Cefixime by Aurobindo Pharma Limited CEFIXIME capsule

Cefixime by

Drug Labeling and Warnings

Cefixime by is a Prescription medication manufactured, distributed, or labeled by Aurobindo Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • 1 INDICATIONS AND USAGE

    1.1 Uncomplicated Urinary Tract Infections

    Cefixime capsules are indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated urinary tract infections caused by susceptible isolates of Escherichia coli and Proteus mirabilis.

    1.3 Pharyngitis and Tonsillitis

    Cefixime capsules are indicated in the treatment of adults and pediatric patients six months of age or older with pharyngitis and tonsillitis caused by susceptible isolates of Streptococcus pyogenes. (Note: Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes infections. Cefixime capsules are generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, data establishing the efficacy of cefixime capsules in the subsequent prevention of rheumatic fever is not available.)

    1.4 Acute Exacerbations of Chronic Bronchitis

    Cefixime capsules are indicated in the treatment of adults and pediatric patients six months of age or older with acute exacerbations of chronic bronchitis caused by susceptible isolates of Streptococcus pneumoniae and Haemophilus influenzae.

    1.5 Uncomplicated Gonorrhea (cervical/urethral)

    Cefixime capsules are indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated gonorrhea (cervical/urethral) caused by susceptible isolates of Neisseria gonorrhoeae (penicillinase-and non-penicillinase-producing isolates).

    1.6 Usage to Reduce Development of Drug-Resistant Bacteria

    To reduce the development of drug resistant bacteria and maintain the effectiveness of cefixime capsules and other antibacterial drugs, cefixime 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 are available, they should be considered in selecting or modifying antimicrobial 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

    The recommended dose of cefixime capsule is 400 mg daily. This may be given as a 400 mg capsule daily. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of 400 mg is recommended. The capsule may be administered without regard to food.


    In the treatment of infections due to Streptococcus pyogenes, a therapeutic dosage of cefixime should be administered for at least 10 days.

    2.2 Pediatric Patients (weighing more than 45 kg or older than 12 years)

    Pediatric patients weighing more than 45 kg or older than 12 years should be treated with the recommended adult dose. Clinical trials of otitis media were conducted with the chewable tablets or suspension, and the chewable tablets or suspension results in higher peak blood levels than the tablet when administered at the same dose. Therefore, the Suprax tablet or cefixime capsule should not be substituted for the Suprax chewable tablets or Suprax for oral suspension in the treatment of otitis media [see CLINICAL PHARMACOLOGY (12.3)].


    In the treatment of infections due to Streptococcus pyogenes, a therapeutic dosage of cefixime should be administered for at least 10 days.

    2.3 Renal Impairment

    Cefixime may be administered in the presence of impaired renal function. Normal dose and schedule may be employed in patients with creatinine clearances of 60 mL/min or greater. Neither hemodialysis nor peritoneal dialysis removes significant amounts of drug from the body.

  • 3 DOSAGE FORMS AND STRENGTHS

    Cefixime capsules are available for oral administration in the following dosage strength:

    • Capsules provide 400 mg of cefixime USP as trihydrate. These are size “0” capsules with pink opaque cap imprinted with “CMI” and pink opaque body imprinted with “400” in black ink. Capsules contain white to yellowish white powder.

  • 4 CONTRAINDICATIONS

    Cefixime capsules are contraindicated in patients with known allergy to cefixime or other cephalosporins.

  • 5 WARNINGS AND PRECAUTIONS

    5.1 Hypersensitivity Reactions

    Anaphylactic/anaphylactoid reactions (including shock and fatalities) have been reported with the use of cefixime.


    Before therapy with cefixime is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to 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 antibacterial drugs has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction to cefixime occurs, discontinue the drug.

    5.2 Clostridioides difficile-Associated Diarrhea

    Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cefixime, 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 isolates 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 antibacterial drug 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 antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

    5.3 Dose Adjustment in Renal Impairment

    The dose of cefixime should be adjusted in patients with renal impairment as well as those undergoing continuous ambulatory peritoneal dialysis (CAPD) and hemodialysis (HD). Patients on dialysis should be monitored carefully [see Dosage and Administration (2)].

    5.4 Coagulation Effects

    Cephalosporins, including cefixime, 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.

    5.5 Development of Drug-Resistant Bacteria

    Prescribing cefixime 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.

  • 6 ADVERSE REACTIONS

    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.


