PIOGLITAZONE tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

International Laboratories, LLC

INN (Mezinárodní Name):

PIOGLITAZONE HYDROCHLORIDE

Složení:

PIOGLITAZONE 15 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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 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)]. 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 their ingredients. Pregnancy Category C. There are no adequate and well-controlled studies of pioglitazone tablets in pregnant women. Animal studies show increased rates of post-implantation loss, delayed development, reduced fetal weights, and delayed parturition at doses 10 to 40 times the maximum re

Přehled produktů:

 Pioglitazone Tablets are available in 15 mg, 30 mg, and 45 mg tablets as follows: 15 mg tablet: White to off-white, round, convex, nonscored tablet with "ACTOS" on one side, and "15" on the other, available in: NDC  54458-885-10        Adherence Packages of 30 30 mg tablet: White to off-white, round, flat, nonscored tablet with "ACTOS" on one side, and "30" on the other, available in: NDC  54458-884-10        Adherence Packages of 30 45 mg tablet: White to off-white, round, flat, nonscored tablet with "ACTOS" on one side, and "45" on the other, available in: NDC  54458-883-10        Adherence Packages of 30 Storage Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Keep container tightly closed, and protect from light, moisture and humidity.

Stav Autorizace:

New Drug Application Authorized Generic

Informace pro uživatele

International Laboratories, LLC
----------
MEDICATION GUIDE
Pioglitazone Tablets
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 that may be
taken alone or with other diabetes medicines.
It is not known if Pioglitazone Tablets are 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 Pioglitazone Tablets if you:
•
have seve

Charakteristika produktu

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 TABLETS, 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
Warnings and Precautions
Urinary Bladder Tumors (5.5)
07/2011
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. (1.1, 14) (1)
Important Limitation of Use: (1)
• Not for treatment of type 1 diabetes or diabetic ketoacidosis.
(1.2) (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 (2)
heart failure. (2.1) (2)
• 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) (2)
• The maximum recommended dos