T-STAT®
Westwood-Squibb
Erythromycin – Ethyl Alcohol
Topical Anti-acne Therapy
Action And Clinical Pharmacology: Ethyl alcohol is a drying and peeling agent. The mechanism of action of topically applied erythromycin in the treatment of acne vulgaris is not known.
Indications And Clinical Uses: For the treatment of the inflammatory papular lesions of acne vulgaris. Not indicated for Grade IV acne.
Contra-Indications: Individuals who have shown hypersensitivity to erythromycin or any of its other ingredients.
Manufacturers’ Warnings In Clinical States: Eye contact should be avoided since T-Stat is irritating to the eyes. Concomitant topical anti-acne therapy should be used with caution because a cumulative irritancy effect may occur, particularly with those preparations containing peeling, desquamating or abrasive agents.
Precautions: Recommended for external use only but care should be taken to avoid contact with the eyes, nostrils, mouth and other mucous membranes.
The use of preparations containing antibiotics, including T-Stat, may be associated with overgrowth of antibiotic-resistant organisms. If this should occur, the administration of T-Stat should be discontinued and appropriate measures taken. A recent report indicates that cross resistance between erythromycin and macrolide antibiotics can occur.
Pregnancy and Lactation: The safety of T-Stat during pregnancy or lactation has not been established.
Adverse Reactions: Adverse reactions associated with the use of T-Stat include dryness, erythema, pruritus, desquamation, fissuring around the mouth, tenderness, scaling, skin irritation and burning sensation.
Symptoms And Treatment Of Overdose: Symptoms and Treatment: Accidental ingestion of T-Stat could result in alcoholic intoxication and/or intestinal tract irritation (manifested by vomiting, cramping, diarrhea). Treat with a demulcent.
If eye contact 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: The topical lotion should be applied twice a day to the areas affected by acne.
Before application, these area should be washed with mild soap, rinsed well, and patted dry. T-Stat should be applied with the applicator, the fingertips, or the pads carefully to avoid the eyes, nose, mouth and other mucous membranes. The hands should be washed thoroughly after applications.
Because ethyl alcohol is potentially irritating, the frequency of application may require adjustment to once a day.
Information for the Patient: See Blue Section – Information for the Patient “T-Stat”.
Availability And Storage: Each mL of topical lotion contains: erythromycin base 2% w/v and ethyl alcohol 75% v/v. Nonmedicinal ingredients: fragrance and propylene glycol, may contain citric acid. Plastic bottles of 60 mL with optional applicator. Premoistened nonwoven pads of 60 in round plastic jars. Store tightly closed, upright, at room temperature (15 to 25°C) and away from open flame.
T-STAT® Westwood-Squibb Erythromycin – Ethyl Alcohol Topical Anti-acne Therapy
Posted by RxMed