Sulfadiazine

Epic Pharma, Llc
Human Prescription Drug
NDC 42806-757

Sulfadiazine is a human prescription drug labeled by 'Epic Pharma, Llc'. National Drug Code (NDC) number for Sulfadiazine is 42806-757. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Sulfadiazine drug includes Sulfadiazine - 500 mg/1 . The currest status of Sulfadiazine drug is Active.

Drug Information:

Drug NDC:	42806-757
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:	Sulfadiazine
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:	Sulfadiazine
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Epic Pharma, Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Tablet
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:	SULFADIAZINE - 500 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:	15 Dec, 2021
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	20 Jan, 2026
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:	ANDA040091
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:	EPIC PHARMA, LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	198228
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:	0342806757604
UPC stands for Universal Product Code.
NUI:	N0000175503 M0020790
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	0N7609K889
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:	Sulfonamide Antibacterial [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 CS:	Sulfonamides [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:	Sulfonamide Antibacterial [EPC] Sulfonamides [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
42806-757-60	60 TABLET in 1 BOTTLE (42806-757-60)	15 Dec, 2021	N/A	No
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.

Other medicines with the same generic name

Sulfadiazine

Tablet
Eon Labs, Inc.
NDC: 0185-0757

Sulfadiazine

Tablet
EPIC PHARMA, LLC
NDC: 42806-757

Product Elements:

Sulfadiazine sulfadiazine sulfadiazine sulfadiazine croscarmellose sodium docusate sodium microcrystalline cellulose povidone, unspecified sodium benzoate sodium starch glycolate type a potato stearic acid e757

Drug Interactions:

Drug interactions administration of a sulfonamide may increase the effect of oral anticoagulants and methotrexate, probably by displacement of these drugs from binding sites on plasma albumin. potentiation of the action of sulfonylurea hypoglycemic agents, thiazide diuretics and uricosuric agents may also be noted. this may also be due to displacement of the drugs from albumin or a pharmacodynamic mechanism may play a role. conversely, agents such as indomethacin, probenecid and salicylates may displace sulfonamides from plasma albumin and increase the concentrations of free drug in plasma.

Indications and Usage:

Indications and usage sulfadiazine tablets, usp are indicated in the following conditions: chancroid trachoma inclusion conjunctivitis nocardiosis urinary tract infections (primarily pyelonephritis, pyelitis and cystitis) in the absence of obstructive uropathy or foreign bodies, when these infections are caused by susceptible strains of the following organisms: esch erichia coli, klebsiella species, enterobacter species, staphylococcus aureus, proteus mirabilis and p. vulgaris . sulfadiazine should be used for urinary tract infections only after use of more soluble sulfonamides has been unsuccessful. toxoplasmosis encephalitis in patients with and without acquired immunodeficiency syndrome, as adjunctive therapy with pyrimethamine. malaria due to chloroquine-resistant strains of plasmodium falciparum , when used as adjunctive therapy. prophylaxis of meningococcal meningitis when sulfonamide-sensitive group a strains are known to prevail in family groups or larger closed populations (th Read more...

e prophylactic usefulness of sulfonamides when group b or c infections are prevalent is not proved and may be harmful in closed population groups). meningococcal meningitis, when the organism has been demonstrated to be susceptible. acute otitis media due to haemophilus influenzae, when used concomitantly with adequate doses of penicilin. prophylaxis against recurrences of rheumatic fever, as an alternative to penicillin. h. influenzae meningitis, as adjunctive therapy with parental streptomycin. important notes in vitro sulfonamide susceptibility tests are not always reliable. the test must be carefully coordinated with bacteriologic and clinical response. when the patient is already taking sulfonamides, follow-up cultures should have aminobenzoic acid added to the culture media. currently, the increasing frequency of resistant organisms limits the usefulness of antibacterial agents, including the sulfonamides, especially in the treatment of recurrent and complicated urinary tract infections. wide variation in blood levels may result with identical doses. blood levels should be measured in patients receiving sulfonamides for serious infections. free sulfonamide blood levels of 5 mg to 15 mg per 100 ml may be considered therapeutically effective for most infections and blood levels of 12 mg to 15 mg per 100 ml may be considered optimal for serious infections. twenty mg per 100 ml should be the maximum total sulfonamide level, since adverse reactions occur more frequently above this level.

