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RIVA-ATENOLOL is a brand name for Atenolol, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: RIVA-ATENOLOL (atenolol) is indicated for: • patients with mild or moderate hypertension. • the long-term management of patients with angina pectoris due to ischemic heart disease. Hypertension It is usually used in combination with other drugs, particularly a thiazide diuretic. However, it may be tried alone as an…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Hypertension RIVA-ATENOLOL is usually used in conjunction with other antihypertensive agents, particularly a thiazide diuretic, but may be used alone (see 1 INDICATIONS). The dose of RIVA-ATENOLOL should be administered in accordance with individual patient’s needs.
2 Recommended Dose and Dosage Adjustment Hypertension The initial dose of RIVA-ATENOLOL is 50 mg administered as one tablet a day either added to diuretic therapy or alone. The full effect of this dose will usually be seen within one to two weeks.
If an adequate response is not achieved, the dose should be increased to RIVA-ATENOLOL 100 mg once daily. Increasing the dose beyond 100 mg a day is unlikely to produce any further benefit. If further lowering of the blood pressure is required, another antihypertensive agent should be added to the regimen.
Angina Pectoris The initial dose of RIVA-ATENOLOL is 50 mg given as one tablet a day. The full effect of this dose will usually be seen within one to two weeks. If an optimal response is not achieved within one week, the dosage should be increased to RIVA-ATENOLOL 100 mg given as one tablet a day or 50 mg twice daily.
Some patients may require a dosage of 200 mg a day for optimal effect. Patients with Renal Impairment Since atenolol is eliminated predominantly via the kidneys, dosage should be adjusted in patients with severe renal impairment. 73 m2).
73 m2) Atenolol Elimination Half- Life(hr) 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 RIVA-ATENOLOL: 25 mg given as one tablet as 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.
1 Adverse Reaction Overview The most serious adverse reactions encountered are congestive heart failure, A-V block and bronchospasm. Bronchospasm may occur in patients with bronchial asthma or a history of asthmatic complaints. The most common adverse reactions reported in clinical trials with oral atenolol in 2,500 patients are bradycardia (3%), dizziness (3%), vertigo (2%), fatigue (3%), diarrhea (2%) and nausea (3%).
3 Less Common Clinical Trial Adverse Reactions Adverse reactions occurring with an incidence of less than 1%, grouped by system, are as follows: Cardiovascular: Heart failure deterioration (see 7 WARNINGS AND PRECAUTIONS), heart block, palpitations, lengthening of P-R interval, chest pain, lightheadedness, postural hypotension which may be associated with syncope, Raynaud’s phenomenon, intermittent claudication, or worsening of preexisting intermittent claudication, leg pain and cold extremities and edema.
Central Nervous System:
Faintness, ataxia, tiredness, lethargy, nervousness, depression, drowsiness, vivid dreams, insomnia, paresthesia, headache, tinnitus, mood changes, visual disturbances, psychoses and hallucinations.
Gastrointestinal:
Constipation, anorexia, abdominal discomfort and indigestion.
RIVA-ATENOLOL (atenolol) Page 12 of 30 Miscellaneous:
Skin rash, itchy and/or dry eyes, psoriasiform skin reactions, exacerbation of psoriasis, decreased exercise tolerance, alopecia, epistaxis, flushes, impotence, decreased libido, sweating, general body aches, thrombocytopenia and purpura.
Respiratory:
Dyspnea, wheeziness, cough, and bronchospasm. 5 Post-Market Adverse Reactions During the post-marketing experience with atenolol, cold extremities, gastrointestinal disturbances and fatigue were commonly reported. The following have been reported in temporal relationship to the use of the drug: elevated liver enzymes and/or bilirubin, headache, confusion, nightmares, impotence, Peyronie’s disease, psoriasiform rash or exacerbation of psoriasis, purpura, reversible alopecia and thrombocytopenia.
Cardiovascular Cardiac Failure Special caution should be exercised when administering RIVA-ATENOLOL to patients with a history of heart failure. Sympathetic stimulation is a vital component supporting circulatory function in congestive heart failure and inhibition with beta blockade always carries the potential hazard of further depressing myocardial contractility and precipitating cardiac failure.
Atenolol acts selectively without abolishing the inotropic action of digitalis on the heart muscle. However, the positive inotropic action of digitalis may be reduced by the negative inotropic effect of atenolol when the two drugs are used concomitantly.
The effects of beta-blockers and digitalis are additive in depressing A-V conduction. In patients without a history of cardiac failure, continued depression of the myocardium over a period of time can, in some cases, lead to cardiac failure.
Therefore, at the first sign or symptom of impending cardiac failure, patients should be fully digitalized and/or given a diuretic and the response observed closely. If cardiac failure continues, despite adequate digitalization and diuretic therapy, atenolol therapy should be immediately withdrawn.
First Degree Heart Block Due to its negative effect on A-V conduction time, atenolol should be used with caution in patients with first degree block. Peripheral Arterial Circulatory Disorders Atenolol may aggravate less severe peripheral arterial circulatory disorders (see 2 CONTRAINDICATIONS).
RIVA-ATENOLOL (atenolol) Page 9 of 30 Prinzmetal’s Angina Atenolol may increase the number and duration of angina attacks in patients with Prinzmetal’s angina due to unopposed alpha-receptor mediated coronary artery vasoconstriction.
