Sitagliptin/Metformin, Oral

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KEY POINTS

• This medicine is taken by mouth to treat type 2 diabetes when diet and exercise have not controlled blood sugar levels. Take it exactly as directed.
• This medicine may cause lactic acidosis or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antidiabetic

Generic and brand names: sitagliptin/metformin, oral; Janumet; Janumet XR

What is this medicine used for?

This is a combination of two medicines. It is taken by mouth to treat type 2 diabetes when diet and exercise have not controlled blood sugar levels.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A blood disorder such as anemia or vitamin B12 deficiency
• A stroke or transient ischemic attack (TIA)
• Diabetic ketoacidosis (increased ketones in the blood or urine) or type 1 diabetes
• Edema (fluid buildup)
• Heart failure or a heart attack
• High triglycerides
• Kidney or liver problems
• Thyroid, pituitary, or adrenal gland problems
• Pancreatitis or gallbladder disease

Also tell your provider if you:

• Are going to have an X-ray procedure such as a CT scan with the injection of dyes
• Are scheduled to have surgery
• Drink alcohol a lot (all the time or short-term "binge" drinking)

Tell your provider if you have recently been injured, or if you have an illness that results in severe vomiting, diarrhea, or fever, or if you have not been drinking much liquid lately.

Women who do not have regular periods, due to menopause or other reasons, may be able to become pregnant while taking this medicine. Talk to your healthcare provider about effective birth control.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. Talk to your healthcare provider about whether you will need to use insulin to control your blood sugar during pregnancy. Do not breast-feed while you are taking this medicine without your healthcare provider's approval.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine every day exactly as your healthcare provider prescribes. Do not stop taking this medicine without your healthcare provider's approval. Follow carefully the diet and exercise plan your healthcare provider gives you. Diet and exercise affect your dosage.

Check with your healthcare provider before using this medicine in children under age 18.

Always take this medicine with a meal.

This medicine comes in several forms. Do not break, crush, or chew extended-release tablets. Swallow them whole with a glass of water. If you are not sure if you have the extended-release tablets, ask your pharmacist.

What if I miss a dose?

If you miss a dose, take it as soon as you remember (with food) unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: hunger, headache, confusion, irritability, drowsiness, weakness, dizziness, tremors, sweating, fast or slow heartbeat, seizures, fainting, coma, chills, muscle pain, shortness of breath, stomach pain, lightheadedness.

What should I watch out for?

Lactic acidosis is a rare but serious complication that can happen with use of this medicine. This condition is caused by a buildup of lactic acid in the blood. This happens more often in people with kidney problems. Most people with kidney problems should not take this medicine. Stop taking this medicine and contact your healthcare provider right away if you develop unexplained symptoms such as:

• Feeling weak or tired
• Unusual muscle pain
• Unusual sleepiness
• Unexplained stomach pain with nausea and vomiting, or diarrhea
• Having trouble breathing
• Feeling cold, especially in your arms or legs
• Feeling dizzy or lightheaded
• Suddenly developing a slow or irregular heartbeat

You will need to have blood tests regularly to see if the medicine is working and to check for any signs of side effects that show up only on blood tests. Test your blood sugar on the schedule your provider recommends and keep track of it. See your provider regularly for an A1c test to check the average of your blood sugar over 2 to 3 months. This average is different from your day to day blood sugar. Keep all appointments for these tests.

Low blood sugar (hypoglycemia) can happen if you miss or delay meals, drink too much alcohol, take too much medicine, or exercise more than usual. Symptoms of low blood sugar include shaking, anxiety, cold sweats, irritability, fast heartbeat, feeling faint, strong hunger, vision problems, headache, nausea, slurred speech, confusion, unusual mood changes, tingling in the lips or tongue, and weakness. Treat the condition quickly by eating or drinking something with sugar in it such as candy, juice, or nondiet soda. Taking glucose tablets or gels (available in drug stores) is another quick way to treat hypoglycemia. Be sure to talk about this with your healthcare provider. If you have low blood sugar often, contact your healthcare provider to find out if you need a dosage adjustment.

Alcohol may affect the way your body responds to this medicine and to food. Do not drink alcohol unless your healthcare provider approves.

Rarely, this medicine may cause pancreatitis. If you have severe stomach pain or back pain, with or without vomiting, or severe back pain, contact your healthcare provider right away.

If you develop hives, an itchy rash, or peeling skin, stop taking the medicine and contact your provider right away.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, X-rays, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine. You may have to stop taking this medicine until after the procedure. Wear some form of ID stating that you are a diabetic (such as a Medic Alert bracelet). If you become unconscious, the ID tells emergency healthcare providers that you are a diabetic and need special care.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Symptoms of hypoglycemia (shaking, anxiety, cold sweats, irritability, fast heartbeat, feeling faint, strong hunger, vision problems, headache, nausea, slurred speech, confusion, unusual mood changes, tingling in the lips or tongue, weakness); unexplained muscle pain; trouble swallowing or breathing; severe back pain; unexplained or severe stomach pain with nausea, vomiting, or diarrhea; severe and constant joint pain; extreme thirst; slow or irregular heartbeat; severe dizziness; unexplained tiredness or weakness; increasing drowsiness; feeling very ill generally; loss of appetite; severe skin swelling, redness, blistering, or peeling; decreased urination or trouble urinating.

