Acebutolol adverse reactions: Difference between revisions

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'''Autoimmune''': In extremely rare instances, [[systemic lupus erythematosus]] has been reported.
'''Autoimmune''': In extremely rare instances, [[systemic lupus erythematosus]] has been reported.


The incidence of drug-related adverse effects (volunteered and solicited) according to Sectral dose is shown below. (Data from 266 [[hypertensive]] patients treated for 3 months on a constant dose.)
The incidence of drug-related adverse effects (volunteered and solicited) according to Sectral dose is shown below. (Data from 266 [[hypertensive]] patients treated for 3 months on a constant dose.){|
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===Potential Adverse Events===
 
In addition, certain adverse effects not listed above have been reported with other β-blocking agents and should also be considered as potential adverse effects of Sectral.
 
'''Central Nervous System''': Reversible mental depression progressing to [[catatonia]] (an acute syndrome characterized by disorientation for time and place), short-term memory loss, emotional lability, slightly clouded sensorium, and decreased performance (neuropsychometrics).
 
'''Cardiovascular''': Intensification of AV block (see CONTRAINDICATIONS).
 
'''Allergic''': [[Erythematous rash]], fever combined with aching and sore throat, [[laryngospasm]], and [[respiratory distress]].
 
'''Hematologic''': [[Agranulocytosis]], [[nonthrombocytopenic]], and thrombocytopenic [[purpura]].
 
'''Gastrointestinal''': Mesenteric arterial thrombosis and [[ischemic colitis]].
 
'''Miscellaneous''': [[Reversible alopecia]] and [[Peyronie’s disease]]. The oculomucocutaneous syndrome associated with the β-blocker practolol has not been reported with Sectral during investigational use and extensive foreign clinical experience.
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Revision as of 19:02, 3 February 2014

Acebutolol
SECTRAL® FDA Package Insert
Indications and Usage
Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
How Supplied/Storage and Handling
Patient Counseling Information
Labels and Packages
Clinical Trials
ClinicalTrials.gov

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

Adverse Reactions

Sectral is well tolerated in properly selected patients. Most adverse reactions have been mild, not required discontinuation of therapy, and tended to decrease as duration of treatment increases.

The following table shows the frequency of treatment-related side effects derived from controlled clinical trials in patients with hypertension, angina pectoris, and arrhythmia. These patients received Sectral, propranolol, or hydrochlorothiazide as monotherapy, or placebo.

The following selected (potentially important) side effects were seen in up to 2% of Sectral patients:

Cardiovascular: hypotension, bradycardia, heart failure.

Central Nervous System: anxiety, hyper/hypoesthesia, impotence.

Dermatological: pruritus.

Gastrointestinal: vomiting, abdominal pain.

Genitourinary: dysuria, nocturia.

Liver and Biliary System: A small number of cases of liver abnormalities (increased SGOT, SGPT, LDH) have been reported in association with acebutolol therapy. In some cases increased bilirubin or alkaline phosphatase, fever, malaise, dark urine, anorexia, nausea, headache, and/or other symptoms have been reported. In some of the reported cases, the symptoms and signs were confirmed by rechallenge with acebutolol. The abnormalities were reversible upon cessation of acebutolol therapy.

Musculoskeletal: back pain, joint pain.

Respiratory: pharyngitis, wheezing.

Special Senses: conjunctivitis, dry eye, eye pain.

Autoimmune: In extremely rare instances, systemic lupus erythematosus has been reported.

The incidence of drug-related adverse effects (volunteered and solicited) according to Sectral dose is shown below. (Data from 266 hypertensive patients treated for 3 months on a constant dose.){| |-

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Potential Adverse Events

In addition, certain adverse effects not listed above have been reported with other β-blocking agents and should also be considered as potential adverse effects of Sectral.

Central Nervous System: Reversible mental depression progressing to catatonia (an acute syndrome characterized by disorientation for time and place), short-term memory loss, emotional lability, slightly clouded sensorium, and decreased performance (neuropsychometrics).

Cardiovascular: Intensification of AV block (see CONTRAINDICATIONS).

Allergic: Erythematous rash, fever combined with aching and sore throat, laryngospasm, and respiratory distress.

Hematologic: Agranulocytosis, nonthrombocytopenic, and thrombocytopenic purpura.

Gastrointestinal: Mesenteric arterial thrombosis and ischemic colitis.

Miscellaneous: Reversible alopecia and Peyronie’s disease. The oculomucocutaneous syndrome associated with the β-blocker practolol has not been reported with Sectral during investigational use and extensive foreign clinical experience. [1]


References

  1. "SECTRAL (ACEBUTOLOL HYDROCHLORIDE) CAPSULE [PROMIUS PHARMA, LLC]". Retrieved 3 February 2014.

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