Acne Cure A

Description

Acne Cure A Gel is indicated for topical treatment of:

• Mild to moderate inflammatory acne vulgaris.
• Non-inflammatory acne.
• Can be used either alone or in combination with other anti-acne products.
• Specifically effective for acne vulgaris where comedones (blackheads/whiteheads), papules (small red bumps), and pustules (pus-filled bumps) predominate.

Dosage & Administration

Adult Dose:

• Apply a thin film of the gel to the affected area of the skin once daily in the evening before going to bed.

Child Dose:

• The safety and effectiveness of this gel in children under the age of 12 have not been established.

Administration Instructions:

1. Cleanse the skin with a mild soap or soap-free cleanser.
2. Rinse thoroughly with water.
3. Apply a small amount of gel with clean fingers and gently rub it into the skin.
4. Use enough gel to lightly cover the entire affected area.

Important Considerations

• Contraindications:
  • Individuals with a history of hypersensitivity (allergic reaction) to clindamycin, lincomycin, or adapalene.
  • A history of regional enteritis (Crohn’s disease) or ulcerative colitis.
  • A history of antibiotic-associated colitis.
• Precautions:
  • Systemic Absorption of Clindamycin: Even with topical application, clindamycin can be absorbed from the skin surface. Cases of diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with topical and systemic clindamycin. These gastrointestinal issues can occur up to several weeks after stopping oral or parenteral clindamycin therapy.
  • Adapalene Specific Precautions:
    • Do not use on areas with cuts, scrapes, sunburned skin, or eczema.
    • Avoid contact with eyes, mouth, angles of the nose, and other very sensitive areas of the body. If accidental contact occurs, immediately wash thoroughly with warm water.
    • Sun Sensitivity: Avoid exposure to strong sunlight and artificial UV light (e.g., tanning beds). The use of sunscreen products and protective clothing over treated areas is recommended.
• Lactation (Breastfeeding): It is unknown if adapalene or clindamycin topical are excreted in breast milk. Use with caution.
• Drug Interactions:
  • Clindamycin: Has neuromuscular blocking properties and may enhance the action of other neuromuscular blocking agents. Use with caution in patients receiving such agents.
  • Adapalene: No known interactions with other topical medications. However, other retinoids or drugs with a similar mode of action should not be used concurrently with adapalene to avoid excessive irritation.
• Adverse Effects (Side Effects):
  • Local Effects (Common with Adapalene + Clindamycin Topical): Burning, itching, dryness, redness (erythema), and peeling of the skin at the application site.
  • Systemic Effects (Rare with Topical Clindamycin but reported): Cases of diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis). Abdominal pain, gastrointestinal disturbances, and gram-negative folliculitis have also been reported with topical clindamycin.
  • Adapalene-Specific Side Effects:
    • Common (up to 1 in 10 people): Dry skin, skin irritation, burning sensation, skin redness (erythema).
    • Uncommon (up to 1 in 100 people): Local skin reaction (contact dermatitis), skin discomfort, sunburn, itching (pruritus), peeling skin (exfoliation), flare-up of acne.