Trandate (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 for a long time, it can cause the heart and arteries to not work properly. This may 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 lower 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. This causes the heart to beat slower and lowers blood pressure. When blood pressure drops, 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 for your doctor to check your progress during regular visits to ensure this medicine is working correctly. You will need blood and urine tests to look for unwanted effects.

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

You may experience dizziness, lightheadedness, or fainting, especially when getting up suddenly from lying or sitting down. These symptoms are more likely when you first start this medicine or when your dose is increased. Getting up slowly may help.

This medicine may cause heart failure in some patients. Contact your doctor immediately if you have chest pain or discomfort, swollen neck veins, extreme fatigue, irregular breathing, an irregular heartbeat, swelling in the face, fingers, feet, or lower legs, or if you gain weight.

This medicine may affect your blood sugar levels. It may also mask signs of low blood sugar in patients with diabetes or those who are fasting (for example, due to surgery, not eating regularly, or vomiting), such as a fast pulse rate. Consult your doctor if you have these issues or if you notice changes in your blood or urine sugar test results.

Contact your doctor immediately if you or your child experience pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellowing of the eyes or skin. These could be signs of a serious liver issue.

If you plan to have cataract surgery, inform your eye doctor (ophthalmologist) that you are taking this medicine or have recently taken it. A serious eye problem called Intraoperative Floppy Iris Syndrome (IFIS) has occurred in some patients who were using this medicine or had recently used it during cataract surgery.

Make sure any doctor or dentist treating you knows that you are taking this medicine. This medicine may affect the results of certain tests.

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

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits. 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, inform 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 injection in children. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not shown geriatric-specific problems that would limit the usefulness of labetalol injection in older adults. However, older patients may need a lower maintenance dose than younger adults.

Breast Feeding

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

Interactions with Medicines

Although some 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 situations, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been selected based on 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 necessary 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
• 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 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
• 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 at or around meal times since interactions may happen. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Angina (severe chest pain)—May cause chest pain if stopped too quickly.

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

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

• Liver disease—Use with caution. The effects may be increased due to slower removal of the medicine from the body.

• 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 occur 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.