glimepiride/pioglitazone (Rx)

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Brand and Other Names:Duetact

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

pioglitazone/glimepiride

tablet

  • 30mg/2mg
  • 30mg/4mg
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Type 2 Diabetes Mellitus

Indicated for management of type 2 diabetes mellitus as adjunct to diet and exercise

Indicated for type 2 diabetes mellitus in patients treated with combination of pioglitazone and a sulfonylurea, or patients not adequately controlled on a sulfonylurea alone, or who have initially responded to pioglitazone and require additional glycemic control Management of diabetes mellitus as adjunct to diet and exercise

30 mg/2 mg, OR 30 mg/4 mg PO qDay; not to exceed 45 mg/8 mg

Dosage Modifications

Renal Impairment

  • CrCl <22 mL/min: 1 mg/day glimepiride PO prior to initiating glimepiride/pioglitazone; titrate conservatively to avoid hypoglycemia
  • Base dose titration on fasting glucose levels
  • CrCl ≥22 mL/min: 30 mg/2 mg or 30 mg/4 mg PO qDay initially

Hepatic Impairment

  • 1 mg/day glimpiride PO prior to initiating glimepiride/pioglitazone; titrate conservatively to avoid hypoglycemia
  • Baseline ALT <2.5 xULN: Use caution
  • Baseline ALT ≥2.5 xULN: Do not initiate
  • ALT >3 xULN or jaundice after initiating therapy: Discontinue

Dosing Considerations

Systolic dysfunction (NYHA I/II): Initiate after patient has been safely titrated to 30 mg of pioglitazone monotherapy

For use in type 2 DM patients treated with combination of pioglitazone and a sulfonylurea, or patients not adequately controlled on a sulfonylurea alone, or patients who have initially responded to pioglitazone and require additional glycemic control

Safety and efficacy not established

1 mg/day glimpiride (as monotherapy) PO prior to initiating glimepiride/pioglitazone; titrate conservatively to avoid hypoglycemia

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Interactions

Interaction Checker

and glimepiride/pioglitazone

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            Adverse Effects

            >10%

            Peripheral edema (6-12%)

            Upper respiratory tract infection (12-15%)

            Weight gain (9-13%)

            Hypoglycemia (13-16%)

            1-10%

            Anemia (<2%)

            Limb pain (4-5%)

            Urinary tract infection (6-7%)

            Headache (4-7%)

            Diarrhea (4-6%)

            Nausea (4-5%)

            Postmarketing Reports

            Thrombocytopenia and thrombocytopenic purpura

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            Warnings

            Black Box Warnings

            Thiazolidinediones (eg, pioglitazone) can cause or exacerbate congestive heart failure in some patients

            After initiation and dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain; dyspnea; and/or edema)

            If these signs or symptoms develop, the heart failure should be managed according to the current standards of care

            Discontinuation or dose reduction of thiazolidinedione must be considered

            Thiazolidinediones not recommended with symptomatic heart failure; initiation in patients with established NYHA class III or IV heart failure is contraindicated

            Contraindications

            Hypersensitivity

            Diabetic ketoacidosis with of without coma

            Active liver disease, increased serum transaminase levels

            Not recommended in heart failure NYHA III-IV patients

            Cautions

            Increased risk of cardiovascular mortality

            Edema; thiazolidinediones, which are peroxisome proliferator-activated receptor (PPAR) gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin

            Hemolytic anemia may occur with glucose 6-phosphate dehydrogenase (G6PD) deficiency when treated with sulfonylurea agents

            Fluid retention may occur and can exacerbate or lead to congestive heart failure; combination use with insulin and use in congestive heart failure NYHA Class I and II may increase risk; monitor patients for signs and symptoms

            Hypoglycemia may be severe. when insulin or an insulin secretagogue is used with pioglitazone, a lower insulin dose or insulin secretagogue dose may be needed to reduce risk of hypoglycemia

            Postmarketing reports for glimepiride include anaphylaxis, angioedema, and Stevens-Johnson syndrome; promptly discontinue glimepiride, assess for other causes, institute appropriate monitoring and treatment, and initiate alternative treatment for diabetes

            Postmarketing reports of hepatic failure, sometimes fatal; causality cannot be excluded; if liver injury detected, promptly interrupt therapy and assess patient for probable cause, then treat cause if possible, to resolution or stabilization; do not restart therapy if liver injury confirmed and no alternate etiology can be found

            Dose-related edema may occur

            Increased incidence of bone fracture reported

            Macular edema reported; recommend regular eye exams in all patients with diabetes according to current standards of care with prompt evaluation for acute visual changes

            No clinical studies establishing conclusive evidence of macrovascular risk reduction with glimepiride/pioglitazone or any other antidiabetic drug exist

            Increase in weight gain possibly related to pioglitazone effects on fluid retention and fat accumulation

            Cancer risk

            • Bladder cancer
              • 5-year interim results of a 10-year cohort study suggest that pioglitazone use >12 months increases the relative risk of developing bladder cancer in any given year by 40%, an increase from ~7 cases in 10,000 to ~10 cases in 10,000
              • Greatest risk was shown in patients with long-term use and the highest cumulative doses
              • FDA recommendations include not prescribing pioglitazone for patients with active bladder cancer and cautious use in patients with a history of bladder cancer
              • 7/22/2015: A prospective study found that during ~7 years' follow-up, the rate of incident bladder cancer was higher in patients who had ever used pioglitazone than nonusers (89.8 vs. 75.9 per 100,000 person-years), but the difference was not significant after adjustment for potential confounders [JAMA 2015 July 21;314(3):265-277]
            • Prostate cancer
              • 7/22/2015: Compared with nonuse, pioglitazone use was associated with increased risk for prostate cancer (453.3 vs. 449.3 per 100,000 person-years) [JAMA 2015 July 21;314(3):265-277]
            • Pancreatic cancer
              • 7/22/2015: Compared with nonuse, pioglitazone use was associated with increased risk for pancreatic cancer (81.1 vs. 48.4 per 100,000 person-years) [JAMA 2015 July 21;314(3):265-277]

            See also individual monographs

            • Pioglitazone
            • Glimepiride
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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: Not known if crosses into breast milk, discontinue drug or breastfeeding

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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