Adapalene + Clindamycin Topical

Indications Clindamycin + Adapalene gel is indicated for topical treatment of acne vulgaris, including mild to moderate inflammatory acne vulgaris and non-inflammatory acne. It may be used alone or in combination with other anti-acne products. It is also indicated for the topical treatment of acne vulgaris in patients with predominantly comedones, papules, and pustules. Directions for Use Clean the skin with a mild soap or soap-free cleanser, rinse with water, and then apply a small amount of the gel with clean fingertips. Gently rub it into the skin. Use enough to lightly cover the entire affected area. Apply a thin film of the gel to the affected areas once daily in the evening before bedtime. The safety and efficacy of this gel have not been established in children below 12 years of age. Contraindications Contraindicated in individuals with: • A history of hypersensitivity to clindamycin, lincomycin, or adapalene. • A history of regional enteritis or ulcerative colitis. • A history of antibiotic-associated colitis. Mechanism of Action Clindamycin binds reversibly to the 50S subunit of bacterial ribosomes and inhibits protein synthesis, thereby blocking the transpeptidation or translocation reactions in susceptible organisms and resulting in inhibition of bacterial growth. Adapalene binds to specific retinoic acid nuclear receptors and normalizes the differentiation of follicular epithelial cells, thereby reducing the formation of microcomedones. Warnings & Precautions Topical formulations of clindamycin can result in absorption of the antibiotic through the skin. Diarrhea, bloody diarrhea, and colitis, including pseudomembranous colitis, have been reported with both topical and systemic clindamycin use. Diarrhea, colitis, and pseudomembranous colitis may occur several weeks after discontinuation of oral or parenteral clindamycin therapy. Do not apply adapalene to areas with cuts, abrasions, sunburned skin, or eczema. Avoid contact with the eyes, mouth, corners of the nose, and other highly sensitive areas. If accidental contact occurs, rinse immediately with warm water. Avoid excessive exposure to strong sunlight and artificial UV light. Use sunscreen on treated areas and wear protective clothing when exposed to sunlight. Breastfeeding: Excretion into breast milk is unknown; use with caution. Side Effects Local Effects: • Burning • Itching • Dryness • Erythema (skin redness) • Peeling Systemic Effects: • Diarrhea • Bloody diarrhea • Colitis, including pseudomembranous colitis • Abdominal pain • Gastrointestinal disturbances • Gram-negative folliculitis These systemic adverse effects have been reported mainly with oral and parenteral clindamycin and rarely with topical clindamycin. Adapalene-related Effects: Common (may affect up to 1 in 10 people): • Dry skin • Skin irritation • Skin discomfort or burning • Skin redness (erythema) Uncommon (may affect up to 1 in 100 people): • Local skin reactions (contact dermatitis) • Skin discomfort • Sunburn • Itching (pruritus) • Skin peeling (exfoliation) • Acne flare-up Drug Interactions Clindamycin has neuromuscular blocking properties and may enhance the effects of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents. There are no known interactions with other medicines that may be used topically at the same time as adapalene. However, other retinoids or medicines with a similar mechanism of action should not be used concomitantly with adapalene.

Acne vulgaris, Indicated for topical application in the treatment of mild to moderate inflammatory acne vulgaris as well as non-inflammatory Acne, either alone or in combination with other anti-acne products and for the cutaneous treatment of acne vulgaris where comedones, papules and pustules predominate.

Clindamycin inhibits protein synthesis by reversibly binding to the 50S subunit of the ribosomal thus blocking the transpeptidation or translocation reactions of susceptible organisms resulting to stunted cell growth. Adapalene binds to specific retinoic acid nuclear receptors which normalises the differentiation of follicular epithelial cells resulting in decreased microcomedone formation.

Adult Dose: Apply a thin film of Gel to the affected area of the skin once daily in the evening before going to bed. Child Dose: Safety and effectiveness of this gel in children under the age of 12 have not been established.

Clean the skin with a mild soap or soap-free cleanser, rinse with water then apply a small amount with clean fingers and rub gently into the skin. Use enough to cover the entire affected area lightly.

Local effects: Burning, itching, dryness, erythema and peeling. Systemic effects: Cases of diarrhea, bloody diarrhea and colitis [including pseudomembranous colitis] have been reported as adverse reactions in patients treated with oral and parenteral formulations of clindamycin and rarely with topical clindamycin. Abdominal pain and gastrointestinal disturbances as well as gram-negative folliculitis have also been reported in association with the use of topical formulations of clindamycin. Adapalene may cause the following side effects at the site of application. Common: may affect up to 1 in 10 people Dry skin, irritation of the skin, burning sensation of the skin, redness of the skin (erythema). Uncommon: may affect up to 1 in 100 people Local skin reaction (contact dermatitis), skin discomfort, sunburn, itching of the skin (pruritus), peeling skin (exfoliation), flare up of acne.

Use of the topical formulation of clindamycin results in absorption of the antibiotic from the skin surface. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin. Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of oral and parenteral therapy with clindamycin. Adapalene should not be used on areas which have cuts or scrapes or on sunburnt skin or in eczema. Contact with the eyes, mouth or angles of the nose and other very sensitive areas of the body should be avoided. If accidental contact does occur, immediately wash with warm water. Avoid exposure to strong sunlight and artificial UV light. Use of sunscreen products and protective clothing over the treated area is recommended. Lactation: Excretion in milk unknown; use with caution.

Contraindicated in individuals with a history of hypersensitivity to clindamycin or lincomycin or adapalene, a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.

Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents. There are no known interactions with other medications which might be used cutaneously and concurrently with Adapalene, however, other retinoids or drugs with a similar mode of action should not be used concurrently with adapalene.