NDC 54348-560 Cephalexin

Cephalexin

NDC Product Code 54348-560

NDC Code: 54348-560

Proprietary Name: Cephalexin What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Cephalexin What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
WHITE (C48325 - WHITE BODY)
GREEN (C48329 - DARK GREEN CAP)
Shape: CAPSULE (C48336)
Size(s):
18 MM
Imprint(s):
250;LUPIN
Score: 1

NDC Code Structure

  • 54348 - Pharmpak, Inc.
    • 54348-560 - Cephalexin

NDC 54348-560-28

Package Description: 1 BOTTLE in 1 BOX > 28 CAPSULE in 1 BOTTLE

NDC Product Information

Cephalexin with NDC 54348-560 is a a human prescription drug product labeled by Pharmpak, Inc.. The generic name of Cephalexin is cephalexin. The product's dosage form is capsule and is administered via oral form.

Labeler Name: Pharmpak, Inc.

Dosage Form: Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Cephalexin Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • CEPHALEXIN 250 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • GELATIN (UNII: 2G86QN327L)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • SHELLAC (UNII: 46N107B71O)
  • POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Cephalosporin Antibacterial - [EPC] (Established Pharmacologic Class)
  • Cephalosporins - [CS]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Pharmpak, Inc.
Labeler Code: 54348
FDA Application Number: ANDA065229 What is the FDA Application Number?
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.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 07-12-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Cephalexin Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

1.1 Respiratory Tract Infections

Cephalexin capsules USP are indicated for the treatment of respiratory tract infections caused by susceptible isolates of


Streptococcus pneumoniae and


Streptococcus pyogenes.

1.2 Otitis Media

Cephalexin capsules USP are indicated for the treatment of otitis media caused by susceptible isolates of


Streptococcus pneumoniae,


Haemophilus influenzae,


Staphylococcus aureus,


Streptococcus pyogenes, and


Moraxella catarrhalis.

1.3 Skin And Skin Structure Infections

Cephalexin capsules USP are indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria:


Staphylococcus aureus and


Streptococcus pyogenes.

1.4 Bone Infections

Cephalexin capsules USP are indicated for the treatment of bone infections caused by susceptible isolates of


Staphylococcus aureus and


Proteus mirabilis.

1.5 Genitourinary Tract Infections

Cephalexin capsules USP are indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of


Escherichia coli,


Proteus mirabilis, and


Klebsiella pneumoniae.

1.6 Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules USP and other antibacterial drugs, cephalexin capsules USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information is available, this information 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.

2.1 Adults And Pediatric Patients At Least 15 Years Of Age

The usual dose of oral cephalexin capsules USP is 250 mg every 6 hours, but a dose of 500 mg every 12 hours may be administered. Treatment is administered for 7 to 14 days.For more severe infections larger doses of oral cephalexin capsules USP may be needed, up to 4 grams daily in two to four equally divided doses.

2.2 Pediatric Patients (Over 1 Year Of Age)

The recommended total daily dose of oral cephalexin capsules USP for pediatric patients is 25 to 50 mg/kg given in equally divided doses for 7 to 14 days. In the treatment of β-hemolytic streptococcal infections, duration of at least 10 days is recommended. In severe infections, a total daily dose of 50 to 100 mg/kg may be administered in equally divided doses.For the treatment of otitis media, the recommended daily dose is 75 to 100 mg/kg given in equally divided doses.

2.3 Dosage Adjustments In Adult And Pediatric Patients At Least 15 Years Of Age With Renal Impairment

Administer the following dosing regimens for cephalexin capsules USP to patients with renal impairment [


see WARNINGS AND PRECAUTIONS (


5.4) and USE IN SPECIFIC POPULATIONS (


8.6)].


