT >2.5x ULN: Do not initiate

Renal Impairment (CrCl 22 mL/min): 30 mg/2 mg or 30 mg/4 mg once daily

* Use as directed by the registered physician

Oral tablet. Take with food (with the first main meal). Swallow whole, do not chew or crush.

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and follow your regular schedule. Do not double the dose.

Common Side Effects:

• Hypoglycemia (low blood sugar)
• Nausea
• Taste change
• Diarrhea
• Stomach pain
• Headache
• Edema (swelling)
• Weight gain
• Blurred vision
• Bone fracture
• Respiratory tract infection

Precautions:

• Hypoglycemia may occur - always carry sugary food or fruit juice.
• Avoid alcohol (increases hypoglycemia risk).
• Risk of edema and heart failure - caution required.
• Regular liver function tests (ALT monitoring) required.
• Not recommended in severe liver disease.

Contraindications:

• History of allergic reaction to sulfonamide derivative
• Established CHF (NYHA class III or IV)
• Type 1 diabetes or diabetic ketoacidosis

Drug Interactions:

• CYP2C8 inhibitors (gemfibrozil) and CYP2C9 inhibitors (fluconazole) increase plasma levels
• CYP2C8 inducers (rifampicin) decrease plasma levels
• Oral miconazole may cause severe hypoglycemia

Food Interactions:

• Unsafe to consume alcohol with Glimepiride + Pioglitazone.

Use in Pregnancy: May be unsafe during pregnancy. Animal studies have shown harmful effects.

Use in Lactation: Probably safe during breastfeeding. Monitor the breastfed baby's blood sugar.

Pediatric Use: Safety and efficacy in pediatric patients have not been established.

Geriatric Use: Start with glimepiride 1 mg/day. May be more sensitive to hypoglycemia.

Renal Impairment: CrCl 22 mL/min: 30 mg/2 mg or 30 mg/4 mg once daily. Not recommended in severe kidney disease.

Hepatic Impairment: ALT >2.5x ULN: Do not initiate. ALT >3x ULN or jaundice: Discontinue. Not recommended in severe liver disease.

Overdose: Severe hypoglycemia with coma, seizure. Administer glucagon or IV glucose. Hypoglycemia may recur - continue monitoring.

Storage: Store in a cool and dry place. Protect from light and moisture. Keep out of reach of children.

Glimepiride + Pioglitazone Tablet