PIOGLITAZONE HYDROCHLORIDE- pioglitazone hydrochloride tablet

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Preferred Pharmaceuticals Inc.

INN (इंटरनेशनल नाम):

PIOGLITAZONE HYDROCHLORIDE

रचना:

PIOGLITAZONE 30 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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)] . Pioglitazone tablets exert their 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)] . Teratogenic Effects: Pregnancy Category C. There are no adequate and well-controlled studies of pioglitazone tablets in pregnant women. Animal studies show increased rates of post-implantation loss, delayed development, reduced fetal weights, and delayed parturition at doses 10 to 40 times the maximum recommended human dose. Pioglitazone hydrochloride tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Clinical Considerations :  Abnorm

उत्पाद समीक्षा:

Pioglitazone tablets USP are available in 15 mg, 30 mg, and 45 mg tablets as follows: 30 mg tablet: White, round, flat face beveled edge, non-scored tablet with “W ” on one side, and “30 ” on the other, available in: NDC 68788-6420-3 Bottles of 30 NDC 68788-6420-6 Bottles of 60 NDC 68788-6420-9 Bottles of 90 NDC 68788-6420-1 Bottles of 100 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.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

PIOGLITAZONE HYDROCHLORIDE- PIOGLITAZONE HYDROCHLORIDE TABLET
Preferred Pharmaceuticals Inc.
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MEDICATION GUIDE
Pioglitazone Tablets USP
(PYE-oh-GLI-ta-zone)
Revised: April 2014
Rx only
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 is not re

उत्पाद विशेषताएं

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 USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1999
WARNING: CONGESTIVE HEART FAILURE
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
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•
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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. (1.1, 14)
Important Limitation of Use:
•
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 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)
Not for treatment of type 1 diabetes or diabetic ketoacidosis. (1.2)
Initiate pioglitazone tablets USP 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 m