CEFDINIR - cefdinir powder, for suspension

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CEFDINIR (UNII: CI0FAO63WC) (CEFDINIR - UNII:CI0FAO63WC)
Available from:
Physicians Total Care, Inc.
INN (International Name):
CEFDINIR
Composition:
CEFDINIR 125 mg in 5 mL
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Authorization status:
Abbreviated New Drug Application
Authorization number:
54868-5768-0, 54868-5768-1, 54868-5769-0, 54868-5769-1

CEFDINIR - cefdinir powder, for suspension

Physicians Total Care, Inc.

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CEFDINIR FOR ORAL SUSPENSION

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 bacteria.

DESCRIPTION

Cefdinir for oral suspension contains the active ingredient cefdinir, an extended-spectrum,

semisynthetic cephalosporin, for oral administration. Chemically, cefdinir is [6R-[6α,7β (Z)]]-7-[[(2-

amino-4-thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-

2-carboxylic acid. Cefdinir is a white to slightly brownish-yellow solid. It is slightly soluble in dilute

hydrochloric acid and sparingly soluble in 0.1 M pH 7 phosphate buffer. The molecular formula is

H N O S and the molecular weight is 395.42. Cefdinir has the structural formula shown below:

Cefdinir for oral suspension, after reconstitution, contains 125 mg cefdinir per 5 mL or 250 mg cefdinir

per 5 mL and the following inactive ingredients: sucrose, sodium benzoate, colloidal silicone dioxide,

xanthan gum, guar gum, citric acid (anhydrous), sodium citrate (dihydrate), strawberry flavour, fresh

cream flavour and magnesium stearate.

CLINICAL PHARMACOLOGY

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%. 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.

mL strength in healthy adults under fasting conditions.

Effect of Food

The C

and AUC of cefdinir from the capsules are reduced by 16% and 10%, respectively, when

given with a high-fat meal. In adults given the 250 mg/5 mL oral suspension with a high-fat meal, the

and AUC of cefdinir are reduced by 44% and 33%, respectively. The magnitude of these

reductions is not likely to be clinically significant because the safety and efficacy studies of oral

suspension in pediatric patients were conducted without regard to food intake. Therefore, cefdinir may

be taken without regard to food.

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

Dos e

C

(mcg/mL)

T

(hr)

AUC

(mcghr/mL)

300 mg

(0.55)

(0.89)

7.05

(2.17)

600 mg

2.87

(1.01)

(0.66)

11.1

(3.87)

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

Dos e

C

(mcg/mL)

t

(hr)

AUC

(mcghr/mL)

7 mg/kg

(0.65)

(0.6)

8.31

(2.5)

14 mg/kg

3.86

(0.62)

(0.4)

13.4

(2.64)

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

) of cefdinir in adult subjects is 0.35 L/kg (±0.29); in pediatric

subjects (age 6 months to 12 years), cefdinir Vd

is 0.67 L/kg (±0.38). Cefdinir is 60% to 70% bound

to plasma proteins in both adult and pediatric subjects; binding is independent of concentration.

max

max

max

max

are a

are a

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

and AUC (0-∞) values were 48% (±13) and 91% (±18) of

corresponding plasma values.

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 0.8) 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) 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

) of 1.7 (±0.6) hours. In

healthy subjects with normal renal function, renal clearance is 2 (±1) mL/min/kg, and apparent oral

clearance is 11.6 (±6) and 15.5 (±5.4) mL/min/kg following doses of 300 and 600 mg, respectively.

Mean percent of dose recovered unchanged in the urine following 300 and 600 mg doses is 18.4%

(±6.4) and 11.6% (±4.6), respectively. Cefdinir clearance is reduced in patients with renal dysfunction

(see Special Populations: Patients with Renal Insufficiency).

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 ). As a result, plasma cefdinir

concentrations were higher and persisted longer in subjects with renal impairment than in those without

renal impairment. In subjects with CL between 30 and 60 mL/min, C

and t

increased by

approximately 2-fold and AUC by approximately 3-fold. In subjects with CL <30 mL/min, C

increased by approximately 2-fold, t

by approximately 5-fold, and AUC by approximately 6-fold.

