Clindamycin Phosphate/Benzoyl Peroxide/Adapalene
FDA Drug Information • Also known as: Cabtreo
- Brand Names
- Cabtreo
- Drug Class
- Retinoid [EPC]
- Route
- TOPICAL
- Dosage Form
- GEL
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
11 DESCRIPTION CABTREO (clindamycin phosphate, adapalene, and benzoyl peroxide) topical gel is a white to off-white, opaque gel. Each gram of CABTREO contains 12 mg (1.2%) clindamycin phosphate, equivalent to 10 mg (1%) clindamycin and 1.5 mg (0.15%) adapalene, and 31 mg (3.1%) benzoyl peroxide. Clindamycin phosphate is a water-soluble ester of the semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. Benzoyl peroxide is an oxidizing agent. The chemical name for clindamycin phosphate is Methyl-7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below: Clindamycin phosphate: Molecular Formula: C 18 H 34 ClN 2 O 8 PS Molecular Weight: 504.97 The chemical name for adapalene is 6-[3-(1-Adamantyl)-4-methoxyphenyl]-2-naphthoic acid. The structural formula for adapalene is represented below: Adapalene: Molecular Formula: C 28 H 28 O 3 Molecular Weight: 412.52 The chemical name for benzoyl peroxide is dibenzoyl peroxide. The structural formula for benzoyl peroxide is represented below: Benzoyl peroxide: Molecular Formula: C 14 H 10 O 4 Molecular Weight: 242.23 CABTREO contains the following inactive ingredients: carbomer homopolymer type C (carbomer 980), potassium hydroxide, propylene glycol, and purified water. image1 image2 image3
What Is Clindamycin Phosphate/Benzoyl Peroxide/Adapalene Used For?
1 INDICATIONS AND USAGE CABTREO is indicated for the topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older. CABTREO is a combination of clindamycin phosphate (a lincosamide antibacterial), adapalene (a retinoid), and benzoyl peroxide indicated for the topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Cleanse the affected area gently. After the skin is dry, apply a thin layer of CABTREO to the affected area once daily. Wash hands thoroughly after application of CABTREO. Avoid the eyes, mouth, paranasal creases, mucous membranes, and areas of broken, eczematous, or sunburned skin [ see Warnings and Precautions ( 5.3 )]. CABTREO is for topical use only. Not for oral, ophthalmic, or intravaginal use. Apply a thin layer of CABTREO to the affected areas once daily. ( 2 ) Avoid the eyes, mouth, paranasal creases, mucous membranes, and areas of broken, eczematous, or sunburned skin. ( 2 ) Not for oral, ophthalmic, or intravaginal use. ( 2 )
Side Effects (Adverse Reactions)
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Hypersensitivity [ see Warnings and Precautions ( 5.1 )] Colitis [see Warnings and Precautions ( 5.2 )] Skin Irritation and Allergic Contact Dermatitis [see Warnings and Precautions ( 5.4 )] The most common adverse reactions (occurring in >1% of the CABTREO group and greater than the vehicle group) were application site reactions, pain, erythema, dryness, irritation, exfoliation, and dermatitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In two multicenter, randomized, double-blind, vehicle-controlled clinical trials (Trial 1 and Trial 2), 363 adult and pediatric subjects 10 years of age and older with facial acne vulgaris were treated with CABTREO or vehicle topically once daily for 12 weeks [see Clinical Studies ( 14 )] . Adverse reactions reported by >1% of subjects treated with CABTREO and more frequently than subjects treated with vehicle are summarized in Table 1. These adverse reactions were mild (59%), moderate (36.4%), and severe (4.5%). Overall, 2.5% (6/242) of subjects discontinued CABTREO because of local skin reactions. Table 1: Adverse Reactions Reported by >1% of Subjects with Facial Acne Vulgaris Treated with CABTREO (and More Frequently than Vehicle) in Trials 1 and 2 Adverse Reactions N (%) CABTREO N=242 Vehicle N=121 Application site pain Application site pain also includes application site stinging and burning 33 (13.6) 1 (0.8) Application site erythema Application site erythema also includes erythema 11 (4.5) 0 Application site dryness Application site dryness also includes xerosis 10 (4.1) 1 (0.8) Application site irritation 5 (2.1) 0 Application site exfoliation 4 (1.7) 0 Application site dermatitis 3 (1.2) 0 Local tolerability evaluations were conducted at each study visit by assessment of erythema, scaling, itching, burning, and stinging. Table 2 presents the signs and symptoms of local