CEFDINIR- cefdinir_capsule

CLINICAL PHARMACOLOGY
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%. Cefdinir oral suspension of 250 mg/5 mL strength was shown to be bioequivalent to the 125 mg/5 mL strength in healthy adults under fasting conditions. The C max max 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 Following Administration of Capsules to Adult Subjects Dose C max t max AUC 300 mg 1. 05 600 mg 2. 1 Cefdinir plasma concentrations and pharmacokinetic parameter values following administration of single 7 and 14 mg/kg oral doses of cefdinir to pediatric subjects (age 6 months to 12 years) are presented in the following table: Mean (+/-SD) Plasma Cefdinir Pharmacokinetic Parameter Values Following Administration of Suspension to Pediatric Subjects Dose C max t max AUC 7 mg/kg 2. 31 14 mg/kg 3. 4 Cefdinir does not accumulate in plasma following once- or twice-daily administration to subjects with normal renal function. The mean volume of distribution (Vd area area 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 (0-infinity) 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. 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 to 2) mcg/g. Mean sinus tissue concentrations were 16% (+/-20) of corresponding plasma concentrations. 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. 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. Data on cefdinir penetration into human cerebrospinal fluid are not available. 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 ½ Special Populations Patients with Renal Insufficiency DOSAGE AND ADMINISTRATION 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 ½ cr max ½ DOSAGE AND ADMINISTRATION 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 ½ DOSAGE AND ADMINISTRATION 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. 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 ½ Patients with Renal Insufficiency 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 Enterobacter Pseudomonas Enterococcus H. influenzae in vitro INDICATIONS AND USAGE Staphylococcus aureus Streptococcus pneumoniae Streptococcus pyogenes Haemophilus influenzae Haemophilus parainfluenzae Moraxella catarrhalis in vitro in vitro Staphylococcus epidermidis Streptococcus agalactiae Citrobacter koseri Escherichia coli Klebsiella pneumoniae Proteus mirabilis Susceptibility Testing https://www.
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%. Cefdinir oral suspension of 250 mg/5 mL strength was shown to be bioequivalent to the 125 mg/5 mL strength in healthy adults under fasting conditions.
Microbiology
Mechanism of Action Enterobacter Pseudomonas Enterococcus H. influenzae in vitro INDICATIONS AND USAGE Staphylococcus aureus Streptococcus pneumoniae Streptococcus pyogenes Haemophilus influenzae Haemophilus parainfluenzae Moraxella catarrhalis in vitro in vitro Staphylococcus epidermidis Streptococcus agalactiae Citrobacter koseri Escherichia coli Klebsiella pneumoniae Proteus mirabilis.

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. Community-Acquired Pneumonia Haemophilus influenzae Haemophilus parainfluenzae Streptococcus pneumoniae Moraxella catarrhalis CLINICAL STUDIES Acute Exacerbations of Chronic Bronchitis Haemophilus influenzae Haemophilus parainfluenzae Streptococcus pneumoniae Moraxella catarrhalis Acute Maxillary Sinusitis Haemophilus influenzae Streptococcus pneumoniae Moraxella catarrhalis NOTE: Pediatric Use DOSAGE AND ADMINISTRATION Streptococcus pyogenes CLINICAL STUDIES NOTE: S. pyogenes Staphylococcus aureus Streptococcus pyogenes Acute Bacterial Otitis Media Haemophilus influenzae Streptococcus pneumoniae Moraxella catarrhalis Streptococcus pyogenes CLINICAL STUDIES S. pyogenes Staphylococcus aureus Streptococcus pyogenes.
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 BID Cefaclor TID 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 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 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

Effect of Food
The C max max
Multiple Dosing
Cefdinir does not accumulate in plasma following once- or twice-daily administration to subjects with normal renal function.
DOSAGE AND ADMINISTRATION
(see INDICATIONS AND USAGE 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 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 For adult patients with creatinine clearance <30 mL/min, the dose of cefdinir should be 300 mg given once daily. cr cr (weight) (140 en dash age) cr 1 cr body length or height 2 3 2 2 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.

