Drugs Details

Drugs Info of Levatol
Drugs Details
  • Drugs Type  : Multum
  • Date : 13th Feb 2015 04:57 am
  • Brand Name : Levatol
  • Generic Name : penbutolol (Pronunciation: pen byoo TOH lol)
Descriptions

levatol® (penbutolol sulfate) is a synthetic β-receptor antagonist for oral administration. The chemical name of penbutolol sulfate is (S)-l-tert-butylamino-3-(o-cyclopentylphenoxy)-2-propanol sulfate. It is provided as the levorotatory isomer. The empirical formula for penbutolol sulfate is C36H60N2O8S. Its molecular weight is 680.94. A dose of 20 mg is equivalent to 29.4 µmol. The structural formula is as follows:

 

levatol® (penbutolol sulfate) Structural Formula Illustration

Penbutolol is a white, odorless, crystalline powder, levatol® is available as tablets for oral administration. Each tablet contains 20 mg of penbutolol sulfate. It also contains corn starch, D&C Yellow No. 10, lactose, magnesium stearate, povidone, silicon dioxide, talc, titanium dioxide, synthetic black iron oxide, hypromellose, simethicone and other inactive ingredients.

What are the possible side effects of penbutolol (Levatol)?

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...

Read All Potential Side Effects and See Pictures of Levatol »

What are the precautions when taking penbutolol sulfate (Levatol)?

Before taking penbutolol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain types of heart rhythm problems (such as a slow heartbeat, second- or third-degree atrioventricular block), severe heart failure, breathing problems (such as asthma, chronic bronchitis, emphysema).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: treated stable heart failure, kidney disease, liver disease,...

Read All Potential Precautions of Levatol »

This monograph has been modified to include the generic and brand name in many instances.

Indications

Levatol® is indicated in the treatment of mild to moderate arterial hypertension. It may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.

Dosage Administration

The usual starting and maintenance dose of levatol®, used alone or in combination with other antihypertensive agents, such as thiazide-type diuretics, is 20 mg given once daily.

Doses of 40 mg and 80 mg have been well-tolerated but have not been shown to give a greater antihypertensive effect. The full effect of a 20- or 40-mg dose is seen by the end of 2 weeks. A dose of 10 mg also lowers blood pressure, but the full effect is not seen for 4 to 6 weeks.

How Supplied

levatol® (penbutolol sulfate) 20 mg tablets are capsule-shaped, film-coated, yellow tablets scored on both sides and imprinted in black with "SP 22" on one side. They are supplied as follows:

Bottles of 100 NDC 0091 -4500-15

Store at 20°-25°C (68°-77°F); excursions permitted between 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Keep tightly closed and protect from light.

Schwarz Pharma, LLC a subsidiary of UCB, Inc. Smyrna, GA 30080. Revised 12/2010

This monograph has been modified to include the generic and brand name in many instances.

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 Levatol (penbutolol sulfate) Side Effects Center for a complete guide to possible side effects

Learn More »

Interactions

levatol® has been used in combination with hydrochlorothiazide in at least 100 patients without unexpected adverse reactions.

In one study, the combination of penbutolol and alcohol increased the number of errors in the eye-hand psychomotor function test.

Penbutolol increases the volume of distribution of lidocaine in normal subjects. This could result in a requirement for higher loading doses of lidocaine.

Cimetidine has no effect on the clearance of penbutolol. The major metabolite of penbutolol is a glucuronide, and it has been shown that cimetidine does not inhibit glucuronidation.

Synergistic hypotensive effects, bradycardia, and arrhythmias have been reported in some patients receiving β-adrenergic blocking agents when an oral calcium antagonist was added to the treatment regimen.

Generally, levatol® should not be used in patients receiving catecholamine-depleting drugs.

Digoxin: Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.

Anesthesia: Care should be taken when using anesthetic agents that depress the myocardium, such as ether, cyclopropane, and trichloroethylene, and it is prudent to use the lowest possible dose of levatol. levatol, like other β-blockers, is a competitive inhibitor of β-receptor agonists, and its effect on the heart can be reversed by cautious administration of such agents (eg, dobutamine or isoproterenol — see OVERDOSAGE). Manifestations of excessive vagal tone (eg, profound bradycardia, hypotension) may be corrected with atropine 1 to 3 mg IV in divided doses.

