CANDESARTAN CILEXETIL tablet

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

CANDESARTAN CILEXETIL (UNII: R85M2X0D68) (CANDESARTAN - UNII:S8Q36MD2XX)

थमां उपलब्ध:

Zydus Pharmaceuticals USA Inc.

INN (इंटरनेशनल नाम):

CANDESARTAN CILEXETIL

रचना:

CANDESARTAN CILEXETIL 4 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Candesartan cilexetil tablets are indicated for the treatment of hypertension in adults and in children 1 to <17 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure

उत्पाद समीक्षा:

Candesartan Cilexetil Tablets USP, 4 mg are light pink, mottled, round, biconvex, uncoated scored tablets engraved with 'ZE' on one side and '58' on other side and are supplied as follows: NDC 68382-190-06 in bottle of 30 tablets NDC 68382-190-16 in bottle of 90 tablets NDC 68382-190-05 in bottle of 500 tablets Candesartan Cilexetil Tablets USP, 8 mg are pink, mottled, round, biconvex, uncoated scored tablets engraved with 'ZE' on one side and '59' on other side and are supplied as follows: NDC 68382-191-06 in bottle of 30 tablets NDC 68382-191-16 in bottle of 90 tablets NDC 68382-191-05 in bottle of 500 tablets Candesartan Cilexetil Tablets USP, 16 mg are white, round, biconvex, uncoated scored tablets engraved with 'ZE' on one side and '60' on other side and are supplied as follows: NDC 68382-192-06 in bottle of 30 tablets NDC 68382-192-16 in bottle of 90 tablets NDC 68382-192-01 in bottle of 100 tablets NDC 68382-192-05 in bottle of 500 tablets NDC 68382-192-10 in bottle of 1000 tablets Candesartan Cilexetil Tablets USP, 32 mg are white to off-white, round, biconvex, uncoated scored tablets engraved with 'ZE' on one side and '61' on other side and are supplied as follows: NDC 68382-193-06 in bottle of 30 tablets NDC 68382-193-16 in bottle of 90 tablets NDC 68382-193-01 in bottle of 100 tablets NDC 68382-193-05 in bottle of 500 tablets NDC 68382-193-10 in bottle of 1000 tablets Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep in a tightly closed container. Dispense in a tight, light-resistant container as defined in the USP.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

Zydus Pharmaceuticals USA Inc.
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Patient Information
Candesartan Cilexetil (kan" de sar' tan sye lex' e til) Tablets, USP
Read the Patient information that comes with candesartan cilexetil
tablets before you start taking it and each
time you get a refill. There may be new information. This leaflet does
not take the place of talking with your
doctor about your medical condition or your treatment. If you have any
questions about candesartan cilexetil
tablets, ask your doctor or pharmacist.
What is the most important information I should know about candesartan
cilexetil tablets?
Candesartan cilexetil tablets can cause harm or death to an unborn
baby. Talk to your doctor about other
ways to lower your blood pressure if you plan to become pregnant. If
you get pregnant while taking
candesartan cilexetil tablets, tell your doctor right away.
What are candesartan cilexetil tablets?
Candesartan cilexetil tablets are a prescription medicine called an
angiotensin receptor blocker (ARB).
Candesartan cilexetil tablets are used to:
•
treat high blood pressure in adults and children, 1 to 17 years of age
•
treat certain types of heart failure in adults, to reduce death and
hospitalization for heart damage and
heart failure
Heart failure is a condition where the heart does not pump blood as
well as it should.
Candesartan cilexetil tablets must not be used in children less than 1
year of age for high blood pressure.
Who should not take candesartan cilexetil tablets?
Do not take candesartan cilexetil tablets if you:
•
are allergic to any of the ingredients in candesartan cilexetil
tablets. See the end of this leaflet for a
complete list of ingredients in candesartan cilexetil tablets.
•
are diabetic and taking aliskiren.
What should I tell my doctor before taking candesartan cilexetil
tablets?
Before you take candesartan cilexetil tablets, tell your doctor if
you:
•
have heart problems
•
have liver problems
•
have kidney problems
•
currently have vomiting or diarrhea
•
are scheduled for surgery or anesth

उत्पाद विशेषताएं

CANDESARTAN CILEXETIL - CANDESARTAN CILEXETIL TABLET
ZYDUS PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CANDESARTAN CILEXETIL
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CANDESARTAN
CILEXETIL TABLETS.
CANDESARTAN CILEXETIL TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WHEN PREGNANCY IS DETECTED, DISCONTINUE CANDESARTAN CILEXETIL AS SOON
AS POSSIBLE.
(5.1)
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH
TO THE DEVELOPING FETUS. (5.1)
RECENT MAJOR CHANGES
Warnings and Precautions (5.5) 02/2016
INDICATIONS AND USAGE
Candesartan cilexetil tablets are an angiotensin II receptor blocker
(ARB) indicated for:
Treatment of hypertension in adults and children 1 to < 17 years of
age, to lower blood pressure.
Lowering blood pressure reduces the risk of fatal and non-fatal
cardiovascular events, primarily strokes
and myocardial infarctions (1.1).
Treatment of heart failure (NYHA class II-IV); candesartan cilexetil
reduces cardiovascular death and
heart failure hospitalization (1.2).
DOSAGE AND ADMINISTRATION
*
STARTING DOSE
TARGET DOSE
Adult Hypertension (2.1)
16 mg tablet once daily
8 to 32 mg tablet total daily dose
Pediatric Hypertension (1 to < 6
years) (2.2)
0.20 mg/kg oral suspension once
daily
0.05 to 0.4 mg/kg oral suspension
once daily or consider divided dose
Pediatric Hypertension (6 to < 17
years) (2.2)
< 50 kg 4 to 8 mg tablet once
daily
> 50 kg 8 to 16 mg tablet once
daily
< 50 kg 4 to 16 mg tablet once daily
or consider divided dose
> 50 kg 4 to 32 mg tablet once daily
or consider divided dose
Adult Heart Failure (2.3)
4 mg tablet once daily
32 mg tablet once daily
DOSAGE FORMS AND STRENGTHS
Tablets 4 mg, 8 mg, 16 mg, 32 mg (3).
CONTRAINDICATIONS
Known hypersensitivity to product components (4).
Do not coadminister aliskiren with candesartan cilexetil in patients
with d