ONGLYZA- saxagliptin tablet, film coated

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

saxagliptin hydrochloride (UNII: Z8J84YIX6L) (saxagliptin - UNII:9GB927LAJW)

Доступно од:

Physicians Total Care, Inc.

INN (Међународно име):

saxagliptin hydrochloride

Састав:

saxagliptin 5 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

ONGLYZA is 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) .] ONGLYZA should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings. ONGLYZA 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 ONGLYZA. [See Warnings and Precautions (5.1) .] History of a serious hypersensitivity reaction to ONGLYZA, such as anaphylaxis, angioedema, or exfoliative skin conditions. [See Warnings and Precautions (5.3) and Adverse Reactions (6.2) .] There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, ONGLYZA, like other antidiabetic medications, should be used during pregnancy only if clearly

Резиме производа:

ONGLYZA® (saxagliptin) tablets have markings on both sides and are available in the strengths and packages listed in Table 12. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Статус ауторизације:

New Drug Application

Информативни летак

Physicians Total Care, Inc.
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MEDICATION GUIDE
ONGLYZA (on-GLY-zah)
(saxagliptin)
tablets
Read this Medication Guide carefully before you start taking ONGLYZA
and each time you get a refill.
There may be new information. This information does not take the place
of talking with your healthcare
provider about your medical condition or treatment. If you have any
questions about ONGLYZA, ask
your healthcare provider.
What is the most important information I should know about ONGLYZA?
Serious side effects can happen to people taking ONGLYZA, including
inflammation of the pancreas
(pancreatitis) which may be severe and lead to death.
Certain medical problems make you more likely to get pancreatitis.
Before you start taking ONGLYZA:
Tell your healthcare provider if you have ever had
•
inflammation of your pancreas (pancreatitis)
•
stones in your gallbladder (gallstones)
•
a history of alcoholism
•
high blood triglyceride levels
It is not known if having these medical problems will make you more
likely to get pancreatitis with
ONGLYZA.
Stop taking ONGLYZA and contact your healthcare provider right away if
you have pain in your stomach
area (abdomen) that is severe and will not go away. The pain may be
felt going from your abdomen
through to your back. The pain may happen with or without vomiting.
These may be symptoms of
pancreatitis.
What is ONGLYZA?
•
ONGLYZA is a prescription medicine used with diet and exercise to
control high blood sugar
(hyperglycemia) in adults with type 2 diabetes.
•
ONGLYZA lowers blood sugar by helping the body increase the level of
insulin after meals.
•
ONGLYZA is unlikely by itself to cause your blood sugar to be lowered
to a dangerous level
(hypoglycemia) because it does not work well when your blood sugar is
low. However,
hypoglycemia may still occur with ONGLYZA. Your risk for getting
hypoglycemia is higher if
you take ONGLYZA with some other diabetes medicines, such as a
sulfonylurea or insulin.
•
ONGLYZA is not for people with type 1 diabetes.
•
ONGLYZA is not

Карактеристике производа

ONGLYZA - SAXAGLIPTIN TABLET, FILM COATED
PHYSICIANS TOTAL CARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ONGLYZA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ONGLYZA.
ONGLYZA (SAXAGLIPTIN) TABLETS
INITIAL U.S. APPROVAL: 2009
RECENT MAJOR CHANGES
Indications and Usage
Important Limitations of Use (1.2) 11/2011
Dosage and Administration
Recommended Dosing (2.1) 12/2011
Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or
with Insulin (2.4) 12/2011
Contraindications (4) 11/2011
Warnings and Precautions
Pancreatitis (5.1) 11/2011
Use with Medications Known to Cause Hypoglycemia (5.2) 12/2011
Hypersensitivity Reactions (5.3) 11/2011
INDICATIONS AND USAGE
ONGLYZA is a dipeptidyl peptidase-4 (DPP4) inhibitor indicated as an
adjunct to diet and exercise to improve glycemic
control in adults with type 2 diabetes mellitus in multiple clinical
settings. (1.1, 14)
Important limitations of use:
Should not be used for the treatment of type 1 diabetes mellitus or
diabetic ketoacidosis. (1.2)
Has not been studied in patients with a history of pancreatitis. (1.2,
5.1)
DOSAGE AND ADMINISTRATION
The recommended dose is 2.5 mg or 5 mg once daily taken regardless of
meals. (2.1)
2.5 mg daily is recommended for patients with moderate or severe renal
impairment, or end-stage renal disease (CrCl
≤50 mL/min). Assess renal function before starting ONGLYZA and
periodically thereafter. (2.2)
2.5 mg daily is recommended for patients also taking strong cytochrome
P450 3A4/5 (CYP3A4/5) inhibitors (e.g.,
ketoconazole). (2.3, 7.1)
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg and 2.5 mg (3)
CONTRAINDICATIONS
History of a serious hypersensitivity reaction (e.g., anaphylaxis,
angioedema, exfoliative skin conditions) to ONGLYZA.
(4)
WARNINGS AND PRECAUTIONS
There have been postmarketing reports of acute pancreatitis. If
pancreatitis is suspected, promptly discontinue
ONGLYZA. (5.1)
When used with an insulin secretagogue (e.g., sulfonylurea)