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Erythromycin-Benzoyl Peroxide

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Overview

What is Erythromycin-Benzoyl Peroxide?

Erythromycin-Benzoyl Peroxide Topical Gel contains erythromycin [(3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-Dideoxy-3--methyl-3--methyl-α-L--hexopyranosyl)-oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexa-methyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-β-D--hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione]. Erythromycin is a macrolide antibiotic produced from a strain of (formerly ). It is a base and readily forms salts with acids.

Chemically, erythromycin is (CHNO). 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.

Erythromycin-Benzoyl Peroxide Topical Gel also contains benzoyl peroxide for topical use. Benzoyl peroxide is an antibacterial and keratolytic agent.

Chemically, benzoyl peroxide is (CHO). 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 Erythromycin-Benzoyl Peroxide Topical Gel contains, as dispensed, 30 mg (3%) of erythromycin and 50 mg (5%) of benzoyl peroxide in a base of purified water USP, carbomer, alcohol 20%, sodium hydroxide NF, docusate sodium and fragrance.



What does Erythromycin-Benzoyl Peroxide look like?



What are the available doses of Erythromycin-Benzoyl Peroxide?

Sorry No records found.

What should I talk to my health care provider before I take Erythromycin-Benzoyl Peroxide?

Sorry No records found

How should I use Erythromycin-Benzoyl Peroxide?

Erythromycin-Benzoyl Peroxide Topical Gel is indicated for the topical treatment of acne vulgaris.

Erythromycin-Benzoyl Peroxide 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.


What interacts with Erythromycin-Benzoyl Peroxide?

Erythromycin-Benzoyl Peroxide Topical Gel is contraindicated in those individuals who have shown hypersensitivity to any of its components.



What are the warnings of Erythromycin-Benzoyl Peroxide?

The management of NMS should include: 1) intensive symptomatic treatment and medical monitoring and 2) treatment of any concomitant serious medical problems for which specific treatments are available. Dopamine agonists, such as bromocriptine, and muscle relaxants, such as dantrolene, are often used in the treatment of NMS; however, their effectiveness has not been demonstrated in controlled studies.

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 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 colitis.


What are the precautions of Erythromycin-Benzoyl Peroxide?

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.

Patients using Erythromycin-Benzoyl Peroxide Topical Gel should receive the following information and instructions:

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.

Animal reproduction studies have not been conducted with Erythromycin-Benzoyl Peroxide 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 Erythromycin-Benzoyl Peroxide Topical Gel. It also is not known whether Erythromycin-Benzoyl Peroxide Topical Gel can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Erythromycin-Benzoyl Peroxide Topical Gel should be given to a pregnant woman only if clearly needed.

It is not known whether Erythromycin-Benzoyl Peroxide 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.

Safety and effectiveness of this product in pediatric patients below the age of 12 have not been established.

  • 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 preparation unless otherwise directed by physician.
  • Patients should report to their physician any signs of local adverse reactions.
  • Erythromycin-Benzoyl Peroxide Topical Gel may bleach hair or colored fabric.
  • Keep product refrigerated and discard after 3 months.



What are the side effects of Erythromycin-Benzoyl Peroxide?

In controlled clinical trials, the incidence of adverse reactions associated with the use of Erythromycin-Benzoyl Peroxide 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.


What should I look out for while using Erythromycin-Benzoyl Peroxide?

Erythromycin-Benzoyl Peroxide Topical Gel is contraindicated in those individuals who have shown hypersensitivity to any of its components.

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 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 colitis.


What might happen if I take too much Erythromycin-Benzoyl Peroxide?

Sorry No Records found


How should I store and handle Erythromycin-Benzoyl Peroxide?

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Prior to dispensing, tap vial until all powder flows freely. Add indicated amount of room temperature 70% ethyl alcohol to vial (to the mark) and immediately shake to completely dissolve erythromycinNOTE: store at room temperature between 15° and 30°C (59° – 86°F).After reconstitution,Do not freeze. Keep tightly closed. Keep out of the reach of children.Prior to dispensing, tap vial until all powder flows freely. Add indicated amount of room temperature 70% ethyl alcohol to vial (to the mark) and immediately shake to completely dissolve erythromycinNOTE: store at room temperature between 15° and 30°C (59° – 86°F).After reconstitution,Do not freeze. Keep tightly closed. Keep out of the reach of children.Prior to dispensing, tap vial until all powder flows freely. Add indicated amount of room temperature 70% ethyl alcohol to vial (to the mark) and immediately shake to completely dissolve erythromycinNOTE: store at room temperature between 15° and 30°C (59° – 86°F).After reconstitution,Do not freeze. Keep tightly closed. Keep out of the reach of children.Prior to dispensing, tap vial until all powder flows freely. Add indicated amount of room temperature 70% ethyl alcohol to vial (to the mark) and immediately shake to completely dissolve erythromycinNOTE: store at room temperature between 15° and 30°C (59° – 86°F).After reconstitution,Do not freeze. Keep tightly closed. Keep out of the reach of children.


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Clinical Information

Chemical Structure

No Image found
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.

Non-Clinical Toxicology
Erythromycin-Benzoyl Peroxide Topical Gel is contraindicated in those individuals who have shown hypersensitivity to any of its components.

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 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 colitis.

Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents.

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.

Patients using Erythromycin-Benzoyl Peroxide Topical Gel should receive the following information and instructions:

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.

Animal reproduction studies have not been conducted with Erythromycin-Benzoyl Peroxide 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 Erythromycin-Benzoyl Peroxide Topical Gel. It also is not known whether Erythromycin-Benzoyl Peroxide Topical Gel can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Erythromycin-Benzoyl Peroxide Topical Gel should be given to a pregnant woman only if clearly needed.

It is not known whether Erythromycin-Benzoyl Peroxide 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.

Safety and effectiveness of this product in pediatric patients below the age of 12 have not been established.

In controlled clinical trials, the incidence of adverse reactions associated with the use of Erythromycin-Benzoyl Peroxide 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.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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Tips

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Interactions

Interactions

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