Cephalexin by AMELLA PHARMA, LLC CEPHALEXIN capsule

Cephalexin by

Drug Labeling and Warnings

Cephalexin by is a Prescription medication manufactured, distributed, or labeled by AMELLA PHARMA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • 1 INDICATIONS AND USAGE

    1.1 Respiratory Tract Infections

    Cephalexin capsules 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 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 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 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 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 and other antibacterial drugs, cephalexin capsules 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 DOSAGE AND ADMINISTRATION

    2.1 Adults and Pediatric Patients At Least 15 years of age

    The usual dose of oral cephalexin capsules 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 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 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 to patients with impaired renal function [see Warnings and Precautions (5.4) and Use in Specific Populations (8.6)].

    Table 1. Recommended Dose Regimen for Patients with Renal Impairment
    *There is insufficient information to make dose adjustment recommendations in patients on hemodialysis.
    Renal function Dose regimen recommendation
    Creatinine 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* 250 mg, every 24 hours
    Creatinine clearance 1 to 4 mL/min not yet on dialysis* 250 mg, every 48 hours or every 60 hours

  • 3 DOSAGE FORMS AND STRENGTHS

    250 mg capsules: Dark green opaque/white size “2” hard gelatin capsule filled with off white granular powder and imprinted with “A 42” on dark green opaque cap and “250 mg” on white body with black ink.

    500 mg capsules: Dark green opaque/light green opaque size “0” hard gelatin capsule filled with off white granular powder and imprinted with “A 43” on dark green opaque cap and “500 mg” on light green opaque body with black ink.

  • 4 CONTRAINDICATIONS

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

  • 5 WARNINGS AND PRECAUTIONS

    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 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 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 ADVERSE REACTIONS

    The following serious events are described in greater detail in the Warning and Precautions section:


    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 Reactions: Fever, colitis, aplastic anemia, hemorrhage, renal dysfunction, and toxic nephropathy.

    Altered Laboratory Tests: Prolonged prothrombin time, increased blood urea nitrogen (BUN), increased creatinine, elevated alkaline phosphatase, elevated bilirubin, elevated lactate dehydrogenase (LDH), pancytopenia, leukopenia, and agranulocytosis.  

  • 7 DRUG INTERACTIONS

    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 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 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    Teratogenic effects

    Pregnancy Category B

    There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

    Reproduction studies have been performed on mice and rats using oral doses of cephalexin monohydrate 0.6 and 1.5 times the maximum daily human dose (66 mg/kg/day) based upon body surface area basis, and have revealed no evidence of impaired fertility or harm to the fetus.

    8.3 Nursing Mothers

    Cephalexin is excreted in human milk. Caution should be exercised when cephalexin is administered to a nursing woman.

    8.4 Pediatric Use

    The safety and effectiveness of cephalexin 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 should be administered with caution in the presence of impaired renal function (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)].

  • 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-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4SH2O and the molecular weight is 365.41.


    Cephalexin has the following structural formula:
    structure



    Each capsule contains cephalexin monohydrate equivalent to 250 mg or 500 mg of cephalexin. The capsules also contain the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Yellow No. 6, gelatin, magnesium stearate, titanium dioxide, and sodium lauryl sulfate.

  • 12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    Cephalexin is a cephalosporin antibacterial drug [see Microbiology (12.4)].

    12.3 Pharmacokinetics

    Absorption:


    Cephalexin 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).


    Distribution:


    Cephalexin is approximately 10% to 15% bound to plasma proteins.


    Excretion:


    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 1 g doses were approximately 1000, 2200, and 5000 mcg/mL respectively.


    Drug Interactions
    In healthy subjects given single 500 mg doses of cephalexin and metformin, plasma metformin mean Cmax 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 Action


    Cephalexin is a bactericidal agent that acts by the inhibition of bacterial cell-wall synthesis.


    Resistance


    Methicillin-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 Activity


    Cephalexin 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)

    Streptococcus pyogenes


    Gram-negative bacteria

    Escherichia coli

    Haemophilus influenzae

    Klebsiella pneumoniae

    Moraxella catarrhalis

    Proteus mirabilis


    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.

  • 13 NONCLINICAL TOXICOLOGY

    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 available in:

    500 mg Capsule

    Dark green opaque/light green opaque size “0” hard gelatin capsule filled with off white granular powder and imprinted with “A 43” on dark green opaque cap and “500 mg” on light green opaque body with black ink.

    Bottles of 100                                                            NDC: 72287-310-01

    Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. 

    Dispense in a tight, light-resistant container.

  • 17 PATIENT COUNSELING INFORMATION

    • Advise 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, other beta-lactams (including cephalosporins) or other allergens (5.1)
    • Advise 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.
    • Counsel patients that antibacterial drugs including cephalexin, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When cephalexin is 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 or other antibacterial drugs in the future.

    Manufactured for:
    Amella Pharma, LLC
    East Brunswick, NJ 08816

    AP3002
    Revised: 06/2018

  • Packaging

    Cephalx

  • INGREDIENTS AND APPEARANCE
    CEPHALEXIN 
    cephalexin capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 72287-310
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CEPHALEXIN (UNII: OBN7UDS42Y) (CEPHALEXIN ANHYDROUS - UNII:5SFF1W6677) CEPHALEXIN ANHYDROUS500 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    ColorGREEN (Dark Green Opaque, Light Green Opaque) Scoreno score
    ShapeCAPSULESize21mm
    FlavorImprint Code A;43;500;mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 72287-310-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/27/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA06525306/27/2018
    Labeler - AMELLA PHARMA, LLC (081189492)
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