PIOGLITAZONE AND METFORMIN tablet, film coated

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Sandoz Inc

SNN (starptautisko nepatentēto nosaukumu):

PIOGLITAZONE HYDROCHLORIDE

Kompozīcija:

PIOGLITAZONE 15 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Pioglitazone and metformin hydrochloride tablets are 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. Pioglitazone and metformin hydrochloride 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 (5.5)] . Risk Summary Limited data with pioglitazone and metformin hydrochloride or pioglitazone in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. Published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [see Data]. There are risks to the mot

Produktu pārskats:

Pioglitazone and metformin hydrochloride tablets, USP are available in 15 mg pioglitazone (as the base)/500 mg metformin hydrochloride and 15 mg pioglitazone (as the base)/850 mg metformin hydrochloride as follows: Pioglitazone and metformin hydrochloride 15 mg/500 mg tablets are white, oval, biconvex, film-coated tablets with “SZ441” on one side and are supplied as follows: Pioglitazone and metformin hydrochloride 15 mg/850 mg tablets are white, oval, biconvex, film-coated tablets with “SZ442” on one side and are supplied as follows: Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep container tightly closed, and protect from moisture and humidity.

Autorizācija statuss:

Abbreviated New Drug Application

Lietošanas instrukcija

PIOGLITAZONE AND METFORMIN- PIOGLITAZONE AND METFORMIN TABLET, FILM
COATED
Sandoz Inc
----------
MEDICATION GUIDE
Pioglitazone and Metformin Hydrochloride Tablets, USP
(pie-oh-GLIT-ah-zohn and met-FORE-min)
Read this Medication Guide carefully before you start taking
pioglitazone and metformin hydrochloride
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 and metformin hydrochloride, ask your
doctor or pharmacist.
What is the most important information I should know about
pioglitazone and metformin hydrochloride
tablets?
Pioglitazone and metformin hydrochloride tablets can cause serious
side effects, including:
•
new or worse heart failure. Pioglitazone, one of the medicines in
pioglitazone and metformin
hydrochloride 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.
o
Do not take pioglitazone and metformin hydrochloride tablets if you
have severe heart failure
o
If you have heart failure with symptoms (such as shortness of breath
or swelling), even if these
symptoms are not severe, pioglitazone and metformin hydrochloride
tablets may not be right for
you.
Call your doctor right away if you have any of the following:
o
swelling or fluid retention, especially in the ankles or legs
o
shortness of breath or trouble breathing, especially when you lie down
o
an unusually fast increase in weight
o
unusual tiredness
•
lactic acidosis. Metformin, one of the medicines in pioglitazone and
metformin hydrochloride
tablets, 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 righ

Produkta apraksts

PIOGLITAZONE AND METFORMIN- PIOGLITAZONE AND METFORMIN TABLET, FILM
COATED
SANDOZ INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PIOGLITAZONE AND METFORMIN
HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR PIOGLITAZONE AND
METFORMIN HYDROCHLORIDE TABLETS.
PIOGLITAZONE AND METFORMIN HYDROCHLORIDE, TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 2005
WARNING: CONGESTIVE HEART FAILURE AND LACTIC ACIDOSIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
CONGESTIVE HEART FAILURE
•
•
•
•
LACTIC ACIDOSIS
•
•
•
INDICATIONS AND USAGE
Pioglitazone and metformin hydrochloride tablets are 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, 14)
Important Limitations of Use:
•
DOSAGE AND ADMINISTRATION
•
•
•
•
THIAZOLIDINEDIONES, INCLUDING PIOGLITAZONE, WHICH IS A COMPONENT OF
PIOGLITAZONE AND METFORMIN
HYDROCHLORIDE, CAUSE OR EXACERBATE CONGESTIVE HEART FAILURE IN SOME
PATIENTS. (5.1)
AFTER INITIATION OF PIOGLITAZONE AND METFORMIN HYDROCHLORIDE, 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 AND METFORMIN
HYDROCHLORIDE MUST BE CONSIDERED. (5.1)
PIOGLITAZONE AND METFORMIN HYDROCHLORIDE IS NOT RECOMMENDED IN
PATIENTS WITH SYMPTOMATIC HEART
FAILURE. (5.1)
INITIATION OF PIOGLITAZONE AND METFORMIN HYDROCHLORIDE 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 BRADYARRHYTHMIA