Warnings:

Warnings the sulfonamides should not be used for the treatment of group a betahemolytic streptococcal infections. in an established infection, they will not eradicate the streptococcus and, therefore, will not prevent sequelae such as rheumatic fever and glomerulonephritis. deaths associated with the administration of sulfonamides have been reported from hypersensitivity reactions, agranulocytosis, aplastic anemia and other blood dyscrasias. the presence of such clinical signs as sore throat, fever, pallor, purpura or jaundice may be early indications of serious blood disorders. the frequency of renal complications is considerably lower in patients receiving the more soluble sulfonamides.

General Precautions:

General sulfonamides should be given with caution to patients with impaired renal or hepatic function and to those with severe allergy or bronchial asthma. hemolysis may occur in individuals deficient in glucose-6-phosphate dehydrogenase. this reaction is dose related. adequate fluid intake must be maintained in order to prevent crystalluria and stone formation.

Dosage and Administration:

Dosage and administration systemic sulfonamides are contraindicated in infants under 2 months of age except as adjunctive therapy with pyrimethamine in the treatment of congenital toxoplasmosis. usual dosage for infants over 2 months of age and children initially, one-half the 24-hour dose. maintenance, 150 mg/kg or 4 g/m 2 , divided into 4 to 6 doses, every 24 hours, with a maximum of 6 g every 24 hours. rheumatic fever prophylaxis, under 30 kg (66 pounds), 500 mg every 24 hours; over 30 kg (66 pounds), 1 g every 24 hours. usual adult dosage initially, 2 g to 4 g. maintenance, 2 g to 4 g, divided into 3 to 6 doses, every 24 hours.

Contraindications:

Contraindications sulfadiazine is contraindicated in the following circumstances: hypersensitivity to sulfonamides. in infants less than 2 months of age (except as adjunctive therapy with pyrimethamine in the treatment of congenital toxoplasmosis). in pregnancy at term and during the nursing period, because sulfonamides cross the placenta and are excreted in breast milk and may cause kernicterus.

Adverse Reactions:

Adverse reactions blood dyscrasias agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, hemolytic anemia, purpura, hypoprothrombinemia and methemoglobinemia. allergic reactions erythema multiforme (stevens-johnson syndrome), generalized skin eruptions, epidermal necrolysis, urticaria, serum sickness, pruritus, exfoliative dermatitis, anaphylactoid reactions, periorbital edema, conjunctival and scleral injection, photosensitization, arthralgia, allergic myocarditis, drug fever and chills. gastrointestinal reactions nausea, emesis, abdominal pains, hepatitis, diarrhea, anorexia, pancreatitis and stomatitis. c.n.s. reactions headache, peripheral neuritis, mental depression, convulsions, ataxia, hallucinations, tinnitus, vertigo and insomnia. renal crystalluria, stone formation, toxic nephrosis with oliguria and anuria; periarteritis nodosa and lupus erythematosus phenomenon have been noted. miscellaneous reactions the sulfonamides bear certain chemical similarities to some goit Read more...

rogens, diuretics (acetazolamide and the thiazides) and oral hypoglycemic agents. goiter production, diuresis and hypoglycemia have occurred rarely in patients receiving sulfonamides. cross-sensitivity may exist with these agents.

Drug Interactions:

Use in Pregnancy:

Pregnancy teratogenic effects the safe use of sulfonamides in pregnancy has not been established. the teratogenic potential of most sulfonamides has not been thoroughly investigated in either animals or humans. however, a significant increase in the incidence of cleft palate and other bony abnormalities in offspring has been observed when certain sulfonamides of the short, intermediate and long acting types were given to pregnant rats and mice in high oral doses (7 to 25 times the human therapeutic dose).

