Cefdinir by Proficient Rx LP CEFDINIR capsule

Cefdinir by

Drug Labeling and Warnings

Cefdinir by is a Prescription medication manufactured, distributed, or labeled by Proficient Rx LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 procedure3 requires the use of standardized inoculum concentrations. This procedure uses paper disks impregnated with 5 mcg cefdinir to test the susceptibility of microorganisms to cefdinir.

Reports from the laboratory providing results of the standard single-disk susceptibility test with a 5 mcg cefdinir disk should be interpreted according to the following criteria:

For organisms other than Haemophilus spp. and Streptococcus spp4:

Zone Diameter (mm)Interpretation

≥20

Susceptible (S)

17-19

Intermediate (I)

≤16

Resistant (R)

For Haemophilus spp5:

Zone Diameter (mm)Interpretation*
  • * The current absence of data on resistant strains precludes defining any results other than “Susceptible.” Strains yielding MIC results suggestive of a “nonsusceptible” category should be submitted to a reference laboratory for further testing.
  • ≥20

    Susceptible (S)

    For Streptococcus spp:

    Isolates of Streptococcus pneumoniae should be tested against a 1 mcg oxacillin disk. Isolates with oxacillin zone sizes ≥20 mm are susceptible to penicillin and can be considered susceptible to cefdinir. Streptococci other than S. pneumoniae should be tested with a 10-unit penicillin disk. Isolates with penicillin zone sizes ≥28 mm are susceptible to penicillin and can be considered susceptible to cefdinir.

    As with standardized dilution techniques, diffusion methods require the use of laboratory control microorganisms to control the technical aspects of laboratory procedures. For the diffusion technique, the 5-mcg cefdinir disk should provide the following zone diameters in these laboratory quality control strains:

    OrganismZone Diameter (mm)
  • * This quality control range is applicable only to testing of H. influenzae ATCC 49766 using HTM.
  • Escherichia coli

    ATCC 25922

    24-28

    Haemophilus influenzae

    ATCC 49766*

    24-31

    Staphylococcus aureus

    ATCC 25923

    25-32


  • 3 National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests, 6th ed. Approved Standard, NCCLS Document M2-A6, Vol 17(1). NCCLS, Villanova, PA, Jan 1997.
  • 4 Because certain strains of Citrobacter, Providencia, and Enterobacter spp. have been reported to give false susceptible results with the cefdinir disk, strains of these genera should not be tested and reported with this disk.
  • 5 These zone diameter standards are applicable only to tests with Haemophilus spp. using HTM. (see reference 2)
  • INDICATIONS AND USAGE

    To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir 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.

    Cefdinir capsules are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.

    Adults and Adolescents

    Community-Acquired Pneumonia caused by Haemophilus influenzae (including β-lactamase producing strains), Haemophilus parainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains) (see CLINICAL STUDIES).

    Acute Exacerbations of Chronic Bronchitis caused by Haemophilus influenzae (including β-lactamase producing strains), Haemophilus parainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains).

    Acute Maxillary Sinusitis caused by Haemophilus influenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains).

    NOTE: For information on use in pediatric patients, see Pediatric Use and DOSAGE AND ADMINISTRATION.

    Pharyngitis/Tonsillitis caused by Streptococcus pyogenes (see CLINICAL STUDIES).

    NOTE: Cefdinir capsules are effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.

    Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus (including β-lactamase producing strains) and Streptococcus pyogenes.

    Pediatric Patients

    Acute Bacterial Otitis Media caused by Haemophilus influenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains).

    Pharyngitis/Tonsillitis caused by Streptococcus pyogenes (see CLINICAL STUDIES).

    NOTE: Cefdinir capsules are effective in the eradication of S. pyogenes from the oropharynx. Cefdinir capsules has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.

    Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus (including β-lactamase producing strains) and Streptococcus pyogenes.

  • CONTRAINDICATIONS

    Cefdinir is contraindicated in patients with known allergy to the cephalosporin class of antibiotics.

  • WARNINGS

    BEFORE THERAPY WITH CEFDINIR IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFDINIR, OTHER CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF CEFDINIR IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG β-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 CEFDINIR OCCURS, THE DRUG SHOULD BE DISCONTINUED. 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.

    Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cefdinir, 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.

  • PRECAUTIONS

    General

    Prescribing cefdinir 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.

