Cephalexin


Belcher Pharmaceuticals, Llc
Human Prescription Drug
NDC 62250-802
Cephalexin is a human prescription drug labeled by 'Belcher Pharmaceuticals, Llc'. National Drug Code (NDC) number for Cephalexin is 62250-802. This drug is available in dosage form of Capsule. The names of the active, medicinal ingredients in Cephalexin drug includes Cephalexin - 500 mg/1 . The currest status of Cephalexin drug is Active.

Drug Information:

Drug NDC: 62250-802
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: Cephalexin
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: Cephalexin
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Belcher Pharmaceuticals, Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Capsule
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:CEPHALEXIN - 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: 22 Dec, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 21 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: ANDA062713
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:Belcher Pharmaceuticals, LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:309112
309114
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.
UNII:OBN7UDS42Y
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:Cephalosporin Antibacterial [EPC]
Cephalosporins [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
62250-802-02100 CAPSULE in 1 BOTTLE (62250-802-02)22 Dec, 2022N/ANo
62250-802-08500 CAPSULE in 1 BOTTLE (62250-802-08)22 Dec, 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:

Cephalexin cephalexin cephalexin cephalexin anhydrous anhydrous lactose gelatin magnesium stearate talc titanium dioxide 801 cephalexin cephalexin cephalexin cephalexin anhydrous anhydrous lactose gelatin magnesium stearate talc titanium dioxide 802

Indications and Usage:

Indications and usage cephalexin capsules are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms: respiratory tract infections caused by streptococcus pneumoniae and streptococcus pyogenes (penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.) otitis media due to streptococcus pneumoniae, haemophilus influenzae, staphylococcus aureus, streptococcus pyogenes , and moraxella catarrhalis skin and skin structure infections caused by staphylococcus aureus and/or streptococcus pyogenes bone infections caused by staphylococcus aureus and/or proteus mirabilis genitourinary tract infections, including
acute prostatitis, caused by escherichia coli, proteus mirabilis, and klebsiella pneumoniae note: culture and susceptibility tests should be initiated prior to and during therapy. renal function studies should be performed when indicated. to reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, cephalexin capsules 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.

Warnings:

Warnings before therapy with cephalexin is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cephalexin, cephalosporins, penicillins, or other drugs. if this product is to be given to penicillin-sensitive patients, caution should be exercised because cross-hypersensitivity among beta-lactam antibiotics has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy. if an allergic reaction to cephalexin occurs, discontinue the drug. serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, pressor amines and airway management, as clinically indicated. there is some clinical and laboratory evidence of partial cross-allergenicity of the penicillins and the cephalosporins. patients have been reported to have had severe reactions (including anaph
ylaxis) to both drugs. any patient who has demonstrated some form of allergy, particularly to drugs, should receive antibiotics cautiously. no exception should be made with regard to cephalexin capsules. clostridium difficile associated diarrhea (cdad) has been reported with use of nearly all antibacterial agents, including cephalexin, 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.

General Precautions:

General prescribing cephalexin capsules in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. patients should be followed carefully so that any side effects or unusual manifestations of drug idiosyncrasy may be detected. if an allergic reaction to cephalexin occurs, the drug should be discontinued and the patient treated with the usual agents (e.g., epinephrine or other pressor amines, antihistamines, or corticosteroids). prolonged use of cephalexin capsules may result in the overgrowth of nonsusceptible organisms. careful observation of the patient is essential. if superinfection occurs during therapy, appropriate measures should be taken. positive direct coombs’ tests have been reported during treatment with the cephalosporin antibiotics. in hematologic studies or in transfusion cross-matching procedures when antiglobulin
tests are performed on the minor side or in coombs’ testing of newborns whose mothers have received cephalosporin antibiotics before parturition, it should be recognized that a positive coombs’ test may be due to the drug. cephalexin capsules should be administered with caution in the presence of markedly impaired renal function. under such conditions, careful clinical observation and laboratory studies should be made because safe dosage may be lower than that usually recommended. indicated surgical procedures should be performed in conjunction with antibiotic therapy. broad-spectrum antibiotics should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. cephalosporins may be associated with a fall in prothrombin activity. those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy. prothrombin time should be monitored in patients at risk and exogenous vitamin k administered as indicated.

