LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH), LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89)

Available from:

Zydus Lifesciences Limited

INN (International Name):

HYDROCHLOROTHIAZIDE

Composition:

HYDROCHLOROTHIAZIDE 12.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Losartan potassium and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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 and hydrochlorothiazide. 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 drugs, f

Product summary:

Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/ 12.5 mg, are white to off-white, capsule-shaped, film-coated tablets debossed with "ZD18" on one side and plain on other side and are supplied as follows: NDC 65841-732-06 in bottle of 30 tablets NDC 65841-732-16 in bottle of 90 tablets NDC 65841-732-10 in bottle of 1000 tablets NDC 65841-732-40 in bottle of 5000 tablets Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/ 25 mg, are white to off-white, capsule-shaped, film-coated tablets debossed with "ZD19" on one side and plain on other side and are supplied as follows: NDC 65841-733-06 in bottle of 30 tablets NDC 65841-733-16 in bottle of 90 tablets NDC 65841-733-10 in bottle of 1000 tablets NDC 65841-733-23 in bottle of 4000 tablets 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE- LOSARTAN POTASSIUM AND
HYDROCHLOROTHIAZIDE TABLET, FILM COATED
Cadila Healthcare Limited
----------
Patient Information
Losartan Potassium and Hydrochlorothiazide (loe-SAR-tan poe-TASS-ee-um
and hye dro klor o THY a zide)
Tablets, USP
Read the Patient Information that comes with losartan potassium and
hydrochlorothiazide 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 and hydrochlorothiazide
tablets?
•
Losartan potassium and hydrochlorothiazide 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 and
hydrochlorothiazide tablets tell your doctor
right away.
What are losartan potassium and hydrochlorothiazide tablets?
Losartan potassium and hydrochlorothiazide tablets contain 2
prescription medicines, an angiotensin receptor
blocker (ARB) and a diuretic (water pill). It is used to:
•
lower high blood pressure (hypertension). Losartan potassium and
hydrochlorothiazide tablets are not
usually the first medicine used to treat high blood pressure.
•
lower the chance of stroke in patients with high blood pressure and a
heart problem called left
ventricular hypertrophy (LVH). Losartan potassium and
hydrochlorothiazide tablets may not help
Black patients with this problem.
Losartan potassium and hydrochlorothiazide tablets have not been
studied in children less than 18 years old.
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. The losartan ingredient
in losartan potassium and hydrochlorothiazide tablets can help your
blood vessels relax so your blood
pres

Summary of Product characteristics

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE - LOSARTAN POTASSIUM
AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED
ZYDUS LIFESCIENCES LIMITED
----------
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-732-06
Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg
30 Tablets
Rx Only
NDC 65841-733-06
Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg
30 Tablets
Rx Only
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
losartan potassium and hydrochlorothiazide tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-732
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH STRENGTH
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE -
UNII:0J48LPH2TH)
HYDROCHLOROTHIAZIDE 12.5 mg
LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89)
LOSARTAN POTASSIUM
50 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
12mm
FLAVOR
IMPRINT CODE
Z D18
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-732-
40
5000 in 1 BOTTLE; Type 0: Not a Combination
Product
04/10/2010
2
NDC:65841-732-
06
30 in 1 BOTTLE; Type 0: Not a Combination
Product
04/10/2010
3
NDC:65841-732-
16
90 in 1 BOTTLE; Type 0: Not a Combination
Product
04/10/2010
4
NDC:65841-732-
10
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
04/10/2010
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION