PIOGLITAZONE HYDROCHLORIDE tablet

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

PIOGLITAZONE HYDROCHLORIDE (UNII: JQT35NPK6C) (PIOGLITAZONE - UNII:X4OV71U42S)

Dostupné z:

NuCare Pharmaceuticals, Inc.

INN (Medzinárodný Name):

PIOGLITAZONE HYDROCHLORIDE

Zloženie:

PIOGLITAZONE 15 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)] . Pioglitazone tablet exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone 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 (5.3)]. Do not initiate in patients with NYHA Class III or IV heart failure [see Boxed Warning] . Do not use in patients with a history of a serious hypersensitivity reaction to pioglitazone tablets or any of its ingredients. Pregnancy Category C. There are no adeq

Prehľad produktov:

Pioglitazone tablets USP are available in 15 mg, tablets as follows: 15 mg tablet: White to off-white, round, biconvex, uncoated tablets debossed with ‘P’ on one side and ‘15’ on other side, available in: NDC 68071-2170-3 Bottles of 30 Storage: Store at 20º to 25ºC (68º to 77 ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container.

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

NuCare Pharmaceuticals, Inc.
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MEDICATION GUIDE
Pioglitazone Tablets USP
Read this Medication Guide carefully before you start taking
pioglitazone 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 tablets, ask
your doctor or pharmacist.
What is the most important information I should know about
pioglitazone tablets?
Pioglitazone tablets can cause serious side effects, including new or
worse heart failure.
•
Pioglitazone 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 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 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 tablets can have other serious side effects. See " What
are the possible side effects of
pioglitazone tablets?"
What are pioglitazone tablets?
Pioglitazone tablet is a prescription medicine used with diet and
exercise to improve blood sugar
(glucose) control in adults with type 2 diabetes. Pioglitazone tablet
is a diabetes medicine called
pioglitazone hydrochloride that may be taken alone or with other
diabetes medicines.
It is not known if pioglitazone tablet is safe and effective in
children.
Who should not take pioglitazone tablets?
See " What is the most important information I should know about
pioglitazone tablets?"
Do not take pioglitazon

Súhrn charakteristických

PIOGLITAZONE HYDROCHLORIDE- PIOGLITAZONE HYDROCHLORIDE TABLET
NUCARE PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PIOGLITAZONE TABLETS,
USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
PIOGLITAZONE TABLETS,
USP.
PIOGLITAZONE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1999
WARNING: CONGESTIVE HEART FAILURE
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
THIAZOLIDINEDIONES, INCLUDING PIOGLITAZONE HYDROCHLORIDE, CAUSE OR
EXACERBATE
CONGESTIVE HEART FAILURE IN SOME PATIENTS. ( 5.1)
AFTER INITIATION OF PIOGLITAZONE 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 TABLETS MUST BE CONSIDERED. ( 5.1)
PIOGLITAZONE TABLETS ARE NOT RECOMMENDED IN PATIENTS WITH SYMPTOMATIC
HEART
FAILURE.
INITIATION OF PIOGLITAZONE TABLETS IN PATIENTS WITH ESTABLISHED NEW
YORK HEART
ASSOCIATION (NYHA) CLASS III OR IV HEART FAILURE IS CONTRAINDICATED. (
4, 5.1)
RECENT MAJOR CHANGES
Indications and Usage
Important Limitations of Use ( 1.2)
01/2011
Dosage and Administration
Recommendations for All Patients ( 2.1)
01/2011
Coadministration with Strong CYP2C8 Inhibitors ( 2.3)
01/2011
Warnings and Precautions
Hepatic Effects ( 5.3)
01/2011
Urinary Bladder Tumors ( 5.5)
07/2011
INDICATIONS AND USAGE
Pioglitazone tablet is a thiazolidinedione and an agonist for
peroxisome proliferator-activated receptor
(PPAR) gamma indicated as an adjunct to diet and exercise to improve
glycemic control in adults with type
2 diabetes mellitus in multiple clinical settings. ( 1.1, 14)
Important Limitation of Use:
Not for treatment of type 1 diabetes or diabetic ketoacidosis. ( 1.2)
DOSAGE AND ADMINISTRATION
Initiate pioglitazone tablets at 15 mg or 30 mg once daily. Limit
initial dose to 15 mg on