    The most commonly seen adverse reactions in U.S. trials of the Suprax tablet formulation were gastrointestinal events, which were reported in 30% of adult patients on either the twice daily or the once daily regimen. Five percent (5%) of patients in the U.S. clinical trials discontinued therapy because of drug-related adverse reactions. Individual adverse reactions included diarrhea 16%, loose or frequent stools 6%, abdominal pain 3%, nausea 7%, dyspepsia 3%, and flatulence 4%. The incidence of gastrointestinal adverse reactions, including diarrhea and loose stools, in pediatric patients receiving the suspension was comparable to the incidence seen in adult patients receiving tablets.

    6.2 Post-marketing Experience

    The following adverse reactions have been reported following the post-approval use of cefixime. Incidence rates were less than 1 in 50 (less than 2%).

    Gastrointestinal


    Several cases of documented pseudomembranous colitis were identified in clinical trials. The onset of pseudomembranous colitis symptoms may occur during or after therapy.

    Hypersensitivity Reactions


    Anaphylactic/anaphylactoid reactions (including shock and fatalities), skin rashes, urticaria, drug fever, pruritus, angioedema, and facial edema. Erythema multiforme, Stevens-Johnson syndrome, and serum sickness-like reactions have been reported.

    Hepatic


    Transient elevations in SGPT, SGOT, alkaline phosphatase, hepatitis, jaundice.

    Renal


    Transient elevations in BUN or creatinine, acute renal failure.

    Central Nervous System


    Headaches, dizziness, seizures.

    Hemic and Lymphatic System


    Transient thrombocytopenia, leukopenia, neutropenia, prolongation in prothrombin time, elevated LDH, pancytopenia, agranulocytosis, and eosinophilia.

    Abnormal Laboratory Tests


    Hyperbilirubinemia.

    Other Adverse Reactions


    Genital pruritus, vaginitis, candidiasis, toxic epidermal necrolysis.

    Adverse Reactions Reported for Cephalosporin-class Drugs


    Allergic reactions, superinfection, renal dysfunction, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemolytic anemia, hemorrhage, and colitis.


    Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced [see Dosage and Administration (2) and Overdosage (10)]. If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

  • 7 DRUG INTERACTIONS

    7.1 Carbamazepine

    Elevated carbamazepine levels have been reported in postmarketing experience when cefixime is administered concomitantly. Drug monitoring may be of assistance in detecting alterations in carbamazepine plasma concentrations.

    7.2 Warfarin and Anticoagulants

    Increased prothrombin time, with or without clinical bleeding, has been reported when cefixime is administered concomitantly.

    7.3 Drug/Laboratory Test Interactions

    A false-positive reaction for ketones in the urine may occur with tests using nitroprusside but not with those using nitroferricyanide.


    The administration of cefixime may result in a false-positive reaction for glucose in the urine when using glucose tests based on the Benedict’s solution or Fehling’s solution. It is recommended that glucose tests based on enzymatic glucose oxidase reactions be used. A false-positive direct Coombs test has been reported during treatment with other cephalosporins; therefore, it should be recognized that a positive Coombs test may be due to the drug.

  • 8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    Risk Summary


    Available data from published observational studies, case series, and case reports over several decades with cephalosporin use, including cefixime, in pregnant women have not established drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). Reproduction studies have been performed in mice and rats at doses equivalent to 40 and 80 times, respectively, the adult human recommended dose and have revealed no evidence of harm to the fetus due to cefixime (see Data).


    The 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 risks of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.


    Clinical Considerations


    Disease-Associated Maternal and/or Embryo/Fetal Risk


    Maternal gonorrhea may be associated with preterm birth, low neonatal birth weight, chorioamnionitis, intrauterine growth restriction, small for gestational age and premature rupture of membranes. Perinatal transmission of gonorrhea to the offspring can result in infant blindness, joint infections, and bloodstream infections.


    Data


    Human Data


    While available studies cannot definitively establish the absence of risk, published data from prospective cohort studies, case series, and case reports over several decades have not identified a consistent association with cephalosporin use, including cefixime, during pregnancy, and major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Available studies have methodological limitations, including small sample size, retrospective data collection, and inconsistent comparator groups.


    Animal Data


    The results of embryo-fetal development studies in mice and rats show that cefixime, at doses up to 3200 mg/kg/day administered during the period of organogenesis did not adversely affect development. In these studies, in mice and rats, cefixime did not affect postnatal development or reproductive capacity of the F1 generation or fetal development of the F2 generation. In an embryo-fetal development study in rabbits, cefixime at doses of 3.2, 10 or 32 mg/kg given daily during the period of organogenesis (gestation days 6 through 18) resulted in abortions and/or maternal deaths at doses > 10 mg/kg (typically associated with the administration of antibiotics in this species), but no malformations were reported at lower doses. A pre- and post-natal development study of cefixime at oral doses up to 3200 mg/kg/day in rats demonstrated no effect on the duration of pregnancy, process of parturition, development and viability of offspring, or reproductive capacity of the F1 generation and development of their fetuses (F2).

