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Drug overview for CABTREO (adapalene/benzoyl peroxide/clindamycin phosphate):
Generic name: adapalene/benzoyl peroxide/clindamycin phosphate (KLIN-da-MYE-sin/a-DAP-a-leen/BEN-zoh-il per-OX-ide)
Drug class: Acne Antibiotics
Therapeutic class: Dermatological
Adapalene is a synthetic, naphthoic acid-derivative retinoid. Clindamycin is a semisynthetic derivative of lincomycin.
No enhanced Uses information available for this drug.
Generic name: adapalene/benzoyl peroxide/clindamycin phosphate (KLIN-da-MYE-sin/a-DAP-a-leen/BEN-zoh-il per-OX-ide)
Drug class: Acne Antibiotics
Therapeutic class: Dermatological
Adapalene is a synthetic, naphthoic acid-derivative retinoid. Clindamycin is a semisynthetic derivative of lincomycin.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for CABTREO (adapalene/benzoyl peroxide/clindamycin phosphate) have been approved by the FDA:
Indications:
Acne vulgaris
Professional Synonyms:
Acne simplex
Common acne
Simple acne
Indications:
Acne vulgaris
Professional Synonyms:
Acne simplex
Common acne
Simple acne
The following dosing information is available for CABTREO (adapalene/benzoyl peroxide/clindamycin phosphate):
The manufacturer states that safety and efficacy of adapalene in children younger than 12 years of age have not been established.
For the topical treatment of acne vulgaris, a thin film of adapalene 0.1% cream or 0.1% gel should be applied to the cleansed affected area once daily in the evening at bedtime.
During the early weeks of therapy with adapalene, an apparent exacerbation of acne may occur. This effect is attributable to the action of the drug on previously unseen lesions and should not be considered a reason to discontinue therapy. Improvement usually is detectable within 8-12 weeks of initiating topical therapy with the drug. Most reported experience to date has been for treatment periods that did not exceed 12 weeks.
For the topical treatment of acne vulgaris, a thin film of adapalene 0.1% cream or 0.1% gel should be applied to the cleansed affected area once daily in the evening at bedtime.
During the early weeks of therapy with adapalene, an apparent exacerbation of acne may occur. This effect is attributable to the action of the drug on previously unseen lesions and should not be considered a reason to discontinue therapy. Improvement usually is detectable within 8-12 weeks of initiating topical therapy with the drug. Most reported experience to date has been for treatment periods that did not exceed 12 weeks.
Adapalene is applied topically to the skin as a 0.1% cream or 0.1% gel.
Prior to application of the cream or gel, the affected areas should be cleansed and dried. A transient feeling of pruritus or burning may occur immediately after application of adapalene cream or gel. If increased sensitivity or irritation occurs, patients should be instructed to reduce the frequency of application or, depending on the severity of the reaction, discontinue use of the drug.
Patients should be advised not to use adapalene cream or gel in amounts larger than instructed or more often than instructed, since such use of the drug will not lead to more rapid or better results but may result in marked erythema, peeling, or discomfort. Care should be taken not to get adapalene cream or gel into the eyes. In addition, contact of the drug with the lips, mouth, angles of the nose, and mucous membranes should be avoided.
If contact with the eye(s) occurs, the eye(s) should be washed with large amounts of water; patients should consult a clinician if ocular irritation persists. Patients receiving topical adapalene therapy should be cautioned to minimize exposure to sunlight or other UV rays, including sunlamps, unless deemed medically necessary; in such cases, exposure should be minimized during the use of adapalene. Patients with sunburn should not use adapalene until full recovery occurs.
In addition, patients should be cautioned to inform their clinician if they are using other drugs that potentially could increase the sensitivity of their skin to sunlight (e.g., fluoroquinolone anti-infectives, thiazide diuretics, sulfonamides, phenothiazines). Patients who may be subjected to considerable sun exposure because of their occupation and those with inherent sensitivity to the sun should be especially cautious; when exposure cannot be avoided, use of sunscreens and protective clothing over treated areas may be prudent. Weather extremes (e.g., wind, cold) may be irritating to patients receiving topical adapalene therapy.
