Sectral

Sectral (acebutolol hydrochloride) is a beta-blocker used to treat hypertension (high blood pressure) and heart rhythm disorders. Sectral is available in generic form. Common side effects of Sectral include:

• dizziness,
• lightheadedness,
• drowsiness,
• tiredness,
• slow heartbeat,
• anxiety,
• nervousness,
• constipation,
• diarrhea,
• stomach upset/gas,
• nausea,
• trouble sleeping (insomnia), or
• unusual dreams your body adjusts to the medication.

Other side effects of Sectral include decreased sex drive, impotence, or difficulty having an orgasm. Tell your doctor if you have serious side effects of Sectral including:

• symptoms of asthma (feelings of tightness in the chest, shortness of breath, cough, wheezing),
• blue fingers or toes,
• fainting,
• very slow heartbeat,
• new or worsening symptoms of heart failure (such as swelling ankles or feet, severe tiredness, shortness of breath, unexplained/sudden weight gain),
• mental/mood changes (such as confusion, depression, memory problems),
• vision changes, or
• symptoms of liver disease (such as dark urine, persistent nausea, vomiting, stomach or abdominal pain, or yellowing eyes or skin).

The initial dosage of Sectral in uncomplicated mild-to-moderate hypertension is 400 mg. The usual initial dose of Sectral to treat ventricular arrhythmia is 400 mg daily given as 200 mg twice daily. Sectral may interact with allergy treatments (or if you are undergoing allergy skin-testing), clonidine, guanabenz, MAO inhibitors, diabetes medications, heart medications, medicines for asthma or other breathing disorders, cold medicines, stimulant medicines, or diet pills. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant during treatment with Sectral; it is not expected to be harmful to a fetus. Sectral can pass into breast milk and may harm a nursing baby. Consult your doctor before breastfeeding.

Our Sectral (acebutolol hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Sectral Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• shortness of breath (even with mild exertion), swelling, rapid weight gain;
• new or worsening chest pain;
• slow heartbeats;
• a light-headed feeling, like you might pass out; or
• dangerously high blood pressure--severe headache, blurred vision, pounding in your neck or ears, nosebleed, anxiety, confusion, severe chest pain, shortness of breath, irregular heartbeats.

Common side effects may include:

• headache, dizziness;
• feeling tired;
• nausea, upset stomach;
• diarrhea, constipation; or
• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Sectral (Acebutolol)

 

Sectral Professional Information

SIDE EFFECTS

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.

TOTAL VOLUNTEERED AND ELICITED (U.S. STUDIES)

Body System/ Adverse Reaction	SECTRAL (N=1002) %	Propranolol (N=424) %	Hydrochloro- thiazide (N=178) %	Placebo (N=314) %
Cardiovascular
Chest Pain	2	4	4	1
Edema	2	2	4	1
Central Nervous System
Depression	2	1	3	1
Dizziness	6	7	12	2
Fatigue	11	17	10	4
Headache	6	9	13	4
Insomnia	3	6	5	1
Abnormal dreams	2	3	0	1
Dermatologic
Rash	2	2	4	1
Gastrointestinal
Constipation	4	2	7	0
Diarrhea	4	5	5	1
Dyspepsia	4	6	3	1
Flatulence	3	4	7	1
Nausea	4	6	3	0
Genitourinary
Micturition (frequency)	3	1	9	< 1
Musculoskeletal
Arthralgia	2	1	3	2
Myalgia	2	1	4	0
Respiratory
Cough	1	1	2	0
Dyspnea	4	6	4	2
Rhinitis	2	1	4	< 1
Special Senses
Abnormal Vision	2	2	3	0

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.)

Body System	400 mg/day (N=132)	800 mg/day (N=63)	1200 mg/day (N=71)
Cardiovascular	5%	2%	1%
Gastrointestinal	3%	3%	7%
Musculoskeletal	2%	3%	4%
Central Nervous System	9%	13%	17%
Respiratory	1%	5%	6%
Skin	1%	2%	1%
Special Senses	2%	2%	6%
Genitourinary	2%	3%	1%

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.

Read the entire FDA prescribing information for Sectral (Acebutolol)

&Copy; Sectral Patient Information is supplied by Cerner Multum, Inc. and Sectral Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.