Erythromycin Ethylsuccinate (Erythromycin Ethylsuccinate)

Trade Name : Erythromycin Ethylsuccinate

Par Pharmaceutical, Inc.

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Strength 200 mg/5mL

ERYTHROMYCIN ETHYLSUCCINATE Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [CS]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Erythromycin Ethylsuccinate (Erythromycin Ethylsuccinate) which is also known as Erythromycin Ethylsuccinate and Manufactured by Par Pharmaceutical, Inc.. It is available in strength of 200 mg/5mL per ml. Read more

Erythromycin Ethylsuccinate (Erythromycin Ethylsuccinate) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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To reduce the development of drug-resistant bacteria and maintain the effectiveness of Erythromycin Ethylsuccinate for Oral Suspension and other antibacterial drugs, Erythromycin Ethylsuccinate for Oral Suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Erythromycin is produced by a strain of (formerly ) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2u2032-(ethyl succinate). The molecular formula is CHNO and the molecular weight is 862.06. The structural formula is:
Erythromycin Ethylsuccinate for Oral Suspension, USP 200nmg/5mLnwhen reconstituted with water, forms a suspension containing erythromycinnethylsuccinate equivalent to 200 mg erythromycin per 5 mL (teaspoonful) or 100nmg per 2.5 mL (dropperful) with an appealing caramel-banana flavor.
Erythromycin Ethylsuccinate for Oral Suspension, USP 400mg/5mL when reconstituted with water, forms a suspension containing erythromycin ethylsuccinate equivalent to 400 mg of erythromycin per 5 mL (teaspoonful) with an appealing caramel-banana flavor.
These products are intended primarily for pediatric use but can also be used in adults.
Arrayn- Inactive Ingredients
Erythromycin Ethylsuccinate for Oral Suspension, USP, 200 mg/5mL, Erythromycin Ethylsuccinate for Oral Suspension, USP, 400 mg/5mL:
polysorbate, sodium citrate dihydrate, sucrose, xanthan gum, and caramel and banana natural and artificial flavors.n

Orally administered erythromycin ethylsuccinate suspension is readily and reliably absorbed under both fasting and nonfasting conditions.
Erythromycin diffuses readily into most body fluids. Only low concentrations are normally achieved in the spinal fluid, but passage of the drug across the blood-brain barrier increases in meningitis. In the presence of normal hepatic function, erythromycin is concentrated in the liver and excreted in the bile; the effect of hepatic dysfunction on excretion of erythromycin by the liver into the bile is not known. Less than 5 percent of the orally administered dose of erythromycin is excreted in active form in the urine.
Erythromycin crosses the placental barrier, but fetal plasma levels are low. The drug is excreted in human milk.
Microbiology
Mechanism of Action
Erythromycin acts by inhibition of protein synthesis by binding 50 ribosomal subunits of susceptible organisms. It does not affect nucleic acid synthesis. Antagonism has been demonstrated between erythromycin and clindamycin, lincomycin, and chloramphenicol.
Resistance
Many strains of are resistant to erythromycin alone but are susceptible to erythromycin and sulfonamides used concomitantly.
Interactions With Other Antimicrobials
Staphylococci resistant to erythromycin may emerge during a course of therapy.
Antimicrobial Activity
Erythromycin has been shown to be active against most strains of the following microorganisms, both and in clinical infections as described in the section.
Gram-positive Organisms:
u00a0u00a0u00a0u00a0 Corynebacterium diphtheriae
u00a0u00a0u00a0u00a0 Corynebacterium minutissimum
u00a0u00a0u00a0u00a0 Listeria monocytogenes
u00a0u00a0u00a0u00a0 Staphylococcus aureus
u00a0u00a0u00a0u00a0 Streptococcus pneumonia
u00a0u00a0u00a0u00a0 Streptococcus pyogenes
Gram-negative Organisms:
u00a0u00a0u00a0 u00a0Bordetella pertussis
u00a0u00a0u00a0u00a0 Legionella pneumophila
u00a0u00a0u00a0 u00a0Neisseria gonorrhoeae
Other Microorganisms:u00a0
u00a0u00a0u00a0u00a0 Chlamydia trachomatis
u00a0u00a0u00a0u00a0 Entamoeba histolytica
u00a0u00a0u00a0u00a0 Mycoplasma pneumoniae
u00a0u00a0u00a0u00a0 Treponema pallidum
u00a0u00a0u00a0u00a0 Ureaplasma urealyticum
The following data are available.
Erythromycin exhibits minimal inhibitory concentrations (MIC's) of 0.5 mcg/mL or less against most (u2265 90%) strains of the following microorganisms; however, the safety and effectiveness of erythromycin in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials.
Gram-positive Organisms:
u00a0u00a0u00a0u00a0 Viridans group streptococci
Gram-negative Organisms:
u00a0u00a0u00a0u00a0 Moraxella catarrhalis
Susceptibility Testing
For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: .

