Prescription Drugs

CLINICAL PHARMACOLOGY Microbiology Erythromycin inhibits protein synthesis without affecting nucleic acid synthesis. Erythromycin is usually active against the following organisms in vitro and in clinical infections: Streptococcus pyogenes (group A β-hemolytic) Alpha-hemolytic streptococci (viridans group) Staphylococcus aureus, including penicillinase-producing strains (methicillin-resistant staphylococci are uniformly resistant to erythromycin) Streptococcus pneumoniae Mycoplasma pneumoniae (Eaton Agent, PPLO) Haemophilus influenzae (not all strains of this organism are susceptible at the erythromycin concentrations ordinarily achieved) Treponema pallidum Corynebacterium diphtheriae Neisseria gonorrhoeae Chlamydia trachomatis

CLINICAL PHARMACOLOGY The exact mechanism by which erythromycin reduces lesions of acne vulgaris is not fully known; however, the effect appears to be due in part to the antibacterial activity of the drug. Microbiology: Erythromycin appears to inhibit protein synthesis in susceptible organisms by reversibly binding to ribosomal subunits, thereby inhibiting translocation of aminoacyl transfer-RNA and inhibiting polypeptide synthesis. Antagonism has been demonstrated between erythromycin, lincomycin, chloramphenicol, and clindamycin.

CLINICAL PHARMACOLOGY The exact mechanism by which erythromycin reduces lesions of acne vulgaris is not fully known; however, the effect appears to be due in part to the antibacterial activity of the drug. Benzoyl peroxide has a keratolytic and desquamative effect which may also contribute to its efficacy. Benzoyl peroxide has been shown to be absorbed by the skin where it is converted to benzoic acid. Microbiology Erythromycin acts by inhibition of protein synthesis in susceptible organisms by reversibly binding to 50 S ribosomal subunits, thereby inhibiting translocation of aminoacyl transfer-RNA and inhibiting polypeptide synthesis. Antagonism has been demonstrated in vitro between erythromycin, lincomycin, chloramphenicol and clindamycin. Benzoyl peroxide is an antibacterial agent which has been shown to be effective against Propionibacterium acnes, an anaerobe found in sebaceous follicles and comedones. The antibacterial action of benzoyl peroxide is believed to be due to the release of active oxygen.

Find Lowest Prices on ILOTYCIN (erythromycin) Ointment DESCRIPTION ILOTYCIN™ Erythromycin Ophthalmic Ointment belongs to the macrolide group of antibiotics. It is basic and readily forms a salt when combined with an acid. The base, as crystals or powder, is slightly soluble in water, moderately soluble in ether, and readily soluble in alcohol or chloroform. Erythromycin ((3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*) -4-[(2,6-dideoxy-3-C-methyl-3-0-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7, 12,13-trihydroxy-3, 5, 7, 9, 11, 13-hexamethyl-6-[[3, 4, 6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2, 10-dione) is an antibiotic produced from a strain of Streptomyces erythraeus. It has the following structural formula: Molecular Formula: C37H67NO13 Molecular Weight: 733.94 Each gram contains Erythromycin USP 5 mg in a sterile ophthalmic base of mineral oil and white petrolatum.

EMGEL (erythromycin) ® TOPICAL GEL USP 2% Rx Only For Dermatologic Use Only-Not for Ophthalmic Use DESCRIPTION EMGEL (erythromycin) Topical Gel contains erythromycin. Erythromycin is a macrolide antibiotic obtained from cultures of Streptomyces erythreus. Erythromycin has the empirical formula C 37 H 67 NO 13 and a molecular weight of 733.94. It has the following structural formula: EMGEL Topical Gel contains erythromycin, USP 2% (20 mg/g) with SD 40-2 alcohol 77%, propylene glycol, and hydroxypropyl cellulose.

