PIOGLITAZONE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NorthStar RxLLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 exerts 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 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 and fetus a

Product summary:

Pioglitazone hydrochloride USP is available in 15 mg, 30 mg, and 45 mg tablets as follows: 15 mg tablet: White to off white, circular, flat face, bevelled edge, uncoated tablet debossed with "ML 86" on one side and plain on the other side available in: NDC 16714-645-01 Bottles of 30 NDC 16714-645-02 Bottles of 90 NDC 16714-645-03 Bottles of 500   30 mg tablet: White to off white, circular, flat face, bevelled edge, uncoated tablet debossed with "ML 87" on one side and plain on the other side available in: NDC 16714-646-01 Bottles of 30 NDC 16714-646-02 Bottles of 90 NDC 16714-646-03 Bottles of 500   45 mg tablet: White to off white, circular, flat face, bevelled edge, uncoated tablet debossed with "ML 91" on one side and plain on the other side available in: NDC 16714-647-01 Bottles of 30 NDC 16714-647-02 Bottles of 90 NDC 16714-647-03 Bottles of 500   Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°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 - PIOGLITAZONE TABLET
NorthStar RxLLC
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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 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
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 for peop

Summary of Product characteristics

PIOGLITAZONE - PIOGLITAZONE TABLET
NORTHSTAR RXLLC
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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, 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 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 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 caut