OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE- olmesartan medoxomil and hydrochlorothiazide 40/12.5 tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

A-S Medication Solutions

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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

Povzetek izdelek:

Product: 50090-5780 NDC: 50090-5780-0 90 TABLET in a BOTTLE

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE- OLMESARTAN
MEDOXOMIL AND HYDROCHLOROTHIAZIDE 40/12.5 TABLET
A-S MEDICATION SOLUTIONS
----------
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 TABLETSAS 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
Indications and Usage (1) 02/2016
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) (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: Corr