Apo-Sitagliptin Malate: Uses, Side Effects and Dosage

What is APO-SITAGLIPTIN MALATE used for?

APO-SITAGLIPTIN MALATE is used in addition to diet and exercise to improve blood sugar levels in adult patients with type 2 diabetes mellitus:

• alone in patients who cannot take metformin
• in combination with metformin
• in combination with metformin and a sulfonylurea (e.g. glyburide, gliclazide or glimepiride)
• in combination with premixed or long/intermediate acting insulin (with or without metformin)
• in combination with pioglitazone (with or without metformin)

How does APO-SITAGLIPTIN MALATE work?

APO-SITAGLIPTIN MALATE contains the medicinal ingredient sitagliptin which belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors). APO-SITAGLIPTIN MALATE helps to improve the levels of insulin when blood sugar level is high, especially after a meal. APO-SITAGLIPTIN MALATE also helps to decrease the amount of sugar made by the body. APO-SITAGLIPTIN MALATE is unlikely to cause low blood sugar (hypoglycemia).

What are the ingredients in APO-SITAGLIPTIN MALATE?

Medicinal ingredients: sitagliptin malate

Non-medicinal ingredients: croscarmellose sodium, dibasic calcium phosphate, ferric oxide red, ferric oxide yellow, hydroxypropyl methyl cellulose, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

APO-SITAGLIPTIN MALATE comes in the following dosage forms:

Tablets: 25 mg, 50 mg, 100 mg

Do not use APO-SITAGLIPTIN MALATE if:

• you are allergic (hypersensitive) to sitagliptin or any of the other ingredients in APO-SITAGLIPTIN MALATE.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-SITAGLIPTIN MALATE. Talk about any health conditions or problems you may have, including if you:

• have or have had pancreatitis (inflammation of the pancreas);

• have risk factors for pancreatitis such as:

  • gallstones (solid particles that form in the gall bladder),
  • a history of alcoholism,
  • high triglyceride levels;
• have type 1 diabetes;
• have or have had diabetic ketoacidosis (increased ketones in the blood or urine);
• have or have had kidney problems;
• have liver problems;
• had an organ transplant;
• have human immunodeficiency syndrome (HIV);

• are pregnant or plan to become pregnant; APO-SITAGLIPTIN MALATE is not recommended for use during pregnancy;

• are breastfeeding or plan to breastfeed. It is not known if APO-SITAGLIPTIN MALATE passes into breast milk.

Other warnings you should know about:

Serious Skin Reactions and Pancreatitis:

• APO-SITAGLIPTIN MALATE can cause serious side effects, including:

  • Pancreatitis (inflammation of the pancreas) which can be life-threatening and cause death.
  • Serious Skin Reactions called Stevens-Johnson syndrome and bullous pemphigoid. These reactions can happen after your first dose or up to 3 months after you start APO-SITAGLIPTIN MALATE.

See the Serious side effects and what to do about them table, below for more information on these and other serious side effects.

Hypoglycemia (low blood sugar):

• When APO-SITAGLIPTIN MALATE is used with metformin and a sulfonylurea medicine or with insulin (with or without metformin), hypoglycemia (low blood sugar) can occur. Lower doses of the sulfonylurea medicine or insulin may be required while you take APO-SITAGLIPTIN MALATE. You should use caution when driving or using machines if you

  • are taking APO-SITAGLIPTIN MALATE with a sulfonylurea medicine or with insulin.

Blood Tests:

APO-SITAGLIPTIN MALATE may cause abnormal blood tests. Your healthcare professional will do blood tests before you start APO-SITAGLIPTIN MALATE and while you are taking it. They may check your blood sugar, liver function and how well your kidneys are working. Your healthcare professional will decide when to perform blood tests and will interpret the results.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements, or alternative medicines.

How to take APO-SITAGLIPTIN MALATE:

• Take APO-SITAGLIPTIN MALATE exactly as your healthcare professional tells you to.
• APO-SITAGLIPTIN MALATE can be taken with or without food.

Usual adult dose:

100 mg once daily. Your healthcare professionals may adjust your dose if you have kidney problems.

Overdose:

Missed Dose:

If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not take a double dose of APO-SITAGLIPTIN MALATE to make up for a missed dose.

What are possible side effects from using APO-SITAGLIPTIN MALATE?

These are not all the possible side effects you may feel when taking APO-SITAGLIPTIN MALATE. If you experience any side effects not listed here, contact your healthcare professional.

Side effects may include:

• Stuffy or runny nose
• Sore throat
• Vomiting
• Constipation
• Headache
• Joint pain
• Muscle aches
• Arm or leg pain
• Back pain
• Itching
• Blisters

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

Storage:

Store at controlled room temperature 15°C to 30°C. Keep in a tightly closed container.

Keep out of reach and sight of children.

If you want more information about APO-SITAGLIPTIN MALATE:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html. Find the Patient Medication information on the manufacturer’s website (http://www.apotex.ca/products) or by calling 1-800-667-4708.

Last Revised: February 15, 2022