Moisturizers may be used if necessary; however, products containing alpha-hydroxy or glycolic acids should be avoided. The manufacturer states that adapalene cream, gel, or solution should not be applied to abraded, eczematous, or sunburned skin. Patients should be advised that use of adapalene with other topical medications that have a strong skin-drying effect should be undertaken with caution.
In patients who have used such agents, sufficient time should elapse for the effects of these drugs to subside before initiating adapalene therapy. Use of topical preparations with high concentrations of alcohol, menthol, spices, or lime rind, such as shaving lotions, astringents, and perfume, also should be used with caution or avoided if possible. Particular caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid in combination with adapalene cream, gel, or solution.
Patients also should avoid the use of irritating cosmetics (e.g., toners, peeling (desquamating) agents), permanent wave solutions, electrolysis, hair depilatories, or other preparations or processes that might dry or irritate the skin during topical therapy with adapalene. Clindamycin phosphate is applied topically to the skin or intravaginally in appropriate formulations.
Prior to application of the cream or gel, the affected areas should be cleansed and dried. A transient feeling of pruritus or burning may occur immediately after application of adapalene cream or gel. If increased sensitivity or irritation occurs, patients should be instructed to reduce the frequency of application or, depending on the severity of the reaction, discontinue use of the drug.
Patients should be advised not to use adapalene cream or gel in amounts larger than instructed or more often than instructed, since such use of the drug will not lead to more rapid or better results but may result in marked erythema, peeling, or discomfort. Care should be taken not to get adapalene cream or gel into the eyes. In addition, contact of the drug with the lips, mouth, angles of the nose, and mucous membranes should be avoided.
If contact with the eye(s) occurs, the eye(s) should be washed with large amounts of water; patients should consult a clinician if ocular irritation persists. Patients receiving topical adapalene therapy should be cautioned to minimize exposure to sunlight or other UV rays, including sunlamps, unless deemed medically necessary; in such cases, exposure should be minimized during the use of adapalene. Patients with sunburn should not use adapalene until full recovery occurs.
In addition, patients should be cautioned to inform their clinician if they are using other drugs that potentially could increase the sensitivity of their skin to sunlight (e.g., fluoroquinolone anti-infectives, thiazide diuretics, sulfonamides, phenothiazines). Patients who may be subjected to considerable sun exposure because of their occupation and those with inherent sensitivity to the sun should be especially cautious; when exposure cannot be avoided, use of sunscreens and protective clothing over treated areas may be prudent. Weather extremes (e.g., wind, cold) may be irritating to patients receiving topical adapalene therapy.
Moisturizers may be used if necessary; however, products containing alpha-hydroxy or glycolic acids should be avoided. The manufacturer states that adapalene cream, gel, or solution should not be applied to abraded, eczematous, or sunburned skin. Patients should be advised that use of adapalene with other topical medications that have a strong skin-drying effect should be undertaken with caution.
In patients who have used such agents, sufficient time should elapse for the effects of these drugs to subside before initiating adapalene therapy. Use of topical preparations with high concentrations of alcohol, menthol, spices, or lime rind, such as shaving lotions, astringents, and perfume, also should be used with caution or avoided if possible. Particular caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid in combination with adapalene cream, gel, or solution.
Patients also should avoid the use of irritating cosmetics (e.g., toners, peeling (desquamating) agents), permanent wave solutions, electrolysis, hair depilatories, or other preparations or processes that might dry or irritate the skin during topical therapy with adapalene. Clindamycin phosphate is applied topically to the skin or intravaginally in appropriate formulations.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| CABTREO 1.2%-0.15%-3.15% GEL | Maintenance | Adults apply a thin layer to the affected area(s) after washing by topical route once daily |
No generic dosing information available.
