STATICIN® Westwood-Squibb Erythromycin–Ethyl Alcohol–Laureth-4 Acne Therapy
Indications And Clinical Uses:
The treatment of acne vulgaris. For use primarily in the treatment of the inflammatory papular lesions of acne.
Contra-Indications:
Hypersensitivity to any of the components.
Warnings in Clinical States:
Eye contact should be avoided since Staticin is irritating to the eyes. Instillation in the rabbit eye is known to provoke corneal damage. Concomitant topical antiacne therapy should be avoided because a cumulative irritancy effect may occur, particularly with those preparations containing peeling, desquamating or abrasive agents.
Precautions:
For external use only. Avoid contact with the eyes, nostrils, mouth and other mucous membranes. Contains drying and peeling agents that are potential irritants, therefore reduction in frequency of application may be necessary to avoid excessive irritation.
The use of preparations containing antibiotics may be associated with overgrowth of antibiotic resistant organisms. Cross resistance between erythromycin and macrolide antibiotics can occur. If this should occur, therapy should be discontinued and appropriate measures taken.
Adverse Reactions:
Symptoms of irritation: erythema, desquamation, tenderness and excessive dryness.
Mild to moderate symptoms of irritation were observed in 70% of Staticin treated patients, while severe irritation was seen in 12%.
Others: pruritus, urticaria, oiliness and fissuring around the mouth.
Symptoms And Treatment Of Overdose:
Symptoms: Accidental ingestion could result in alcoholic intoxication and/or intestinal tract irritation manifested by vomiting, cramping, diarrhea.
Treatment: Treat with a demulcent. If eye contact with Staticin should occur, wash with copious amounts of water for at least 5 minutes. If discomfort persists, a physician should be contacted.
Excessive frequency of application can cause erythema, excessive scaling and sensations of burning and tenderness. Appropriate anti-inflammatory measures (e.g. compresses or topical corticosteroids) may be employed.
Dosage And Administration:
Apply each morning and evening to the areas affected by acne. Before applying, areas should be washed with mild soap, rinsed well, and patted dry. Use fingertips to apply medication. Wash hands after use. Because the drying and peeling agents in Staticin are potentially irritating, the frequency of application may require adjustment to once a day or less. Ethyl alcohol and Laureth-4 contribute significantly to the effectiveness of Staticin due to their drying and peeling properties. The erythromycin component significantly reduces the number of papular lesions after four weeks of treatment. Staticin reduced the total acne lesion count (closed and open comedones, papules and pustules) to a significant degree by 12 weeks of therapy.
Availability And Storage:
Each bottle contains: erythromycin base 1.5% w/v, ethyl alcohol 55% v/v and 6% w/v laureth-4. Nonmedicinal ingredients: fragrance and propylene glycol. Plastic bottles of 60 and 120 mL, with optional applicator. Store tightly closed in a cool, dry place, and avoid contact with open flame.
STATICIN® Westwood-Squibb Erythromycin–Ethyl Alcohol–Laureth-4 Acne Therapy
Posted by RxMed