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M-Sitagliptin: Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx)
Strength:
25 mg, 50 mg, 100 mg

Patient Medication Information: uses, side effects, how to take - M-Sitagliptin

What is M-SITAGLIPTIN used for?

M-SITAGLIPTIN 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 M-SITAGLIPTIN work?

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

What are the ingredients in M-SITAGLIPTIN?

Medicinal ingredient: sitagliptin (as sitagliptin phosphate monohydrate).

Non-medicinal ingredients: Calcium hydrogen phosphate, croscarmellose sodium, instacoat pink, instacoat beige, instacoat peach, purified water, microcrystalline cellulose, and sodium stearyl fumerate.

M-SITAGLIPTIN comes in the following dosage forms:

Tablets: 25 mg, 50 mg and 100 mg

Do not use M-SITAGLIPTIN if:

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

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take M-SITAGLIPTIN. 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; M-SITAGLIPTIN is not recommended for use during pregnancy;

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

Other warnings you should know about:

Serious Skin Reactions and Pancreatitis:

  • M-SITAGLIPTIN 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 M-SITAGLIPTIN.

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 M-SITAGLIPTIN 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 M-SITAGLIPTIN. You should use caution when driving or using machines if you are taking M-SITAGLIPTIN with a sulfonylurea medicine or with insulin.

Blood Tests:

M-SITAGLIPTIN may cause abnormal blood tests. Your healthcare professional will do blood tests before you start M-SITAGLIPTIN 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 M-SITAGLIPTIN:

  • Take M-SITAGLIPTIN exactly as your healthcare professional tells you to.
  • M-SITAGLIPTIN 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:

If you think you, or a person you are caring for, have taken too much M-SITAGLIPTIN, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

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 M-SITAGLIPTIN to make up for a missed dose.

What are possible side effects from using M-SITAGLIPTIN?

These are not all the possible side effects you may feel when taking M-SITAGLIPTIN. 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.

Serious side effects and what to do about them

Frequency/Side Effect/SymptomTalk to your healthcare professionalStop taking the drug and get immediate medical help
Only if severeIn all cases
VERY COMMON
Hypoglycemia (low blood sugar – when used with metformin and a sulfonylurea, or when used with insulin with or without metformin): shaking, sweating, rapid heartbeat, change in vision, hunger, headache and change in mood.✓
RARE

Pancreatitis (inflammation of the pancreas): prolonged

severe stomach pain and possible vomiting.

✓

Allergic reactions: rash, hives, and swelling of the face, lips, tongue, and throat that may

cause difficulty in breathing or swallowing.

✓

Serious skin reactions including Stevens-Johnson syndrome, bullous pemphigoid: blisters or

breakdown of your skin.

✓

Acute kidney failure (sometimes requiring dialysis): nausea, loss of appetite and weakness, pass little or no urine,

breathlessness.

✓
VERY RARE
Rhabdomyolysis (breakdown of damaged muscle): muscle spasms, weakness, red-brown (tea-coloured) urine.✓

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

You can report any suspected side effects associated with the use of health products to Health Canada by:

  • Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
  • Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Preserve in well-closed containers. Store at room temperature (15°C to 30°C).

Keep out of reach and sight of children.

If you want more information about M-SITAGLIPTIN:

•

  • 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 Database website

    (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html) or by contacting Mantra Pharma Inc. at medinfo@mantrapharma.ca or at 1-833-248-7326.

1000 rue Du Lux, Suite 201

Brossard, Quebec

J4 0E3

Last Revised: NOV 4, 2025

About this document

Source: Health Canada – Drug Product Database (DPD) and product monographs · DIN (Drug Identification Number): 02534983

Revision date stated in the text: November 4, 2025

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for M-Sitagliptin

Rx or OTC
Prescription (Rx)?
DIN 02534983, 02534991, 02535009
Schedule(s) PRESCRIPTION
Active ingredient(s) Sitagliptin (sitagliptin phosphate monohydrate)
Dosage form(s) Tablet
Route(s) of administration Oral
Drug class (WHO ATC)
  1. A Alimentary tract and metabolism drugs
    1. A10 Drugs used in diabetes
      1. A10B Blood glucose lowering drugs, excl. insulins
        1. A10BH Dipeptidyl peptidase 4 (DPP-4) inhibitors for blood glucose lowering
          1. A10BH01 Sitagliptin
Company MANTRA PHARMA INC
Current status Marketed
Current status date May 11, 2026
Strengths and forms
DIN Strength Dosage form(s) Current status
02534983 25 MG Tablet Marketed May 11, 2026
02534991 50 MG Tablet Marketed May 11, 2026
02535009 100 MG Tablet Marketed May 11, 2026

Source: Health Canada – Drug Product Database (DPD) and product monographs, data as of November 1, 2026. Data from the Health Canada Drug Product Database, as published there. Not a substitute for the advice of a doctor or pharmacist.