ATENOLOL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

INN (International Name):

ATENOLOL

Composition:

ATENOLOL 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Atenolol tablets USP 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, USP. 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 diffe

Product summary:

Atenolol tablets USP, 25 mg (White to off-white marble finish, round, flat beveled edge tablets. Debossed with "TEVA" on one side and with "787" on the other side.) are supplied in bottles of 10, 30, 60 and 90. 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, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In Czech Republic By: TEVA Czech Industries, s.r.o. Opava-Komarov, Czech Republic Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. AB 11/2012 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ATENOLOL- ATENOLOL TABLET
PROFICIENT RX LP
----------
ATENOLOL TABLETS USP
RX ONLY
DESCRIPTION
Atenolol, USP, a synthetic, beta -selective (cardioselective)
adrenoreceptor blocking
agent, may be chemically described as benzeneacetamide,
4-[2'-hydroxy-3'-[(1-
methylethyl) amino] propoxy]-. The molecular and structural formulas
are:
C
H
N O M.W. (free base) 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).
Each tablet, for oral administration, contains 25 mg of atenolol, USP.
In addition, each
tablet contains the following inactive ingredients: magnesium
stearate, microcrystalline
cellulose, povidone, and sodium starch glycolate.
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 inhibits
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
1
14
22
2
3
1
2
like nadolol, atenolol undergoes 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 also differs from propranolol in that only a small amount (6%
to 16%) is bound
to proteins in the plasma. This kinetic profile results in relatively
consistent plasma drug
levels with about