Adapalene-Benzoyl Peroxide-Clindamycin Topical

Adapalene-Benzoyl Peroxide-Clindamycin Topical is a combination medication indicated for topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older.

• Adapalene-Benzoyl Peroxide-Clindamycin Topical is available under the following different brand names: Cabtreo

Common side effects of Adapalene-Benzoyl Peroxide-Clindamycin Topical include:

• stinging/burning/pain
• erythema
• dryness
• irritation 
• exfoliation

Serious side effects of Adapalene-Benzoyl Peroxide-Clindamycin Topical include:

• allergic reactions include hives, rash, or severe itching, swelling of your face, eyes, lips, tongue, or throat, trouble breathing or throat tightness, feeling faint, dizzy, or light headache
• inflammation of the colon (colitis)
• skin irritation includes redness, scaling, dryness, stinging, burning, itching, and swelling

Rare side effects of Adapalene-Benzoyl Peroxide-Clindamycin Topical include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to the FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Topical gel

• 0.15%/3.1%/1.2%

Acne Vulgaris

Adult and pediatric dosage

• Apply to the affected area once a day

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Adapalene-Benzoyl Peroxide-Clindamycin Topical has severe interactions with no other drugs
• Adapalene-Benzoyl Peroxide-Clindamycin Topical has serious interactions with no other drugs
• Adapalene-Benzoyl Peroxide-Clindamycin Topical has moderate interactions with no other drugs
• Adapalene-Benzoyl Peroxide-Clindamycin Topical has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Known hypersensitivity to clindamycin, adapalene, benzoyl peroxide, any other components, or lincomycin
• History of regional enteritis, ulcerative colitis, or antibiotic-associated colitis

Effects of drug abuse

• None

Short-Term Effects

• See "What Are Side Effects Associated with Using Adapalene-Benzoyl Peroxide-Clindamycin Topical?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Adapalene-Benzoyl Peroxide-Clindamycin Topical?"

Cautions

• Hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria, reported; discontinue immediately and initiate appropriate therapy if serious hypersensitivity occurs
• May increase sensitivity to ultraviolet light; avoid or minimize sun exposure (including the use of tanning beds and sun lamps) following application; instruct patients to use sunscreen products and wear protective apparel when exposure to the sun cannot be avoided
• Skin irritation and allergic contact dermatitis
• Stinging/burning/pain, erythema, dryness, irritation, exfoliation, and dermatitis reported
• These adverse reactions are most likely to occur during the first 4 weeks of treatment
• Irritant and allergic contact dermatitis were also reported
• Weather extremes (eg, wind, cold) may be irritating to patients during treatment
• Depending on severity, instruct patients to use a moisturizer, reduce application frequency adapalene/benzoyl peroxide/clindamycin, or discontinue use
• Avoid applying to areas of broken, eczematous, or sunburned skin
• Avoid use of "waxing" as a depilatory method on skin treated with adapalene/benzoyl peroxide/clindamycin
• Avoid concomitant use of other potentially irritating topical products (eg, peeling, desquamating, or abrasive agents) and products with high concentrations of alcohol, astringents, spices, or limes
• Use with concomitant topical acne therapy has not been evaluated
• Colitis
  • Diarrhea, bloody diarrhea, and colitis reported with topical and systemic clindamycin
  • Severe colitis has occurred with an onset of up to several weeks following cessation of therapy
  • Antiperistalsis agents (eg, opiates, diphenoxylate with atropine) may prolong and/or worsen severe colitis
  • Severe colitis may result in death
  • Discontinue if diarrhea occurs
• Drug interaction overview
  • Neuromuscular blocking agents
    • Use caution
  • Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents

Pregnancy and Lactation

• Available data regarding use in pregnant women are insufficient to evaluate a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Adapalene
  • Adapalene topical gel use in pregnant women is insufficient to establish a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes
• Benzoyl peroxide
  • Systemic exposure of topical benzoyl peroxide is unknown
  • Benzoyl peroxide is rapidly metabolized to benzoic acid (an endogenous substance), which is eliminated in the urine
  • Therefore, maternal use is not expected to result in fetal exposure to the drug
• Clindamycin
  • In 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
• Clinical considerations
  • To minimize potential exposure to breastfed infants via breastmilk, use on the smallest area of skin and for the shortest duration possible while breastfeeding
  • To avoid direct infant exposure, advise patients who are breastfeeding not to apply directly to the nipple and areola
  • If applied to the patient's chest, care should be taken to avoid exposure via direct contact with the infant's skin
• Lactation
  • Adapalene
    • There are no data on the presence of topical adapalene gel or its metabolite in human milk, its effects on breastfed infants, or milk production
  • Benzoyl peroxide
    • There are no data on the presence of topical benzoyl peroxide in human milk, its effects on breastfed infants, or milk production
  • Clindamycin
    • There are no data on the presence of clindamycin in human milk, its effects on breastfed children, or milk production following topical administration
    • Clindamycin has been reported to be present in human milk in small amounts following oral and parenteral administration