Other: Mild nausea or vomiting, mild diarrhea, bloating, headache, chest infection, stuffy or runny nose, sore throat.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• ACE inhibitors such as benazepril (Lotensin), captopril, enalapril (Vasotec), fosinopril, lisinopril (Prinivil, Zestril), quinapril (Accupril), and ramipril (Altace)
• Alcohol
• Allergy, cold, or cough medicines that contain phenylephrine (Neo-Synephrine, Sudafed PE) or pseudoephedrine (Sudafed)
• Angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan)
• Antiarrhythmic medicines (to treat irregular heartbeat) such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), procainamide, and quinidine
• Antibiotics such as cephalexin (Keflex), chloramphenicol, ciprofloxacin (Cipro), clarithromycin (Biaxin), isoniazid, levofloxacin (Levaquin), moxifloxacin (Avelox), ofloxacin, rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), telithromycin (Ketek), trimethoprim (Primsol), and vancomycin (Vancocin)
• Antidepressants such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), and sertraline (Zoloft)
• Antipsychotic medicines such as chlorpromazine, perphenazine, prochlorperazine (Compro), thioridazine, and trifluoperazine
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenytoin (Dilantin, Phenytek), topiramate (Qudexy, Topamax, Trokendi), and zonisamide (Zonegran)
• Aspirin and other salicylates
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), bisoprolol (Zebeta), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), nebivolol (Bystolic), pindolol, and sotalol (Betapace, Sorine)
• Calcium channel blockers such as diltiazem (Cardizem, Cartia, Tiazac), felodipine, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), and verapamil (Calan, Covera, Verelan)
• Carbonic anhydrase inhibitors such as acetazolamide (Diamox) and methazolamide (Neptazane)
• Cholesterol-lowering medicines such as cholestyramine (Prevalite), colesevelam (Welchol), colestipol (Colestid), fenofibrate (Antara, Fenoglide, Lipofen, TriCor, Triglide), and gemfibrozil (Lopid)
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Digoxin (Lanoxin)
• Diuretics (water pills) such as amiloride, bumetanide, chlorothiazide (Diuril), chlorthalidone, furosemide (Lasix), hydrochlorothiazide (Microzide), torsemide (Demadex), and triamterene (Dyrenium)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), dolutegravir (Tivicay), efavirenz (Sustiva), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), saquinavir (Invirase), stavudine (Zerit), and tipranavir (Aptivus)
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings, and hormones such as conjugated estrogens (Premarin), estradiol (Climara, Estrace, Estraderm, Vivelle), and norethindrone (Aygestin, Micronor) (Talk to your healthcare provider if you need birth control.)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune) and tacrolimus (Astagraf, Prograf, Protopic)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Medicines to block or prevent stomach acid such as cimetidine (Tagamet) and ranitidine (Zantac)
• Morphine (Kadian, MS Contin)
• Natural remedies such as aloe, bilberry, bitter melon, chromium, fenugreek, garcinia, garlic, ginger, ginseng, gotu kola, gymnema, St. John's wort, and stinging nettle
• Niacin
• Octreotide (Sandostatin)
• Other diabetes medicines such as alogliptin (Nesina), alogliptin/metformin (Kazano), canagliflozin/metformin (Invokamet), chlorpropamide, dapagliflozin/metformin (Xigduo), glimepiride (Amaryl), glipizide (Glucotrol), glipizide/metformin, glyburide (Glynase), insulin, linagliptin (Tradjenta), linagliptin/metformin (Jentadueto), nateglinide (Starlix), pioglitazone/metformin (Actoplus Met), repaglinide (Prandin), repaglinide/metformin (PrandiMet), rosiglitazone/metformin (Avandamet), saxagliptin (Onglyza), saxagliptin/metformin (Kombiglyze), sitagliptin (Januvia), sitagliptin/metformin (Janumet), and tolbutamide
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Pegvisomant (Somavert)
• Probenecid
• Propranolol (Hemangeol, Inderal, InnoPran)
• Psyllium (Take psyllium 2 hours before or 2 hours after you take this medicine.)
• Quinine
• Ranolazine (Ranexa)
• Somatropin (Genotropin, Humatrope, Nutropin, Serostim)
• Sulfamethoxazole/trimethoprim (Bactrim, Septra)
• Thyroid medicines such as levothyroxine (Levo-T, Levothroid, Levoxyl, Synthroid, Unithroid), liothyronine (Cytomel, Triostat), liotrix (Thyrolar), and thyroid USP (Armour Thyroid, Nature-Throid)
• Trospium

Do not drink large amounts of alcohol while you are taking this medicine. Talk to your healthcare provider about this.

Many medicines may change how well this medicine controls your blood sugar. Be sure to tell the healthcare provider who prescribed this medicine about any other medicines you are taking, including nonprescription products. Also, tell any other healthcare providers who treat you that you are taking this medicine for diabetes.

Many nonprescription products contain sugar, alcohol, or other ingredients that may interfere with this medicine or increase your blood sugar. Check product labels for warnings for diabetics or ask your healthcare provider or pharmacist for advice.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine in the original container at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.