Dosage and Administration:

Dosage and administration cephalexin capsules are administered orally. adults — the adult dosage ranges from 1 to 4 g daily in divided doses. the 333 mg and the 750 mg strengths should be administered such that the daily dose is within 1 to 4 grams per day. the usual adult dose is 250 mg every 6 hours. for the following infections, a dosage of 500 mg may be administered every 12 hours: streptococcal pharyngitis, skin and skin structure infections, and uncomplicated cystitis in patients over 15 years of age. cystitis therapy should be continued for 7 to 14 days. for more severe infections or those caused by less susceptible organisms, larger doses may be needed. if daily doses of cephalexin greater than 4 g are required, parenteral cephalosporins, in appropriate doses, should be considered. pediatric patients — the usual recommended daily dosage for pediatric patients is 25 to 50 mg/kg in divided doses. for streptococcal pharyngitis in patients over 1 year of age and for skin
and skin structure infections, the total daily dose may be divided and administered every 12 hours. in severe infections, the dosage may be doubled. in the therapy of otitis media, clinical studies have shown that a dosage of 75 to 100 mg/kg/day in 4 divided doses is required. in the treatment of β-hemolytic streptococcal infections, a therapeutic dosage of cephalexin should be administered for at least 10 days.

Contraindications:

Contraindications cephalexin capsules are contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

Adverse Reactions:

Adverse reactions gastrointestinal — onset of pseudomembranous colitis may occur during or after antibacterial treatment (see warnings section). nausea and vomiting have been reported rarely. the most frequent side effect has been diarrhea. it was very rarely severe enough to warrant cessation of therapy. dyspepsia, gastritis, and abdominal pain have also occurred. as with some penicillins and some other cephalosporins, transient hepatitis and cholestatic jaundice have been reported rarely. hypersensitivity — allergic reactions in the form of rash, urticaria, angioedema, and, rarely, erythema multiforme, stevens-johnson syndrome, or toxic epidermal necrolysis have been observed. these reactions usually subsided upon discontinuation of the drug. in some of these reactions, supportive therapy may be necessary. anaphylaxis has also been reported. other reactions have included genital and anal pruritus, genital moniliasis, vaginitis and vaginal discharge, dizziness, fatigue, head
ache, agitation, confusion, hallucinations, arthralgia, arthritis, and joint disorder. reversible interstitial nephritis has been reported rarely. eosinophilia, neutropenia, thrombocytopenia, hemolytic anemia, and slight elevations in ast and alt have been reported. in addition to the adverse reactions listed above that have been observed in patients treated with cephalexin, the following adverse reactions and altered laboratory tests have been reported for cephalosporin class antibiotics: adverse reactions — fever, colitis, aplastic anemia, hemorrhage, renal dysfunction, and toxic nephropathy. several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced (see indications and usage and precautions , general section). if seizures associated with drug therapy should occur, the drug should be discontinued. anticonvulsant therapy can be given if clinically indicated. altered laboratory tests — prolonged prothrombin time, increased bun, increased creatinine, elevated alkaline phosphatase, elevated bilirubin, elevated ldh, pancytopenia, leukopenia, and agranulocytosis.

Overdosage:

Overdosage signs and symptoms — symptoms of oral overdose may include nausea, vomiting, epigastric distress, diarrhea, and hematuria. if other symptoms are present, it is probably secondary to an underlying disease state, an allergic reaction, or toxicity due to ingestion of a second medication. treatment — to obtain up-to-date information about the treatment of overdose, a good resource is your certified regional poison control center. telephone numbers of certified poison control centers are listed in the physicians’ desk reference (pdr). in managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient. unless 5 to 10 times the normal dose of cephalexin has been ingested, gastrointestinal decontamination should not be necessary. protect the patient’s airway and support ventilation and perfusion. meticulously monitor and maintain, within acceptable limits, the patient’s vital signs, blood gases, serum electrolytes, etc. absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective than emesis or lavage; consider charcoal instead of or in addition to gastric emptying. repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. safeguard the patient’s airway when employing gastric emptying or charcoal. forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been established as beneficial for an overdose of cephalexin; however, it would be extremely unlikely that one of these procedures would be indicated. the oral median lethal dose of cephalexin in rats is >5000 mg/kg.

Description:

Description cephalexin, usp is a semisynthetic cephalosporin antibiotic intended for oral administration. it is 7-(d-α-amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. cephalexin has the molecular formula c 16 h 17 n 3 o 4 s h 2 o and the molecular weight is 365.41. cephalexin has the following structural formula: the nucleus of cephalexin is related to that of other cephalosporin antibiotics. the compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. the isoelectric point of cephalexin in water is approximately 4.5 to 5. the crystalline form of cephalexin which is available is a monohydrate. it is a white crystalline solid having a bitter taste. solubility in water is low at room temperature; 1 or 2 mg/ml may be dissolved readily, but higher concentrations are obtained with increasing difficulty. the cephalosporins differ from penicillins in the structure of the bicyclic ring system. cephalexin has a d -phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. each capsule contains cephalexin monohydrate equivalent to 250 mg or 500 mg of cephalexin. the capsules also contain anhydrous lactose, gelatin, magnesium stearate, talc and titanium dioxide. the capsules are imprinted with edible ink containing black iron oxide. structure

