Levatol (Oral)

Penbutolol is used by itself or with other medicines, including a diuretic or "water pill" like hydrochlorothiazide (HCTZ), to treat high blood pressure (hypertension). High blood pressure makes the heart and arteries work harder. If it lasts a long time, the heart and arteries may not work well. This can harm the blood vessels in the brain, heart, and kidneys, leading to a stroke, heart failure, or kidney failure. High blood pressure may also raise the risk of heart attacks. Controlling blood pressure may help reduce the chances of these problems.

This medicine is a beta-blocker. It works by changing how the body responds to nerve signals in certain areas, such as the heart. This leads to a slower heart rate and lower blood pressure. When blood pressure decreases, more blood and oxygen reach the heart.

This medicine is available only with your doctor's prescription.

It is very important that your doctor checks your progress at regular visits to ensure this medicine is working properly and to look for unwanted effects.

This medicine may cause heart failure in some patients. Stop using this medicine and contact your doctor immediately if you experience chest pain or discomfort; dilated neck veins; extreme fatigue; irregular breathing; an irregular heartbeat; shortness of breath; swelling of the face, fingers, feet, or lower legs; weight gain; or wheezing.

Do not interrupt or stop taking this medicine without first consulting your doctor. Your doctor may want you to gradually reduce the dose before stopping it completely. Some conditions may worsen if the medicine is stopped suddenly, which can be dangerous.

This medicine may cause a serious allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you develop a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while using this medicine.

Make sure any doctor or dentist who treats you knows that you are using this medicine. Do not stop taking this medicine before surgery without your doctor's approval.

This medicine may cause changes in your blood sugar levels. Additionally, this medicine may mask signs of low blood sugar, such as a rapid pulse rate. Check with your doctor if you have these issues or if you notice a change in your blood or urine sugar test results.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks and benefits of the medicine. The following points should be taken into account for this medicine:

Allergies

Tell your doctor if you have had any unusual or allergic reactions to this medicine or any other medicines. Also, inform your healthcare professional about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on the effects of penbutolol in children have not been conducted. Its safety and effectiveness in this age group have not been established.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the use of penbutolol. However, older patients may have age-related issues with their liver, kidneys, or heart, which could require caution and adjustments in the dose for those taking penbutolol.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if interactions could happen. In these cases, your doctor may change the dose or take other precautions. It is particularly important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been selected based on their potential significance and are not an exhaustive list.

Using this medicine with any of the following medicines is usually not recommended but may be necessary in some cases. If both medicines are prescribed, your doctor may adjust the dose or how often you take one or both medicines.

• Albuterol
• Ceritinib
• Clonidine
• Crizotinib
• Darunavir
• Diltiazem
• Dronedarone
• Epinephrine
• Fenoldopam
• Fexinidazole
• Fingolimod
• Formoterol
• Indacaterol
• Iobenguane I 131
• Iohexol
• Lacosamide
• Levalbuterol
• Olodaterol
• Oxymetazoline
• Ponesimod
• Rivastigmine
• Salmeterol
• Siponimod
• Terbutaline
• Verapamil
• Vilanterol

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be the best treatment option for you. If both medicines are prescribed together, your doctor may change the dose or frequency of use for one or both medicines.