Dosage adjustment is recommended in patients with markedly compromised renal function (creatinine

clearance <30 mL/min; see 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

from 16 (±3.5) to

3.2 (±1.2) hours. Dosage adjustment is recommended in this patient population (see 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

by 44% and AUC by 86%. This increase was due to a reduction in cefdinir clearance.

The apparent volume of distribution was also reduced, thus no appreciable alterations in apparent

elimination t

were observed (elderly: 2.2 ± 0.6 hours vs young: 1.8 ± 0.4 hours). Since cefdinir

clearance has been shown to be primarily related to changes in renal function rather than age, elderly

patients do not require dosage adjustment unless they have markedly compromised renal function

(creatinine clearance <30 mL/min, see Patients with Renal Insufficiency, above).

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

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, β-lactamase enzymes. As a result, many

organisms resistant to penicillins and some cephalosporins are susceptible to cefdinir.

Cefdinir has been shown to be active against most strains of the following microorganisms, both in vitro

and in clinical infections as described in INDICATIONS AND USAGE.

Aerobic Gram-Positive Microorganisms

Staphylococcus aureus (including β-lactamase producing strains)

NOTE: Cefdinir is inactive against methicillin-resistant staphylococci.

Streptococcus pneumoniae (penicillin-susceptible strains only)

Streptococcus pyogenes

Aerobic Gram-Negative Microorganisms

Haemophilus influenzae (including β-lactamase producing strains)

Haemophilus parainfluenzae (including β-lactamase producing strains)

Moraxella catarrhalis (including β-lactamase producing strains)

The following in vitro data are available, but their clinical significance is unknown.

Cefdinir exhibits in vitro minimum inhibitory concentrations (MICs) of 1 mcg/mL or less against (≥90%)

strains of the following microorganisms; however, the safety and effectiveness of cefdinir in treating

clinical infections due to these microorganisms have not been established in adequate and well-

controlled clinical trials.

Aerobic Gram-Positive Microorganisms

Staphylococcus epidermidis (methicillin-susceptible strains only)

Streptococcus agalactiae

Viridans group streptococci

NOTE: Cefdinir is inactive against Enterococcus and methicillin-resistant Staphylococcus species.

Aerobic Gram-Negative Microorganisms

Citrobacter diversus

Escherichia coli

Klebsiella pneumoniae

Proteus mirabilis

NOTE: Cefdinir is inactive against Pseudomonas and Enterobacter species.

Susceptibility Tests

Dilution Techniques

Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MICs).

These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs

should be determined using a standardized procedure. Standardized procedures are based on a dilution

method

(broth or agar) or equivalent with standardized inoculum concentrations and standardized

concentrations of cefdinir powder. The MIC values should be interpreted according to the following

criteria:

For organisms other than Haemophilus spp. and Streptococcus spp:

MIC (mcg/mL) Interpretation

≤1

Susceptible (S)

Intermediate (I)

≥4

Resistant (R)

For Haemophilus spp:

MIC (mcg/mL)

Interpretation

These interpretive standards are applicable only

to broth microdilution susceptibility tests with

Haemophilus spp. using Haemophilus Test

Medium (HTM).

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.

≤1

Susceptible (S)

For Streptococcus spp:

Streptococcus pneumoniae that are susceptible to penicillin (MIC ≤0.06 mcg/mL), or streptococci other

than S. pneumoniae that are susceptible to penicillin (MIC≤0.12 mcg /mL), can be considered susceptible

to cefdinir. Testing of cefdinir against penicillin-intermediate or penicillin-resistant isolates is not

recommended. Reliable interpretive criteria for cefdinir are not available.

A report of “Susceptible” indicates that the pathogen is likely to be inhibited if the antimicrobial

compound in the blood reaches the concentration usually achievable. A report of “Intermediate”

indicates that the result should be considered equivocal, and, if the microorganism is not fully

susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies

possible clinical applicability in body sites where the drug is physiologically concentrated or in

situations where high dosage of drug can be used. This category also provides a buffer zone which

prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A

report of “Resistant” indicates that the pathogen is not likely to be inhibited if the antimicrobial

compound in the blood reaches the concentrations usually achievable; other therapy should be selected.

