Sotalol (Intravenous route)
To minimize the risk of induced arrhythmia, patients initiated or reinitiated on IV sotalol or converted from IV to oral therapy should be placed in a facility that can provide continuous cardiac monitoring and calculations of creatinine clearance. Do not initiate sotalol therapy if the baseline QTc is longer than 450 milliseconds. If the QT interval prolongs to 500 milliseconds or greater, reduce dose, reduce rate of infusion, or discontinue drug. Adjust dosing interval based on creatinine clearance .
Antiarrhythmic, Group III
Beta-Adrenergic Blocker, Nonselective
Uses of This Medicine:
Sotalol injection is used to control rapid heartbeats and abnormal heart rhythms that are serious or life-threatening. The injection may also be used when patients are not able to take the oral form.
Sotalol is a beta-blocker and antiarrhythmic. 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 available only with your doctor's prescription.
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:
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.
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.
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.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
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.
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.
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.
- Arsenic Trioxide
- Chloral Hydrate
- Ethacrynic Acid
- Perflutren Lipid Microsphere
- Sodium Phosphate
- Sodium Phosphate, Dibasic
- Sodium Phosphate, Monobasic
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.
- Amtolmetin Guacil
- Choline Salicylate
- Flufenamic Acid
- 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
- Mefenamic Acid
- Niflumic Acid
- Nimesulide Beta Cyclodextrin
- Salicylic Acid
- Sodium Salicylate
- St John's Wort
- Tiaprofenic Acid
- Tolfenamic Acid
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
- Hypotension (low blood pressure) Use with caution. May make these conditions worse.
- Asthma or
- AV block (type of abnormal heart rhythm), with no pacemaker or
- Bradycardia (slow heartbeat) or
- Breathing problems or
- Cardiogenic shock or
- Heart failure, uncontrolled or
- Heart rhythm problems (e.g., congenital long QT interval) or
- Hypokalemia (low potassium in the blood) or
- Hypomagnesemia (low magnesium in the blood) or
- Kidney disease, severe or
- Sick sinus syndrome (type of abnormal heart rhythm), with no 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 of This Medicine:
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.
Tell your doctor or nurse right away if you develop pain or swelling at the site where the needle is placed.
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 may be needed to check for unwanted effects.
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; shortness of breath; swelling of the face, fingers, feet, or lower legs; weight gain; or wheezing.
This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis 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.
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
- chest pain or discomfort
- 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
- shortness of breath
- slow or irregular heartbeat
- tightness in the chest
- unusual tiredness or weakness
- Less common
- Arm, back, or jaw pain
- body aches or pain
- chest tightness or heaviness
- cold hands and feet
- decreased urine output
- difficulty with breathing
- difficulty with speaking
- dilated neck veins
- double vision
- ear congestion
- extreme fatigue
- general feeling of discomfort or illness
- 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
- nasal congestion
- noisy breathing
- pounding in the ears
- runny nose
- slow speech
- sore throat
- swelling of the face, fingers, feet, or lower legs
- trouble sleeping
- troubled breathing
- 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, sometimes with wheezing
- 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
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
- Acid or sour stomach
- lack or loss of strength
- stomach discomfort, upset, or pain
- unable to sleep
- Less common
- Abdominal or stomach distension
- abnormal ejaculation
- back pain
- bloated feeling
- blurred or loss of vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- decreased appetite
- decreased sexual performance or desire
- disturbed color perception
- double vision
- excess air or gas in the stomach or intestines
- full feeling
- halos around lights
- mood changes
- muscle or bone pain
- night blindness
- overbright appearance of lights
- passing gas
- tunnel vision
- Incidence not known
- difficulty with moving
- feeling of constant movement of self or surroundings
- hair loss
- increased sensitivity of the skin to sunlight
- itching skin
- lack of coordination
- mental depression
- muscle aching or cramping
- muscle pains or stiffness
- pain, itching, burning, swelling, or a lump under your skin where the needle is placed
- quick to react or overreact emotionally
- rapidly changing moods
- redness or other discoloration of the skin
- sensation of spinning
- severe sunburn
- swollen joints
- thinning of the hair
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.
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