ATENOLOL- atenolol tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

American Health Packaging

Designació comuna internacional (DCI):

ATENOLOL

Composición:

ATENOLOL 50 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Atenolol tablets are indicated in the management of hypertension. They may be used alone or concomitantly with other antihypertensive agents, particularly with a thiazide-type diuretic. Atenolol tablets are indicated for the long-term management of patients with angina pectoris. Atenolol tablets are indicated in the management of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment can be initiated as soon as the patient’s clinical condition allows. (See DOSAGE AND ADMINISTRATION , CONTRAINDICATIONS , and WARNINGS ). In general, there is no basis for treating patients like those who were excluded from the ISIS-1 trial (blood pressure less than 100 mm Hg systolic, heart rate less than 50 bpm) or have other reasons to avoid beta blockade. As noted above, some subgroups (e.g., elderly patients with systolic blood pressure below 120 mm Hg) seemed less likely to benefit. Atenolol tablets are contraindicated in sinus bradycardia, heart

Resumen del producto:

Atenolol tablets, USP for oral administration, are supplied as: 50 mg: round, white, scored tablets debossed GG 263 on one side and plain on the reverse side, and supplied as: Unit Dose Packages of 100 (10 x 10) NDC 62584-467-01 100 mg: round, white, unscored tablets debossed GG 264 on one side and plain on the reverse side, and supplied as: Unit Dose Packages of 100 (10 x 10) NDC 62584-715-01. Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). 1. Based on the maximum dose of 100 mg/day in a 50 kg patient. PACKAGING INFORMATION American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Sandoz Inc. as follows: (50 mg / 100 UD) NDC 62584-467-01 packaged from NDC 0781-1506 (100 mg / 100 UD) NDC 62584-715-01 packaged from NDC 0781-1507 Packaged and Distributed by: American Health Packaging Columbus, OH 43217 8006201/0412

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

ATENOLOL- ATENOLOL TABLET
AMERICAN HEALTH PACKAGING
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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 interpat