Sitagliptin and metformin (Oral)

Sitagliptin and metformin combination is used along with a proper diet and exercise to treat high blood sugar levels caused by type 2 diabetes. Sitagliptin helps control blood sugar levels by increasing substances in the body that make the pancreas release more insulin. It also tells the liver to stop producing sugar (glucose) when there is too much sugar in the blood. Metformin reduces the absorption of sugar from the intestines, decreases the release of stored sugar from the liver, and helps your body use sugar more effectively.

This medicine is available only with your doctor's prescription.

It is very important that your doctor checks your progress at regular visits, especially during the first few weeks you take this medicine. Blood and urine tests may be needed to check for unwanted effects.

Under certain conditions, too much metformin can cause lactic acidosis. This usually happens when other serious health problems are present, such as a heart attack or kidney failure. Symptoms of lactic acidosis include: stomach discomfort, decreased appetite, diarrhea, fast or shallow breathing, a general feeling of discomfort, muscle pain or cramping, and unusual sleepiness, tiredness, or weakness. If you have more than one of these symptoms together, you should get immediate emergency medical help.

Do not let yourself get dehydrated. Be sure to drink extra fluids when you exercise or increase your activity, or if you have vomiting or diarrhea.

Pancreatitis may occur while you are using this medicine. Check with your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, loss of appetite, fever, or lightheadedness.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine before having major surgery or diagnostic tests, especially tests that use a contrast dye.

It is very important to carefully follow any instructions from your health care team about:

• Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
• Other medicines—Do not take other medicines unless they have been discussed with your doctor. This especially includes nonprescription medicines, such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
• Counseling—Other family members need to learn how to help with side effects if they occur. Also, patients with diabetes may need special counseling about the changes in the dosing of their diabetes medicine that might happen with lifestyle changes, such as changes in exercise or diet. Furthermore, counseling on contraception and pregnancy may be needed, because of the problems that can occur in patients with diabetes during pregnancy.
• Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you normally would. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.
• In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. Be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says you have diabetes and lists all of your medicines.

Check with your doctor right away if you have chest pain or tightness, decreased urine output, dilated neck veins, extreme fatigue, irregular breathing, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, trouble breathing, or weight gain. These may be signs of heart failure.

This medicine can cause kidney problems, including acute kidney failure. Check with your doctor right away if you have agitation, coma, confusion, decreased urine output, depression, dizziness, headache, hostility, irritability, lethargy, muscle twitching, nausea, rapid weight gain, seizures, stupor, swelling of the face, ankles, or hands, or unusual tiredness or weakness.

This medicine may cause hypoglycemia (low blood sugar). This is more common when this medicine is taken with certain other medicines. Low blood sugar must be treated before it causes you to pass out (unconsciousness). People feel different symptoms of low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly. Some symptoms of low blood sugar include: behavior changes that are similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty with thinking, drowsiness, excessive hunger, a fast heartbeat, headache, nausea, shakiness, slurred speech, or unusual tiredness or weakness. Talk to your doctor about how to treat low blood sugar.

Call your doctor right away if you have severe joint pain while using this medicine.

This medicine may cause bullous pemphigoid. Tell your doctor right away if you have large, hard skin blisters while using this medicine.

Limit the amount of alcohol you drink while using this medicine. Heavy alcohol use can increase your chances of serious side effects.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to think about the risks versus the benefits. Here are some important points to consider for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies on how the sitagliptin and metformin combination affects children. Safety and effectiveness have not been established.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the effectiveness of the sitagliptin and metformin combination. However, older patients are more likely to have age-related liver, kidney, or heart issues, which may require careful monitoring and possibly a dose adjustment for patients taking this medicine.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be combined even if there is a possibility of interaction. In these situations, your doctor may adjust the dose or take other precautions. It is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been chosen based on their significance and may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Acetrizoic Acid
• Diatrizoate
• Ethiodized Oil
• Iobenzamic Acid
• Iobitridol
• Iocarmic Acid
• Iocetamic Acid
• Iodamide
• Iodipamide
• Iodixanol
• Iodohippuric Acid
• Iodopyracet
• Iodoxamic Acid
• Ioglicic Acid
• Ioglycamic Acid
• Iohexol
• Iomeprol
• Iopamidol
• Iopanoic Acid
• Iopentol
• Iophendylate
• Iopronic Acid
• Ioseric Acid
• Iosimide
• Iotasul
• Iothalamate
• Iotrolan
• Iotroxic Acid
• Ioxaglate
• Ioxitalamic Acid
• Ipodate
• Metrizamide
• Metrizoic Acid
• Tyropanoate Sodium

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Abiraterone Acetate
• Acarbose
• Acetazolamide
• Alogliptin
• Aspirin
• Bexagliflozin
• Bictegravir
• Brinzolamide
• Bupropion
• Capmatinib
• Chloroquine
• Chlorothiazide
• Chlorpropamide
• Chlorthalidone
• Cimetidine
• Ciprofloxacin
• Dasabuvir
• Delafloxacin
• Dichlorphenamide
• Dofetilide
• Dolutegravir
• Dorzolamide
• Enoxacin
• Fedratinib
• Fexinidazole
• Furosemide
• Gatifloxacin
• Gemifloxacin
• Glimepiride
• Glipizide
• Glyburide
• Grepafloxacin
• Hydrochlorothiazide
• Hydroflumethiazide
• Hydroxychloroquine
• Indapamide
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glargine, Recombinant
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Iopromide
• Ioversol
• Isavuconazole
• Lanreotide
• Levofloxacin
• Levoketoconazole
• Liraglutide
• Lomefloxacin
• Metformin
• Methazolamide
• Metolazone
• Moxifloxacin
• Nateglinide
• Norfloxacin
• Octreotide
• Ofloxacin
• Ombitasvir
• Paritaprevir
• Pasireotide
• Pioglitazone
• Polythiazide
• Pramlintide
• Ranolazine
• Repaglinide
• Semaglutide
• Simeprevir
• Sitagliptin
• Somatrogon-ghla
• Sotagliflozin
• Sparfloxacin
• Tafenoquine
• Thioctic Acid
• Tolazamide
• Tolbutamide
• Topiramate
• Triamterene
• Trovafloxacin
• Vandetanib
• Zonisamide

