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IPG-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: The dose of atenolol should be administered in accordance with individual patient's needs. The following guidelines are recommended: The initial dose of atenolol is 50 mg a day, administered as two 25 mg tablets a day, either added to diuretic therapy or alone. The full effect of this dose will usually be seen within…
Verbatim from this product's HC label. Tap a section to expand.
). 73 m2 . Respiratory Bronchospastic Disorders Patients with bronchospastic diseases should, in general, not receive beta-blockers. Due to the relative beta1-selectivity of atenolol, 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 atenolol should be used. Despite these precautions, the respiratory status of some patients may worsen, and in such cases, atenolol should be withdrawn.
1 Pregnant Women Atenolol can cause fetal harm when administered to a pregnant woman. Atenolol crosses the placental barrier and appears in the cord blood. Atenolol should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.
No randomized controlled studies have been performed on the use of atenolol in the first trimester and the possibility of fetal injury cannot be excluded. Administration of atenolol, starting in the second trimester of pregnancy, has been associated with the birth of infants that are small for gestational age.
In general, beta-blockers reduce placental perfusion, which has been associated with growth retardation, intrauterine death, abortion and early labour. Studies in humans have shown that transplacental passage of atenolol does occur in pregnant women, with fetal drug serum levels equal to those of the mother.
In a limited number of patients who were given the drug during the last trimester of pregnancy, low birth weight, neonatal hypoglycemia, bradycardia in the fetus/newborn, and placental insufficiency were observed. 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 dose.
2 Breast-feeding In humans, there is a significant accumulation of atenolol in the breast milk of lactating women. Neonates born to mothers who are breastfeeding may be at risk for hypoglycemia and bradycardia. If the use of atenolol is considered essential, then mothers should stop nursing.
3 Pediatrics Pediatrics (0-18 years): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 4 Geriatrics Clinical studies of atenolol did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
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:
Dermatologic: Psoriasiform rash or exacerbation of psoriasis, purpura, reversible alopecia Hematologic: Thrombocytopenia Liver and Biliary diseases: Elevated liver enzymes and/or bilirubin Neurologic: Headache, confusion, nightmares Reproductive system: Impotence, Peyronie's disease Rare cases of hepatic toxicity including intrahepatic cholestasis have been reported.
IPG-ATENOLOL Product Monograph Page 12 of 27 Atenolol, like other beta blockers, has been associated with the development of antinuclear antibodies (ANA) and lupus syndrome.
Potential Adverse Reactions:
The following adverse reactions have occurred with other beta- blockers but have not been reported with atenolol: 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.
Allergic:
Laryngospasm, status asthmaticus and fever combined with aching and sore throat.
Dermatological:
Exfoliative dermatitis.
Ophthalmological:
Blurred vision, burning and grittiness.
Hematological:
Driving and Operating Machinery Use of 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 Thyrotoxicosis 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 atenolol withdrawal may be followed by an exacerbation of the symptoms of hyperthyroidism, including thyroid storm.
Diabetes and Patients Subject to Hypoglycemia 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 IPG-ATENOLOL Product Monograph Page 8 of 27 symptoms of acute hypoglycemia. Immune Anaphylaxis-Epinephrine and Beta-blockers 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 pharmacologic 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 include 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Other reported clinical experience has not identified differences in responses between 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 concomitant diseases or other drug therapy.
IPG-ATENOLOL Product Monograph Page 10 of 27 8. 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 2500 patients are bradycardia (3%), dizziness (3%), vertigo (2%), fatigue (3%), diarrhea (2%) and nausea (3%). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
2%). 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:
Dermatologic: Psoriasiform rash or exacerbation of psoriasis, purpura, reversible alopecia Hematologic: Thrombocytopenia Liver and Biliary diseases: Elevated liver enzymes and/or bilirubin Neurologic: Headache, confusion, nightmares Reproductive system: Impotence, Peyronie's disease Rare cases of hepatic toxicity […]
Agranulocytosis.
