CEFDINIR- cefdinir_capsule

CLINICAL PHARMACOLOGY
Absorption Oral Bioavailability Maximal plasma cefdinir concentrations occur 2 to 4 hours postdose following capsule or suspension administration. Plasma cefdinir concentrations increase with dose, but the increases are less than dose-proportional from 300 mg (7 mg/kg) to 600 mg (14 mg/kg). Following administration of suspension to healthy adults, cefdinir bioavailability is 120% relative to capsules. Estimated bioavailability of cefdinir capsules is 21% following administration of a 300 mg capsule dose, and 16% following administration of a 600 mg capsule dose. Estimated absolute bioavailability of cefdinir suspension is 25%. Effect of Food The C max max Cefdinir Capsules Cefdinir plasma concentrations and pharmacokinetic parameter values following administration of single 300 and 600 mg oral doses of cefdinir to adult subjects are presented in the following table: Mean (+/-SD) Plasma Cefdinir Pharmacokinetic Parameter Values Dose C max (mcg /mL) t max AUC(mcghr/mL) Multiple Dosing Cefdinir does not accumulate in plasma following once- or twice-daily administration to subjects with normal renal function. Distribution The mean volume of distribution (Vd area area Skin Blister In adult subjects, median (range) maximal blister fluid cefdinir concentrations of 0. 9) mcg/mL were observed 4 to 5 hours following administration of 300 and 600 mg doses, respectively. Mean (+/-SD) blister C max Tonsil Tissue In adult patients undergoing elective tonsillectomy, respective median tonsil tissue cefdinir concentrations 4 hours after administration of single 300 and 600 mg doses were 0. Mean tonsil tissue concentrations were 24% (+/-8) of corresponding plasma concentrations. Sinus Tissue In adult patients undergoing elective maxillary and ethmoid sinus surgery, respective median sinus tissue cefdinir concentrations 4 hours after administration of single 300 and 600 mg doses were < 0. Mean sinus tissue concentrations were 16% (+/-20) of corresponding plasma concentrations. Lung Tissue In adult patients undergoing diagnostic bronchoscopy, respective median bronchial mucosa cefdinir concentrations 4 hours after administration of single 300 and 600 mg doses were 0. 92) mcg/mL, and were 31% (+/-18) of corresponding plasma concentrations. Respective median epithelial lining fluid concentrations were 0. 59) mcg/mL, and were 35% (+/-83) of corresponding plasma concentrations. Middle Ear Fluid In 14 pediatric patients with acute bacterial otitis media, respective median middle ear fluid cefdinir concentrations 3 hours after administration of single 7 and 14 mg/kg doses were 0. Mean middle ear fluid concentrations were 15% (+/-15) of corresponding plasma concentrations. CSF Data on cefdinir penetration into human cerebrospinal fluid are not available. Metabolism and Excretion Cefdinir is not appreciably metabolized. Activity is primarily due to parent drug. Cefdinir is eliminated principally via renal excretion with a mean plasma elimination half-life (t 1/2 Special Populations: Because renal excretion is the predominant pathway of elimination, dosage should be adjusted in patients with markedly compromised renal function or who are undergoing hemodialysis (see DOSAGE AND ADMINISTRATION Special Populations Patients with Renal Insufficiency Cefdinir pharmacokinetics were investigated in 21 adult subjects with varying degrees of renal function. Decreases in cefdinir elimination rate, apparent oral clearance (CL/F), and renal clearance were approximately proportional to the reduction in creatinine clearance (CL cr cr max 1/2 cr max 1/2 DOSAGE AND ADMINISTRATION Hemodialysis Cefdinir pharmacokinetics were studied in 8 adult subjects undergoing hemodialysis. Dialysis (4 hours duration) removed 63% of cefdinir from the body and reduced apparent elimination t 1/2 DOSAGE AND ADMINISTRATION Hepatic Disease Because cefdinir is predominantly renally eliminated and not appreciably metabolized, studies in patients with hepatic impairment were not conducted. It is not expected that dosage adjustment will be required in this population. Geriatric Patients The effect of age on cefdinir pharmacokinetics after a single 300 mg dose was evaluated in 32 subjects 19 to 91 years of age. Systemic exposure to cefdinir was substantially increased in older subjects (N=16), C max 1/2 Patients with