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be the best option for you. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Acebutolol
• Atenolol
• Betaxolol
• Bisoprolol
• Bitter Melon
• Carteolol
• Carvedilol
• Celiprolol
• Colesevelam
• Esmolol
• Fenugreek
• Glucomannan
• Guar Gum
• Isocarboxazid
• Labetalol
• Levobunolol
• Linezolid
• Methylene Blue
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Oxprenolol
• Ozanimod
• Patiromer
• Penbutolol
• Phenelzine
• Pindolol
• Practolol
• Procarbazine
• Propranolol
• Psyllium
• Rasagiline
• Rifampin
• Safinamide
• Selegiline
• Sotalol
• Timolol
• Tirzepatide
• Tranylcypromine
• Verapamil

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used near mealtimes or with certain foods because interactions may happen. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions have been selected based on their potential significance and may not include all possible interactions.

Other Medical Problems

Having other medical issues may affect how you can use this medicine. Be sure to inform your doctor if you have any other medical conditions, especially:

• Alcohol, excessive use or
• Cardiovascular collapse (shock) or
• Dehydration or
• Heart attack, acute or
• Heart failure, history of or
• Hypoxemia (decreased oxygen in the blood) or
• Liver disease or
• Sepsis (severe infection)—Use with caution. May worsen side effects.

• Anemia (low blood cells) or
• Vitamin B12 deficiency—Use with caution. May worsen these conditions.

• Angioedema (swelling of the face, lips, tongue, throat, arms, or legs), history with this medication or other dipeptidyl peptidase-4 (DPP-4) inhibitors—Use with caution. May increase the risk of this condition happening again.

• Diabetic ketoacidosis or metabolic acidosis (high ketones or acid in the blood or urine) or
• Kidney disease, severe or
• Type 1 diabetes—Should not be used in patients with these conditions.

• Fever or
• Infection or
• Surgery or
• Trauma—Use with caution. These conditions may lead to problems with blood sugar control.

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects will occur, but if they do, you may need medical attention.

Check with your doctor right away if you experience any of the following side effects:

Incidence not known

• Agitation
• anxiety
• blistering, peeling, or loosening of the skin
• bloating
• bloody or cloudy urine
• blurred vision
• chest pain or tightness
• chills
• clay-colored stools
• cold sweats
• coma
• confusion
• constipation
• cough
• dark urine
• decreased appetite
• decreased urine output
• depression
• diarrhea
• difficulty moving
• difficulty swallowing
• dilated neck veins
• dizziness
• fast heartbeat
• fever
• general feeling of discomfort
• headache
• hives, itching, skin rash
• hostility
• increased hunger
• indigestion
• irregular heartbeat
• irritability
• joint or muscle pain
• large, hard skin blisters
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• lethargy
• loss of appetite
• muscle cramps, pain, spasms, stiffness, or twitching
• nausea
• nervousness
• nightmares
• pains in the stomach, side, or abdomen, possibly radiating to the back
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid weight gain
• red irritated eyes
• red skin lesions, often with a purple center
• shakiness
• seizures
• sleepiness
• slurred speech
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• stomach pain or discomfort
• stupor
• swelling of the face, ankles, or hands
• trouble breathing
• unpleasant breath odor
• unusual tiredness or weakness
• vomiting
• vomiting blood
• weight gain
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to suggest ways to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects persist or are bothersome, or if you have any questions about them:

More common

• Body aches or pain
• ear congestion
• loss of voice
• sneezing
• stuffy or runny nose

Incidence not known

• Arm or leg pain
• back pain
• inflammation, irritation, soreness, or swelling of the mouth

Other side effects not listed may also occur in some patients. If you notice any other effects, consult your healthcare professional.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Zituvimet

Pharmacologic Class: Dipeptidyl Peptidase IV Inhibitor

Chemical Class: Metformin

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Carefully follow the special meal plan your doctor gave you. This is the most important part of controlling your diabetes, and is necessary if the medicine is to work properly. Exercise regularly and test for sugar in your blood or urine as directed.

You may take this medicine with food.

Swallow the tablet whole. Do not break or cut it.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):For type 2 diabetes: Adults: Patients not currently treated with metformin—At first, 50 milligrams (mg) of sitagliptin and 500 mg of metformin 2 times a day. Your doctor may adjust your dose until your blood sugar is controlled. However, the dose is usually not more than 100 mg of sitagliptin and 2000 mg of metformin per day. Patients already treated with metformin—At first, give 50 milligrams (mg) of sitagliptin 2 times a day and the same metformin dose you are already taking. For patients already taking 850 mg of metformin 2 times a day, take 50 mg of sitagliptin and 1000 mg of metformin 2 times a day. Your doctor may adjust your dose until your blood sugar is controlled. However, the dose is usually not more than 100 mg of sitagliptin and 2000 mg of metformin per day. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.