PIOGLITAZONE tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Major Pharmaceuticals

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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)] . Risk Summary Limited data with pioglitazone 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] . In animal reproduction studies, no adverse developmental effects were observed when pioglitazone was administered to pregnant rats a

Povzetek izdelek:

Pioglitazone is available in 15 mg, 30 mg, and 45 mg tablets as follows: Pioglitazone Tablets USP, 15 mg are white to off-white, round, biconvex, uncoated tablets, debossed with “31” on one side and “H” on other side. Carton of 100 (10 tablets per blister pack x 10), NDC 0904-7090-61           Pioglitazone Tablets USP, 30 mg are white to off-white, round, flat faced, beveled edge uncoated tablets, debossed with “32” on one side and “H” on other side. Carton of 100 (10 tablets per blister pack x 10), NDC 0904-7096-61              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.

Status dovoljenje:

Abbreviated New Drug Application

Navodilo za uporabo

PIOGLITAZONE- PIOGLITAZONE TABLET
Major Pharmaceuticals
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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 no

Lastnosti izdelka

PIOGLITAZONE- PIOGLITAZONE TABLET
MAJOR PHARMACEUTICALS
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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
•
•
•
•
RECENT MAJOR CHANGES
Warnings and Precautions
Urinary bladder tumors (5.4) 12/2016
INDICATIONS AND USAGE
Pioglitazone 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:
•
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 15 mg, 30 mg, and 45 mg (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
THIAZOLIDINEDIONES, INCLUDING PIOGLITAZONE, CAUSE OR EXACERBATE
CONGESTIVE HEART
FAILURE IN SOME PATIENTS. (5.1)
AFTER INITIATION OF PIOGLITAZONE, 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 MUST BE CONSIDERED. (5.1)
PIOGLITAZONE IS NOT RECOMMENDED IN PATIENTS WITH SYMPTOMATIC HEART
FAILURE. (5.1)
INITIATION OF PIOGLITAZONE 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 increments up to a
maximum of 45 mg once daily. (2.1)
Obtain liver tests before starting pioglitazone tablets. If abnormal,
use caution w