ACTOPLUS MET XR- pioglitazone and metformin hydrochloride tablet, film coated, extended release

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

pioglitazone hydrochloride (UNII: JQT35NPK6C) (pioglitazone - UNII:X4OV71U42S), metformin hydrochloride (UNII: 786Z46389E) (metformin - UNII:9100L32L2N)

Доступна з:

Takeda Pharmaceuticals America, Inc.

ІПН (Міжнародна Ім'я):

pioglitazone hydrochloride

Склад:

pioglitazone 15 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

ACTOPLUS MET XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both pioglitazone and metformin is appropriate [see Clinical Studies (14)] . Important Limitations of Use Pioglitazone exerts its antihyperglycemic effect only in the presence of endogenous insulin. ACTOPLUS MET XR 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 (5.5)]. - Initiation in patients with established NYHA Class III or IV heart failure [see Boxed Warning] . - Severe renal impairment ( eGFR below 30 mL/min/1.73 m2 ) [see Warnings and Precautions (5.2)]. - Use in patients with known hypersensitivity to pioglitazone, metformin or any other component of ACTOPLUS MET XR. - Metabolic acidosis, including diabetic ketoacidosis. Diabetic ketoacidosis should be treated with insulin. Risk Summary

Огляд продуктів:

ACTOPLUS MET XR is available in 15 mg pioglitazone (as the base)/1000 mg metformin hydrochloride extended-release and 30 mg pioglitazone (as the base)/1000 mg metformin hydrochloride extended-release tablets as follows: 15 mg/1000 mg tablet: white to off-white, round, film-coated tablets imprinted with "4833X" and "15/1000" in red on one side, available in: NDC 64764-510-30 Bottles of 30 NDC 64764-510-60 Bottles of 60 NDC 64764-510-90 Bottles of 90 30 mg/1000 mg tablet: white to off-white round, film-coated tablets imprinted with "4833X" and "30/1000" in light blue on one side, available in: NDC 64764-310-30 Bottles of 30 NDC 64764-310-60 Bottles of 60 NDC 64764-310-90 Bottles of 90 Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed, and protect from moisture and humidity.

Статус Авторизація:

New Drug Application

інформаційний буклет

ACTOPLUS MET XR- PIOGLITAZONE AND METFORMIN HYDROCHLORIDE TABLET, FILM
COATED, EXTENDED
RELEASE
Takeda Pharmaceuticals America, Inc.
----------
MEDICATION GUIDE
ACTOPLUS MET XR (ak-TŌ-plus-met eX-R)
(pioglitazone and metformin hydrochloride extended-release) tablets
Read this Medication Guide carefully before you start taking ACTOPLUS
MET XR 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 ACTOPLUS
MET XR, ask your doctor or pharmacist.
What is the most important information I should know about ACTOPLUS
MET XR?
ACTOPLUS MET XR can cause serious side effects, including:
•
new or worse heart failure. Pioglitazone, one of the medicines in
ACTOPLUS MET XR, 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 ACTOPLUS MET XR 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, ACTOPLUS MET XR 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
•
lactic acidosis. Metformin, one of the medicines in ACTOPLUS MET XR,
can cause a rare but
serious condition called lactic acidosis (a buildup of an acid in the
blood) that can cause death.
Lactic acidosis is a medical emergency and must be treated in the
hospital.
Call your doctor right away if you have any of the following symptoms,
which could be signs of
lactic acidosis:
•
you feel cold in your hands or feet
•
you feel dizzy or lightheaded
•
you have a slow

Характеристики продукта

ACTOPLUS MET XR- PIOGLITAZONE AND METFORMIN HYDROCHLORIDE TABLET, FILM
COATED, EXTENDED
RELEASE
TAKEDA PHARMACEUTICALS AMERICA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ACTOPLUS MET XR SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR ACTOPLUS MET XR.
ACTOPLUS MET XR (PIOGLITAZONE AND METFORMIN HYDROCHLORIDE
EXTENDED-RELEASE) TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 2009
WARNING: CONGESTIVE HEART FAILURE AND LACTIC ACIDOSIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
CONGESTIVE HEART FAILURE
•
•
•
•
LACTIC ACIDOSIS
•
•
•
RECENT MAJOR CHANGES
Warnings and Precautions
Urinary Bladder Tumors (5.6)
12/2016
INDICATIONS AND USAGE
ACTOPLUS MET XR is a thiazolidinedione and biguanide combination
product indicated as an adjunct to diet and exercise
to improve glycemic control in adults with type 2 diabetes mellitus
when treatment with both pioglitazone and metformin is
appropriate. (1)
Important Limitations of Use:
•
DOSAGE AND ADMINISTRATION
•
•
THIAZOLIDINEDIONES, INCLUDING PIOGLITAZONE, WHICH IS A COMPONENT OF
ACTOPLUS MET XR, CAUSE OR
EXACERBATE CONGESTIVE HEART FAILURE IN SOME PATIENTS. (5.1)
AFTER INITIATION OF ACTOPLUS MET XR, 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 ACTOPLUS MET XR MUST BE CONSIDERED. (5.1)
ACTOPLUS MET XR IS NOT RECOMMENDED IN PATIENTS WITH SYMPTOMATIC HEART
FAILURE. (5.1)
INITIATION OF ACTOPLUS MET XR IN PATIENTS WITH ESTABLISHED NEW YORK
HEART ASSOCIATION (NYHA)
CLASS III OR IV HEART FAILURE IS CONTRAINDICATED. (4, 5.1)
POST-MARKETING CASES OF METFORMIN-ASSOCIATED LACTIC ACIDOSIS HAVE
RESULTED IN DEATH, HYPOTHERMIA,
HYPOTENSION, AND RESISTANT BRADYARRHYTHMIAS. SYMPTOMS INCLUDED
MALAISE, MYALGIAS, RESPIRATORY
DISTRESS, SOMNOLENCE,