Find Lowest Prices on Benzamycin® Pak (erythromycin 3%-benzoyl peroxide 5%) Topical Gel For Dermatological Use Only Not for Ophthalmic Use DESCRIPTION Benzamycin® Pak contains erythromycin [(3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6- dideoxy-3-C-methyl-3-O-methyl-a- L-ribo-hexopyranosyl)-oxy]-14- ethyl-7,12,13-trihydroxy- 3,5,7,9,11,13-hexa-methyl-6-[ [3,4,6-trideoxy-3-(dimethylamino)-b-D- xylo-hexopyranosyl] oxy]oxacyclotetradecane-2,10- dione]. Erythromycin is a macrolide antibiotic produced from a strain of Saccharopolyspora erythraea (formerly Streptomyces erythreus). It is a base and readily forms salts with acids. Chemically, erythromycin is (C37H67NO13). It has the following structural formula: Erythromycin has the molecular weight of 733.94. It is a white crystalline powder and has a solubility of approximately 1 mg/mL in water and is soluble in alcohol at 25°C. Benzamycin (erythromycin) ® Pak also contains benzoyl peroxide for topical use. Benzoyl peroxide is an oxidizing agent demonstrating antibacterial activity. Chemically, benzoyl peroxide is (C14H10O4). It has the following structural formula: Benzoyl peroxide has the molecular weight of 242.23. It is a white granular powder and is sparingly soluble in water and alcohol and soluble in acetone, chloroform and ether. Each gram of product, as dispensed, contains 30 mg of erythromycin and 50 mg of benzoyl peroxide in a base of SD Alcohol 40B, purified water, hydroxypropyl cellulose, carbomer 934, sodium hydroxide, dioctyl sodium sulfosuccinate 75%. Each Benzamycin (erythromycin) ® Pak contains 0.8 grams of product.

INDICATIONS For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to erythromycin. For prophylaxis of ophthalmia neonatorum due to N. gonorrhoeae or C. trachomatis. The effectiveness of erythromycin in the prevention of ophthalmia caused by penicillinase-producing N. gonorrhoeae is not established. For infants born to mothers with clinically apparent gonorrhea, intravenous or intramuscular injections of aqueous crystalline penicillin G should be given; a single dose of 50,000 units for term infants or 20,000 units for infants of low birth weight. Topical prophylaxis alone is inadequate for these infants. DOSAGE AND ADMINISTRATION In the treatment of superficial ocular infections, a ribbon approximately 1 cm in length of ILOTYCIN™ Ophthalmic Ointment should be applied directly to the infected structure up to 6 times daily, depending on the severity of the infection. For prophylaxis of neonatal gonococcal or chlamydial conjunctivitis, a ribbon of ointment approximately 1 cm in length should be instilled into each lower conjunctival sac. The ointment should not be flushed from the eye following instillation. A new tube should be used for each infant. HOW SUPPLIED Sterile ILOTYCIN™ Ophthalmic Ointment USP, 5 mg/g as follows: 1 g tamper-evident tubes NDC 48102-016-11 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid excessive heat. Protect from freezing. Manufactured for: Fera Pharmaceuticals, LLC, Locust Valley, NY 11560. Rev. 06/10

INDICATIONS EMGEL (erythromycin) Topical Gel is indicated for the topical treatment of acne vulgaris. DOSAGE AND ADMINISTRATION Apply sparingly as a thin layer to affected area(s) twice a day, in the morning and the evening, after the skin has been thoroughly washed with soap and water and patted dry. The hands should be washed after application. If there has been no improvement after 6 to 8 weeks, or if the condition becomes worse, treatment should be discontinued, and the physician should be reconsulted. Spread the medication lightly rather than rubbing it in. HOW SUPPLIED ERYGEL® (Erythromycin Topical Gel USP) 2% is supplied in plastic tubes in the following sizes: 30g - NDC 0259-4312-30 and 60 g - NDC 0259-4312-60. Note: FLAMMABLE. Keep away from heat and flame. Store and dispense in original container. Keep tube tightly closed. Store between 15° and 25°C (59° and 77°F). Manufactured for: Merz Pharmaceuticals, Greensboro, NC 27410 70-2057-00 Rev 10/01