    As with other broad-spectrum antibiotics, prolonged treatment may result in the possible emergence and overgrowth of resistant organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate alternative therapy should be administered.

    Cefdinir, as with other broad-spectrum antimicrobials (antibiotics), should be prescribed with caution in individuals with a history of colitis.

    In patients with transient or persistent renal insufficiency (creatinine clearance <30 mL/min), the total daily dose of cefdinir should be reduced because high and prolonged plasma concentrations of cefdinir can result following recommended doses (see DOSAGE AND ADMINISTRATION).

    Information for Patients

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

    Antacids containing magnesium or aluminum interfere with the absorption of cefdinir. If this type of antacid is required during cefdinir therapy, cefdinir should be taken at least 2 hours before or after the antacid.

    Iron supplements, including multivitamins that contain iron, interfere with the absorption of cefdinir. If iron supplements are required during cefdinir therapy, cefdinir should be taken at least 2 hours before or after the supplement.

    Iron-fortified infant formula does not significantly interfere with the absorption of cefdinir.

    Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, 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 antibiotic. If this occurs, patients should contact their physician as soon as possible.

    Drug Interactions

    Antacids:

    (aluminum- or magnesium-containing): Concomitant administration of 300 mg cefdinir capsules with 30 mL Maalox® TC suspension reduces the rate (Cmax) and extent (AUC) of absorption by approximately 40%. Time to reach Cmax is also prolonged by 1 hour. There are no significant effects on cefdinir pharmacokinetics if the antacid is administered 2 hours before or 2 hours after cefdinir. If antacids are required during cefdinir therapy, cefdinir should be taken at least 2 hours before or after the antacid.

    Probenecid:

    As with other β-lactam antibiotics, probenecid inhibits the renal excretion of cefdinir, resulting in an approximate doubling in AUC, a 54% increase in peak cefdinir plasma levels, and a 50% prolongation in the apparent elimination t½.

    Iron Supplements and Foods Fortified With Iron:

    Concomitant administration of cefdinir with a therapeutic iron supplement containing 60 mg of elemental iron (as FeSO4) or vitamins supplemented with 10 mg of elemental iron reduced extent of absorption by 80% and 31%, respectively. If iron supplements are required during cefdinir therapy, cefdinir should be taken at least 2 hours before or after the supplement.

    The effect of foods highly fortified with elemental iron (primarily iron-fortified breakfast cereals) on cefdinir absorption has not been studied.

    Concomitantly administered iron-fortified infant formula (2.2 mg elemental iron/6 oz) has no significant effect on cefdinir pharmacokinetics.

    There have been reports of reddish stools in patients receiving cefdinir. In many cases, patients were also receiving iron-containing products. The reddish color is due to the formation of a nonabsorbable complex between cefdinir or its breakdown products and iron in the gastrointestinal tract.

    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 cefdinir may result in a false-positive reaction for glucose in urine using Clinitest®, Benedict’s solution, or Fehling's solution. It is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix® or Tes-Tape®) be used. Cephalosporins are known to occasionally induce a positive direct Coombs’ test.

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    The carcinogenic potential of cefdinir has not been evaluated. No mutagenic effects were seen in the bacterial reverse mutation assay (Ames) or point mutation assay at the hypoxanthine-guanine phosphoribosyltransferase locus (HGPRT) in V79 Chinese hamster lung cells. No clastogenic effects were observed in vitro in the structural chromosome aberration assay in V79 Chinese hamster lung cells or in vivo in the micronucleus assay in mouse bone marrow. In rats, fertility and reproductive performance were not affected by cefdinir at oral doses up to 1000 mg/kg/day (70 times the human dose based on mg/kg/day, 11 times based on mg/m2/day).

    Pregnancy

    Teratogenic Effects

    Pregnancy Category B:

    Cefdinir was not teratogenic in rats at oral doses up to 1000 mg/kg/day (70 times the human dose based on mg/kg/day, 11 times based on mg/m2/day) or in rabbits at oral doses up to 10 mg/kg/day (0.7 times the human dose based on mg/kg/day, 0.23 times based on mg/m2/day). Maternal toxicity (decreased body weight gain) was observed in rabbits at the maximum tolerated dose of 10 mg/kg/day without adverse effects on offspring. Decreased body weight occurred in rat fetuses at ≥100 mg/kg/day, and in rat offspring at ≥32 mg/kg/day. No effects were observed on maternal reproductive parameters or offspring survival, development, behavior, or reproductive function.

