ERYSOL®
Stiefel
Erythromycin – Ethyl Alcohol
Topical Acne Therapy
Action And Clinical Pharmacology: Erythromycin exerts its antibacterial action by binding to the 50s ribosomal subunit of susceptible bacteria and suppressing protein synthesis. Erythromycin is usually bacteriostatic but may be bactericidal in high concentrations or against highly susceptible organisms. The precise mechanism of action of erythromycin in the treatment of acne has not been established.
Ethyl alcohol is a drying and peeling agent.
Indications And Clinical Uses: In the treatment of inflammatory papular and pustular lesions of acne vulgaris.
Erysol is not indicated for the treatment of cysts or nodules. It is not indicated for use in Grade IV acne.
Contra-Indications: In persons who have shown hypersensitivity to erythromycin or any of the other ingredients.
Manufacturers’ Warnings In Clinical States: Erysol is intended for external use only and should be kept away from the eyes, nostrils, mouth and other mucous membranes because of its irritant effects. Concomitant topical anti-acne therapy should be used with caution because a cumulative irritancy effect may occur, especially with preparations having peeling, desquamating or abrasive properties.
Precautions: The use of preparations containing antibiotics such as Erysol may be associated with overgrowth of antibiotic resistant organisms, including those initially sensitive to the drug. Cross-resistance between erythromycin and macrolide antibiotics can occur. If this should occur, therapy should be discontinued and appropriate measures taken. A cross-resistance between erythromycin and clindamycin has rarely been reported.
Pregnancy: The safety of Erysol during pregnancy has not been established. Erythromycin crosses the placental barrier.
Lactation: Erythromycin is excreted in human milk. Caution should be exercised whenever Erysol is given to a nursing mother.
Adverse Reactions: Adverse reactions reported with topical erythromycin preparations such as Erysol include mild to severe skin irritation symptoms including dryness, tenderness, pruritus, desquamation, scaling, coriaceousness, fissuring around the mouth, erythema, urticaria, oiliness and burning sensation.
Symptoms And Treatment Of Overdose: Symptoms and Treatment: Accidental ingestion of Erysol could cause alcoholic intoxication and/or intestinal tract irritation (manifested by abdominal discomfort, cramping, diarrhea or vomiting). Treat with a demulcent.
If Erysol comes into contact with the eye, irrigate with copious amounts of water or irrigation solutions for at least 5 minutes. If discomfort persists, consult a physician.
Excessive frequency of application may result in excessive dryness and scaling, pruritus, tenderness, erythema, desquamation and burning sensation. Discontinue use until condition subsides. Appropriate anti-inflammatory measures may be employed.
Dosage And Administration: Apply twice a day to areas affected by acne. These areas should be washed first with a mild soap, rinsed well, and patted dry, followed by application of the gel in a gentle rubbing motion, using fingertips to apply the medication. Wash hands thoroughly after application. Care should be taken to avoid eyes, nostrils, mouth and other mucous membranes.
Ethyl alcohol contributes significantly to the efficacy of Erysol due to its drying and peeling properties. Because ethyl alcohol is potentially irritating, the frequency of application may require adjustment to once a day.
Availability And Storage: Each g of clear, colorless gel with characteristic odor contains: erythromycin USP 2% (20 mg/g), ethyl alcohol (75%), Parsol MCX 7.5% and Parsol 1789 2%. Sunscreens: SPF15. Nonmedicinal ingredients: cyclomethicone NF, dioctyl maleate, hydroxypropyl cellulose NF and isoarachidyl neopentanoate. Tubes of 25 g. Store at 15 to 30°C.
ERYSOL® Stiefel Erythromycin – Ethyl Alcohol Topical Acne Therapy
Posted by RxMed