PIOGLITAZONE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aphena Pharma Solutions - Tennessee, LLC

INN (International Name):

PIOGLITAZONE HYDROCHLORIDE

Composition:

PIOGLITAZONE 45 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Monotherapy and Combination Therapy Pioglitazone tablets, USP 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 exert 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. Teratogenic Effects Pregnancy Category C. There are no adequate and well-controlled studies of pioglitazone in pregnant women. Animal studies show increased rates of post-implantation

Product summary:

Pioglitazone is available in 15 mg, 30 mg, and 45 mg tablets as follows: 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.          Bottles of 30                                NDC 52343-053-30          Bottles of 90                                NDC 52343-053-90          Bottles of 500                              NDC 52343-053-05  Pioglitazone Tablets USP, 30 mg are white to off-white, round, flat faced, beveled edge uncoated tablets, debossed with "32" on one side and "H" on other side.          Bottles of 30                                NDC 52343-054-30          Bottles of 90                                NDC 52343-054-90          Bottles of 500                              NDC 52343-054-05  Pioglitazone Tablets USP, 45 mg are white to off-white, round, flat faced, beveled edge uncoated tablets, debossed with "33" on one side and  "H" on other side.          Bottles of 30                                NDC 52343-055-30          Bottles of 90                                NDC 52343-055-90          Bottles of 500                              NDC 52343-055-05           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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

PIOGLITAZONE HYDROCHLORIDE - PIOGLITAZONE HYDROCHLORIDE TABLET
Aphena Pharma Solutions - Tennessee, LLC
----------
MEDICATION GUIDE
Pioglitazone Tablets, USP
[Pioglitazone (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 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 no

Summary of Product characteristics

PIOGLITAZONE HYDROCHLORIDE - PIOGLITAZONE HYDROCHLORIDE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
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 USP, 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)
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,
investigate the probable cause, tre