Labetalol Intravenous

In the U.S.

• Normodyne
• Trandate

Available Dosage Forms:

• Solution

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Alpha/Beta-Adrenergic Blocker

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 labetalol, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to labetalol 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 injection in the pediatric population. Safety and efficacy have not been established .

Geriatric

No information is available on the relationship of age to the effects of labetalol in geriatric patients. However, elderly patients are more likely to have age-related liver and heart problems, which may require an adjustment in the dose for patients receiving labetalol injection .

Pregnancy

Breast Feeding

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

Interactions with Medicines

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 receiving labetalol, 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 labetalol 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.

• Crizotinib
• Diltiazem
• Dronedarone
• Fenoldopam
• Fingolimod
• Halothane
• Indacaterol
• Iobenguane I 123
• Lacosamide
• Oxymetazoline
• Rivastigmine
• Verapamil

Using labetalol 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
• Amiodarone
• Amtolmetin Guacil
• Arbutamine
• 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
• 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
• Iobenguane I 131
• Isoflurane
• Ketoprofen
• Ketorolac
• Linagliptin
• Liraglutide
• Lixisenatide
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Magnesium Sulfate
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Metformin
• Metildigoxin
• Mibefradil
• 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

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 labetalol. 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 (slow heartbeat) 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 cover up some of the signs and symptoms of these diseases, such as a fast heartbeat .

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

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

• Pheochromocytoma (adrenal gland tumor)—Use with caution. May require an increased dose .

A nurse or other trained health professional will give you labetalol. labetalol is given through a needle placed in one of your veins .

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:

• Dizziness
• tingling of the scalp or skin

• Abdominal or stomach pain
• 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
• sweating
• unpleasant breath odor
• unusual tiredness or weakness
• vomiting of blood
• wheezing
• yellow eyes or skin

• Chest pain or discomfort
• cough
• difficult or labored breathing
• difficulty swallowing
• hives or welts
• hoarseness
• irritation
• joint pain, stiffness, or swelling
• large, hive-like swelling on 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
• shortness of breath
• slow heartbeat
• swelling of eyelids, face, lips, hands, or feet
• tightness in chest
• troubled breathing or swallowing

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

• Convulsions
• dilated neck veins
• extreme fatigue
• irregular breathing
• loss of bladder control
• muscle spasm or jerking of all extremities
• noisy breathing
• 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:

• Stuffy nose

• 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.

Consult your pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Consult your pharmacist.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.