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Duetact

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Duetact

DUETACT
(pioglitazone and glimepiride) Tablets

WARNING

CONGESTIVE HEART FAILURE

  • Thiazolidinediones, including pioglitazone, which is a component of DUETACT, cause or exacerbate congestive heart failure in some patients [see WARNINGS AND PRECAUTIONS].
  • After initiation of DUETACT and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea, and/or edema). If heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of DUETACT must be considered [see WARNINGS AND PRECAUTIONS].
  • DUETACT is not recommended in patients with symptomatic heart failure [see WARNINGS AND PRECAUTIONS].
  • Initiation of DUETACT in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

DUETACT tablets are a thiazolidinedione and a sulfonylurea combination product that contains two oral antihyperglycemic agents: pioglitazone and glimepiride. The concomitant use of pioglitazone and a sulfonylurea, the class of drugs that includes glimepiride, has been previously approved based on clinical trials in patients with type 2 diabetes inadequately controlled on a sulfonylurea. Additional efficacy and safety information about pioglitazone and glimepiride monotherapies may be found in the prescribing information for each individual drug.

Pioglitazone is an oral antidiabetic medication.

Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown:

pioglitazone hydrochloride

Pioglitazone - Structural Formula Illustration

Pioglitazone hydrochloride is an odorless, white crystalline powder that has a molecular formula of C19H20N2O3S•HCl and a molecular weight of 392.90 daltons. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether.

Glimepiride is an oral sulfonylurea chemically identified as 1-[[p-[2-(3-ethyl-4-methyl-2- oxo-3-pyrroline-1-carboxamido)ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)-urea (C24H34N4O5S) with a molecular weight of 490.62. Glimepiride is a white to yellowishwhite, crystalline, odorless to practically odorless powder and is practically insoluble in water. The structural formula is:

glimepiride

Glimepiride - Formula Illustration

DUETACT is available as a tablet for oral administration containing 30 mg pioglitazone (as the base) with 2 mg glimepiride (30 mg/2 mg) or 30 mg pioglitazone (as the base) with 4 mg glimepiride (30 mg/4 mg) formulated with the following excipients: croscarmellose sodium NF, lactose monohydrate NF, magnesium stearate NF, hydroxypropyl cellulose NF, polysorbate 80 NF, and microcrystalline cellulose NF.

What are the possible side effects of glimepiride and pioglitazone (Duetact)?

Stop using glimepiride and pioglitazone and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • stomach pain, blood in your urine, painful urination;
  • swelling in your feet, rapid weight gain, feeling short of breath (even with mild exertion);
  • pale skin, easy bruising or bleeding;
  • pain or burning when you urinate; or
  • dark urine, clay-colored...

Read All Potential Side Effects and See Pictures of Duetact »

What are the precautions when taking pioglitazone hydrochloride and glimepiride tablets (Duetact)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to pioglitazone or glimepiride; or to other "glitazones" (e.g., rosiglitazone); or to other sulfonylureas (e.g., glipizide, tolbutamide); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: newly diagnosed or worsening heart failure (acute congestive heart failure), active liver disease, active bladder cancer.

Before taking this medication, tell your doctor or pharmacist your medical history, especially of: heart...

Read All Potential Precautions of Duetact »

Last reviewed on RxList: 11/25/2013
This monograph has been modified to include the generic and brand name in many instances.

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Duetact - User Reviews

Duetact User Reviews

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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