Adult Dosing
Type II diabetes mellitus
Currently on glimepiride monotherapy
- Start 30 mg/2 mg or 30 mg/4 mg PO qd
- Adjust dose as per therapeutic response
Currently on pioglitazone monotherapy
- Start 30 mg/2 mg PO qd
- Adjust dose as per therapeutic response
Switching from combination therapy of pioglitazone plus glimepiride as separate tablets
- Start 30 mg/2 mg or 30 mg/4 mg PO qd
Switching from combination therapy of pioglitazone plus a different sulfonylurea or different sulfonylurea monotherapy
- Start 30 mg/2 mg PO qd
- Adjust dose as per therapeutic response
Notes- Maximum daily dose for pioglitazone 45 mg and glimepiride 8 mg
- Carefully monitor for hypoglycemia for 1-2 wks when switching to glimepiride/pioglitazone combination therapy
Pediatric Dosing
- Safety and efficacy in pediatric patients have not been established
[Outline]
See Supplemental Patient Information
- Based on the study conducted by University Group Diabetes Program (UGDP), oral hypoglycemic drugs increases the risk of cardiovascular mortality as compared to treatment with diet alone or diet plus insulin
- Thiazolidinediones including pioglitazone, alone or in combination with other hypoglycemic agents, cause fluid retention leading to or exacerbating heart failure [US Black Box Warning]
- Use lowest approved dose of pioglitazone in patients with type 2 diabetes and systolic heart failure (NYHA Class II). If dose acceleration is necessary, increase it gradually after several months of treatment and with careful monitoring for the signs and symptoms of CHF exacerbation
- Do not use glimepiride/ pioglitazone in type I diabetes or diabetic ketoacidosis as pioglitazone exerts its antihyperglycemic effect only in the presence of insulin
- Pioglitazone in combination with insulin or oral hypoglycemic agents increases the risk of hypoglycemia, dose adjustment as per FBS is necessary
- Pioglitazone alone or in combination with other hypoglycemic agents cause weight gain probably due to fluid retention and fat accumulation
- Thiazolidinediones causes ovulation in some premenopausal anovulatory women. Advice patient to use adequate contraception
- Decline in mean hemoglobin values by 2% to 4% occurs with pioglitazone. Patients taking glimepiride/pioglitazone will have low Hb and hematocrit
- Pioglitazone causes hepatitis and elevates liver enzyme levels. Evaluate serum ALT levels before starting glimepiride/ pioglitazone therapy and periodically during the treatment, any sign of hepatic dysfunction discontinue the therapy
- Do not initiate glimepiride/pioglitazone therapy if active liver disease or serum ALT levels >2.5 times the upper limit of normal
- Consider risk of fracture in patients treated with pioglitazone especially females, provide attention to assess and maintain bone health according to current standards of care
- Sulfonylurea drugs cause hypoglycemia, risk is more in patients with renal insufficiency, adrenal, pituitary, or hepatic insufficiency, debilitated or malnourished patients. Use cautiously and start with 1 mg/day of glimepiride followed by appropriate dose titration
- Sulfonylurea agents cause hemolytic anemia in glucose-6-phosphate dehydrogenase (G6PD) deficiency. Use cautiously in G6PD deficiency or consider non-sulfonylurea alternative
- Monitor FPG and A1C periodically to monitor glycemic control and therapeutic response to therapy
Cautions: use cautiously in
- Renal impairment
- Hepatic insufficiency/ALT 1-2.5 x UL of normal
- NYHA Class I-II heart failure
- Risk of CHF
- G6PD deficiency
- Elderly or debilitated patients
- Adrenal, pituitary insufficiency
- Female patients
- Premenopausal anovulatory women
- Edema
Supplemental Patient Information
- Premenopausal women should be recommended to take adequate contraception
Pregnancy Category:C
Breastfeeding: Information not available on pioglitazone/glimepiride use during breastfeeding, use alternate drug especially while nursing a newborn or preterm infant. Monitor blood glucose level of breastfed infant during maternal hypoglycemic treatment. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 16 December 2010). No studies conducted on nursing women with combined pioglitazone/glimepiride therapy. Manufacturer advises to discontinue pioglitazone/gimepiride combination therapy as the potential for hypoglycemia in nursing infants may exist. If diet alone is inadequate for controlling blood glucose, consider insulin therapy.
US Trade Name(s)
US Availability
glimepiride/pioglitazone (generic)
Duetact (glimepiride/pioglitazone)
Canadian Trade Name(s)
Canadian Availability
UK Trade Name(s)
UK Availability
Australian Trade Name(s)
Australian Availability
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- Duetact 30-2 MG TABS [Bottle] (TAKEDA PHARMACEUTICALS)
30 mg = $294.86
90 mg = $856.64 - Duetact 30-4 MG TABS [Bottle] (TAKEDA PHARMACEUTICALS)
30 mg = $289.98
90 mg = $849.98
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
Drug Name: Duetact 30/2 MG Oral Tablet
Ingredient(s): Glimepiride mixture with pioglitazone
Imprint: 30;2;4833G
Color(s): White
Shape: Round
Size (mm): 8.00
Score: 1
Inactive Ingredient(s): croscarmellose sodium / lactose monohydrate / magnesium stearate / hydroxypropyl cellulose / polysorbate 80 / cellulose, microcrystalline
Drug Label Author:
Takeda Pharmaceuticals America, Inc.
DEA Schedule:
Non-Scheduled
Drug Name: Duetact 30/4 MG Oral Tablet
Ingredient(s): Glimepiride mixture with pioglitazone
Imprint: 30;4;4833G
Color(s): White
Shape: Round
Size (mm): 9.00
Score: 1
Inactive Ingredient(s): croscarmellose sodium / lactose monohydrate / magnesium stearate / hydroxypropyl cellulose / polysorbate 80 / cellulose, microcrystalline
Drug Label Author:
Takeda Pharmaceuticals America, Inc.
DEA Schedule:
Non-Scheduled