ATENOLOL AND CHLORTHALIDONE- atenolol and chlorthalidone tablet

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

ATENOLOL (UNII: 50VV3VW0TI) (ATENOLOL - UNII:50VV3VW0TI), CHLORTHALIDONE (UNII: Q0MQD1073Q) (CHLORTHALIDONE - UNII:Q0MQD1073Q)

から入手可能:

Aphena Pharma Solutions - Tennessee, LLC

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Atenolol and chlorthalidone tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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 atenolol and chlorthalidone. 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 Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharma

製品概要:

Atenolol and Chlorthalidone Tablets, USP are available containing 50 mg of atenolol, USP and 25 mg of chlorthalidone, USP or 100 mg of atenolol, USP and 25 mg of chlorthalidone, USP. The 50 mg/25 mg tablets are white round, scored tablets debossed with M above the score and 63 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-2063-01 bottles of 100 tablets The 100 mg/25 mg tablets are white round, unscored tablets debossed with M over 64 on one side of the tablet and blank on the other. They are available as follows: NDC 0378-2064-93 bottles of 30 tablets NDC 0378-2064-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. REVISED FEBRUARY 2013 ATCTHL:R15

認証ステータス:

Abbreviated New Drug Application

製品の特徴

ATENOLOL AND CHLORTHALIDONE- ATENOLOL AND CHLORTHALIDONE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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DESCRIPTION
Atenolol and chlorthalidone tablets, USP are for the treatment of
hypertension. They combine the
antihypertensive activity of two agents: a beta -selective
(cardioselective) hydrophilic blocking agent
(atenolol) and a monosulfonamyl diuretic (chlorthalidone). Atenolol,
USP is Benzeneacetamide, 4-[2’-
hydroxy-3’-[(1-methylethyl)amino]propoxy]-. Its structural formula
is:
C
H N O M.W. 266.34
Atenolol (free base) is a relatively polar hydrophilic compound with a
water solubility of 26.5 mg/mL
at 37°C. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less
soluble in chloroform (3 mg/mL at
25°C).
Chlorthalidone, USP is 2-Chloro-5-(1-hydroxy-3-oxo-1-isoindolinyl)
benzene sulfonamide. Its
structural formula is:
C
H CLN O S M.W. 338.76
Chlorthalidone has a water solubility of 12 mg/100 mL at 20°C.
Each tablet, for oral administration, contains: 50 mg of atenolol and
25 mg of chlorthalidone or 100 mg
of atenolol and 25 mg of chlorthalidone.
In addition, each tablet contains the following inactive ingredients:
colloidal silicon dioxide, magnesium
stearate, microcrystalline cellulose, pregelatinized starch, sodium
lauryl sulfate, sodium starch
glycolate and stearic acid.
CLINICAL PHARMACOLOGY
ATENOLOL AND CHLORTHALIDONE
Atenolol and chlorthalidone have been used singly and concomitantly
for the treatment of hypertension.
1
14
22
2
3
14
11
2
4
The antihypertensive effects of these agents are additive, and studies
have shown that there is no
interference with bioavailability when these agents are given together
in the single combination tablet.
Therefore, this combination provides a convenient formulation for the
concomitant administration of
these two entities. In patients with more severe hypertension,
atenolol and chlorthalidone may be
administered with other antihypertensives such as vasodilators.
ATENOLOL
Atenolol is a beta -selective (cardioselective) beta-adrenergic
receptor bloc