Erythromycin


Torrent Pharmaceuticals Limited
Human Prescription Drug
NDC 13668-606
Erythromycin is a human prescription drug labeled by 'Torrent Pharmaceuticals Limited'. National Drug Code (NDC) number for Erythromycin is 13668-606. This drug is available in dosage form of Tablet, Coated. The names of the active, medicinal ingredients in Erythromycin drug includes Erythromycin - 250 mg/1 . The currest status of Erythromycin drug is Active.

Drug Information:

Drug NDC: 13668-606
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Erythromycin
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Erythromycin
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Torrent Pharmaceuticals Limited
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Tablet, Coated
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:ERYTHROMYCIN - 250 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 06 Jul, 2020
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 27 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: ANDA212015
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Torrent Pharmaceuticals Limited
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:197650
598006
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UPC:0313668606300
0313668607307
UPC stands for Universal Product Code.
NUI:N0000009982
N0000175877
N0000175935
M0028311
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:63937KV33D
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:Macrolide [EPC]
Macrolide Antimicrobial [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:Decreased Sebaceous Gland Activity [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class CS:Macrolides [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:Decreased Sebaceous Gland Activity [PE]
Macrolide Antimicrobial [EPC]
Macrolide [EPC]
Macrolides [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
13668-606-01100 TABLET, COATED in 1 BOTTLE (13668-606-01)06 Jul, 2020N/ANo
13668-606-05500 TABLET, COATED in 1 BOTTLE (13668-606-05)07 Jul, 2020N/ANo
13668-606-3030 TABLET, COATED in 1 BOTTLE (13668-606-30)12 Apr, 2022N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Product Elements:

Erythromycin erythromycin silicon dioxide croscarmellose sodium hydroxypropyl cellulose, unspecified hypromellose 2910 (3 mpa.s) magnesium stearate mannitol starch, corn monosodium citrate talc calcium silicate methacrylic acid - ethyl acrylate copolymer (1:1) type a poloxamer 407 sodium bicarbonate sodium lauryl sulfate titanium dioxide erythromycin erythromycin white to off-white ac412 erythromycin erythromycin silicon dioxide croscarmellose sodium hydroxypropyl cellulose, unspecified hypromellose 2910 (3 mpa.s) magnesium stearate mannitol starch, corn monosodium citrate talc calcium silicate methacrylic acid - ethyl acrylate copolymer (1:1) type a poloxamer 407 sodium bicarbonate sodium lauryl sulfate titanium dioxide erythromycin erythromycin white to off-white ac413

Indications and Usage:

Indications and usage to reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin tablets, usp and other antibacterial drugs, erythromycin tablets, usp 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 tablet, usp are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the diseases listed below: upper respiratory tract infections of mild to moderate degree caused by streptococcus pyogenes ; streptococcus pneumoniae ; haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of h. influenzae are not sus
ceptible to the erythromycin concentrations ordinarily achieved). (see appropriate sulfonamide labeling for prescribing information.) lower respiratory tract infections of mild to moderate severity caused by streptococcus pyogenes or streptococcus pneumoniae . listeriosis caused by listeria monocytogenes . respiratory tract infections due to mycoplasma pneumoniae . skin and skin structure infections of mild to moderate severity caused by streptococcus pyogenes or staphylococcus aureus (resistant staphylococci may emerge during treatment). pertussis (whooping cough) caused by bordetella pertussis . 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. diphtheria: infections due to corynebacterium diphtheriae , 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 corynebacterium minutissimum . intestinal amebiasis caused by entamoeba histolytica (oral erythromycins only). extraenteric amebiasis requires treatment with other agents. acute pelvic inflammatory disease caused by neisseria gonorrhoeae : erythrocin tm lactobionate i.v. (erythromycin lactobionate for injection, usp) followed by erythromycin base orally, as an alternative drug treatment of acute pelvic inflammatory disease caused by n. gonorrhoeae 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. erythromycins are indicated for treatment of the following infections caused by chlamydia trachomatis : 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 chlamydia trachomatis . 3 when tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by ureaplasma urealyticum . 3 primary syphilis caused by treponema pallidum . erythromycin (oral forms only) is an alternative choice of treatment for primary syphilis in patients allergic to the penicillins. in treatment of primary syphilis, spinal fluid should be examined before treatment and as part of the follow-up after therapy. legionnaires’ disease caused by legionella pneumophila . although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating legionnaires’ disease. prophylaxis 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 streptococcus pyogenes infections of the upper respiratory tract e.g., tonsillitis, or pharyngitis). 1 erythromycin is indicated for the treatment of penicillin-allergic patients. the therapeutic dose should be administered for ten days. 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). 1

