Apo-Sitagliptin Malate/Metformin Hydrochloride

The initial dose of sitagliptin - metformin is based on the dose of each medication that is currently being taken. Your doctor will determine the dose that is appropriate for you. This medication should be taken 2 times a day with meals. The maximum dose of sitagliptin is 100 mg per day and the maximum dose of metformin is 2,000 mg per day.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important that this medication be taken exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

50 mg/500 mg
Each light pink, oval, film-coated tablet, engraved "50-500" on one side and "APO" on the other side, contains 50 mg of sitagliptin (as sitagliptin malate) and 500 mg of metformin (as metformin hydrochloride). Nonmedicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, magnesium stearate, methyl cellulose, microcrystalline cellulose, polyethylene glycol, red ferric oxide, and titanium dioxide.

50 mg/850 mg
Each pink, oval, film-coated tablet, engraved "50-850" on one side and "APO" on the other side, contains 50 mg of sitagliptin (as sitagliptin malate) and 850 mg of metformin (as metformin hydrochloride). Nonmedicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, magnesium stearate, methyl cellulose, microcrystalline cellulose, polyethylene glycol, red ferric oxide, and titanium dioxide.

50 mg/1000 mg
Each red, oval, film-coated tablet, engraved "50-1000" on one side and "APO" on the other side, contains 50 mg of sitagliptin (as sitagliptin malate) and 1,000 mg of metformin (as metformin hydrochloride). Nonmedicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, magnesium stearate, methyl cellulose, microcrystalline cellulose, polyethylene glycol, red ferric oxide, and titanium dioxide.

Do not take sitagliptin - metformin if you:

• are allergic to sitagliptin, metformin, or any ingredients of the medication

• are breast-feeding

• are pregnant or planning to become pregnant

• are undergoing radiologic studies involving use of iodinated contrast materials

• are severely dehydrated

• drink a lot of alcohol in a short term or on a regular basis

• have cardiovascular collapse (sudden failure of blood circulation) or cardio-respiratory insufficiency (reduced oxygen supply to tissues)

• have metabolic acidosis (including diabetic ketoacidosis) or a history of ketoacidosis or lactic acidosis (too much acid in the blood)

• have or are recovering from a severe infection, trauma, or surgery

• have poor blood glucose control or insulin-dependent (Type 1) diabetes mellitus

• have reduced kidney function or kidney disease

• have severely reduced liver function or liver disease

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• arm, back, or leg pain

• bloating

• constipation

• diarrhea

• headache

• itching

• joint or muscle pain

• loss of appetite

• metallic taste in mouth

• nausea

• passing of gas

• sore throat

• stomach upset

• stuffy or runny nose

• vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• blisters

• signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)

• signs of kidney failure (e.g., decreased urine production, swelling, fatigue, abdominal pain, nausea, loss of appetite)

• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)

• signs of muscle damage (e.g., unexplained muscle pain, tenderness, or weakness, or brown or discoloured urine)

• symptoms of low blood sugar (e.g., anxiety, difficulty concentrating, nausea, cold sweat, cool pale skin, headache, fast heartbeat, weakness, shakiness)

• symptoms of decreased thyroid function (e.g., weight gain, feeling cold, fatigue)

• symptoms of low levels of vitamin B12 in the body (e.g., fatigue, shortness of breath, difficulty walking properly, irritability, confusion, tender calves)

• tingling and numbness of feet or hands

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of brain disease (e.g., muscle weakness in one area; poor decision-making; difficulty speaking, swallowing, or concentrating; or seizures)

• signs of lactic acidosis (e.g., nausea, vomiting, increased breathing rate, abdominal pain, unusual tiredness, dizziness, rapid heart rate, muscle pain or cramping, feeling cold)

• signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)

• signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort

• symptoms of a severe allergic reaction (e.g., hives; difficulty breathing or swallowing; swelling of the face, lips, tongue, or throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Alcohol intake: Large amounts of alcohol or regular use of alcohol increases the risk of developing lactic acidosis when taking metformin. People taking this medication should avoid excessive alcohol intake.

Blood glucose control: People taking this medication who have a fever, experience trauma, or have surgery may experience a temporary loss of blood glucose control. At such times, it may be necessary to stop this medication and temporarily inject insulin. This medication may be started again after the problem is resolved.

Congestive heart failure (CHF): Congestive heart failure can increase the risk of lactic acidosis caused by metformin. For this reason, this medication is not recommended for people with CHF. If you have CHF, speak to your doctor.