Risk of Anaphylactic Reaction: While taking β-blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction.

Read the Levatol Drug Interactions Center for a complete guide to possible interactions

Learn More »

This monograph has been modified to include the generic and brand name in many instances.

Warnings

Cardiac Failure

Sympathetic stimulation may be essential for supporting circulatory function in patients with heart failure, and its inhibition by β-adrenergic receptor blockade may precipitate more severe failure. Although β-blockers should be avoided in overt congestive heart failure, levatol® can, if necessary, be used with caution in patients with a history of cardiac failure who are well compensated, on treatment with vasodilators, digitalis and/or diuretics. Both digitalis and penbutolol slow AV conduction. Beta-adrenergic receptor antagonists do not inhibit the inotropic action of digitalis on heart muscle. If cardiac failure persists, treatment with levatol® should be discontinued.

Patients Without History of Cardiac Failure

Continued depression of the myocardium with β-blocking agents over a period of time can, in some cases, lead to cardiac failure. At the first evidence of heart failure, patients receiving levatol® should be given appropriate treatment, and the response should be closely observed. If cardiac failure continues despite adequate intervention with appropriate drugs, levatol® should be withdrawn (gradually, if possible).

Exacerbation oflschemic Heart Disease Following Abrupt Withdrawal

Hypersensitivity to catecholamines has been observed in patients who were withdrawn from therapy with β-blocking agents; exacerbation of angina and, in some cases, myocardial infarction have occurred after abrupt discontinuation of such therapy. When discontinuing levatol®, particularly in patients with ischemic heart disease, the dosage should be reduced gradually over a period of 1 to 2 weeks and the patient should be monitored carefully. If angina becomes more pronounced or acute coronary insufficiency develops, administration of levatol® should be reinstated promptly, at least on a temporary basis, and appropriate measures should be taken for the management of unstable angina. Patients should be warned against interruption or discontinuation of therapy without the physician's advice. Because coronary artery disease is common and may not be recognized, it may not be prudent to discontinue levatol® abruptly, even in patients who are being treated only for hypertension.

Nonallergic Bronchospasm (eg, chronic bronchitis,emphysema)

levatol® is contraindicated in bronchial asthma. In general, patients with bronchospastic diseases should not receive β-blockers. levatol® should be administered with caution because it may block bronchodilation produced by endogenous catecholamine stimulation of β-2 receptors.

Major Surgery

Chronically administered beta-blocking therapy should not be routinely withdrawn prior to major surgery; however, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures.

Diabetes Mellitus and Hypoglycemia

Beta-adrenergic receptor blockade may prevent the appearance of signs and symptoms of acute hypoglycemia, such as tachycardia and blood pressure changes. This is especially important in patients with labile diabetes. Beta-blockade also reduces the release of insulin in response to hyperglycemia; therefore, it may be necessary to adjust the dose of hypoglycemic drugs. Beta-adrenergic blockade may also impair the homeostatic response to hypoglycemia; in that event, the spontaneous recovery from hypoglycemia may be delayed during treatment with β-adrenergic receptor antagonists.

Thyrotoxicosis

Beta-adrenergic blockade may mask certain clinical signs (eg, tachycardia) of hyperthyroidism. Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of β-adrenergic receptor blockers that might precipitate a thyroid storm.

Precautions

Included as part of the PATIENT INFORMATION section.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

There was no evidence of carcinogenicity observed in a 21-month study in mice or a 2-year study in rats. Mice were given penbutolol in the diet for 18 months at doses up to 395 mg/kg/day (about 500 times the Maximum Recommended Human Dose (MRHD) of 40 mg in a 50 kg person). Rats were given 141 mg/kg/day for the same length of time. Mice were observed for 3 months and rats for 5.5 to 7 months after termination of treatment before necropsy was performed.

No evidence of mutagenic activity of penbutolol was seen in the Salmonella mutagenicity test (Ames test), the point mutation induction test (Saccharomyces), and the micronucleus test.

