sitagliptin-metformin Treatment Report

Precautions

Instructions

Side Effects

Interactions

Some people have developed a life-threatening condition called lactic acidosis while taking metformin. Get emergency medical help if you have any of these symptoms of lactic acidosis: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.

You may be more likely to develop lactic acidosis if you have liver disease, kidney disease, congestive heart failure, a stroke or heart attack, a serious infection, if you are dehydrated, or if you drink large amounts of alcohol. Talk with your doctor about your individual risk.

Do not use this medication if you are allergic to metformin (Actoplus Met, Avandamet, Fortamet, Glucophage, Riomet) or sitagliptin (Januvia), if you have kidney disease, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

If you need to have any type of x-ray or CT scan using a dye that is injected into a vein, you will need to temporarily stop taking metformin and sitagliptin. Be sure the doctor knows ahead of time that you are using this medication.

Before taking metformin and sitagliptin, tell your doctor if you are allergic to any drugs, or if you have:

• liver disease;
• kidney disease;
• a history of heart disease; or
• if you are over 80 years old and have not recently had your kidney function checked.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Your name may need to be listed on a Janumet pregnancy registry if you become pregnant while you are taking this medication. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether metformin and sitagliptin had any effect on the baby.

It is not known whether metformin and sitagliptin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Metformin and sitagliptin should not be given to a child younger than 18 years old without a doctor’s advice.

Avoid drinking large amounts of alcohol while taking metformin and sitagliptin. Alcohol may increase the risk of lactic acidosis while you are taking this medicine.

▲ Back to top

Take the missed dose as soon as you remember (be sure to take the medicine with food if your doctor has instructed you to). If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

▲ Back to top

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• feeling short of breath, even with mild exertion;
• swelling or rapid weight gain;
• fever, chills, body aches, flu symptoms; or
• a severe blistering, peeling, and red skin rash.

Less serious side effects may include:

• runny or stuffy nose, sore throat;
• headache, weakness; or
• mild nausea, vomiting, diarrhea, gas, stomach pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

▲ Back to top

You may be more likely to have hyperglycemia (high blood sugar) if you are taking metformin and sitagliptin with other drugs that raise blood sugar. Drugs that can raise blood sugar include:

• isoniazid;
• diuretics (water pills);
• steroids (prednisone and others);
• phenothiazines (Compazine and others);
• thyroid medicine (Synthroid and others);
• birth control pills and other hormones;
• seizure medicines (Dilantin and others); and
• diet pills, or medicines to treat asthma, colds or allergies.

You may be more likely to have hypoglycemia (low blood sugar) if you are taking metformin and sitagliptin with other drugs that lower blood sugar. Drugs that can lower blood sugar include:

• some nonsteroidal anti-inflammatory drugs (NSAIDs);
• aspirin or other salicylates (including Pepto-Bismol);
• sulfa drugs (Bactrim and others);
• a monoamine oxidase inhibitor (MAOI);
• beta-blockers (Tenormin and others); or
• probenecid (Benemid).

Some medications may interact with metformin and sitagliptin. Tell your doctor if you are using any of the following drugs:

• amiloride (Midamor) or triamterene (Dyrenium);
• cimetidine (Tagamet) or ranitidine (Zantac);
• digoxin (Lanoxin);
• furosemide (Lasix);
• morphine (MS Contin, Kadian, Oramorph);
• nifedipine (Adalat, Procardia);
• procainamide (Procan, Pronestyl, Procanbid);
• quinidine (Cardioquin, Quinidex, Quinaglute);
• trimethoprim (Proloprim, Primsol, Bactrim, Cotrim, Septra); or
• vancomycin (Vancocin, Lyphocin).

This list is not complete and there may be other drugs that can interact with metformin and sitagliptin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Janumet, metformin-sitagliptin, and sitagliptin-metformin

▲ Back to top