OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE- olmesartan medoxomil and hydrochlorothiazide 20/12.5 tablet OLMESARTAN MEDOXOMIL

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Beschikbaar vanaf:

Torrent Pharmaceuticals Limited

INN (Algemene Internationale Benaming):

OLMESARTAN MEDOXOMIL

Samenstelling:

OLMESARTAN MEDOXOMIL 20 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Olmesartan medoxomil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Olmesartan medoxomil and hydrochlorothiazide tablets are not indicated for the initial therapy of hypertension [see Dosage and Administration (2)] . Lowering blood pressure reduces the risk of fatal and nonfatal 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. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil and hydrochlorothiazide tablets. 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

Product samenvatting:

20 mg/12.5 mg - Yellow to light orange colored, round, biconvex, film coated tablets, debossed with "1251" on one side and plain on the other side. Each tablet contains 20 mg of olmesartan medoxomil, USP and 12.5 mg of hydrochlorothiazide, USP. Bottles of 30                           NDC 13668-251-30 Bottles of 90                           NDC 13668-251-90 Bottles of 1000                       NDC 13668-251-01 40 mg/12.5 mg - Yellowish pink to pink colored, oval shaped, biconvex, film coated tablets, debossed with "1252" on one side and plain on the other side. Each tablet contains 40 mg of olmesartan medoxomil, USP and 12.5 mg of hydrochlorothiazide, USP. Bottles of 30                           NDC 13668-252-30 Bottles of 90                           NDC 13668-252-90 Bottles of 1000                       NDC 13668-252-01 40 mg/25 mg - Pink to peach colored, oval shaped, biconvex, film coated tablets, debossed with "1253" on one side and plain on the other side. Each tablet contains 40 mg of olmesartan medoxomil, USP and 25 mg of hydrochlorothiazide, USP. Bottles of 30                           NDC 13668-253-30 Bottles of 90                           NDC 13668-253-90 Bottles of 1000                       NDC 13668-253-01 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE- OLMESARTAN
MEDOXOMIL AND HYDROCHLOROTHIAZIDE 20/12.5 TABLET
TORRENT PHARMACEUTICALS LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OLMESARTAN
MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLETS SAFELY AND EFFECTIVELY. SEE
FULL
PRESCRIBING INFORMATION FOR OLMESARTAN MEDOXOMIL AND
HYDROCHLOROTHIAZIDE
TABLETS.
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2003
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WHEN PREGNANCY IS DETECTED, DISCONTINUE OLMESARTAN MEDOXOMIL AND
HYDROCHLOROTHIAZIDE TABLETS 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).
INDICATIONS AND USAGE
Olmesartan medoxomil and hydrochlorothiazide tablets are a combination
of olmesartan, an
angiotensin II receptor blocker and hydrochlorothiazide, a thiazide
diuretic indicated for the treatment
of hypertension, to lower blood pressure. Lowering blood pressure
reduces the risk of fatal and nonfatal
cardiovascular events, primarily strokes and myocardial infarctions.
(1)
DOSAGE AND ADMINISTRATION
Recommended starting dose in patients not adequately controlled with
olmesartan monotherapy,
40/12.5 mg (2)
Recommended starting dose in patients not adequately controlled with
hydrochlorothiazide
monotherapy, 20/12.5 mg (2)
Adjust dose after 2 to 4 weeks, as needed, to a maximum of 40 mg / 25
mg olmesartan /
hydrochlorothiazide (2)
DOSAGE FORMS AND STRENGTHS
Tablets: (olmesartan medoxomil and hydrochlorothiazide) 20/12.5 mg;
40/12.5 mg; 40/25 mg (3)
CONTRAINDICATIONS
Hypersensitivity to any component of olmesartan medoxomil and
hydrochlorothiazide tablets (4)
Anuria (4)
Do not co-administer aliskiren with olmesartan medoxomil and
hydrochlorothiazide tablets in patients
with diabetes. (4)
WARNINGS AND PRECAUTIONS
Hypotension: Correct volume-depletion prior to administration. (5.2)