Warnings:

Warnings 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 associated diarrhea (cdad) has been reported with the use of nearly all antibacterial agents, including erythromycin tablets, and may range in severity from mild diarrhea to fatal colitis. treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of c. difficile . c. difficile produces toxins a and b which contribute to the development of cdad. hypertoxin producing strains of c. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. cdad must be considered in all patients who present with diarrhea following antibiotic use. careful medical history is necessary since cdad has been reported to occur over two months after the administration of antibacterial agents. 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 c. difficile , 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 precautions – drug interactions ). 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 precautions – drug interactions ). 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.)

Dosage and Administration:

Dosage and administration in most patients, erythromycin tablets are well absorbed and may be dosed orally without regard to meals. however optimal blood levels are obtained when erythromycin tablets are given in the fasting state (at least ½ hour and preferably 2 hours before meals). adults the usual dosage of erythromycin tablets is one 250 mg tablet four times daily in equally spaced doses or one 500 mg tablet every 12 hours. dosage may be increased up to 4 g per day according to the severity of the infection. however, twice-a-day dosing is not recommended when doses larger than 1g daily are administered. children age, weight, and severity of the infection are important factors in determining the proper dosage. the usual dosage is 30 to 50 mg/kg/day, in equally divided doses. for more severe infections this dosage may be doubled but should not exceed 4 g per day. in the treatment of streptococcal infections of the upper respiratory tract (e.g., tonsillitis or pharyngitis), the th
erapeutic dosage of erythromycin should be administered for at least ten days. the american heart association suggests a dosage of 250 mg of erythromycin orally, twice a day in long-term prophylaxis of streptococcal upper respiratory tract infections for the prevention of recurring attacks of rheumatic fever in patients allergic to penicillin and sulfonamides. 1 conjunctivitis of the newborn caused by chlamydia trachomatis oral erythromycin suspension 50 mg/kg/day in 4 divided doses for at least 2 weeks. 3 pneumonia of infancy caused by chlamydia trachomatis although the optimal duration of therapy has not been established, the recommended therapy is oral erythromycin suspension 50 mg/kg/day in 4 divided doses for at least 3 weeks. urogenital infections during pregnancy due to chlamydia trachomatis although the optimal dose and duration of therapy have not been established, the suggested treatment is 500 mg of erythromycin by mouth four times a day on an empty stomach for at least 7 days. for women who cannot tolerate this regimen, a decreased dose of one erythromycin 500 mg tablet orally every 12 hours or 250 mg by mouth four times a day should be used for at least 14 days. 3 for adults with uncomplicated urethral, endocervical, or rectal infections caused by chlamyia trachomatis, when tetracycline is contraindicated or not tolerated 500 mg of erythromycin by mouth four times a day for at least 7 days. 3 for patients with nongonococcal urethritis caused by ureaplasma urealyticum when tetracycline is contraindicated or not tolerated 500 mg of erythromycin by mouth four times a day for at least seven days. 3 primary syphilis 30 to 40 g given in divided doses over a period of 10 to 15 days. acute pelvic inflammatory disease caused by n. gonorrhoeae 500 mg erythrocin tm lactobionate-i.v. (erythromycin lactobionate for injection, usp) every 6 hours for 3 days, followed by 500 mg of erythromycin base orally every 12 hours for 7 days. intestinal amebiasis adults 500 mg every 12 hours or 250 mg every 6 hours for 10 to 14 days. children 30 to 50 mg/kg/day in divided doses for 10 to 14 days. pertussis although optimal dosage and duration have not been established, doses of erythromycin utilized in reported clinical studies were 40 to 50 mg/kg/day, given in divided doses for 5 to 14 days. legionnaires’ disease although optimal dosage has not been established, doses utilized in reported clinical data were 1 to 4 g daily in divided doses.

Contraindications:

Contraindications erythromycin is contraindicated in patients with known hypersensitivity to this antibiotic. erythromycin is contraindicated in patients taking terfenadine, astemizole, cisapride, pimozide, ergotamine, or dihydroergotamine. (see precautions – drug interactions ) 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.

Adverse Reactions:

Adverse reactions 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 warnings .) onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment. (see warnings .) erythromycin has been associated with qt prolongation and ventricular arrhythmias, including ventricular tachycardia and torsades de pointes. (see warnings .) 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 hea
ring loss occurring chiefly in patients with renal insufficiency and in patients receiving high doses of erythromycin.

