Why is this medicine prescribed?
Sotagliflozin is used to reduce the risk of death, hospitalization for heart failure, and urgent visits for heart failure-related concerns in patients with
- heart failure (condition in which the heart is unable to pump enough blood to the other parts of the body)
- type 2 diabetes mellitus (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood) and chronic kidney disease and other cardiovascular risk factors
Sotagliflozin is in a class of medications called sodium-glucose co-transporter 2 (SGLT2) inhibitors. It works by helping the kidneys remove glucose (sugar) and excess fluid through the urine.
Are there other uses for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
How should this medicine be used?
Sotagliflozin comes as a tablet to take by mouth. Take once a day one hour before the first meal of the day. It should not be taken more than one hour before the first meal. Take sotagliflozin at around the same time every day.
Take sotagliflozin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow the tablets whole; do not split, chew, or crush them.
Your doctor will probably start you on a low dose of sotagliflozin and increase your dose after 2 weeks.
Continue to take sotagliflozin even if you feel well. Do not stop taking sotagliflozin without talking to your doctor.
Sotagliflozin can cause dehydration. It is important that you drink plenty of water while taking sotagliflozin. Talk to your doctor or pharmacist about the right amount of water to drink to prevent dehydration while taking sotagliflozin.
What special precautions should I follow?
Before taking sotagliflozin,
- tell your doctor and pharmacist if you are allergic to to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking sotagliflozin. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you regularly drink alcohol or sometimes drink large amounts of alcohol in a short time (binge drinking), are on a low sodium diet, or if you have an infection. Also, tell your doctor if you have type 1 diabetes or diabetic ketoacidosis, have or have ever had low blood pressure, urinary tract infections or urinary problems, pancreatic disease including pancreatitis (swelling of the pancreas) or have had surgery on your pancreas, yeast infections or any other infections in the genital area, or kidney or liver disease. If you are male, tell your doctor if you have never been circumcised. Tell your doctor if you are eating or drinking less due to illness, surgery, or a change in your diet; if you are following a ketogenic diet (a high fat, low carbohydrate diet); or have recently had diarrhea, vomiting, been in the sun too long, or have been sweating a lot, which may cause dehydration (loss of a large amount of body fluids).
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking sotagliflozin, call your doctor immediately. Sotagliflozin may harm the fetus.
- do not breastfeed while you are taking sotagliflozin.
- ask your doctor what to do if you get sick, develop an infection or fever, experience unusual stress, or are injured. These conditions can affect your blood sugar and the amount of sotagliflozin you may need.
- you should know that sotagliflozin may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking sotagliflozin. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
- this medication may cause changes in your blood sugar. You should know the symptoms of low blood sugar (shakiness, nervousness, sweating, chills irritability, confusion, fast heart beat, feeling lightheaded or dizzy, hunger, headaches, nausea, blurred vision, or feeling weak). If you have these symptoms, consume about 15 grams of carbs [ex. half cup of juice or regular soda],
- this medication can cause ketoacidosis (a serious condition that may develop if high blood sugar is not treated) If you develop any of the following symptoms, call your doctor immediately or get emergency medical treatment: nausea, vomiting, stomach pain, fruity-smelling breath, tiredness, or difficulty breathing.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking sotagliflozin. Your doctor may tell you to stop taking sotagliflozin at least 3 days before your scheduled surgery.
- ask your doctor about the safe use of alcoholic beverages while you are taking sotagliflozin. Alcohol can make the side effects from sotagliflozin worse.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget to take a dose?
Take the missed dose as soon as you remember it. However, if more than 6 hours have passed, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What should I do in case of overdose?
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help . If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
What side effects can this medicine cause?
Sotagliflozin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- diarrhea
- increased thirst
- dry mouth
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:
- frequent, urgent, burning or painful urination; urine that is cloudy, red, pink or brown; strong smelling urine; pelvic or rectal pain; or fever back pain, nausea, or vomiting.
- dry mouth, dark urine, decreased sweating, dry skin, and other signs of dehydration
- feeling tired, weak, or uncomfortable; along with a fever and pain, tenderness, redness, or swelling of the genitals or the area between the genitals and the rectum.
- vaginal odor, white or yellowish vaginal discharge (may be lumpy or look like cottage cheese), vaginal itching
- redness, itching or swelling of the penis, foul smelling discharge from the penis, pain in the skin around the penis
Sotagliflozin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( https://www.fda.gov/Safety/MedWatch ) or by phone ( 1-800-332-1088).What should I know about storage and disposal of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.What other information should I know?
Keep all appointments with your doctor.
Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking sotagliflozin.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.