OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE 20/5/12.5 MG- olmesartan medoxomil, amlodipine and hydrochlorothiazide

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10), AMLODIPINE (UNII: 1J444QC288) (AMLODIPINE - UNII:1J444QC288), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Διαθέσιμο από:

Torrent Pharmaceuticals Limited

INN (Διεθνής Όνομα):

OLMESARTAN MEDOXOMIL

Σύνθεση:

OLMESARTAN MEDOXOMIL 20 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) 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, amlodipine 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. For specific advice on goals and management, see published guidelines, su

Περίληψη προϊόντος:

Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contain olmesartan medoxomil, USP, amlodipine besylate, USP at a dose equivalent to 5 or 10 mg amlodipine, and hydrochlorothiazide, USP in the strengths described below. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are differentiated by tablet color/size. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are supplied for oral administration in the following strength and package configurations: 20/5/12.5 mg tablets are orange white colored, round, biconvex, film coated debossed with '26' on one side and plain on the other side. Bottles of 30                           NDC 13668-397-30 Bottles of 90                           NDC 13668-397-90 Bottles of 500                         NDC 13668-397-05 40/5/12.5 mg tablets are light yellow to yellow colored, round, biconvex, film coated debossed with '1386' on one side and plain on the other side. Bottles of 30                           NDC 13668-386-30 Bottles of 90                           NDC 13668-386-90 Bottles of 500                         NDC 13668-386-05 40/5/25 mg tablets are light yellow to yellow colored, oval shaped, biconvex, film coated debossed with '1385' on one side and plain on the other side. Bottles of 30                           NDC 13668-385-30 Bottles of 90                           NDC 13668-385-90 Bottles of 500                         NDC 13668-385-05 40/10/12.5 mg tablets are grayish red colored, round, biconvex, film coated, debossed with '1383' on one side and plain on the other side. Bottles of 30                           NDC 13668-383-30 Bottles of 90                           NDC 13668-383-90 Bottles of 500                         NDC 13668-383-05 40/10/25 mg tablets are grayish red colored, oval shaped, biconvex, film coated, debossed with '1382' on one side and plain on the other side. Bottles of 30                           NDC 13668-382-30 Bottles of 90                           NDC 13668-382-90 Bottles of 500                         NDC 13668-382-05 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].

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
20/5/12.5 MG- OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
TABLET 20/5/12.5 MG TABLET
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
40/5/12.5 MG- OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
TABLET 40/5/12.5 MG TABLET
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
40/5/25 MG- OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
TABLET 40/5/25 MG TABLET
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
40/10/12.5 MG- OLMESARTAN MEDOXOMIL, AMLODIPINE AND
HYDROCHLOROTHIAZIDE
TABLET 40/10/12.5 MG TABLET
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
40/10/25 MG- OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
TABLET 40/10/25 MG TABLET
TORRENT PHARMACEUTICALS LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OLMESARTAN
MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE TABLETS SAFELY AND
EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR OLMESARTAN MEDOXOMIL, AMLODIPINE
AND
HYDROCHLOROTHIAZIDE TABLETS.
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE TABLETS, FOR
ORAL USE
INITIAL U.S. APPROVAL: 2010
WARNING: FETAL TOXICITY
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
WHEN PREGNANCY IS DETECTED, DISCONTINUE OLMESARTAN MEDOXOMIL,
AMLODIPINE AND
HYDROCHLOROTHIAZIDE TABLETS AS SOON AS POSSIBLE ( 5.1, 8.1).
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH
TO THE DEVELOPING FETUS ( 5.1, 8.1).
INDICATIONS AND USAGE
Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are a
combination of olmesartan
medoximil, an angiotensin II receptor blocker, amlodipine, a
dihydropyridine calcium channel 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).
Limitations of