PIOGLITAZONE tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

DIRECT RX

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske 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)]. 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 tablets. 8.1 Pregnancy 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

Proizvod sažetak:

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. 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. Pioglitazone Tablets USP, 45 mg are white to off-white, round, flat faced, beveled edge uncoated tablets, debossed with “33” on one side and “H” on other side. 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 autorizacije:

Abbreviated New Drug Application

Uputa o lijeku

PIOGLITAZONE- PIOGLITAZONE TABLET
DIRECT RX
----------
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 not for people with type 1 diabetes.
Pioglitazone tablets a

Svojstava lijeka

PIOGLITAZONE- PIOGLITAZONE TABLET
DIRECT RX
----------
PIOGLITAZONE
WARNING: CONGESTIVE HEART FAILURE
Thiazolidinediones, including pioglitazone, cause or exacerbate
congestive heart failure in some
patients [see WARNINGS AND PRECAUTIONS (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.
Pioglitazone is not recommended in patients with symptomatic heart
failure.
Initiation of pioglitazone in patients with established New York Heart
Association (NYHA) Class
III or IV heart failure is contraindicated [see CONTRAINDICATIONS (4)
and WARNINGS
AND PRECAUTIONS (5.1)].
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)].
2.1 Recommendations for All Patients
Pioglitazone tablets should be taken once daily and can be taken
without regard to meals.
The recommended starting dose for patients without congestive heart
failure is 15 mg or 30 mg once
daily.
The recommended starting dose for patients with congestive heart
failure (NYHA Class I or II) is 15 mg
once daily.
The dose can be titrated in increments of 15 mg up to a maximum of 45
mg once daily based on glycemic
response as determined by HbA1c.
After initiation of pioglitazone tablets or with dose increase,
monitor patients carefully for adverse
reacti