Brand Name

    US Brand Name

    Normodyne

    Trandate


    Description

    Labetalol is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

    This medicine is a beta-blocker. It works by affecting the response to nerve impulses in certain parts of the body, like the heart. As a result, the heart beats slower and decreases the blood pressure. When the blood pressure is lowered, the amount of blood and oxygen is increased to the heart.

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

    This product is available in the following dosage forms:

    • Tablet

    Before Using

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies have not been performed on the relationship of age to the effects of labetalol in the pediatric population. Safety and efficacy have not been established.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of labetalol in the elderly.

    Breastfeeding

    Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

    Drug Interactions

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

    • Albuterol
    • Carbamazepine
    • Ceritinib
    • Clonidine
    • Crizotinib
    • Darunavir
    • Diltiazem
    • Dronedarone
    • Epinephrine
    • Fenoldopam
    • Fexinidazole
    • Fingolimod
    • Formoterol
    • Halothane
    • Indacaterol
    • Iobenguane I 123
    • Iobenguane I 131
    • Iohexol
    • Lacosamide
    • Levalbuterol
    • Levoketoconazole
    • Lonafarnib
    • Mavacamten
    • Methotrexate
    • Olodaterol
    • Oxymetazoline
    • Ponesimod
    • Rivastigmine
    • Salmeterol
    • Siponimod
    • Terbutaline
    • Verapamil
    • Vilanterol

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

    • Acarbose
    • Aceclofenac
    • Acemetacin
    • Acetyldigoxin
    • Albiglutide
    • Alfuzosin
    • Alogliptin
    • Amtolmetin Guacil
    • Aspirin
    • Bromfenac
    • Bufexamac
    • Bunazosin
    • Canagliflozin
    • Celecoxib
    • Chlorpropamide
    • Choline Salicylate
    • Cimetidine
    • Clonixin
    • Dapagliflozin
    • Deslanoside
    • Dexibuprofen
    • Dexketoprofen
    • Diclofenac
    • Diflunisal
    • Digitoxin
    • Digoxin
    • Dipyrone
    • Doxazosin
    • Droxicam
    • Dulaglutide
    • Empagliflozin
    • Enflurane
    • Ertugliflozin
    • Etodolac
    • Etofenamate
    • Etoricoxib
    • Exenatide
    • Felbinac
    • Fenoprofen
    • Fepradinol

    Other Interactions

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Angina (severe chest pain)—May provoke chest pain if stopped too quickly.
    • Asthma or
    • Bradycardia, severe (slow heartbeat) or
    • Cardiogenic shock (shock caused by heart attack) or
    • Obstructive airway disease, or
    • Heart block or
    • Heart failure or
    • Hypotension (low blood pressure), severe and prolonged—Should not be used in patients with these conditions.
    • Diabetes or
    • Hyperthyroidism (overactive thyroid) or
    • Hypoglycemia (low blood sugar)—May cover up some of the signs and symptoms of these diseases, such as a fast heartbeat.
    • Hypotension (low blood pressure) or
    • Ischemic heart disease or
    • Lung disease or
    • Pheochromocytoma (adrenal gland tumor)—Use with caution. May make these conditions worse.
    • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
    • Patients who are fasting (eg, surgery, not eating regularly, vomiting)—May increase risk of hypoglycemia (low blood sugar).

    Proper Use

    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. 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.

    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, 100 milligrams (mg) 2 times a day. Your doctor may adjust your dose as 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.


    Precautions

    It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects. Blood and urine tests may be needed to check for unwanted effects.

    Do not use this medicine together with verapamil (Isoptin®).

    Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. These symptoms are more likely to occur when you begin using this medicine, or when the dose is increased. Getting up slowly may help.

    This medicine may cause heart failure in some patients. Check with your doctor right away if you are having chest pain or discomfort, swollen neck veins, extreme fatigue, irregular breathing, an uneven heartbeat, swelling of the face, fingers, feet, or lower legs, or weight gain.

    Do not interrupt or stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely. Some conditions may become worse when the medicine is stopped suddenly, which can be dangerous.

    This medicine may cause changes in blood sugar levels. Also, this medicine may cover up the symptoms of low blood sugar (including fast heartbeat) and increase the risk for serious or prolonged hypoglycemia (low blood sugar). Check with your doctor if you notice a change in your normal symptoms or a change in the results of your blood or urine sugar tests. Call your doctor right away if you have anxiety, blurred vision, chills, cold sweats, confusion, cool, pale skin, depression, dizziness, fast heartbeat, headache, increased hunger, nausea, nervousness, nightmares, seizures, shakiness, slurred speech, or unusual tiredness or weakness.

    Check with your doctor right away if you start having itchy skin, dark urine, loss of appetite, yellow eyes or skin, flu-like symptoms, or stomach pain or tenderness. These could be symptoms of serious liver problem.

    Make sure any doctor or dentist who treats you knows that you are using this medicine, especially before having any kind of surgery (including cataract surgery). A serious eye problem called Intraoperative Floppy Iris Syndrome (IFIS) has occurred in some patients who were taking this medicine, or who had recently taken this medicine, when they had cataract surgery. You may need to stop using this medicine several days before having surgery or medical tests.

    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.


    Side Effects

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

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

    Less common

    • Blurred vision or other changes in vision
    • chest tightness
    • chills
    • cold sweats
    • confusion
    • dizziness, faintness, or lightheadedness when getting up suddenly from lying or sitting position
    • swelling of the face, fingers, feet, or lower legs
    • trouble breathing

    Get emergency help immediately if any of the following symptoms of overdose occur:

    Symptoms of overdose

    • Dilated neck veins
    • extreme fatigue
    • irregular breathing
    • loss of bladder control
    • muscle spasm or jerking of all extremities
    • noisy breathing
    • seizures
    • sudden loss of consciousness
    • 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

    • Nausea

    Less common

    • Acid or sour stomach
    • belching
    • change in taste or bad, unusual, or unpleasant (after) taste
    • decreased interest in sexual intercourse
    • feeling of constant movement of self or surroundings
    • headache
    • heartburn
    • inability to have or keep an erection
    • indigestion
    • lack or loss of strength
    • loss in sexual ability, desire, drive, or performance
    • not able to ejaculate semen
    • rash
    • sensation of spinning
    • stomach discomfort, upset, or pain
    • stuffy nose

    Rare

    • Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
    • diarrhea
    • increased sweating
    • vomiting

    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.






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