Pediatric Use:

Pediatric use sulfadiazine is contraindicated in infants less than 2 months of age (except as adjunctive therapy with pyrimethamine in the treatment of congenital toxoplasmosis). see contraindications and dosage and administration .

Description:

Description sulfadiazine is an oral sulfonamide antibacterial agent. each tablet, for oral administration, contains 500 mg sulfadiazine. in addition, each tablet contains the following inactive ingredients: croscarmellose sodium, docusate sodium, microcrystalline cellulose, povidone, sodium benzoate, sodium starch glycolate and stearic acid. sulfadiazine occurs as a white or slightly yellow powder. it is odorless or nearly so and slowly darkens on exposure to light. it is practically insoluble in water and slightly soluble in alcohol. the chemical name of sulfadiazine is n 1 -2-pyrimidinylsulfanilamide. the molecular formula is c 10 h 10 n 4 o 2 s. it has a molecular weight of 250.27. the structural formula is shown below: most sulfonamides slowly darken on exposure to light. structure-formula.jpg

Clinical Pharmacology:

Clinical pharmacology the systemic sulfonamides are bacteriostatic agents having a similar spectrum of activity. sulfonamides competitively inhibit bacterial synthesis of folic acid (pteroylglutamic acid) from aminobenzoic acid. resistant strains are capable of utilizing folic acid precursors or preformed folic acid. sulfonamides exist in the blood in 3 forms â free, conjugated (acetylated and possibly others) and protein bound. the free form is considered to be the therapeutically active one. sulfadiazine given orally is readily absorbed from the gastrointestinal tract. after a single 2 g oral dose, a peak of 6.04 mg/100 ml is reached in 4 hours; of this, 4.65 mg/100 ml is free drug. when a dose of 100 mg/kg of body weight is given initially and followed by 50 mg/kg every 6 hours, blood levels of free sulfadiazine are about 7 mg/100ml. protein binding is 38% to 48%. sulfadiazine diffuses into the cerebrospinal fluid; free drug reaches 32% to 65% of blood levels and total drug 40% Read more...

to 60%. sulfadiazine is excreted largely in the urine, where concentrations are 10 to 25 times greater than serum levels. approximately 10% of a single oral dose is excreted in the first 6 hours, 50% within 24 hours and 60% to 85% in 48 to 72 hours. of the amount excreted in the urine, 15% to 40% is in the acetyl form.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis, mutagenesis, impairment of fertility the sulfonamides bear certain chemical similarities to some goitrogens. rats appear to be especially susceptible to the goitrogenic effects of sulfonamides and long-term administration has produced thyroid malignancies in rats.

How Supplied:

How supplied sulfadiazine tablets, usp for oral administration are available as 500 mg white, unscored, capsule-shaped tablets, debossed â e 757â on one face and supplied as: ndc 42806-757-60 bottles of 60 storage store at 20Â° to 25Â°c (68Â° to 77Â°f) [see usp controlled room temperature]. protect from moisture. dispense contents in a tight, light-resistant container as defined in the usp with a child-resistant closure, as required. keep tightly closed. keep out of the reach of children. to report suspected adverse reactions, contact epic pharma, llc at 1-888-374-2791 or fda at 1-800-fda-1088 or www.fda.gov/medwatch. distributed by: epic pharma, llc laurelton, ny 11413 rev. 07-2021-00 mf757rev07/21 os0006

Information for Patients:

Information for patients patients should be instructed to drink an eight ounce glass of water with each dose of medication and at frequent intervals throughout the day. caution patients to report promptly the onset of sore throat, fever, pallor, purpura or jaundice when taking this drug, since these may be early indications of serious blood disorders.

Package Label Principal Display Panel:

Package/label principal display panel â 500 mg 500mg-60ct.jpg

Comments/ Reviews:

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