ERYGEL® Topical Gel contains erythromycin (3R*, 4S*, 5S*,6R*,7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-Dideoxy-3-C-methyl-3-O-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)-ß-D-xylo-hexopyranosyl] oxy] oxacy-clotetradecane-2,10-dione), for topical dermatological use. Erythromycin is a macrolide antibiotic produced from a strain of Saccaropolyspora erythraea (formerly Streptomyces erythreus). It is a base and readily forms salts with acids.

Chemically, erythromycin is C₃₇H₆₇NO₁₃. It has the following structural formula:

STRUCTURAL FORMULA

Erythromycin has a molecular weight of 733.94. It is a white or slightly yellow, odorless or practically odorless, bitter crystalline powder. Erythromycin is very soluble in very polar organic solvents such as alcohols, acetone, chloroform, acetonitrile and ethyl acetate. It is moderately soluble in less polar solvents such as ether, dichloroethyl-ene and amyl acetate. It is slightly soluble in nonpolar solvents such as hexane. It is very poorly soluble in water.

Each gram of ERYGEL® Topical Gel contains 20 mg of erythromycin, USP in a base of alcohol 92% and hydroxypropyl cellulose.

Last updated on RxList: 9/10/2008

ERYGEL® Topical Gel is indicated for the topical treatment of acne vulgaris.

ERYGEL® Topical Gel should be applied sparingly as a thin film to affected area(s) once or twice a day after the skin is thoroughly cleansed and patted dry. 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. There are no data directly comparing the safety and efficacy of b.i.d. versus q.d. dosing.

ERYGEL® (Erythromycin Topical Gel USP) 2% is supplied in plastic tubes in the following sizes: 30 g - NDC 0023-4312-30 and 60 g - NDC 0023-4312-60.

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).

Distributed by: Merz Pharmaceuticals, Greensboro, NC 27410. Rev 1/00. FDA revision date: 12/9/2002

Last updated on RxList: 9/10/2008

In controlled clinical trials, the incidence of burning associated with ERYGEL® Topical Gel was approximately 25%. The following additional local adverse reactions 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. Ageneralized urticarial reaction, possibly related to the use of erythromycin, which required systemic steroid therapy has been reported.

No information provided.

Last updated on RxList: 9/10/2008

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.

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. The use of antibiotic agents may be associated with the overgrowth of antibiotic-resistant organisms. If this occurs, discontinue use and take appropriate measures.

Avoid contact with eyes and all mucous membranes.

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 Women: 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 pediatric patients have not been established.

Last updated on RxList: 9/10/2008

No information provided.

ERYGEL® Topical Gel is contraindicated in those individuals who have shown hypersensitivity to any of its components.

Last updated on RxList: 9/10/2008

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 acts by inhibition of protein synthesis in susceptible organisms by reversibly binding to 50S ribosomal subunits, thereby inhibiting translocation of aminoacyl transfer-RNAand inhibiting polypeptide synthesis. Antagonism has been demonstrated in vitro between erythromycin, lincomycin, chloramphenicol, and clindamycin.

Last updated on RxList: 9/10/2008

Patients using ERYGEL® Topical Gel should receive the following information and instructions:

This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes, nose, mouth, and all mucous membranes.

This medication should not be used for any disorder other than that for which it was prescribed.

Patients should not use any other topical acne medication unless otherwise directed by their physician.

Patients should report to their physician any signs of local adverse reactions.

Last updated on RxList: 9/10/2008

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

ERYTHROMYCIN BASE GEL - TOPICAL

(eh-rith-row-MY-sin)

COMMON BRAND NAME(S): A/T/S, Emgel, Erygel

USES: This medication is used to treat acne. It helps to reduce the number of pimples. Erythromycin is an antibiotic (macrolide-type). It works by stopping the growth of bacteria. This product contains a large amount of alcohol which dries extra oils from the skin.

HOW TO USE: This medication is for use on the skin only. Clean and dry the affected area as directed. Then apply a thin layer of the medication on the skin, usually once or twice a day or as directed by your doctor. Wash your hands after use.

Do not use large amounts or apply this more often or for a longer period than directed. Your condition will not clear faster, but the risk of side effects may be increased.

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time(s) each day.

Avoid getting this medication in your eyes or inside the nose or mouth. If this occurs, rinse thoroughly with water.

Inform your doctor if your condition does not improve or if it worsens. It may take up to 3 months of regular use before the full benefits of this medication take effect.

SIDE EFFECTS: This medication may cause burning, redness, itching, or dry/peeling/oily skin, especially in the first few days as your body adjusts to the medication. Eye irritation may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Rarely, use of this medication may result in other types of skin infections (fungal or other bacterial infections). Contact your doctor if you notice any unusual skin irritation or other symptoms.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using erythromycin, tell your doctor or pharmacist if you are allergic to it; or to other antibiotics (e.g., azithromycin, clarithromycin); or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

This product should not be used with the following medications because very serious interactions may occur: disulfiram, metronidazole, tinidazole.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting erythromycin gel.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other skin products (especially those that also cause peeling/irritated skin)

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

NOTES: Do not share this medication with others.

For the best results, this medication is often used as part of a total skin care program. Follow your doctor's recommendations.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store the tightly-closed container at room temperature between 59-86 degrees F (15-30 degrees C). This medication is flammable, so keep it away from heat and open flame. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.