JENTADUETO- linagliptin tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

linagliptin (UNII: 3X29ZEJ4R2) (linagliptin - UNII:3X29ZEJ4R2), metformin hydrochloride (UNII: 786Z46389E) (metformin - UNII:9100L32L2N)

Available from:

Physicians Total Care, Inc.

INN (International Name):

linagliptin

Composition:

linagliptin 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

JENTADUETO 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 linagliptin and metformin is appropriate [see Dosage and Administration (2.1) and Clinical Studies (14.1)]. JENTADUETO should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. JENTADUETO has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using JENTADUETO [see Warnings and Precautions (5.2)]. JENTADUETO is contraindicated in patients with: - Renal impairment (e.g., serum creatinine ≥1.5 mg/dL for men, ≥1.4 mg/dL for women, or abnormal creatinine clearance), which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia [see Warnings and Precautions (5.1, 5.3)] - Ac

Product summary:

JENTADUETO (linagliptin and metformin hydrochloride) tablets 2.5 mg/1000 mg are supplied as follows:  Bottles of 60 (NDC 54868-6461-0) Storage Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Protect from exposure to high humidity. Store in a safe place out of reach of children.

Authorization status:

New Drug Application

Patient Information leaflet

JENTADUETO- LINAGLIPTIN TABLET, FILM COATED
Physicians Total Care, Inc.
----------
MEDICATION GUIDE
JENTADUETO (JEN ta doo e' toe)
(linagliptin and metformin hydrochloride)
Tablets
Read this Medication Guide carefully before you start taking
JENTADUETO and each time you get a
refill. There may be new information. This information does not take
the place of talking to your doctor
about your medical condition or your treatment. If you have any
questions about JENTADUETO, ask
your doctor or pharmacist.
What is the most important information I should know about JENTADUETO?
Serious side effects can happen in people taking JENTADUETO,
including:
1.
Lactic Acidosis. Metformin, one of the medicines in JENTADUETO, can
cause a rare but serious
condition called lactic acidosis (a build-up of lactic acid in the
blood) that can cause death. Lactic
acidosis is a medical emergency and must be treated in the hospital.
Stop taking JENTADUETO and call your doctor right away if you get any
of the following
symptoms of lactic acidosis:
•
feel very weak or tired
•
have unusual (not normal) muscle pain
•
have trouble breathing
•
have unusual sleepiness or sleep longer than usual
•
have sudden stomach or intestinal problems with nausea and vomiting or
diarrhea
•
feel cold, especially in your arms and legs
•
feel dizzy or lightheaded
•
have a slow or irregular heart beat
You have a higher chance of getting lactic acidosis if you:
•
have kidney problems. People whose kidneys are not working properly
should not take
JENTADUETO.
•
have liver problems
•
have congestive heart failure that requires treatment with medicines
•
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, vomiting, or diarrhea. Dehydration can also happen when you
sweat a lot with
activity or exercise and do not drink enough fluids.
•
have certain x-ray tests with dyes or contrast agents that are
injected into yo

Summary of Product characteristics

JENTADUETO- LINAGLIPTIN TABLET, FILM COATED
PHYSICIANS TOTAL CARE, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
JENTADUETO SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR JENTADUETO.
JE NTADUE TO (LINAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLETS
INITIAL U.S. APPROVAL: 2012
WARNING: RISK OF LACTIC ACIDOSIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
LACTIC ACIDOSIS CAN OCCUR DUE TO METFORMIN ACCUMULATION. THE RISK
INCREASES WITH CONDITIONS SUCH AS
RENAL IMPAIRMENT, SEPSIS, DEHYDRATION, EXCESS ALCOHOL INTAKE, HEPATIC
IMPAIRMENT, AND ACUTE
CONGESTIVE HEART FAILURE. (5.1)
SYMPTOMS INCLUDE MALAISE, MYALGIAS, RESPIRATORY DISTRESS, INCREASING
SOMNOLENCE, AND NONSPECIFIC
ABDOMINAL DISTRESS. LABORATORY ABNORMALITIES INCLUDE LOW PH, INCREASED
ANION GAP, AND ELEVATED BLOOD
LACTATE. (5.1)
IF ACIDOSIS IS SUSPECTED, DISCONTINUE JENTADUETO AND HOSPITALIZE THE
PATIENT IMMEDIATELY (5.1)
RECENT MAJOR CHANGES
Dosage and
Administration
Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or
with Insulin
(2.2)
9/2013
Contraindications
(4)
5/2014
Warnings and
Pre cautions
Use with Medications Known to Cause Hypoglycemia (5.5)
9/2013
Hypersensitivity Reactions (5.6)
5/2014
INDICATIONS AND USAGE
JENTADUETO is a dipeptidyl peptidase-4 (DPP-4) inhibitor and biguanide
combination product indicated as an adjunct to
diet and exercise to improve glycemic control in adults with type 2
diabetes mellitus when treatment with both linagliptin
and metformin is appropriate (1.1)
Important limitations of use:
Not for treatment of type 1 diabetes or diabetic ketoacidosis (1.2)
Has not been studied in patients with a history of pancreatitis (1.2)
DOSAGE AND ADMINISTRATION
Individualize the starting dose of JENTADUETO based on the patient's
current regimen (2.1)
The maximum recommended dose is 2.5 mg linagliptin/1000 mg metformin
twice daily (2.1)
Should be given twice daily with meals, with gradual dose escalation
to reduce the gastro