ALOGLIPTIN AND PIOGLITAZONE- alogliptin benzoate and pioglitazone hydrochloride tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Alogliptin Benzoate (UNII: EEN99869SC) (Alogliptin - UNII:JHC049LO86), Pioglitazone hydrochloride (UNII: JQT35NPK6C) (Pioglitazone - UNII:X4OV71U42S)

Available from:

Padagis Israel Pharmaceuticals Ltd

INN (International Name):

Alogliptin Benzoate

Composition:

Alogliptin 12.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Alogliptin and pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Alogliptin and pioglitazone tablets should not be used in patients with type 1 diabetes mellitus. Serious hypersensitivity reaction to alogliptin or pioglitazone or any of the excipients in alogliptin and pioglitazone tablets, such as anaphylaxis, angioedema and severe cutaneous adverse reactions have been reported [see Warnings and Precautions (5.3), Adverse reactions (6.2)] . Do not initiate in patients with NYHA Class III or IV heart failure [see Boxed Warning] . Risk Summary Limited data with alogliptin and pioglitazone tablets in pregnant women are not sufficient to inform a drug-associated risk for major birth defects or miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations]. In animal reproduction studies, no adverse developmental effects were observ

Product summary:

Alogliptin and pioglitazone tablets are available in the following strengths and packages: 25 mg/15 mg tablet: yellow, round, biconvex and film-coated with both "A/P" and "25/15" printed on one side, available in: 25 mg/30 mg tablet: peach, round, biconvex and film-coated with both "A/P" and "25/30" printed on one side, available in: 25 mg/45 mg tablet: red, round, biconvex, film-coated and with both "A/P" and "25/45" printed on one side, available in: 12.5 mg/15 mg tablet: pale yellow, round, biconvex and film-coated with both "A/P" and "12.5/15" printed on one side, available in: 12.5 mg/30 mg tablet: pale peach, round, biconvex and film-coated with both "A/P" and "12.5/30" printed on one side, available in: 12.5 mg/45 mg tablet: pale red, round, biconvex and film-coated with both "A/P" and "12.5/45" printed on one side, available in: Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed and protect from moisture and humidity.

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

COATED
Padagis Israel Pharmaceuticals Ltd
----------
MEDICATION GUIDE
ALOGLIPTIN AND PIOGLITAZONE TABLETS
ALS333 R6
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
03/2022
Read this Medication Guide carefully before you start taking
alogliptin and 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 alogliptin and
pioglitazone tablets, ask your doctor or pharmacist.
What is the most important information I should know about alogliptin
and pioglitazone tablets?
Alogliptin and pioglitazone tablets can cause serious side effects,
including:
1.
Heart failure: Heart failure means your heart does not pump blood well
enough. alogliptin and
pioglitazone tablets can cause heart failure and 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.
Before you start taking alogliptin and pioglitazone tablets:
Tell your doctor if you have ever had heart failure or have problems
with your kidneys.
Call your doctor right away if you have any of the following symptoms:
•
increasing shortness of breath or trouble breathing, especially when
you lie down
•
an unusually fast increase in weight
•
swelling or fluid retention, especially in the feet, ankles, or legs
•
unusual tiredness
These may be symptoms of heart failure.
2.
Inflammation of the pancreas (pancreatitis): Alogliptin, one of the
medicines in alogliptin and
pioglitazone tablets, may cause pancreatitis, which may be severe.
Certain medical conditions make
you more likely to get pancreatitis.
Before you start taking alogliptin and pioglitazone tablets:
Tell your doctor if you have ever had:
•
pancreatitis
•
high blood
triglyceride
levels
•
kidney problems
•
stones in your gallbladder (gall
stones)
•
liver problems
•
a hist

Summary of Product characteristics

ALOGLIPTIN AND PIOGLITAZONE- ALOGLIPTIN BENZOATE AND PIOGLITAZONE
HYDROCHLORIDE TABLET, FILM COATED
PADAGIS ISRAEL PHARMACEUTICALS LTD
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ALOGLIPTIN AND
PIOGLITAZONE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
ALOGLIPTIN AND PIOGLITAZONE TABLETS.
ALOGLIPTIN AND PIOGLITAZONE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2013
WARNING: CONGESTIVE HEART FAILURE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
THIAZOLIDINEDIONES, INCLUDING PIOGLITAZONE, CAUSE OR EXACERBATE
CONGESTIVE HEART
FAILURE IN SOME PATIENTS. (5.1)
AFTER INITIATION OF ALOGLIPTIN AND PIOGLITAZONE 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 IN ALOGLIPTIN AND PIOGLITAZONE TABLETS MUST
BE CONSIDERED.
(5.1)
ALOGLIPTIN AND PIOGLITAZONE TABLETS ARE NOT RECOMMENDED IN PATIENTS
WITH
SYMPTOMATIC HEART FAILURE. (5.1)
INITIATION OF ALOGLIPTIN AND PIOGLITAZONE TABLETS IN PATIENTS WITH
ESTABLISHED NEW
YORK HEART ASSOCIATION (NYHA) CLASS III OR IV HEART FAILURE IS
CONTRAINDICATED. (4, 5.1)
INDICATIONS AND USAGE
Alogliptin and pioglitazone tablets are a combination of alogliptin, a
dipeptidyl peptidase-4 inhibitor and
pioglitazone, a thiazolidinedione which is indicated as an adjunct to
diet and exercise to improve glycemic
control in adults with type 2 diabetes mellitus. (1)
Limitations of Use: Should not be used in patients with type 1
diabetes. (1)
DOSAGE AND ADMINISTRATION
Individualize the starting dose of alogliptin and pioglitazone tablets
based on the patient's current
regimen and concurrent medical condition but do not exceed a daily
dose of alogliptin 25 mg and
pioglitazone 45 mg. (2.1)
Can be taken with or without food. (2.1)
Limit initial dose of pi