PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE- pioglitazone hydrochloride and metformin hydrochloride tablet, film coat

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

PIOGLITAZONE HYDROCHLORIDE

Composition:

PIOGLITAZONE 15 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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)] . Limited data with pioglitazone and metformin hydrochloride tablets 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 mother a

Product summary:

Pioglitazone and Metformin Hydrochloride Tablets, USP are available in 15 mg pioglitazone hydrochloride, USP (as the base)/500 mg metformin hydrochloride, USP or 15 mg pioglitazone hydrochloride, USP (as the base)/850 mg metformin hydrochloride, USP tablets. The 15 mg/500 mg tablets are white to off-white, film-coated, oval, unscored tablets debossed with MYLAN on one side of the tablet and P155 on the other side. They are available as follows: NDC 0378-1550-91 bottles of 60 tablets The 15 mg/850 mg tablets are white to off-white, film-coated, oval, unscored tablets debossed with MYLAN on one side of the tablet and P157 on the other side. They are available as follows: NDC 0378-1575-91 bottles of 60 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture and humidity. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE- PIOGLITAZONE
HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED
Mylan Pharmaceuticals Inc.
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MEDICATION GUIDE
Pioglitazone and Metformin Hydrochloride Tablets, USP
(pye′′ oh gli′ ta zone met for′ min hye′′ droe klor′
ide)
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 tablets, 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.
•
Do not take pioglitazone and metformin hydrochloride 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 and metformin
hydrochloride 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
•
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
b

Summary of Product characteristics

PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE- PIOGLITAZONE
HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED
MYLAN PHARMACEUTICALS 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
•
•
•
RECENT MAJOR CHANGES
Warnings and Precautions
Urinary Bladder Tumors (5.6) 12/2016
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 TABLETS, CAUSE OR EXACERBATE CONGESTIVE HEART FAILURE IN
SOME PATIENTS. (5.1)
AFTER INITIATION OF PIOGLITAZONE AND METFORMIN HYDROCHLORIDE 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 AND METFORMIN
HYDROCHLORIDE TABLETS MUST BE CONSIDERED. (5.1)
PIOGLITAZONE AND METFORMIN HYDROCHLORIDE TABLETS ARE NOT RECOMMENDED
IN PATIENTS WITH
SYMPTOMATIC HEART FAILURE. (5.1)
INITIATION OF PIOGLITAZONE AND METFORMIN HYDROCHLORIDE TABLETS IN
PATIENTS WITH ESTABLISHED NEW
YORK HEART ASSOCIATION (NYHA) CLASS III OR IV