    8.2 Lactation

    Risk Summary


    There are no available data on the presence of cefixime in human milk, the effects on the breast­fed infant, or the effects on milk production. Cefixime is present in animal milk (see Data). When a drug is present in animal milk, it is likely the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for cefixime and any potential adverse effects on the breast-fed infant from cefixime or from the mother’s underlying condition.


    Data


    In a study on disposition of cefixime in pregnant and lactating rats, continuous intra-peritoneal infusion of 2.54 mg/kg/day of 14C-cefixime from days 10 to 14 postpartum resulted in steady state plasma concentrations of radioactivity in the dams that were 70 times greater than in their nursing pups.


    After 102 hours of drug infusion, total radioactivity in the body of the pups, including the stomach and intestinal contents, was 1.5% of the 14C-cefixime estimated to be in the mother's body at steady state.1 

    8.4 Pediatric Use

    The safety and effectiveness of cefixime have been established in pediatric patients 6 months of age and older. Safety and effectiveness of cefixime in pediatric patients younger than 6 months of age have not been established. The incidence of gastrointestinal adverse reactions, including diarrhea and loose stools, in the pediatric patients receiving the Suprax for oral suspension, was comparable to the incidence seen in adult patients receiving tablets.

    8.5 Geriatric Use

    Clinical studies did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. A pharmacokinetic study in the elderly detected differences in pharmacokinetic parameters [see Clinical Pharmacology (12.3)]. These differences were small and do not indicate a need for dosage adjustment of cefixime in the elderly.

    8.6 Renal Impairment

    The dose of cefixime should be adjusted in patients with renal impairment as well as those undergoing continuous ambulatory peritoneal dialysis (CAPD) and hemodialysis (HD). Patients on dialysis should be monitored carefully [see Dosage and Administration (2.3)].

  • 10 OVERDOSAGE

    Gastric lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of cefixime did not differ from the profile seen in patients treated at the recommended doses.

  • 11 DESCRIPTION

    Cefixime is a semisynthetic, cephalosporin antibacterial for oral administration. Chemically, it is (6R,7R)-7-[2-(2-Amino-4-thiazolyl)glyoxylamido]-8-oxo-3-vinyl-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid, 72-(Z)-[O-(carboxy methyl) oxime] trihydrate.


    Molecular weight = 507.50 as the trihydrate. Chemical Formula is C16H15N5O7S2.3H2O


    The structural formula for cefixime is:



    str

    • Inactive ingredients contained in cefixime 400 mg capsules are: colloidal silicon dioxide, croscarmellose sodium, low-substituted hydroxypropyl cellulose, magnesium stearate, and mannitol. The capsule shell contains the following inactive ingredients: gelatin, iron oxide red, sodium lauryl sulfate and titanium dioxide. The capsules are imprinted with black ink containing black iron oxide, potassium hydroxide, propylene glycol and shellac.
  • 12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

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

    12.3 Pharmacokinetics

    Suprax tablets and Suprax for oral suspension, given orally, are about 40% to 50% absorbed whether administered with or without food; however, time to maximal absorption is increased approximately 0.8 hours when administered with food. A single 200 mg tablet of Suprax produces an average peak serum concentration of approximately 2 mcg/mL (range 1 to 4 mcg/mL); a single 400 mg Suprax tablet produces an average peak concentration of approximately 3.7 mcg/mL (range 1.3 to 7.7 mcg/mL). The Suprax for oral suspension produces average peak concentrations approximately 25% to 50% higher than the tablets, when tested in normal adult volunteers. Two hundred and 400 mg doses of Suprax for oral suspension produce average peak concentrations of 3 mcg/mL (range 1 to 4.5 mcg/mL) and 4.6 mcg/mL (range 1.9 to 7.7 mcg/mL), respectively, when tested in normal adult volunteers. The area under the time versus concentration curve (AUC) is greater by approximately 10% to 25% with the Suprax for oral suspension than with the Suprax tablet after doses of 100 to 400 mg, when tested in normal adult volunteers. This increased absorption should be taken into consideration if the Suprax for oral suspension is to be substituted for the Suprax tablet. Because of the lack of bioequivalence, SUPRAX tablets should not be substituted for SUPRAX for oral suspension in the treatment of otitis media [see Dosage and Administration (2)]. Cross-over studies of Suprax tablet versus Suprax for oral suspension have not been performed in pediatric patients.


