DUETACT- pioglitazone and glimepiride tablet

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

pioglitazone hydrochloride (UNII: JQT35NPK6C) (pioglitazone - UNII:X4OV71U42S), glimepiride (UNII: 6KY687524K) (glimepiride - UNII:6KY687524K)

Հասանելի է:

Takeda Pharmaceuticals America, Inc.

INN (Միջազգային անվանումը):

pioglitazone hydrochloride

Կազմը:

pioglitazone 30 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

DUETACT is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a thiazolidinedione and sulfonylurea or who have inadequate glycemic control on a thiazolidinedione alone or a sulfonylurea alone [see Clinical Studies (14)] . Important Limitations of Use Pioglitazone exerts its antihyperglycemic effect only in the presence of endogenous insulin. DUETACT should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.5)] . Reported hypersensitivity reactions with glimepiride include cutaneous eruptions with or without pruritus as well as more serious reactions (e.g., anaphylaxis, angioedema, Stevens-Johnson Syndrome, dyspnea) [see Warnings and Precautions ( 5.3) and Adverse Reactions (6.2)] Risk Summary Limited data with DUETACT or pioglitazone in pregnant women are not sufficient to determine a d

Ապրանքի ամփոփագիր:

DUETACT is available in 30 mg pioglitazone plus 2 mg glimepiride or 30 mg pioglitazone plus 4 mg glimepiride tablets as follows: 30 mg/2 mg tablet: white to off-white, round, convex tablets, debossed with 4833G on one side and 30/2 on the other, available in: NDC 64764-302-30 Bottles of 30 NDC 64764-302-90 Bottles of 90 30 mg/4 mg tablet: white to off-white, round, convex tablets, debossed with 4833G on one side and 30/4 on the other, available in: NDC 64764-304-30 Bottles of 30 NDC 64764-304-90 Bottles of 90 Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed and protect from moisture and humidity.

Լիազորման կարգավիճակը:

New Drug Application

Տեղեկատվական թերթիկ

DUETACT- PIOGLITAZONE AND GLIMEPIRIDE TABLET
Takeda Pharmaceuticals America, Inc.
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MEDICATION GUIDE
DUETACT (doo-et' -ăct)
(pioglitazone and glimepiride) tablets
Read this Medication Guide carefully before you start taking DUETACT
and each time you get a refill.
There may be new information. This information does not take the place
of talking with your doctor about
your medical condition or your treatment. If you have any questions
about DUETACT, ask your doctor or
pharmacist.
What is the most important information I should know about DUETACT?
DUETACT can cause serious side effects, including new or worse heart
failure.
•
Pioglitazone, one of the medicines in DUETACT, can cause your body to
keep extra fluid (fluid
retention), which leads to swelling (edema) and weight gain. Extra
body fluid can make some heart
problems worse or lead to heart failure. Heart failure means your
heart does not pump blood well
enough
•
Do not take DUETACT if you have severe heart failure
•
If you have heart failure with symptoms (such as shortness of breath
or swelling), even if these
symptoms are not severe, DUETACT may not be right for you
Call your doctor right away if you have any of the following:
•
swelling or fluid retention, especially in the ankles or legs
•
shortness of breath or trouble breathing, especially when you lie down
•
an unusually fast increase in weight
•
unusual tiredness
DUETACT can have other serious side effects. See "What are the
possible side effects of DUETACT?"
What is DUETACT?
DUETACT is a prescription medicine used with diet and exercise to
improve blood sugar (glucose) control
in adults with type 2 diabetes.
DUETACT contains 2 prescription diabetes medicines called pioglitazone
(ACTOS) and glimepiride, a
sulfonylurea.
DUETACT is not for people with type 1 diabetes.
DUETACT is not for people with diabetic ketoacidosis (increased
ketones in your blood or urine).
It is not known if DUETACT is safe and effective in children under the
age of 18. DUETACT is not
recommended for use in

Ապրանքի հատկությունները

DUETACT- PIOGLITAZONE AND GLIMEPIRIDE TABLET
TAKEDA PHARMACEUTICALS AMERICA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DUETACT SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DUETACT.
DUETACT (PIOGLITAZONE AND GLIMEPIRIDE) TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 2006
WARNING: CONGESTIVE HEART FAILURE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
•
RECENT MAJOR CHANGES
Warnings and Precautions
Urinary bladder tumors (5.6)
12/2016
INDICATIONS AND USAGE
DUETACT is a thiazolidinedione and a sulfonylurea combination product
indicated as an adjunct to diet and
exercise to improve glycemic control in adults with type 2 diabetes
mellitus when treatment with both
pioglitazone and glimepiride is appropriate. (1)
Important Limitations of Use:
•
DOSAGE AND ADMINISTRATION
•
•
•
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DOSAGE FORMS AND STRENGTHS
•
•
CONTRAINDICATIONS
•
•
THIAZOLIDINEDIONES, INCLUDING PIOGLITAZONE, WHICH IS A COMPONENT OF
DUETACT,
CAUSE OR EXACERBATE CONGESTIVE HEART FAILURE IN SOME PATIENTS. (5.1)
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. (5.1)
DUETACT IS NOT RECOMMENDED IN PATIENTS WITH SYMPTOMATIC HEART FAILURE.
(5.1)
INITIATION OF DUETACT IN PATIENTS WITH ESTABLISHED NEW YORK HEART
ASSOCIATION
(NYHA) CLASS III OR IV HEART FAILURE IS CONTRAINDICATED. (4, 5.1)
Not for treatment of type 1 diabetes or diabetic ketoacidosis. (1)
Individualize the starting dose of DUETACT based on the patient's
current regimen. (2.1)
May adjust the dosing based on effectiveness and tolerability while
not exceeding the maximum
recommended daily dose of pioglitazone 45 mg and glimepiride 8 mg.
(2.1)
DUETACT should be given in a single do