Pioglitazone + Glimepiride

Indications & Dose:

To improve glycernic control in the following patients with type-2 diabetes. Those who are already on combination therapy with pioglitazone & a sulfonylurea.

Those whose diabetes is not adequately controlled with a sulfonylurea alone. Those who have initially responded to pioglitazone alone and require additional glycernic control.

• BY MOUTH

Therapy in Patients inadequately controlled on Glimpepiride Monotherapy:

Therapy should be started with 15mg/2mg, 30mg/ 2mg or 30mg/4mg tablet once daily followed by titration to reach the required dose.

3)  Dosage Guideline for Starting Therapy in Patients inadequately Controlled on Pioglitazone monotherapy:   

• Therapy should be started with 15mg/2mg, 30mg/ 2mg tablet once daily followed by titration to reach the required dose.

4) Dosage Guideline for Starting Therapy in Patients on Separate Tablets of Pioglitazone & Glimepiride: 

• Therapy should be started with 15mg/2mg, 30mg/ 2mg or 30mg/4mg tablet once daily as per the dose of each already being taken.

5)  Dosage Guideline for Patients on Other Sulfonylurea Monotherapy or switching from Combination

• Therapy of Pioglitazone Plus other sulfonylurea.  Therapy should be started with 15mg/2mg or 30 mg /2 mg once daily followed by titration to reach the required dose.

6)  Special Patient Populations: 

•  Not recommended in pregnancy, nursing mothers or children. 

Contraindications:

Known hypersensitivity to pioglitazone, glimepiride or any other component of the product. Diabetic ketaacidosis, with or without coma 

Side Effects:

Cardiovascular: Combined edema/peripheral edema

CNS: Headache

EENT: Pharyngitis

GI: Diarrhea  : nausea, tooth disorder

Genitourinary: UTI

Hepatic: Hepatic enzyme elevations, hepatitis (postmarketing).

Metabolic-Nutritional: Hypoglycemia : weight gain.

Musculoskeletal: Myalgia, pain in limb.

Respiratory: Upper respiratory tract infection.

Miscellaneous: Lower limb edema

Cautions:

Precautions:

General: Ploglitazone should be cautiously used in patients with congestive cardiac failure (CCF) and in those at the risk of developing CCF. Concomitant administration with other hypoglycemic agents and insulin might lead to hypoglycemia.

Should be used with cautions in patients with edema.

All sulfonylurea drugs might cause serve hypoglycemia, particularly in patients with renal dysfunction, debilitated or mainourished patients, and those with adrenal, pituitary, or hepatic insufficiency. Hence dose should be titrated in these patients.

Carcinogenesis, mutagenesis & impairment of fertility:

In doses approx. 14 times the human dose resulted in urinary bladder tumors.

Use in pregnancy: Hence the combination should be used with used with caution in nursing mothers only if benefit outweighs risk.

Use in nursing mothers: Hence the combination should be used with used with caution in nursing mothers only if benefit outweighs risk.

Use in geriatric patients: Should be given with caution in old age patients.

Use in hepatic Impairment: Should be given under strict observation with periodic monitoring of ALT levels.

Interaction:

Warnings:

Adverse Effects:

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Patient And Carer Advice: