ALOGLIPTIN AND METFORMIN HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ALOGLIPTIN BENZOATE (UNII: EEN99869SC) (ALOGLIPTIN - UNII:JHC049LO86), METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)

Available from:

A-S Medication Solutions

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Alogliptin and metformin HCl 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 metformin HCl tablets should not be used in patients with type 1 diabetes mellitus. Alogliptin and metformin HCl tablets are contraindicated in patients with: - Severe renal impairment (eGFR below 30 mL/min/1.73 m2 ) [see Warnings and Precautions (5.1)]. - Acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma. - Serious hypersensitivity reaction to alogliptin or metformin or any of the exciptients, such as anaphylaxis, angioedema and severe cutaneous adverse reactions [see Warnings and Precautions (5.4), Adverse Reactions (6.2)] . Risk Summary Limited available data with alogliptin and metformin HCl tablets or alogliptin in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. Published studies with metformin use during pregnan

Product summary:

Product: 50090-5993 NDC: 50090-5993-0 90 TABLET, FILM COATED in a BOTTLE

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

FILM COATED
A-S Medication Solutions
----------
MEDICATION GUIDE
alogliptin and metformin hydrochloride
tablets
Read this Medication Guide carefully before you start taking
alogliptin with 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
treatment. If you have any questions
about alogliptin with metformin hydrochloride tablets, ask your doctor
or pharmacist.
What is the most important information I should know about alogliptin
with metformin hydrochloride
tablets?
Alogliptin with metformin hydrochloride tablets can cause serious side
effects, including:
1.
Lactic Acidosis. Metformin, one of the medicines in alogliptin with
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 emergency
and must be treated in the
hospital.
Call your doctor right away if you have any of the following symptoms,
which could be signs of lactic
acidosis:
•
you feel cold in your hands or feet
•
you feel dizzy or lightheaded
•
you have a slow or irregular heartbeat
•
you feel very weak or tired
•
you have unusual (not normal) muscle pain
•
you have trouble breathing
•
you feel sleepy or drowsy
•
you have stomach pains, nausea or vomiting
Most people who have had lactic acidosis with metformin have other
things that, combined with
metformin, led to the lactic acidosis. Tell your doctor if you have
any of the following, because you have
a higher chance for getting lactic acidosis with alogliptin with
metformin hydrochloride tablets if you:
•
have severe kidney problems or your kidneys are affected by certain
x-ray tests that use injectable
dye
•
have liver problems
•
drink alcohol very often, or drink a lot of alcohol in short-term
"binge" drinking
•
get dehydrated (lose a large amount of body fluids). This can happen
if you are sick with a fever,

Summary of Product characteristics

ALOGLIPTIN AND METFORMIN HYDROCHLORIDE- ALOGLIPTIN AND METFORMIN
HYDROCHLORIDE TABLET, FILM COATED
A-S MEDICATION SOLUTIONS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ALOGLIPTIN AND
METFORMIN HCL TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
ALOGLIPTIN AND METFORMIN HCL TABLETS.
ALOGLIPTIN AND METFORMIN HYDROCHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2013
WARNING: LACTIC ACIDOSIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
POSTMARKETING 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. (5.1)
RISK FACTORS INCLUDE RENAL IMPAIRMENT, CONCOMITANT USE OF CERTAIN
DRUGS, AGE ≥65
YEARS OLD, RADIOLOGICAL STUDIES WITH CONTRAST, SURGERY AND OTHER
PROCEDURES, HYPOXIC
STATES, EXCESSIVE ALCOHOL INTAKE, AND HEPATIC IMPAIRMENT. STEPS TO
REDUCE THE RISK
OF AND MANAGE METFORMIN-ASSOCIATED LACTIC ACIDOSIS IN THESE HIGH RISK
GROUPS ARE
PROVIDED IN THE FULL PRESCRIBING INFORMATION. (5.1)
IF LACTIC ACIDOSIS IS SUSPECTED, DISCONTINUE ALOGLIPTIN AND METFORMIN
HCL TABLETS AND
INSTITUTE GENERAL SUPPORTIVE MEASURES IN A HOSPITAL SETTING. PROMPT
HEMODIALYSIS IS
RECOMMENDED. (5.1)
INDICATIONS AND USAGE
Alogliptin and metformin HCl tablets are a combination of alogliptin,
a dipeptidyl-peptidase-4 (DPP-4)
inhibitor and metformin, a biguanide 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 mellitus. (1)
DOSAGE AND ADMINISTRATION
Individualize the starting dose based on the patient's current
regimen. (2.1)
Give twice daily with food. (2.1)