Drugs Details

Drugs Info of A/T/S, Akne-Mycin, Emcin Clear, Emgel, Eryderm, Erygel, Erymax, Romycin, Theramycin Z
Drugs Details
  • Drugs Type  : Multum
  • Date : 9th Feb 2015 01:57 am
  • Brand Name : A/T/S, Akne-Mycin, Emcin Clear, Emgel, Eryderm, Erygel, Erymax, Romycin, Theramycin Z
  • Generic Name : erythromycin topical (Pronunciation: ee RITH roe MYE sin)
Descriptions

ERYGEL® (erythromycin topical gel) 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

Erygel (erythromycin) structural formula illustration

 

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® (erythromycin topical gel) Topical Gel contains 20 mg of erythromycin, USP in a base of alcohol 92% and hydroxypropyl cellulose.

 

What are the possible side effects of erythromycin topical?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using erythromycin topical and call your doctor at once if you have any of these serious side effects:

  • severe burning, stinging, or redness;
  • oozing or other signs of skin infection;
  • worsening of your skin condition; or
  • diarrhea that is watery or bloody.

Less serious side effects may include:

  • mild skin irritation or tenderness;
  • dry or oily...

Read All Potential Side Effects and See Pictures of Erygel »

What are the precautions when taking erythromycin topical gel (Erygel)?

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. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

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...

Read All Potential Precautions of Erygel »

 

This monograph has been modified to include the generic and brand name in many instances.

Indications

ERYGEL® (erythromycin topical gel) Topical Gel is indicated for the topical treatment of acne vulgaris.

Dosage Administration

ERYGEL® (erythromycin topical gel) 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.

How Supplied

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

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

In controlled clinical trials, the incidence of burning associated with ERYGEL® (erythromycin topical gel) 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.

Read the Erygel (erythromycin topical gel) Side Effects Center for a complete guide to possible side effects

Learn More »
 
 
 

Interactions

No information provided.

This monograph has been modified to include the generic and brand name in many instances.

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 byClostridium 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, proteinsupplementation and treatment with an antibacterial drug clinically effective againstC. difficile colitis.

 
Warnings

 

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. 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, duringgestation 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.

This monograph has been modified to include the generic and brand name in many instances.

OverDose

No information provided.

ContrainDications

ERYGEL® (erythromycin topical gel) Topical Gel is contraindicated in those individuals who have shown hypersensitivity to any of its components.

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

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 antibacterialactivity 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.

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

Patients using ERYGEL® (erythromycin topical gel) 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.

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

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.

Consumer Overview Side 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 (especially of the face/tongue/throat), 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.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Erygel (erythromycin topical gel) Side Effects Center for a complete guide to possible side effects

Learn More »
 

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. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

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.

Consumer Overview Missed Dose

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 a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

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 March 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: A/T/S, Akne-Mycin, Emcin Clear, Emgel, Eryderm, Erygel, Erymax, Romycin, Theramycin Z

Generic Name: erythromycin topical (Pronunciation: ee RITH roe MYE sin)

  • What is erythromycin topical (Erygel)?
  • What are the possible side effects of erythromycin topical?
  • What is the most important information I should know about erythromycin topical?
  • What should I discuss with my healthcare provider before using erythromycin topical?
  • How should I use erythromycin topical?
  • What happens if I miss a dose?
  • What happens if I overdose?
  • What should I avoid while taking erythromycin topical?
  • What other drugs will affect erythromycin topical?
  • Where can I get more information?

What is erythromycin topical (Erygel)?

 

Erythromycin topical is an antibiotic that fights skin infection caused by bacteria.

Erythromycin topical (for the skin) is used to treat bacterial infections such as severe acne.

Erythromycin topical may also be used for purposes not listed in this medication guide.

What are the possible side effects of erythromycin topical?

 

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using erythromycin topical and call your doctor at once if you have any of these serious side effects:

  • severe burning, stinging, or redness;
  • oozing or other signs of skin infection;
  • worsening of your skin condition; or
  • diarrhea that is watery or bloody.

Less serious side effects may include:

  • mild skin irritation or tenderness;
  • dry or oily skin;
  • itching;
  • peeling; or
  • mild eye irritation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Erygel (erythromycin topical gel) Side Effects Center for a complete guide to possible side effects

Learn More »
 

What is the most important information I should know about erythromycin topical?

 

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Wash your hands before and after using this medicine.

Avoid using other medications on the areas you treat with erythromycin topical unless your doctor tells you to.

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, rinse with water.

It may take up to 12 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 6 weeks of treatment.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking erythromycin topical and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Side Effects Centers
  • Emgel
  • Erygel

Patient Detailed How Take

What should I discuss with my healthcare provider before using erythromycin topical?

 

You should not use erythromycin topical if you are allergic to it.

FDA pregnancy category C. It is not known whether erythromycin topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Erythromycin topical can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not use this medicine on a child younger than 18 years old without the advice of a doctor.

How should I use erythromycin topical?

 

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Do not use erythromycin topical to treat any skin condition that has not been checked by your doctor.

Wash your hands before and after using this medicine.

Clean and dry the skin area before you apply erythromycin topical. Spread the medicine on lightly, without rubbing it in.

Erythromycin topical is usually applied once or twice daily. Follow your doctor's instructions.

It may take up to 12 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 6 weeks of treatment.

Store at room temperature away from moisture and heat. Keep the tube or bottle tightly closed when not in use.

The gel form of this medicine is flammable. Do not use near high heat or open flame.

Side Effects Centers
  • Emgel
  • Erygel

Patient Detailed Avoid Taking

What happens if I miss a dose?

 

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

 

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking erythromycin topical?

 

Avoid using other medications on the areas you treat with erythromycin topical unless your doctor tells you to.

Avoid using skin products that can cause irritation, such as harsh soaps or skin cleansers, or skin products with alcohol, spices, astringents, or lime.

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, rinse with water.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking erythromycin topical and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

What other drugs will affect erythromycin topical?

 

It is not likely that other drugs you take orally or inject will have an effect on topically applied erythromycin. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

 

Your pharmacist can provide more information about erythromycin topical.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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Side Effects Centers
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