PIOGLITAZONE AND GLIMEPIRIDE tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Prasco Laboratories

INN (Kansainvälinen yleisnimi):

pioglitazone hydrochloride

Koostumus:

pioglitazone 30 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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)]. - Initiation in patients with established NYHA Class III or IV heart failure [see Boxed Warning] . - Use in patients with known hypersensitivity to pioglitazone, glimepiride or any other component of pioglitazone and glimepiride tablets [see Warnings and Precautions (5.3)] . - Use in patients with known history of an alle

Tuoteyhteenveto:

Pioglitazone and glimepiride tablets 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 tablet: white to off-white, round, convex tablets, debossed with 4833G on one side and 30/2 on the other, available in: NDC 66993-821-30 Bottles of 30 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 66993-822-30 Bottles of 30 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.

Valtuutuksen tilan:

New Drug Application Authorized Generic

Pakkausseloste

Prasco Laboratories
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MEDICATION GUIDE
Pioglitazone and Glimepiride Tablets
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.
Pioglitazone and glimepiride tablets contain 2 prescription diabetes
medicines called pioglitazone (ACTOS)
and glimepiride, a sulfonylurea.
Pio

Valmisteyhteenveto

PIOGLITAZONE AND GLIMEPIRIDE- PIOGLITAZONE AND GLIMEPIRIDE TABLET
PRASCO LABORATORIES
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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._
THIAZOLIDINEDIONES, INCLUDING PIOGLITAZONE, WHICH IS A COMPONENT OF
PIOGLITAZONE AND
GLIMEPIRIDE TABLETS, CAUSE OR EXACERBATE CONGESTIVE HEART FAILURE IN
SOME PATIENTS.
(5.1)
AFTER INITIATION OF PIOGLITAZONE AND GLIMEPIRIDE TABLETS, 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 TABLETS MUST BE CONSIDERED.
(5.1)
PIOGLITAZONE AND GLIMEPIRIDE TABLETS ARE NOT RECOMMENDED IN PATIENTS
WITH
SYMPTOMATIC HEART FAILURE. (5.1)
INITIATION OF PIOGLITAZONE AND GLIMEPIRIDE TABLETS IN PATIENTS WITH
ESTABLISHED NEW
YORK HEART ASSOCIATION (NYHA) CLASS III OR IV HEART FAILURE IS
CONTRAINDICATED. (4, 5.1)
RECENT MAJOR CHANGES
Warnings and Precautions
Urinary Bladder Tumors (5.6)
12/2016
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:
Not for treatment of type 1 diabetes or diabetic ketoacidosis. (1)
DOSAGE AND ADMINISTRATION
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