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Generic Name: Sitagliptin/Metformin Tablets (si-ta-GLIP-tin/met-FOR-min)
Brand Name: Janumet
Janumet may rarely cause a serious and sometimes fatal condition called lactic acidosis. Most of these cases have occurred in diabetic patients who also have certain kidney problems. The risk of lactic acidosis may be greater if you have liver problems, kidney problems, or heart failure. The risk may also be greater in patients who are elderly or drink alcohol. Lab tests, including kidney function, may be performed while you take Janumet .
Do not begin to take Janumet if you are more than 80 years old unless lab tests show that you do not have decreased kidney function. Do not take it if you have a severe infection, have low blood oxygen levels, or are dehydrated. Tell your doctor you take Janumet before you
have any surgery or lab procedures.
Contact your doctor right away if you notice symptoms such as muscle pain or tenderness; unusual drowsiness, dizziness, or lightheadedness; slow or irregular heartbeat; fast or difficult breathing; unusual stomach discomfort;
or unusual weakness or tiredness. Contact your doctor right away if you start to feel unusually cold, or if you have a general feeling of being unwell.
Janumet is used for:
Treating type 2 diabetes in certain patients. It is used along with diet and exercise.
Janumet is a dipeptidyl peptidase-4 inhibitor and biguanide combination. It works by increasing insulin release. It decreases the amount of sugar that the liver produces and the intestines absorb. It also helps to make your body more sensitive to the insulin that you naturally produce.
Do NOT use Janumet if:
- you are allergic to any ingredient in Janumet
- you have type 1 diabetes
- you have
congestive heart failure that is treated by medicine
- you have a severe infection, low blood oxygen levels, kidney or liver problems, or high blood ketone or acid levels (eg, diabetic ketoacidosis), or you are severely dehydrated
- you have had a stroke or a recent heart attack, or you are in shock
- you are at least 80 years old and have not had a kidney function test
- you will be having surgery or certain lab procedures
Contact your doctor or health care provider right away if any of these apply to you.
Before using Janumet :
Some medical conditions may interact with Janumet . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal
preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of heart problems (eg, heart failure), lung or breathing problems, thyroid problems, stomach or bowel problems (eg, paralysis, blockage), adrenal or pituitary problems, or lactic acidosis
- if you have vomiting, diarrhea, poor health or nutrition, low blood calcium or vitamin B12 levels, or anemia, or if you are dehydrated
- if you have an infection, fever, recent injury, or moderate to severe burns
- if you drink alcohol or have a history of alcohol abuse
- if you will be having surgery or certain lab procedures
- if you take a beta-blocker (eg, propranolol)
Some MEDICINES MAY INTERACT with Janumet . Tell your health care provider if you are taking any other medicines, especially any of the following:
- Amiloride, cimetidine, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, or vancomycin because they may increase the risk of Janumet "s side effects
- Calcium channel blockers (eg, nifedipine), corticosteroids (eg, prednisone), diuretics (eg, furosemide, hydrochlorothiazide), estrogen, hormonal contraceptives
(eg, birth control pills), insulin, isoniazid, nicotinic acid, phenothiazine
(eg, chlorpromazine), phenytoin, sulfonylureas (eg, glipizide), sympathomimetics
(eg, albuterol, pseudoephedrine), or thyroid hormones (eg, levothyroxine)
because the risk of high or low blood sugar may be increased
This may not be a complete list of all interactions that may occur. Ask your health care provider if Janumet may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Janumet :
Use Janumet as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Janumet . Talk to your pharmacist if you have questions about this information.
- Take Janumet by mouth with food.
- Drinking extra fluids while you are taking Janumet is recommended. Check with your doctor for instructions.
- Take Janumet on a regular schedule to get the most benefit from it. Taking Janumet at the same times each day will help you remember to take it.
- Continue to take Janumet even if you feel well. Do not miss any doses.
- If you miss a dose of Janumet , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any
questions you may have about how to use Janumet .
Important safety information:
- Dizziness may occur while you are taking Janumet . This effect may be worse if you take it with alcohol or certain medicines. Use Janumet with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Follow the diet and exercise program given to you by your health care provider.
- Do not drink large amounts of alcohol while you use Janumet . Talk to your doctor or health care provider before you drink alcohol while you use Janumet .
- Do NOT take more than the recommended dose without checking with your doctor.
- Tell your doctor or dentist that you take Janumet before you receive any medical or dental care, emergency care, or surgery.
- If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for
- Carry an ID card at all times that says you have diabetes. Check your blood sugar levels as directed by your doctor. If they are often higher or lower than they should be and you take Janumet exactly as prescribed, tell your doctor.
- Janumet does not usually lower your blood sugar levels. Low blood sugar may be more likely to occur if you skip a meal, exercise heavily, or drink alcohol. It may also be more likely if you take Janumet along with certain medicines for diabetes (eg, sulfonylureas, insulin). It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not
- Fever, infection, injury, or surgery may increase your risk for high or low blood sugar levels. If any of these occur, check your blood sugar closely and tell your doctor right away.
- Janumet may commonly cause stomach upset, indigestion, nausea, vomiting, or diarrhea at the beginning of treatment. If you develop unusual or unexpected stomach problems, or if you develop stomach problems later during treatment, contact your doctor at once. This may be a sign of lactic acidosis.
- Lab tests, including kidney function, fasting blood glucose, hemoglobin A1c, and blood counts, may be performed while you use Janumet . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Janumet with caution in the ELDERLY; they may be more sensitive to its effects. Low blood sugar levels may also be more difficult to
recognize in the elderly.
- Janumet should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Janumet while you are pregnant. It is not known if Janumet is found in breast milk. If you are or will be breast-feeding while you use Janumet , check with your doctor. Discuss any possible risks to your baby.
When used for long periods of time, Janumet may not work as well. If your blood sugar has been under control and then becomes hard to manage, contact your doctor. Do not change the dose of your medicine without checking with your doctor.
Possible side effects of Janumet :
All medicines may cause side
effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Diarrhea; gas; headache; indigestion; nausea; sore throat; stomach upset;
stuffy or runny nose; vomiting; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing;
tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain or discomfort; dizziness or lightheadedness; fast or difficult breathing;
feeling of being unusually cold; fever, chills, or persistent sore throat;
general feeling of being unwell; muscle pain or weakness; slow or irregular heartbeat; unusual drowsiness; unusual or persistent stomach pain or discomfort;
unusual tiredness or weakness.
This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care
provider. You may report side effects to the FDA at 1-800-FDA-1088
(1-800-332-1088) or at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include dizziness or lightheadedness;
fast or difficult breathing; feeling of being unusually cold; general feeling of being unwell; muscle pain or tenderness; slow or irregular heartbeat; unusual drowsiness; unusual stomach discomfort; unusual weakness or tiredness.
Proper storage of Janumet :
Store Janumet at room temperature, between 68 and 77 degrees F
(20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep
Janumet out of the reach of children and away from pets.
- If you have any questions about Janumet , please talk with your doctor, pharmacist, or other health care provider.
- Janumet is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Janumet . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Issue Date: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.
Where can I get more information about Janumet ? We recommend to use www.Drugs.com
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