Cefdinir

Cefdinir Recall

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Questions & Answers

Side Effects & Adverse Reactions

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.

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Legal Issues

There is currently no legal information available for this drug.

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

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

Adults and Adolescents

Community-Acquired Pneumonia

caused by Haemophilusinfluenzae (including β-lactamase producing strains), Haemophilusparainfluenzae (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

Acute Maxillary Sinusitis

caused by Haemophilusinfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains).

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

Pharyngitis/Tonsillitis

caused by Streptococcus pyogenes (see CLINICAL STUDIES).

NOTE: Cefdinir 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

Pharyngitis/Tonsillitis

caused by Streptococcus pyogenes (see CLINICAL STUDIES).

Uncomplicated Skin and Skin Structure Infections

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

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History

There is currently no drug history available for this drug.

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Other Information

Cefdinir capsules contain 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 7.0 phosphate buffer. The empirical formula is C14H13N5O5S2 and the molecular weight is 395.42.

Cefdinir capsules contain 300 mg cefdinir and the following inactive ingredients: carboxymethylcellulose calcium, colloidal silicone dioxide, magnesium stearate, and polyoxyl 40 stearate. The capsule shells contain FD&C Blue #2; gelatin, and titanium dioxide.

Sources

Cefdinir Manufacturers

Northwind Pharmaceuticals, Llc

Cefdinir | Northwind Pharmaceuticals, Llc

PLEASE REVIEW THE MANUFACTURER'S RECOMMENDATIONS HERE:
http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=befe82b9-e822-4917-9774-b4cbd0c66a1e

No Recall
Blenheim Pharmacal, Inc.

Cefdinir | Blenheim Pharmacal, Inc.

(see INDICATIONS AND USAGE for Indicated Pathogens)

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

Adults and Adolescents (Age 13 Years and Older) Type of Infection Dosage Duration    Community-Acquired Pneumonia
300 mg q12h
10 days
   Acute Exacerbations of Chronic Bronchitis

300 mg q12h
or
600 mg q24h
5 to 10 days
10 days
   Acute Maxillary Sinusitis

300 mg q12h
or
600 mg q24h
10 days
10 days
   Pharyngitis/Tonsillitis

300 mg q12h
or
600 mg q24h
5 to 10 days
10 days
   Uncomplicated Skin and Skin Structure Infections
300 mg q12h
10 days
Patients With Renal Insufficiency
For adult patients with creatinine clearance <30 mL/min, the dose of cefdinir should be 300 mg given once daily.

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

Males:              CL cr =      (weight) (140 – age)
                                       (72) (serum creatinine)

Females:           CL cr = 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 (3).

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

CL cr =      K x body length or height
                            serum creatinine

Where K=0.55 for pediatric patients older than 1 year (4) and 0.45 for infants (up to 1 year) (5).

In the above equation, creatinine clearance is in mL/min/1.73 m 2, 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 2, 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.

No Recall
Physicians Total Care, Inc.

Cefdinir | Physicians Total Care, Inc.

(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
or
   14 mg/kg q24h
   5 to 10 days

10 days
   Acute Maxillary Sinusitis
7 mg/kg q12h
or
   14 mg/kg q24h
10 days

10 days
   Pharyngitis/Tonsillitis
7 mg/kg q12h
or
   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 a 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 kga/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 cr) in adult patients. For estimates to be valid, serum creatinine levels should reflect steady-state levels of renal function.

Males:              CL cr =      (weight) (140 – age)
                                       (72) (serum creatinine)

Females:           CL cr = 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 (3).

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

CL cr =      K x body length or height
                            serum creatinine

Where K=0.55 for pediatric patients older than 1 year (4) and 0.45 for infants (up to 1 year) (5).

In the above equation, creatinine clearance is in mL/min/1.73 m 2, 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 2, 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
60
100
38 mL
63 mL
   Tap bottle to loosen powder, then
   add water in 2 portions. Shake well
   after each aliquot.
   250 mg/5 mL
60
100
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.

