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CABTREO is a brand name for Adapalene, supplied as a gel. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. CABTREO contains an antibacterial ingredient, clindamycin. To reduce the risk of development of drug-resistant bacteria and maintain the effectiveness of…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment Apply a thin layer of CABTREO to the affected area once daily. CABTREO is for topical use only. Not for oral, ophthalmic, or intravaginal use. 3 Pediatrics). 4 Administration Before applying CABTREO, wash the affected area, rinse with warm water, and pat the skin dry.
Dispense a pea-sized amount of CABTREO onto one fingertip, dot onto the chin, cheeks, nose, and forehead, then gently rub over the entire face once daily. If a bath or shower is taken prior to application, the skin should be dry before applying the gel.
PrCABTREOTM Clindamycin Phosphate, Adapalene and Benzoyl Peroxide Gel Product Monograph Page 5 of 30 Wash hands thoroughly after applying CABTREO. If needed, use a moisturizer before or after the use of CABTREO and allow sufficient time for the skin to dry between both applications.
Avoid the eyes, mouth, paranasal creases of the nose, mucous membranes and areas of broken, eczematous, or sunburned skin. If CABTREO gets in or near eyes, rinse thoroughly with water. 5 Missed Dose Apply the missed dose as soon as you remember.
Skip the missed dose if it is almost time for your next dose. Do not use extra medicine to make up the missed dose.
1 Adverse Reaction Overview The most frequent adverse reactions that may occur with CABTREO are mild to moderate application site reactions, such as skin irritation characterized by scaling, dryness, erythema, and burning/stinging.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. In 2 multicenter, randomized, double-blind, vehicle-controlled clinical trials, subjects aged 9 years and older applied CABTREO or vehicle once daily for 12 weeks.
Adverse reactions reported by >1% of subjects treated with CABTREO and more frequently than subjects treated with vehicle are summarized in Table 2. Most adverse reactions were mild to moderate in severity. 8% of the subjects treated.
8) 0 1Application site pain defined as application site stinging, burning, or pain. Local tolerability evaluations were conducted at each study visit in the clinical trials by assessment of erythema, scaling, itching, burning, and stinging.
Table 3 presents the signs and symptoms of local facial tolerability at during the 12-week treatment period in subjects treated with CABTREO or vehicle. Both the assessments at week 12 and the maximum assessed incidence throughout the trial are presented.
8 0 0 *The denominators for calculating the percentages were the number of subjects with at least one post-baseline cutaneous tolerability assessment. **The denominators for calculating the percentages were the number of subjects with Week 12 assessment.
, Gastrointestinal). In the event of accidental ingestion, treatment should be symptomatic. Inadvertent oral ingestion of adapalene may lead to the same adverse effects as those associated with excessive oral intake of Vitamin A (hypervitaminosis) or other retinoids, including teratogenesis in women of childbearing age.
If accidental oral ingestion occurs, the patient should be monitored, and appropriate supportive measures should be administered as necessary, including pregnancy testing in women of childbearing age. For management of a suspected drug overdose, contact your regional poison control centre.
1% w/w) Carbomer Homopolymer Type C (Carbomer 980), Potassium Hydroxide, Propylene Glycol and Purified Water PrCABTREOTM Clindamycin Phosphate, Adapalene and Benzoyl Peroxide Gel Product Monograph Page 6 of 30 CABTREO is a triple combination of clindamycin phosphate, adapalene and benzoyl peroxide.
CABTREO is a white to off-white, opaque, smooth, water-based polymeric gel supplied in a 50 g pump. 5 g laminate tubes. 7 WARNINGS AND PRECAUTIONS General CABTREO is for external use only. Not for ophthalmic use. Avoid contact with the eyes, eyelids, paranasal creases of the nose, lips, mucous membranes, severely inflamed skin.
The product should not be applied to cuts, open lesions, abrasions, eczematous or sunburned skin or to other areas where treatment is not intended. CABTREO should be applied only to the affected areas. Excessive use should be avoided.
