PIOGLITAZONE tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

International Laboratories, LLC

INN (International Adı):

PIOGLITAZONE HYDROCHLORIDE

Kompozisyon:

PIOGLITAZONE 15 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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 their 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. Teratogenic Effects Pregnancy category C. There are no adequate and well-controlled studies of pioglitazone hydrochloride in pregnant women. Animal studies show increased rates of post-implantation loss, delayed development,

Ürün özeti:

Pioglitazone tablets USP are available as follows: 15 mg: white to off-white, round convex tablets, debossed with “TEVA” on one side of the tablet and “7271” on the other side, available in adherence packages of 30 (NDC 54458-866-10). 30 mg: white to off-white, round flat tablets, debossed with “TEVA” on one side of the tablet and “7272” on the other side, available in adherence packages of 30  (NDC 54458-865-10). 45 mg: white to off-white, round flat tablets, debossed with “TEVA” on one side of the tablet and “7273” on the other side, available in adherence packages of 30  (NDC 54458-864-10). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light, moisture and humidity.

Yetkilendirme durumu:

Abbreviated New Drug Application

Bilgilendirme broşürü

International Laboratories, LLC
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MEDICATION GUIDE
Pioglitazone (pye oh gli′ ta zone) 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 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

Ürün özellikleri

PIOGLITAZONE- PIOGLITAZONE TABLET
INTERNATIONAL LABORATORIES, LLC
----------
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 HYDROCHLORIDE, 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 HYDROCHLORIDE 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)
INDICATIONS AND USAGE
Pioglitazone tablets are 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,
investig