AMLODIPINE AND OLMESARTAN MEDOXOMIL tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Torrent Pharmaceuticals Limited

INN (Tên quốc tế):

AMLODIPINE

Thành phần:

AMLODIPINE 5 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Amlodipine and olmesartan medoxomil 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 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 amlodipine and olmesartan medoxomil 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, such as those of the National High Blood Pressure

Tóm tắt sản phẩm:

Amlodipine and olmesartan medoxomil tablets contain amlodipine besylate, USP at a dose equivalent to 5 or 10 mg amlodipine and olmesartan medoxomil, USP in the strengths described below. Amlodipine and olmesartan medoxomil tablets are differentiated by tablet color/size. Amlodipine and olmesartan medoxomil tablets are supplied for oral administration in the following strength and package configurations: Amlodipine and olmesartan medoxomil tablets 5/20 mg are white to off white, round, film coated tablets debossed with "24" on one side and plain on the other side. Bottles of 30                                           NDC 13668-324-30 Bottles of 90                                           NDC 13668-324-90 Bottles of 500                                         NDC 13668-324-05 Bottles of 1,000                                       NDC 13668-324-10 Amlodipine and olmesartan medoxomil tablets 10/20 mg are pale orange to light brown, round, film coated tablets debossed with "72" on one side and plain on the other side. Bottles of 30                                           NDC 13668-312-30 Bottles of 90                                           NDC 13668-312-90 Bottles of 500                                         NDC 13668-312-05 Bottles of 1,000                                       NDC 13668-312-10 Amlodipine and olmesartan medoxomil tablets 5/40 mg are cream to yellow, round, film coated tablets debossed with "1313" on one side and plain on the other side. Bottles of 30                                           NDC 13668-313-30 Bottles of 90                                           NDC 13668-313-90 Bottles of 500                                         NDC 13668-313-05 Bottles of 1,000                                       NDC 13668-313-10 Amlodipine and olmesartan medoxomil tablets 10/40 mg are brownish red, round, film coated tablets debossed with "1311" on one side and plain on the other side. Bottles of 30                                           NDC 13668-311-30 Bottles of 90                                           NDC 13668-311-90 Bottles of 500                                         NDC 13668-311-05 Bottles of 1,000                                       NDC 13668-311-10 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].

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

AMLODIPINE AND OLMESARTAN MEDOXOMIL- AMLODIPINE AND OLMESARTAN
MEDOXOMIL TABLET
TORRENT PHARMACEUTICALS LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMLODIPINE AND
OLMESARTAN MEDOXOMIL TABLETS SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION
FOR AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS.
AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS, FOR ORAL USE
RX ONLY
INITIAL U.S. APPROVAL: 2007
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WHEN PREGNANCY IS DETECTED, DISCONTINUE AMLODIPINE AND OLMESARTAN
MEDOXOMIL
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
Amlodipine and olmesartan medoxomil tablets are a combination of a
dihydropyridine calcium channel
blocker and angiotensin II receptor blocker combination product
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 events
(CV), primarily strokes and
myocardial infarctions. ( 1).
Amlodipine and olmesartan medoxomil tablets may also be used as
initial therapy in patients likely to
need multiple antihypertensive agents to achieve their blood pressure
goals ( 1).
DOSAGE AND ADMINISTRATION
Recommended starting dose: 5/20 mg once daily ( 2).
Titrate as needed in two-week intervals up to a maximum of 10/40 mg
once daily ( 2).
DOSAGE FORMS AND STRENGTHS
Tablets: (amlodipine/olmesartan medoxomil content) 5/20 mg, 10/20 mg,
5/40 mg, and 10/40 mg ( 3).
CONTRAINDICATIONS
Do not co-administer aliskiren with amlodipine and olmesartan
medoxomil tablets in patients with
diabetes ( 4).
WARNINGS AND PRECAUTIONS
Anticipate hypotension in volume-or salt-depleted patients with
treatment initiation. Start treatment
under close supervision ( 5.2).
Increased angina or myocardial infarction may occ