PIOGLITAZONE - pioglitazone tablet

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

A-S Medication Solutions

INN (Nama Antarabangsa):

PIOGLITAZONE HYDROCHLORIDE

Komposisi:

PIOGLITAZONE 45 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Monotherapy and Combination Therapy 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)  ] . Important Limitations of Use Pioglitazone tablets, USP exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone tablets USP 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) ]. • Initiation in patients with established NYHA Class III or IV heart failure [see Boxed Warning]. • Use in patients with known hypersensitivity to pioglitazone or any other component of pioglitazone tablets. Risk Summary Limited data with pioglitazone hydrochloride in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. There are risks to the mother an

Ringkasan produk:

Product: 50090-2637 NDC: 50090-2637-1 90 TABLET in a BOTTLE

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

PIOGLITAZONE - PIOGLITAZONE TABLET
A-S Medication Solutions
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MEDICATION GUIDE
Pioglitazone Tablets
(PYE o GLIT a zone)
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 is pioglitazone tablet?
Pioglitazone tablets are a prescription medicine used with diet and
exercise to improve blood sugar
(glucose) control in adults with type 2 diabetes. Pioglitazone tablets
are a diabetes medicine called
pioglitazone hydrochloride that may be taken alone or with other
diabetes medicines.
It is not known if pioglitazone hydrochloride is safe and effective in
children under the age of 18.
Pioglitazone tablet is not recommended for use in children.
Pioglitazone tablet is not f

Ciri produk

PIOGLITAZONE - PIOGLITAZONE TABLET
A-S MEDICATION SOLUTIONS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PIOGLITAZONE TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PIOGLITAZONE
TABLETS.
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 HYDROCHLORIDE IS NOT RECOMMENDED IN PATIENTS WITH
SYMPTOMATIC HEART FAILURE. (5.1)
INITIATION OF PIOGLITAZONE HYDROCHLORIDE 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 (5.4) 12/2016
INDICATIONS AND USAGE
Pioglitazone hydrochloride 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, 14)
Important Limitation of Use:
Not for treatment of type 1 diabetes or diabetic ketoacidosis. (1)
DOSAGE AND ADMINISTRATION
•Initiate pioglitazone tablets at 15 mg or 30 mg once daily. Limit
initial dose to 15 mg once daily in patients with NYHA Class
I or II heart failure. (2.1)
•If there is inadequate glycemic control, the dose can be increased
in 15 mg increments up to a maximum of 45 mg once
daily. (2.1)
•Obtain liver tests before starting pioglitazone tablet