INDICATIONS BENZAMYCIN (erythromycin) Topical Gel is indicated for the topical treatment of acne vulgaris. DOSAGE AND ADMINISTRATION BENZAMYCIN (erythromycin) Topical Gel should be applied twice daily, morning and evening, or as directed by a physician, to affected areas after the skin is thoroughly washed, rinsed with warm water and gently patted dry. HOW SUPPLIED Compounding Directions Size (Net Weight) NDC 0066- Benzoyl Peroxide Gel Active Erythromycin Powder (In Plastic Vial) Ethyl Alcohol (70%) To Be Added 23.3 grams (as dispensed) 0510-23 20 grams 0.8 grams 3 mL 46.6 grams (as dispensed) 0510-46 40 grams 1.6 grams 6 mL Prior to dispensing, tap vial until powder flows freely. Add indicated amount of ethyl alcohol (70%) to vial (to the mark) and immediately shake to completely dissolve erythromycin. Add this solution to gel and stir until homogeneous in appearance (1 to 1½ minutes). BENZAMYCIN (erythromycin) Topical Gel should then be stored under refrigeration. Do not freeze. Place a 3-month expiration date on the label. NOTE: Prior to reconstitution, store at room temperature between 15° and 30°C (59° - 86°F). After reconstitution, store under refrigeration between 2° and 8°C (36° - 46°F). Do not freeze. Keep tightly closed. Keep out of the reach of children. Prescribing Information as of January 2003. Manufactured for Dermik Laboratories, A Division of Aventis Pharmaceuticals Inc. Berwyn, PA 19312, USA. by Aventis Pharmaceuticals Puerto Rico Inc. Manati, Puerto Rico 00674. FDA Rev date: 1/27/2003

PATIENT INFORMATION Avoid contaminating the applicator tip with material from the eye, fingers, or other source.

OVERDOSE No information provided. CONTRAINDICATIONS This drug is contraindicated in patients with a history of hypersensitivity to erythromycin.

OVERDOSE No Information Provided. CONTRAINDICATIONS EMGEL (erythromycin) Topical Gel is contraindicated in those individuals who have shown hypersensitivity to any of its components.

OVERDOSE No information provided. CONTRAINDICATIONS BENZAMYCIN (erythromycin) Topical Gel is contraindicated in those individuals who have shown hypersensitivity to any of its components.

SIDE EFFECTS The most frequently reported adverse reactions are minor ocular irritations, redness, and hypersensitivity reactions. To report SUSPECTED ADVERSE REACTIONS, contact Fera Pharmaceuticals, LLC at (414) 434-6604 Monday-Friday 9am-5pm EST or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS No information provided.

SIDE EFFECTS The most common adverse reaction reported with EMGEL (erythromycin) Topical Gel was burning. The following have been reported occasionally: peeling, dryness, itching, erythema, and oiliness. Irritation of the eyes and tenderness of the skin have also been reported with the topical use of erythromycin. A generalized urticarial reaction, which was possibly related to the use of erythromycin and required systemic steroid therapy, has been reported. DRUG INTERACTIONS No Information Provided.

SIDE EFFECTS In controlled clinical trials, the incidence of adverse reactions associated with the use of BENZAMYCIN (erythromycin) Topical Gel was approximately 3%. These were dryness and urticarial reaction. The following additional local adverse reactions have been reported occasionally: irritation of the skin including peeling, itching, burning sensation, erythema, inflammation of the face, eyes and nose, and irritation of the eyes. Skin discoloration, oiliness and tenderness of the skin have also been reported. DRUG INTERACTIONS No information provided.

WARNINGS No information provided. PRECAUTIONS General The use of antimicrobial agents may be associated with the overgrowth of nonsusceptible organisms including fungi; in such a case, antibiotic administration should be stopped and appropriate measures taken. Carcinogenesis, Mutagenesis, Impairment of Fertility Two year oral studies conducted in rats with erythromycin did not provide evidence of tumorigenicity. Mutagenicity studies have not been conducted. No evidence of impaired fertility that appeared related to erythromycin was reported in animal studies. Pregnancy Teratogenic effects -Pregnancy category B Reproduction studies have been performed in rats, mice, and rabbits using erythromycin and its various salts and esters, at doses that were several multiples of the usual human dose. No evidence of harm to the fetus that appeared related to erythromycin was reported in these studies. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, the erythromycins should be used during pregnancy only if clearly needed. Nursing Mothers Caution should be exercised when erythromycin is administered to a nursing woman. Pediatric Use See INDICATIONS and DOSAGE AND ADMINISTRATION.

