ATENOLOL- atenolol tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AvKARE, Inc.

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 as follows: Bottles of 45 (42291-140-45) Bottles of 90 (42291-140-90) Bottles of 180 (42291-140-18) Bottles of 1000 (42291-140-10) 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 as follows: Bottles of 45 (42291-141-45) Bottles of 90 (42291-141-90) Bottles of 180 (42291-141-18) Bottles of 1000 (42291-141-10) Atenolol tablets USP, 100 mg (White to off-white marble finish, round, flat beveled edge tablets. Debossed with "TEVA" on one side and with "753" on the other side.) are supplied as follows: Bottles of 45 (42291-142-45) Bottles of 90 (42291-142-90) Bottles of 180 (42291-142-18) Bottles of 500 (42291-142-50) 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 for: AvKARE, Inc. Pulaski, TN. 38478 Mfg. Rev. AB 11/2012 AV 06/13 (P)

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ATENOLOL- ATENOLOL TABLET
AVKARE, INC.
----------
ATENOLOL TABLETS USP
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 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 consistent plasma drug levels with about
a fourfold