ATENOLOL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Apotheca Inc.

INN (International Name):

ATENOLOL

Composition:

ATENOLOL 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Atenolol is 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 mechanisms of

Product summary:

Atenolol Tablets USP, 100 mg are white to off-white, round uncoated tablets debossed with ‘Z’,’67’ on one side and plain on the other side and are supplied as follows: NDC 12634-605-00 Bottles of 10 NDC 12634-605-01 Bottles of 100 NDC 12634-605-09 Bottles of 35 NDC 12634-605-40 Bottles of 40 NDC 12634-605-42 Bottles of 42 NDC 12634-605-45 Bottles of 45 NDC 12634-605-50 Bottles of 50 NDC 12634-605-52 Blister Pack of 12 NDC 12634-605-54 Blister Pack of 14 NDC 12634-605-57 Blister Pack of 20 NDC 12634-605-58 Blister Pack of 28 NDC 12634-605-59 Blister Pack of 30 NDC 12634-605-60 Bottles of 60 NDC 12634-605-61 Blister Pack of 10 NDC 12634-605-63 Blister Pack of 3 NDC 12634-605-66 Blister Pack of 6 NDC 12634-605-67 Blister Pack of 7 NDC 12634-605-69 Blister Pack of 9 NDC 12634-605-71 Bottles of 30 NDC 12634-605-74 Bottles of 24 NDC 12634-605-78 Bottles of 28 NDC 12634-605-79 Bottles of 25 NDC 12634-605-80 Bottles of 20 NDC 12634-605-81 Bottles of 21 NDC 12634-605-82 Bottles of 12 NDC 12634-605-84 Bottles of 14 NDC 12634-605-85 Bottles of 15 NDC 12634-605-90 Bottles of 90 NDC 12634-605-91 Blister Pack of 1 NDC 12634-605-92 Bottles of 2 NDC 12634-605-93 Bottles of 3 NDC 12634-605-94 Bottles of 4 NDC 12634-605-95 Bottles of 5 NDC 12634-605-96 Bottles of 6 NDC 12634-605-97 Bottles of 7 NDC 12634-605-98 Bottles of 8 NDC 12634-605-99 Bottles of 9 Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. All trademarks are the property of Zydus Group. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ATENOLOL- ATENOLOL TABLET
APOTHECA INC.
----------
ATENOLOL TABLETS, USP
DESCRIPTION
Atenolol, 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:
Atenolol, USP has a molecular weight of 266. It is a white or almost
white powder, sparingly soluble in
water; soluble in absolute alcohol and practically insoluble in ether.
Atenolol tablets, for oral administration, are available as 25 mg, 50
mg and 100 mg tablets.
Inactive Ingredients: Citric acid (anhydrous), colloidal silicon
dioxide, croscarmellose sodium,
magnesium stearate, microcrystalline cellulose, povidone.
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 interpatient variation.
The elimination half-life of oral atenolol is approximately 6 to 7
hours, and there