Concomitant topical acne therapy is not recommended because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. Avoid concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have strong skin-drying effect and products with high concentrations of alcohol, astringents, spices, or limes).
• Patients who are hypersensitive to clindamycin phosphate, to adapalene, to benzoyl peroxide or to any ingredient in the formulation or component of the container. For a complete listing, see the 6 DOSAGE FORMS, COMPOSITION AND PACKAGING section of the Product Monograph.
• CABTREO is contraindicated in patients with a history of regional enteritis (Crohn’s disease), ulcerative colitis, or antibiotic-associated colitis. 1 Pregnant Women).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Adapalene in Canada.
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Local tolerability scores for erythema, scaling, itching, burning, and stinging generally rose during the first two weeks of treatment and decreased thereafter. These reactions usually occur early in the treatment and tend to gradually lessen over time.
3 Less Common Clinical Trial Adverse Reactions (< 1%) Psychiatric disorders: Depression.
Skin and subcutaneous tissue disorders:
Dermatitis contact, dry skin, and swelling face. 5 Post-Market Adverse Reactions There is no post-marketing experience with CABTREO. The following adverse reactions have been identified during post-approval use of products containing clindamycin phosphate, adapalene and benzoyl peroxide as the active ingredients: anaphylaxis, allergic reactions, sunburn, blister, pruritis, hyperpigmentation, and hypopigmentation.
Because post-marketing adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Use of electrolysis, “waxing” and chemical depilatories for hair removal should be avoided on skin treated with CABTREO. CABTREO may bleach hair and coloured fabric. 3 Drug- Behavioral Interactions). 3 Drug- Behavioral Interactions). Certain cutaneous signs and symptoms such as erythema, dryness, scaling, burning, or pruritus are associated with the topical application of retinoids and can also be expected with the use of CABTREO.
These treatment-related effects generally occur during the first four weeks of therapy, are mostly mild to moderate in intensity, and usually lessen as the skin adjusts with continued use. 4 Administration). Carcinogenesis and Mutagenesis Only animal data are available (see 16 NON-CLINICAL TOXICOLOGY, Carcinogenicity).
Gastrointestinal Orally and parenterally administered clindamycin have been associated with severe colitis, which may result in patient death. Use of the topical formulation of clindamycin can result in absorption of the antibiotic from the skin surface.
Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of oral and PrCABTREOTM Clindamycin Phosphate, Adapalene and Benzoyl Peroxide Gel Product Monograph Page 7 of 30 parenteral therapy with clindamycin If significant diarrhea occurs, CABTREO should be discontinued.
Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen severe colitis. Studies indicate toxin(s) produced by Clostridia is one primary cause of antibiotic-associated colitis. The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus.
Endoscopic examination may reveal pseudomembranous colitis. Stool cultures for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically. When significant diarrhea occurs, the drug should be discontinued.
Large bowel endoscopy should be considered to establish a definitive diagnosis in cases of severe diarrhea. g. damaged skin barrier, excessive use) (see 2 CONTRAINDICATIONS). Sensitivity/Resistance Development of Drug-Resistant Bacteria Prescribing CABTREO in the absence of the authorized indications is unlikely to provide benefit to the patient and risks the development of drug-resistant bacteria.
Potential for Microbial Overgrowth Prolonged use of CABTREO may result in overgrowth of non-susceptible organisms including fungi. If this should occur, therapy with CABTREO should be discontinued and appropriate measures taken. Cutibacterium acnes (C.
acnes; previously called Propionibacterium acnes)resistance to clindamycin has been documented. Resistance to clindamycin is often associated with resistance to erythromycin. If this should occur, therapy with CABTREO should be discontinued and alternative therapy should be initiated.
Skin Photosensitivity CABTREO may increase sensitivity to ultraviolet light. Avoid or minimize sun exposure (including use of tanning beds, and sun lamps) following CABTREO application. Instruct patients to use sunscreen products (minimum SPF of 15) and wear […]