Table1. Recommended Dose Regimen for Patients with Renal ImpairmentRenal functionDose regimen recommendationCreatinine clearance ≥ 60 mL/min


No dose adjustment


Creatinine clearance 30 to 59 mL/min


No dose adjustment; maximum daily dose should not exceed 1 g


Creatinine clearance 15 to 29 mL/min


250 mg, every 8 hours or every 12 hours


Creatinine clearance 5 to 14 mL/min not yet on dialysis


There is insufficient information to make dose adjustment recommendations in patients on hemodialysis250 mg, every 24 hours


Creatinine clearance 1 to 4 mL/min not yet on dialysis


250 mg, every 48 hours or every 60 hours

Other

250 mg CapsulesA white to yellowish-white granular powder filled into size "2" capsules (white and dark green) that are imprinted with "250" on dark green cap, and "LUPIN" on the white body in edible black ink.500 mg CapsulesA white to yellowish-white granular powder filled into size "0" capsules (light green and dark green) that are imprinted with "500" on the dark green cap, and "LUPIN" on the light green body in edible black ink.

Cephalexin capsules are contraindicated in patients with known hypersensitivity to cephalexin or other members of the cephalosporin class of antibacterial drugs.


  • The following serious events are described in greater detail in the Warning and Precautions section:Hypersensitivity reactions
  • [see WARNING AND PRECAUTIONS (
  • 5.1)]
  • Clostridium difficile -associated diarrhea
  • [see WARNINGS AND PRECAUTIONS (
  • 5.2)]
  • Direct Coombs' Test Seroconversion
  • [see WARNINGS AND PRECAUTIONS (
  • 5.3)]
  • Seizure Potential
  • [see WARNINGS AND PRECAUTIONS (
  • 5.4)]
  • Effect on Prothrombin Activity
  • [see WARNINGS AND PRECAUTIONS (
  • 5.5)]
  • Development of Drug-Resistant Bacteria
  • [see WARNINGS AND PRECAUTIONS (
  • 5.6)]

5.1 Hypersensitivity Reactions

Allergic reactions in the form of rash, urticaria, angioedema, anaphylaxis, erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis have been reported with the use of cephalexin.  Before therapy with cephalexin capsules is instituted, inquire whether the patient has a history of hypersensitivity reactions to cephalexin, cephalosporins, penicillins, or other drugs. Cross-hypersensitivity among beta-lactam antibacterial drugs may occur in up to 10% of patients with a history of penicillin allergy.If an allergic reaction to cephalexin occurs, discontinue the drug and institute appropriate treatment.

5.2 Clostridium Difficile-Associated Diarrhea

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.

5.3 Direct Coombs’ Test Seroconversion

Positive direct Coombs' tests have been reported during treatment with the cephalosporin antibacterial drugs including cephalexin. Acute intravascular hemolysis induced by cephalexin therapy has been reported. If anemia develops during or after cephalexin therapy, perform a diagnostic work-up for drug-induced hemolytic anemia, discontinue cephalexin and institute appropriate therapy.

5.4 Seizure Potential

Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. If seizures occur, discontinue cephalexin. Anticonvulsant therapy can be given if clinically indicated.

5.5 Prolonged Prothrombin Time

Cephalosporins may be associated with prolonged prothrombin time. Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antibacterial therapy, and patients receiving anticoagulant therapy. Monitor prothrombin time in patients at risk and manage as indicated.

5.6 Development Of Drug-Resistant Bacteria

Prescribing cephalexin capsules in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.Prolonged use of cephalexin 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.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.In clinical trials, the most frequent adverse reaction was diarrhea. Nausea and vomiting, dyspepsia, gastritis, and abdominal pain have also occurred. As with penicillins and other cephalosporins, transient hepatitis and cholestatic jaundice have been reported.Other reactions have included hypersensitivity reactions, genital and anal pruritus, genital candidiasis, vaginitis and vaginal discharge, dizziness, fatigue, headache, agitation, confusion, hallucinations, arthralgia, arthritis, and joint disorder. Reversible interstitial nephritis has been reported. Eosinophilia, neutropenia, thrombocytopenia, hemolytic anemia, and slight elevations in aspartate transaminase (AST) and alanine transaminase (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 other altered laboratory tests have been reported for cephalosporin class antibacterial drugs:Other Adverse ReactionsFever, colitis, aplastic anemia, hemorrhage, renal dysfunction, and toxic nephropathy.Altered Laboratory TestsProlonged prothrombin time, increased blood urea nitrogen (BUN), increased creatinine, elevated alkaline phosphatase, elevated bilirubin, elevated lactate dehydrogenase (LDH), pancytopenia, leukopenia, and agranulocytosis.