    There are, however, 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.

    Labor and Delivery

    Cefdinir has not been studied for use during labor and delivery.

    Nursing Mothers

    Following administration of single 600 mg doses, cefdinir was not detected in human breast milk.

    Pediatric Use

    Safety and efficacy in neonates and infants less than 6 months of age have not been established. Use of cefdinir for the treatment of acute maxillary sinusitis in pediatric patients (age 6 months through 12 years) is supported by evidence from adequate and well-controlled studies in adults and adolescents, the similar pathophysiology of acute sinusitis in adult and pediatric patients, and comparative pharmacokinetic data in the pediatric population.

    Geriatric Use

    Efficacy is comparable in geriatric patients and younger adults. While cefdinir has been well-tolerated in all age groups, in clinical trials geriatric patients experienced a lower rate of adverse events, including diarrhea, than younger adults. Dose adjustment in elderly patients is not necessary unless renal function is markedly compromised (see DOSAGE AND ADMINISTRATION).

  • ADVERSE EVENTS

    Clinical Trials - Cefdinir Capsules (Adult and Adolescent Patients)

    In clinical trials, 5093 adult and adolescent patients (3841 U.S. and 1252 non-U.S.) were treated with the recommended dose of cefdinir capsules (600 mg/day). Most adverse events were mild and self-limiting. No deaths or permanent disabilities were attributed to cefdinir. One hundred forty-seven of 5093 (3%) patients discontinued medication due to adverse events thought by the investigators to be possibly, probably, or definitely associated with cefdinir therapy. The discontinuations were primarily for gastrointestinal disturbances, usually diarrhea or nausea. Nineteen of 5093 (0.4%) patients were discontinued due to rash thought related to cefdinir administration.

    In the U.S., the following adverse events were thought by investigators to be possibly, probably, or definitely related to cefdinir capsules in multiple-dose clinical trials (N = 3841 cefdinir-treated patients):

    ADVERSE EVENTS ASSOCIATED WITH CEFDINIR CAPSULES U.S. TRIALS IN ADULT AND ADOLESCENT PATIENTS (N=3841)*

     Incidence 1% 

     Diarrhea

     15%

     Vaginal moniliasis

     4% of women

     Nausea

     3%

     Headache

     2%

     Abdominal pain1%

     1%

     Vaginitis

     1% of women

     Incidence <1% but >0.1%

     Rash

     0.9%

     Dyspepsia

     0.7%

     Flatulence

     0.7%

     Vomiting

     0.7%

     Abnormal stools

     0.3%

     Anorexia

     0.3%

     Constipation

     0.3%

     Dizziness

     0.3%

     Dry mouth

     0.3%

     Asthenia

     0.2%

     Insomnia

     0.2%

    Leukorrhea

    0.2% of women

    Moniliasis

    0.2%

    Pruritus

    0.2%

    Somnolence

    0.2%

     *1733 males, 2108 females

    The following laboratory value changes of possible clinical significance, irrespective of relationship to therapy with cefdinir, were seen during clinical trials conducted in the U.S.:

    LABORATORY VALUE CHANGES OBSERVED WITH CEFDINIR CAPSULES U.S. TRIALS IN ADULT AND ADOLESCENT PATIENTS (N=3841)

    Incidence 1%

    Urine leukocytes

    2%

    Urine protein

    2%

    Gamma-glutamyltransferase*

    1%

    Lymphocytes, Lymphocytes

    1%, 0.2%

    Microhematuria

    1%

    Incidence <1% but >0.1%

    Glucose*

    0.9%

    Urine glucose

    0.9%

    White blood cells, White blood cells

    0.9%, 0.7%

    Alanine aminotransferase (ALT)

    0.7%

    Eosinophils

    0.7%

    Urine specific gravity, Urine specific gravity*

    0.6%, 0.2%

    Bicarbonate*

    0.6%

    Phosphorus, Phosphorus*

    0.6%, 0.3%

    Aspartate aminotransferase (AST)

    0.4%

    Alkaline phosphatase

    0.3%

    Blood urea nitrogen (BUN)

