PIOGLITAZONE tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Zydus Pharmaceuticals USA Inc.

INN (Nome Internazionale):

PIOGLITAZONE HYDROCHLORIDE

Composizione:

PIOGLITAZONE 15 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 hydrochloride exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone hydrochloride 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 hydrochloride. 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 t

Dettagli prodotto:

Pioglitazone Tablets, USP equivalent to 15 mg of pioglitazone are off-white to cream white, round flat faced beveled edge uncoated tablet debossed with "306" on one side and plain on other side and are supplied as follows: NDC 68382-306-06 in bottle of 30 tablets NDC 68382-306-16 in bottle of 90 tablets NDC 68382-306-01 in bottle of 100 tablets NDC 68382-306-05 in bottle of 500 tablets NDC 68382-306-10 in bottle of 1000 tablets NDC 68382-306-77 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Pioglitazone Tablets, USP equivalent to 30 mg of pioglitazone are off-white to cream white, round flat faced beveled edge uncoated tablet debossed with "307" on one side and plain on other side and are supplied as follows: NDC 68382-307-06 in bottle of 30 tablets NDC 68382-307-16 in bottle of 90 tablets NDC 68382-307-01 in bottle of 100 tablets NDC 68382-307-05 in bottle of 500 tablets NDC 68382-307-10 in bottle of 1000 tablets NDC 68382-307-77 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Pioglitazone Tablets, USP equivalent to 45 mg of pioglitazone are off-white to cream white, round flat faced beveled edge uncoated tablet debossed with "308" on one side and plain on other side and are supplied as follows: NDC 68382-308-06 in bottle of 30 tablets NDC 68382-308-16 in bottle of 90 tablets NDC 68382-308-01 in bottle of 100 tablets NDC 68382-308-05 in bottle of 500 tablets NDC 68382-308-10 in bottle of 1000 tablets NDC 68382-308-77 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets 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.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

Zydus Pharmaceuticals USA Inc.
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Medication Guide
Pioglitazone (PYE o GLIT a zone) Tablets, USP
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 tablets are safe and effective in
children under the age of 18. Pioglitazone
hydrochloride is not recommended for use in children.
Pioglitazone hydrochloride is not for

Scheda tecnica

PIOGLITAZONE - PIOGLITAZONE TABLET
ZYDUS PHARMACEUTICALS USA 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 HYDROCHLORIDE, 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 HYDROCHLORIDE MUST BE CONSIDERED. (5.1)
PIOGLITAZONE HYDROCHLORIDE IS NOT RECOMMENDED IN PATIENTS WITH
SYMPTOMATIC HEART
FAILURE.(5.2)
INITIATION OF PIOGLITAZONE HYDROCHLORIDE IN PATIENTS WITH ESTABLISHED
NEW YORK HEART
ASSOCIATION (NYHA) CLASS III OR IV HEART FAILURE IS CONTRAINDICATED.
(4, 5.1)
INDICATIONS AND USAGE
Pioglitazone tablets, USP 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 hydrochloride. If
abnormal, use caution when treating with
pioglitazone hydrochl