Atenolol Tablets, USP

/Atenolol Tablets, USP
Atenolol Tablets, USP2018-09-06T09:12:40+00:00

Prescription Drug Name:

Atenolol Tablets, USP

ID:

71451006-441f-4427-b839-b35fc22410a6

Code:

34391-3

DESCRIPTION


id: 70d11ee6-13f1-41b4-967b-8c8b009fe924
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Atenolol, a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4 -[2’-hydroxy-3’-[(1- methylethyl) amino] propoxy]-. The molecular formula is C14H22N2O3 and its structural formula is: 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 are available as 25, 50 and 100 mg tablets for oral administration. Inactive Ingredients: Colloidal silicon dioxide, corn starch, magnesium carbonate, magnesium stearate, sodium lauryl sulfate, sodium starch glycolate.

CLINICAL PHARMACOLOGY


id: ba6cec86-1894-44dc-9887-cf932c082c09
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: 54d5e212-5e44-4abe-90b4-3514bb1da549
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: 3df4a888-f669-4c98-b06b-91b9ba02be94
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
    Lightheadedness 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

OVERDOSAGE


id: 1f6fcc63-3bb5-47ec-aa2f-576946d490b1
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: 1a7da8c7-4ae5-422b-a776-ade2b1667be6
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Product: 50436-3330 NDC: 50436-3330-1 30 TABLET in a BOTTLE NDC: 50436-3330-3 90 TABLET in a BOTTLE

ATENOLOL 50MG TABLET


id: 56c0a838-976b-4794-ba5f-24290a80bdab
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4