Erythromycin Ethylsuccinate And Sulfisoxazole Acetyl Granule
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Questions & Answers
Side Effects & Adverse Reactions
FATALITIES ASSOCIATED WITH THE ADMINISTRATION OF SULFONAMIDES, ALTHOUGH RARE, HAVE OCCURRED DUE TO SEVERE REACTIONS, INCLUDING STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS, FULMINANT HEPATIC NECROSIS, AGRANULOCYTOSIS, APLASTIC ANEMIA, AND OTHER BLOOD DYSCRASIAS.
SULFONAMIDES, INCLUDING SULFONAMIDE-CONTAINING PRODUCTS SUCH AS ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL FOR ORAL SUSPENSION, SHOULD BE DISCONTINUED AT THE FIRST APPEARANCE OF SKIN RASH OR ANY SIGN OF ADVERSE REACTION. In rare instances, a skin rash may be followed by a more severe reaction, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, hepatic necrosis, and serious blood disorders. (See PRECAUTIONS.)
Clinical signs such as sore throat, fever, pallor, rash, purpura, or jaundice may be early indications of serious reactions.
There have been reports of hepatic dysfunction, with or without jaundice, occurring in patients receiving oral erythromycin products.
Cough, shortness of breath, and pulmonary infiltrates are hypersensitivity reactions of the respiratory tract that have been reported in association with sulfonamide treatment.
The sulfonamides should not be used for the treatment of group A beta-hemolytic streptococcal infections. In an established infection, they will not eradicate the streptococcus and, therefore, will not prevent sequelae such as rheumatic fever.
Pseudomembranous colitis has been reported with nearly all antibacterial agents, including erythromycin ethylsuccinate and sulfisoxazole acetyl for oral suspension, 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 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 Clostridium difficile colitis.
There have been reports suggesting that erythromycin does not reach the fetus in adequate concentration to prevent congenital syphilis. Infants born to women treated during pregnancy with erythromycin for early syphilis should be treated with an appropriate penicillin regimen.
Rhabdomyolysis with or without renal impairment has been reported in seriously ill patients receiving erythromycin concomitantly with lovastatin. Therefore, patients receiving concomitant lovastatin and erythromycin should be carefully monitored for creatine kinase (CK) and serum transaminase levels. (See package insert for lovastatin.)
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
For treatment of ACUTE OTITIS MEDIA in children that is caused by susceptible strains of Haemophilus influenzae.
History
There is currently no drug history available for this drug.
Other Information
Erythromycin ethylsuccinate and sulfisoxazole acetyl, when reconstituted with water as directed on the label, the granules form a white, cherry flavored suspension that provides the equivalent of 200 mg erythromycin activity and the equivalent of 600 mg of sulfisoxazole activity per teaspoonful (5 mL).
Erythromycin is produced by a strain of Saccaropolyspora erythraea and belongs to the macrolide group of antibiotics. It is basic and readily forms salts and esters. Erythromycin ethylsuccinate is the 2’-ethylsuccinyl ester of erythromycin. It is essentially a tasteless form of the antibiotic suitable for oral administration, particularly in suspension dosage forms. The chemical name is erythromycin 2’-(ethylsuccinate). Erythromycin ethylsuccinate has the following structural formula:
C45H75NO16 Molecular Weight: 862.06
Sulfisoxazole acetyl or N1-acetyl sulfisoxazole is an ester of sulfisoxazole. Chemically, sulfisoxazole is N1-(3,4-dimethyl-5-isoxazotyl) sulfanilamide. Sulfisoxazole acetyl has the following structural formula:
C13H15N3O4S Molecular Weight: 309.34
Artificial flavor, lactose anhydrous, methylparaben, polysorbate 80, povidone, simethicone, sodium citrate anhydrous and sucrose.
Sources
Erythromycin Ethylsuccinate And Sulfisoxazole Acetyl Granule Manufacturers
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Physicians Total Care, Inc.
![Erythromycin Ethylsuccinate And Sulfisoxazole Acetyl Granule, For Suspension [Physicians Total Care, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Erythromycin Ethylsuccinate And Sulfisoxazole Acetyl Granule | Physicians Total Care, Inc.
ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL FOR ORAL SUSPENSION SHOULD NOT BE ADMINISTERED TO INFANTS UNDER 2 MONTHS OF AGE BECAUSE OF CONTRAINDICATIONS OF SYSTEMIC SULFONAMIDES IN THIS AGE GROUP.
For Acute Otitis Media in Children:The dose of erythromycin ethylsuccinate and sulfisoxazole acetyl for oral suspension can be calculated based on the erythromycin component (50 mg/kg/day) or the sulfisoxazole component (150 mg/kg/day to a maximum of 6 g/day). The total daily dose of erythromycin ethylsuccinate and sulfisoxazole acetyl for oral suspension should be administered in equally divided doses three or four times a day for 10 days. Erythromycin ethylsuccinate and sulfisoxazole acetyl for oral suspension may be administered without regard to meals.