No Recall
Rebel Distributors Corp

Cefdinir | Rebel Distributors Corp

(see
INDICATIONS AND USAGE
for 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
or
   14 mg/kg q24h
   5 to 10 days

10 days
   Acute Maxillary Sinusitis
7 mg/kg q12h
or
   14 mg/kg q24h
10 days

10 days
   Pharyngitis/Tonsillitis
7 mg/kg q12h
or
   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 a 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 kga/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
cr
) in adult patients. For estimates to be valid, serum creatinine levels should reflect steady-state levels of renal function.
Males:              CL
cr
=

(weight) (140 – age)

                                       (72) (serum creatinine)
Females:           CL
cr
= 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
(3)
.

The following formula may be used to estimate creatinine clearance in pediatric patients:
CL
cr
=      K x
body length or height
                            serum creatinine
Where K=0.55 for pediatric patients older than 1 year
(4)
and 0.45 for infants (up to 1 year)
(5)
.
In the above equation, creatinine clearance is in mL/min/1.73 m
2
, 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
2
, 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
60
100
38 mL
63 mL
   Tap bottle to loosen powder, then
   add water in 2 portions. Shake well
   after each aliquot.
   250 mg/5 mL
60
100
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.

No Recall
Lupin Pharmaceuticals Inc

Cefdinir | Lupin Pharmaceuticals Inc

(see INDICATIONS AND USAGE for Indicated Pathogens)
The recommended dosage and duration of treatment for infections in adults and adolescents are described in the following chart; the total daily dose for all infections is 600 mg. Once-daily dosing for 10 days is as effective as BID dosing. Once-daily dosing has not been studied in pneumonia or skin infections; therefore, cefdinir capsules should be administered twice daily in these infections. Cefdinir capsules may be taken without regard to meals.
Adults and Adolescents (Age 13 years and Older) Type of Infection
Dosage
Duration
Community-Acquired Pneumonia
300 mg q12h
10 days
Acute Exacerbations of Chronic Bronchitis
300 mg q12h
5 to 10 days

or

Acute Maxillary Sinusitis
600 mg q24h
10 days

300 mg q12h
10 days

or

Pharyngitis/Tonsillitis
600 mg q24h
10 days

300 mg q12h
5 to 10 days

or

Uncomplicated Skin and Skin Structure Infections
600 mg q24h
10 days

300 mg q12h
10 days
Patients With Renal Insufficiency:
For adult patients with creatinine clearance <30 mL/min, the dose of cefdinir should be 300 mg given once daily.
Creatinine clearance is difficult to measure in outpatients. However, the following formula may be used to estimate creatinine clearance (CLcr) in adult patients. For estimates to be valid, serum creatinine levels should reflect steady-state levels of renal function.
                                                                                     (weight) (140 – age)
                                                           Males: CLcr = ——————————
                                                                                     (72) (serum creatinine)
                                                           Females: CLcr = 0.85 x above value
where creatinine clearance is in mL/min, age is in years, weight is in kilograms, and serum creatinine is in mg/dL.(3)
The following formula may be used to estimate creatinine clearance in pediatric patients:
                                                                                        body length or height
                                                           CLcr =      K x ——————————
                                                                                        serum creatinine
where K = 0.55 for pediatric patients older than 1 year(4) and 0.45 for infants (up to 1 year)(5).
In the above equation, creatinine clearance is in mL/min/1.73 m2, body length or height is in centimeters, and serum creatinine is in mg/dL.
For pediatric patients with a creatinine clearance of <30 mL/min/1.73 m2, the dose of cefdinir should be 7 mg/kg (up to 300 mg) given once daily.
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.

No Recall
Lupin Pharmaceuticals Inc

Cefdinir | Lupin Pharmaceuticals Inc

(see INDICATIONS AND USAGE for 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 or
5 to 10 days

