ATENOLOL- atenolol tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Preferred Pharmaceuticals, Inc.

Designació comuna internacional (DCI):

ATENOLOL

Composición:

ATENOLOL 25 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

Each 25 mg atenolol tablet, USP is available as white to off-white round, flat face, beveled edge tablet, debossed with 'RE' on one side and ‘19’ on the other side. They are supplied as follows: Bottle of 30 - 68788-9047-3 Bottle of 60 - 68788-9047-6 Bottle of 90 - 68788-9047-9 Bottle of 100 - 68788-9047-1 Each 50 mg atenolol tablet, USP is available as white to off-white round, flat face, beveled edge tablet, debossed with 'RE 20' on one side and scoreline on the other side. They are supplied as follows: Bottle of 30 - 68788-9048-3 Bottle of 60 - 68788-9048-6 Bottle of 90 - 68788-9048-9 Bottle of 100 - 68788-9048-1 Each 100 mg atenolol tablet, USP is available as white to off-white round, flat face, beveled edge tablet, debossed with 'RE 21' on one side and plain on the other side. They are supplied as follows: Bottle of 30 - 68788-9049-3 Bottle of 60 - 68788-9049-6 Bottle of 90 - 68788-9049-9 Bottle of 100 - 68788-9049-1 Store at 20 - 25° C (68 - 77° F) [See USP Controlled Room Temperature]. Dispense in well-closed, light-resistant containers. You may report side effects to FDA at 1-800-FDA-1088.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

ATENOLOL- ATENOLOL TABLET
PREFERRED PHARMACEUTICALS, INC.
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ATENOLOL TABLETS, USP
RX ONLY
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 formula is C
H N O and its structural formula is:
Atenolol (free base) has a molecular weight of 266. 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, USP are available as 25, 50 and 100 mg tablets for
oral administration.
Inactive Ingredients: Colloidal silicon dioxide, corn starch,
magnesium carbonate, magnesium stearate,
sodium lauryl sulfate, 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
1
14
22
2
3
1
2
propranolol in that only a small amount (6% to 16%) is bound to
proteins in the plasma. This kinet