Acebutolol

Acebutolol should not be administered to female patients during the first trimester of pregnancy unless the physician considers it essential. In such cases the lowest possible dose should be used.

Beta blockers administered in late pregnancy may give rise to bradycardia, hypoglycaemia and cardiac or pulmonary complications in the foetus/neonate.

Beta-blockers can reduce placental perfusion, which may result in intrauterine foetal death, immature and premature deliveries.

Animal studies have shown no teratogenic hazard.

Acebutolol and its active metabolites are excreted in human milk and effects have been shown in breastfed newborns/infants of treated mothers. Acebutolol should not be used during breast-feeding.

No studies on the effects on the ability to drive and use machines have been performed. As with all beta-blockers, dizziness or fatigue may occur occasionally. This should be taken into account when driving or operating machinery.

Adverse reactions associated with acebutolol during controlled clinical trials in patients with hypertension, angina pectoris or arrhythmia (1002 patients exposed to acebutolol) are presented by system organ class and by decreasing order of frequency.

The frequency of the events “anti-nuclear antibody” and “lupus like syndrome” was found from 1440 patients suffering from hypertension, angina pectoris or arrhythmia and exposed to acebutolol in open or double blind studies performed in the United States.

Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).

When the exact frequency of the event was not reported, the frequency category assigned is “not known” (ADRs with *).

Adverse reactions reported from post-marketing experience are also listed. These adverse reactions are derived from spontaneous reports and therefore, the frequency of these adverse reactions is “not known” (cannot be estimated from the available data).

The most frequent and serious adverse reactions of acebutolol are related to the beta-adrenergic blocking activity. The most frequent reported clinical adverse reactions are fatigue and gastrointestinal disorders. Among the most serious adverse reactions are cardiac failure, atrioventricular block and bronchospasm. Abrupt withdrawal as for all beta-blockers may exacerbate angina pectoris and precaution is especially required in patients with ischaemic heart disease.

Immune system disorders

Very common: Antinuclear antibody

Uncommon: Lupus like syndrome

Psychiatric disorders

Common: Depression, nightmare

Not known: Psychoses, hallucinations, confusion, loss of libido*, sleep disorder

Nervous system disorders

Very common: Fatigue

Common: Dizziness, headache

Not known: Paraesthesia*, central nervous system disorder

Eye disorders

Common: Visual impairment

Not known: Dry eye*

Cardiac disorders

Not known: Cardiac failure*, atrioventricular block first degree, increase of an existing atrioventricular block, bradycardia*

Vascular disorders

Not known: Intermittent claudication, Raynaud’s syndrome, cyanosis peripheral and peripheral coldness, hypotension*

Respiratory, thoracic and mediastinal disorders

Common: Dyspnoea

Not known: Pneumonitis, lung infiltration, bronchospasm

Gastrointestinal disorders

Very common: Gastrointestinal disorders

Common: Nausea, diarrhoea

Not known: Vomiting*

Skin and subcutaneous tissue disorders

Common: Rash

General disorders and administration site condition

Not known: Withdrawal syndrome

Hepatobiliary disorders

Not known: Hepatic enzymes increased, liver injury mainly hepatocellular