ATENOLOL TABLETS USP, Rx only

DESCRIPTION

id: 37260efc-aef0-02ef-e054-00144ff88e88
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Atenolol, USP, 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: C
₁₄H
₂₂N
₂O
₃          M.W. (free base) 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). Each tablet, for oral administration, contains 25 mg, 50 mg or 100 mg of atenolol, USP. In addition, each tablet contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate.

CLINICAL PHARMACOLOGY

id: 37260efc-aef1-02ef-e054-00144ff88e88
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.

CONTRAINDICATIONS

id: 37260efc-aef9-02ef-e054-00144ff88e88
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

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.

ADVERSE REACTIONS

id: 37260efc-af13-02ef-e054-00144ff88e88
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.

POTENTIAL ADVERSE EFFECTS

id: 37260efc-af15-02ef-e054-00144ff88e88
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5

In addition, a variety of adverse effects have been reported with other beta-adrenergic blocking agents, and may be considered potential adverse effects of atenolol.

OVERDOSAGE

id: 37260efc-af1c-02ef-e054-00144ff88e88
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: 37274cec-55a6-2851-e054-00144ff88e88
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Atenolol tablets USP, 25 mg (White to off-white marble finish, round, flat beveled edge tablets. Debossed with “TEVA” on one side and with “787” on the other side.) are supplied in bottles of : NDC 12634-604-00 Bottles of 10 NDC 12634-604-01 Bottles of 100 NDC 12634-604-09 Bottles of 35 NDC 12634-604-40 Bottles of 40 NDC 12634-604-42 Bottles of 42 NDC 12634-604-45 Bottles of 45 NDC 12634-604-50 Bottles of 50 NDC 12634-604-52 Blister Pack of 12 NDC 12634-604-54 Blister Pack of 14 NDC 12634-604-57 Blister Pack of 20 NDC 12634-604-58 Blister Pack of 28 NDC 12634-604-59 Blister Pack of 30 NDC 12634-604-60 Bottles of 60 NDC 12634-604-61 Blister Pack of 10 NDC 12634-604-63 Blister Pack of 3 NDC 12634-604-66 Blister Pack of 6 NDC 12634-604-67 Blister Pack of 7 NDC 12634-604-69 Blister Pack of 9 NDC 12634-604-71 Bottles of 30 NDC 12634-604-74 Bottles of 24 NDC 12634-604-78 Bottles of 28 NDC 12634-604-79 Bottles of 25 NDC 12634-604-80 Bottles of 20 NDC 12634-604-81 Bottles of 21 NDC 12634-604-82 Bottles of 12 NDC 12634-604-84 Bottles of 14 NDC 12634-604-85 Bottles of 15 NDC 12634-604-90 Bottles of 90 NDC 12634-604-91 Blister Pack of 1 NDC 12634-604-92 Bottles of 2 NDC 12634-604-93 Bottles of 3 NDC 12634-604-94 Bottles of 4 NDC 12634-604-95 Bottles of 5 NDC 12634-604-96 Bottles of 6 NDC 12634-604-97 Bottles of 7 NDC 12634-604-98 Bottles of 8 NDC 12634-604-99 Bottles of 9

Package/Label Display Panel

id: 37277327-989c-7098-e054-00144ff8d46c
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4