To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate for oral suspension and other antibacterial drugs,u00a0 erythromycin ethylsuccinate for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Erythromycin ethylsuccinate for oral suspension is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below:
Upper respiratory tract infections of mild to moderate degree caused by , , or n
Lower-respiratory tract infections of mild to moderate severity caused by or .
Listeriosis caused by .
Pertussis (whooping cough) caused by . Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals.
Respiratory tract infections due to .
Skin and skin structure infections of mild to moderate severity caused by or (resistant staphylococci may emerge during treatment).
Diphtheria: Infections due to , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers.
Erythrasma: In the treatment of infections due to . Intestinal amebiasis caused by (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents.
Acute Pelvic Inflammatory Disease Caused by : As an alternative drug in treatment of acute pelvic inflammatory disease caused by in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months.
Syphilis Caused by : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy.
Erythromycins are indicated for the treatment of the following infections caused by : Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to .
When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by .
Legionnaires' Disease caused by . Although no controlled clinical efficacy studies have been conducted, and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease.
Prophylaxis:
Arrayn- Prevention of Initial Attacks of Rheumatic Fever
Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.The therapeutic dose should be administered for 10 days.
Arrayn- Prevention of Recurrent Attacks of Rheumatic Fever:
Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of Streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).n

Erythromycin is contraindicated in patients with known hypersensitivity to this antibiotic.
Erythromycin is contraindicated in patients taking terfenadine, astemizole, pimozide, or cisapride. (See .)
Do not use erythromycin concomitantly with HMG CoA reductase inhibitors (statins) that are extensively metabolized by CYP 3A4 (lovastatin or simvastatin), due to the increased risk of myopathy, including rhabdomyolysis.

Hepatotoxicity:
There have been reports of hepatic dysfunction, including increased liver enzymes, and hepatocellular and/or cholestatic hepatitis, with or without jaundice, occurring in patients receiving oral erythromycin products.
QT Prolongation:
Erythromycin has been associated with prolongation of the QT interval and infrequent cases of arrhythmia. Cases of torsades de pointes have been spontaneously reported during postmarketing surveillance in patients receiving erythromycin. Fatalities have been reported. Erythromycin should be avoided in patients with known prolongation of the QT interval, patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and in patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents. Elderly patients may be more susceptible to drug-associated effects on the QT interval.
Syphilis in Pregnancy:
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 oral erythromycin for early syphilis should be treated with an appropriate penicillin regimen.
Clostridium difficile Associated Diarrhea:
Clostridium difficile n- C. difficile
C. difficile n- C. difficile
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.
Drug Interactions
Serious adverse reactions have been reported in patients taking erythromycin concomitantly with CYP3A4 substrates. These include colchicine toxicity with colchicine; rhabdomyolysis with simvastatin, lovastatin, and atorvastatin; and hypotension with calcium channel blockers metabolized by CYP3A4 (e.g. verapamil, amlodipine, diltiazem) (see ).
There have been post-marketing reports of colchicine toxicity with concomitant use of erythromycin and colchicine. This interaction is potentially life-threatening, and may occur while using both drugs at their recommended doses (see ).
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).

No data

The most frequent side effects of oral erythromycin preparations are gastrointestinal and are dose-related. They include nausea, vomiting, abdominal pain, diarrhea and anorexia. Symptoms of hepatitis, hepatic dysfunction and/or abnormal liver function test results may occur. (See u00a0section.)
Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment. (See .)
Erythromycin has been associated with QT prolongation and ventricular arrhythmias, including ventricular tachycardia and torsades de pointes. (See .)
Allergic reactions ranging from urticaria to anaphylaxis have occurred. Skin reactions ranging from mild eruptions to erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported rarely.
There have been reports of interstitial nephritis coincident with erythromycin use.
There have been rare reports of pancreatitis and convulsions.
There have been isolated reports of reversible hearing loss occurring chiefly in patients with renal insufficiency and in patients receiving high doses of erythromycin.

In case of overdosage, erythromycin should be discontinued. Overdosage should be handled with the prompt elimination of unabsorbed drug and all other appropriate measures should be instituted.
Erythromycin is not removed by peritoneal dialysis or hemodialysis.

Erythromycin Ethylsuccinate Oral Suspensions, USP may be administered without regard to meals.
Arrayn- Children
The following dosage schedule is suggested for mild to moderate infections: n
Adults:
For adult dosage calculation, use a ratio of 400 mg of erythromycin activity as the ethylsuccinate to 250 mg of erythromycin activity as the stearate, base or estolate.
In the treatment of streptococcal infections, a therapeutic dosage of erythromycin ethylsuccinate should be administered for at least 10 days. In continuous prophylaxis against recurrences of streptococcal infections in persons with a history of rheumatic heart disease, the usual dosage is 400 mg twice a day.
For treatment of urethritis due to or n
For treatment of primary syphilis
For intestinal amebiasis
For use in pertussis
For treatment of Legionnaires' Disease

Erythromycin Ethylsuccinate for Oral Suspension, USP, 200 mg/5 mL is supplied in bottles of 100 mL (NDC 0254-1020-47)
Erythromycin Ethylsuccinate for Oral Suspension, USP, 400 mg/5 mL is supplied in bottles of 100 mL (NDC 0254-1021-47)
Recommended Storage
Store Erythromycin Ethylsuccinate for Oral Suspension, USP, 200 mg/5 mL and Erythromycin Ethylsuccinate for Oral Suspension, USP, 400 mg/5 mL, prior to mixing,u00a0 at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted from 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature].
After reconstitution, Erythromycin Ethylsuccinate for Oral Suspension, USP,u00a0 200 mg/5 mL and Erythromycin Ethylsuccinate for Oral Suspension, USP, 400 mg/5 mL must be stored at or below 77u00b0F (25u00b0C) and used within 35 days; refrigeration is not required.

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I: 09/19
Distributed by:
Par Pharmaceutical
Chestnut Ridge, NY 10977

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Erythromycin Ethylsuccinate (Erythromycin Ethylsuccinate)

Trade Name : Erythromycin Ethylsuccinate

FOR SUSPENSION

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Erythromycin Ethylsuccinate (Erythromycin Ethylsuccinate)

Trade Name : Erythromycin Ethylsuccinate

FOR SUSPENSION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

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Fluoxetine Hydrochloride (Fluoxetine)

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