PIOGLITAZONEHYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PIOGLITAZONE HYDROCHLORIDE (UNII: JQT35NPK6C) (PIOGLITAZONE - UNII:X4OV71U42S)

Available from:

Proficient Rx LP

INN (International Name):

PIOGLITAZONE HYDROCHLORIDE

Composition:

PIOGLITAZONE 30 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Monotherapy and Combination Therapy Pioglitazone tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)] . Important Limitation of Use Pioglitazone tablets, USP exert its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone tablets, USP 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 (5.3)] . Pregnancy Category C.   There are no adequate and well-controlled studies of pioglitazone hydrochloride in pregnant women. Animal studies show increased rates of post-implantation loss, delayed development, reduced fetal weights, and delayed parturition at doses 10 to 40 times the maximum recommended human dose. Pioglitazone hydrochloride should be used during pregnancy only if the potential benefit justifies the potential

Product summary:

Pioglitazone hydrochloride, USP is available in 15 mg, 30 mg, and 45 mg tablets as follows: 30 mg Tablet: White to off-white, round, flat faced beveled edge, uncoated tablets debossed with '1119' on one side and plain on other side, available in: Bottles of 30                             NDC 63187-746-30 Bottles of 60                             NDC 63187-746-60 Bottles of 90                            NDC 63187-746-90 Storage Store at 20°-25°C (68°-77°F); excursions permitted to 15-30°C (59°-86°F) [see USP Controlled Room Temperature]. Keep container tightly closed, and protect from moisture.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

PIOGLITAZONEHYDROCHLORIDE- PIOGLITAZONEHYDROCHLORIDE TABLET
Proficient Rx LP
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MEDICATION GUIDE
MEDICATION GUIDE
Pioglitazone (pye-oh-GLI-ta-zone) Tablets, USP
Read this Medication Guide carefully before you start taking
pioglitazone 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 tablets, ask
your doctor or pharmacist.
What is the most important information I should know about
pioglitazone tablets?
Pioglitazone tablets can cause serious side effects, including new or
worse heart failure.
•
– Pioglitazone 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 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 tablets may not be right for you
Call your doctor right away if you have any of the following:
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– 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
Pioglitazone tablets can have other serious side effects. See "What
are the possible side effect of
pioglitazone tablets?"
What are pioglitazone tablets?
Pioglitazone tablets are a prescription medicine used with diet and
exercise to improve blood sugar
(glucose) control in adults with type 2 diabetes. Pioglitazone tablets
are a diabetes medicine called
pioglitazone that may be taken alone or with other diabetes medicines.
It is not known if pioglitazone tablets are safe and effective in
children under the age of 18.
Pioglitazone is not recommended for

Summary of Product characteristics

PIOGLITAZONEHYDROCHLORIDE- PIOGLITAZONEHYDROCHLORIDE TABLET
PROFICIENT RX LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PIOGLITAZONE HYDROCHLORIDE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PIOGLITAZONE
HYDROCHLORIDE.
PIOGLITAZONE TABLETS, USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1999
WARNING: CONGESTIVE HEART FAILURE
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
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INDICATIONS AND USAGE
Pioglitazone tablets, USP are a thiazolidinedione and an agonist for
peroxisome proliferator-activated receptor (PPAR)
gamma indicated as an adjunct to diet and exercise to improve glycemic
control in adults with type 2 diabetes mellitus in
multiple clinical settings. (1, 14) (1)
Important Limitation of Use: (1)
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tablets: 15 mg, 30 mg, and 45 mg (3) (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions (≥5%) are upper respiratory tract
infection, headache, sinusitis, myalgia, and pharyngitis.
(6.1) (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TORRENT PHARMA INC. AT
1-269-544-2299 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. (6)
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
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SEE 17 FOR PATIENT COUNSELING INFORMATION AND MEDICATION GUIDE.
REVISED: 1/2021
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: CONGESTIVE HEART FAILURE
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommendations for All Patients
2.2 Concomitant Use with an Insulin Secretagogue or Insulin
2.3 Concomitant Use with Strong CYP2C8 Inhibitors
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Congestive Heart Failure
5.2 Hypoglycemia
5.3 Hepatic Effects
5.4 Urinary Bladder Tumors
5.5 Edema
5.6 Fractures
5.7 Macular Edema
5.8 Ovulation
5.9 Macrovascular Outcomes
– THIAZOLIDINEDIONES, INCLUDING PIOGLITAZONE HYDROCHLORIDE, CAUSE OR
EXA