The following drug interaction information is available for CABTREO (adapalene/benzoyl peroxide/clindamycin phosphate):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for CABTREO (adapalene/benzoyl peroxide/clindamycin phosphate):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Pregnancy |
There are 5 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Clostridioides difficile infection |
| Crohn's disease |
| Exfoliative dermatitis |
| Skin photosensitivity |
| Ulcerative colitis |
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Atopic dermatitis |
The following adverse reaction information is available for CABTREO (adapalene/benzoyl peroxide/clindamycin phosphate):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 20 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Erythema Pruritus of skin |
Skin irritation |
| Rare/Very Rare |
|---|
|
Anaphylaxis Angioedema Bloody diarrhea Clostridioides difficile infection Dermatitis due to topical drug Dyspnea Eczema Eyelid edema Facial edema Hypersensitivity drug reaction Periorbital edema Pharyngeal edema Pruritus of skin Skin rash Syncope Throat constriction Urticaria |
There are 26 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Abnormal desquamation Dry skin Erythema Pruritus of skin Skin irritation Skin scaling Stinging of skin |
Abnormal desquamation Atopic dermatitis Dry skin Erythema Headache disorder Oily skin Sensation of warmth Skin irritation Stinging of skin |
| Rare/Very Rare |
|---|
|
Acute abdominal pain Conjunctivitis Contact dermatitis Diarrhea Dyschromia Gram-negative folliculitis Lip swelling Ocular pain Skin inflammation Skin photosensitivity |
The following precautions are available for CABTREO (adapalene/benzoyl peroxide/clindamycin phosphate):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Reproduction studies in pregnant rats and mice receiving oral and parenteral dosages of clindamycin up to 600 mg/kg daily (62 and 25 times, respectively, the maximum human dosage based on mg/m2) revealed no evidence of harm to the fetus. In one mouse strain, cleft palate was observed in fetuses of pregnant mice treated with clindamycin; this effect was not observed in other mouse strains or in other species. Intravaginal clindamycin has been used to treat bacterial vaginosis in pregnant women during the second and third trimester of pregnancy (for 7 nights of therapy).
In one clinical study of pregnant women receiving clindamycin phosphate vaginal cream or placebo during the second trimester of pregnancy, abnormal labor was reported in about 1.1 or 0.5% of patients, respectively.
Adverse effects have been reported in about 23% of pregnant patients receiving intravaginal clindamycin and have required discontinuance of the drug in about 2% of such patients. Candidal infection (including vaginal and nonvaginal candidiasis; either symptomatic or confirmed by culture) and vaginitis (including vulvovaginitis, vulvovaginal disorder, vaginal discharge, and trichomonal vaginitis) have been reported in about 13.3 and 7.2%
of pregnant patients receiving clindamycin phosphate vaginal cream for 7 days. Vaginal candidiasis and vulvovaginal disorders occurred in 13.3 and 6.7%,
respectively, of pregnant women receiving intravaginal clindamycin for 7 days while each of these adverse effects was reported in 7.1% of pregnant patients receiving placebo. Dysuria, metrorrhagia, vaginal pain, pruritus (at the application site), and trichomonal vaginitis occurred in less than 1% of pregnant patients receiving clindamycin phosphate vaginal cream.
Other adverse effects reported in pregnant patients receiving intravaginal clindamycin include fungal infections and pruritus (in areas other than at the application site) in 1.7 and 1.1%, respectively; these effects were not reported in pregnant women receiving placebo.
Upper respiratory infection and erythema were reported in less than 1% of pregnant women receiving clindamycin phosphate vaginal cream. There are no adequate and controlled studies to date using intravaginal clindamycin cream (Cleocin(R)) during the first trimester of pregnancy or using clindamycin intravaginal suppositories or intravaginal clindamycin cream (Clindesse(R)) during pregnancy; Clindamycin phosphate vaginal cream (Cleocin(R)) should be used during the first trimester of pregnancy only when clearly needed, and intravaginal suppositories and intravaginal clindamycin cream (Clindesse(R)) should be used during pregnancy only when clearly needed. In addition, because there are no adequate and controlled studies to date using topical preparations containing clindamycin phosphate (gel, solution, or lotion) or gels containing clindamycin phosphate in fixed combination with benzoyl peroxide during pregnancy, these preparations should be used during pregnancy only if clearly needed.
Screening and/or treatment for bacterial vaginosis in pregnant women as clinically indicated should be conducted during the first prenatal visit. In one study in women treated with intravaginal clindamycin early in the pregnancy (i.e., before 20 weeks' gestation), administration of clindamycin was associated with a reduction in preterm birth. In other studies, such therapy administered at 16-32 weeks' gestation did not reduce the incidence of adverse pregnancy outcomes.