RIVA-ATENOLOL, therefore, should only be used in these patients with the utmost care. Sinus Bradycardia Severe sinus bradycardia may occur with the use of atenolol treatment from unopposed vagal activity remaining after blockade of beta1-adrenergic receptors; in such cases, dosage should be reduced.
RIVA-ATENOLOL is contraindicated in patients: • who are hypersensitive to this drug or to any ingredient in the formulation, including any nonmedicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• with sinus bradycardia, or bradycardia of other origin • with second- and third-degree A-V block • with sick sinus syndrome • with right ventricular failure secondary to pulmonary hypertension • with uncontrolled heart failure • with cardiogenic shock • with hypotension • with severe peripheral arterial disorders • under anesthesia with agents that produce myocardial depression • with pheochromocytoma, in the absence of alpha-blockade • with metabolic acidosis RIVA-ATENOLOL (atenolol) Page 5 of 30
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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. 4 Administration RIVA-ATENOLOL tablets should be swallowed whole with water.
5 Missed Dose In case of missed dose, the next dose should be taken as scheduled. A double dose should not be taken.
Rare cases of hepatic toxicity including intrahepatic cholestasis have been reported. Atenolol, like other beta blockers, has been associated with the development of antinuclear antibodies (ANA) and lupus syndrome. 2%). The following adverse reactions have occurred with other beta-blockers but have not been reported with atenolol: Allergic: Laryngospasm, status asthmaticus and fever combined with aching and sore throat Cardiovascular: Pulmonary edema, cardiac enlargement, hot flushes and sinus arrest Central Nervous System: aggressiveness, anxiety, short term memory loss, and emotional lability with slightly clouded sensorium Dermatological: Exfoliative dermatitis Gastrointestinal: Mesenteric arterial thrombosis and ischemic colitis Hematological: Agranulocytosis Ophthalmological: Blurred vision, burning, and grittiness
Driving and Operating Machinery Use of RIVA-ATENOLOL is unlikely to result in any impairment of the ability of patients to drive or operate machinery. However, it should be taken into account that dizziness or fatigue may occur. Endocrine and Metabolism In patients with thyrotoxicosis, possible deleterious effects from long-term use of atenolol have not been adequately appraised.
Beta-blockade may mask the clinical signs of continuing hyperthyroidism or its complications and give a false impression of improvement. Therefore, abrupt withdrawal of atenolol may be followed by an exacerbation of the symptoms of hyperthyroidism, including thyroid storm.
Hepatic/Biliary/Pancreatic Atenolol should be administered with caution to patients subject to spontaneous hypoglycemia, or to diabetic patients (especially those with labile diabetes) who are receiving insulin or oral hypoglycemic agents.
, tachycardia) and symptoms of acute hypoglycemia. Immune There may be increased difficulty in treating an allergic type reaction in patients on beta blockers. In these patients, the reaction may be more severe due to pharmacological effects of beta-blockers and problems with fluid changes.
Epinephrine should be administered with caution since it may not have its usual effects in the treatment of anaphylaxis. On the one hand, larger doses of epinephrine may be needed to overcome the bronchospasm, while on the other, these doses can be associated with excessive alpha adrenergic stimulation with consequent hypertension, reflex bradycardia and heart- block and possible potentiation of bronchospasm.
Alternatives to the use of large doses of epinephrine included vigorous supportive care such as fluids and the use of beta agonists including parenteral salbutamol or isoproterenol to overcome bronchospasm, and norepinephrine to overcome hypotension.
Peri-Operative Considerations It is not advisable to withdraw beta-adrenoceptor blocking drugs prior to surgery in the majority of patients. However, care should be taken when using RIVA-ATENOLOL with anaesthetic agents such as those which may depress the myocardium.
Vagal dominance, if it occurs, may be corrected with atropine (1-2 mg IV). Some patients receiving beta-adrenergic blocking agents have been subject to protracted severe hypotension during anesthesia. Difficulty in restarting and maintaining the heartbeat has also been reported.
In emergency surgery, since atenolol is a competitive inhibitor of beta-adrenergic receptor agonists, its effects may be reversed, if necessary, by sufficient doses of such agonists as isoproterenol or norepinephrine. RIVA-ATENOLOL (atenolol) Page 10 of 30 Renal Atenolol should be used with caution in patients with impaired renal function (see 4 DOSAGE AND ADMINISTRATION).
73m2. Respiratory Patients with bronchospastic diseases should, in general, not receive beta-blockers. Due to the relative beta1-selectivity of atenolol, RIVA-ATENOLOL may be used with caution in patients with bronchospastic disease who do not respond to, or cannot tolerate, other antihypertensive treatment.
Since beta1- selectivity is not absolute, a beta2-stimulating agent should be administered concomitantly, the lowest possible dose of RIVA-ATENOLOL should be used. Despite these precautions, the respiratory status of some patients may worsen, and, in such cases, RIVA-ATENOLOL should be withdrawn.
Skin Various skin rashes and conjunctival xerosis have been reported with beta-blockers, including atenolol. A severe syndrome (oculomucocutaneous syndrome) whose signs include conjunctivitis sicca and psoriasiform rashes, otitis, and sclerosing serositis has occurred with the chronic use of one beta- […]