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MINT-ATENOL 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.
). Duration of Effect Following intravenous administration, peak plasma levels were reached within 5 minutes. Declines from peak plasma levels are rapid (5-to 10-fold) during the first 7 hours; thereafter, plasma levels decay with a half-life similar to that of orally administered drug.
Over 85% of an intravenous dose is excreted in urine within 24 hours. 34 Structural formula: Physiocochemical properties: Atenolol is a white or almost white crystalline powder. 23. Atenolol is freely soluble in 1N HCl (300mg/mL at 25°C).
0°C. ) was conducted under fasting conditions with 27 healthy adult male human subjects. Table 1. 69) * MINT-ATENOL 100mg tablets manufactured by Mint Pharmaceuticals Inc. ) were purchased in Canada. 5 times the maximum recommended human dose) and an 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 dose, respectively).
Effect on cardiovascular system: _______________________________________________________________________________________ MINT-ATENOL Product Monograph Page 18 of 28 In anesthetized cats, atenolol infusion reduces the chronotropic response to isoproterenol and right cardiac sympathetic nerve stimulation.
03 mg/kg intravenous depresses the heart rate by 22%, cardiac contractile force by 16% and diastolic blood pressure by 11%. Studies in rats showed that atenolol was devoid of intrinsic sympathomimetic activity. Atenolol in concentrations up to 10 mg/mL had no local anesthetic effect on the isolated sciatic nerve of the frog.
Atenolol (5-20 mg/kg intravenous) was without effect on the ventricular tachycardia produced by toxic levels of ouabain in anesthetized dogs. 2 mg/kg intravenous) protected coronary ligated dogs from the arrhythmogenic activity of adrenaline on the fourth day after l igation (when the cardiac rhythm was predominantly sinus).
Single oral doses of 100 mg atenolol given to volunteers reduced exercise -induced tachycardia by 31% at 4 hours and by 15% at 24 hours after administration. The maximal suppression of the systolic blood pressure response to exercise was 21% at 4 hours.
Effect on plasma renin activity:
Studies in hypertensive patients have shown that the antihypertensive effect of atenolol is associated with a decrease in plasma renin activity.
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 _______________________________________________________________________________________ MINT-ATENOL Product Monograph Page 12 of 28 Neurologic: Headache, confusion, nightmares Reproductive system: Impotence, Peyronie's disease 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.
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.
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 imp rovement. Therefore, abrupt atenolol withdrawal may be followed by an exacerbation of the symptoms of hyperthyroidism, including thyroid storm.
Diabetes and Patients Subject to Hypoglycemia _______________________________________________________________________________________ MINT-ATENOL Product Monograph Page 8 of 28 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 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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Effect on pulmonary function:
The effects of a single 100 mg dose of atenolol on forced expiratory volume (FEV1) and airways resistance (AWR) were assessed in ten patients with labile asthma. The cardioselective agents tested in this comparative trial, including atenolol, usually had a lesser dose-related effect on airway function than non-selective beta-blockers.
Atenolol produced a smaller decrease in FEV1 than did the non-selective agents and did not inhibit the bronchodilator response to isoprenaline. The decrease in FEV1 was 8-9%. Other studies in asthmatic patients have reported similar decreases in FEV1 with atenolol.
Dose-effect comparisons with cardioselective agents have shown a fall in FEV1 values at the higher doses, indicating some beta2-blocking effect.
Metabolic effects:
MINT-ATENOL did not potentiate the hypoglycemic effects of insulin in 12 patients with diabetes. Carcinogenicity Atenolol was administered to 3 groups of 65 male and 65 female CR7B1/10J mice at dietary levels of 0, 150 and 300 mg/kg/day for 18 months followed by the control diet for an additional three months.
A fourth group received 2-AAF (positive control) and a fifth was the negative control group. Retardation in weight gain was observed. There was no statistically significant difference in mortality, number of tumor bearers, number of tumors in each animal or the total number of tumors in treated and negative control animals.
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Hematological:
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 b e 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 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 beta 1 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 _______________________________________________________________________________________ MINT-ATENOL Product Monograph Page 14 of 28 The mechanism of the […]
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 o ccurred 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 4 DOSAGE AND _______________________________________________________________________________________ MINT-ATENOL Product Monograph Page 9 of 28 ADMINISTRATION).
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 pregn ant 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 wei ght, 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 […]