Clinical Pharmacology:

Clinical pharmacology human pharmacology cephalexin is acid stable and may be given without regard to meals. it is rapidly absorbed after oral administration. following doses of 250 mg, 500 mg, and 1 g, average peak serum levels of approximately 9, 18, and 32 µg/ml respectively were obtained at 1 hour. measurable levels were present 6 hours after administration. cephalexin is excreted in the urine by glomerular filtration and tubular secretion. studies showed that over 90% of the drug was excreted unchanged in the urine within 8 hours. during this period, peak urine concentrations following the 250 mg, 500 mg, and 1g doses were approximately 1000, 2200, and 5000 µg/ml respectively. microbiology in vitro tests demonstrate that the cephalosporins are bactericidal because of their inhibition of cell-wall synthesis. cephalexin has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections as described in the indications and u
sage section. aerobes, gram-positive: staphylococcus aureus (including penicillinase-producing strains) streptococcus pneumoniae (penicillin-susceptible strains) streptococcus pyogenes aerobes, gram-negative: escherichia coli haemophilus influenzae klebsiella pneumoniae moraxella (branhamella) catarrhalis proteus mirabilis note: methicillin-resistant staphylococci and most strains of enterococci ( enterococcus faecalis [formerly streptococcus faecalis ]) are resistant to cephalosporins, including cephalexin. it is not active against most strains of enterobacter spp., morganella morganii , and proteus vulgaris . it has no activity against pseudomonas spp. or acinetobacter calcoaceticus . penicillin-resistant streptococcus pneumoniae is usually cross-resistant to beta-lactam antibiotics. susceptibility tests dilution techniques — quantitative methods are used to determine antimicrobial minimal inhibitory concentrations (mic’s). these mic’s provide estimates of the susceptibility of bacteria to antimicrobial compounds. the mic’s should be determined using a standardized procedure. standardized procedures are based on a dilution method 1-3 (broth or agar) or equivalent with standardized inoculum concentrations and standardized concentrations of cephalothin powder. the mic values should be interpreted according to the following criteria: mic (µg/ml) interpretation ≤8 susceptible (s) 16 intermediate (i) ≥32 resistant (r) a report of "susceptible" indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable. a report of "intermediate" indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. this category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. this category also provides a buffer zone which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. a report of "resistant" indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected. standardized susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures. standard cephalothin powder should provide the following mic values: microorganism mic (µg/ml) e. coli atcc 25922 4 to 16 s. aureus atcc 29213 0.12 to 0.5 diffusion techniques — quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. one such standardized procedure 2,3 requires the use of standardized inoculum concentrations. this procedure uses paper disks impregnated with 30µg cephalothin to test the susceptibility of microorganisms to cephalexin. reports from the laboratory providing results of the standard single-disk susceptibility test with a 30 µg cephalothin disk should be interpreted according to the following criteria: zone diameter (mm) interpretation ≥18 susceptible (s) 15 to 17 intermediate (i) ≤14 resistant (r) interpretation should be as stated above for results using dilution techniques. interpretation involves correlation of the diameter obtained in the disk test with the mic for cephalexin. as with standard dilution techniques, diffusion methods require the use of laboratory control microorganisms that are used to control the technical aspects of the laboratory procedures. for the diffusion technique, the 30µg cephalothin disk should provide the following zone diameters in these laboratory test quality control strains: microorganism zone diameter (mm) e. coli atcc 25922 15 to 21 s. aureus atcc 29213 29 to 37

How Supplied:

How supplied cephalexin capsules, usp are available in: the 250 mg capsules are a white to off white powder filled into size 2 capsules (white opaque cap and white opaque body) that are imprinted with 801 on the cap in black. they are available as follows: bottles of 100 ndc 62250-801-02 bottles of 500 ndc 62250-801-08 the 500 mg capsules are a white to off white powder filled into size 0 capsules (white opaque cap and white opaque body) that are imprinted with 802 on the cap in black. they are available as follows: bottles of 100 ndc 62250-802-02 bottles of 500 ndc 62250-802-08 store at 20°c to 25°c (68°f to 77°f) [see usp controlled room temperature].

Package Label Principal Display Panel:

Package label.principal display panel bottles of 100 ndc 62250-801-02 bottles of 500 ndc 62250-801-08 bottles of 100 ndc 62250-802-02 bottles of 500 ndc 62250-802-08 250mg1 250mg2 500mg1 500mg2


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