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Levatol

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Levatol

Levatol Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Levatol (penbutolol sulfate), a beta-antagonist type of drug, is indicated in the treatment of mild to moderate arterial hypertension. Levatol is not available as a generic. Levatol is usually well tolerated in properly selected patients. Most adverse effects observed during clinical trials have been mild and reversible (headache, fatigue, dizziness, nausea).

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. 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. Serious side effects are few; chest pain, AV block intensification, rashes, hair loss and Peyronie's disease have been reported.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Levatol in Detail - Patient Information: Side Effects

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

Call your doctor at once if you have a serious side effect such as:

  • slow or uneven heartbeats;
  • feeling short of breath, even with mild exertion;
  • swelling, rapid weight gain; or
  • feeling like you might pass out.

Less serious side effects may include:

  • headache;
  • feeling tired;
  • dizziness;
  • nausea, diarrhea, upset stomach;
  • decreased interest in sex; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

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 Levatol (penbutolol sulfate) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Levatol Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning and Precautions sections.

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)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Levatol FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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
Experience
Penbutolol
(N=628)
Placebo
(N=212)
Propranolol
(N=266)
Body as a Whole % % %
  Asthenia 1.6 0.9 4.9
  Pain, chest 2.4 2.8 2.3
  Pain, limb 2.4 1.4 1.5
Digestive System
  Diarrhea 3.3 1.9 2.6
  Nausea 4.3 0.9 2.3
  Dyspepsia 2.7 1.4 5.3
Nervous System
  Dizziness 4.9 2.4 4.2
  Fatigue 4.4 1.9 2.6
  Headache 7.8 6.1 7.5
  Insomnia 1.9 0.9 2.6
Respiratory System
  Cough 2.1 0.5 1.1
  Dyspnea 2.1 1.4 3.4
  Upper respiratory infection 2.5 3.3 4.9
Skin and Appendages
  Sweating, excessive 1.6 0.5 2.3
Urogenital System
  Impotence, sexual 0.5 0.0 0.8

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
Experience
Penbutolol
(N=628)
Placebo
(N=212)
Propranolol
(N=266)
Body as a Whole % % %
  Asthenia 0.6 0.0 0.4
  Pain, chest 0.6 1.4 0.4
Digestive System
  Nausea 0.8 0.0 0.8
Nervous System
  Depression 0.6 0.5 0.8
  Dizziness 0.6 0.0 0.4
  Fatigue 0.5 0.5 0.0
  Headache 0.6 0.5 0.4

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.

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 levatol® during investigational use and extensive foreign clinical experience.

Read the entire FDA prescribing information for Levatol (penbutolol sulfate) »

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Levatol - User Reviews

Levatol User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Levatol sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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