Canagliflozin (Oral route)
Based on new data from two large clinical trials, the U.S. Food and Drug Administration (FDA) has concluded that canagliflozin increased the risk of leg and foot amputations. Before starting canagliflozin, consider factors that may predispose patients to the need for amputations. These factors include a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers. Monitor patients receiving canagliflozin for the signs and symptoms described above and discontinue canagliflozin if these complications occur .
Sodium Glucose Co-Transporter 2 Inhibitor
Uses of This Medicine:
Canagliflozin is used together with proper diet and exercise to treat type 2 diabetes. It works in the kidney to prevent absorption of glucose (blood sugar). This helps lower the blood sugar level. Canagliflozin does not help patients who have insulin-dependent or type 1 diabetes. Type 1 diabetic patients must use insulin injections.
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 canagliflozin in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of canagliflozin in the elderly. However, elderly patients are more likely to have unwanted effects (eg, lightheadedness, dizziness, fainting, or dehydration), which may require caution in patients receiving canagliflozin.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
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 taking 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.
- Thioctic Acid
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.
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:
- Alcohol abuse, history of or
- Pancreatic insulin deficiency, history of—May increase risk for more serious side effects.
- Dehydration or
- Genital yeast (fungus) infection (eg, balanitis, balanoposthitis, vulvovaginitis), history of or
- Hyperkalemia (high potassium in the blood) or
- Hypotension (low blood pressure) or
- Hypovolemia (low blood volume) or
- Kidney disease or
- Urinary tract infection (eg, pyelonephritis, urosepsis), history of—Use with caution. May make these conditions worse.
- Diabetic ketoacidosis (high ketones and acid in the blood) or
- Kidney disease, severe or
- Liver disease, severe or
- Type I diabetes—Should not be used in patients with these conditions.
Proper Use of This Medicine:
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Tell your doctor if you are on a low-salt or sodium diet.
Carefully follow the special meal plan your doctor gave you. This is the most important part of controlling your diabetes, and will help the medicine work properly. Exercise regularly and test for sugar in your blood or urine as directed.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For type 2 diabetes:
- Adults—At first, 100 milligrams (mg) once a day, taken before the first meal of the day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 300 mg once a day.
- Children—Use and dose must be determined by your doctor.
- For type 2 diabetes:
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using This Medicine:
It is very important that your doctor check your progress at regular visits, especially during the first few weeks that you take this medicine. Blood and urine tests may be needed to check for unwanted effects.
Dizziness, lightheadedness, or fainting may occur with this medicine. This is more common if you have kidney disease, low blood pressure, or if you are taking a diuretic (water pill). Taking plenty of fluids each day may help. Drink plenty of water during exercise or in hot weather. Check with your doctor if you have severe nausea, vomiting, or diarrhea that does not stop. This may cause you to lose too much water.
Ketoacidosis (high ketones and acid in the blood) may occur while you are using this medicine. This can be life-threatening and requires immediate medical attention. Your doctor may give you insulin, fluid, and carbohydrate replacement to treat this condition. Tell your doctor right away if you have nausea, vomiting, trouble breathing, increased thirst or urination.
Tell your doctor if you have bloody urine, decrease in how much or how often you urinate, painful or difficult urination, lower back or side pain, fever, chills, or swelling of the face, finger, or lower legs. These may be symptoms of a serious kidney problem.
This medicine may cause vaginal yeast infections in women and yeast infections of the penis in men. This is more common in patients who have a history of genital yeast infections or in men who are not circumcised. Women may have a vaginal discharge, itching, or odor. Men may have redness, itching, swelling, or pain around the penis, or a discharge with a strong odor from the penis. Check with your doctor right away if you have any of these symptoms.
Serious allergic reactions may occur with this medicine. Check with your doctor right away if you have a skin rash, hives or welts, itching, redness of the skin, trouble breathing, or large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs.
This medicine may increase the risk of bone fractures. Ask your doctor about ways to keep your bones strong to help prevent fractures.
This medicine may cause hypoglycemia (low blood sugar). This is more common when this medicine is taken together with other diabetes medicines (eg, insulin, glipizide, or glyburide). The symptoms of low blood sugar must be treated before they cause you to pass out. People feel different symptoms with low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly. Some symptoms of low blood sugar include behavior changes that are similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty with thinking, drowsiness, excessive hunger, a fast heartbeat, headaches that continue, nausea, shakiness, slurred speech, or unusual tiredness or weakness. Talk to your doctor about how to treat low blood sugar.
Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your diabetes medicine, overeat or do not follow your diet plan, have a fever or infection, or do not exercise as much as usual. Some symptoms of high blood sugar include blurred vision, drowsiness, dry mouth, flushed and dry skin, a fruit-like breath odor, increased frequency and amount of urination, ketones in the urine, loss of appetite, nausea or vomiting, rapid and deep breathing, tiredness, or unusual thirst. If symptoms of high blood sugar occur, check your blood sugar level and call your doctor for instructions.
This medicine may cause high levels of potassium in your blood. Do not use medicines, supplements, or salt substitutes that contain potassium unless you have discussed this with your doctor.
This medicine may increase risk of having urinary tract infections, including pyelonephritis or urosepsis. Check with your doctor right away if you have bladder pain, bloody or cloudy urine, difficult, burning, or painful urination, or lower back or side pain.
Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests (eg, urine glucose tests may not be accurate).
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:
- More common
- Bladder pain
- bloody or cloudy urine
- decreased frequency or amount of urine
- difficult, burning, or painful urination
- discharge with a strong odor from the penis
- frequent urge to urinate
- increased thirst
- itching of the vagina or outside of the genitals
- loss of appetite
- lower back or side pain
- pain during sexual intercourse
- pain in the skin around the penis
- redness, itching, or swelling of the penis
- swelling of the face, fingers, or lower legs
- troubled breathing
- unusual tiredness or weakness
- vaginal discharge without odor or with mild odor
- weight gain
- Less common
- blurred vision
- cold sweats
- cool, pale skin
- dry mouth
- fast or irregular heartbeat
- hives or welts, itching skin, rash
- increased hunger
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- redness of the skin
- slurred speech
- unusual tiredness or weakness
- Incidence not known
- Abdominal or stomach pain
- blurred vision
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- flushed, dry skin
- frequent or painful urination
- frequent urge to urinate
- fruit-like breath odor
- increased urination
- loss of consciousness
- numbness or tingling in the hands, feet, or lips
- stomach pain
- unexplained weight loss
- weakness or heaviness of the legs
- Less common
- Difficulty having a bowel movement (stool)
- lack or loss of strength
- pain or swelling in the arms or legs without an injury
- Increased sensitivity of the skin to sunlight
- redness or other discoloration of the skin
- severe sunburn
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 immediately if any of the following side effects occur:
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:
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.
Last Updated: 7/4/2017