Description
Sotalol injection is used to treat life-threatening heart rhythm problem called ventricular arrhythmia. It is also used to treat heart rhythm problems called atrial fibrillation or atrial flutter.
Sotalol 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.
This medicine is to be given only by or under the direct supervision of your doctor.
This product is available in the following dosage forms:
- Solution
Before Using
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.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of sotalol 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 sotalol injection in elderly patients. However, elderly patients are more likely to have age-related kidney disease, which may require an adjustment in the dose for patients receiving sotalol injection.
Breastfeeding
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.
Drug Interactions
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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bepridil
- Cisapride
- Dronedarone
- Fingolimod
- Grepafloxacin
- Levoketoconazole
- Levomethadyl
- Mesoridazine
- Pimozide
- Piperaquine
- Saquinavir
- Sparfloxacin
- Terfenadine
- Thioridazine
- Vernakalant
- Ziprasidone
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.
- Acetazolamide
- Adagrasib
- Albuterol
- Alfuzosin
- Amiloride
- Amiodarone
- Amisulpride
- Amitriptyline
- Amoxapine
- Anagrelide
- Apomorphine
- Arformoterol
- Aripiprazole
- Arsenic Trioxide
- Artemether
- Asenapine
- Astemizole
- Atazanavir
- Azithromycin
- Azosemide
- Bambuterol
- Bedaquiline
- Bemetizide
- Bendroflumethiazide
- Benzthiazide
- Bitolterol
- Bretylium
- Broxaterol
- Bumetanide
- Buprenorphine
- Buserelin
- Canrenoate
- Ceritinib
- Chloral Hydrate
- Chloroquine
- Chlorpromazine
- Chlorthalidone
- Ciprofloxacin
- Citalopram
- Clarithromycin
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.
- Abarelix
- Acarbose
- Aceclofenac
- Acemetacin
- Albiglutide
- Alogliptin
- Amtolmetin Guacil
- Aspirin
- Bromfenac
- Bufexamac
- Bunazosin
- Canagliflozin
- Celecoxib
- Chlorpropamide
- Choline Salicylate
- Clonixin
- Dapagliflozin
- Dexibuprofen
- Dexketoprofen
- Diclofenac
- Diflunisal
- Dipyrone
- Doxazosin
- Droxicam
- Dulaglutide
- Empagliflozin
- Ertugliflozin
- Etodolac
- Etofenamate
- Etoricoxib
- Exenatide
- Felbinac
- Fenoprofen
- Fepradinol
- Feprazone
- Floctafenine
- Flufenamic Acid
- Flurbiprofen
- Glimepiride
- Glipizide
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:
- Angina (severe chest pain) or
- Heart attack, recent or
- Heart disease or
- Heart failure, history of or
- Heart rhythm problem (eg, QT prolongation) or
- Hypomagnesemia (low magnesium levels in the blood) or
- Hypotension (low blood pressure)—Use with caution. May make these conditions worse.
- Asthma or
- Bradycardia (slow heartbeat), without a pacemaker or
- Bronchospasm or
- Cardiogenic shock (shock caused by heart attack) or
- Heart block, without a pacemaker or
- Heart failure, uncontrolled or
- Heart rhythm problem (eg, long QT syndrome) or
- Hypokalemia (low potassium levels in the blood) or
- Kidney disease, severe or
- Sick sinus syndrome (type of abnormal heart rhythm), without pacemaker—Should not be used in patients with these conditions.
- Diabetes or
- Hyperthyroidism (overactive thyroid) or
- Hypoglycemia (low blood sugar)—Use with caution. May cover up some of the symptoms of these diseases, such as a fast heartbeat.
- Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
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.
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
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, urine, and ECG tests will be needed to check for unwanted effects.
Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.
Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. These symptoms are more likely to occur when you begin using this medicine, or when the dose is increased. Getting up slowly may help.
Sotalol 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, swelling of the face, fingers, feet, or lower legs, trouble breathing, unusual tiredness or weakness, or weight gain.
This medicine may cause a serious type of allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are receiving this medicine.
This medicine may cause changes in your blood sugar levels. Also, this medicine may cover up 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.
Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine.
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
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
- chest pain, discomfort, or tightness
- confusion
- difficult or labored breathing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast, irregular, pounding, or racing heartbeat or pulse
- increased sweating
- slow or irregular heartbeat
- sweating
- swelling
- trouble breathing
- unusual tiredness or weakness
Less common
- Arm, back, or jaw pain
- body aches or pain
- chest heaviness
- chills
- cold hands and feet
- cough
- decreased urine output
- diarrhea
- difficulty with breathing
- difficulty with speaking
- dilated neck veins
- dizziness
- double vision
- ear congestion
- fainting
- fever
- general feeling of discomfort or illness
- headache
- inability to move the arms, legs, or facial muscles
- inability to speak
- irregular breathing
- joint pain
- loss of appetite
- loss of voice
- muscle aches and pains
- nausea
- nervousness
- noisy breathing
- pounding in the ears
- runny or stuffy nose
- shivering
- slow speech
- sneezing
- sore throat
- swelling of the face, fingers, feet, or lower legs
- trouble sleeping
- vomiting
- weight gain
Incidence not known
- Black, tarry stools
- bleeding gums
- blood in the urine or stools
- blue lips and fingernails
- coughing that sometimes produces a pink frothy sputum
- difficult, fast, or noisy breathing
- increased sweating
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- sores, ulcers, or white spots on the lips or in the mouth
- swelling in the legs and ankles
- swollen glands
- unusual bleeding or bruising
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Anxiety
- blurred vision
- chest pain or discomfort
- cold sweats
- confusion
- cool, pale skin
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- depression
- fast, pounding, or irregular heartbeat or pulse
- increased hunger
- nightmares
- seizures
- shakiness
- slow or irregular heartbeat
- slurred speech
- 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:
Less common
- Abnormal ejaculation
- back pain
- bloated feeling
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- decreased appetite
- decreased interest in sexual intercourse
- excess air or gas in the stomach or intestines
- full feeling
- inability to have or keep an erection
- loss in sexual ability, desire, drive, or performance
- muscle or bone pain
- passing gas
- rash
- stomach distension
Incidence not known
- Hair loss or thinning of the hair
- itching skin
- loss or thinning of the hair
- muscle aches, cramps, pains, or stiffness
- pain, itching, burning, swelling, or a lump under your skin where the needle is placed
- severe sunburn
- swollen joints
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.
DRG-20074369
