Canagliflozin and Metformin

Canagliflozin/metformin is a prescription medication used to treat Type 2 Diabetes.

It is a single product containing 2 different medications: canagliflozin and metformin. Canagliflozin belongs to a group of drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors. SGLT2 inhibitors work by allowing the kidneys to get rid of more sugar by dumping it in the urine. Metformin belongs to a group of drugs called biguanides. Biguanides work by reducing the amount of sugar produced by the liver. Together, these medications work to lower blood sugars. 

This medication comes in a tablet form and is usually taken twice a day with food.

Canagliflozin/metformin is also available as an extended-release tablet and is taken once daily in the morning, with a meal. Do not split, crush, dissolve, or chew the extended-release tablets. Swallow them whole. 

Common side effects of canagliflozin/metformin include diarrhea, bloating, frequent urination, and thirst.

Canagliflozin/metformin is a prescription medication used to treat Type 2 Diabetes.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

Regular release tablets:

The recommended dose of canagliflozin/metformin for the treatment is 50 mg/500 mg twice a day. The maximum dose of canagliflozin/metformin for the treatment of Type 2 Diabetes is 150 mg/1000 mg twice a day.

Extended release tablets:

The recommended maximum dose of metformin is 2,000 mg a day and 300 mg of canagliflozin a day. 

WARNING: LACTIC ACIDOSIS

• Lactic acidosis is a rare but serious complication that can occur due to metformin accumulation. The risk increases with conditions such as renal impairment, sepsis, dehydration, excess alcohol intake, hepatic impairment, and acute congestive heart failure.
• The onset is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress.
• Laboratory abnormalities include low pH, increased anion gap, and elevated blood lactate.
• If lactic acidosis is suspected, canagliflozin/metformin should be discontinued and the patient hospitalized immediately

Serious side effects have been reported with canagliflozin/metformin including the following:

• Lactic acidosis. Tell your healthcare provider right away if you have some or all of the following symptoms of lactic acidosis:
  • Feeling very weak, tired, or uncomfortable
  • Unusual muscle pain
  • Trouble breathing
  • Unusual or unexpected stomach discomfort
  • Feeling cold
  • Feeling dizzy or lightheaded
  • Suddenly developing a slow or irregular heartbeat
• Hypoglycemia (low blood sugar). Tell your healthcare provider right away if you have some or all of the following symptoms of low blood sugar:
  • Feeling shaky
  • Feeling nervous
  • Sweating
  • Feeling cold or clammy
  • Confusion
  • Fast or irregular heart rate
• Genital fungal infections (yeast infections). Tell your healthcare provider right away if you have some or all of the following symptoms of a yeast infection:
  • Abnormal vaginal discharge. Vaginal discharge can range from slightly watery to thick/chunky and white.
  • Burning or itching of the vagina
  • Pain while urinating or peeing
  • Pain during intercourse or sex
  • Redness of the skin around the vagina
• High levels of potassium in your blood (hyperkalemia). Tell your healthcare provider right away if you have some or all of the following symptoms of having high levels of potassium in your blood:
  • Muscle weakness
  • Irregular heart rhythm
  • Nausea
  • Suddenly collapsing
• Low blood pressure (hypotension). Tell your healthcare provider right away if you have some or all of the following symptoms of low blood pressure:
  • Tiredness
  • Feeling lightheaded, especially when standing up
  • Dizziness
  • Nausea
• Low levels of Vitamin B12. Tell your healthcare provider right away if you have some or all of the following symptoms of having low levels of vitamin B12:
  • Wanting to eat ice or items that are not food
  • Feeling extremely tired or fatigue
  • No desire to eat or no appetite
  • Diarrhea or constipation
  • Having pale skin
  • Having difficulty concentrating
  • Shortness of breath
  • Having a swollen tongue
  • Having gums that are bleeding
• Bone fractures. Patients taking canagliflozin/metformin are at an increased risk of bone fractures. In addition, this medication may decrease bone mineral density. 

Do not take canagliflozin/metformin if you:

• are allergic to canagliflozin, metformin or to any of its ingredients 
• have kidney damage
• have acute or chronic metabolic acidosis
• are undergoing radiologic exams where contrast dye is used

Serious side effects have been reported with canagliflozin/metformin. See the “Drug Precautions” section.

Common side effects of canagliflozin/metformin include the following:

• Frequent urination
• Genital fungal infections (yeast infections)
• Urinary tract infections (UTI)
• Diarrhea
• Flatulence (gas)
• Bloating
• Thirst

This is not a complete list of side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Alcohol
• Pimozide
• Diuretics such as
  • Acetazolamide (Diamox)
  • Amiloride (Midamor)
  • Bumetanide (Bumex)
  • Chlorothiazide (Diuril)
  • Chlorthalidone (Thalitone)
  • Ethacrynic acid (Edecrin)
  • Furosemide (Lasix)
  • Hydrochlorothiazide (Microzide, HCTZ)
  • Metolazone (Zaroxolyn)
  • Torsemide (Demadex)
  • Triamterene (Dyrenium, Dyazide, Maxzide)
• Angiotensin-converting enzyme (ACE) blockers such as
  • Benazepril (Lotensin, Lotensin HCT)
  • Captopril (Capoten, Capozide)
  • Enalapril (Vasotec, Vaseretic)
  • Fosinopril (Monopril, Monopril HCT)
  • Lisinopril (Prinivil, Prinzide, Zestril, Zestoretic)
  • Moexipril (Univasc, Uniretic)
  • Quinapril (Accupril, Accuretic, Quinaretic)
  • Ramipril (Altace)
  • Trandolapril (Mavik, Tarka)
• Angiotensin receptor II blockers such as
  • Azilsartan (Edarbi)
  • Candesartan (Atacand)
  • Irbesartan (Avapro)
  • Losartan (Cozaar)
  • Olmesartan (Benicar)
  • Telmisartan (Micardis, Twynsta)
  • Valsartan (Diovan)
• Blood pressure medications such as
  • Potassium-sparing diuretics such as spironolactone (Aldactone), triamterene (Dyrenium), amiloride (Midamor)
  • Beta blockers such as metoprolol (Toprol XL, Lopressor), carvedilol (Coreg), bisoprolol (Zebeta), betaxolol (Kerlone), nebivolol (Bystolic), propranolol (Inderal)
  • Calcium channel blockers such as nifedipine (Adalat, Nifedical, Procardia), amlodipine (Norvasc), verapamil (Calan, Isoptin, Covera-HS, Verelan), diltiazem (Cardizem)
  • Vasodilators such as doxazosin (Cardura), prazosin (Minipress), terazosin (Hytrin), clonidine (Catapres), hydralazine (Bidil, Hydra-Zide), minoxidil

This is not a complete list of drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Canagliflozin/metformin falls into category C. No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Canagliflozin/metformin should be given to a pregnant woman only if clearly needed.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Metformin has been detected in human breast milk, but canagliflozin is not known if it crosses into human breast milk. Because of the possibility for adverse reactions in nursing infants from canagliflozin/metformin, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.