    The 400 mg cefixime capsule is bioequivalent to the 400 mg Suprax tablet under fasting conditions. However, food reduces the absorption following administration of the capsule by approximately 15% based on AUC and 25% based on Cmax.


    Peak serum concentrations occur between 2 and 6 hours following oral administration of a single 200 mg tablet, a single 400 mg Suprax tablet or 400 mg of Suprax for oral suspension. Peak serum concentrations occur between 2 and 5 hours following a single administration of 200 mg of Suprax for oral suspension. Peak serum concentrations occur between 3 and 8 hours following oral administration of a single 400 mg cefixime capsule.

    Distribution


    Serum protein binding is concentration independent with a bound fraction of approximately 65%. In a multiple dose study conducted with a research formulation which is less bioavailable than the Suprax tablet or Suprax for oral suspension, there was little accumulation of drug in serum or urine after dosing for 14 days. Adequate data on CSF levels of cefixime are not available.

    Elimination


    Metabolism and Excretion


    There is no evidence of metabolism of cefixime in vivo. Approximately 50% of the absorbed dose is excreted unchanged in the urine in 24 hours. In animal studies, it was noted that cefixime is also excreted in the bile in excess of 10% of the administered dose. The serum half-life of cefixime in healthy subjects is independent of dosage form and averages 3 to 4 hours but may range up to 9 hours in some normal volunteers.

    Specific Populations 

    Geriatric Patients: Average AUCs at steady state in elderly patients are approximately 40% higher than average AUCs in other healthy adults. Differences in the pharmacokinetic parameters between 12 young and 12 elderly subjects who received 400 mg of cefixime once daily for 5 days are summarized as follows:                                      

    Table 4. Pharmacokinetic Parameters for Cefixime in Both Young and Elderly Subjects
     Pharmacokinetic Parameters (mean ± SD) for Cefixime in Both Young and Elderly Subjects
     
     Pharmacokinetic parameter
         		 Young
         		 Elderly
     
     Cmax (mg/L)
         		 4.74 ± 1.43
         		 5.68 ± 1.83
     
     Tmax (h)*
         		 3.9 ± 0.3
         		 4.3 ± 0.6
     
     AUC (mg.h/L)*
         		 34.9 ± 12.2
         		 49.5 ± 19.1
     
     T½ (h)*
         		 3.5 ± 0.6
         		 4.2 ± 0.4
     
     Cave (mg/L)*
         		 1.42 ±0.50
         		 1.99 ± 0.75
     
     *Difference between age groups was significant. (p<0.05)
     

    However, these increases were not clinically significant [see Dosage and Administration (2)].

    Patients with Renal Impairment: In subjects with moderate impairment of renal function (20 to 40 mL/min creatinine clearance), the average serum half-life of cefixime is prolonged to 6.4 hours. In severe renal impairment (5 to 20 mL/min creatinine clearance), the half-life increased to an average of 11.5 hours. The drug is not cleared significantly from the blood by hemodialysis or peritoneal dialysis. However, a study indicated that with doses of 400 mg of cefixime, patients undergoing hemodialysis have similar blood profiles as subjects with creatinine clearances of 21 to 60 mL/min.

    12.4 Microbiology

    Mechanism of Action


    As with other cephalosporins, the bactericidal action of cefixime results from inhibition of cell wall synthesis. Cefixime is stable in the presence of certain beta-lactamase enzymes. As a result, certain organisms resistant to penicillins and some cephalosporins due to the presence of beta-lactamases may be susceptible to cefixime.


    Resistance


    Resistance to cefixime in isolates of Haemophilus influenzae and Neisseria gonorrhoeae is most often associated with alterations in penicillin-binding proteins (PBPs). Cefixime may have limited activity against Enterobacteriaceae producing extended spectrum beta-lactamases (ESBLs). Pseudomonas species, Enterococcus species, strains of Group D streptococci, Listeria monocytogenes, most strains of staphylococci (including methicillin-resistant strains), most strains of Enterobacter species, most strains of Bacteroides fragilis, and most strains of Clostridium species are resistant to cefixime.


    Antimicrobial Activity


    Cefixime has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections [see Indications and Usage (1)].


