Consumer Information for: VANCOMYCIN HYDROCHLORIDE CAPSULES, USP

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

Vancomycin Hydrochloride Capsules, USP is an antibiotic. It is used to treat bacterial infections of the intestine such as pseudomembranous colitis or colitis. Colitis refers to swelling or inflammation of the large intestine (colon) that may occur due to an overgrowth of Clostridium difficile (C difficile) bacteria. This infection is a common cause of diarrhea after antibiotic use.

Antibacterial drugs like Vancomycin Hydrochloride Capsules, USP treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, Vancomycin Hydrochloride Capsules, USP should be used exactly as directed. Misuse or overuse of Vancomycin Hydrochloride Capsules, USP could lead to the growth of bacteria that will not be killed by Vancomycin Hydrochloride Capsules, USP (resistance). This means that Vancomycin Hydrochloride Capsules, USP may not work for you in the future. Do not share your medicine.

What it does

Vancomycin is in a class of medications called glycopeptide antibiotics. It works by killing certain bacteria in the intestines.

What the medicinal ingredient is

Vancomycin hydrochloride.

What the non-medicinal ingredients are

FD&C Blue No.2, gelatin, iron oxide, polyethylene glycol 6000, and titanium dioxide.

What dosage form it comes in

Vancomycin Hydrochloride Capsules, USP comes as capsules to take by mouth.
Vancomycin Hydrochloride Capsules, USP is available in two strengths containing 125mg or 250mg of vancomycin (as vancomycin hydrochloride).

When it should not be used
  • vancomycin hydrochloride
  • any ingredient in the formulation or component of the container. (Please see “What are the ingredients in Vancomycin Hydrochloride Capsules, USP ?” section above).
Warnings and precautions

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

  • You have hearing problems
  • You have had previous hearing loss
  • You have kidney problems
  • You have or have ever had:
    • inflammatory bowel disease (swelling of the intestine that can cause painful cramps or diarrhea)
    • Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever)
    • ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum)
    Vancomycin Hydrochloride Capsules, USP works mainly in the intestines and does not get in the blood. If you have problems in the intestines some medicine may get into blood and you may have some side effects
  • You are pregnant or planning to become pregnant
  • You are nursing or planning to nurse (Vancomycin is excreted in breast milk)

Other warnings you should know about

While you are using Vancomycin Hydrochloride Capsules, USP

  • Your healthcare professional may require that you do regular liver, kidney, blood or urine tests.
  • If you are 65 or older, you could have more side effects. The risk of hearing or kidneys problems may be greater in older adults. See “Serious side effects and what to do about them” table for signs of hearing or kidneys problems.
  • Driving and using machines: Ringing in your ears and dizziness have been reported and this may affect your ability to drive and use machines.

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

Interactions with this medication
  • Ethacrynic acid, a diuretic (“water pills”)
  • Medications that affect your kidney or your nervous systems
  • Medications given during surgery to relax the muscles (neuromuscular blocking agents)
  • Other antibiotics such as:
    • Aminoglycoside antibiotics such as amikacin, gentamicin, kanamycin, paromomycin, tobramycin etc.
    • Polymixin B
    • Colistin
    • Viomycin (not marketed in Canada)
  • Cisplatin, a medicine used to treat cancer

Always keep a list of your medicines and show it to your healthcare professional when you get a new medicine. It is important that your healthcare professional reviews all medications and supplements you are taking before prescribing Vancomycin Hydrochloride Capsules, USP.

Proper use of this medication

Take Vancomycin Hydrochloride Capsules by mouth. Vancomycin Hydrochloride capsules work mainly in the intestines.

Usual dose of Vancomycin Hydrochloride Capsules, USP

  • Adults: 125mg to 500mg 3 to 4 times a day for7 to 10 days.

  • Children who can swallow: The dose required will depend on the child weigh: 40mg/kg body weight daily in 3 or 4 doses for 7 to 10 days. The maximum daily dose is 2g.

Your healthcare professional will work out the right dose of Vancomycin Hydrochloride Capsules, USP for you or your child and how often it must be given each day. Ask your healthcare professional if you have any questions about Vancomycin Hydrochloride Capsules, USP dosing instructions.

Overdose

If you think you have taken too much Vancomycin Hydrochloride Capsules, USP, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Missed Dose

If you miss a dose of Vancomycin Hydrochloride Capsules, USP, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and continue with your next scheduled dose. Do not take two doses at the same time.

Side effects and what to do about them

These are not all the possible side effects you may feel when taking Vancomycin Hydrochloride Capsules, USP. If you experience any side effects not listed here, contact your healthcare professional.

Vancomycin Hydrochloride Capsules, USP may cause the following side effects:

  • Drug fever • Nausea • Chills • Itching, hives, skin rash • Hypotension (low blood pressure): dizziness, fainting, light headedness

Tell your doctor or your healthcare professional if you experience any of the side effects listed above. Some side effects such as skin rash may be a sign of a more serious reaction.

Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
COMMON
Allergic reactions:
  • severe rash, hives, itching
  • swelling of face, lips, mouth, throat or tongue
  • wheezing
  • tightness in the chest or throat
  • difficulty breathing or talking
     ✔
Redness of the skin above your waist (“red neck”)     ✔
RARE
Blood problems such as:
  • Loss of blood cells that help the blood clot (platelets):
    • unusual bleeding or bruising, o Nosebleeds o Pinpoint red spots on the skin

  • Low white blood cells (neutropenia):
    • more likely to develop infections, sore throat, fever, chills, and other signs of infection.
  • Increased numbers of certain white blood cells (eosinophilia):
    • rash, weight loss, wheezing, abdominal pain.
     ✔
Kidney problems:
  • Swelling in the arms or legs,
  • fatigue
  • loss of appetite
  • nausea and vomiting
  • thirst
  • unable to pass urine
  • change in the amount of urine you pass
     ✔
Hearing problems:
  • dizziness, problems with balance
  • vertigo (spinning sensation)
  • ringing in the ears (is a potential warning sign of hearing loss)
  • change in hearing
  • temporary or permanent hearing loss
     ✔
Pain and muscle tightness of the chest and back     ✔
Serious life-threatening skin reactions
(Stevens-Johnson syndrome, Toxic Epidermal Necrolysis, Drug Reaction/Rash with Eosinophilia and Systemic Symptoms (DRESS)):
  • unexplained widespread skin pain
  • flu-like symptoms (fever, sore mouth and throat, cough, burning eyes etc.)
  • followed by a painful red or purplish rash that spreads and blisters on mouth, nose, eyes and genitals
  • shedding of your skin within days after blisters form
  • swelling of the face or swollen glands in the neck, armpits or groin
  • yellowing of your skin or eye
  • dark urine, light-colored bowel movements;
  • severe nausea or vomiting; stomach pain
     ✔

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.
How to store

Store Vancomycin Hydrochloride Capsules at room temperature, 15° to 25°C. Protect from moisture. Do not use beyond the expiration date.
Keep out of reach and sight of children.

Reporting side effects

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

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.

More information
  • 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 (health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website www.meruslabs.com, or by calling Fresenius Kabi Canada Ltd., at 1-877-821-7724.

This leaflet was prepared by:
Fresenius Kabi Canada Ltd.
165 Galaxy Blvd, Suite 100
Toronto, ON, M9W 0C8

Last Revised: November 22, 2017

Date modified: