PIOGLITAZONE- pioglitazone tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Institutional Inc.

INN (International Name):

PIOGLITAZONE HYDROCHLORIDE

Composition:

PIOGLITAZONE 15 mg

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 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. Limited data with pioglitazone tablets 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 associated with poorly controlled di

Product summary:

Pioglitazone Tablets, USP are available containing pioglitazone hydrochloride, USP equivalent to 15 mg or 30 mg of pioglitazone base. The 15 mg tablets are white to off-white, round, unscored tablets debossed with M over 48 on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-513-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 30 mg tablets are white to off-white, round, unscored tablets debossed with M over 228 on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-514-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Storage:   Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light, moisture and humidity. PHARMACIST: Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Mylan Institutional 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 d

Summary of Product characteristics

PIOGLITAZONE- PIOGLITAZONE TABLET
MYLAN INSTITUTIONAL 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 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. ( 5.1)
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 ( 5.4) 12/2016
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 ca