• Acarbose
• Aceclofenac
• Acemetacin
• Acetyldigoxin
• Albiglutide
• Alfuzosin
• Alogliptin
• Amtolmetin Guacil
• Aspirin
• Bromfenac
• Bufexamac
• Bunazosin
• Canagliflozin
• Celecoxib
• Chlorpropamide
• Choline Salicylate
• Clonixin
• Dapagliflozin
• Deslanoside
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Digitoxin
• Digoxin
• Dipyrone
• Doxazosin
• Droxicam
• Dulaglutide
• Empagliflozin
• Ertugliflozin
• Etodolac
• Etofenamate
• Etoricoxib
• Exenatide
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Glimepiride
• Glipizide
• Glyburide
• Ibuprofen
• Indomethacin
• Insulin Aspart, Recombinant
• Insulin Degludec
• Insulin Detemir
• Insulin Glargine, Recombinant
• Insulin Glulisine
• Insulin Human Inhaled
• Insulin Human Isophane (NPH)
• Insulin Human Regular
• Insulin Lispro, Recombinant
• Ketoprofen
• Ketorolac
• Lidocaine
• Linagliptin
• Liraglutide
• Lixisenatide
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Metformin
• Metildigoxin
• Miglitol
• Morniflumate
• Moxisylyte
• Nabumetone
• Naproxen
• Nateglinide
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenoxybenzamine
• Phentolamine
• Phenylbutazone
• Piketoprofen
• Pioglitazone
• Piroxicam
• Pramlintide
• Pranoprofen
• Prazosin
• Proglumetacin
• Propyphenazone
• Proquazone
• Repaglinide
• Rofecoxib
• Rosiglitazone
• Salicylic Acid
• Salsalate
• Saxagliptin
• Sitagliptin
• Sodium Salicylate
• St John's Wort
• Sulindac
• Tamsulosin
• Tenoxicam
• Terazosin
• Tiaprofenic Acid
• Tolazamide
• Tolbutamide
• Tolfenamic Acid
• Tolmetin
• Trimazosin
• Urapidil
• Valdecoxib
• Vildagliptin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Discuss with your healthcare professional about the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect the use of this medicine. Make sure to inform your doctor about any other medical problems you have, especially:

• History of severe anaphylactic reactions—This may increase the risk of repeated anaphylactic reactions.

• Severe angina (chest pain) or
• Recent heart attack or
• History of heart failure or
• Heart or blood vessel disease (e.g., coronary artery disease)—Use with caution. It may worsen these conditions.

• Asthma or
• Bradycardia (slow heartbeat) or
• Cardiogenic shock (shock from heart attack) or
• Heart block—Should not be used in patients with these conditions.

• Diabetes or
• Hyperthyroidism (overactive thyroid) or
• Hypoglycemia (low blood sugar)—It may hide some signs and symptoms of these conditions, such as a fast heartbeat.

• Kidney disease—Use with caution. Effects may be stronger due to slower removal from the body.

• Lung disease (e.g., bronchitis, emphysema)—Use with caution. It may cause breathing difficulties in patients with this condition.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Chest pain
• difficult or labored breathing
• increased sweating
• pain in the limbs
• shortness of breath
• tightness in the chest
• wheezing

Incidence not known

• Abdominal or stomach tenderness
• abdominal or stomach pain, usually after eating a meal
• black, tarry stools
• blood in the urine
• bloody nose
• bloody stools
• constipation
• cough or hoarseness
• diarrhea
• fever with or without chills or sore throat
• general feeling of tiredness or weakness
• heavier menstrual periods
• lower back or side pain
• nausea
• painful or difficult urination
• pinpoint red spots on the skin
• rectal bleeding
• skin rash
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting
• worsening of heart block

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Symptoms of overdose

• Blurred vision
• chest pain or discomfort
• confusion
• difficulty with breathing
• dilated neck veins
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• extreme fatigue
• irregular breathing
• noisy breathing
• slow or irregular heartbeat
• sweating
• swelling of the face, fingers, feet, or lower legs
• weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Headache

Less common

• Acid or sour stomach
• belching
• body aches or pain
• chills
• difficulty with breathing
• ear congestion
• fever
• heartburn
• indigestion
• lack or loss of strength
• loss of voice
• nasal congestion
• nausea
• runny nose
• sleeplessness
• sneezing
• sore throat
• stomach discomfort, upset, or pain
• trouble sleeping
• unable to sleep

Rare

• Decreased interest in sexual intercourse
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance

Incidence not known

• Crying
• decreased awareness or responsiveness
• depersonalization
• dysphoria
• euphoria
• hair loss or thinning of the hair
• memory loss
• mental depression
• mimicry of speech or movements
• mutism
• negativism
• pain of the penis on erection
• paranoia
• peculiar postures or movements, mannerisms or grimacing
• quick to react or overreact emotionally
• rapidly changing moods
• reddened skin
• severe sleepiness
• skin rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Levatol

Pharmacologic Class: Penbutolol

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

You may take this medicine with or without food.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):For high blood pressure: Adults—At first, 20 milligrams (mg) once a day. Your doctor may increase your dose if needed. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.