Pronunciation:

met-FOR-min hye-droe-KLOR-ide, sit-a-GLIP-tin FOS-fate

Brand Names:

• Janumet

Dosage Forms:

• Tablet

Warnings:

• Lactic acidosis
  • Lactic acidosis is a rare, but serious complication that can occur due to metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic insufficiency, renal impairment, and acute congestive heart failure.
  • The onset is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress.
  • Laboratory abnormalities include low pH, increased anion gap and elevated blood lactate.
  • If acidosis is suspected, metformin hydrochloride/sitagliptin phosphate should be discontinued and the patient hospitalized immediately .

Lactic acidosis is a rare, but serious complication that can occur due to metformin accumulation. The risk of lactic acidosis increases with conditions such as sepsis, dehydration, excessive alcohol intake, hepatic insufficiency, renal impairment, and acute congestive heart failure. Discontinue therapy immediately and institute supportive measures promptly for suspected lactic acidosis .

Classifications:

Therapeutic—

Antidiabetic

Pharmacologic—

Sitagliptin

Chemical—

Metformin

Uses of This Medicine:

Metformin and sitagliptin combination is used to treat a type of diabetes mellitus (sugar diabetes) called type 2 diabetes. Normally, after you eat, your pancreas releases insulin to help your body store excess sugar for later use. This process occurs during normal digestion of food. In type 2 diabetes, your body does not work properly to store the excess sugar and the sugar remains in your blood. Chronic high blood sugar can lead to serious health problems in the future. Proper diet is the first step in managing type 2 diabetes, but often medicines are needed to help your body. Metformin reduces the absorption of sugar, reduces the release of stored sugar from the liver, and helps your body's cells use sugar better. Sitagliptin helps to control blood sugar levels by increasing substances in the body that make the pancreas release more insulin. It also signals the liver to stop producing glucose when there is too much sugar in the blood .

Metformin and sitagliptin combination does not help patients who have insulin-dependent or type 1 diabetes, because they cannot produce insulin from their pancreas. Their blood glucose is best controlled by insulin injections .

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of metformin and sitagliptin combination in the pediatric population. Safety and efficacy have not been established in children below 18 years of age .

Older adults—

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of metformin and sitagliptin combination in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving metformin and sitagliptin combination .

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

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
• Iopromide
• Iopronic Acid
• Ioseric Acid
• Iosimide
• Iotasul
• Iothalamate
• Iotrolan
• Iotroxic Acid
• Ioversol
• Ioxaglate
• Ioxitalamic Acid
• Ipodate
• Metrizamide
• Metrizoic Acid
• Tyropanoate Sodium

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Acid in the blood (diabetic ketoacidosis or metabolic acidosis) or
• Kidney disease or
• Type 1 diabetes—This medicine should not be used in patients with these conditions .

• Alcohol intoxication or
• Congestive heart failure, acute or
• Dehydration, severe or
• Liver disease or
• Sepsis (severe infection) or
• Shock—These conditions can cause serious problems. If they happen, stop taking this medicine as soon as possible .

• Fever or
• Infection of any type or
• Surgery (major) or
• Trauma—These conditions may cause temporary problems with blood sugar control and your doctor may want to treat you with insulin .

• Radiologic procedures (e.g., X-rays, CT scans, and MRIs) that require dyes to be injected in your vein—This medicine should be stopped before you have one of these procedures .

• Vitamin B12 deficiency—This medicine may make this condition worse .

Proper Use of This Medicine:

Metformin and sitagliptin combination should be taken with meals to help reduce any stomach upset that may occur during treatment .

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

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:
  • For type 2 diabetes:
    • For patients taking metformin alone:
      • Adults—At first, 50 milligrams (mg) sitagliptin plus the dose of metformin already being taken, two times a day. Your doctor may gradually increase your dose until your blood sugar is controlled. If you are taking 850 mg of metformin two times a day, you may start with 50 mg sitagliptin and 1000 mg metformin two times a day.
      • Children—Use and dose must be determined by your doctor .
    • For patients taking sitagliptin alone:
      • Adults—At first, 50 milligrams (mg) sitagliptin and 500 mg metformin two times a day. Your doctor may gradually increase your dose until your blood sugar is controlled up to a maximum of 50 mg sitagliptin and 1000 mg metformin two times a day.
      • Children—Use and dose must be determined by your doctor .
    • For patients switching from a combination of metformin and sitagliptin as separate tablets:
      • Adults—The dose is the same as the dose you are already taking. Your doctor may gradually increase your dose until your blood sugar is controlled.
      • 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—

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

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to see if the medicine is working properly. Blood and urine tests may be needed to check for unwanted effects .

Under certain conditions, too much metformin and sitagliptin can cause lactic acidosis. Symptoms of lactic acidosis are severe and quick to appear. They usually occur when other health problems not related to the medicine are present and are very severe, such as a heart attack or kidney failure. Symptoms of lactic acidosis include abdominal or stomach discomfort; decreased appetite; diarrhea; fast, shallow breathing; a general feeling of discomfort; muscle pain or cramping; and unusual sleepiness, tiredness, or weakness .

If symptoms of lactic acidosis occur, you should check your blood sugar and get immediate emergency medical help.

This medicine may cause hypoglycemia (low blood sugar). Low blood sugar can also occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, cannot eat because of nausea or vomiting, take certain medicines, or take this medicine with another type of diabetes medicine. Symptoms of low blood sugar must be treated before they cause you to pass out (unconsciousness). People feel different symptoms with low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly .

Symptoms of low blood sugar include anxiety; behavior changes similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty in thinking; drowsiness; excessive hunger; fast heartbeat; headaches that continue; nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; or unusual tiredness or weakness .

If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, non-diet soft drinks, or sugar dissolved in water. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your family should also know how to use it .

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your diabetes medicine, overeat or do not follow your diet plan, have a fever or infection, or do not exercise as much as usual .

Symptoms of high blood sugar include blurred vision; drowsiness; dry mouth; flushed, dry skin; fruit-like breath odor; increased urination (frequency and amount); ketones in the urine; loss of appetite; sleepiness; stomachache, nausea, or vomiting; tiredness; troubled breathing (rapid and deep); unconsciousness (passed out); or unusual thirst .

If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions .

There may be a time when you need emergency help for a problem caused by your diabetes. You need to 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 a list of all your medicines .

It is important to tell your doctor that you are taking this medicine if you are going to have any medical procedures or surgical procedures .

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Anxiety

blurred vision

chills

cold sweats

confusion

cool, pale skin

depression

dizziness

fast heartbeat

headache

increased hunger

loss of consciousness

mental cloudiness

nausea

nervousness

nightmares

not thinking clearly

seizures

shakiness

slurred speech

unusual tiredness or weakness

Rare

Abdominal discomfort

decreased appetite

diarrhea

fast, shallow breathing

general feeling of discomfort

muscle pain or cramping

shortness of breath

sleepiness

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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Bloated

excess air or gas in stomach or intestines

fever

full feeling

indigestion

lack or loss of strength

muscle aches

passing gas

sore throat

stuffy or runny nose

vomiting

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