ADVERSE EVENTS
In clinical trials, 5093 adult and adolescent patients (3841 U. and 1252 non-U. ) 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. ADVERSE EVENTS ASSOCIATED WITH CEFDINIR CAPSULES U. TRIALS IN ADULT AND ADOLESCENT PATIENTS (N = 3841) a Incidence >=1% Diarrhea 15% Vaginal moniliasis 4% of women Nausea 3% Headache 2% Abdominal pain 1% Vaginitis 1% of women Incidence 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% a 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. : LABORATORY VALUE CHANGES OBSERVED WITH CEFDINIR CAPSULES U. TRIALS IN ADULT AND ADOLESCENT PATIENTS (N = 3841) Incidence >=1% up arrowUrine leukocytes 2% up arrowUrine protein 2% up arrowGamma-glutamyltransferase a 1% down arrowLymphocytes, up arrowLymphocytes 1%, 0. 2% up arrowMicrohematuria 1% Incidence 0. 1% up arrowGlucose a 0. 9% up arrowUrine glucose 0. 9% up arrowWhite blood cells, down arrowWhite blood cells 0. 7% up arrowAlanine aminotransferase (ALT) 0. 7% up arrowEosinophils 0. 7% up arrowUrine specific gravity, down arrowUrine specific gravity a 0. 2% down arrowBicarbonate a 0. 6% up arrowPhosphorus, down arrowPhosphorus a 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. 2% up arrowBilirubin 0. 2% up arrowLactate dehydrogenase a 0. 2% up arrowPlatelets 0. 2% up arrowPotassium a 0. 2% up arrowUrine pH a 0. 2% a In clinical trials, 2289 pediatric patients (1783 U. and 506 non-U. ) were treated with the recommended dose of cefdinir suspension (14 mg/kg/day). Forty of 2289 (2%) patients discontinued medication due to adverse events considered by the investigators to be possibly, probably, or definitely associated with cefdinir therapy. Discontinuations were primarily for gastrointestinal disturbances, usually diarrhea. Five of 2289 (0. 2%) patients were discontinued due to rash thought related to cefdinir administration. , the following adverse events were thought by investigators to be possibly, probably, or definitely related to cefdinir suspension in multiple-dose clinical trials (N = 1783 cefdinir-treated patients): a b ADVERSE EVENTS ASSOCIATED WITH CEFDINIR SUSPENSION U. TRIALS IN PEDIATRIC PATIENTS (N = 1783) a Incidence >=1% Diarrhea 8% Rash 3% Vomiting 1% Incidence 0. 1% Cutaneous moniliasis 0. 9% Abdominal pain 0. 8% Leukopenia b 0. 3% Vaginal moniliasis 0. 3% of girls Vaginitis 0. 3% of girls Abnormal stools 0. 2% Dyspepsia 0. 2% Hyperkinesia 0. 2% Increased AST b 0. 2% Maculopapular rash 0. 2% Nausea 0. 2% NOTE: In both cefdinir- and control-treated patients, rates of diarrhea and rash were higher in the youngest pediatric patients. The incidence of diarrhea in cefdinir-treated patients <=2 years of age was 17% (95/557) compared with 4% (51/1226) in those >2 years old. The incidence of rash (primarily diaper rash in the younger patients) was 8% (43/557) in patients <=2 years of age compared with 1% (8/1226) in those >2 years old. 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. : a LABORATORY VALUE CHANGES OF POSSIBLE CLINICAL SIGNIFICANCE OBSERVED WITH CEFDINIR SUSPENSION U. TRIALS IN PEDIATRIC PATIENTS (N = 1783) Incidence >=1% up arrowLymphocytes, down arrowLymphocytes 2%, 0. 8% up arrowAlkaline phosphatase 1% down arrowBicarbonate a 1% up arrowEosinophils 1% up arrowLactate dehydrogenase 1% up arrowPlatelets 1% up arrowPMNs, down arrowPMNs 1%, 1% up arrowUrine protein 1% Incidence 0. 1% up arrowPhosphorus, down arrowPhosphorus 0. 4% up arrowUrine pH 0. 8% down arrowWhite blood cells, up arrowWhite blood cells 0. 3% down arrowCalcium a 0. 5% down arrowHemoglobin 0. 5% up arrowUrine leukocytes 0. 5% up arrowMonocytes 0. 4% up arrowAST 0. 3% up arrowPotassium a 0. 3% up arrowUrine specific gravity, down arrowUrine specific gravity 0. 1% down arrowHematocrit a 0. 2% 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, leukopenia, 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. The following adverse events and altered laboratory tests have been reported for cephalosporin-class antibiotics in general: WARNINGS DOSAGE AND ADMINISTRATION OVERDOSAGE.
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, leukopenia, 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: WARNINGS DOSAGE AND ADMINISTRATION OVERDOSAGE

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

Adults and Adolescents
Community-Acquired Pneumonia Haemophilus influenzae Haemophilus parainfluenzae Streptococcus pneumoniae Moraxella catarrhalis CLINICAL STUDIES Acute Exacerbations of Chronic Bronchitis Haemophilus influenzae Haemophilus parainfluenzae Streptococcus pneumoniae Moraxella catarrhalis Acute Maxillary Sinusitis Haemophilus influenzae Streptococcus pneumoniae Moraxella catarrhalis NOTE: Pediatric Use DOSAGE AND ADMINISTRATION Streptococcus pyogenes CLINICAL STUDIES NOTE: S. pyogenes S. pyogenes Staphylococcus aureus Streptococcus pyogenes
Pediatric Patients
Acute Bacterial Otitis Media Haemophilus influenzae Streptococcus pneumoniae Moraxella catarrhalis Streptococcus pyogenes CLINICAL STUDIES S. pyogenes S. pyogenes Staphylococcus aureus Streptococcus pyogenes
Pregnancy - Teratogenic Effects
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
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
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 cr (weight) (140 en dash age) cr 1 cr body length or height 2 3 2 2
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.

Drug Interactions
Concomitant administration of 300 mg cefdinir capsules with 30 mL Maalox registered max max 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 ½ Concomitant administration of cefdinir with a therapeutic iron supplement containing 60 mg of elemental iron (as FeSO 4.
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 registered registered registered

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 Following Administration of Capsules to Adult Subjects Dose C max t max AUC 300 mg 1.6 2.9 7.05 600 mg 2.87 3 11.1
Cefdinir Suspension
Cefdinir plasma concentrations and pharmacokinetic parameter values following administration of single 7 and 14 mg/kg oral doses of cefdinir to pediatric subjects (age 6 months to 12 years) are presented in the following table: Mean (+/-SD) Plasma Cefdinir Pharmacokinetic Parameter Values Following Administration of Suspension to Pediatric Subjects Dose C max t max AUC 7 mg/kg 2.3 2.2 8.31 14 mg/kg 3.86 1.8 13.4

REMEDYREPACK INC.

CEFDINIR- cefdinir_capsule Product manual source documgent