CANDESARTAN CILEXETIL tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Zydus Lifesciences Limited

INN (Mezinárodní Name):

CANDESARTAN CILEXETIL

Složení:

CANDESARTAN CILEXETIL 4 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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

Přehled produktů:

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 70771-1204-3 in bottle of 30 tablets NDC 70771-1204-9 in bottle of 90 tablets NDC 70771-1204-5 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 70771-1205-3 in bottle of 30 tablets NDC 70771-1205-9 in bottle of 90 tablets NDC 70771-1205-5 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 70771-1206-3 in bottle of 30 tablets NDC 70771-1206-9 in bottle of 90 tablets NDC 70771-1206-1 in bottle of 100 tablets NDC 70771-1206-5 in bottle of 500 tablets NDC 70771-1206-0 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 70771-1207-3 in bottle of 30 tablets NDC 70771-1207-9 in bottle of 90 tablets NDC 70771-1207-1 in bottle of 100 tablets NDC 70771-1207-5 in bottle of 500 tablets NDC 70771-1207-0 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.

Stav Autorizace:

Abbreviated New Drug Application

Informace pro uživatele

Cadila Healthcare Limited
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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 anesthesia.

Charakteristika produktu

CANDESARTAN CILEXETIL - CANDESARTAN CILEXETIL TABLET
ZYDUS LIFESCIENCES LIMITED
----------
CANDESARTAN CILEXETIL TABLETS
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1204-5
Candesartan Cilexetil Tablets USP, 4 mg
Rx Only
500 tablets
NDC 70771-1205-5
Candesartan Cilexetil Tablets USP, 8 mg
Rx Only
500 tablets
NDC 70771-1206-5
Candesartan Cilexetil Tablets USP, 16 mg
Rx Only
500 tablets
NDC 70771-1207-5
Candesartan Cilexetil Tablets USP, 32 mg
Rx Only
500 tablets
CANDESARTAN CILEXETIL
candesartan cilexetil tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1204
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH STRENGTH
CANDESARTAN CILEXETIL (UNII: R85M2X0D68) (CANDESARTAN -
UNII:S8Q36MD2XX)
CANDESARTAN
CILEXETIL
4 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)
FERRIC OXIDE RED (UNII: 1K09F3G675)
HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
STARCH, CORN (UNII: O8232NY3SJ)
PRODUCT CHARACTERISTICS
COLOR
PINK (LIGHT PINK)
SCORE
2 pieces
SHAPE
ROUND (ROUND)
SIZE
7mm
FLAVOR
IMPRINT CODE
Z E;58
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1204-3
30 in 1 BOTTLE; Type 0: Not a Combination
Product
02/22/2018
2
NDC:70771-
1204-9
90 in 1 BOTTLE; Type 0: Not a Combination
Product
02/22/2018
3
NDC:70771-
1204-5
500 in 1 BOTTLE; Type 0: Not a Combination
Product
02/22/2018
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA091390
02/22/2018
CANDESARTAN CILEXETIL
candesartan cilexetil tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1205
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH STRENGTH
CANDESARTAN CILEXETIL (UNII: R85M2X0D68) (