Standardized susceptibility test procedures require the use of laboratory control microorganisms to

control the technical aspects of laboratory procedures. Standard cefdinir powder should provide the

following MIC values:

Microorganis m

MIC Range (mcg/mL)

This quality control range is applicable only to H. influenzae ATCC

49766 tested by a broth microdilution procedure using HTM.

Escherichia coli ATCC 25922

0.12-0.5

Haemophilus influenzae ATCC 49766

0.12-0.5

Staphylococcus aureus ATCC 29213

0.12-0.5

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 procedure

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.

b

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 spp:

Zone Diameter (mm)

Interpretation

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.

≥20

Susceptible (S)

17-19

Intermediate (I)

≤16

Resistant (R)

For Haemophilus spp:

Zone Diameter (mm)

Interpretation

These zone diameter standards are applicable only

to tests with Haemophilus spp. using HTM.

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:

This quality control range is applicable only to testing of H. influenzae

ATCC 49766 using HTM.

Organism

Zone Diameter (mm)

Escherichia coli ATCC 25922

24-28

Haemophilus influenzae ATCC 49766

24-31

Staphylococcus aureus ATCC 25923

25-32

INDICATIONS AND USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and

f

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 for oral suspension is 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 PRECAUTIONS, Pediatric Use and

DOSAGE AND ADMINISTRATION.

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

NOTE: Cefdinir is 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 is 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.

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. Therefore,

cefdinir for oral suspension can be administered with iron-fortified infant formula.

Diabetic patients and caregivers should be aware that the 125 mg/5 mL oral suspension contains 2.94 g

of sucrose per teaspoon and the 250 mg/5 mL oral suspension contains 2.82 g of sucrose for teaspoon.

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 (C

) and extent (AUC) of absorption by approximately 40%. Time to reach C

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 t

Iron Supplements and Foods Fortified With Iron

Concomitant administration of cefdinir with a therapeutic iron supplement containing 60 mg of elemental

iron (as FeSO ) 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. Therefore, cefdinir for oral suspension can be administered with

iron-fortified infant formula.

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/m /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/m /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/m /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 REACTIONS

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

Vaginal moniliasis

4% of Women

Nausea

Headache

Abdominal pain

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%

a

1733 males, 2108 females

Leukorrhea

0.2% of Women

Moniliasis

0.2%

Pruritus

0.2%

Somnolence

0.2%

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)

N <3841 for these parameters

Incidence ≥1%

↑Urine leukocytes

↑Urine protein

↑Gamma-glutamyltransferase

↓Lymphocytes, ↑Lymphocytes

1%, 0.2%

↑Microhematuria

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%

Clinical Trials - Cefdinir for Oral Suspension (Pediatric Patients)

In clinical trials, 2289 pediatric patients (1783 U.S. and 506 non-U.S.) were treated with the

recommended dose of cefdinir suspension (14 mg/kg/day). Most adverse events were mild and self-

limiting. No deaths or permanent disabilities were attributed to cefdinir. 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.

In the U.S., 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

ADVERSE EVENTS ASSOCIATED WITH CEFDINIR SUSPENSION

U.S. TRIALS IN PEDIATRIC PATIENTS

(N = 1783)

977 males, 806 females

Laboratory changes were occasionally reported as adverse events.

Incidence ≥ 1%

Diarrhea

Rash

Vomiting

Incidence <1% but >0.1%

Cutaneous moniliasis

0.9%

Abdominal pain

0.8%

Leukopenia

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

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 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.S.:

LABORATORY VALUE CHANGES OF POSSIBLE CLINICAL

SIGNIFICANCE OBSERVED WITH CEFDINIR SUSPENSION

U.S. TRIALS IN PEDIATRIC PATIENTS

(N = 1783)

