Prescription Drug Name:
Atenolol Tablets, USP, Rx only
ID:
b72f170e-bfa6-463c-9345-31f8a37e43e2
Code:
34391-3
DESCRIPTION
id: 53f2f2db-9951-4f6a-b8ae-2c00ba404192
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 structural and molecular formulas are:
Atenolol (free base) has a molecular weight of 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).
Atenolol is available as 25, 50 and 100 mg tablets for oral administration.
Inactive Ingredients: sodium starch glycolate, crospovidone, povidone, silicified microcrystalline cellulose, magnesium stearate.
CLINICAL PHARMACOLOGY
id: 7d050c5a-a09a-43f4-9002-18a957d35b8c
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.
INDICATIONS AND USAGE
id: 21e56a24-6f3a-4026-9cf2-980e16895bfa
displayName: Indications & Usage Section
FDA Article Code: 34067-9
CONTRAINDICATIONS
id: 5694be6d-256f-4217-beda-3c680aa4423f
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
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: 92a843b1-1df8-4422-b96a-cdebabef7118
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 |
||||
| Wheeziness | 0 | 0 | 3 | 3 |
| Dyspnea | 0.6 | 1 | 6 | 4 |
OVERDOSAGE
id: 1a77e1b2-0210-4955-b222-970ba43fb29d
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: f2bfbca1-6a8d-48f5-adb1-74ef435b456d
displayName: How Supplied Section
FDA Article Code: 34069-5
Bottles of 100 NDC 13107-168-01
Bottles of 1000 NDC 13017-168-99
Atenolol Tablets USP, 50 mg round, flat-face, beveled-edge, white to off-white uncoated tablets with “D” debossed above the break line on one side and “22” debossed on the other side.
Bottles of 100 NDC 13017-169-01
Bottles of 1000 NDC 13017-169-99
Atenolol Tablets USP, 100 mg round, flat-face, beveled-edge, white to off-white uncoated tablets with “D” debossed on one side and “23” debossed on the other side.
Bottles of 100 NDC 13017-170-01
Bottles of 1000 NDC 13017-170-99
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in well-closed, light-resistant containers.
Manufactured by:
Dayton, NJ 08810
Manufactured for:
Dayton, NJ 08810
Issued: 09/2010
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL – 25 mg (1000 Tablet Bottle)
id: 8a9fe68e-f91b-4644-9bfc-eb1e322b2b97
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
25 mg
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL – 50 mg (1000 Tablet Bottle)
id: 31c24730-8f0e-413b-88cb-c9a5dc526deb
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5
50 mg
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL – 100 mg (1000 Tablet Bottle)
id: cd36e864-08f0-4cd0-8504-fc3adda9fbd5
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5
Atenolol Tablets, USP
100 mg
Rx only 1000 Tablets
Aurobinod