PIOGLITAZONE tablet

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

PIOGLITAZONE (UNII: X4OV71U42S) (PIOGLITAZONE - UNII:X4OV71U42S)

Fáanlegur frá:

Solco Healthcare LLC

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Monotherapy and Combination Therapy Pioglitazone tablets are indicated as adjuncts 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 their antihyperglycemic effects 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 tablets 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 and rabbits duri

Vörulýsing:

Pioglitazone tablets, USP, are available in 15 mg, 30 mg, and 45 mg tablets as follows: 15 mg tablet: White to off-white, round, convex, nonscored tablet with “295” on one side, and “S” on the other, available in: NDC 43547-426-03         Bottles of 30 NDC 43547-426-09         Bottles of 90 NDC 43547-426-50         Bottles of 500 30 mg tablet: White to off-white, round, flat, nonscored tablet with “293” on one side, and “S” on the other, available in: NDC 43547-427-03         Bottles of 30 NDC 43547-427-09         Bottles of 90 NDC 43547-427-50         Bottles of 500 45 mg tablet: White to off-white, round, flat, nonscored tablet with “294” on one side, and “S” on the other, available in: NDC 43547-428-03         Bottles of 30 NDC 43547-428-09         Bottles of 90 NDC 43547-428-50         Bottles of 500 Storage Store at 20-25o C (68-77o F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Keep container tightly closed, and protect from light, moisture and humidity.

Leyfisstaða:

Abbreviated New Drug Application

Upplýsingar fylgiseðill

PIOGLITAZONE- PIOGLITAZONE TABLET
Solco Healthcare LLC
----------
MEDICATION GUIDE
Pioglitazone Tablets, USP
(pie-oh-GLIT-ah-zohn)
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 prescription medicines used with diet and
exercise to improve blood sugar (glucose)
control in adults with type 2 diabetes. Pioglitazone tablets are
diabetes medicines 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

Vara einkenni

PIOGLITAZONE- PIOGLITAZONE TABLET
SOLCO HEALTHCARE LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PIOGLITAZONE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PIOGLITAZONE.
PIOGLITAZONE (PIOGLITAZONE) TABLET FOR ORAL USE.
INITIAL U.S. APPROVAL: 1999
WARNING: CONGESTIVE HEART FAILURE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
•
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 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)
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 m