Penbutolol had no adverse effects on fertility or general reproductive performance in mice and rats at oral doses up to 172 mg/kg/day.

Pregnancy

Teratogenic Effects: Pregnancy Category C

Teratology studies in rats and rabbits revealed no teratogenic effects related to treatment with penbutolol at oral doses up to 200 mg/kg/day (250 times the MRHD). In rabbits, a slight increase in the intrauterine fetal mortality and a reduced 24-hour offspring survival rate were observed in the groups treated with 125 mg/kg/day (156 times the MRHD) but not in the groups treated with 0.2 and 5 mg (0.25 to 6 times the MRHD).

There are no adequate and well-controlled studies in pregnant women, levatol® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects

In a perinatal and postnatal study in rats, the pup body weight and pup survival rate were reduced at the highest dose level of 160 mg/kg/day (200 times the MRHD).

Nursing Mothers

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.

Pediatric Use

Safety and effectiveness of levatol® in pediatric patients have not been established.

Geriatric Use

Clinical studies of levatol® did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

This monograph has been modified to include the generic and brand name in many instances.

OverDose

There is no actual experience with levatol® overdose. The signs and symptoms that would be expected with overdosage of β-adrenergic receptor antagonists are symptomatic bradycardia, hypotension, bronchospasm, and acute cardiac failure. In addition to discontinuation of levatol®, gastric emptying, and close observation of the patient, the following measures might be considered as appropriate:

Excessive Bradycardia

Administer atropine sulfate to induce vagal blockade. If bradycardia persists, intravenous isoproterenol hydrochloride may be administered cautiously; larger than usual doses may be needed. In refractory cases, the use of a trans venous cardiac pacemaker may be necessary.

Hypotension

Sympathomimetic drug therapy, such as dopamine, dobutamine, or levarterenol, may be considered if hypotension persists despite correction of bradycardia. In refractory cases, administration of glucagon hydrochloride has been reported to be useful.

Bronchospasm

A β-2-agonist or isoproterenol hydrochloride may be administered. Additional therapy with aminophylline may be considered.

Acute Cardiac Failure

Institute conventional therapy immediately. Intravenous administration of dobutamine and glucagon hydrochloride has been reported to be useful.

Heart Block (Second or Third Degree)

Isoproterenol hydrochloride or a transvenous cardiac pacemaker may be used.

ContrainDications

levatol® is contraindicated in patients with cardiogenic shock, sinus bradycardia, second and third degree atrioventricular conduction block, bronchial asthma, and those with known hypersensitivity to this product (see WARNINGS).

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Penbutolol is a β-1,β-2 (nonselective) adrenergic receptor antagonist. Experimental studies showed a dose-dependent increase in heart rate in reserpinized (norepinephrine-depleted) rats given penbutolol intravenously at doses of 0.25 to 1.0 mg/kg, suggesting that penbutolol has some intrinsic sympathomimetic activity. In human studies, however, heart rate decreases have been similar to those seen with propranolol.

Penbutolol antagonizes the heart rate effects of exercise and infused isoproterenol. The β-blocking potency of penbutolol is approximately 4 times that of propranolol. An oral dose of less than 10 mg will reduce exercise-induced tachycardia to one-half its usual level; maximum antagonism follows doses of 10 to 20 mg. The peak effect is between 1.5 and 3 hours after oral administration. The duration of effect exceeds 20 hours during a once-daily dosing regimen. During chronic administration of penbutolol, the duration of antihypertensive effects permits a once-daily dosage schedule.

Acute hemodynamic effects of penbutolol have been studied following single intravenous doses between 0.1 and 4 mg. The cardiovascular responses included significant reductions in heart rate, left ventricular maximum dP/dt, cardiac output, stroke volume index, stroke work, and stroke work index. Systolic pressure and mean arterial pressure were reduced, and total peripheral resistance was increased.

Chronic administration of penbutolol to hypertensive patients results in the hemodynamic pattern typical of β-adrenergic blocking drugs: a reduction in cardiac index, heart rate, systolic and diastolic blood pressures, and the product of heart rate and mean arterial pressure both at rest and with all levels of exercise, without significant change in total peripheral resistance. Penbutolol causes a reduction in left ventricular contractility. Penbutolol decreases glomerular filtration rate, but not significantly.

