Normodyne (Intravenous)

Labetalol injection is used to treat severe high blood pressure (hypertension). High blood pressure puts extra strain on the heart and arteries. If it lasts 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 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 certain parts of the body respond to nerve signals, including the heart. As a result, the heart beats slower and blood pressure goes down. When blood pressure is reduced, more blood and oxygen reach the heart.

This medicine is to be given only by or under the direct supervision of your doctor.

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

You should not receive this medicine together with verapamil (Calan®).

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. These symptoms are more likely to happen when you start 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 have chest pain or discomfort, dilated neck veins, extreme fatigue, irregular breathing, an irregular heartbeat, swelling of the face, fingers, feet, or lower legs, or weight gain.

This medicine may cause changes in your blood sugar levels. Also, this medicine may hide signs of low blood sugar in patients who have diabetes or are fasting (for example, surgery, not eating regularly, vomiting), such as a rapid pulse rate. Check with your doctor if you have these issues or if you notice a change in the results of your blood or urine sugar tests.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

If you plan to have cataract surgery, tell your eye doctor (ophthalmologist) that you are receiving this medicine or that you have received this medicine. 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.

Make sure any doctor or dentist who treats you knows that you are receiving this medicine. This medicine may affect the results of certain 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.

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

Allergies

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

Pediatric

Studies have not been done to determine how labetalol injection affects children. Safety and effectiveness have not been established for this age group.

Geriatric

Studies so far have not shown specific problems in older adults that would limit the use of labetalol injection. However, older patients may need a lower maintenance dose than younger adults.

Breast Feeding

Research in women suggests that this medication poses minimal risk to an infant when used during breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while others may be used together even if there is a risk of interaction. If you are receiving this medicine, it is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are significant but may not include all possible interactions.

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

• 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 both drugs may be necessary for your treatment. If both medicines are prescribed, your doctor may adjust the dose or how often you take one or both.

• 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 taken around the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines can also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

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

• Asthma or
• Bradycardia (slow heartbeat) or
• Cardiogenic shock (shock caused by heart attack) or
• Heart block or
• Heart failure or
• Severe and prolonged low blood pressure—Should not use in patients with these conditions.

• Diabetes or
• Hypoglycemia (low blood sugar)—May mask some signs and symptoms of these conditions, like a fast heartbeat.

• Liver disease—Use with caution. Effects may be stronger because the body removes the medicine more slowly.

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

• Pheochromocytoma (adrenal gland tumor)—Use with caution. May require a higher dose.

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 or nurse immediately if any of the following side effects occur:

More common

• Dizziness
• Tingling of the scalp or skin

Less common

• Black, tarry stools
• Blurred vision
• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• Chills
• Clay-colored stools
• Confusion
• Dark urine
• Diarrhea
• Dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• Fast, pounding, or irregular heartbeat or pulse
• Feeling of constant movement of self or surroundings
• Fever
• General tiredness and weakness
• Headache
• Itching skin
• Light-colored stools
• Loss of appetite
• Nausea and vomiting
• Palpitations
• Sensation of spinning
• Skin rash
• Stomach pain
• Sweating
• Unpleasant breath odor
• Unusual tiredness or weakness
• Vomiting of blood
• Yellow eyes or skin

Rare

• Chest pain, discomfort, or tightness
• Cough
• Difficulty swallowing
• Hives or welts
• Hoarseness
• Irritation
• Joint pain, stiffness, or swelling
• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• Lightheadedness, dizziness, or fainting
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Redness of skin
• Slow heartbeat
• Stomach pain
• Swelling of the eyelids, face, lips, hands, or feet
• Trouble breathing or swallowing

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

• Stuffy nose

Less common

• Acid or sour stomach
• Belching
• Change in taste or bad, unusual, or unpleasant (after) taste
• Decreased interest in sexual intercourse
• Heartburn
• Inability to have or keep an erection
• Increased yawning
• Indigestion
• Loss in sexual ability, desire, drive, or performance
• Sleepiness or unusual drowsiness
• Stomach discomfort or upset
• 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:

• Solution

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Alpha/Beta-Adrenergic Blocker

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins. You will need to remain lying down for up to 3 hours after you receive this medicine.

Your doctor will give you a few doses of this medicine until your condition improves, and then switch you to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.