Overdosage:

Overdosage 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.

Description:

Description erythromycin tablets, usp are an antibacterial product containing erythromycin, usp in a unique, nonenteric film coating for oral administration. erythromycin tablets are available in two strengths containing 250 mg or 500 mg erythromycin base. erythromycin is produced by a strain of saccharopolyspora erythraea (formerly streptomyces erythraeus ) and belongs to the macrolide group of antibiotics. it is basic and readily forms salts with acids. erythromycin is a white to off-white powder, slightly soluble in water, and soluble in alcohol, chloroform, and ether. erythromycin is known chemically as (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)- β-d- xylo –hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. the molecular formula is c 37 h 67 no 13 , and the molecular weight is 733.94. the structural formula is: chemical-structure inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, magnesium stearate, mannitol, pregelatinized maize starch, sodium citrate, talc, calcium silicate, methacrylic acid & ethyl acetate copolymer, poloxamer, sodium bicarbonate, sodium lauryl sulfate, titanium dioxide.

Clinical Pharmacology:

Clinical pharmacology orally administered erythromycin base and its salts are readily absorbed in the microbiologically active form. interindividual variations in the absorption of erythromycin are, however, observed, and some patients do not achieve optimal serum levels. erythromycin is largely bound to plasma proteins. after absorption, erythromycin diffuses readily into most body fluids. in the absence of meningeal inflammation, low concentrations are normally achieved in the spinal fluid but the passage of the drug across the blood-brain barrier increases in meningitis. erythromycin crosses the placental barrier, but fetal plasma levels are low. the drug is excreted in human milk. erythromycin is not removed by peritoneal dialysis or hemodialysis. in the presence of normal hepatic function, erythromycin is concentrated in the liver and is excreted in the bile; the effect of hepatic dysfunction on biliary excretion of erythromycin is not known. after oral administration, less than 5
% of the administered dose can be recovered in the active form in the urine. optimal blood levels are obtained when erythromycin tablets are given in the fasting state (at least ½ hour and preferably 2 hours before meals). microbiology mechanism of action erythromycin acts by inhibition of protein synthesis by binding 50s ribosomal subunits of susceptible organisms. it does not affect nucleic acid synthesis. resistance the major route of resistance is modification of the 23s rrna in the 50s ribosomal subunit to insensitivity while efflux can also be significant. interactions with other antimicrobials antagonism exists in vitro between erythromycin and clindamycin, lincomycin, and chloramphenicol. antimicrobial activity erythromycin has been shown to be active against most isolates of the following bacteria both in vitro and in clinical infections as described in the indications and usage section. gram-positive bacteria: corynebacterium diphtheriae corynebacterium minutissimum listeria monocytogenes staphylococcus aureus (resistant organisms may emerge during treatment) streptococcus pneumoniae streptococcus pyogenes gram-negative bacteria: bordetella pertussis haemophilus influenzae legionella pneumophila neisseria gonorrhoeae other microorganisms: chlamydia trachomatis entamoeba histolytica mycoplasma pneumoniae treponema pallidum ureaplasma urealyticum the following in vitro data are available, but their clinical significance is unknown. at least 90% of the following bacteria exhibit in vitro minimum inhibitory concentrations (mic) less than or equal to the susceptible breakpoint for erythromycin. however, the efficacy of erythromycin in treating clinical infections due to these bacteria has not been established in adequate and well controlled clinical trials. gram-positive bacteria: viridans group streptococci gram-negative bacteria: 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: https://www.fda.gov/stic.

How Supplied:

How supplied erythromycin tablets, usp 250 mg and 500 mg are supplied as: 250 mg film-coated tablets are white to off-white, oval shaped coated tablets, debossed with “ac412” on one side and plain on the other side bottles of 30 (ndc 13668-606-30) bottles of 100 (ndc 13668-606-01) bottles of 500 (ndc 13668-606-05) 500 mg film-coated tablets are white to off-white, oval shaped tablets, debossed with “ac413” on one side and plain on the other side bottles of 30 (ndc 13668-607-30) bottles of 100 (ndc 13668-607-01) bottles of 500 (ndc 13668-607-05)

Package Label Principal Display Panel:

Package/label principal display panel - 250 mg erythromycin tablets, usp 250 mg rx only erythromycin-250mg-30s

Package/label principal display panel - 500 mg erythromycin tablets, usp 500 mg rx only erythromycin-500mg-30s


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.