Incidence ≥1%

↑Lymphocytes, ↓Lymphocytes

2%, 0.8%

↑Alkaline phosphatase

↓Bicarbonate

↑Eosinophils

↑Lactate dehydrogenase

↑Platelets

↑PMNs, ↓PMNs

1%, 1%

↑Urine protein

Incidence <1% but >0.1% ↑Phosphorus, ↓Phosphorus

0.9%, 0.4%

↑Urine pH

0.8%

↓White blood cells, ↑White blood cells

0.7%, 0.3%

↓Calcium

0.5%

↓Hemoglobin

0.5%

↑Urine leukocytes

0.5%

↑Monocytes

0.4%

↑AST

0.3%

↑Potassium

0.3%

↑Urine specific gravity, ↓Urine specific gravity 0.3%, 0.1%

a

N = 1387 for these parameters

↓Hematocrit

0.2%

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:

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-lactame 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 USAGEfor Indicated Pathogens)

The recommended dosage and duration of treatment for infections in pediatric patients are described in

the following chart; the total daily dose for all infections is 14 mg/kg, up to a maximum dose of 600 mg

per day. Once-daily dosing for 10 days is as effective as BID dosing. Once-daily dosing has not been

studied in skin infections; therefore, cefdinir for oral suspension should be administered twice daily in

this infection. Cefdinir for oral suspension may be administered without regard to meals.

Pediatric Patients (Age 6 Months Through 12 Years)

Type of Infection

Dosage

Duration

Acute Bacterial Otitis Media

7 mg/kg q12h

14 mg/kg q24h

5 to 10 days

10 days

Acute Maxillary Sinusitis

7 mg/kg q12h

14 mg/kg q24h

10 days

10 days

Pharyngitis/Tonsillitis

7 mg/kg q12h

14 mg/kg q24h

5 to 10 days

10 days

Uncomplicated Skin and Skin Structure Infections 7 mg/kg q12h

10 days

CEFDINIR FOR ORAL SUSPENSION PEDIATRIC DOSAGE CHART

Pediatric patients who weight ≥ 43 kg should receive the maximum daily dose of 600 mg.

Weight

125 mg/5 mL

250 mg/5 mL

9 kg/20 lbs

2.5 mL q12h or 5 mL q24h

Use 125 mg/5 mL product

18 kg/40 lbs

5 mL q12h or 10 mL q24h

2.5 mL q12h or 5 mL q24h

27 kg/60 lbs

7.5 mL q12h or 15 mL q24h

3.75 mL q12h or 7.5 mL q24h

36 kg/80 lbs

10 mL q12h or 20 mL q24h

5 mL q12h or 10 mL q24h

≥ 43 kg /95 lbs

12 mL q12h or 24 mL q24h

6 mL q12h or 12 mL q24h

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 (CL ) in adult patients. For estimates to be valid, serum creatinine

levels should reflect steady-state levels of renal function.

Males: CL = (weight) (140 – age)

(72) (serum creatinine)

Females: CL = 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/dL

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

CL = K x body length or height

serum creatinine

Where K=0.55 for pediatric patients older than 1 year

and 0.45 for infants (up to 1 year)

In the above equation, creatinine clearance is in mL/min/1.73 m , 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 m , the dose of cefdinir should be

7 mg/kg (up to 300 mg) given once daily.

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.

Directions for Mixing Cefdinir for Oral Suspension

Final

Concentration

Final Volume

(mL)

Amount of

Water

Directions

125 mg/5 mL

38 mL

63 mL

Tap bottle to loosen powder, then

add water in 2 portions. Shake well

after each aliquot.

250 mg/5 mL

38 mL

63 mL

Tap bottle to loosen powder, then

add water in 2 portions. Shake well

after each aliquot.

After mixing, the suspension can be stored at room temperature (25°C/77°F). The container should be

kept tightly closed, and the suspension should be shaken well before each administration. The

suspension may be used for 10 days, after which any unused portion must be discarded.

HOW SUPPLIED

Cefdinir for Oral Suspension 125 mg/5 mL is a off-white to yellowish — white colored granular

powder, on constitution with water, forming an off-white to yellowish-white colored suspension with

strawberry and cream flavors.

60 mL Bottle NDC 54868-5768-0

100 mL Bottle NDC 54868-5768-1

Cefdinir for Oral Suspension 250 mg/5 mL is a off-white to yellowish — white colored granular

powder, on constitution with water, forming an off-white to yellowish-white colored suspension with

strawberry and cream flavors.

60 mL Bottle NDC 54868-5769-0

100 mL Bottle NDC 54868-5769-1

Store dry powder 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]. Once reconstituted, the oral suspension can be stored at

controlled room temperature for 10 days.