WARNINGS Pseudomembranous colitis has been reported with nearly all antibacterial agents, including erythromycin, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of "antibiotic-associated colitis". After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against C. difficile colitis. PRECAUTIONS General: For topical use only; not for ophthalmic use. Concomitant topical acne therapy should be used with caution since a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. Avoid contact with eyes and all mucous membranes. The use of antibiotic agents may be associated with the overgrowth of antibiotic-resistant organisms. If this occurs, discontinue use and take appropriate measures. Carcinogenesis, Mutagenesis, Impairment of Fertility: No animal studies have been performed to evaluate carcinogenic and mutagenic potential or effects on fertility of topical erythromycin. However, long-term (2-year) oral studies in rats with erythromycin ethylsuccinate and erythromycin base did not provide evidence of tumorigenicity. There was no apparent effect on male or female fertility in rats fed erythromycin (base) at levels up to 0.25% of diet. Pregnancy: Teratogenic effects: Pregnancy Category B: There was no evidence of teratogenicity or any other adverse effect on reproduction in female rats fed erythromycin base (up to 0.25% of diet) prior to and during mating, during gestation and through weaning of two successive litters. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed. Erythromycin has been reported to cross the placental barrier in humans, but fetal plasma levels are generally low. Nursing Mothers: It is not known whether erythromycin is excreted in human milk after topical application. However, erythromycin is excreted in human milk following oral and parenteral erythromycin administration. Therefore, caution should be exercised when erythromycin is administered to a nursing woman. Pediatric Use: Safety and effectiveness in children have not been established.

WARNINGS Pseudomembranous colitis has been reported with nearly all antibacterial agents, including erythromycin, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of "antibiotic-associated colitis." After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against C. difficile colitis. PRECAUTIONS General: For topical use only; not for ophthalmic use. Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating or abrasive agents. If severe irritation develops, discontinue use and institute appropriate therapy. The use of antibiotic agents may be associated with the overgrowth of nonsusceptible organisms including fungi. If this occurs, discontinue use and take appropriate measures. Avoid contact with eyes and all mucous membranes. Carcinogenesis, Mutagenesis And Impairment Of Fertility Data from a study using mice known to be highly susceptible to cancer suggests that benzoyl peroxide acts as a tumor promoter. The clinical significance of this is unknown. No animal studies have been performed to evaluate the carcinogenic and mutagenic potential or effects on fertility of topical erythromycin. However, long-term (2-year) oral studies in rats with erythromycin ethylsuccinate and erythromycin base did not provide evidence of tumorigenicity. There was no apparent effect on male or female fertility in rats fed erythromycin (base) at levels up to 0.25% of diet. Pregnancy: Teratogenic Effects: Pregnancy CATEGORY C: Animal reproduction studies have not been conducted with BENZAMYCIN (erythromycin) Topical Gel or benzoyl peroxide. There was no evidence of teratogenicity or any other adverse effect on reproduction in female rats fed erythromycin base (up to 0.25% diet) prior to and during mating, during gestation and through weaning of two successive litters. There are no well-controlled trials in pregnant women with BENZAMYCIN (erythromycin) Topical Gel. It also is not known whether BENZAMYCIN (erythromycin) Topical Gel can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. BENZAMYCIN (erythromycin) Topical Gel should be given to a pregnant woman only if clearly needed. Nursing Women: It is not known whether BENZAMYCIN (erythromycin) Topical Gel is excreted in human milk after topical application. However, erythromycin is excreted in human milk following oral and parenteral erythromycin administration. Therefore, caution should be exercised when erythromycin is administered to a nursing woman. Pediatric Use: Safety and effectiveness of this product in pediatric patients below the age of 12 have not been established.