Atenolol by NuCare Pharmaceuticals, Inc. ATENOLOL tablet

Atenolol by

Drug Labeling and Warnings

Atenolol by is a Prescription medication manufactured, distributed, or labeled by NuCare Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • PRECAUTIONS

    General

    Patients already on a beta blocker must be evaluated carefully before atenolol is administered. Initial and subsequent atenolol dosages can be adjusted downward depending on clinical observations including pulse and blood pressure. Atenolol may aggravate peripheral arterial circulatory disorders.

    Impaired Renal Function

    The drug should be used with caution in patients with impaired renal function. (See DOSAGE AND ADMINISTRATION).

    Drug Interactions

    Catecholamine-depleting drugs (e.g., reserpine) may have an additive effect when given with beta-blocking agents. Patients treated with atenolol plus a catecholamine depletor should therefore be closely observed for evidence of hypotension and/or marked bradycardia which may produce vertigo, syncope or postural hypotension.

    Calcium channel blockers may also have an additive effect when given with atenolol. (See WARNINGS).

    Disopyramide is a Type I antiarrhythmic drug with potent negative inotropic and chronotropic effects. Disopyramide has been associated with severe bradycardia, asystole and heart failure when administered with beta blockers.

    Amiodarone is an antiarrhythmic agent with negative chronotropic properties that may be additive to those seen with beta blockers.

    Beta blockers may exacerbate the rebound hypertension which can follow the withdrawal of clonidine. If the two drugs are coadministered, the beta blocker should be withdrawn several days before the gradual withdrawal of clonidine. If replacing clonidine by beta blocker therapy, the introduction of beta blockers should be delayed for several days after clonidine administration has stopped.

    Concomitant use of prostaglandin synthase inhibiting drugs, e.g., indomethacin, may decrease the hypotensive effects of beta-blockers.

    Information on concurrent usage of atenolol and aspirin is limited. Data from several studies, i.e., TIMI-II, ISIS-2, currently do not suggest any clinical interaction between aspirin and beta blockers in the acute myocardial infarction setting.

    While taking beta blockers, patients with a history of anaphylactic reaction to a variety of allergens may have a more severe reaction on repeated challenge, either accidental, diagnostic or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat the allergic reaction.

    Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    Two long-term (maximum dosing duration of 18 or 24 months) rat studies and one long-term (maximum dosing duration of 18 months) mouse study, each employing dose levels as high as 300 mg/kg/day or 150 times the maximum recommended human antihypertensive dose, 3 did not indicate a carcinogenic potential of atenolol. A third (24 month) rat study, employing doses of 500 and 1,500 mg/kg/day (250 and 750 times the maximum recommended human antihypertensive dose 4) resulted in increased incidences of benign adrenal medullary tumors in males and females, mammary fibroadenomas in females, and anterior pituitary adenomas and thyroid parafollicular cell carcinomas in males. No evidence of a mutagenic potential of atenolol was uncovered in the dominant lethal test (mouse), in vivo cytogenetics test (Chinese hamster) or Ames test (S typhimurium).

    Fertility of male or female rats (evaluated at dose levels as high as 200 mg/kg/day or 100 times the maximum recommended human dose 5) was unaffected by atenolol administration.


  • 3 Based on the maximum dose of 100 mg/day in a 50 kg patient.
  • 4 Based on the maximum dose of 100 mg/day in a 50 kg patient.
  • 5 Based on the maximum dose of 100 mg/day in a 50 kg patient.
  • Animal Toxicology

    Chronic studies employing oral atenolol performed in animals have revealed the occurrence of vacuolation of epithelial cells of Brunner’s glands in the duodenum of both male and female dogs at all tested dose levels of atenolol (starting at 15 mg/kg/day or 7.5 times the maximum recommended human antihypertensive dose 6) and increased incidence of atrial degeneration of hearts of male rats at 300 but not 150 mg atenolol/kg/day (150 and 75 times the maximum recommended human antihypertensive dose, 7 respectively).


  • 6 Based on the maximum dose of 100 mg/day in a 50 kg patient.
  • 7 Based on the maximum dose of 100 mg/day in a 50 kg patient.
  • Usage in Pregnancy

    Pregnancy Category D

    See WARNINGS: Pregnancy and Fetal Injury.

