ATENOLOL TABLETS, USP, Rx only

/ATENOLOL TABLETS, USP, Rx only
ATENOLOL TABLETS, USP, Rx only2018-09-06T09:12:40+00:00

Prescription Drug Name:

ATENOLOL TABLETS, USP, Rx only

ID:

2c9479d8-ddb7-4d42-93bb-cdc7be1ba8b1

Code:

34391-3

DESCRIPTION


id: e4848389-f710-4a85-94c5-57e7dff88340
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: 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). Each tablet for oral administration contains 25 mg, 50 mg or 100 mg of atenolol, USP and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and sodium starch glycolate.

CLINICAL PHARMACOLOGY


id: df5415d3-eb4c-4993-a487-3fb02be8a00b
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: 3b498ffc-8b64-4932-a33b-3c6072f5ee51
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 is contraindicated in those patients with a history of hypersensitivity to the atenolol or any of the drug product’s components.

ADVERSE REACTIONS


id: aab63b8c-c5fe-4b20-93ec-155ce847b85a
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

OVERDOSAGE


id: 1ac1bb0b-d253-4aef-a046-b5812f751c61
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: a7ea0248-952c-414d-9325-3696e9877152
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Atenolol Tablets, USP are available containing 25 mg, 50 mg or 100 mg of atenolol, USP. The 25 mg tablets are white to off-white, round, unscored tablets debossed with A2 on one side of the tablet and M on the other side. The 50 mg tablets are white, round, scored tablets debossed with 231 above the score on one side of the tablet and M on the other side. The 100 mg tablets are white, round, unscored tablets debossed with M on one side of the tablet and 757 on the other side. They are available as follows: NDC 0615-3533-39
blistercards of 30 tablets
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.
REVISED JANUARY 2013
ATEN:R25

PRINCIPAL DISPLAY PANEL


id: b7c1fd45-d429-4b14-b325-1856683a5114
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4