ATENOLOL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

ATENOLOL

Composition:

ATENOLOL 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Atenolol tablets USP, 50 mg (White to off-white marble finish, round, flat beveled edge tablets. Scored and debossed with “93” above the score and “752” below the score on one side, debossed with “TEVA” on the other side.) are supplied in bottles of 30 (NDC 43063-765-30) and 90 (NDC 43063-765-90). 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ATENOLOL- ATENOLOL TABLET
PD-RX PHARMACEUTICALS, INC.
----------
ATENOLOL TABLETS USP
0787
0752
0753
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, 50 mg or 100 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
1
14
22
2
3
1
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 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