    0.3%

    Hemoglobin

    0.3%

    Polymorphonuclear neutrophils (PMNs),PMNs

    0.3%, 0.2%

    Bilirubin

    0.2%

    Lactate dehydrogenase*

    0.2%

    Platelets

    0.2%

    Potassium*

    0.2%

    Urine pH*

    0.2%

    *N<3841 for these parameters

    Postmarketing Experience

    The following adverse experiences and altered laboratory tests, regardless of their relationship to cefdinir, have been reported during extensive postmarketing experience, beginning with approval in Japan in 1991: shock, anaphylaxis with rare cases of fatality, facial and laryngeal edema, feeling of suffocation, serum sickness-like reactions, conjunctivitis, stomatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, erythema multiforme, erythema nodosum, acute  hepatitis, cholestasis, fulminant hepatitis, hepatic failure, jaundice, increased amylase, acute enterocolitis, bloody diarrhea, hemorrhagic colitis, melena, pseudomembranous colitis, pancytopenia, granulocytopenia, leucopenia, thrombocytopenia, idiopathic thrombocytopenic purpura, hemolytic anemia, acute respiratory failure, asthmatic attack, drug-induced pneumonia, eosinophilic pneumonia, idiopathic interstitial pneumonia, fever, acute renal failure, nephropathy, bleeding tendency, coagulation disorder, disseminated intravascular coagulation, upper GI bleed, peptic ulcer, ileus, loss of consciousness, allergic vasculitis, possible cefdinir-diclofenac interaction, cardiac failure, chest pain, myocardial infarction, hypertension, involuntary movements, and rhabdomyolysis.

    Cephalosporin Class Adverse Events

    The following adverse events and altered laboratory tests have been reported for cephalosporin-class antibiotics in general:

    Allergic reactions, anaphylaxis, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, renal dysfunction, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemolytic anemia, hemorrhage, false-positive test for urinary glucose, neutropenia, pancytopenia, and agranulocytosis. Pseudomembranous colitis symptoms may begin during or after antibiotic treatment (see WARNINGS).

    Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced (see DOSAGE AND ADMINISTRATION and OVERDOSAGE). If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

  • OVERDOSAGE

    Information on cefdinir overdosage in humans is not available. In acute rodent toxicity studies, a single oral 5600 mg/kg dose produced no adverse effects. Toxic signs and symptoms following overdosage with other β-lactam antibiotics have included nausea, vomiting, epigastric distress, diarrhea, and convulsions. Hemodialysis removes cefdinir from the body. This may be useful in the event of a serious toxic reaction from overdosage, particularly if renal function is compromised.

  • DOSAGE AND ADMINISTRATION

    (see INDICATIONS AND USAGE for Indicated Pathogens)

    The recommended dosage and duration of treatment for infections in adults and adolescents are described in the following chart; the total daily dose for all infections is 600 mg. Once-daily dosing for 10 days is as effective as BID dosing. Once-daily dosing has not been studied in pneumonia or skin infections; therefore, Cefdinir Capsules should be administered twice daily in these infections. Cefdinir Capsules may be taken without regard to meals.

    Adults and Adolescents (Age 13 Years and Older)

    Type of Infection

    Dosage

    Duration

    Community-Acquired Pneumonia

    300 mg q12h

    10 days

    Acute Exacerbations of Chronic Bronchitis

    300 mg q12h
    or
    600 mg q24h

    5 to 10 days

    10 days

    Acute Maxillary Sinusitis

    300 mg q12h
    or
    600 mg q24h

    10 days

    10 days

    Pharyngitis/Tonsillitis

    300 mg q12h
    or
    600 mg q24h

    5 to 10 days

    10 days

    Uncomplicated Skin and Skin Structure Infections

    300 mg q12h

    10 days

    Patients With Renal Insufficiency

    For adult patients with creatinine clearance <30 mL/min, the dose of cefdinir should be 300 mg given once daily.

    Creatinine clearance is difficult to measure in outpatients. However, the following formula may be used to estimate creatinine clearance (CLcr) in adult patients. For estimates to be valid, serum creatinine levels should reflect steady-state levels of renal function.

    Males:                    CLcr = (weight) (140 – age)

                                              (72) (serum creatinine)

    Females:                CLcr = 0.85 x above value

    where creatinine clearance is in mL/min, age is in years, weight is in kilograms, and serum creatinine is in mg/dL6.

