Atenolol Tablets USP 25 mg. 50 mg and 100 mg

CLINICAL PHARMACOLOGY

id: 101ced94-a62b-0123-e054-00144ff8d46c
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

Atenolol is a beta
₁-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
₂-adrenoreceptors, chiefly located in the bronchial and vascular musculature.

INDICATIONS AND USAGE

id: 101ced94-a62e-0123-e054-00144ff8d46c
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

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 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 USP may be administered with other antihypertensive agents.

CONTRAINDICATIONS

id: 101ced94-a631-0123-e054-00144ff8d46c
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Atenolol is contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure (see
WARNINGS).
Atenolol is contraindicated in those patients with a history of hypersensitivity to the atenolol or any of the drug product’s components.

ADVERSE REACTIONS

id: 101ced94-a647-0123-e054-00144ff8d46c
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

Most adverse effects have been mild and transient. The frequency estimates in the following table were derived from controlled studies in hypertensive patients in which adverse reactions were either volunteered by the patient (U.S. studies) or elicited, e.g., by checklist (foreign studies). The reported frequency of elicited adverse effects was higher for both atenolol and placebo-treated patients than when these reactions were volunteered. Where frequency of adverse effects of atenolol and placebo is similar, causal relationship to atenolol is uncertain.

OVERDOSAGE

id: 101ced94-a64a-0123-e054-00144ff8d46c
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

Overdosage with atenolol has been reported with patients surviving acute doses as high as 5 g. One death was reported in a man who may have taken as much as 10 g acutely. The predominant symptoms reported following atenolol overdose are lethargy, disorder of respiratory drive, wheezing, sinus pause and bradycardia. Additionally, common effects associated with overdosage of any beta-adrenergic blocking agent and which might also be expected in atenolol overdose are congestive heart failure, hypotension, bronchospasm and/or hypoglycemia. Treatment of overdose should be directed to the removal of any unabsorbed drug by induced emesis, gastric lavage, or administration of activated charcoal. Atenolol can be removed from the general circulation by hemodialysis. Other treatment modalities should be employed at the physician’s discretion and may include: BRADYCARDIA: Atropine intravenously. If there is no response to vagal blockade, give isoproterenol cautiously. In refractory cases, a transvenous cardiac pacemaker may be indicated. HEART BLOCK (SECOND OR THIRD DEGREE): Isoproterenol or transvenous cardiac pacemaker. CARDIAC FAILURE: Digitalize the patient and administer a diuretic. Glucagon has been reported to be useful. HYPOTENSION: Vasopressors such as dopamine or norepinephrine (levarterenol). Monitor blood pressure continuously. BRONCHOSPASM: A beta
₂ stimulant such as isoproterenol or terbutaline and/or aminophylline. HYPOGLYCEMIA: Intravenous glucose. Based on the severity of symptoms, management may require intensive support care and facilities for applying cardiac and respiratory support.

HOW SUPPLIED

id: 101ced94-a651-0123-e054-00144ff8d46c
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Atenolol Tablets USP: Tablets of 25 mg atenolol, NDC 16571-430-11 (circular, biconvex, film coated white to offwhite tablets identified with “ATN” engraved on one side and 25 engraved on the other side) are supplied in bottles of 1000 tablets. Tablets of 50 mg atenolol, NDC 16571-431-11 (circular, biconvex, film coated white to offwhite tablets identified with “ATN” and “50” engraved on one side and lip like score engraved on the other side) are supplied in bottles of 1000 tablets. Tablets of 100 mg atenolol, NDC 16571-441-11 (circular, biconvex, film coated white to offwhite tablets identified with “ATN” and “100” engraved on one side and lip like score engraved on the other side) are supplied in bottles of 1000 tablets. Store at controlled room temperature 20°-25°C (68°-77°F). [See USP]. Dispense in a well-closed, light-resistant containers. Manufactured in India by
Unique Pharmaceutical Laboratories

(A Div. of J. B. Chemicals & Pharmaceuticals Ltd.)

Mumbai – 400 030. Distributed by:

PACK Pharmaceuticals, LLC

Buffalo Grove, IL 60089

(800) 521-5340 113658 January 2013

Principal Display Panel

id: 101ced94-a65a-0123-e054-00144ff8d46c
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Atenolol Tablets, USP 25mg 30 Tablets NDC 10544-167-30

Principal Display Panel

id: 101ced94-a65d-0123-e054-00144ff8d46c
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Atenolol Tablets, USP 50mg 30 Tablets NDC 10544-586-30

DESCRIPTION

id: 101ced94-a658-0123-e054-00144ff8d46c
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Atenolol, a synthetic, beta
₁-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4 -[2’-hydroxy-3’-[(1- methylethyl) amino] propoxy]-. The molecular and structural formulas are: Atenolol (free base) has a molecular weight of 266. 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, USP is available as 25, 50 and 100 mg tablets for oral administration. Inactive Ingredients: Magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, hydroxypropyl methylcellulose, titanium dioxide and glycerine