ATENOLOL TABLETS USP, 0787, 0752, 0753

/ATENOLOL TABLETS USP, 0787, 0752, 0753
ATENOLOL TABLETS USP, 0787, 0752, 07532018-09-06T09:12:40+00:00

Prescription Drug Name:

ATENOLOL TABLETS USP, 0787, 0752, 0753

ID:

045a1d78-1ac0-4f65-958e-8777ab4b1cf2

Code:

34391-3

DESCRIPTION


id: 8d950a88-5bc6-47c7-b1a4-2dbcfb9159f9
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Atenolol, USP, a synthetic, beta1-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: C14H22N2O3          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: f5e5f173-de09-47f8-a693-88e8c4dd0492
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

Atenolol is a beta1-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 beta2-adrenoreceptors, chiefly located in the bronchial and vascular musculature.

CONTRAINDICATIONS


id: 2dbca67b-eb8e-454d-99a1-41810717e76b
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: 5d9d2543-fcce-4471-9340-8ca7e8b60e92
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: aa45f226-a84d-4f93-a71b-177b62b8f45e
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: 60a3521c-89df-4520-b8a9-51ab765026a3
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 beta2 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: 9d1928f5-11f2-4f8d-b36d-237d97608364
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Repackaged by Aphena Pharma Solutions – TN.
See Repackaging Information for available configurations.
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 100 and 1000. 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 in bottles of 100 and 1000. 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 in bottles of 100 and 500.

Repackaging Information


id: eca2d9b4-0ac4-4021-9c8f-97178554eb6a
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5

Please reference the How Supplied section listed above for a description of individual tablets or capsules. This drug product has been received by Aphena Pharma – TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count 50mg
15 67544-326-15
30 67544-326-30
45 67544-326-45
90 67544-326-60
135 67544-326-73
180 67544-326-80
Count 25mg
30 43353-833-30
45 43353-833-45
90 43353-833-60
180 43353-833-80
270 43353-833-92
Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children. Repackaged by:

Cookeville, TN 38506

20140514SC

PRINCIPAL DISPLAY PANEL – 50mg


id: 59b4150b-9630-48a2-89e7-4e52d65cb7aa
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

NDC 67544-326 – Atenolol 50mg – Rx Only