Cabtreo: Uses, Side Effects and Dosage

What is CABTREO used for?

• CABTREO is used to treat acne (acne vulgaris) with comedones (clogged hair follicles - blackheads, whiteheads) and inflammatory papules and pustules (e.g., pimples) in patients 12 years of age and older.
• CABTREO contains an antibacterial ingredient called clindamycin, and it should be used exactly as directed by your healthcare professional. Misuse or overuse of CABTREO could lead to the growth of bacteria that will not be killed by clindamycin. This means that CABTREO or other medicines that contain clindamycin may not work for you in the future. Do not share your medicine.

How does CABTREO work?

CABTREO works in multiple ways. The 3 medicinal ingredients work together to unplug your blocked oil glands and to prevent these plugs from forming in the first place. They also help kill the bacteria present in acne and help reduce inflammation.

What are the ingredients in CABTREO?

Medicinal ingredients: Clindamycin Phosphate, Adapalene and Benzoyl Peroxide

Non-medicinal ingredients: Carbomer Homopolymer Type C (Carbomer 980), Potassium Hydroxide, Propylene Glycol and Purified Water.

CABTREO comes in the following dosage forms:

• Gel; 3.5 g tubes (sample) and 50 g pumps

Do not use CABTREO if:

• You are allergic to clindamycin phosphate, adapalene, benzoyl peroxide or any of the other ingredients in CABTREO.
• You have a history of regional enteritis (Crohn’s disease), ulcerative colitis, or antibiotic-associated colitis.

• You are pregnant or plan to become pregnant.

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

• have Crohn’s disease, ulcerative colitis.
• have developed colitis with past antibiotic use.
• plan to have surgery. CABTREO may affect how certain medicines work that may be given during surgery.
• are breastfeeding or plan to breastfeed. It is not known if CABTREO passes into your breast milk. Talk to your healthcare professional about the best way to feed your baby during treatment with CABTREO.
• use during breastfeeding, do not apply CABTREO to the chest region. Make sure to avoid accidental contact to your baby.
• have other skin problems, including cuts, abrasions, sunburn, or eczema.

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

The following may interact with CABTREO:

• Topical or oral erythromycin-containing products
• Neuromuscular blocking agents
• Aminoglycoside antibiotics
• Other acne products that have a drying effect on the skin (e.g. products containing sulphur, resorcinol, or salicylic acid)

How to take CABTREO:

• Use CABTREO exactly as your healthcare provider tells you to use it.
• CABTREO is for use on the skin only.
• Do not use more CABTREO than you need to cover the treatment area. Using too much CABTREO or using it more than 1 time a day may increase your chance of skin irritation.
• Avoid sunlight, including sunlamps during treatment with CABTREO. CABTREO can make you more sensitive to the sun, and the light from sunlamps and tanning beds. You could get severe sunburn. Use sunscreen (minimum SPF of 15) and wear a wide-brimmed hat and clothes that cover your skin if you have to be in sunlight.
• If you get sunburnt, let your skin heal before using CABTREO.
• Cold weather and wind may irritate skin treated with CABTREO.
• Avoid applying CABTREO to cuts, abrasions, skin with eczema, and sunburned skin.

• Avoid skin products that may dry or irritate your skin such as medicated or harsh soaps, astringents, cosmetics that make your skin dry, and products containing high levels of alcohol, spices, or limes.

• Avoid the use of “waxing” as a hair removal method on skin treated with CABTREO.
• Avoid getting CABTREO in your hair or on colored fabric. CABTREO may bleach hair or colored fabric.

• Do not use other topical acne preparations or other topical products, including cosmetics, on the affected area unless directed to do so by your healthcare

  • . Many cosmetic products may also contain other peeling agents, which may interfere with the medication or make possible side effects worse.
• You may use a moisturizer after applying CABTREO as needed. Make sure to allow skin to dry after you apply CABTREO.

Usual dose

• Apply a thin layer of CABTREO to your face one (1) time each day.
• Before you apply CABTREO, wash your face gently, rinse with warm water, and pat your skin dry.

Step 1:

Wash your face gently, rinse with warm water and pat it dry with a clean towel.

Step 2:

To apply CABTREO, use the pump to dispense one pea-sized amount only of CABTREO onto your fingertip (see Figure 1).

One pea-sized amount of CABTREO should be enough to cover your entire face.

Figure 1

Step 3:

Dot CABTREO onto the five (5) areas of your face (chin, left cheek, right cheek, nose, and forehead).

Step 4:

Spread the gel over your face and gently rub it in. It is important to spread the gel over your entire face. If your healthcare professional tells you to put CABTREO on other areas of your skin with acne, be sure to ask how much you should use.

Step 5:

Wash your hands with soap and water after applying CABTREO.

Overdose:

If you apply too much CABTREO, you will not get faster or better results. This may cause redness, peeling or discomfort. Taking CABTREO by mouth by accident may cause the same side effects as that of taking too much Vitamin A by mouth. If you accidentally take CABTREO by mouth, talk to your healthcare professional.

Missed Dose:

If you forget to apply CABTREO on your skin at the usual time, apply it when you remember, unless it is almost time for your next application, in which case wait and apply at the next application time. The dose should not be doubled to make up for a missed dose.

What are possible side effects from using CABTREO?

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

• burning or stinging sensation
• dryness
• itching
• peeling of skin
• rash
• redness
• scaling
• swelling
• sunburn
• blisters
• dark or light skin patches (hyperpigmentation or hypopigmentation)

Do not be discouraged if CABTREO causes side effects when you first start to use it. This happens when your skin is adjusting to CABTREO action of unplugging clogged pores. If these problems continue to happen or if they are getting worse, talk to your healthcare professional. Your healthcare professional may recommend the use of a moisturizer, a change in your dose, or a change to how often you use CABTREO.

Serious side effects and what to do about them

Reporting Side Effects

Storage:

• Store CABTREO at room temperature (15 to 25°C).
• Do not freeze.
• CABTREO should be used within 10 weeks after first opening. Any unused CABTREO should be thrown away 10 weeks after first opening.
• Keep CABTREO out of light and away from heat.
• Keep the container tightly closed.
• Keep out of reach and sight of children.
• Store pump upright.

If you want more information about CABTREO:

• 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); the manufacturer’s website (www.bauschhealth.ca), or by calling 1-800-361-4261.

Bausch Health, Canada Inc.

2150 St-Elzear Blvd. West

Laval (Québec) H7L 4A8

www.bauschhealth.ca

Last Revised: AUG 14, 2024