LOSARTAN POTASSIUM tablet, film coated

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89)

Tillgänglig från:

Zydus Lifesciences Limited

INN (International namn):

LOSARTAN POTASSIUM

Sammansättning:

LOSARTAN POTASSIUM 25 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Losartan potassium tablets are indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including losartan. 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 1 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 (JNC). Numerous antihypertensive

Produktsammanfattning:

Losartan Potassium Tablets USP, 25 mg are white to off-white, capsule-shaped, film-coated tablets debossed with the logo of "Z" on one side and "2"on other side and are supplied as follows: NDC 65841-729-06 in bottle of 30 tablets NDC 65841-729-16 in bottle of 90 tablets NDC 65841-729-01 in bottle of 100 tablets NDC 65841-729-10 in bottle of 1,000 tablets NDC 65841-729-24 in bottle of 10,000 tablets Losartan Potassium Tablets USP, 50 mg are white to off-white, capsule-shaped, film-coated tablets debossed with the logo of "Z16" on one side and lip type breakline on other side and are supplied as follows: NDC 65841-730-06 in bottle of 30 tablets NDC 65841-730-16 in bottle of 90 tablets NDC 65841-730-01 in bottle of 100 tablets NDC 65841-730-10 in bottle of 1,000 tablets NDC 65841-730-24 in bottle of 10,000 tablets Losartan Potassium Tablets USP, 100 mg are white to off-white, capsule-shaped, film-coated tablets debossed with the logo of "Z18" on one side and plain on other side and are supplied as follows: NDC 65841-731-06 in bottle of 30 tablets NDC 65841-731-16 in bottle of 90 tablets NDC 65841-731-01 in bottle of 100 tablets NDC 65841-731-10 in bottle of 1,000 tablets NDC 65841-731-77 in cartons of 100 tablets (10 x 10 unit-dose) Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep container tightly closed. Protect from light. Dispense in a tight, light-resistant container.

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

LOSARTAN POTASSIUM- LOSARTAN POTASSIUM TABLET, FILM COATED
Cadila Healthcare Limited
----------
Patient Information
Losartan Potassium (loe-SAR-tan poe-TASS-ee-um) Tablets, USP
Read the Patient Information that comes with losartan potassium
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 condition and treatment.
What is the most important information I should know about losartan
potassium tablets?
•
Losartan potassium 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 losartan potassium tablets, tell your
doctor right away.
What are losartan potassium tablets?
Losartan potassium tablets are a prescription medicine called an
angiotensin receptor blocker (ARB). It is
used:
•
alone or with other blood pressure medicines to lower high blood
pressure (hypertension).
•
to lower the chance of stroke in patients with high blood pressure and
a heart problem called left
ventricular hypertrophy. Losartan potassium tablets may not help Black
patients with this problem.
•
to slow the worsening of diabetic kidney disease (nephropathy) in
patients with type 2 diabetes who
have or had high blood pressure.
Losartan potassium tablets have not been studied in children less than
6 years old or in children with certain
kidney problems.
High Blood Pressure (hypertension). Blood pressure is the force in
your blood vessels when your heart beats
and when your heart rests. You have high blood pressure when the force
is too much. Losartan potassium
tablets can help your blood vessels relax so your blood pressure is
lower.
Left Ventricular Hypertrophy (LVH) is an enlargement of the walls of
the left chamber of the heart (the
heart's main pumping chamber). LVH can happen from several things.
High blood pressure is the most
common cause of LVH.
Type 2 Diabetes with Nephropath

Produktens egenskaper

LOSARTAN POTASSIUM - LOSARTAN POTASSIUM TABLET, FILM COATED
ZYDUS LIFESCIENCES LIMITED
----------
LOSARTAN POTASSIUM TABLETS
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-729-01
Losartan Potassium Tablets USP, 25 mg
Rx Only
100 Tablets
Zydus
NDC 65841-730-01
Losartan Potassium Tablets USP, 50 mg
Rx Only
100 Tablets
Zydus
NDC 65841-731-01
Losartan Potassium Tablets USP, 100 mg
Rx Only
100 Tablets
Zydus
LOSARTAN POTASSIUM
losartan potassium tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-729
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH STRENGTH
LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89)
LOSARTAN POTASSIUM 25 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)
STARCH, CORN (UNII: O8232NY3SJ)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PRODUCT CHARACTERISTICS
COLOR
WHITE (WHITE TO OFF-WHITE)
SCORE
no score
SHAPE
CAPSULE (CAPSULE)
SIZE
8mm
FLAVOR
IMPRINT CODE
Z ;2
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-729-
06
30 in 1 BOTTLE; Type 0: Not a Combination
Product
10/04/2010
2
NDC:65841-729-
16
90 in 1 BOTTLE; Type 0: Not a Combination
Product
10/04/2010
3
NDC:65841-729-
01
100 in 1 BOTTLE; Type 0: Not a Combination
Product
10/04/2010
4
NDC:65841-729-
10
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
10/04/2010
5
NDC:65841-729-
24
10000 in 1 BOTTLE; Type 0: Not a Combination
Product
10/04/2010
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA078243
10/04/2010
LOSARTAN POTASSIU