ATENOLOL tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Mylan Institutional Inc.

INN (International Name):

ATENOLOL

Sammensetning:

ATENOLOL 25 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol tablets may be administered with other antihypertensive agents. 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 block greater than first degree, cardiogenic shock, and overt cardiac failure. (See WARNINGS.) Atenolol tablets are contraindicated in those patients with a history of hypersensitivity to the atenolol or any of the drug product’s components.

Produkt oppsummering:

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 51079-759-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). 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 51079-684-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). 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 51079-685-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: ALPHAPHARM PTY LTD 15 Garnet Street Carole Park QLD 4300 Australia Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-12768 10/21

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

ATENOLOL- ATENOLOL TABLET
MYLAN INSTITUTIONAL INC.
----------
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 drug levels wit