PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

PIOGLITAZONE HYDROCHLORIDE (UNII: JQT35NPK6C) (PIOGLITAZONE - UNII:X4OV71U42S), GLIMEPIRIDE (UNII: 6KY687524K) (GLIMEPIRIDE - UNII:6KY687524K)

Tillgänglig från:

Sandoz Inc

INN (International namn):

PIOGLITAZONE HYDROCHLORIDE

Sammansättning:

PIOGLITAZONE 30 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Pioglitazone and glimepiride tablets are 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. Pioglitazone and glimepiride tablets 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 pioglitazone and

Produktsammanfattning:

Pioglitazone and glimepiride tablets, USP are available in 30 mg pioglitazone plus 2 mg glimepiride or 30 mg pioglitazone plus 4 mg glimepiride tablets as follows: 30 mg/2 mg tablets are, white, oval, biconvex, embossed with ‘SZ 468’ on one side. NDC 0781-5634-31, bottle of 30 tablets NDC 0781-5634-10, bottle of 1000 tablets NDC 0781-5634-08, carton of 28 tablets (4 x 7 Unit-Dose) 30 mg/4 mg tablets are white, oval, biconvex, embossed with “SZ 469” on one side. NDC 0781-5635-31, bottle of 30 tablets NDC 0781-5635-10, bottle of 1000 tablets NDC 0781-5635-08, carton of 28 tablets (4 x 7 Unit-Dose) Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep container tightly closed and protect from moisture and humidity.

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE- PIOGLITAZONE HYDROCHLORIDE
AND
GLIMEPIRIDE TABLET
Sandoz Inc
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MEDICATION GUIDE
Pioglitazone and Glimepiride Tablets, USP
(pie-oh-GLIT-ah-zohn and glye-MEH-per-ide)
Read this Medication Guide carefully before you start taking
pioglitazone and glimepiride tablets 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
pioglitazone and glimepiride tablets, ask your doctor or pharmacist.
What is the most important information I should know about
pioglitazone and glimepiride tablets?
Pioglitazone and glimepiride tablets can cause serious side effects,
including new or worse heart failure.
•
Pioglitazone, one of the medicines in pioglitazone and glimepiride
tablets, 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 pioglitazone and glimepiride tablets 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, pioglitazone and glimepiride tablets 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
Pioglitazone and glimepiride tablets can have other serious side
effects. See “What are the possible side
effects of pioglitazone and glimepiride tablets?”
What are pioglitazone and glimepiride tablets?
Pioglitazone and glimepiride tablets are a prescription medicine used
with diet and exercise to improve
blood sugar (glucose) control in adults with type 2 diabetes.
Piogli

Produktens egenskaper

PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE- PIOGLITAZONE HYDROCHLORIDE
AND
GLIMEPIRIDE TABLET
SANDOZ INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PIOGLITAZONE AND GLIMEPIRIDE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
PIOGLITAZONE AND GLIMEPIRIDE
TABLETS.
PIOGLITAZONE AND GLIMEPIRIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2006
WARNING: CONGESTIVE HEART FAILURE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
•
INDICATIONS AND USAGE
Pioglitazone and glimepiride tablets are 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
•
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CONTRAINDICATIONS
•
•
•
THIAZOLIDINEDIONES, INCLUDING PIOGLITAZONE, WHICH IS A COMPONENT OF
PIOGLITAZONE AND GLIMEPIRIDE,
CAUSE OR EXACERBATE CONGESTIVE HEART FAILURE IN SOME PATIENTS. (5.1)
AFTER INITIATION OF PIOGLITAZONE AND GLIMEPIRIDE, 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 PIOGLITAZONE AND GLIMEPIRIDE MUST
BE CONSIDERED. (5.1)
PIOGLITAZONE AND GLIMEPIRIDE IS NOT RECOMMENDED IN PATIENTS WITH
SYMPTOMATIC HEART FAILURE. (5.1)
INITIATION OF PIOGLITAZONE AND GLIMEPIRIDE 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 pioglitazone and glimepiride
tablets based on the patient’s current regimen. (2.1)
May adjust the dosing based on effectiveness a