Acebutolol (acebutolol HCl)

Dosage of acebutolol hydrochloride is expressed in terms of acebutolol.

Dosage of acebutolol must be individualized and adjusted according to the patient's response and tolerance. If long-term acebutolol therapy is to be discontinued, dosage of the drug should be reduced gradually over a period of about 2 weeks. (See Cautions: Precautions and Contraindications.) When another beta-adrenergic blocking agent (beta-blocker) is to be substituted for acebutolol, the new drug should be initiated at a comparable dosage without interruption of beta-blocker therapy.

The fact that the beta-adrenergic blocking selectivity of acebutolol hydrochloride diminishes as dosage is increased should be considered.

When acebutolol is used in geriatric patients, reduction of maintenance dosage may be necessary, since peak plasma concentrations and areas under the concentration-time curves (AUCs) of acebutolol and diacetolol in these patients may be approximately twofold those observed in younger patients. Dosages greater than 800 mg daily should be avoided in geriatric patients.

Because the active metabolite of acebutolol is eliminated principally by the kidneys, doses and/or frequency of administration of acebutolol must be modified in response to the degree of renal impairment in patients with impaired renal function. The usual daily dose of the drug should be reduced by 50% in patients with creatinine clearances of 25-49 mL/minute and by 75% in patients with creatinine clearances of less than 25 mL/minute. Since acebutolol and diacetolol are removed by hemodialysis, dosage of acebutolol must be individualized carefully in patients with severe renal impairment who undergo chronic intermittent hemodialysis.

Acebutolol should be used with caution in patients with impaired hepatic function. Limited data suggest that the presence of cirrhosis does not substantially affect the pharmacokinetics of acebutolol or diacetolol, but the effects of hepatic impairment on the elimination of the drug have not been fully evaluated.

Acebutolol hydrochloride is administered orally. Acebutolol hydrochloride has also been administered IV+, but a parenteral dosage form of the drug is currently not commercially available in the US.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

There is no enhanced messaging for this drug.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

There is no enhanced messaging for this drug.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

No enhanced messaging available.

Reproduction studies in rats and rabbits using acebutolol dosages up to 630 and 135 mg/kg daily (about 31.5 and 6.8 times the maximum recommended daily human dosage), respectively, have not revealed evidence of harm to the fetus. However, acebutolol dosages of 135 mg/kg daily in rabbits produced maternal toxicity associated with slight fetal growth retardation, reduced food intake, decreased rate of weight gain, and mortality. Reproduction studies in rats and rabbits using diacetolol dosages up to 1800 and 450 mg/kg daily, respectively, have not revealed evidence of harm to the fetus; however, diacetolol dosages of 450 mg/kg daily were associated with increased postimplantation loss and decreased food consumption and weight gain in pregnant rabbits, and diacetolol dosages of 1800 mg/kg daily were associated with a slightly increased incidence of fetal bilateral cataract in rats. Acebutolol has been used effectively for the management of hypertension in a limited number of pregnant women and was well tolerated. Infants of mothers who received acebutolol for the management of hypertension during pregnancy had lower birthweights, decreased systolic blood pressures and heart rates during the first 72 hours after delivery, and, in one case, transient hypoglycemia. It is not known whether use of acebutolol in pregnant women affects the usual course of labor and delivery; in animals, no specific effects have been observed. There are no adequate and controlled studies to date using acebutolol in pregnant women, and the drug should be used during pregnancy only when the potential benefits justify the possible risks to the fetus.

Acebutolol and diacetolol are distributed into milk in higher concentrations than in maternal plasma, with acebutolol and diacetolol milk-to-plasma ratios of about 7.1 and 12.2, respectively. Further studies are needed, but some data suggest that clinically important amounts of acebutolol and diacetolol may be absorbed by nursing infants. The manufacturer recommends that acebutolol not be used in nursing women.

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