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erythromycin and benzoyl peroxide
Overview
What is Benzamycin?
BENZAMYCIN 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-hexamethyl-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.
BENZAMYCIN 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 BENZAMYCIN 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 Homopolymer Type C, alcohol 20%, sodium hydroxide NF, docusate sodium and fragrance.
What does Benzamycin look like?
What are the available doses of Benzamycin?
Sorry No records found.
What should I talk to my health care provider before I take Benzamycin?
Sorry No records found
How should I use Benzamycin?
BENZAMYCIN Topical Gel is indicated for the topical treatment of acne vulgaris.
BENZAMYCIN 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 Benzamycin?
BENZAMYCIN Topical Gel is contraindicated in those individuals who have shown hypersensitivity to any of its components.
What are the warnings of Benzamycin?
Caution is advised for patients receiving concomitant high-dose aspirin and acetazolamide, as anorexia, tachypnea, lethargy, coma and death have been reported.
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 Benzamycin?
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.
Information for Patients
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Patients using BENZAMYCIN Topical Gel should receive the following information and instructions:
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
Animal reproduction studies have not been conducted with BENZAMYCIN 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 Topical Gel. It also is not known whether BENZAMYCIN Topical Gel can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. BENZAMYCIN Topical Gel should be given to a pregnant woman only if clearly needed.
Nursing Women
It is not known whether BENZAMYCIN 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.
What are the side effects of Benzamycin?
In controlled clinical trials, the incidence of adverse reactions associated with the use of BENZAMYCIN 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.
To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What should I look out for while using Benzamycin?
BENZAMYCIN 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 Benzamycin?
Sorry No Records found
How should I store and handle Benzamycin?
Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Pharmacist: Dispense in a tight, light-resistant container with a child-resistant closure and medication guide. Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Pharmacist: Dispense in a tight, light-resistant container with a child-resistant closure and medication guide. 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 erythromycin.NOTE: store at room temperature between 15°C to 30°C (59°F to 86°F).After reconstitution,Do not freeze. Keep tightly closed. Keep out of reach of children.Rx onlyPrior 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 erythromycin.NOTE: store at room temperature between 15°C to 30°C (59°F to 86°F).After reconstitution,Do not freeze. Keep tightly closed. Keep out of reach of children.Rx onlyPrior 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 erythromycin.NOTE: store at room temperature between 15°C to 30°C (59°F to 86°F).After reconstitution,Do not freeze. Keep tightly closed. Keep out of reach of children.Rx onlyPrior 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 erythromycin.NOTE: store at room temperature between 15°C to 30°C (59°F to 86°F).After reconstitution,Do not freeze. Keep tightly closed. Keep out of reach of children.Rx onlyPrior 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 erythromycin.NOTE: store at room temperature between 15°C to 30°C (59°F to 86°F).After reconstitution,Do not freeze. Keep tightly closed. Keep out of reach of children.Rx only
Clinical Information
Chemical Structure
No Image foundClinical 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
BENZAMYCIN 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.
Due to the potential for additive effects, caution and careful titration are warranted in patients receiving diltiazem hydrochloride concomitantly with any agents known to affect cardiac contractility and/or conduction (see ). Pharmacologic studies indicate that there may be additive effects in prolonging AV conduction when using beta-blockers or digitalis concomitantly with diltiazem hydrochloride (see ). As with all drugs, care should be exercised when treating patients with multiple medications. Diltiazem hydrochloride undergoes biotransformation by cytochrome P-450 mixed function oxidase. Coadministration of diltiazem hydrochloride with other agents which follow the same route of biotransformation may result in the competitive inhibition of metabolism. Especially in patients with renal and/or hepatic impairment, dosages of similarly metabolized drugs, particularly those of low therapeutic ratio such as cyclosporine, may require adjustment when starting or stopping concomitantly administered diltiazem hydrochloride to maintain optimum therapeutic blood levels. Concomitant administration of diltiazem with carbamazepine has been reported to result in elevated plasma levels of carbamazepine, resulting in toxicity in some cases.
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.
In controlled clinical trials, the incidence of adverse reactions associated with the use of BENZAMYCIN 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.
To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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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