ATENOLOL tablet

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

ATENOLOL (UNII: 50VV3VW0TI) (ATENOLOL - UNII:50VV3VW0TI)

Доступно од:

Mylan Pharmaceuticals Inc.

INN (Међународно име):

ATENOLOL

Састав:

ATENOLOL 25 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Atenolol 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. 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 1 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 pharmacologic classes and with different mech

Резиме производа:

Atenolol Tablets, USP are available containing 25 mg, 50 mg or 100 mg of atenolol, USP. The 25 mg tablets are white to off-white, round, unscored tablets debossed with A2 on one side of the tablet and M on the other side. They are available as follows: NDC 0378-0218-01 bottles of 100 tablets NDC 0378-0218-10 bottles of 1000 tablets The 50 mg tablets are white, round, scored tablets debossed with 231 above the score on one side of the tablet and M on the other side. They are available as follows: NDC 0378-0231-01 bottles of 100 tablets NDC 0378-0231-10 bottles of 1000 tablets The 100 mg tablets are white, round, unscored tablets debossed with M on one side of the tablet and 757 on the other side. They are available as follows: NDC 0378-0757-01 bottles of 100 tablets NDC 0378-0757-10 bottles of 1000 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: ALPHAPHARM PTY LTD 15 Garnet Street Carole Park QLD 4300 Australia Revised: 9/2022 ALP:ATEN:R2 (3391/1)

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

ATENOLOL- ATENOLOL TABLET
MYLAN PHARMACEUTICALS INC.
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DESCRIPTION
Atenolol, USP, a synthetic, beta -selective (cardioselective)
adrenoreceptor blocking
agent, may be chemically described as 2-[p-[2-Hydroxy-3-
(isopropylamino)propoxy]phenyl]acetamide. The molecular and structural
formulas are:
C
H
N O
Atenolol (free base) has a molecular weight of 266.34. It is a
relatively polar hydrophilic
compound with a water solubility of 26.5 mg/mL at 37°C and a log
partition coefficient
(octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at
25°C) and less
soluble in chloroform (3 mg/mL at 25°C).
Atenolol tablets are available as 25, 50 and 100 mg tablets for oral
administration.
Inactive Ingredients: colloidal silicon dioxide, magnesium stearate,
microcrystalline
cellulose, sodium lauryl sulfate and sodium starch glycolate (potato).
CLINICAL PHARMACOLOGY
Atenolol is a beta -selective (cardioselective) beta-adrenergic
receptor blocking agent
without membrane stabilizing or intrinsic sympathomimetic (partial
agonist) activities.
This preferential effect is not absolute, however, and at higher
doses, atenolol tablets
inhibit beta -adrenoreceptors, chiefly located in the bronchial and
vascular musculature.
PHARMACOKINETICS AND METABOLISM
In man, absorption of an oral dose is rapid and consistent but
incomplete.
Approximately 50% of an oral dose is absorbed from the
gastrointestinal tract, the
remainder being excreted unchanged in the feces. Peak blood levels are
reached
between two (2) and four (4) hours after ingestion. Unlike propranolol
or metoprolol, but
like nadolol, atenolol tablets undergo little or no metabolism by the
liver, and the
absorbed portion is eliminated primarily by renal excretion. Over 85%
of an intravenous
dose is excreted in urine within 24 hours compared with approximately
50% for an oral
dose. Atenolol tablets also differ from propranolol in that only a
small amount (6%-16%)
is bound to proteins in the plasma. This kinetic profile results in
relatively consistent
1
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