PIOGLITAZONE tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

DirectRX

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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 tablet exerts 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 hydrochloride 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 associ

Produkto santrauka:

Pioglitazone tablets, USP are available in 15 mg, 30 mg, and 45 mg tablets as follows: 15 mg tablet: White to off-white, round, biconvex, uncoated tablets debossed with ‘P’ on one side and '15' on other side, available in: NDC 16729-020-10 Bottles of 30 NDC 16729-020-15 Bottles of 90 NDC 16729-020-16 Bottles of 500 30 mg tablet: White to off-white, flat, round, uncoated tablets with beveled edges debossed with ‘PIO’ on one side and ‘30’ on the other side, available in: NDC 16729-021-10 Bottles of 30 NDC 16729-021-15 Bottles of 90 NDC 16729-021-16 Bottles of 500 45 mg tablet: White to off-white, flat, round, uncoated tablets with beveled edges debossed with ‘PIO’ on one side and ‘45’ on the other side, available in: NDC 16729-022-10 Bottles of 30 NDC 16729-022-15 Bottles of 90 NDC 16729-022-16 Bottles of 500 Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container.

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

PIOGLITAZONE- PIOGLITAZONE TABLET
DirectRX
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MEDICATION GUIDE
Pioglitazone Tablets
(PYE o GLIT a 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 ta

Prekės savybės

PIOGLITAZONE- PIOGLITAZONE TABLET
DIRECTRX
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PIOGLITAZONE
WARNING: CONGESTIVE HEART FAILURE
Thiazolidinediones, including pioglitazone hydrochloride, cause or
exacerbate congestive heart
failure in some patients [see Warnings and Precautions (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 hydrochloride must
be considered.
Pioglitazone tablets are not recommended in patients with symptomatic
heart failure
Initiation of pioglitazone hydrochloride in patients with established
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 tablet exerts 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 patie