    Gram-positive Bacteria
    Streptococcus pneumoniae
    Streptococcus pyogenes


    Gram-negative Bacteria
    Escherichia coli
    Haemophilus influenzae
    Moraxella catarrhalis
    Neisseria gonorrhoeae
    Proteus mirabilis


    The following in vitro data are available, but their clinical significance is unknown. At least 90 percent of the following bacteria exhibit an in vitro minimum inhibitory concentration (MIC) less than or equal to the susceptible breakpoint for cefixime against isolates of similar genus or organism group. However, the efficacy of cefixime in treating clinical infections caused by these bacteria has not been established in adequate and well-controlled clinical trials.


    Gram-positive Bacteria
    Streptococcus agalactiae


    Gram-negative Bacteria
    Citrobacter amalonaticus
    Citrobacter diversus
    Haemophilus parainfluenzae
    Klebsiella oxytoca
    Klebsiella pneumoniae
    Pasteurella multocida
    Proteus vulgaris
    Providencia species
    Salmonella species
    Serratia marcescens
    Shigella species


    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 to evaluate carcinogenic potential have not been conducted. Cefixime did not cause point mutations in bacteria or mammalian cells, DNA damage, or chromosome damage in vitro and did not exhibit clastogenic potential in vivo in the mouse micronucleus test. In the fertility and reproductive performance study in rats, no difference between control and drug-treated animals was detected in mating behavior, pregnancy rate, or litter parameters (determined at sacrifice on day 13 of pregnancy) at oral doses up to 1000 mg/kg/day (25 times the adult therapeutic dose) administered to males (for 68 days prior to pairing and during the cohabitation period) and females (for 14 days before pairing to weaning).

  • 15 REFERENCES

    1. Halperin-Walega, E. Batra VK, Tonelli AP, Barr A, Yacobi A. ‘Disposition of Cefixime in the Pregnant and Lactating Rat. Transfer to the Fetus and Nursing Pup’. Drug Metabolism and Disposition. 1988:16(1): pp130–134.
  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    Cefixime Capsules, 400 mg are size “0” capsules with pink opaque cap imprinted with “CMI” and pink opaque body imprinted with “400” in black ink containing white to yellowish white powder containing 400 mg of cefixime USP as the trihydrate. They are supplied as follows:


                         Bottles of 50                                                   NDC: 59651-647-50

                         Cartons of 10 (1 x 10) Unit-dose Capsules    NDC: 59651-647-10


    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]

  • 17 PATIENT COUNSELING INFORMATION

    Development of Drug Resistance Bacteria

    Patients should be counseled that antibacterial drugs, including cefixime, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When cefixime is prescribed to treat a bacterial infection, patients should be told 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 cefixime or other antibacterial drugs in the future.


    Diarrhea


    Advise patients that diarrhea is a common problem caused by antibacterial drugs, including cefixime, which usually ends when the antibacterial drug is discontinued. Sometimes after starting treatment with antibacterial drugs, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial drug. If this occurs, patients should contact their physician as soon as possible.


    The brands listed are trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited.


    Distributed by:
    Aurobindo Pharma USA, Inc.
    279 Princeton-Hightstown Road
    East Windsor, NJ 08520

    Manufactured by:
    Aurobindo Pharma Limited
    Hyderabad-500 032, India

    Revised: 03/2026

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 400 mg Container Label (50 Capsules Bottle)

    NDC: 59651-647-50

    Cefixime Capsules
    400 mg

    Rx only       50 Capsules

    Aurobindo

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 400 mg Container Label (50 Capsules Bottle)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 400 mg Blister Carton Label (10 Capsules)

    NDC: 59651-647-10

    Rx only

    Cefixime Capsules
    400 mg

    SINGLE UNIT PACKAGE

    Aurobindo     10 Capsules
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 400 mg Container Carton Label (50 Capsules Bottle)

  • INGREDIENTS AND APPEARANCE
    CEFIXIME 
    cefixime capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 59651-647
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CEFIXIME (UNII: 97I1C92E55) (CEFIXIME ANHYDROUS - UNII:XZ7BG04GJX) CEFIXIME ANHYDROUS400 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 120000 MW) (UNII: NZ94SDL6WR)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeCAPSULESize21mm
    FlavorImprint Code CMI;400
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 59651-647-5050 in 1 BOTTLE; Type 0: Not a Combination Product03/23/2026
    2NDC: 59651-647-101 in 1 CARTON03/23/2026
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21760703/23/2026
    Labeler - Aurobindo Pharma Limited (650082092)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited918917639ANALYSIS(59651-647) , MANUFACTURE(59651-647)
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