Renal Insufficiency Gender and Race The results of a meta-analysis of clinical pharmacokinetics (N=217) indicated no significant impact of either gender or race on cefdinir pharmacokinetics. Mechanism of Action As with other cephalosporins, bactericidal activity of cefdinir results from inhibition of cell wall synthesis. Cefdinir is stable in the presence of some, but not all, beta-lactamase enzymes. As a result, many organisms resistant to penicillins and some cephalosporins are susceptible to cefdinir. Mechanism of Resistance Resistance to cefdinir is primarily through hydrolysis by some beta-lactamases, alteration of penicillinbinding proteins (PBPs) and decreased permeability. Cefdinir is inactive against most strains of Enterobacter Pseudomonas Enterococcus H. influenza Antimicrobial Activity Cefdinir has been shown to be active against most strains of the following microorganisms, both in vitro INDICATIONS AND USAGE Gram-Po sitive Bacteria Staphylococcus aureus Streptococcus pneumoniae Streptococcus pyogenes Gram-Neg ative Bacteria Haemophilus influenzae Haemophilus parainfluenza Moraxella catarrhalis The following in vitro data are available, but their clinical significance is unknown. Cefdinir exhibits in vitro Gram-Po sitive Bacteria Staphylococcus epidermidis Streptococcus agalactiae Viridans group streptococci Gram-Neg ative Bacteria Citrobacter koseri Escherichia coli Klebsiella pneumoniae 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.
Pharmacokinetics and Drug Metabolism
Absorption Oral Bioavailability Maximal plasma cefdinir concentrations occur 2 to 4 hours postdose following capsule or suspension administration. Plasma cefdinir concentrations increase with dose, but the increases are less than dose-proportional from 300 mg (7 mg/kg) to 600 mg (14 mg/kg). Following administration of suspension to healthy adults, cefdinir bioavailability is 120% relative to capsules. Estimated bioavailability of cefdinir capsules is 21% following administration of a 300 mg capsule dose, and 16% following administration of a 600 mg capsule dose. Estimated absolute bioavailability of cefdinir suspension is 25%. Effect of Food The C max max Cefdinir Capsules Cefdinir plasma concentrations and pharmacokinetic parameter values following administration of single 300 and 600 mg oral doses of cefdinir to adult subjects are presented in the following table: Mean (+/-SD) Plasma Cefdinir Pharmacokinetic Parameter Values Dose C max (mcg /mL) t max AUC(mcghr/mL) Multiple Dosing Cefdinir does not accumulate in plasma following once- or twice-daily administration to subjects with normal renal function. Distribution The mean volume of distribution (Vd area area Skin Blister In adult subjects, median (range) maximal blister fluid cefdinir concentrations of 0.65 (0.33 to 1.1) and 1.1 (0.49 to 1.9) mcg/mL were observed 4 to 5 hours following administration of 300 and 600 mg doses, respectively. Mean (+/-SD) blister C max Tonsil Tissue In adult patients undergoing elective tonsillectomy, respective median tonsil tissue cefdinir concentrations 4 hours after administration of single 300 and 600 mg doses were 0.25 (0.22 to 0.46) and 0.36 (0.22 to 0.80) mcg/g. Mean tonsil tissue concentrations were 24% (+/-8) of corresponding plasma concentrations. Sinus Tissue In adult patients undergoing elective maxillary and ethmoid sinus surgery, respective median sinus tissue cefdinir concentrations 4 hours after administration of single 300 and 600 mg doses were < 0.12 (< 0.12 to 0.46) and 0.21 (< 0.12 to 2.0) mcg/g. Mean sinus tissue concentrations were 16% (+/-20) of corresponding plasma concentrations. Lung Tissue In adult patients undergoing diagnostic bronchoscopy, respective median bronchial mucosa cefdinir concentrations 4 hours after administration of single 300 and 600 mg doses were 0.78 (< 0.06 to 1.33) and 1.14 (< 0.06 to 1.92) mcg/mL, and were 31% (+/-18) of corresponding plasma concentrations. Respective median epithelial lining fluid concentrations were 0.29 (< 0.3 to 4.73) and 0.49 (< 0.3 to 0.59) mcg/mL, and were 35% (+/-83) of corresponding plasma concentrations. Middle Ear Fluid In 14 pediatric patients with acute bacterial otitis media, respective median middle ear fluid cefdinir concentrations 3 hours after administration of single 7 and 14 mg/kg doses were 0.21 (< 0.09 to 0.94) and 0.72 (0.14 to 