ACTOPLUS MET- pioglitazone hydrochloride and metformin hydrochloride tablet, film coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

PIOGLITAZONE HYDROCHLORIDE (UNII: JQT35NPK6C) (PIOGLITAZONE - UNII:X4OV71U42S), METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)

Tilgængelig fra:

Physicians Total Care, Inc.

INN (International Name):

PIOGLITAZONE HYDROCHLORIDE

Sammensætning:

PIOGLITAZONE HYDROCHLORIDE 15 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

ACTOPLUS MET 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 who are already treated with a thiazolidinedione and metformin or who have inadequate glycemic control on a thiazolidinedione alone or metformin alone. Initiation of ACTOPLUS MET in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated (see BOXED WARNING ). In addition, ACTOPLUS MET is contraindicated in patients with: - Renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥ 1.5 mg/dL [males], ≥ 1.4 mg/dL [females], or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (see WARNINGS, Metformin hydrochloride and PRECAUTIONS, General: Metformin hydrochloride ). - Known hypersensitivity to pioglitazone, metformin or any other component of ACTOP

Produkt oversigt:

ACTOPLUS MET is available in 15 mg pioglitazone hydrochloride (as the base)/500 mg metformin hydrochloride and 15 mg pioglitazone hydrochloride (as the base)/850 mg metformin hydrochloride tablets as follows: 15 mg/500 mg tablet: white to off-white, oblong, film-coated tablet with "4833M" on one side, and "15/500" on the other, available in: 15 mg/850 mg tablet: white to off-white, oblong, film-coated tablet with "4833M" on one side, and "15/850" on the other, available in: 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.

Autorisation status:

New Drug Application

Indlægsseddel

ACTOPLUS MET - PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
TABLET, FILM COATED
Physicians Total Care, Inc.
----------
MEDICATION GUIDE
ACTOPLUS MET® (ak-TŌ-plus-met)
(pioglitazone hydrochloride and metformin hydrochloride) tablets
Read this Medication Guide carefully before you start taking ACTOPLUS
MET 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, ask
your doctor or pharmacist.
What is the most important information I should know about ACTOPLUS
MET?
ACTOPLUS MET can cause serious side effects, including new or worse
heart failure.
•
Pioglitazone, one of the medicines in ACTOPLUS MET, 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 ACTOPLUS MET.
•
If you have heart failure with symptoms (such as shortness of breath
or swelling), even if these
symptoms are not severe, ACTOPLUS MET 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.
Metformin, one of the medicines in ACTOPLUS MET, 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.
Most people who have had lactic acidosis with metformin have other
things that, combined with the
metformin, led to the lactic acidosis. Tell your doctor if you have
any of the following, because you have
a higher chance for getting lactic acidosis with ACTOPLUS

Produktets egenskaber

ACTOPLUS MET - PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
TABLET, FILM COATED
PHYSICIANS TOTAL CARE, INC.
----------
ACTOPLUS MET®
(PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE) TABLETS
WARNING: CONGESTIVE HEART FAILURE
Thiazolidinediones, including pioglitazone, which is a component of
ACTOPLUS MET,
cause or exacerbate congestive heart failure in some patients (see
WARNINGS, _PIOGLITAZONE_
_HYDROCHLORIDE_). After initiation of ACTOPLUS MET, 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 ACTOPLUS MET must be considered.
ACTOPLUS MET is not recommended in patients with symptomatic heart
failure. Initiation of
ACTOPLUS MET in patients with established NYHA Class III or IV heart
failure is
contraindicated (see CONTRAINDICATIONS and WARNINGS, _PIOGLITAZONE_
_HYDROCHLORIDE_).
DESCRIPTION
ACTOPLUS MET (pioglitazone hydrochloride and metformin hydrochloride)
tablets contain two oral
antihyperglycemic drugs used in the management of type 2 diabetes:
pioglitazone hydrochloride and
metformin hydrochloride. The concomitant use of pioglitazone and
metformin has been previously
approved based on clinical trials in patients with type 2 diabetes
inadequately controlled on metformin.
Additional efficacy and safety information about pioglitazone and
metformin monotherapies may be
found in the prescribing information for each individual drug.
Pioglitazone hydrochloride is an oral antihyperglycemic agent that
acts primarily by decreasing insulin
resistance. Pioglitazone is used in the management of type 2 diabetes.
Pharmacological studies indicate
that pioglitazone improves sensitivity to insulin in muscle and
adipose tissue and inhibits hepatic
gluconeogenesis. Pioglitazone improves glycemic control while reducing
circulating insulin l