Glycopyrrolate Injection USP (Sandoz Canada): Uses, Side Effects and Dosage

What GLYCOPYRROLATE INJECTION USP is used for:

GLYCOPYRROLATE INJECTION USP is used in adults and children to:

• reduce saliva and other secretions (e.g., mucus and fluid produced in the nose, throat, and lungs) before surgery; and
• protect the heart after surgery when muscle relaxants were used.

GLYCOPYRROLATE INJECTION USP is also used in adults only to:

• manage certain stomach problems when oral medicine does not work or fast relief is needed.

How GLYCOPYRROLATE INJECTION USP works:

GLYCOPYRROLATE INJECTION USP belongs to a group of medicines known as “anticholinergics”. It works by blocking the effects of a substance called “acetylcholine” on smooth muscles and glands. This helps to reduce unwanted effects such as a slow heart rate, too much saliva, and muscle spasms.

The ingredients in GLYCOPYRROLATE INJECTION USP are:

Medicinal ingredient(s): glycopyrrolate.

Non-medicinal ingredients: benzyl alcohol (only for the multidose vial), hydrochloric acid (pH adjuster), sodium chloride, sodium hydroxide (pH adjuster), and water for injection.

GLYCOPYRROLATE INJECTION USP comes in the following dosage form(s):

Solution, 0.2 mg/mL of glycopyrrolate.

Do not use GLYCOPYRROLATE INJECTION USP if:

• you are allergic to glycopyrrolate or any of the other ingredients in GLYCOPYRROLATE INJECTION USP.
• You are under 3 years old and if GLYCOPYRROLATE INJECTION USP comes in a multidose vial because it contains benzyl alcohol.

• you are frail or are at least 65 years old and:

  • the muscles of your intestines are weak, or
  • you have chronic lung problems.
• you have a blocked digestive tract.
• you have paralytic ileus (muscles of the intestines stop moving food along the digestive tract).
• your large intestine (colon) is severely inflamed or swollen (i.e., ulcerative colitis or toxic megacolon).
• you have glaucoma (increased pressure in the eyes).
• you have difficulties urinating or cannot urinate (e.g., from an enlarged prostate).
• you have an unstable heart condition due to sudden, heavy blood loss.
• you have myasthenia gravis (a muscle weakness condition).

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

• have an abnormally fast heartbeat.
• have had an ileostomy or a colostomy (surgeries that connect part of the intestine to the abdominal wall for stool to exit the body).
• have Down syndrome.
• have an abnormally fast heartbeat.
• have bile duct or gall bladder problems.
• are in an area with a high temperature.

• are pregnant, plan to become pregnant, or are able to become pregnant.

• are breastfeeding or plan to breastfeed.

• are at least 65 years old and you:

  • have kidney, liver, heart, or intestinal problems,
  • have high levels of thyroid hormone (hyperthyroidism),
  • have high blood pressure,
  • are at a higher risk of glaucoma (increased pressure in the eyes),
  • have autonomic neuropathy (nerve damage that affects your automatic body functions),
  • have prostatic hypertrophy (prostate is larger than normal),
  • have hiatal hernia (stomach bulges from the chest).

Other warnings you should know about:

Driving and using machines: GLYCOPYRROLATE INJECTION USP can cause blurred vision or make you feel drowsy. You should not drive or do tasks that require special attention after taking GLYCOPYRROLATE INJECTION USP.

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

How to take GLYCOPYRROLATE INJECTION USP:

• GLYCOPYRROLATE INJECTION USP will be prepared and given to you by your healthcare professional.
• You will receive GLYCOPYRROLATE INJECTION USP through your veins (intravenously) or into your muscles (intramuscularly).

Usual dose:

Your healthcare professional will decide the right dose of GLYCOPYRROLATE INJECTION USP for you. This will depend on your medical condition, health, age, weight, and if you take certain medication. Your dose may change throughout your treatment depending on how you react to GLYCOPYRROLATE INJECTION USP.

Overdose:

If you think you, or a person you are caring for, have taken too much GLYCOPYRROLATE INJECTION USP, 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.

Possible side effects from using GLYCOPYRROLATE INJECTION USP:

These are not all the possible side effects you may have when taking GLYCOPYRROLATE INJECTION USP. If you experience any side effects not listed here, tell your healthcare professional.

The side effects of GLYCOPYRROLATE INJECTION USP may include:

• dry mouth,
• trouble urinating,
• sensitivity to light,
• fast heartbeat,
• palpitations,
• sweating less than normal,
• skin dryness,
• trouble handling heat,
• loss of taste,
• headache,
• nervousness,
• drowsiness,
• tiredness,
• feeling weak,
• dizziness,
• trouble sleeping,
• producing lower amounts of breast milk,
• constipation,
• bloating,
• confusion,
• excitement,
• sexual problems.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell 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 healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

• GLYCOPYRROLATE INJECTION USP will be stored by your healthcare professional between 15°C and 30°C.
• Keep out of reach and sight of children.

If you want more information about GLYCOPYRROLATE INJECTION USP:

• Talk to your healthcare professional.
• Find the full Product Monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (www.sandoz.ca); or by calling 1-800-361-3062.

Date of Authorization: 2025-12-02