Diabetes complications: The use of this medication will not prevent the development of complications of diabetes mellitus (e.g., kidney disease, nerve disease, eye disease).

**Driving and operating machinery: **Low blood glucose levels can cause dizziness, headache and confusion, affecting your ability to drive or operate machinery. Avoid driving, operating machinery, or performing other potentially hazardous tasks if you are at risk of having low blood sugar.

Dye or contrast agents: If you are going to have an X-ray procedure that uses dye or a contrast agent, you may need to stop taking this medication for a short time. Contact your doctor for instructions.

Hypersensitivity reaction: A severe allergic reaction called a hypersensitivity reaction has occurred for some people with the use of sitagliptin. Stop taking the medication and get immediate medical attention if you have symptoms of a severe allergic reaction, including fever, swollen glands, yellowing of the skin or eyes, or flu-like symptoms with skin rash or blistering.

Kidney function: Kidney disease or reduced kidney function may cause metformin or sitagliptin to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Sitagliptin may cause decreased kidney function, including kidney failure. Your doctor may recommend regular testing to check your kidney function while you are taking this medication. This medication is not recommended for people with reduced kidney function.

Lactic acidosis: Lactic acidosis is a rare but serious problem that occurs due to metformin accumulation (i.e., the body doesn't get rid of the medication fast enough) during treatment. People with severe kidney disease, heart failure, or dehydration are at higher risk of developing lactic acidosis. Since alcohol may increase the risk of lactic acidosis, do not drink a lot of alcohol over the short or long term while taking this medication. When it does occur (very rarely), it is fatal in 50% of cases. If you experience symptoms of lactic acidosis (e.g., weakness; tiredness; drowsiness; unusual muscle pain; trouble breathing; stomach pain with nausea, vomiting, or diarrhea; feeling cold; dizziness; light-headedness; slow or irregular heartbeat), stop taking this medication and get immediate medical attention.

Liver function: This medication is not recommended for people with severely reduced liver function. If you have moderately reduced liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Low blood glucose: Low blood glucose can occur when sitagliptin – metformin is used in combination with other medications to treat diabetes. Low blood glucose may also occur when not enough food is eaten, especially when strenuous exercise is undertaken at the same time or when large amounts of alcohol have been consumed. If you experience low blood sugar (e.g., headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, and feeling jittery) while taking this medication, contact your doctor.

Pancreatitis: This medication may cause pancreatitis (inflammation of the pancreas). If you have a history of pancreatitis, gallstones, alcoholism, or high triglycerides you may be more at risk of experiencing this. If you experience prolonged and severe abdominal pain with or without vomiting while taking this medication, contact your doctor immediately.

Reduced response: Over a period of time, people may become progressively less responsive to a particular treatment for diabetes because their diabetes worsens. If your blood glucose control worsens or you are not staying within your target levels, talk to your doctor.

Surgery: This medication should be stopped temporarily for surgery (except for minor surgery where food and fluid intake is not restricted). You will be restarted on this medication once you are eating and drinking and your kidney function has been tested and is normal. Talk to your doctor for specific instructions.

Thyroid function: People with low thyroid function may develop further decreases in the function of their thyroid. Symptoms of these changes include feeling cold all the time, weight gain, fatigue, dry skin, and decreased memory and concentration. Contact your doctor if you experience these symptoms.

Medication to treat an underactive thyroid may reduce the effectiveness of metformin.  If there are any changes to your thyroid replacement medication, you may need to monitor your blood glucose more carefully.

Vitamin B12 levels: This medication may decrease vitamin B12 levels. Your doctor will monitor your B12 levels with blood tests while you are taking this medication.

Pregnancy: This medication is not recommended for use during pregnancy or for people who are planning to become pregnant. If you become pregnant while taking this medication, contact your doctor immediately. Insulin is usually used during pregnancy to control blood glucose levels.

Breast-feeding: It is not known if sitagliptin passes into breast milk. Metformin does pass into breast milk. If you are breast-feeding and are taking this medication, it may affect your baby. This medication should not be used by people who are breast-feeding.

Children: The safety and effectiveness of this medication have not been established for children less than 18 years of age.

Seniors: Kidney function often decreases with age. As a result, seniors may be more likely to experience side effects of this medication.

**For a full list of interactions, use the Drug Interaction Checker **available on the Drugs.com website.

If you are taking other medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,

• change one of the medications to another,

• change how you are taking one or both of the medications, or

• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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