14 mg/kg q24h
10 days
Acute Maxillary Sinusitis
7 mg/kg q12h or
10 days

14 mg/kg q24h
10 days
Pharyngitis/Tonsilitis
7 mg/kg q12h or
5 to 10 days

14 mg/kg q24h
10 days
Uncomplicated Skin and Skin Structure Infections
7 mg/kg q12h
10 days
CEFDINIR FOR ORAL SUSPENSION PEDIATRIC DOSAGE CHART Weight
125 mg/5 mL
250 mg/5 mL
a Pediatric patients who weight ≥43 kg should receive the maximum daily dose of 600 mg.
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 a/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 (CLcr) in adult patients. For estimates to be valid, serum creatinine levels should reflect steady-state levels of renal function.
                                                                                    (weight) (140 – age)
                                                    Males: CLcr =   ————————————
                                                                                    (72) (serum creatinine)
                                                   Females:   CLcr = 0.85 x above value
where creatinine clearance is in mL/min, age is in years, weight is in kilograms, and serum creatinine is in mg/dL.(3)
The following formula may be used to estimate creatinine clearance in pediatric patients:
                                                                           body length or height
                                                     CLcr = K x ———————————
                                                                            serum creatinine
where K = 0.55 for pediatric patients older than 1 year(4) and 0.45 for infants (up to 1 year)(5).
In the above equation, creatinine clearance is in mL/min/1.73 m2, body length or height is in centimeters, and serum creatinine is in mg/dL.
For pediatric patients with a creatinine clearance of <30 mL/min/1.73 m2, the dose of cefdinir should be 7 mg/kg (up to 300 mg) given once daily.
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 Final Concentration
Final Volume(mL)
Amount of Water
Directions
125 mg/5 mL
60
35 mL
Tap bottle to loosen the powder, then add water in 2

100
58 mL
portions. Shake well after each aliquot.
250 mg/5 mL
60
35 mL
Tap bottle to loosen the powder, then add water in 2

100
58 mL
portions. Shake well after each aliquot.
After mixing, the suspension can be stored at 20°-25°C (68°-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.

No Recall
Rebel Distributors Corp

Cefdinir | Rebel Distributors Corp

(see INDICATIONS AND USAGE for Indicated Pathogens)
The recommended dosage and duration of treatment for infections in adults and adolescents are described in the following chart; the total daily dose for all infections is 600 mg. Once-daily dosing for 10 days is as effective as BID dosing. Once-daily dosing has not been studied in pneumonia or skin infections; therefore, cefdinir capsules should be administered twice daily in these infections. Cefdinir capsules may be taken without regard to meals.
Adults and Adolescents (Age 13 Years and Older) Type of Infection Dosage Duration    Community-Acquired Pneumonia
300 mg q12h
10 days
   Acute Exacerbations of Chronic Bronchitis

300 mg q12h
or
600 mg q24h
5 to 10 days
10 days
   Acute Maxillary Sinusitis

300 mg q12h
or
600 mg q24h
10 days
10 days
   Pharyngitis/Tonsillitis

300 mg q12h
or
600 mg q24h
5 to 10 days
10 days
   Uncomplicated Skin and Skin Structure Infections
300 mg q12h
10 days
Patients With Renal Insufficiency
For adult patients with creatinine clearance <30 mL/min, the dose of cefdinir should be 300 mg given once daily.
Creatinine clearance is difficult to measure in outpatients. However, the following formula may be used to estimate creatinine clearance (CLcr) in adult patients. For estimates to be valid, serum creatinine levels should reflect steady-state levels of renal function.
Males: CLcr =     (weight) (140 – age)     (72) (serum creatinine)
Females: CLcr = 0.85 x above value
where creatinine clearance is in mL/min, age is in years, weight is in kilograms, and serum creatinine is in mg/dL(3).
The following formula may be used to estimate creatinine clearance in pediatric patients:
CLcr = K x  body length or height serum creatinine
Where K=0.55 for pediatric patients older than 1 year(4) and 0.45 for infants (up to 1 year)(5).
In the above equation, creatinine clearance is in mL/min/1.73 m2, body length or height is in centimeters, and serum creatinine is in mg/dL.
For pediatric patients with a creatinine clearance of <30 mL/min/1.73 m2, the dose of cefdinir should be 7 mg/kg (up to 300 mg) given once daily.
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.

No Recall
Redpharm Drug Inc.

Cefdinir | Redpharm Drug Inc.