Clinical trial doses of 10 to 80 mg per day in single daily doses have reduced supine and standing systolic and diastolic blood pressures. In most studies, effects were small, generally a change in blood pressure 5 to 8/3 to 5 mm Hg greater than seen with a placebo measured 24 hours after dosing. It is not clear whether this relatively small effect reflects a characteristic of penbutolol or the particular population studied (the population had relatively mild hypertension but did not appear unusual in other respects). In a direct comparison of penbutolol with adequate doses of twice daily propranolol, no difference in blood pressure effect was seen. In a comparison of placebo and 10-, 20-, and 40-mg single daily doses of penbutolol, no significant dose-related difference was seen in response to active drug at 6 weeks, but, compared to the 10-mg dose, the two larger doses showed greater effects at 2 and 4 weeks and reached their maximum effect at 2 weeks. In several studies, dose increases from 40 to 80 mg were without additional effect on blood pressure. Response rates to penbutolol are unaffected by sex or age but are greater in Caucasians than blacks.

Penbutolol decreases plasma renin activity in normal subjects and in patients with essential and renovascular hypertension. The mechanisms of the antihypertensive actions of β-receptor antagonists have not been established. However, factors that may be involved are: (1) competitive antagonism of catecholamines at peripheral adrenergic receptor sites (especially cardiac) that leads to decreased cardiac output; (2) a central nervous system (CNS) action that results in a decrease in tonic sympathetic neural outflow to the periphery; and (3) a reduction of renin secretion through blockade of β-receptors involved in release of renin from the kidneys.

Penbutolol dose dependently increases the RR and QT intervals. There is no influence on the PR, QRS, or QT c (corrected) intervals.

Pharmacokinetics

Following oral administration, penbutolol is rapidly and completely absorbed. Peak plasma concentrations of penbutolol occur between 2 and 3 hours after oral administration and are proportional to single and multiple doses between 10 and 40 mg once a day. The average plasma elimination half-life of penbutolol is approximately 5 hours in normal subjects. There is no significant difference in the plasma half-life of penbutolol in healthy elderly persons or patients on renal dialysis. Twelve to 24 hours after oral administration of doses up to 120 mg, plasma concentrations of parent drug are 0% to 10% of the peak level. No accumulation of penbutolol is observed in hypertensive patients after 8 days of therapy at doses of 40 mg daily or 20 mg twice a day. Penbutolol is approximately 80% to 98% bound to plasma proteins.

The metabolism of penbutolol in humans involves conjugation and oxidation. The metabolites are excreted principally in the urine. When radiolabeled penbutolol was administered to humans, approximately 90% of the radioactivity was excreted in the urine. Approximately 1/6 of the dose of penbutolol was recovered as penbutolol conjugate while the remaining fraction was not identified. Conjugated penbutolol has a plasma elimination half-life of approximately 20 hours in healthy persons, 25 hours in healthy elderly persons, and 100 hours in patients on renal dialysis. Thus, accumulation of penbutolol conjugate may be expected upon multiple-dosing in renal insufficiency. An oxidative metabolite of penbutolol, 4-hydroxy penbutolol, has been identified in small quantities in plasma and urine. It is 1/8 to 1/15 times as active as the parent compound in blocking isoproterenol-induced β-adrenergic receptor responses in isolated guinea-pig trachea and is 1/8 to 1 times as potent in anesthetized dogs.

Animal Toxicology

Studies in rats indicated that the combination of penbutolol, triamterene, and hydrochlorothiazide (up to 40, 50 and 25 mg/kg respectively) increased the incidence and severity of renal tubular dilation and regeneration when compared to that in rats treated only with triamterene and hydrochlorothiazide. Dogs administered the same doses of triamterene and hydrochlorothiazide alone and in combination with penbutolol had an increase in serum alkaline phosphatase and serum alanine transferase, but there were no gross or microscopic abnormalities observed. No significant toxicologic findings were observed in rats and dogs treated with a combination of penbutolol and hydrochlorothiazide.

