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Drugs reference index «Duetact»

Duetact

Generic Name: pioglitazone and glimepiride (Oral route)

glye-MEP-ir-ide, Pioglitazone Hydrochloride

Oral routeTablet
  • Congestive Heart Failure
  • Thiazolidinediones, including pioglitazone hydrochloride, which is a component of glimepiride/pioglitazone hydrochloride, cause or exacerbate congestive heart failure in some patients. After initiation of glimepiride/pioglitazone hydrochloride, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation of glimepiride/pioglitazone hydrochloride must be considered.
  • Glimepiride/pioglitazone hydrochloride is not recommended in patients with symptomatic heart failure. Initiation of glimepiride/pioglitazone hydrochloride in patients with established NYHA Class III or IV heart failure is contraindicated .

Pioglitazone hydrochloride, a component of glimepiride/pioglitazone hydrochloride, may cause or worsen congestive heart failure; monitor patients for signs and symptoms of heart failure after initiation. Should such signs and symptoms develop, manage according to current standards of care. Consider discontinuation. Glimepiride/pioglitazone hydrochloride is not recommended in patients with symptomatic heart failure; contraindicated in established NYHA Class III or IV heart failure .

Commonly used brand name(s):

In the U.S.

  • Duetact

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antidiabetic

Chemical Class: 2nd Generation Sulfonylurea

Uses For Duetact

Pioglitazone and glimepiride combination is used to treat high blood sugar levels that are caused by a type of diabetes mellitus (sugar diabetes) called type 2 diabetes. It is used together with proper diet and exercise to help control your blood sugar.

This medicine is available only with your doctor's prescription.

Before Using Duetact

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of pioglitazone and glimepiride combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pioglitazone and glimepiride combination in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving pioglitazone and glimepiride combination.

Pregnancy

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alatrofloxacin
  • Balofloxacin
  • Ciprofloxacin
  • Clinafloxacin
  • Disopyramide
  • Enoxacin
  • Fleroxacin
  • Flumequine
  • Gatifloxacin
  • Gemifloxacin
  • Grepafloxacin
  • Levofloxacin
  • Lomefloxacin
  • Moxifloxacin
  • Norfloxacin
  • Ofloxacin
  • Pefloxacin
  • Prulifloxacin
  • Rufloxacin
  • Sparfloxacin
  • Temafloxacin
  • Tolvaptan
  • Tosufloxacin
  • Trovafloxacin Mesylate

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acebutolol
  • Aceclofenac
  • Acemetacin
  • Alclofenac
  • Alprenolol
  • Apazone
  • Atenolol
  • Atorvastatin
  • Benoxaprofen
  • Betaxolol
  • Bevantolol
  • Bisoprolol
  • Bitter Melon
  • Bromfenac
  • Bucindolol
  • Bufexamac
  • Carprofen
  • Carteolol
  • Carvedilol
  • Celiprolol
  • Clometacin
  • Clonixin
  • Clorgyline
  • Dexketoprofen
  • Diclofenac
  • Diflunisal
  • Dilevalol
  • Dipyrone
  • Droxicam
  • Esmolol
  • Ethinyl Estradiol
  • Etodolac
  • Etofenamate
  • Felbinac
  • Fenbufen
  • Fenofibrate
  • Fenoprofen
  • Fentiazac
  • Fenugreek
  • Floctafenine
  • Fluconazole
  • Flufenamic Acid
  • Flurbiprofen
  • Gemfibrozil
  • Glucomannan
  • Guar Gum
  • Ibuprofen
  • Indomethacin
  • Indoprofen
  • Iproniazid
  • Isocarboxazid
  • Isoxicam
  • Ketoconazole
  • Ketoprofen
  • Ketorolac
  • Labetalol
  • Levobunolol
  • Levonorgestrel
  • Lornoxicam
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Mepindolol
  • Mestranol
  • Metipranolol
  • Metoprolol
  • Moclobemide
  • Nabumetone
  • Nadolol
  • Naproxen
  • Nebivolol
  • Nialamide
  • Niflumic Acid
  • Nimesulide
  • Norethindrone
  • Norgestrel
  • Oxaprozin
  • Oxprenolol
  • Oxyphenbutazone
  • Pargyline
  • Penbutolol
  • Phenelzine
  • Phenylbutazone
  • Pindolol
  • Pirazolac
  • Piroxicam
  • Pirprofen
  • Procarbazine
  • Propranolol
  • Propyphenazone
  • Proquazone
  • Psyllium
  • Rifampin
  • Selegiline
  • Sotalol
  • St John's Wort
  • Sulindac
  • Suprofen
  • Talinolol
  • Tenidap
  • Tenoxicam
  • Tertatolol
  • Tiaprofenic Acid
  • Timolol
  • Tolmetin
  • Toloxatone
  • Topiramate
  • Tranylcypromine
  • Zomepirac

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Alcohol intoxication or
  • Debilitation or weakened physical condition or
  • Malnutrition or
  • Underactive adrenal glands or
  • Underactive pituitary gland or
  • Any other condition that causes low blood sugar—Patients with these conditions may be more likely to develop low blood sugar while taking this medicine.
  • Diabetic ketoacidosis (ketones in the blood) or
  • Type 1 diabetes—Should not be used in patients with these conditions. Insulin is needed to control these conditions.
  • Fever or
  • Infection or
  • Surgery or
  • Trauma—These conditions may cause temporary problems with blood sugar control and your doctor may want to treat you temporarily with insulin.
  • Glucose 6-phosphate dehydrogenase (G6PD) deficiency (an enzyme problem)—May cause hemolytic anemia (blood disorder) in patients with this condition.
  • Heart failure, severe or
  • Liver disease, active—This medicine should not be used in patients with these conditions.
  • Heart or blood vessel disorders or
  • Problems with fluid retention and swelling—Use with caution. This medicine may make these conditions worse.
  • Kidney problems—Use with caution. Dosage adjustment may be needed.