The following approximate dosage schedules are recommended for using erythromycin ethylsuccinate and sulfisoxazole acetyl for oral suspension:
Children:Two months of age or older
FOUR-TIMES-A-DAY SCHEDULE Weight Dose - every 6 hours Less than 8 kg (<18 lbs) Adjust dosage by body weight 8 kg (18 lbs) 1/2 teaspoonful (2.5 mL) 16 kg (35 lbs) 1 teaspoonful (5 mL) 24 kg (53 lbs) 1-1/2 teaspoonfuls (7.5 mL) Over 32 kg (over 70 lbs) 2 teaspoonfuls (10 mL) THREE-TIMES-A-DAY SCHEDULE Weight Dose - every 8 hours Less than 6 kg (>13 lbs) Adjust dosage by body weight 6 kg (13 lbs) 1/2 teaspoonful (2.5 mL) 12 kg (26 lbs) 1 teaspoonful (5 mL) 18 kg (40 lbs) 1-1/2 teaspoonfuls (7.5 mL) 24 kg (53 lbs) 2 teaspoonfuls (10 mL) Over 30 kg (over 66 lbs) 2-1/2 teaspoonfuls (12.5 mL) -
Rebel Distributors Corp
Erythromycin Ethylsuccinate And Sulfisoxazole Acetyl Granule | Rebel Distributors Corp
ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL FOR ORAL SUSPENSION SHOULD NOT BE ADMINISTERED TO INFANTS UNDER 2 MONTHS OF AGE BECAUSE OF CONTRAINDICATIONS OF SYSTEMIC SULFONAMIDES IN THIS AGE GROUP.
For Acute Otitis Media in Children:The dose of erythromycin ethylsuccinate and sulfisoxazole acetyl for oral suspension can be calculated based on the erythromycin component (50 mg/kg/day) or the sulfisoxazole component (150 mg/kg/day to a maximum of 6 g/day). The total daily dose of erythromycin ethylsuccinate and sulfisoxazole acetyl for oral suspension should be administered in equally divided doses three or four times a day for 10 days. Erythromycin ethylsuccinate and sulfisoxazole acetyl for oral suspension may be administered without regard to meals.
The following approximate dosage schedules are recommended for using erythromycin ethylsuccinate and sulfisoxazole acetyl for oral suspension:
Children:Two months of age or older
FOUR-TIMES-A-DAY SCHEDULE Weight Dose - every 6 hours Less than 8 kg (<18 lbs) Adjust dosage by body weight 8 kg (18 lbs) 1/2 teaspoonful (2.5 mL) 16 kg (35 lbs) 1 teaspoonful (5 mL) 24 kg (53 lbs) 1-1/2 teaspoonfuls (7.5 mL) Over 32 kg (over 70 lbs) 2 teaspoonfuls (10 mL) THREE-TIMES-A-DAY SCHEDULE Weight Dose - every 8 hours Less than 6 kg (>13 lbs) Adjust dosage by body weight 6 kg (13 lbs) 1/2 teaspoonful (2.5 mL) 12 kg (26 lbs) 1 teaspoonful (5 mL) 18 kg (40 lbs) 1-1/2 teaspoonfuls (7.5 mL) 24 kg (53 lbs) 2 teaspoonfuls (10 mL) Over 30 kg (over 66 lbs) 2-1/2 teaspoonfuls (12.5 mL) -
Teva Women’s Health, Inc.
Erythromycin Ethylsuccinate And Sulfisoxazole Acetyl Granule | Teva Women's Health, Inc.
ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL FOR ORAL SUSPENSION SHOULD NOT BE ADMINISTERED TO INFANTS UNDER 2 MONTHS OF AGE BECAUSE OF CONTRAINDICATIONS OF SYSTEMIC SULFONAMIDES IN THIS AGE GROUP.
For Acute Otitis Media in Children:The dose of erythromycin ethylsuccinate and sulfisoxazole acetyl for oral suspension can be calculated based on the erythromycin component (50 mg/kg/day) or the sulfisoxazole component (150 mg/kg/day to a maximum of 6 g/day). The total daily dose of erythromycin ethylsuccinate and sulfisoxazole acetyl for oral suspension should be administered in equally divided doses three or four times a day for 10 days. Erythromycin ethylsuccinate and sulfisoxazole acetyl for oral suspension may be administered without regard to meals.
The following approximate dosage schedules are recommended for using erythromycin ethylsuccinate and sulfisoxazole acetyl for oral suspension:
Children:Two months of age or older
FOUR-TIMES-A-DAY SCHEDULE Weight Dose - every 6 hours Less than 8 kg (<18 lbs) Adjust dosage by body weight 8 kg (18 lbs) 1/2 teaspoonful (2.5 mL) 16 kg (35 lbs) 1 teaspoonful (5 mL) 24 kg (53 lbs) 1-1/2 teaspoonfuls (7.5 mL) Over 32 kg (over 70 lbs) 2 teaspoonfuls (10 mL) THREE-TIMES-A-DAY SCHEDULE Weight Dose - every 8 hours Less than 6 kg (>13 lbs) Adjust dosage by body weight 6 kg (13 lbs) 1/2 teaspoonful (2.5 mL) 12 kg (26 lbs) 1 teaspoonful (5 mL) 18 kg (40 lbs) 1-1/2 teaspoonfuls (7.5 mL) 24 kg (53 lbs) 2 teaspoonfuls (10 mL) Over 30 kg (over 66 lbs) 2-1/2 teaspoonfuls (12.5 mL)
![Erythromycin Ethylsuccinate And Sulfisoxazole Acetyl Granule, For Suspension [Rebel Distributors Corp]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=60d1aea0-f106-4b20-8ef4-7a80e37f8a50&name=60d1aea0-f106-4b20-8ef4-7a80e37f8a50-03.jpg)
![Erythromycin Ethylsuccinate And Sulfisoxazole Acetyl Granule, For Suspension [Teva Women’s Health, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ada6f6c3-f755-400f-9300-e0bc696f71ce&name=3f02d3cc-1cc2-4fcf-bbe3-2e2df7e310e2-03.jpg)
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