canagliflozin and metformin

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Pronunciation: KAN a gli FLOE zin and met FOR min

Brand: Invokamet, Invokamet XR

What is the most important information I should know about canagliflozin and metformin?

You should not use this medicine if you have moderate to severe kidney disease, diabetic ketoacidosis, or if you are on dialysis.

This medicine may cause a serious condition called lactic acidosis. Get emergency medical help if you have: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.

What is canagliflozin and metformin?

Canagliflozin and metformin are oral diabetes medicines that help control blood sugar levels.

Canagliflozin and metformin is a combination medicine used with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

Canagliflozin and metformin may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking canagliflozin and metformin?

You should not use this medicine if you are allergic to canagliflozin (Invokana) or metformin (Glucophage, Avandamet, and others), or if you have:

  • moderate to severe kidney disease (or if you are on dialysis); or
  • diabetic ketoacidosis (call your doctor for treatment with insulin).

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you will need to temporarily stop taking this medicine.

Some people taking metformin develop a serious condition called lactic acidosis. This may be more likely if you have liver or kidney disease, a severe infection, surgery, a heart attack or stroke, if you are dehydrated, or if you drink large amounts of alcohol. Talk with your doctor about your risk.

To make sure canagliflozin and metformin is safe for you, tell your doctor if you have ever had:

  • liver or kidney disease;
  • bladder infections or other urination problems;
  • heart disease, congestive heart failure;
  • blood circulation problems;
  • nerve problems caused by diabetes;
  • a diabetic foot ulcer or amputation;
  • a pancreas disorder or surgery;
  • an electrolyte imbalance (such as high levels of potassium in your blood); or
  • if you are on a low salt diet.

Using canagliflozin and metformin during pregnancy could harm the unborn baby, especially during the second or third trimester. Tell your doctor if you are pregnant or if you become pregnant while using this medicine. Some women using metformin have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need for birth control.

It is not known whether canagliflozin and metformin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Canagliflozin and metformin is not approved for use by anyone younger than 18 years old.

How should I take canagliflozin and metformin?

Your doctor may perform kidney function tests before you start taking canagliflozin and metformin.

This medicine is usually taken 2 times per day with meals. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office.

Your doctor may have you take extra vitamin B12 while you are taking canagliflozin and metformin. Take only the amount of vitamin B12 that your doctor has prescribed.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking this medicine, which can lead to severely low blood pressure or a serious electrolyte imbalance.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.

Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination, blurred vision, headache, and tiredness.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your insulin dose or schedule.

If you need to fast (stop eating) before a surgery, tell the surgeon ahead of time that you take canagliflozin and metformin. You may need to stop using the medicine for a short time.

Canagliflozin and metformin can cause positive results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using canagliflozin.

Canagliflozin and metformin is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Store tablets in their original container at room temperature, away from moisture and heat. Do not keep canagliflozin and metformin tablets in a daily pill box for longer than 30 days.

What happens if I miss a dose?

Take the missed dose as soon as you remember (be sure to take the medicine with food). Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of metformin may cause lactic acidosis. Get emergency medical help if you have any of these symptoms of lactic acidosis: weakness, increasing sleepiness, slow heart rate, cold feeling, muscle pain, shortness of breath, stomach pain, feeling light-headed, and fainting.

What should I avoid while taking canagliflozin and metformin?

Avoid drinking alcohol. It lowers blood sugar and may increase your risk of lactic acidosis while taking canagliflozin and metformin.

What are the possible side effects of canagliflozin and metformin?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Early symptoms of lactic acidosis may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.

Call your doctor at once if you have:

  • new pain, tenderness, sores, ulcers, or infections in your legs or feet;
  • a light-headed feeling, like you might pass out;
  • high potassium --slow heart rate, weak pulse, muscle weakness, tingly feeling;
  • ketoacidosis (too much acid in the blood) --nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing;
  • signs of a kidney problem --little or no urination, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath;
  • signs of a bladder infection --pain or burning when you urinate, urine that looks cloudy, pain in pelvis or back; or
  • signs of a genital infection (penis or vagina) --pain, burning, itching, rash, redness, odor, or discharge.

You may be more likely to have bone fractures (even after only a minor impact trauma) while you are taking medicine that contains canagliflozin. Talk with your doctor about how to avoid the risk of fractures.

Older adults may be more likely to have kidney problems while taking this medicine.

Common side effects may include:

  • urinating more than usual;
  • headache, weakness;
  • gas, stomach pain, indigestion;
  • nausea, vomiting; or
  • diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect canagliflozin and metformin?

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • digoxin (digitalis, Lanoxin);
  • a diuretic or "water pill";
  • insulin or other oral diabetes medications;
  • rifampin;
  • ritonavir; or
  • seizure medicine --phenobarbital, phenytoin.

This list is not complete. Other drugs may interact with canagliflozin and metformin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your pharmacist can provide more information about canagliflozin and metformin.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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