Pronunciation:

lan-DYE-oh-lol

Brand Names:

• Rapiblyk

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Cardiovascular Agent

Pharmacologic—

Beta-Adrenergic Blocker, Cardioselective

Uses of This Medicine:

Landiolol injection is used to treat heart rhythm problems in patients with supraventricular tachycardia (eg, atrial fibrillation and atrial flutter). Landiolol 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 at a regular rhythm. Z

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

Before Using This Medicine:

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.

Children—

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

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of landiolol injection in the elderly. However, elderly patients are more likely to have age-related kidney or heart problems, which may require an adjustment in the dose for patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other 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 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.

• Acebutolol
• Albuterol Sulfate
• Amlodipine
• Amphetamine
• Apraclonidine Hydrochloride
• Aranidipine
• Arformoterol Tartrate
• Armodafinil
• Atenolol
• Atomoxetine Hydrochloride
• Bepridil
• Betaxolol
• Bisoprolol
• Brimonidine Tartrate
• Carteolol
• Carvedilol
• Celiprolol
• Cilnidipine
• Clevidipine
• Clonidine
• Dexmethylphenidate Hydrochloride
• Dextroamphetamine
• Diltiazem
• Droxidopa
• Ephedrine Hydrochloride
• Ephedrine Sulfate
• Epinephrine
• Esmolol
• Felodipine
• Fenoldopam
• Fingolimod
• Fluticasone Propionate
• Formoterol Fumarate
• Indacaterol
• Isocarboxazid
• Isoproterenol Hydrochloride
• Isradipine
• Labetalol
• Lercanidipine
• Levalbuterol
• Levalbuterol Hydrochloride
• Levalbuterol Tartrate
• Levobunolol
• Linezolid
• Lisdexamfetamine Dimesylate
• Manidipine
• Methamphetamine Hydrochloride
• Methylene Blue
• Methylphenidate
• Metipranolol
• Metoprolol
• Midodrine Hydrochloride
• Modafinil
• Nadolol
• Nebivolol
• Nicardipine
• Nifedipine
• Nimodipine
• Nisoldipine
• Nitrendipine
• Norepinephrine Bitartrate
• Olodaterol
• Oxprenolol
• Oxymetazoline Hydrochloride
• Ozanimod
• Penbutolol
• Phenelzine
• Phenylephrine Hydrochloride
• Pindolol
• Procarbazine
• Propranolol
• Pseudoephedrine Hydrochloride
• Rasagiline
• Reserpine
• Safinamide
• Salmeterol
• Salmeterol Xinafoate
• Selegiline
• Sotalol
• Terbutaline
• Terbutaline Sulfate
• Tetrahydrozoline Hydrochloride
• Timolol
• Tranylcypromine
• 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.

• Acetyldigoxin
• Deslanoside
• Digitoxin
• Digoxin
• Metildigoxin

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:

• Bradycardia (slow heartbeat) or
• Cardiogenic shock (shock caused by heart attack) or
• Heart block or
• Heart failure or
• Lung or breathing problems (eg, pulmonary hypertension) or
• Sick sinus syndrome (type of abnormal heart rhythm)—Should not be used in patients with these conditions.

• Blood vessel or circulation problems (eg, Raynaud's disease) or
• Heart disease (eg, coronary artery disease) or
• Hypovolemia (low fluid in the body) or
• Kidney disease or
• Metabolic acidosis or
• Pheochromocytoma (adrenal gland tumor) or
• Prinzmetal's angina (severe chest pain)—Use with caution. May make these conditions worse.

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

• Liver disease, moderate to severe—Use is not recommended in patients with this condition.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through an IV catheter that is placed in one of your veins.

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress while you are receiving this medicine to make sure the medicine is working properly. Blood and urine tests will be needed to check for unwanted effects.

This medicine may cause hypotension (low blood pressure) and heart problems (eg, slow heartbeat, heart failure). Check with your doctor right away if you have blurred vision, chest pain, discomfort, or tightness, confusion, decreased urine output, dilated neck veins, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, irregular breathing, slow or irregular heartbeat, sweating, swelling of the face, fingers, feet, or lower legs, unusual tiredness or weakness, or weight gain.

Check with your doctor right away if you have chest tightness, cough, or trouble breathing. These may be symptoms of serious lung or breathing problems.

This medicine may cause changes in your blood sugar levels. Also, this medicine may cover up signs of low blood sugar in patients who have diabetes or are fasting (eg, surgery, not eating regularly, vomiting), 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.

Check with your doctor right away if you have flushing, redness of the skin, pain or swelling of the skin, or unusually warm skin. These may be symptoms of infusion site reactions.

This medicine may cause hyperkalemia (high potassium levels in the blood). Check with your doctor right away if you have confusion, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, stomach pain, trouble breathing, or weakness or heaviness of the legs.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, fast heartbeat, hives, itching, skin rash, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, or unusual tiredness or weakness.

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 of This Medicine:

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

Blurred vision

confusion

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

sweating

unusual tiredness or weakness

Incidence not known

Anxiety

change in consciousness

chest discomfort, pain, or tightness

chills

cold sweats

cool, pale skin

cough

decreased urine output

depression

difficulty swallowing

dilated neck veins

dizziness

fast heartbeat

hives, itching, skin rash

increased hunger

irregular heartbeat

loss of consciousness

mood or mental changes

nausea or vomiting

nervousness

no blood pressure or pulse

noisy breathing

numbness or tingling in the hands, feet, or lips

pale or blue lips, fingernails, or skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

seizures

shakiness

slurred speech

stomach pain

stopping of the heart

swelling of the face, fingers, feet, or lower legs

trouble breathing

trouble sleeping

unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness

weakness or heaviness of the legs

weight gain

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.