Tenormin Drug Information
Generic name: ATENOLOL
beta-Adrenergic Blocker [EPC]
Uses of Tenormin
Hypertension TENORMIN is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits.
The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. TENORMIN may be administered with other antihypertensive agents. Angina Pectoris Due to Coronary Atherosclerosis TENORMIN is indicated for the long-term management of patients with angina pectoris.
Acute Myocardial Infarction TENORMIN is indicated in the management of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment can be initiated as soon as the patient’s clinical condition allows. (See DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS. ) In general, there is no basis for treating patients like those who were excluded from the ISIS-1 trial (blood pressure less than 100 mm Hg systolic, heart rate less than 50 bpm) or have other reasons to avoid beta blockade. As noted above, some subgroups (e.g., elderly patients with systolic blood pressure below 120 mm Hg) seemed less likely to benefit.
Dosage & Administration of Tenormin
| Creatinine Clearance(mL/min/1.73m2) | AtenololElimination Half-Life(h) |
|---|---|
| 15-35 | 16-27 |
| <15 | >27 |
Side Effects of Tenormin
Light-headedness 1 0 3 0.7 Tiredness 0.6 0.5 26 13 Fatigue 3
1 6 5 Lethargy 1 0 3
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 TENORMIN treatment, the dosage of intravenous and subsequent oral TENORMIN was either discontinued or reduced for the following reasons: Reasons for Reduced Dosage I.V. Atenolol Reduced Dose (<5 mg) Full dosage was 10 mg and some patients received less than 10 mg but more than 5 mg.
Oral Partial Dose Hypotension/Bradycardia 105 (1.3%) 1168 (14.5%) Cardiogenic Shock 4 (.04%) 35 (.44%) Reinfarction 0 (0%) 5 (.06%) Cardiac Arrest 5 (.06%) 28 (.34%) Heart Block (> first degree) 5 (.06%) 143 (1.7%) Cardiac Failure 1 (.01%) 233 (2.9%) Arrhythmias 3 (.04%) 22 (.27%) Bronchospasm 1 (.01%) 50 (.62%) During postmarketing experience with TENORMIN, 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. TENORMIN, 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 TENORMIN. 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 TENORMIN. Furthermore, a number of patients who had previously demonstrated established practolol reactions were transferred to TENORMIN therapy with subsequent resolution or quiescence of the reaction. To report SUSPECTED ADVERSE REACTIONS, contact Upsher-Smith Laboratories, LLC at 1-855-899-9180 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch for voluntary reporting of adverse reactions.
Warnings & Cautions for Tenormin
Cardiac Failure Sympathetic stimulation is necessary in supporting circulatory function in congestive heart failure, and beta blockade carries the potential hazard of further depressing myocardial contractility and precipitating more severe failure. In patients with acute myocardial infarction, cardiac failure which is not promptly and effectively controlled by 80 mg of intravenous furosemide or equivalent therapy is a contraindication to beta-blocker treatment. In Patients Without a History of Cardiac Failure Continued depression of the myocardium with beta-blocking agents over a period of time can, in some cases, lead to cardiac failure.
At the first sign or symptom of impending cardiac failure, patients should be treated appropriately according to currently recommended guidelines, and the response observed closely. If cardiac failure continues despite adequate treatment, TENORMIN should be withdrawn. (See DOSAGE AND ADMINISTRATION.) Cessation of Therapy with TENORMIN Patients with coronary artery disease, who are being treated with TENORMIN, should be advised against abrupt discontinuation of therapy. Severe exacerbation of angina and the occurrence of myocardial infarction and ventricular arrhythmias have been reported in angina patients following the abrupt discontinuation of therapy with beta-blockers.
The last two complications may occur with or without preceding exacerbation of the angina pectoris. As with other beta-blockers, when discontinuation of TENORMIN is planned, the patients should be carefully observed and advised to limit physical activity to a minimum. If the angina worsens or acute coronary insufficiency develops, it is recommended that TENORMIN be promptly reinstituted, at least temporarily.
Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue TENORMIN therapy abruptly even in patients treated only for hypertension. (See DOSAGE AND ADMINISTRATION. ) Concomitant Use of Calcium Channel Blockers Bradycardia and heart block can occur and the left ventricular end diastolic pressure can rise when beta-blockers are administered with verapamil or diltiazem. Patients with pre-existing conduction abnormalities or left ventricular dysfunction are particularly susceptible. (See PRECAUTIONS. ) Bronchospastic Diseases PATIENTS WITH BRONCHOSPASTIC DISEASE SHOULD, IN GENERAL, NOT RECEIVE BETA-BLOCKERS. Because of its relative beta 1 selectivity, however, TENORMIN may be used with caution in patients with bronchospastic disease who do not respond to, or cannot tolerate, other antihypertensive treatment. Since beta 1 selectivity is not absolute, the lowest possible dose of TENORMIN should be used with therapy initiated at 50 mg and a beta 2 -stimulating agent (bronchodilator) should be made available.
If dosage must be increased, dividing the dose should be considered in order to achieve lower peak blood levels. Major Surgery Chronically administered beta-blocking therapy should not be routinely withdrawn prior to major surgery, however the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures. Hypoglycemia Beta-blockers may prevent early warning signs of hypoglycemia, such as tachycardia, and increase the risk for severe or prolonged hypoglycemia at any time during treatment, especially in patients with diabetes mellitus or children and patients who are fasting (i.e., surgery, not eating regularly, or are vomiting). If severe hypoglycemia occurs, patients should be instructed to seek emergency treatment.
Thyrotoxicosis Beta-adrenergic blockade may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Abrupt withdrawal of beta blockade might precipitate a thyroid storm; therefore, patients suspected of developing thyrotoxicosis from whom TENORMIN therapy is to be withdrawn should be monitored closely. (See DOSAGE AND ADMINISTRATION.) Untreated Pheochromocytoma TENORMIN should not be given to patients with untreated pheochromocytoma. Pregnancy and Fetal Injury Atenolol can cause fetal harm when administered to a pregnant woman.
Atenolol crosses the placental barrier and appears in cord blood. Administration of atenolol, starting in the second trimester of pregnancy, has been associated with the birth of infants that are small for gestational age. No studies have been performed on the use of atenolol in the first trimester and the possibility of fetal injury cannot be excluded.
If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Neonates born to mothers who are receiving TENORMIN at parturition or breastfeeding may be at risk for hypoglycemia and bradycardia. Caution should be exercised when TENORMIN is administered during pregnancy or to a woman who is breastfeeding. (See PRECAUTIONS, Nursing Mothers.) Atenolol has been shown to produce a dose-related increase in embryo/fetal resorptions in rats at doses equal to or greater than 50 mg/kg/day or 25 or more times the maximum recommended human antihypertensive dose. * Although similar effects were not seen in rabbits, the compound was not evaluated in rabbits at doses above 25 mg/kg/day or 12.5 times the maximum recommended human antihypertensive dose. * *Based on the maximum dose of 100 mg/day in a 50 kg patient.
Drug Interactions with Tenormin
Drug Interactions Catecholamine-depleting drugs (e.g., reserpine) may have an additive effect when given with beta-blocking agents. Patients treated with TENORMIN 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 TENORMIN (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.
Pregnancy Safety for Tenormin
Pregnancy See WARNINGS - Pregnancy and Fetal Injury. *Based on the maximum dose of 100 mg/day in a 50 kg patient.
Pediatric Use of Tenormin
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
Contraindications for Tenormin
is contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure. (See WARNINGS. ) TENORMIN is contraindicated in those patients with a history of hypersensitivity to the atenolol or any of the drug product’s components.
Overdosage Information for Tenormin
Overdosage with TENORMIN 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 TENORMIN 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 TENORMIN 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. TENORMIN 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.
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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