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:

NuCare Pharmaceuticals,Inc.

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 exert 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)] . - 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

Ringkasan produk:

Pioglitazone Tablets USP, 15 mg are white to off-white, round, biconvex, uncoated tablets, debossed with 31 on one side and H on other side. NDC 68071-5199-3 BOTTLES OF 30 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep container tightly closed, and protect from light, moisture and humidity.

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

NuCare Pharmaceuticals,Inc.
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MEDICATION GUIDE
Pioglitazone Tablets, USP
(pye" oh gli' ta 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 are pioglitazone tablets?
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 that may be taken alone or with other diabetes medicines.
It is not known if pioglitazone tablets are safe and effective in
children under the age of 18.
Pioglitazone tablets are not recommended for use in children.
Pioglitazone tablets are not for people with type 1 dia

Ciri produk

PIOGLITAZONE- PIOGLITAZONE 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 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, CAUSE OR EXACERBATE
CONGESTIVE HEART FAILURE IN SOME
PATIENTS. (5.1)
AFTER INITIATION OF PIOGLITAZONE, 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 MUST BE CONSIDERED. (5.1)
PIOGLITAZONE IS NOT RECOMMENDED IN PATIENTS WITH SYMPTOMATIC HEART
FAILURE. (5.1)
INITIATION OF PIOGLITAZONE 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 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 Limitations 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 tablets. If abnormal,
use caution when treating with pioglitazone tablets,
inves