ATENOLOL tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Aphena Pharma Solutions - Tennessee, LLC

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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

Povzetek izdelek:

Atenolol Tablets, USP are available containing 25 mg, 50 mg or 100 mg of atenolol, USP. The 25 mg tablets are white to off-white, round, unscored tablets debossed with A2 on one side of the tablet and M on the other side. They are available as follows: NDC 0378-0218-77 bottles of 90 tablets NDC 0378-0218-01 bottles of 100 tablets NDC 0378-0218-10 bottles of 1000 tablets The 50 mg tablets are white, round, scored tablets debossed with 231 above the score on one side of the tablet and M on the other side. They are available as follows: NDC 0378-0231-77 bottles of 90 tablets NDC 0378-0231-01 bottles of 100 tablets NDC 0378-0231-10 bottles of 1000 tablets The 100 mg tablets are white, round, unscored tablets debossed with M on one side of the tablet and 757 on the other side. They are available as follows: NDC 0378-0757-77 bottles of 90 tablets NDC 0378-0757-01 bottles of 100 tablets NDC 0378-0757-10 bottles of 1000 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 9/2017 ATEN:R26

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

ATENOLOL- ATENOLOL TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
DESCRIPTION
Atenolol, USP, a synthetic, beta -selective (cardioselective)
adrenoreceptor blocking agent, may be
chemically described as
2-[p-[2-Hydroxy-3-(isopropylamino)propoxy]phenyl]acetamide. The
molecular and structural formulas are:
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 tablets are available as 25, 50 and 100 mg tablets for oral
administration.
Inactive Ingredients: colloidal silicon dioxide, magnesium stearate,
microcrystalline cellulose, sodium
lauryl sulfate and sodium starch glycolate (potato).
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 tablets inhibit
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 tablets undergo 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 tablets
also differ 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