7.1 Metformin

Administration of cephalexin with metformin results in increased plasma metformin concentrations and decreased renal clearance of metformin. Careful patient monitoring and dose adjustment of metformin is recommended in patients concomitantly taking cephalexin and metformin


[see CLINICAL PHARMACOLOGY (


12.3].

7.2 Probenecid

The renal excretion of cephalexin is inhibited by probenecid. Co-administration of probenecid with cephalexin capsules is not recommended.

7.3 Interaction With Laboratory Or Diagnostic Testing

A false-positive reaction may occur when testing for the presence of glucose in the urine using Benedict's solution or Fehling's solution.

8.1 Pregnancy

Risk SummaryAvailable data from published epidemiologic studies and pharmacovigilance case reports over several decades with cephalosporin use, including cephalexin use in pregnant women have not established drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes


(see Data).


Animal reproduction studies with mice and rats using oral doses of cephalexin that are 0.6- and 1.2-times the maximum recommended human dose (MRHD) based on body surface area during organogenesis revealed no evidence of harm to the fetus


(see Data).The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.DataHuman Data:While available studies cannot definitively establish the absence of risk, published data from epidemiologic studies and postmarketing case reports over several decades have not identified a consistent association with cephalosporin use, including cephalexin, during pregnancy, and major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Available studies have methodologic limitations, including small sample size, retrospective data collection, and inconsistent comparator groups.Animal Data:In animal reproduction studies, pregnant mice and rats administered oral cephalexin doses of 250 or 500 mg/kg/day (approximately 0.6 and 1.2 times the MRHD) based on body surface area, respectively during the period of organogenesis showed no adverse effects on embryofetal development.In a pre-and post-natal developmental toxicity study, pregnant rats that received oral doses of 250 or 500 mg/kg/day of cephalexin from Day 15 of pregnancy to litter Day 21 showed no adverse effects on parturition, litter size, or growth of offspring.

8.2 Lactation

Risk SummaryData from a published clinical lactation study reports that cephalexin is present in human milk. The Relative Infant Dose (RID) is considered to be <1% of the maternal weight adjusted dose. There are no data on the effects of cephalexin on the breastfed child or on milk production.The development of health benefits of breastfeeding should be considered along with the mother's clinical need for cephalexin and any potential adverse effects on the breastfed child from cephalexin or from the underlying maternal condition.

8.4 Pediatric Use

The safety and effectiveness of cephalexin capsules in pediatric patients was established in clinical trials for the dosages described in the dosage and administration section


[see DOSAGE AND ADMINISTRATION (


2.2)]

8.5 Geriatric Use

Of the 701 subjects in 3 published clinical studies of cephalexin, 433 (62%) were 65 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients.This drug is substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection


[see WARNINGS AND PRECAUTIONS (


5.4)].

8.6 Renal Impairment

Cephalexin capsules should be administered with careful monitoring in the presence of renal impairment (creatinine clearance < 30 mL/min, with or without dialysis). Under such conditions, careful clinical observation and laboratory studies renal function monitoring should be conducted because safe dosage may be lower than that usually recommended


[see DOSAGE AND ADMINISTRATION (


2.3)].


Monitor patients longer for toxicity and drug interactions due to delayed clearance.

10 Overdosage

Symptoms of oral overdose may include nausea, vomiting, epigastric distress, diarrhea, and hematuria. In the event of an overdose, institute general supportive measures.Forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been established as beneficial for an overdose of cephalexin.

11 Description

Cephalexin capsules USP is a semisynthetic cephalosporin antibacterial drug intended for oral administration. It is 7- (D-a-Amino-a-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C


16H


17N


3O


4S•H


2O and the molecular weight is 365.41.