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

Patients, especially those with evidence of coronary artery insufficiency, should be warned against interruption or discontinuation of levatol® without the physician's advice. Although cardiac failure rarely occurs in properly selected patients, those being treated with β-adrenergic receptor antagonists should be advised of the symptoms of heart failure and to report such symptoms immediately, should they develop.

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

PENBUTOLOL - ORAL

 

(pen-BYOO-toe-lole)

 

COMMON BRAND NAME(S): Levatol

 

WARNING: Do not stop taking this medication without consulting your doctor. Some conditions may become worse when you suddenly stop this drug. Some people who have suddenly stopped taking similar drugs have had chest pain, heart attack, and irregular heartbeat. If your doctor decides you should no longer use this drug, he or she may direct you to gradually decrease your dose over 1 to 2 weeks.

When gradually stopping this medication, it is recommended that you temporarily limit physical activity to decrease strain on the heart. Seek immediate medical attention if you develop chest pain/tightness/pressure, chest pain spreading to the jaw/neck/arm, unusual sweating, trouble breathing, or fast/irregular heartbeat.

 

USES: Penbutolol is used with or without other medications to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems.

This medication belongs to a class of drugs known as beta blockers. It works by blocking the action of certain natural chemicals in your body such as epinephrine on the heart and blood vessels. This effect lowers the heart rate, blood pressure, and strain on the heart.

 

HOW TO USE: See also Warning section.

Take this medication by mouth with or without food, usually once a day or as directed by your doctor.

Dosage is based on your medical condition and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick. It may take several weeks before you get the full benefit of this drug.

Tell your doctor if your condition does not improve or if it worsens (for example, your blood pressure readings remain high or increase).

Consumer Overview Side Effect

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 Levatol (penbutolol sulfate) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before taking penbutolol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain types of heart rhythm problems (such as a slow heartbeat, second- or third-degree atrioventricular block), severe heart failure, breathing problems (such as asthma, chronic bronchitis, emphysema).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: treated stable heart failure, kidney disease, liver disease, overactive thyroid disease (hyperthyroidism), serious allergic reactions including those needing treatment with epinephrine, blood circulation problems (such as Raynaud's disease, peripheral vascular disease), mental/mood disorders (such as depression), a certain muscle disease (myasthenia gravis).

If you have diabetes, this product may prevent the fast/pounding heartbeat you would usually feel when your blood sugar level falls too low (hypoglycemia). Other symptoms of a low blood sugar level, such as dizziness and sweating, are unaffected by this drug. This product may also make it harder to control your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of high blood sugar such as increased thirst/urination. Your diabetes medication or diet may need to be adjusted.

Before having surgery, tell your doctor or dentist that you are taking this medication.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, older adults may be more sensitive to the side effects of this drug, including dizziness and tiredness.

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk or if it may harm a nursing infant. Discuss the risks and benefits with your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: See also Precautions section.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: fingolimod.

Check the labels on all your medicines (such as cough-and-cold products, diet aids, nonsteroidal anti-inflammatory drugs-NSAIDs such as ibuprofen for pain/fever reduction) because they may contain ingredients that could increase your blood pressure or heart rate. Ask your pharmacist about using those products safely.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: very slow heartbeat, severe dizziness, severe weakness, fainting, trouble breathing.

 

NOTES: Do not share this medication with others.

Talk with your doctor about making changes to your lifestyle that may help this medication work better (such as stress reduction programs, exercise, and dietary changes).

Have your blood pressure and pulse (heart rate) checked regularly while taking this medication. Learn how to check your own blood pressure and pulse at home, and share the results with your doctor.

Laboratory and/or medical tests should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

 

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

 

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Levatol

Generic Name: penbutolol (Pronunciation: pen byoo TOH lol)

  • What is penbutolol (Levatol)?
  • What are the possible side effects of penbutolol (Levatol)?
  • What is the most important information I should know about penbutolol (Levatol)?
  • What should I discuss with my healthcare provider before taking penbutolol (Levatol)?
  • How should I take penbutolol (Levatol)?
  • What happens if I miss a dose (Levatol)?
  • What happens if I overdose (Levatol)?
  • What should I avoid while taking penbutolol (Levatol)?
  • What other drugs will affect penbutolol (Levatol)?
  • Where can I get more information?