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 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

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 rtes, 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

218/227

196/227

Cefdinir superior to

(97%)

(96%)

(86%)

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

1. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial

Susceptibility Tests for Bacteria That Grow Aerobically, 4th ed. Approved Standard, NCCLS

Document M7-A4, Vol 17(2). NCCLS, Villanova, PA, Jan 1997.

2. 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.

3. Cockcroft DW, Gault MH. Prediction of creatinine clearance from secum creatinine. Nephron

1976;16:31-41.

4. 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.

5. 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.

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 Eli Lilly and company.

Manufactured for:

Aurobindo Pharma USA, Inc.

2400 Route 130 North

Dayton, NJ 08810

Manufactured by:

Aurobindo Pharma Limited

Chitkul (V)-502 307, A.P., India

Issued: October 2007

Relabeling of "Additional Barcode" label by:

Physicians Total Care, Inc.

Tulsa, Oklahoma 74146

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 125 mg/5 mL (60 mL Bottle) Carton Label

Rx only

Cefdinir for Oral Suspension

125 mg/5 mL

SHAKE WELL BEFORE USING.

Keep bottle tightly closed.

Any unused portion must be

discarded 10 days after mixing.

RECONSTITUTE WITH 38 mL WATER

60 mL when reconstituted

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/5 mL (60 mL) Carton Label

Rx only

Cefdinir for Oral Suspension

250 mg/5 mL

SHAKE WELL BEFORE USING.

Keep bottle tightly closed.

Any unused portion must be

discarded 10 days after mixing.

RECONSTITUTE WITH 38 mL WATER

60 mL when reconstituted

CEFDINIR

cefdinir powder, for suspension

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:548 6 8 -576 8 (NDC:6 58 6 2-218 )

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CEFDINIR (UNII: CI0 FAO6 3WC) (CEFDINIR - UNII:CI0 FAO6 3WC)

CEFDINIR

125 mg in 5 mL

Inactive Ingredients

Ingredient Name

Stre ng th

SUCRO SE (UNII: C151H8 M554)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

XANTHAN GUM (UNII: TTV12P4NEE)

GUAR GUM (UNII: E8 9 I16 37KE)

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

TRISO DIUM CITRATE DIHYDRATE (UNII: B22547B9 5K)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

Product Characteristics

Color

white (Off-white to Yello wish)

S core

S hap e

S iz e

Flavor

STRAWBERRY (Strawberry and Fresh Cream Flavo r)

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:548 6 8 -576 8 -0

1 in 1 CARTON

1

6 0 mL in 1 BOTTLE

2

NDC:548 6 8 -576 8 -1

1 in 1 CARTON

2

10 0 mL in 1 BOTTLE

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 6 5473

0 5/0 8 /20 0 7

CEFDINIR

cefdinir powder, for suspension

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:548 6 8 -576 9 (NDC:6 58 6 2-219 )

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CEFDINIR (UNII: CI0 FAO6 3WC) (CEFDINIR - UNII:CI0 FAO6 3WC)

CEFDINIR

250 mg in 5 mL

Inactive Ingredients

Ingredient Name

Stre ng th

SUCRO SE (UNII: C151H8 M554)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

XANTHAN GUM (UNII: TTV12P4NEE)

GUAR GUM (UNII: E8 9 I16 37KE)

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

TRISO DIUM CITRATE DIHYDRATE (UNII: B22547B9 5K)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

Product Characteristics

Color

white (Off-white to Yello wish)

S core

S hap e

S iz e

Flavor

STRAWBERRY (Strawberry and Fresh Cream Flavo r)

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:548 6 8 -576 9 -0

1 in 1 CARTON

1

6 0 mL in 1 BOTTLE

2

NDC:548 6 8 -576 9 -1

1 in 1 CARTON

Physicians Total Care, Inc.

2

10 0 mL in 1 BOTTLE

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 6 5473

0 5/0 9 /20 0 7

Labeler -

Physicians T otal Care, Inc. (194123980)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Physicians To tal Care, Inc.

19 41239 8 0

re la be l

Revised: 12/2009

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