1.42) mcg/mL. Mean middle ear fluid concentrations were 15% (+/-15) of corresponding plasma concentrations. CSF Data on cefdinir penetration into human cerebrospinal fluid are not available. Metabolism and Excretion Cefdinir is not appreciably metabolized. Activity is primarily due to parent drug. Cefdinir is eliminated principally via renal excretion with a mean plasma elimination half-life (t 1/2 Special Populations: Because renal excretion is the predominant pathway of elimination, dosage should be adjusted in patients with markedly compromised renal function or who are undergoing hemodialysis (see DOSAGE AND ADMINISTRATION Special Populations Patients with Renal Insufficiency Cefdinir pharmacokinetics were investigated in 21 adult subjects with varying degrees of renal function. Decreases in cefdinir elimination rate, apparent oral clearance (CL/F), and renal clearance were approximately proportional to the reduction in creatinine clearance (CL cr cr max 1/2 cr max 1/2 DOSAGE AND ADMINISTRATION Hemodialysis Cefdinir pharmacokinetics were studied in 8 adult subjects undergoing hemodialysis. Dialysis (4 hours duration) removed 63% of cefdinir from the body and reduced apparent elimination t 1/2 DOSAGE AND ADMINISTRATION Hepatic Disease Because cefdinir is predominantly renally eliminated and not appreciably metabolized, studies in patients with hepatic impairment were not conducted. It is not expected that dosage adjustment will be required in this population. Geriatric Patients The effect of age on cefdinir pharmacokinetics after a single 300 mg dose was evaluated in 32 subjects 19 to 91 years of age. Systemic exposure to cefdinir was substantially increased in older subjects (N=16), C max 1/2 Patients with Renal Insufficiency Gender and Race The results of a meta-analysis of clinical pharmacokinetics (N=217) indicated no significant impact of either gender or race on cefdinir pharmacokinetics.
Microbiology
Mechanism of Action As with other cephalosporins, bactericidal activity of cefdinir results from inhibition of cell wall synthesis. Cefdinir is stable in the presence of some, but not all, beta-lactamase enzymes. As a result, many organisms resistant to penicillins and some cephalosporins are susceptible to cefdinir. Mechanism of Resistance Resistance to cefdinir is primarily through hydrolysis by some beta-lactamases, alteration of penicillinbinding proteins (PBPs) and decreased permeability. Cefdinir is inactive against most strains of Enterobacter Pseudomonas Enterococcus H. influenza Antimicrobial Activity Cefdinir has been shown to be active against most strains of the following microorganisms, both in vitro INDICATIONS AND USAGE Gram-Po sitive Bacteria Staphylococcus aureus Streptococcus pneumoniae Streptococcus pyogenes Gram-Neg ative Bacteria Haemophilus influenzae Haemophilus parainfluenza Moraxella catarrhalis The following in vitro data are available, but their clinical significance is unknown. Cefdinir exhibits in vitro Gram-Po sitive Bacteria Staphylococcus epidermidis Streptococcus agalactiae Viridans group streptococci Gram-Neg ative Bacteria Citrobacter koseri Escherichia coli Klebsiella pneumoniae 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.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir capsules and other antibacterial drugs, cefdinir capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. 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 Haemophilus parainfluenzae Streptococcus pneumoniae Moraxella catarrhalis CLINICAL STUDIES Acute Exacerbations of Chronic Bronchitis Caused by Haemophilus influenzae Haemophilus parainfluenzae Streptococcus pneumoniae Moraxella catarrhalis Acute Maxillary Sinusitis Caused by Haemophilus influenzae Streptococcus pneumoniae Moraxella catarrhalis NOTE: Pediatric Use DOSAGE AND ADMINISTRATION Pharyngitis/Tonsillitis Caused by Streptococcus pyogenes CLINICAL STUDIES NOTE: S. pyogenes S. pyogenes Uncomplicated Skin and Skin Structure Infections Caused by Staphylococcus aureus Streptococcus pyogenes Pediatric Patients Acute Bacterial Otitis Media Caused by Haemophilus influenzae Streptococcus pneumoniae Moraxella catarrhalis Pharyngitis/Tonsillitis Caused by Streptococcus pyogenes CLINICAL STUDIES NOTE: S. pyogenes S. pyogenes Uncomplicated Skin and Skin Structure Infections Caused by Staphylococcus aureus Streptococcus pyogenes

