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    Invokamet

    GENERIC NAME(S): Canagliflozin-Metformin

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    WARNINGS:

    Rarely, too much metformin can build up in the body and cause a serious (sometimes fatal) condition called lactic acidosis. Lactic acidosis is more likely to happen in certain medical conditions such as kidney or liver disease, recent surgery, a serious infection, worsening heart failure, heavy alcohol use, a severe loss of body fluids (dehydration), or X-ray or scanning procedures that use iodinated contrast. Tell your doctor right away if any of these conditions occur or if you notice a big change in your overall health. You may need to stop taking this medication for a short time. Older adults are also at higher risk. (See also Side Effects and Precautions sections.)

    Stop taking this medication and get medical help right away if you develop any of the following symptoms of lactic acidosis: unusual tiredness, dizziness, severe drowsiness, chills, blue/cold skin, muscle pain, fast/difficult breathing, slow/irregular heartbeat, stomach pain with nausea, vomiting, or diarrhea.

    Canagliflozin may rarely increase the risk of losing a lower limb. This risk may be greater in people who have a history of heart disease, blood circulation disease (peripheral vascular disease), nerve problems (neuropathy), foot ulcers, or previous loss of limbs. Talk to your doctor for more details. Tell your doctor right away if you have any pain/tenderness/redness/swelling/sores on your legs and feet.

    Who should not take Invokamet?
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    Uses

    This medication is a combination of 2 drugs: canagliflozin and metformin. It is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. This medication works by helping to restore your body's proper response to the insulin you naturally produce. It also increases the removal of sugar by your kidneys, decreases how much sugar is made in your liver, and decreases how much sugar your body takes in through your stomach and intestines.

    How to use Invokamet

    Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking canagliflozin/metformin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

    Take this medication by mouth as directed by your doctor, usually twice a day with meals. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. Drink plenty of fluids while taking this medication unless otherwise directed by your doctor.

    The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). To reduce your risk of side effects (such as upset stomach), your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.

    Check your blood sugar regularly as directed by your doctor. Keep track of the results, and share them with your doctor. Tell your doctor if your blood sugar results are often too high or too low. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

    Side Effects

    See also Warning section.

    Nausea, vomiting, stomach upset, diarrhea, bloating/gas, frequent urination, unusual dry mouth, or weakness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. If stomach symptoms return later (after taking the same dose for several days or weeks), tell your doctor right away. Stomach symptoms that occur after the first days of your treatment may be signs of lactic acidosis.

    Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

    Tell your doctor right away if you have any serious side effects, including: signs of a urinary tract infection (such as burning/painful/frequent/urgent urination, pink/bloody urine), signs of kidney problems (such as change in the amount of urine, swelling legs/feet), signs of high level of potassium in the blood (such as muscle weakness and slow/irregular heartbeat).

    Use of this medication may result in a new yeast infection in the vagina or penis. You are more likely to get a yeast infection if you have had yeast infections in the genital area before. Uncircumcised men are also at an increased risk for infections. Tell your doctor right away if you have signs of yeast infection in the vagina (such as unusual vaginal discharge/burning/itching/odor) or in the penis (such as redness/itching/swelling of the penis, unusual discharge from the penis). Your doctor may direct you to use nonprescription antifungal products to treat these infections. Tell your doctor if your condition persists or worsens after treatment.

    This medication does not usually cause low blood sugar (hypoglycemia). Low blood sugar may occur if this drug is prescribed with other diabetes medications, or if you do not consume enough calories from food, or if you do unusually heavy exercise. Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor right away about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.

    Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor right away. Your doctor may need to adjust your diabetes medications.

    This medication may cause you to lose too much body water (dehydration). This can lead to serious kidney damage. Drink plenty of fluids to prevent dehydration. Tell your doctor or pharmacist right away if you are not able to drink fluids as usual, or losing fluid (such as due to vomiting, diarrhea, or heavy sweating). Also, tell your doctor right away if you have any signs of dehydration, such as urinating less than usual, unusual dry mouth/thirst, fast heartbeat, or dizziness/lightheadedness/fainting. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

    Canagliflozin may cause some bone loss, or even a broken bone. Lifestyle habits that help promote healthy bones include weight-bearing exercises, stopping smoking, limiting alcohol, and eating well-balanced meals that contain adequate calcium and vitamin D. You may also need to take calcium and vitamin D supplements. Talk to your doctor for specific advice.

    A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

    This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

    In the US -

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

    In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

    Precautions

    See also Warning section.

    Before taking this medication, tell your doctor or pharmacist if you are allergic to canagliflozin or metformin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

    Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (such as asthma, obstructive lung disease), blood problems (such as anemia, vitamin B12 deficiency), dehydration, low blood pressure, heart failure, kidney disease, liver problems, blood mineral imbalances (such as high levels of potassium), yeast infections in the vagina or penis.

    Before having surgery or any X-ray/scanning procedure using iodinated contrast, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). You may need to stop this medication for a short time for the surgery/procedure. Ask your doctor or dentist for instructions before your surgery/procedure.