For the treatment of bacterial vaginosis and reduction in the incidence of adverse pregnancy outcomes associated with bacterial vaginosis (e.g., preterm birth), particularly in pregnant women at high risk for complications of pregnancy, a 7-day regimen of oral metronidazole or a 7-day regimen of oral clindamycin is recommended. CDC states that clindamycin vaginal preparations should only be used during the first half of pregnancy.
In one clinical study of pregnant women receiving clindamycin phosphate vaginal cream or placebo during the second trimester of pregnancy, abnormal labor was reported in about 1.1 or 0.5% of patients, respectively.
Adverse effects have been reported in about 23% of pregnant patients receiving intravaginal clindamycin and have required discontinuance of the drug in about 2% of such patients. Candidal infection (including vaginal and nonvaginal candidiasis; either symptomatic or confirmed by culture) and vaginitis (including vulvovaginitis, vulvovaginal disorder, vaginal discharge, and trichomonal vaginitis) have been reported in about 13.3 and 7.2%
of pregnant patients receiving clindamycin phosphate vaginal cream for 7 days. Vaginal candidiasis and vulvovaginal disorders occurred in 13.3 and 6.7%,
respectively, of pregnant women receiving intravaginal clindamycin for 7 days while each of these adverse effects was reported in 7.1% of pregnant patients receiving placebo. Dysuria, metrorrhagia, vaginal pain, pruritus (at the application site), and trichomonal vaginitis occurred in less than 1% of pregnant patients receiving clindamycin phosphate vaginal cream.
Other adverse effects reported in pregnant patients receiving intravaginal clindamycin include fungal infections and pruritus (in areas other than at the application site) in 1.7 and 1.1%, respectively; these effects were not reported in pregnant women receiving placebo.
Upper respiratory infection and erythema were reported in less than 1% of pregnant women receiving clindamycin phosphate vaginal cream. There are no adequate and controlled studies to date using intravaginal clindamycin cream (Cleocin(R)) during the first trimester of pregnancy or using clindamycin intravaginal suppositories or intravaginal clindamycin cream (Clindesse(R)) during pregnancy; Clindamycin phosphate vaginal cream (Cleocin(R)) should be used during the first trimester of pregnancy only when clearly needed, and intravaginal suppositories and intravaginal clindamycin cream (Clindesse(R)) should be used during pregnancy only when clearly needed. In addition, because there are no adequate and controlled studies to date using topical preparations containing clindamycin phosphate (gel, solution, or lotion) or gels containing clindamycin phosphate in fixed combination with benzoyl peroxide during pregnancy, these preparations should be used during pregnancy only if clearly needed.
Screening and/or treatment for bacterial vaginosis in pregnant women as clinically indicated should be conducted during the first prenatal visit. In one study in women treated with intravaginal clindamycin early in the pregnancy (i.e., before 20 weeks' gestation), administration of clindamycin was associated with a reduction in preterm birth. In other studies, such therapy administered at 16-32 weeks' gestation did not reduce the incidence of adverse pregnancy outcomes.
For the treatment of bacterial vaginosis and reduction in the incidence of adverse pregnancy outcomes associated with bacterial vaginosis (e.g., preterm birth), particularly in pregnant women at high risk for complications of pregnancy, a 7-day regimen of oral metronidazole or a 7-day regimen of oral clindamycin is recommended. CDC states that clindamycin vaginal preparations should only be used during the first half of pregnancy.
Although it is not known whether clindamycin is distributed into milk following topical or intravaginal application, the drug is distributed into milk following systemic administration. Because of the potential for serious adverse reactions to clindamycin in nursing infants, a decision should be made whether to discontinue nursing or to discontinue topical or intravaginal application of the drug, taking into account the importance of the drug to the woman.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for CABTREO (adapalene/benzoyl peroxide/clindamycin phosphate):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for CABTREO (adapalene/benzoyl peroxide/clindamycin phosphate)'s list of indications:
| Acne vulgaris | |
| L70.0 | Acne vulgaris |
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