Normodyne (Oral)

Labetalol is used on its own or with other medicines to treat high blood pressure (hypertension). High blood pressure puts extra strain on the heart and arteries. If it lasts for a long time, the heart and arteries may not work properly. This can harm the blood vessels in the brain, heart, and kidneys, leading to a stroke, heart failure, or kidney failure. High blood pressure can also raise the chances of heart attacks. Controlling blood pressure can help reduce the likelihood of these problems.

This medicine is a beta-blocker. It works by changing how the body responds to nerve signals in certain areas, like the heart. This causes the heart to beat more slowly and lowers blood pressure. When blood pressure is reduced, more blood and oxygen reach the heart.

This medicine is available only with a 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.

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 signs of a liver injury.

Labetalol may cause heart failure in some patients. Check with your doctor right away if you are having 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.

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

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.

In deciding to use a medicine, you and your doctor will weigh the risks against the benefits. For this medicine, consider the following:

Allergies

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

Pediatric

Appropriate studies have not been done on how labetalol affects children. Safety and effectiveness have not been established.

Geriatric

There is no information available on how labetalol affects older patients.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together, while others can be used together even if an interaction might happen. If you are taking this medicine, it is especially 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 importance and are not necessarily all-inclusive.

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 together, your doctor may adjust the dose or how often you use one or both of the medicines.

• Albuterol
• Ceritinib
• Crizotinib
• Darunavir
• Diltiazem
• Dronedarone
• Fenoldopam
• Fexinidazole
• Fingolimod
• Formoterol
• Halothane
• Indacaterol
• Iobenguane I 123
• Iobenguane I 131
• Iohexol
• Lacosamide
• Levalbuterol
• Levoketoconazole
• Methotrexate
• 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 medicines 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
• Epinephrine
• 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
• Isoflurane
• Ketoprofen
• Ketorolac
• Linagliptin
• Liraglutide
• Lixisenatide
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Magnesium Sulfate
• 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 used when eating food or certain types of food, as interactions may occur. Using alcohol or tobacco with some medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how you can use this medicine. Make sure to tell your doctor if you have any other medical problems, especially:

• Angina (severe chest pain)—Stopping this medicine too quickly may cause chest pain.

• Asthma or
• Bradycardia (slow heartbeat) or
• Chronic obstructive pulmonary disease (COPD), history of or
• Heart block or
• Heart failure or
• Hypotension (low blood pressure), severe and prolonged—Should not use in patients with these conditions.

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

• Liver disease—Use with caution. May worsen this condition.

• Lung disease—May cause breathing difficulties in patients with this condition.

• Pheochromocytoma (adrenal gland tumor)—Use with caution. There may be an unusual increase in blood pressure.

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
• chills
• cold sweats
• confusion
• difficult or labored breathing
• dizziness, faintness, or lightheadedness when getting up from lying or sitting position
• shortness of breath
• swelling of face, fingers, feet, or lower legs
• tightness in chest
• wheezing

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

Symptoms of overdose

• Chest pain or discomfort
• lightheadedness, dizziness, or fainting
• slow or irregular heartbeat
• sweating
• unusual tiredness or weakness

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.

In the U.S.

• Normodyne
• Trandate

Available Dosage Forms:

• Tablet

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Alpha/Beta-Adrenergic Blocker

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.

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.

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) two times 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.