    Nursing Mothers

    Atenolol is excreted in human breast milk at a ratio of 1.5 to 6.8 when compared to the concentration in plasma. Caution should be exercised when atenolol is administered to a nursing woman. Clinically significant bradycardia has been reported in breast fed infants. Premature infants, or infants with impaired renal function, may be more likely to develop adverse effects.

    Neonates born to mothers who are receiving atenolol at parturition or breast-feeding may be at risk for hypoglycemia and bradycardia. Caution should be exercised when atenolol is administered during pregnancy or to a woman who is breast-feeding (see WARNINGS, Pregnancy and Fetal Injury).

    Pediatric Use

    Safety and effectiveness in pediatric patients have not been established.

    Geriatric Use

    Hypertension and Angina Pectoris Due to Coronary Atherosclerosis

    Clinical studies of atenolol did not include sufficient number of patients aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

    Acute Myocardial Infarction

    Of the 8,037 patients with suspected acute myocardial infarction randomized to atenolol in the ISIS-1 trial (see CLINICAL PHARMACOLOGY), 33% (2,644) were 65 years of age and older. It was not possible to identify significant differences in efficacy and safety between older and younger patients; however, elderly patients with systolic blood pressure <120 mmHg seemed less likely to benefit (see INDICATIONS AND USAGE).

    In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Evaluation of patients with hypertension or myocardial infarction should always include assessment of renal function.

  • ADVERSE REACTIONS

    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

    Acute Myocardial Infarction

    In a series of investigations in the treatment of acute myocardial infarction, bradycardia and hypotension occurred more commonly, as expected for any beta blocker, in atenolol-treated patients than in control patients. However, these usually responded to atropine and/or to withholding further dosage of atenolol. The incidence of heart failure was not increased by atenolol. Inotropic agents were infrequently used. The reported frequency of these and other events occurring during these investigations is given in the following table.

    In a study of 477 patients, the following adverse events were reported during either intravenous and/or oral atenolol administration:

    Conventional
    Therapy Plus
    Atenolol
    (n = 244)
    Conventional
    Therapy
    Alone
    (n = 233)

    Bradycardia

    43

    (18%)

    24

    (10%)

    Hypotension

    60

    (25%)

    34

    (15%)

    Bronchospasm

    3

    (1.2%)

    2

    (0.9%)

    Heart Failure

    46

    (19%)

    56

    (24%)

    Heart Block

    11

    (4.5%)

    10

    (4.3%)

    BBB + Major Axis Deviation

    16

    (6.6%)

    28

    (12%)

    Supraventricular Tachycardia

    28

    (11.5%)

    45

    (19%)

    Atrial Fibrillation

    12

    (5%)

    29

    (11%)

    Atrial Flutter

    4

    (1.6%)

    7

    (3%)

    Ventricular Tachycardia

    39

    (16%)

    52

    (22%)

    Cardiac Reinfarction

    0

    (0%)

    6

    (2.6%)

    Total Cardiac Arrests

    4

    (1.6%)

    16

    (6.9%)

    Nonfatal Cardiac Arrests

    4

    (1.6%)

    12

    (5.1%)

    Deaths

    7

    (2.9%)

    16

    (6.9%)

    Cardiogenic Shock

    1

    (0.4%)

    4

    (1.7%)

    Development of Ventricular Septal Defect

    0

    (0%)

    2

    (0.9%)

    Development of Mitral Regurgitation

    0

    (0%)

    2

    (0.9%)

    Renal Failure

    1

    (0.4%)

    0

    (0%)

    Pulmonary Emboli

    3

    (1.2%)

    0

    (0%)

    In the subsequent International Study of Infarct Survival (ISIS-1) including over 16,000 patients of whom 8,037 were randomized to receive atenolol treatment, the dosage of intravenous and subsequent oral atenolol was either discontinued or reduced for the following reasons:

  • * Full dosage was 10 mg and some patients received less than 10 mg but more than 5 mg.
  • Reasons for Reduced Dosage

    IV Atenolol

    Reduced Dose

    (< 5 mg)*

    Oral

    Partial Dose

    Hypotension/Bradycardia

    105

    (1.3%)

    1168

    (14.5%)

    Cardiogenic Shock

    4

    (0.04%)

    35

    (0.44%)

    Reinfarction

    0

    (0%)

    5

    (0.06%)

    Cardiac Arrest

    5

    (0.06%)

    28

    (0.34%)

    Heart Block (> first degree)

