Medical Editor: John P. Cunha, DO, FACOEP
Levatol (penbutolol sulfate) is a beta-antagonist drug indicated in the treatment of mild to moderate high blood pressure (arterial hypertension). Side effects of Levatol are usually mild and reversible and include:
- upset stomach
- decreased interest in sex, or
- cold symptoms (stuffy nose, sneezing, and sore throat)
Serious side effects of Levatol are uncommon but may include chest pain, AV block intensification, rashes, hair loss and Peyronie's disease.
Levatol (penbutolol sulfate) is available only in 20 mg strength tablets. The usual starting and maintenance dose of Levatol is 20 mg given once daily, but may be increased, if necessary. Levatol may interact with digoxin, tizanidine, diuretics (water pills), asthma medications, blood pressure medications also used to treat a prostate disorder, calcium channel blockers, or heart or blood pressure medications. Tell your doctor all medications and supplements you use. There are no adequate and well-controlled studies in pregnant women. Therefore, Levatol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Levatol is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Levatol is administered to a nursing woman. Patients, especially those with evidence of coronary artery insufficiency, should be warned against interruption or discontinuation of Levatol without the physician's advice.
Our Levatol (penbutolol sulfate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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.
Tiredness, slow heartbeat, and dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
This drug may reduce blood flow to your hands and feet, causing them to feel cold. Smoking may worsen this effect. Dress warmly and avoid tobacco use.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: very slow heartbeat, severe dizziness, fainting, blue fingers/toes, trouble breathing, new or worsening symptoms of heart failure (such as swelling ankles/feet, severe tiredness, shortness of breath, unexplained/sudden weight gain), mental/mood changes (such as confusion, mood swings, depression).
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Levatol (penbutolol sulfate)
levatol® is usually well tolerated in properly selected patients. Most adverse effects observed during clinical trials have been mild and reversible.
Table 1 lists the adverse reactions reported from 4 controlled studies conducted in the United States involving once-a-day administration of levatol® (at doses ranging from 10 to 120 mg) as monotherapy or in combination with hydrochlorothiazide. levatol® doses above 40 mg/day are not, however, recommended. The table includes only those events where the prevalence rate in the levatol® group was at least 1.5%, or where the reaction is of particular interest.
Over a dose range from 10 to 40 mg, once a day, fatigue, nausea, and sexual impotence occurred at a greater frequency as the dose was increased.
Table 1: ADVERSE REACTIONS DURING CONTROLLED US STUDIES
| Body System
|Body as a Whole||%||%||%|
|Upper respiratory infection||2.5||3.3||4.9|
|Skin and Appendages|
In a double-blind clinical trial comparing levatol® (40 mg and greater once a day) and propranolol (40 mg or more twice a day), heart rates of less than 60 beats/min. were recorded at least once in 25% of the patients in the group receiving levatol® and in 37% of the patients in the propranolol group. Corresponding figures for heart rates of less than 50 beats/min. were 1.2% and 6% respectively. No symptoms associated with bradycardia were reported.
Discontinuations of levatol® because of adverse reactions have ranged between 2.4% and 6.9% of patients in double-blind, parallel, controlled clinical trials, as compared to 1.8% to 4.1% in the corresponding control groups that were given placebo. The frequency and severity of adverse reactions have not increased during long-term administration of levatol®. The prevalence of adverse reactions reported from 4 controlled clinical trials (referred to in Table 1) as reasons for discontinuation of therapy by ≥ 0.5% of the levatol® group is listed in Table 2.
Table 2: DISCONTINUATIONS DURING CONTROLLED US STUDIES
| Body System
|Body as a Whole||%||%||%|
Potential Adverse Effects: 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 levatol®.
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.
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 levatol® during investigational use and extensive foreign clinical experience.
Read the entire FDA prescribing information for Levatol (penbutolol sulfate)