PIOGLITAZONE HYDROCHLORIDE- pioglitazone hydrochloride tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

PD-Rx Pharmaceuticals, Inc.

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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 tablet 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 associated with poo

Produkto santrauka:

Pioglitazone tablets, USP are available in 45 mg tablets as follows: 45 mg tablet: White to off-white, flat, round, uncoated tablets with beveled edges debossed with ‘PIO’ on one side and ‘45’ on the other side, available in: NDC 43063-896-90 Bottles of 90 Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container.

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

PD-Rx Pharmaceuticals, Inc.
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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 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 diabetes.
Pi

Prekės savybės

PIOGLITAZONE HYDROCHLORIDE- PIOGLITAZONE HYDROCHLORIDE TABLET
PD-RX PHARMACEUTICALS, 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 HYDROCHLORIDE, 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)
INDICATIONS AND USAGE
Pioglitazone tablet 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,
inves