Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
ATENOLOL (UNII: 50VV3VW0TI) (ATENOLOL - UNII:50VV3VW0TI)
Preferred Pharmaceutials Inc.
ATENOLOL
ATENOLOL 100 mg
ORAL
PRESCRIPTION DRUG
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
Atenolol tablets, USP for oral administration, are supplied as: 100 mg: round, white, unscored tablets debossed GG 264 on one side and plain on the reverse side, and supplied as: 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 Re-Packaged By: Preferred Pharmaceuticals Inc .
Abbreviated New Drug Application
ATENOLOL- ATENOLOL TABLET PREFERRED PHARMACEUTIALS 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]-. 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 inte Přečtěte si celý dokument