PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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Patient Information leaflet (PIL)

08-11-2022

Summary of Product characteristics (SPC)

08-11-2022

Active ingredient:

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

Available from:

Aurobindo Pharma Limited

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 they 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 pioglitazone and metformin hydrochloride tablets. - Metabolic acidosis, includin

Product summary:

Pioglitazone and Metformin Hydrochloride Tablets USP, 15 mg/500 mg are white to off-white, oblong, biconvex film-coated tablets, debossed with ‘H’ on one side and ‘92’ on other side. Bottles of 60 NDC 65862-525-60 Bottles of 180 NDC 65862-525-18 Pioglitazone and Metformin Hydrochloride Tablets USP, 15 mg/850 mg are white to off-white, oblong, biconvex film-coated tablets, debossed with ‘H’ on one side and ‘93’ on other side. Bottles of 60 NDC 65862-526-60 Bottles of 180 NDC 65862-526-18 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE - PIOGLITAZONE
HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED
Aurobindo Pharma Limited
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MEDICATION GUIDE
Pioglitazone and Metformin Hydrochloride Tablets, USP
(pye'' oh gli' ta zone and 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 blood) that

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Summary of Product characteristics

PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE -
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM
COATED
AUROBINDO PHARMA LIMITED
----------
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
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)
LACTIC ACIDOSIS
POST-MARKETING CASES OF METFORMIN-ASSOCIATED LACTIC ACIDOSIS HAVE
RESULTED IN
DEATH, HYPOTHERMIA, HYPOTENSION, AND RESISTANT BRADYARRHYTHMIAS.
SYMPTOMS
INCLUDED MALAISE, MYALGIAS, RESPIRATORY DISTRESS, SOMNOLENCE, AND
ABDOMINAL PAIN.
LABORATORY ABNORMALITIES INCLUDED ELEVATED BLOOD LACTATE LEVELS, ANION
GAP ACIDOSIS,
INCREASED LACTATE:PYRUVATE RATIO; AND METFORMIN PLASMA LEVELS
GENERALLY GREATER
THAN 5 MCG/ML. (5.2)
RISK FACTORS INCLUDE RENAL IMPAIRMENT, CONCOMITANT USE OF CERTAIN
DRUGS, A

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