Cephalexin has the following structural formula:Each capsule contains cephalexin USP equivalent to 250 mg, or 500 mg of anhydrous cephalexin. The capsules also contain the following inactive ingredients D&C Yellow 10, FD&C Blue 1, FD&C Green 3, FD&C Yellow 6, ferric oxide black, gelatin, magnesium stearate, microcrystalline cellulose, potassium hydroxide, propylene glycol, shellac and titanium dioxide.

12.1 Mechanism Of Action

Cephalexin is a cephalosporin antibacterial drug


[see Microbiology (


12.4)].

12.3 Pharmacokinetics

AbsorptionCephalexin is acid stable and may be given without regard to meals. Following doses of 250 mg, 500 mg, and 1 g, average peak serum levels of approximately 9, 18, and 32 mcg/mL, respectively, were obtained at 1 hour. Serum levels were detectable 6 hours after administration (at a level of detection of 0.2 mcg/mL).DistributionCephalexin is approximately 10% to 15% bound to plasma proteins.ExcretionCephalexin 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 1 g doses were approximately 1000, 2200, and 5000 mcg/mL respectively.Drug InteractionsIn healthy subjects given single 500 mg doses of cephalexin and metformin, plasma metformin mean C


max and AUC increased by an average of 34% and 24%, respectively, and metformin mean renal clearance decreased by 14%. No information is available about the interaction of cephalexin and metformin following multiple doses of either drug.

12.4 Microbiology

Mechanism of ActionCephalexin is a bactericidal agent that acts by the inhibition of bacterial cell-wall synthesis.ResistanceMethicillin-resistant staphylococci and most isolates of enterococci are resistant to cephalexin. Cephalexin is not active against most isolates of


Enterobacter spp.,


Morganella morganii, and


Proteus vulgaris. Cephalexin has no activity against


Pseudomonas spp., or


Acinetobacter calcoaceticus. Penicillin-resistant


Streptococcus pneumoniae is usually cross-resistant to beta-lactam antibacterial drugs.


Antimicrobial ActivityCephalexin has been shown to be active against most isolates of the following bacteria both


in vitro and in clinical infections


[see INDICATIONS AND USAGE (


1)].


Gram-Positive Bacteria:Staphylococcus aureus (methicillin-susceptible isolates only)


Streptococcus pneumoniae (penicillin-susceptible isolates)


Gram-Negative Bacteria:Escherichia coli Haemophilus influenzae Klebsiella pneumoniae Moraxella catarrhalis Proteus mirabilisSusceptibility TestingFor 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.

13.1 Carcinogenesis, Mutagenesis, Impairment Of Fertility

Lifetime studies in animals have not been performed to evaluate the carcinogenic potential of cephalexin. Tests to determine the mutagenic potential of cephalexin have not been performed. In male and female rats, fertility and reproductive performance were not affected by cephalexin oral doses up to 1.5 times the highest recommended human dose based upon body surface area.

16 How Supplied/Storage And Handling

  • Cephalexin capsules USP, are supplied as follows:250 mg Capsules, Bottles of 28 NDC 54348-560-28Cephalexin capsules USP should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container.

17 Patient Counseling Information

Allergic ReactionsAdvise patients that allergic reactions, including serious allergic reactions, could occur and that serious reactions require immediate treatment. Ask the patient about any previous hypersensitivity reactions to cephalexin capsules, other beta-lactams (including cephalosporins) or other allergens (


5.1)


DiarrheaAdvise patients that diarrhea is a common problem caused by antibacterial drugs and usually resolves when the drug is discontinued. Sometimes, frequent watery or bloody diarrhea may occur and may be a sign of a more serious intestinal infection. If severe watery or bloody diarrhea develops, advise patients to contact their healthcare provider.Antibacterial ResistanceCounsel patients that antibacterial drugs including cephalexin capsules, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When cephalexin capsules are prescribed to treat a     bacterial infection, tell patients that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by cephalexin capsules or other antibacterial drugs in the futureManufactured for:Lupin Pharmaceuticals, Inc.Baltimore, Maryland 21202United StatesManufactured by:Lupin LimitedMandideep (M.P.) - 462046IndiaRevised: March 2019ID#: 259035

* Please review the disclaimer below.

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