Dapagliflozin & Metformin hydrochloride

Dapagliflozin/metformin is a prescription medication used to improve blood sugar control in patients with type 2 diabetes. It must be used in conjunction with a healthy diet and exercise plan. Dapagliflozin/metformin is not appropriate for treatment of type 1 diabetes.

It is a single product containing 2 medications: dapagliflozin and metformin. Dapagliflozin belongs to a group of drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors. These work by helping the kidneys get glucose out of the body in the urine. Metformin belongs to a group of drugs called biguanides. These work by decreasing the amount of glucose your body can absorb from food and decreasing the amount of glucose made by the liver.

This medication comes in extended-release tablet form and is taken once a day, in the morning with food.

Do not chew, divide, or break dapagliflozin/metformin tablets. Swallow tablets whole.

Common side effects of dapagliflozin/metformin include yeast infection in females, a cold, urinary tract infection, diarrhea, and headache.

Dapagliflozin/metformin can also cause dizziness. Do not drive or operate heavy machinery until you know how dapagliflozin/metformin affects you.

Dapagliflozin/metformin is a prescription medication used to improve blood sugar control in patients with type 2 diabetes. It must be used in conjunction with a healthy diet and exercise plan. Dapagliflozin/metformin is not appropriate for treatment of type 1 diabetes.

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

Dapagliflozin & Metformin hydrochloride may be found in some form under the following brand names:

• Xigduo XR

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

Common side effects of dapagliflozin/metformin include the following:

• yeast infection in females
• runny nose and sore throat
• urinary tract infection
• diarrhea
• nausea
• vomiting
• headache

This is not a complete list of Dapagliflozin/metformin 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:

• amiloride (Midamor)
• calcium channel blockers such as nifedipine (Adalat, Nifedical, Procardia), amlodipine (Norvasc), verapamil (Calan, Isoptin, Covera, Verelan), diltiazem (Cardizem)
• cimetidine (Tagamet)
• digoxin (Lanoxin)
• 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), and triamterene (Dyrenium, Dyazide, Maxzide)
• isoniazid
• morphine (Avinza, Duramorph, DepoDur, Astramorph, Kadian)
• phenothiazines such as chlorpromazine (Thorazine, Chlor-PZ), thioridazine (Mellaril), fluphenazine (Prolixin), perphenazine (Triavil), prochlorperazine (Compazine), and trifluoperazine (Stelazine)
• procainamide (Pronestyl, Procan, Procanbid)
• quinidine
• quinine (Qualaquin)
• ranitidine (Zantac, Deprizine)
• steroids such as prednisone (Cortan, Deltasone, Orasone, Sterapred), budesonide (Entocort), dexamethasone (Decadron), triamcinolone (Kenacort, Aristocort), flunisolide (AeroBid. Aerospan), ciclesonide (Alvesco), mometasone (Asmanex, Dulera), fluticasone (Flovent), methylprednisolone (Medrol, Solu-Medrol), fludrocortisone (Florinef), and hydrocortisone (Cortef)
• trimethoprim (Proloprim, Primsol, Bactrim, Septra)
• vancomycin (Vancocin)
• thyroid medications such as levothyroxine, Synthroid, and Levothroid
• estrogens and oral contraceptives
• phenytoin (Phenytek, Dilantin, Dilantin-125)
• nicotinic acid (Niaspan, Niacor)
• sympathomimetic drugs such as norepinephrine, phenylephrine (in Sudafed PE, Dimetapp products, Triaminic products, and others), and isoprenaline (Isuprel)

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

Serious side effects have been reported with dapagliflozin/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.
  • tiredness
  • muscle aches and pains
  • trouble breathing
  • unusual or increasing sleepiness
  • nonspecific abdominal distress, including stomach pain, nausea, or vomiting
• Decreased blood pressure. Tell your healthcare provider right away if you have some or all of the following symptoms of decreased blood pressure.
  • fatigue
  • lightheadedness
  • dizziness
  • nausea
  • clammy skin
  • depression
  • loss of consciousness
  • blurry vision

Dapagliflozin/metformin can cause dizziness. Do not drive or operate heavy machinery until you know how dapagliflozin/metformin affects you.

Do not take dapagliflozin/metformin if you:

• are allergic to dapagliflozin/metformin or to any of its ingredients
• have moderate to severe kidney impairment
• have metabolic acidosis, including diabetic ketoacidosis

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of dapagliflozin/metformin, there are no specific foods that you must exclude from your diet when receiving this medication.

Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. It is important to eat a healthful diet and exercise regularly if you have type 2 diabetes.

Follow your doctor's instructions about drinking enough fluids throughout the day while you are on this medication.

Before taking dapagliflozin/metformin tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to dapagliflozin/metformin or to any of its ingredients
• have type 1 diabetes or have had diabetic ketoacidosis
• have kidney problems
• have liver problems
• have heart problems, including congestive heart failure
• drink alcohol very often, or drink a lot of alcohol in short-term “binge” drinking
• are going to get an injection of dye or contrast agents for an x-ray procedure
• are going to have surgery and will not be able to eat or drink much
• have or have had bladder cancer
• are pregnant or breastfeeding

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

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.

Dapagliflozin/metformin falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

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

It is not known if dapagliflozin/metformin crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using dapagliflozin/metformin.

Take dapagliflozin/metformin exactly as prescribed.

Dapagliflozin/metformin comes in extended-release tablet form. It is taken once a day, in the morning with food.

Do not chew, divide, or break dapagliflozin/metformin tablets. Swallow tablets whole.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of dapagliflozin/metformin at the same time.

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:

• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The dose dapagliflozin/metformin for blood glucose control in adults with type 2 diabetes should be initiated at a low dose and slowly increased on the basis of patient response and tolerability. The maximum recommended daily dose of dapagliflozin/metformin is 10 mg dapagliflozin and 2000 mg metformin.

If you take too much dapagliflozin/metformin, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If dapagliflozin/metformin is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store dapagliflozin/metformin at room temperature.
• Keep this and all medicines out of the reach of children.

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 sepsis, dehydration, excess alcohol intake, hepatic impairment, renal impairment, and acute congestive heart failure.

The onset of lactic acidosis 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 acidosis is suspected, dapagliflozin/metformin should be discontinued and the patient hospitalized immediately.