(see INDICATIONS AND USAGE Type of Infection Dosage Duration Community-Acquired Pneumonia 300 mg q12h 10 days Acute Exacerbations of Chronic 300 mg q12h 5 to 10 days Acute Maxillary Sinusitis 300 mg q12h 10 days Pharyngitis/Tonsillitis 300 mg q12h 5 to 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. cr Males: CL cr (weight) (140en dashage) (72) (serum creatinine) Females: CL cr 0 .8 5 x above value where creatinine clearance is in mL/min, age is in years, weight is in kilograms, and serum creatinine is in mg/dL. 1 The following formula may be used to estimate creatinine clearance in pediatric patients: CL cr body length or height serum creatinine where K=0.55 for pediatric patients older than 1 year 2 3 In the above equation, creatinine clearance is in mL/min/1.73 m 2 For pediatric patients with a creatinine clearance of < 30 mL/min/1.73 m 2 Patients on Hemodialysis

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 pain 1% Vaginitis 1% of women Incidence < 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 Incidence >=1% up arrowUrine leukocytes 2% up arrowUrine protein 2% up arrowGamma-glutamyltransferase * 1% down arrowLymphocytes, up arrowLymphocytes 1%, 0.2% up arrowMicrohematuria 1% Incidence < 1% up arrowGlucose * 0.9% up arrowUrine glucose 0.9% up arrowWhite blood cells, down arrowWhite blood cells 0.9%,0.7% up arrowAlanine aminotransferase (ALT) 0.7% up arrowEosinophils 0.7% up arrowUrine specific gravity, down arrowUrine specific gravity * 0.6%,0.2% down arrowBicarbonate 0.6% up arrowPhosphorus, down arrowPhosphorus 0.6%, 0.3% up arrowAspartate aminotransferase (AST) 0.4% up arrowAlkaline phosphatase 0.3% up arrowBlood urea nitrogen (BUN) 0.3% down arrowHemoglobin 0.3% up arrowPolymorphonuclear neutrophils (PMNs), down arrowPMNs 0.3%,0.2% up arrowBilirubin 0.2% up arrowLactate dehydrogenase * 0.2% up arrowPlatelets 0.2% up arrowPotassium * 0.2% up arrowUrine pH * 0.2% * N < 3841 for these parameters Postmarketing Experience 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 OVERDOSAGE Anticonvulsant therapy can be given if clinically indicated.

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

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/m 2 2 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.
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

DRUG INTERACTIONS
Antacids (Aluminum- or Magnesium-Containing) Concomitant administration of 300 mg cefdinir capsules with 30 mL Maalox registered max max Probenecid As with other beta-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 t 1/2 Iron Supplements and Foods Fortified With Iron Concomitant administration of cefdinir with a therapeutic iron supplement containing 60 mg of elemental iron (as FeSO 4 The effect of foods highly fortified with elemental iron (primarily iron-fortified breakfast cereals) on cefdinir absorption has not been studied. 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 & OR 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 Clinitestregistered, Benedict’s solution, or Fehling’s solution. It is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistixregistered or Tes-Taperegistered) be used. Cephalosporins are known to occasionally induce a positive direct Coombs’ test.

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 beta-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO 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 C. difficile C. difficile C. difficile If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile C. difficile
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 vivo 2
LABOR & DELIVERY
Cefdinir has not been studied for use during labor and delivery.
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 beta-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.
CLINICAL STUDIES
Community-Acquired Bacterial Pneumonia In a controlled, double-blind study in adults and adolescents conducted in the U.S., cefdinir b.i.d. was compared with cefaclor 500 mg t.i.d.. 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 b.i.d. Cefaclort.i.d Outcome 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 b.i.d. was compared with amoxicillin/clavulanate 500/125 mg t.i.d. 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 b.i.d. Amoxicillin/ Clavulanate t.i.d. 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 q.d. or b.i.d. to penicillin 250 mg or 10 mg/kg q.i.d. 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 C e f d i n i r q.d. C e f d i n i r b.i.d. P e n i c illi n q.i.d. O u t c o m e Adults/ Adolescents Eradication of S. pyogenes 192/210 199 /217 (92%) 181/217 Cefdinir superior to control 199/210 209 /217 193/217 Cefdinir superior to control Pediatric Patients Eradication of S. 215/228 214/227 159/227 Cefdinir superior to control 222/228 218/227 196/227 Cefdinir superior to control Two studies (one in adults and adolescents, the other in pediatric patients) compared 5 days of cefdinir b.i.d. to 10 days of penicillin 250 mg or 10 mg/kg q.i.d.. Using strict evaluability and microbiologic/clinical response criteria 4 to 10 days post therapy, 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 b.i.d. Penicillin q.i.d. Outcome Adults/ Adolescents Eradication of S. pyogenes 193/218 (89%) 176/214 (82%) Cefdinir equivalent to control 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 179/196 (91%) 173/193 (90%) Cefdinir equivalent to control
REFERENCES
Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976;16:31-41. 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. 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. All brand names listed are the registered trademarks of their respective owners and are not trademarks of Alkem Laboratories Ltd. Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC 339 Jefferson Road, Parsippany, NJ 07054 Revised: June, 2023 PT2808-02

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