ATENOLOL TABLETS USP

/ATENOLOL TABLETS USP
ATENOLOL TABLETS USP2018-09-06T09:12:40+00:00

Prescription Drug Name:

ATENOLOL TABLETS USP

ID:

62d7b3c5-cfaf-08d3-e053-2a91aa0abb8f

Code:

34391-3

DESCRIPTION


id: 62d7b3c5-cf79-08d3-e053-2a91aa0abb8f
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: 62d7b3c5-cf7a-08d3-e053-2a91aa0abb8f
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: 62d7b3c5-cf82-08d3-e053-2a91aa0abb8f
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: 62d7b3c5-cf9c-08d3-e053-2a91aa0abb8f
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.

Volunteered (U.S. Studies) Total – Volunteered and Elicited

(Foreign + U.S. Studies)

Atenolol (n = 164) Placebo (n = 206) Atenolol (n = 399) Placebo (n = 407)
% % % %
CARDIOVASCULAR
Bradycardia 3 0 3 0
Cold Extremities 0 0.5 12 5
Postural Hypotension 2 1 4 5
Leg Pain 0 0.5 3 1
CENTRAL NERVOUS SYSTEM/NEUROMUSCULAR
Dizziness 4 1 13 6
Vertigo 2 0.5 2 0.2
Light-headedness 1 0 3 0.7
Tiredness 0.6 0.5 26 13
Fatigue 3 1 6 5
Lethargy 1 0 3 0.7
Drowsiness 0.6 0 2 0.5
Depression 0.6 0.5 12 9
Dreaming 0 0 3 1
GASTROINTESTINAL
Diarrhea 2 0 3 2
Nausea 4 1 3 1
RESPIRATORY (see
WARNINGS)
Wheeziness 0 0 3 3
Dyspnea 0.6 1 6 4

POTENTIAL ADVERSE EFFECTS


id: 62d7b3c5-cf9e-08d3-e053-2a91aa0abb8f
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: 62d7b3c5-cfa5-08d3-e053-2a91aa0abb8f
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: 62d7b3c5-cfac-08d3-e053-2a91aa0abb8f
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 as follows:

Bottles of 45 (42291-140-45)

Bottles of 90 (42291-140-90)

Bottles of 180 (42291-140-18)

Bottles of 1000 (42291-140-10) Atenolol tablets USP, 50 mg (White to off-white marble finish, round, flat beveled edge tablets. Scored and debossed with “93” above the score and “752” below the score on one side, debossed with “TEVA” on the other side.) are supplied as follows:

Bottles of 45 (42291-141-45)

Bottles of 90 (42291-141-90)

Bottles of 180 (42291-141-18)

Bottles of 1000 (42291-141-10) Atenolol tablets USP, 100 mg (White to off-white marble finish, round, flat beveled edge tablets. Debossed with “TEVA” on one side and with “753” on the other side.) are supplied as follows:

Bottles of 45 (42291-142-45)

Bottles of 90 (42291-142-90)

Bottles of 180 (42291-142-18)

Bottles of 500 (42291-142-50)

PRINCIPAL DISPLAY PANEL


id: 62d7b3c5-cfae-08d3-e053-2a91aa0abb8f
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

AvKARE

NDC
42291-140-45 Atenolol Tablets, USP

25 mg

45 Tablets          Rx Only Each tablet contains: 25 mg Atenolol, USP.

Usual Dosage: One tablet daily or as directed by physician. See package insert for full prescribing information. Store at 20
o to 25
oC (68
o to 77
oF) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured for:

AvKARE, Inc.

Pulaski, TN 38478 Mfg. Rev. D 01/12           AV 05/13 (P) N3   42291-140-45   5 AvKARE

NDC
42291-141-18 Atenolol Tablets, USP

50 mg

180 Tablets        Rx Only Each tablet contains: 50 mg Atenolol, USP.

Usual Dosage: One tablet daily or as directed by physician. See package insert for full prescribing information. Store at 20
o to 25
oC (68
o to 77
oF) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured for:

AvKARE, Inc.

Pulaski, TN 38478 Mfg. Rev. I 01/12           AV Rev. 02/14 (P) N3   42291-141-18   6 AvKARE

NDC
42291-142-50 Atenolol Tablets, USP

100 mg

500 Tablets         Rx Only Each tablet contains: 100 mg Atenolol, USP.

Usual Dosage: One tablet daily or as directed by physician. See package insert for full prescribing information. Store at 20
o to 25
oC (68
o to 77
oF) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured for:

AvKARE, Inc.

Pulaski, TN 38478 Mfg. Rev. H 01/12           AV Rev. 05/14 (P) N3   4229114250   3