    5

    (0.06%)

    143

    (1.7%)

    Cardiac Failure

    1

    (0.01%)

    233

    (2.9%)

    Arrhythmias

    3

    (0.04%)

    22

    (0.27%)

    Bronchospasm

    1

    (0.01%)

    50

    (0.62%)

    During postmarketing experience with atenolol, the following have been reported in temporal relationship to the use of the drug: elevated liver enzymes and/or bilirubin, hallucinations, headache, impotence, Peyronie’s disease, postural hypotension which may be associated with syncope, psoriasiform rash or exacerbation of psoriasis, psychoses, purpura, reversible alopecia, thrombocytopenia, visual disturbance, sick sinus syndrome, and dry mouth. Atenolol, like other beta blockers, has been associated with the development of antinuclear antibodies (ANA), lupus syndrome and Raynaud’s phenomenon.

  • POTENTIAL ADVERSE EFFECTS

    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.

    Hematologic

    Agranulocytosis.

    Allergic

    Fever, combined with aching and sore throat, laryngospasm, and respiratory distress.

    Central Nervous System

    Reversible mental depression progressing to catatonia; an acute reversible syndrome characterized by disorientation of time and place; short-term memory loss; emotional lability with slightly clouded sensorium; and, decreased performance on neuropsychometrics.

    Gastrointestinal

    Mesenteric arterial thrombosis, ischemic colitis.

    Other

    Erythematous rash.

    Miscellaneous

    There have been reports of skin rashes and/or dry eyes associated with the use of beta-adrenergic blocking drugs. The reported incidence is small, and in most cases, the symptoms have cleared when treatment was withdrawn. Discontinuance of the drug should be considered if any such reaction is not otherwise explicable. Patients should be closely monitored following cessation of therapy (see DOSAGE AND ADMINISTRATION).

    The oculomucocutaneous syndrome associated with the beta blocker practolol has not been reported with atenolol. Furthermore, a number of patients who had previously demonstrated established practolol reactions were transferred to atenolol therapy with subsequent resolution or quiescence of the reaction.

  • OVERDOSAGE

    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.

  • DOSAGE AND ADMINISTRATION

    Hypertension

    The initial dose of atenolol is 50 mg given as one tablet a day either alone or added to diuretic therapy. The full effect of this dose will usually be seen within one to two weeks. If an optimal response is not achieved, the dosage should be increased to atenolol 100 mg given as one tablet a day. Increasing the dosage beyond 100 mg a day is unlikely to produce any further benefit.

    Atenolol may be used alone or concomitantly with other antihypertensive agents including thiazide-type diuretics, hydralazine, prazosin, and alpha-methyldopa.

    Angina Pectoris

    The initial dose of atenolol is 50 mg given as one tablet a day. If an optimal response is not achieved within one week, the dosage should be increased to atenolol 100 mg given as one tablet a day. Some patients may require a dosage of 200 mg once a day for optimal effect.

    Twenty-four hour control with once daily dosing is achieved by giving doses larger than necessary to achieve an immediate maximum effect. The maximum early effect on exercise tolerance occurs with doses of 50 to 100 mg, but at these doses the effect at 24 hours is attenuated, averaging about 50% to 75% of that observed with once a day oral doses of 200 mg.

    Acute Myocardial Infarction

    In patients with definite or suspected acute myocardial infarction, treatment with atenolol I.V. injection should be initiated as soon as possible after the patient’s arrival in the hospital and after eligibility is established. Such treatment should be initiated in a coronary care or similar unit immediately after the patient’s hemodynamic condition has stabilized. Treatment should begin with the intravenous administration of 5 mg atenolol over 5 minutes followed by another 5 mg intravenous injection 10 minutes later. Atenolol I.V. injection should be administered under carefully controlled conditions including monitoring of blood pressure, heart rate, and electrocardiogram. Dilutions of atenolol I.V. injection in Dextrose Injection USP, Sodium Chloride Injection USP, or Sodium Chloride and Dextrose Injection may be used. These admixtures are stable for 48 hours if they are not used immediately.

    In patients who tolerate the full intravenous dose (10 mg), atenolol tablets 50 mg should be initiated 10 minutes after the last intravenous dose followed by another 50 mg oral dose 12 hours later. Thereafter, atenolol can be given orally either 100 mg once daily or 50 mg twice a day for a further 6 to 9 days or until discharge from the hospital. If bradycardia or hypotension requiring treatment or any other untoward effects occur, atenolol should be discontinued. (See full prescribing information prior to initiating therapy with atenolol tablets).