    You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely.

    Limit alcohol while using this medication because it can increase your risk of developing lactic acidosis, low blood sugar, and a high ketone level.

    High fever, "water pills" (diuretics such as hydrochlorothiazide), too much sweating, diarrhea, or vomiting may cause loss of too much body water (dehydration) and increase your risk of lactic acidosis. Stop taking this medication and tell your doctor right away if you have prolonged diarrhea or vomiting. Be sure to drink enough fluids to prevent dehydration unless your doctor directs you otherwise.

    It may be harder to control your blood sugar when your body is stressed (such as due to fever, infection, injury, or surgery). Also, if you are eating less or not able to eat due to these conditions or any illness, this can lead to a high ketone level while you are taking this medication. Consult your doctor because this may require a change in your treatment plan, medications, or blood sugar or ketone testing.

    Older adults may be at greater risk for side effects such as low blood sugar, dehydration, lactic acidosis, dizziness/fainting (usually when standing) or some bone loss.

    Metformin can cause changes in the menstrual cycle (promote ovulation) and increase the risk of becoming pregnant. Consult your doctor or pharmacist about the use of reliable birth control while using this medication.

    During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Your doctor may direct you to use insulin instead of this product during your pregnancy. Follow your doctor's instructions carefully.

    Metformin passes into breast milk in small amounts. It is unknown if canagliflozin passes into breast milk. Consult your doctor before breast-feeding.

    Interactions

    Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

    Other medications can affect the removal of canagliflozin from your body, which may affect how this medication works. Examples include rifamycins (such as rifampin, rifabutin), certain drugs used to treat seizures (such as phenobarbital, phenytoin), ritonavir, among others.

    Beta-blocker medications (such as metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar falls too low (hypoglycemia). Other symptoms of low blood sugar, such as dizziness, hunger, or sweating, are unaffected by these drugs.

    Many drugs can affect your blood sugar, making it harder to control. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your diabetes medication, exercise program, or diet.

    Your urine will test positive for glucose. Make sure laboratory personnel and all your doctors know you use this drug.

    Overdose

    If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Overdose can cause lactic acidosis. Symptoms of overdose may include: severe drowsiness, severe nausea/vomiting/diarrhea, rapid breathing, slow/irregular heartbeat.

    Notes

    Do not share this medication with others.

    Attend a diabetes education program to learn more about how to manage your diabetes with medications, diet, exercise, and regular medical exams.

    Learn the symptoms of high and low blood sugar and how to treat low blood sugar. Check your blood sugar regularly as directed.

    Lab and/or medical tests (such as kidney function, liver function, blood sugar, hemoglobin A1c, ketones, complete blood counts, blood pressure, cholesterol, mineral levels including potassium, bone density) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.

    Missed Dose

    If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip themissed dose and resume your usual dosing schedule. Do not double the dose to catch up.

    Storage

    Store at room temperature away from light and moisture. Do not store in the bathroom. The medication should be kept in the original bottle to protect from moisture. If the medication is kept in a pill box or medication reminder box, it should be used within 30 days. Keep all medications away from children and pets.

    Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised July 2017. Copyright(c) 2017 First Databank, Inc.

    Images

    Invokamet 50 mg-500 mg tablet
    Invokamet 50 mg-500 mg tablet
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    CM, 155
    Invokamet 50 mg-1,000 mg tablet
    Invokamet 50 mg-1,000 mg tablet
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    color
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    CM, 551
    Invokamet 150 mg-500 mg tablet
    Invokamet 150 mg-500 mg tablet
    View Larger Picture
    color
    yellow
    shape
    oblong
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    CM, 215
    Invokamet 150 mg-1,000 mg tablet
    Invokamet 150 mg-1,000 mg tablet
    View Larger Picture
    color
    purple
    shape
    oblong
    imprint
    CM, 611
    Invokamet 50 mg-500 mg tablet
    Invokamet 50 mg-500 mg tablet

    Identification

    color
    white
    shape
    oblong
    imprint
    CM, 155
    This medicine is a white, oblong, film-coated, tablet imprinted with "CM" and "155".
    Invokamet 50 mg-1,000 mg tablet
    Invokamet 50 mg-1,000 mg tablet

    Identification

    color
    beige
    shape
    oblong
    imprint
    CM, 551
    This medicine is a beige, oblong, film-coated, tablet imprinted with "CM" and "551".
    Invokamet 150 mg-500 mg tablet
    Invokamet 150 mg-500 mg tablet

    Identification

    color
    yellow
    shape
    oblong
    imprint
    CM, 215
    This medicine is a yellow, oblong, film-coated, tablet imprinted with "CM" and "215".
    Invokamet 150 mg-1,000 mg tablet
    Invokamet 150 mg-1,000 mg tablet

    Identification

    color
    purple
    shape
    oblong
    imprint
    CM, 611
    This medicine is a purple, oblong, film-coated, tablet imprinted with "CM" and "611".

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    Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

    CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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