PIOGLITAZOLE AND METFORMIN HYDROCHLORIDE tablet

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:

Macleods Pharmaceuticals 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 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 pioglitazone and metformin hydrochloride tablets. • Metabolic acidosis, including diab

Product summary:

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 tablets as follows: Pioglitazone and metformin hydrochloride tablets, USP 15 mg / 500 mg: White to off-white coloured, capsule shaped, film-coated tablets debossed with 'C27' on one side and plain on the other side and are available as follows: Bottles of 60 tablets           (NDC 33342-176-09) Bottles of 100 tablets         (NDC 33342-176-11) Bottles of 180 tablets         (NDC 33342-176-57) Bottles of 1000 tablets       (NDC 33342-176-44) Cartons of 100 unit dose tablets (10×10)  (NDC 33342-176-12) Pioglitazone and Metformin hydrochloride tablets, USP 15 mg / 850 mg: White to off-white coloured, capsule shaped, film-coated tablets debossed with 'C28' on one side and plain on the other side. Bottles of 60 tablets           (NDC 33342-177-09) Bottles of 100 tablets         (NDC 33342-177-11) Bottles of 180 tablets         (NDC 33342-177-57)   Bottles of 1000 tablets       (NDC 33342-177-44) Cartons of 100 unit dose tablets (10×10)  (NDC 33342-177-12) Storage: Store at 20º to 25º C (68º to 77º F); excursions permitted to 15º to 30º C (59º to 86º 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

PIOGLITAZOLE AND METFORMIN HYDROCHLORIDE - PIOGLITAZOLE AND METFORMIN
HYDROCHLORIDE TABLET
Macleods Pharmaceuticals Limited
----------
SPL MEDGUIDE SECTION
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.
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 emerge

Summary of Product characteristics

PIOGLITAZOLE AND METFORMIN HYDROCHLORIDE - PIOGLITAZOLE AND
METFORMIN HYDROCHLORIDE TABLET
MACLEODS PHARMACEUTICALS 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 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 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, CO