ATENOLOL- atenolol tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Sandoz Inc

Designació comuna internacional (DCI):

ATENOLOL

Composición:

ATENOLOL 25 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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. 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

Resumen del producto:

Atenolol tablets, USP for oral administration, are supplied as: 25 mg: round, white, unscored tablets debossed GG L7 on one side and plain on the reverse side, and supplied as: NDC 0781-5220-01 bottles of 100 NDC 0781-5220-05 bottles of 500 NDC 0781-5220-10 bottles of 1000 50 mg: round, white, scored tablets debossed GG 263 on one side and plain on the reverse side, and supplied as: NDC 0781-5225-01 bottles of 100 NDC 0781-5225-05 bottles of 500 NDC 0781-5225-10 bottles of 1000 100 mg: round, white, unscored tablets debossed GG 264 on one side and plain on the reverse side, and supplied as: NDC 0781-5229-01 bottles of 100 NDC 0781-5229-05 bottles of 500 NDC 0781-5229-10 bottles of 1000 Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Dispense in a tight, light-resistant container. 11-2014M 7442 Product of Italy Sandoz Inc. Princeton, NJ 08540

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

ATENOLOL- ATENOLOL TABLET
SANDOZ INC
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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]-. It has
the following structural formula:
Atenolol (free base) has a molecular weight of 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).
Atenolol is available as 25, 50 or 100 mg tablets for oral
administration. Inactive ingredients include
colloidal silicon dioxide, magnesium stearate, microcrystalline
cellulose, 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%-16%) is bound to proteins
in the plasma. This kinetic profile
results in relatively consistent plasma drug levels with about a
fourfold interpatient variation.