Kombiglyze XR (as a combination product containing Metformin, Saxagliptin)

Name: Kombiglyze XR (as a combination product containing Metformin, Saxagliptin)

How should this medicine be used?

Metformin comes as a liquid, a tablet, and an extended-release (long-acting) tablet to take by mouth. The liquid is usually taken with meals one or two times a day. The regular tablet is usually taken with meals two or three times a day. The extended-release tablet is usually taken once daily with the evening meal. To help you remember to take metformin, take it around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take metformin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow metformin extended-release tablets whole; do not split, chew, or crush them.

Your doctor may start you on a low dose of metformin and gradually increase your dose not more often than once every 1–2 weeks. You will need to monitor your blood sugar carefully so your doctor will be able to tell how well metformin is working.

Metformin controls diabetes but does not cure it. Continue to take metformin even if you feel well. Do not stop taking metformin without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What other information should I know?

Your doctor will tell you how to check your response to this medication by measuring your blood sugar levels at home. Follow these instructions carefully.

If you are taking the extended-release tablets, you may notice something that looks like a tablet in your stool. This is just the empty tablet shell, and this does not mean that you did not get your complete dose of medication.

You should always wear a diabetic identification bracelet to be sure you get proper treatment in an emergency.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand names

  • Fortamet®
  • Glucophage®
  • Glumetza®
  • Riomet®
  • Kazano® (as a combination product containing Metformin, Alogliptin)
  • Synjardy® (as a combination product containing Metformin, Empagliflozin)

Why is this medication prescribed?

Saxagliptin is used along with diet and exercise to lower blood sugar levels in patients with type 2 diabetes (condition in which blood sugar is too high because the body does not produce or use insulin normally). Saxagliptin is in a class of medications called dipeptidyl peptidase-4 (DPP-4) inhibitors. It works by increasing the amount of insulin produced by the body after meals when blood sugar is high. Saxagliptin is not used to treat type 1 diabetes (condition in which the body does not produce insulin and, therefore, cannot control the amount of sugar in the blood) or diabetic ketoacidosis (a serious condition that may develop if high blood sugar is not treated).

Over time, people who have diabetes and high blood sugar can develop serious or life-threatening complications, including heart disease, stroke, kidney problems, nerve damage, and eye problems. Taking medication(s), making lifestyle changes (e.g., diet, exercise, quitting smoking), and regularly checking your blood sugar may help to manage your diabetes and improve your health. This therapy may also decrease your chances of having a heart attack, stroke, or other diabetes-related complications such as kidney failure, nerve damage (numb, cold legs or feet; decreased sexual ability in men and women), eye problems, including changes or loss of vision, or gum disease. Your doctor and other healthcare providers will talk to you about the best way to manage your diabetes.

What special precautions should I follow?

Before taking saxagliptin,

  • tell your doctor and pharmacist if you are allergic to saxagliptin, any other medications, or any of the ingredients in saxagliptin tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: certain antifungal medications such as itraconazole (Onmel, Sporanox) and ketoconazole (Nizoral); clarithromycin (Biaxin); certain medications for HIV (human immunodeficiency virus) or AIDS (acquired immunodeficiency syndrome) such as atazanavir (Reyataz, in Evotaz), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), and saquinavir (Invirase); insulin or oral medications for diabetes such as chlorpropamide (Diabinese), glimepiride (Amaryl, in Duetact), glipizide (Glucotrol), glyburide (Diabeta, Glynase, in Glucovance), nateglinide (Starlix), pioglitazone (Actos, in Actoplus Met, in Duetact), repaglinide (Prandin, in Prandimet), rosiglitazone (Avandia), tolazamide, and tolbutamide; nefazodone; and telithromycin (no longer available in the U.S.; Ketek). You doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you drink or have ever drunk large amounts of alcohol, if you have or have ever had pancreatitis (swelling of the pancreas), gallstones, high levels of triglycerides (fatty substances) in your blood, heart failure, diabetic ketoacidosis, or kidney disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking saxagliptin, call your doctor.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking saxagliptin.
  • talk to your doctor about what you should do if you get hurt or if you develop a fever or infection. These conditions may affect your blood sugar and the amount of saxagliptin you may need.

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Brand names of combination products

  • Kombiglyze® XR (containing Metformin, Saxagliptin)
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