ACTOS- 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:

Rebel Distributors Corp.

INN (इंटरनेशनल नाम):

pioglitazone hydrochloride

रचना:

pioglitazone hydrochloride 15 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

ACTOS is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Initiation of ACTOS in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated (see BOXED WARNING ).       ACTOS is contraindicated in patients with known hypersensitivity to this product or any of its components.

उत्पाद समीक्षा:

ACTOS is available in 15 mg, 30 mg, and 45 mg tablets as follows: 15 mg Tablet: white to off-white, round, convex, non-scored tablet with “ACTOS” on one side, and “15” on the other, available in: NDC 21695-147-15 Bottles of 15 30 mg Tablet: white to off-white, round, flat, non-scored tablet with “ACTOS” on one side, and “30” on the other, available in: NDC 21695-148-15 Bottles of 15 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Keep container tightly closed, and protect from moisture and humidity.

प्राधिकरण का दर्जा:

New Drug Application

सूचना पत्रक

Rebel Distributors Corp.
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MEDICATION GUIDE
ACTOS® (ak-TŌS)
(pioglitazone hydrochloride) tablets
Read this Medication Guide carefully before you start taking ACTOS 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 ACTOS, ask your doctor or
pharmacist.
What is the most important information I should know about ACTOS?
ACTOS can cause serious side effects, including new or worse heart
failure.
•
ACTOS 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.
•
If you have severe heart failure, you cannot start ACTOS.
•
If you have heart failure with symptoms (such as shortness of breath
or swelling), even if these
symptoms are not severe, ACTOS 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.
ACTOS can have other serious side effects. See "What are the possible
side effects of ACTOS?"
What is ACTOS?
ACTOS is a prescription medicine used with diet and exercise to
improve blood sugar (glucose) control
in adults with type 2 diabetes. ACTOS is a diabetes medicine called
pioglitazone hydrochloride that may
be taken alone or with other diabetes medicines.
Your doctor will decide if you should take ACTOS.
It is important to eat the right foods, lose weight if needed, and
exercise regularly in order to manage your
type 2 diabetes. Diet, weight loss, and exercise are the main
treatments for type 2 diabetes and they also
help your diabetes medicines work better for you.
ACTOS has not been studied in children and is not r

उत्पाद विशेषताएं

ACTOS- PIOGLITAZONE HYDROCHLORIDE TABLET
REBEL DISTRIBUTORS CORP.
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ACTOS
(PIOGLITAZONE HYDROCHLORIDE) TABLETS
WARNING: CONGESTIVE HEART FAILURE
Thiazolidinediones, including ACTOS, cause or exacerbate congestive
heart failure in some
patients (see WARNINGS). After initiation of ACTOS, and after dose
increases, observe
patients carefully for signs and symptoms of heart failure (including
excessive, rapid weight
gain, dyspnea, and/or edema). If these signs and symptoms develop, the
heart failure should be
managed according to the current standards of care. Furthermore,
discontinuation or dose
reduction of ACTOS must be considered.
ACTOS is not recommended in patients with symptomatic heart failure.
Initiation of ACTOS in
patients with established NYHA Class III or IV heart failure is
contraindicated (see
CONTRAINDICATIONS and WARNINGS).
DESCRIPTION
ACTOS (pioglitazone hydrochloride) is an oral antidiabetic agent that
acts primarily by decreasing
insulin resistance. ACTOS is used in the management of type 2 diabetes
mellitus (also known as non-
insulin-dependent diabetes mellitus [NIDDM] or adult-onset diabetes).
Pharmacological studies indicate
that ACTOS improves sensitivity to insulin in muscle and adipose
tissue and inhibits hepatic
gluconeogenesis. ACTOS improves glycemic control while reducing
circulating insulin levels.
Pioglitazone
[(±)-5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-]
thiazolidinedione
monohydrochloride belongs to a different chemical class and has a
different pharmacological action
than the sulfonylureas, metformin, or the α-glucosidase inhibitors.
The molecule contains one
asymmetric carbon, and the compound is synthesized and used as the
racemic mixture. The two
enantiomers of pioglitazone interconvert _in vivo_. No differences
were found in the pharmacologic
activity between the two enantiomers. The structural formula is as
shown:
Pioglitazone hydrochloride is an odorless white crystalline powder
that has a molecular formula of
C
H N O S•HCl and a molecular weight