    Data from other beta blocker trials suggest that if there is any question concerning the use of IV beta blocker or clinical estimate that there is a contraindication, the IV beta blocker may be eliminated and patients fulfilling the safety criteria may be given atenolol tablets 50 mg twice daily or 100 mg once a day for at least seven days (if the IV dosing is excluded).

    Although the demonstration of efficacy of atenolol is based entirely on data from the first seven postinfarction days, data from other beta blocker trials suggest that treatment with beta blockers that are effective in the post-infarction setting may be continued for one to three years if there are no contraindications.

    Atenolol is an additional treatment to standard coronary care unit therapy.

    Elderly Patients or Patients with Renal Impairment

    Atenolol is excreted by the kidneys; consequently dosage should be adjusted in cases of severe impairment of renal function. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Evaluation of patients with hypertension or myocardial infarction should always include assessment of renal function. Atenolol excretion would be expected to decrease with advancing age.

    No significant accumulation of atenolol occurs until creatinine clearance falls below 35 mL/min/1.73m 2. Accumulation of atenolol and prolongation of its half-life were studied in subjects with creatinine clearance between 5 and 105 mL/min. Peak plasma levels were significantly increased in subjects with creatinine clearances below 30 mL/min.

    The following maximum oral dosages are recommended for elderly, renally-impaired patients and for patients with renal impairment due to other causes:

    Creatinine Clearance

    (mL/min/1.73m 2)

    Atenolol

    Elimination

    Half-Life (h)

    Maximum Dosage

    15-35

    16-27

    50 mg daily

    < 15

    > 27

    25 mg daily

    Some renally-impaired or elderly patients being treated for hypertension may require a lower starting dose of atenolol: 25 mg given as one tablet a day. If this 25 mg dose is used, assessment of efficacy must be made carefully. This should include measurement of blood pressure just prior to the next dose (“trough” blood pressure) to ensure that the treatment effect is present for a full 24 hours.

    Although a similar dosage reduction may be considered for elderly and/or renally-impaired patients being treated for indications other than hypertension, data are not available for these patient populations.

    Patients on hemodialysis should be given 25 mg or 50 mg after each dialysis; this should be done under hospital supervision as marked falls in blood pressure can occur.

    Cessation of Therapy in Patients with Angina Pectoris

    If withdrawal of atenolol therapy is planned, it should be achieved gradually and patients should be carefully observed and advised to limit physical activity to a minimum.

  • HOW SUPPLIED

    Atenolol tablets, USP for oral administration, are supplied as:

    100 mg: round, white, unscored tablets debossed GG 264 on one side and plain on the reverse side, and supplied as:

    NDC: 68071-3224-3 bottles of 30

    NDC: 68071-3224-6 bottles of 60

    NDC: 68071-3224-9 bottles of 90

    NDC: 68071-3224-1 bottles of 120

    NDC: 68071-3224-8 bottles of 180

    Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature).

    Dispense in a tight, light-resistant container.

    11-2014M

    7249

    Sandoz Inc.

    Princeton, NJ 08540

  • 100 mg Label

    pdp

  • INGREDIENTS AND APPEARANCE
    ATENOLOL 
    atenolol tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 68071-3224(NDC:0781-1507)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATENOLOL (UNII: 50VV3VW0TI) (ATENOLOL - UNII:50VV3VW0TI) ATENOLOL100 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code GG264
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 68071-3224-330 in 1 BOTTLE; Type 0: Not a Combination Product05/24/2017
    2NDC: 68071-3224-660 in 1 BOTTLE; Type 0: Not a Combination Product05/24/2017
    3NDC: 68071-3224-990 in 1 BOTTLE; Type 0: Not a Combination Product05/24/2017
    4NDC: 68071-3224-2120 in 1 BOTTLE; Type 0: Not a Combination Product05/24/2017
    5NDC: 68071-3224-8180 in 1 BOTTLE; Type 0: Not a Combination Product05/24/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07302609/17/1991
    Labeler - NuCare Pharmaceuticals, Inc. (010632300)
    Establishment
    NameAddressID/FEIBusiness Operations
    NuCare Pharmaceuticals, Inc.010632300repack(68071-3224)

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