Proper Use of Duetact

Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

This medicine should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine should be taken with the first meal of the day.

Do not change your dose without asking your doctor. Your doctor may need to change your dose to control your blood sugar.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For type 2 diabetes:
    • For oral dosage form (tablets):
      • For patients already taking glimepiride alone:
        • Adults—At first, 1 tablet (either the 30 milligrams (mg) pioglitazone plus 2 mg glimepiride tablet or the 30 mg pioglitazone plus 4 mg glimepiride tablet) once a day, as instructed by your doctor. Your doctor may adjust your dose until your blood sugar is controlled.
        • Children—Use and dose must be determined by your doctor.
      • For patients already taking pioglitazone alone:
        • Adults—At first, 1 tablet (30 milligrams (mg) pioglitazone plus 2 mg glimepiride) once a day, as instructed by your doctor. Your doctor may adjust your dose until your blood sugar is controlled.
        • Children—Use and dose must be determined by your doctor.
      • For patients switching from a combination of pioglitazone and glimepiride as separate tablets:
        • Adults—At first, 1 tablet (either the 30 milligrams (mg) pioglitazone plus 2 mg glimepiride tablet or the 30 mg pioglitazone plus 4 mg glimepiride tablet) once a day, based on the doses of pioglitazone and glimepiride already being taken, as instructed by your doctor. Your doctor may adjust your dose until your blood sugar is controlled.
        • Children—Use and dose must be determined by your doctor.
      • For patients switching from different diabetes medicines or combination therapy:
        • Adults—At first, 1 tablet (30 milligrams (mg) pioglitazone plus 2 mg glimepiride) once a day, as instructed by your doctor. Your doctor may adjust your dose until your blood sugar is controlled.
        • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Duetact

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Certain women may be at an increased risk for pregnancy while taking this medicine. If you have had problems ovulating before (have irregular periods), this medicine may cause you to ovulate. This could increase your chance of becoming pregnant. Talk with your doctor if you have questions or concerns about this.

Check with your doctor immediately if blurred vision, decreased vision, or any other change in vision occurs during your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may increase the risk of bone fractures in women. Ask your doctor about ways to keep your bones strong to help prevent fractures.

Tell your doctor right away if you have any of these symptoms: loss of appetite, nausea, vomiting, stomach pain, unusual tiredness or weakness, weight loss, or yellow eyes or skin. These may be symptoms of liver problems.

If you are rapidly gaining weight, or having shortness of breath, or excessive swelling of hands, wrist, ankles, or feet, check with your doctor immediately. These may be symptoms of heart problems or your body keeping too much water.

Pioglitazone and glimepiride combination can cause hypoglycemia (low blood sugar). However, this can also occur if you delay or miss a meal or snack, exercise more than the usual amount, drink alcohol, or when you take other types of diabetes medicine. Symptoms of low blood sugar may include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty with thinking; drowsiness; excessive hunger; fast heartbeat; headache (continuing); nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; or unusual tiredness or weakness. It is important that you learn which symptoms of low blood sugar you usually have so that you can treat it quickly.

Hyperglycemia (high blood sugar) may also occur if you do not exercise as much as usual, have a fever or infection, do not take enough or skip a dose of your diabetes medicine, or overeat or do not follow your meal plan. Symptoms of hyperglycemia may include blurred vision; drowsiness; dry mouth; flushed, dry skin; fruit-like breath odor; increased urination (frequency and volume); ketones in the urine; loss of appetite; sleepiness; stomachache, nausea or vomiting; tiredness; troubled breathing (rapid and deep); unconsciousness; or unusual thirst.

If symptoms of low blood sugar or high blood sugar occur, check your blood sugar level and then call your doctor for instructions.

Duetact Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Anxiety
  • bladder pain
  • bloody or cloudy urine
  • blurred vision
  • chills
  • cold sweats
  • coma
  • confusion
  • cool, pale skin
  • depression
  • difficult, burning, or painful urination
  • fast heartbeat
  • frequent urge to urinate
  • headache
  • increased hunger
  • increased weight
  • lower back or side pain
  • nausea
  • nervousness
  • nightmares
  • seizures
  • shakiness
  • slurred speech
  • swelling of the feet or lower legs
  • unusual tiredness or weakness
Less common
  • Accidental injury
  • loss of appetite
  • pain or swelling in the arms or legs without any injury
  • pale skin
  • stomach pain
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • vomiting
  • weight loss
  • yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Body aches or pain
  • cough
  • diarrhea
  • difficulty with moving
  • dryness or soreness of the throat
  • ear congestion
  • fever
  • hoarseness
  • joint pain
  • loss of voice
  • muscle aching or cramping
  • muscle pains or stiffness
  • nasal congestion
  • runny nose
  • sneezing
  • swollen joints
  • tender, swollen glands in the neck
  • tooth disorder
  • trouble with swallowing
  • voice changes
Less common
  • Dizziness
  • itching skin
  • lack or loss of strength
  • skin rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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  • Duetact Prescribing Information (FDA)
  • Duetact Detailed Consumer Information (PDR)
  • Duetact MedFacts Consumer Leaflet (Wolters Kluwer)
  • Duetact Consumer Overview

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