Gastrointestinal:
Mesenteric arterial thrombosis and ischemic colitis. 9. 4 Drug-Drug Interactions Clonidine: Beta-blockers may exacerbate the rebound hypertension which can follow the withdrawal of clonidine. If the 2 drugs are co-administered, the beta-blocker should be withdrawn several days before discontinuing clonidine.
If replacing clonidine by beta-blocker therapy, the introduction of beta-blockers should be delayed for several days after clonidine administration has stopped (see also prescribing information for clonidine).
Reserpine or Guanethidine:
Patients receiving catecholamine-depleting drugs, such as reserpine or guanethidine, should be closely monitored because the added beta-adrenergic blocking action of atenolol may produce an excessive reduction of sympathetic activity.
Atenolol should not be combined with other beta- blockers. g. disopyramide) and amiodarone may have potentiating effect on atrial-conduction time and induce negative inotropic effect.
Calcium Channel Blockers:
Combined use of beta-blockers and calcium channel blockers with negative inotropic effects can lead to prolongation of S-A and A-V conduction, particularly in patients with impaired ventricular function, conduction abnormalities or diminished cardiac output.
This may result in severe IPG-ATENOLOL Product Monograph Page 13 of 27 hypotension, bradycardia and cardiac failure. g, nifedipine, may increase the risk of hypotension, and cardiac failure may occur in patients with latent cardiac insufficiency.
Digitalis Glycosides:
Digitalis glycosides may potentiate the bradycardia of beta1-blockade.
Non-steroidal Anti-inflammatory Agents:
The concomitant use of non-steroidal anti-inflammatory agents may blunt the antihypertensive effects of beta-blockers.
Anaesthetic Agents:
Anaesthetics can produce a hypotensive state with associated reflex tachycardia. Since beta- blockade will inhibit reflex tachycardia, the hypotensive potential of anaesthetic agents is increased with concomitant use of atenolol. The anaesthetist should be informed and the choice of anaesthetic should be an agent with as little negative inotropic activity as possible (see 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS, PERIOPERATIVE CONSIDERATIONS).
Fingolimod:
Concomitant use of fingolimod with beta blockers may potentiate bradycardic effects and is not recommended. e. at least overnight monitoring, is recommended. 1 Mechanism of Action Atenolol is a beta1 -selective, beta adrenergic blocking agent, devoid of membrane stabilizing or intrinsic sympathomimetic (partial agonist) activities.
It is a racemic mixture and the beta1 properties reside in the S (-) enantiomer. Beta1-selectivity decreases with increasing dose. The mechanism of the antihypertensive effect has not been established. Among the factors that may be involved are: (a) competitive ability to antagonize catecholamine-induced tachycardia at the beta- receptor sites in the heart, thus decreasing cardiac output (b) inhibition of renin release by the kidneys (c) inhibition of the vasomotor centres The mechanism of the anti-anginal effect is also uncertain.
An important factor may be the reduction of myocardial oxygen requirements by blocking catecholamine-induced increase in heart rate, systolic blood pressure, and the velocity and extent of myocardial contraction. In man, atenolol reduces both isoproterenol-and exercise-induced increases in heart rate over the dose range of 50 to 200 mg.
At an oral dose of 100 […]
Ophthalmologic Oculomucocutaneous Syndrome 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-adrenergic blocking agent (practolol).
This syndrome has not been observed with atenolol or any other such agent. However, physicians should be alert to the possibility of such reactions and should discontinue treatment in the event that they occur. Peri-Operative Considerations Elective or Emergency Surgery 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 atenolol with anaesthetic agents such as those which may depress the myocardium. Vagal dominance, if it occurs, may be corrected with atropine (1 to 2 mg intravenous). 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.
Renal Impaired Renal Function Atenolol should be used with caution in patients with impaired renal function (see