    The following formula may be used to estimate creatinine clearance in pediatric patients:

                                CLcr = K x body length or height

                                              serum creatinine

    where K = 0.55 for pediatric patients older than 1 year7 and 0.45 for infants (up to 1 year)8.

    In the above equation, creatinine clearance is in mL/min/1.73 m2, body length or height is in centimeters, and serum creatinine is in mg/dL.

    For pediatric patients with a creatinine clearance of <30 mL/min/1.73 m2, the dose of cefdinir should be 7 mg/kg (up to 300 mg) given once daily.


  • 6 Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976; 16:31-41.
  • 7 Schwartz GJ, Haycock GB, Edelmann CM, Spitzer A. A simple estimate of glomerular filtration rate in children derived from body length and plasma creatinine. Pediatrics 1976; 58:259-63.
  • 8 Schwartz GJ, Feld LG, Langford DJ. A simple estimate of glomerular filtration rate in full-term infants during the first year of life. J Pediatrics 1984; 104:849-54.
  • Patients on Hemodialysis

    Hemodialysis removes cefdinir from the body. In patients maintained on chronic hemodialysis, the recommended initial dosage regimen is a 300 mg or 7 mg/kg dose every other day. At the conclusion of each hemodialysis session, 300 mg (or 7 mg/kg) should be given. Subsequent doses (300 mg or 7 mg/kg) are then administered every other day.

  • HOW SUPPLIED

    Cefdinir Capsules USP, 300 mg: Purple Opaque Cap / Teal Opaque body, size “0” hard gelatin capsules imprinted “C” on cap & “300” on body with black ink, filled with off-white to yellow granular powder.

    They are supplied as follows:

    Bottles of 20 NDC: 63187-593-20

    Bottles of 28 NDC: 63187-593-28

    Bottles of 30 NDC: 63187-593-30

    Bottles of 40 NDC: 63187-593-40

    Bottles of 60 NDC: 63187-593-60

    Store the capsules at 20 to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

  • CLINICAL STUDIES

    Community-Acquired Bacterial Pneumonia

    In a controlled, double-blind study in adults and adolescents conducted in the U.S., cefdinir BID was compared with cefaclor 500 mg TID. Using strict evaluability and microbiologic/clinical response criteria 6 to 14 days posttherapy, the following clinical cure rates, presumptive microbiologic eradication rates, and statistical outcomes were obtained:

    U.S. Community-Acquired Pneumonia Study Cefdinir vs Cefaclor
    Cefdinir BIDCefaclor TIDOutcome

    Clinical Cure Rates

    150/187 (80%)

    147/186 (79%)

    Cefdinir equivalent
    to control

    Eradication Rates
    Overall

    177/195 (91%)

    184/200 (92%)

    Cefdinir equivalent
    to control

    S. pneumoniae

    31/31 (100%)

    35/35 (100%)

    H. influenzae

    55/65 (85%)

    60/72 (83%)

    M. catarrhalis

    10/10 (100%)

    11/11 (100%)

    H. parainfluenzae

    81/89 (91%)

    78/82 (95%)

    In a second controlled, investigator-blind study in adults and adolescents conducted primarily in Europe, cefdinir BID was compared with amoxicillin/clavulanate 500/125 mg TID. Using strict evaluability and clinical response criteria 6 to 14 days posttherapy, the following clinical cure rates, presumptive microbiologic eradication rates, and statistical outcomes were obtained:

    European Community-Acquired Pneumonia Study Cefdinir vs Amoxicillin/Clavulanate
    Cefdinir BID Amoxicillin/
    Clavulanate TID
    Outcome

    Clinical Cure Rates

    83/104 (80%)

    86/97 (89%)

    Cefdinir not equivalent
    to control

    Eradication Rates
    Overall

    85/96 (89%)

    84/90 (93%)

    Cefdinir equivalent
    to control

    S. pneumoniae

    42/44 (95%)

    43/44 (98%)

    H. influenzae

    26/35 (74%)

    21/26 (81%)

    M. catarrhalis

    6/6 (100%)

    8/8 (100%)

    H. parainfluenzae

    11/11 (100%)

    12/12 (100%)

