PIOGLITAZONE HYDROCHLORIDE tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Preferred Pharmaceuticals Inc.

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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)] . 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 poorly controlled diabetes in pregnancy [see Clinical Considerations]

Resumen del producto:

Pioglitazone tablets, USP are available in 15 mg, 30 mg, and 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 68788-6888-3 Bottles of 30 NDC 68788-6888-6 Bottles of 60 NDC 68788-6888-9 Bottles of 90 NDC 68788-68881- Bottles of 100 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.

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

PIOGLITAZONE HYDROCHLORIDE- pioglitazone hydrochloride tablet
Preferred 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
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Do not take pioglitazone tablets if you have severe heart failure
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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:
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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.

Ficha técnica

PIOGLITAZONE HYDROCHLORIDE- PIOGLITAZONE HYDROCHLORIDE TABLET
PREFERRED 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.
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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:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tablets: 15 mg, 30 mg, and 45 mg ( 3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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)
Not for treatment of type 1 diabetes or diabetic ketoacidosis. ( 1)
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