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TEVA-ACEBUTOLOL is a brand name for Acebutolol, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
, ether). 5% of patients on chronic acebutolol hydrochloride therapy, an increase in antinuclear antibody (ANA) titer was observed. Rare cases (<1 %) of a syndrome resembling lupus erythematosus have been observed with maintenance acebutolol hydrochloride therapy.
Similar symptoms were occasionally reported with some other β- blockers. In addition to increased ANA titers, the main presenting symptoms were polyarthralgia, myalgia and pleuritic pain. Upon discontinuation of acebutolol hydrochloride therapy, symptoms and ANA titers appear reversible.
If symptoms appear or if the results of ANA testing are significantly positive, the drug should be withdrawn. Until resolution of symptoms patients should be followed up both clinically and serologically. b) Cardiac Failure When administering TEVA-ACEBUTOLOL (acebutolol hydrochloride) to patients with a history of heart failure, special caution should be exercised.
Sympathetic stimulation is a vital component supporting circulatory function in congestive heart failure, and inhibition with β - blockade always carries the hazardous possibility of further depressing myocardial contractility and precipitating cardiac failure.
TEVA-ACEBUTOLOL’s action is selective and does not abolish the inotropic action of digitalis on the heart muscle. However, when the two drugs are used concomitantly, the positive inotropic action of digitalis may be reduced by the negative inotropic effect of acebutolol hydrochloride.
The effects of β-blockers and digitalis are additive in depressing A-V conduction. In patients without a history of cardiac failure, continued depression of myocardium over a period of time can, in some instances, result in cardiac failure.
Therefore, patients should be fully digitalised and/or given a diuretic and the response observed closely, at the first sign or symptom of impending cardiac failure. TEVA-ACEBUTOLOL therapy should be immediately withdrawn if cardiac failure continues despite adequate digitalisation and diuretic therapy.
6 c) Abrupt Cessation of Therapy with TEVA-ACEBUTOLOL Patients with angina should be cautioned against abrupt discontinuation of TEVA- ACEBUTOLOL. Following abrupt discontinuation of β-blocker therapy, there have been reports of severe exacerbation of angina and of myocardial infarction or ventricular arrhythmias occurring in patients with angina pectoris.
Exacerbation of angina pectoris mayor may not precede the occurrence of the last two complications. Therefore, when discontinuation of TEVA-ACEBUTOLOL is planned in patients with angina pectoris, the dosage should be reduced gradually and careful observation of the patient is necessary.
The same frequency of administration should be maintained. In situations of greater urgency, stepwise discontinuation of acebutolol hydrochloride under conditions of closer observation is necessary. It is recommended that treatment with acebutolol hydrochloride be reinstituted promptly, at least temporarily if angina markedly worsens or acute coronary insufficiency develops.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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d) Various skin rashes and conjunctival xerosis have been observed with use of β-blockers, including acebutolol hydrochloride. A severe syndrome (oculo-muco-cutaneous syndrome) whose symptoms include conjunctivitis sicca and psoriasiform rashes, otitis and sclerosing serositis has occurred with the chronic use of a particular β-adrenergic-blocking agent (practolol).
This syndrome has not been observed with acebutolol hydrochloride or any other such agent. However, physicians should be alert to the possibility of such reactions and should discontinue treatment should they occur. e) With the use of acebutolol hydrochloride, severe sinus bradycardia may occur from unopposed vagal activity remaining after blockade of β1-adrenergic receptors.
Dosage should be reduced in such cases. f} The possible deleterious effects from long-term use of acebutolol hydrochloride have not been adequately appraised in patients with thyrotoxicosis. By masking the clinical signs of continuing hyperthyroidism or its complications, TEVA-ACEBUTOLOL may give a false impression of improvement.
Therefore, abrupt cessation of TEVA-ACEBUTOLOL may be followed by an exacerbation of the symptoms of hyperthyroidism, including thyroid storm. v. doses of up to 18 mg/kg/day. In one rabbit study where acebutolol hydrochloride was administered intravenously the following malformations were observed: rib defects, gastroschisis, ventricular septal defect, dysplasia of urogenital system and umbilical hernia.
These results were not confirmed in a repeat intravenous study and were not observed in an oral study. o. o. in rats. In rabbit dams receiving 450 mg/kg/day, a level at which food consumption and 7 body weight gain were reduced, there was significant elevation of postimplantation loss.
A non-statistically significant increase in incidence of bilateral cataracts was observed in rat fetuses from dams receiving 1800 mg/kg/day. To date, there has been no experience with acebutolol hydrochloride in pregnant women. Studies have shown, however, that both acebutolol and diacetolol cross the placenta.
TEVA- ACEBUTOLOL should not be administered to pregnant patients. The use of TEVA- ACEBUTOLOL in women with child bearing potential requires that the anticipated benefit be cautiously […]