facial tolerability during the 12 Week treatment period in subjects treated with CABTREO. Table 2: Facial Cutaneous Tolerability Assessment During 12-Week Treatment Period in Subjects with Acne Vulgaris Treated with CABTREO in Trials 1 and 2 Maximum During Treatment The denominators for calculating the percentages were the number of subjects with at least one post-baseline cutaneous tolerability assessment. Week 12 (End of Treatment) The denominators for calculating the percentages were the number of subjects with Week 12 assessment. Mild (%) Mod (%) Severe (%) Mild (%) Mod (%) Severe (%) CABTREO (N = 242) Erythema 34.2 19.7 2.1 22.4 6.5 0.5 Burning 29.6 10.7 3.0 4.2 1.4 0.9 Scaling 26.7 3.4 0 7.0 0.9 0 Itching 24.3 3.4 0.4 6.0 0.9 0 Stinging 20.5 5.1 2.6 2.3 0.9 0.5 Vehicle (N = 121) Erythema 22.5 21.7 1.7 25.5 5.5 0 Burning 2.5 0.8 0.8 0.9 0 0 Scaling 12.5 0 0 4.5 0 0 Itching 11.6 0.8 0 1.8 0 0 Stinging 3.3 0.8 0 1.8 0 0 Local tolerability scores for erythema, scaling, itching, burning, and stinging increased during the first two weeks of treatment and decreased thereafter. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of products containing clindamycin phosphate, adapalene, and benzoyl peroxide as the active ingredients. 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. Immune system disorders: anaphylaxis and allergic reactions including eyelid edema, throat tightness, swelling...
Drug Interactions
7 DRUG INTERACTIONS Neuromuscular Blocking Agents Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Use CABTREO with caution in patients receiving such agents. Neuromuscular Blocking Agents: Use CABTREO with caution in patients receiving neuromuscular blocking agents. ( 7 )
Contraindications
4 CONTRAINDICATIONS CABTREO is contraindicated in patients with: Known hypersensitivity to clindamycin, adapalene, benzoyl peroxide, any other components of CABTREO, or lincomycin [ see Warnings and Precautions ( 5.1 )]. A history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis [ see Warnings and Precautions ( 5.2 )]. Known hypersensitivity to clindamycin, adapalene, benzoyl peroxide, any components of the formulation, or lincomycin. ( 4 ) History of regional enteritis, ulcerative colitis, or antibiotic-associated colitis. ( 4 )
Pregnancy and Breastfeeding
8.1 Pregnancy Risk Summary Available data with CABTREO use in pregnant women are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with CABTREO. Clindamycin In published clinical trials and observational studies with pregnant women, oral or IV administration of clindamycin has not been associated with an increased frequency of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, clindamycin phosphate did not cause malformations or embryofetal development toxicity in pregnant rats and mice when administered during the period of organogenesis at systemic doses up to 192 times the maximum recommended human dose (MRHD) of 2.5 g CABTREO, based on a body surface area (mg/m 2 ) comparison. Adapalene Available data from clinical trials with adapalene topical gel use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of adapalene to pregnant rats and rabbits during organogenesis at doses 64 and 128 times, respectively, the MRHD resulted in fetal skeletal and visceral malformations ( see Data) . Benzoyl peroxide The systemic exposure of topical benzoyl peroxide is unknown. Based on published literature, benzoyl peroxide is rapidly metabolized to benzoic acid (an endogenous substance), which is eliminated in the urine. Hence, maternal use is not expected to result in fetal exposure of the drug. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, and other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%,...
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied CABTREO (clindamycin phosphate, adapalene, and benzoyl peroxide) topical gel is a white to off-white, opaque topical gel. CABTREO contains 1.2% clindamycin phosphate, 0.15% adapalene, and 3.1% benzoyl peroxide and is supplied as follows: 20 g pump (NDC 0187-0006-10) 50 g pump (NDC 0187-0006-25) Storage and Handling Prior to Dispensing: Store CABTREO in a refrigerator between 2° to 8°C (36° to 46°F) until dispensed to the patient. Dispense CABTREO with a 10-week expiration date. After Dispensing: Store CABTREO at room temperature at or below 25°C (77°F). Do not freeze. Keep away from heat. Store pump upright.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.