Pioglitazone and Glimepiride (Oral Route)

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ARTICLE SECTIONS

US Brand Names

Duetact

Description

Pioglitazone and glimepiride combination is used to treat high blood sugar levels that are caused by a certain 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 .

This product is available in the following dosage forms:

Tablet

Before Using

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

No information is available 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 geriatrics-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 adjustment of dosage in patients receiving pioglitazone and glimepiride combination .

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal 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.

Breastfeeding

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.

Drug Interactions

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
Enoxacin
Fleroxacin
Flumequine
Gatifloxacin
Gemifloxacin
Grepafloxacin
Levofloxacin
Lomefloxacin
Moxifloxacin
Norfloxacin
Ofloxacin
Pefloxacin
Prulifloxacin
Rufloxacin
Sparfloxacin
Temafloxacin
Tosufloxacin
Trovafloxacin Mesylate

Other Interactions

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:

Adrenal gland problems or
Debilitation or weakened physical condition or
Malnutrition or
Pituitary gland problems 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—This medicine 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 .

Heart failure, severe
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

Carefully follow 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 be taken with the first meal of the day .

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

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to check you for any problems or unwanted effects that may be caused by this medicine .

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 .

Your doctor will need to check your blood or urine at regular visits while you are using this medicine. Be sure to keep all appointments .

This medicine may cause women to ovulate, which could increase the chances of pregnancy. If you are a woman of childbearing potential, you should discuss birth control options with your doctor .

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 in 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 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 .

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 feet or lower legs
Unusual tiredness or weakness

Less common

Accidental injury
Loss of appetite
Pain or swelling in 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