What is penbutolol (Levatol)?

Penbutolol is a beta-blocker. Beta-blockers affect the heart and circulation (blood flow through arteries and veins).

Penbutolol is used to treat hypertension (high blood pressure).

Penbutolol may also be used for purposes not listed in this medication guide.

What are the possible side effects of penbutolol (Levatol)?

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 Levatol (penbutolol sulfate) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about penbutolol (Levatol)?

Do not stop taking penbutolol without first talking to your doctor. Stopping suddenly may make your condition worse.

If you need surgery, tell the surgeon ahead of time that you are using penbutolol. You may need to stop using the medicine for a short time.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol can increase certain side effects of penbutolol.

Penbutolol is only part of a complete program of treatment for hypertension that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely if you are being treated for hypertension.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Side Effects Centers
  • Levatol

Patient Detailed How Take

What should I discuss with my healthcare provider before taking penbutolol (Levatol)?

You should not take penbutolol if you are allergic to it, or if you have:

  • asthma; or
  • certain serious heart conditions such as"AV block" or slow heart rhythm.

To make sure you can safely take penbutolol, tell your doctor if you have any of these other conditions:

  • kidney disease;
  • liver disease;
  • bronchitis, emphysema, or other breathing disorder;
  • congestive heart failure;
  • diabetes; or
  • a thyroid disorder.

FDA pregnancy category C. It is not known whether penbutolol will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether penbutolol passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take penbutolol (Levatol)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take penbutolol at the same time every day.

Your blood pressure will need to be checked often, and you may need other blood tests at your doctor's office. Visit your doctor regularly.

Do not stop taking this medication without first talking to your doctor. You may need to use less and less before you stop the medication completely. Stopping a beta-blocker too quickly can cause serious heart problems.

If you need surgery, tell the surgeon ahead of time that you are using penbutolol. You may need to stop using the medicine for a short time.

Penbutolol is only part of a complete program of treatment for hypertension that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely if you are being treated for hypertension.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Store at room temperature away from moisture, heat, and light.

Side Effects Centers
  • Levatol

Patient Detailed Avoid Taking

What happens if I miss a dose (Levatol)?

Take the missed dose as soon as you remember. If your next dose is less than 8 hours away, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Levatol)?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include slow heart rate, wheezing, chest tightness, trouble breathing, weak pulse, fainting, or slow breathing.

What should I avoid while taking penbutolol (Levatol)?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol can increase certain side effects of penbutolol.

What other drugs will affect penbutolol (Levatol)?

Tell your doctor about all other medicines you use, especially:

  • digoxin (digitalis, Lanoxin);
  • tizanidine (Zanaflex);
  • a diuretic (water pill);
  • asthma medications such as albuterol (Ventolin, Proventil), aminophylline (Phyllocontin, Truphylline), metaproterenol (Alupent), pirbuterol (Maxair), salmeterol (Advair, Serevent), terbutaline (Brethaire, Brethine, Bricanyl), or theophylline (Elixophyllin, Theo-24, Theochron, Uniphyl);
  • blood pressure medications also used to treat a prostate disorder, such as doxazosin (Cardura), prazosin (Minipress), or terazosin (Hytrin);
  • a calcium channel blocker such as amlodipine (Norvasc, Caduet, Exforge, Lotrel, Tekamlo, Tribenzor, Twynsta, Amturnide), diltiazem (Cartia, Cardizem), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others; or
  • heart or blood pressure medication such as clonidine (Catapres), guanabenz (Wytensin), guanfacine (Intuniv, Tenex), hydralazine (Apresoline, BiDil), methyldopa (Aldomet), or minoxidil (Loniten).

This list is not complete and other drugs may interact with penbutolol. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist has additional information about penbutolol written for health professionals that you may read.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 5.01. Revision date: 8/10/2011.

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Side Effects Centers
  • Levatol

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