    Streptococcal Pharyngitis/Tonsillitis

    In four controlled studies conducted in the United States, cefdinir was compared with 10 days of penicillin in adult, adolescent, and pediatric patients. Two studies (one in adults and adolescents, the other in pediatric patients) compared 10 days of cefdinir QD or BID to penicillin 250 mg or 10 mg/kg QID. Using strict evaluability and microbiologic/clinical response criteria 5 to 10 days posttherapy, the following clinical cure rates, microbiologic eradication rates, and statistical outcomes were obtained:

    Pharyngitis/Tonsillitis Studies
    Cefdinir (10 days) vs Penicillin (10 days)

    Study

    Efficacy Parameter

    Cefdinir QD

    Cefdinir BID

    Penicillin QID

    Outcome

    Adults/
    Adolescents

    Eradication of
    S. pyogenes

    192/210
    (91%)

    199/217
    (92%)

    181/217
    (83%)

    Cefdinir
    superior
    to control

    Clinical Cure Rates

    199/210
    (95%)

    209/217
    (96%)

    193/217
    (89%)

    Cefdinir
    superior
    to control

    Pediatric
    Patients

    Eradication of
    S. pyogenes

    215/228
    (94%)

    214/227
    (94%)

    159/227
    (70%)

    Cefdinir
    superior
    to control

    Clinical Cure
    Rates

    222/228
    (97%)

    218/227
    (96%)

    196/227
    (86%)

    Cefdinir
    superior
    to control

    Two studies (one in adults and adolescents, the other in pediatric patients) compared 5 days of cefdinir BID to 10 days of penicillin 250 mg or 10 mg/kg QID. Using strict evaluability and microbiologic/clinical response criteria 4 to 10 days posttherapy, the following clinical cure rates, microbiologic eradication rates, and statistical outcomes were obtained:

    Pharyngitis/Tonsillitis Studies
    Cefdinir (5 days) vs Penicillin (10 days)

    Study

    Efficacy
    Parameter

    Cefdinir
    BID

    Penicillin
    QID

    Outcome

    Adults/
    Adolescents

    Eradication of
    S. pyogenes

    193/218
    (89%)

    176/214
    (82%)

    Cefdinir equivalent
    to control

    Clinical Cure
    Rates

    194/218
    (89%)

    181/214
    (85%)

    Cefdinir equivalent
    to control

    Pediatric Patients

    Eradication of
    S. pyogenes

    176/196
    (90%)

    135/193
    (70%)

    Cefdinir superior
    to control

    Clinical Cure
    Rates

    179/196
    (91%)

    173/193
    (90%)

    Cefdinir equivalent
    to control

  • REFERENCES

    Maalox® is a registered trademark of Rhone-Poulenc Rorer.

    Clinistix® and Clinitest® are registered trademarks of Miles Diagnostics.

    Tes-Tape® is a registered trademark of Lilly.

  • SPL UNCLASSIFIED SECTION

    Manufactured for : OrchidPharma, Inc.
    Princeton, NJ 08540, USA

    Manufactured by : Hospira Healthcare India Pvt.Ltd.,
    At Irungattukottai – 602 105, India

    On behalf of : Orchid Healthcare
    (A Division of Orchid Chemicals & Pharmaceuticals Ltd.)
    At Irungattukottai – 602 105, India

    Relabeled by:

    Proficient Rx LP

    Thousand Oaks, CA 91320

    I06/13

    949999291

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Rx only

    NDC: 63187-593-14

    Cefdinir Capsules, USP

    300 mg

    14 Capsules

    63187-593-14
  • INGREDIENTS AND APPEARANCE
    CEFDINIR 
    cefdinir capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 63187-593(NDC: 42043-250)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CEFDINIR MONOHYDRATE (UNII: 6E7SN358SE) (CEFDINIR - UNII:CI0FAO63WC) CEFDINIR300 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    SHELLAC (UNII: 46N107B71O)  
    ALCOHOL (UNII: 3K9958V90M)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    AMMONIA (UNII: 5138Q19F1X)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Product Characteristics
    Colorpurple (purple opaque) , blue (teal opaque) Scoreno score
    ShapecapsuleSize21mm
    FlavorImprint Code C;300
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 63187-593-1414 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2016
    2NDC: 63187-593-2020 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2015
    3NDC: 63187-593-2828 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2015
    4NDC: 63187-593-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2015
    5NDC: 63187-593-4040 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2015
    6NDC: 63187-593-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA06541807/04/2014
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079502574REPACK(63187-593) , RELABEL(63187-593)

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