(see INDICATIONS AND USAGE for Indicated Pathogens)
The recommended dosage and duration of treatment for infections in adults and adolescents are described in the following chart; the total daily dose for all infections is 600 mg. Once-daily dosing for 10 days is as effective as BID dosing. Once-daily dosing has not been studied in pneumonia or skin infections; therefore, cefdinir capsules should be administered twice daily in these infections. Cefdinir capsules may be taken without regard to meals.
Patients With Renal Insufficiency:
For adult patients with creatinine clearance less than 30 mL/min, the dose of cefdinir should be 300 mg given once daily.
Creatinine clearance is difficult to measure in outpatients. However, the following formula may be used to estimate creatinine clearance (CLcr) in adult patients. For estimates to be valid, serum creatinine levels should reflect steady-state levels of renal function.
                                                                                     (weight) (140 – age)
                                                           Males: CLcr = ——————————
                                                                                     (72) (serum creatinine)
                                                           Females: CLcr = 0.85 x above value
where creatinine clearance is in mL/min, age is in years, weight is in kilograms, and serum creatinine is in mg/dL.(3)
The following formula may be used to estimate creatinine clearance in pediatric patients:
                                                                                        body length or height
                                                           CLcr =      K x ——————————
                                                                                        serum creatinine
where K = 0.55 for pediatric patients older than 1 year(4) and 0.45 for infants (up to 1 year)(5).
In the above equation, creatinine clearance is in mL/min/1.73 m2, body length or height is in centimeters, and serum creatinine is in mg/dL.
For pediatric patients with a creatinine clearance of less than 30 mL/min/1.73 m2, 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.

No Recall
H.j. Harkins Company, Inc.

Cefdinir | H.j. Harkins Company, Inc.

(see INDICATIONS AND USAGE for Indicated Pathogens)

The recommended dosage and duration of treatment for infections in adults and adolescents are described in the following chart; the total daily dose for all infections is 600 mg. Once-daily dosing for 10 days is as effective as BID dosing. Once-daily dosing has not been studied in pneumonia or skin infections; therefore, cefdinir capsules should be administered twice daily in these infections. Cefdinir capsules may be taken without regard to meals.
Adults and Adolescents (Age 13 Years and Older) Type of Infection Dosage Duration    Community-Acquired Pneumonia
300 mg q12h
10 days
   Acute Exacerbations of Chronic Bronchitis

300 mg q12h
or
600 mg q24h
5 to 10 days
10 days
   Acute Maxillary Sinusitis

300 mg q12h
or
600 mg q24h
10 days
10 days
   Pharyngitis/Tonsillitis

300 mg q12h
or
600 mg q24h
5 to 10 days
10 days
   Uncomplicated Skin and Skin Structure Infections
300 mg q12h
10 days
Patients With Renal Insufficiency
For adult patients with creatinine clearance <30 mL/min, the dose of cefdinir should be 300 mg given once daily.

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

Males:              CL cr =      (weight) (140 – age)
                                       (72) (serum creatinine)

Females:           CL cr = 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 (3).

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

CL cr =      K x body length or height
                            serum creatinine

Where K=0.55 for pediatric patients older than 1 year (4) and 0.45 for infants (up to 1 year) (5).

In the above equation, creatinine clearance is in mL/min/1.73 m 2, 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 2, 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.

No Recall
Physicians Total Care, Inc.

Cefdinir | Physicians Total Care, Inc.

(see INDICATIONS AND USAGE for Indicated Pathogens)

The recommended dosage and duration of treatment for infections in adults and adolescents are described in the following chart; the total daily dose for all infections is 600 mg. Once-daily dosing for 10 days is as effective as BID dosing. Once-daily dosing has not been studied in pneumonia or skin infections; therefore, cefdinir capsules should be administered twice daily in these infections. Cefdinir capsules may be taken without regard to meals.
Adults and Adolescents (Age 13 Years and Older) Type of Infection Dosage Duration    Community-Acquired Pneumonia
300 mg q12h
10 days
   Acute Exacerbations of Chronic Bronchitis

300 mg q12h
or
600 mg q24h
5 to 10 days
10 days
   Acute Maxillary Sinusitis

300 mg q12h
or
600 mg q24h
10 days
10 days
   Pharyngitis/Tonsillitis

300 mg q12h
or
600 mg q24h
5 to 10 days
10 days
   Uncomplicated Skin and Skin Structure Infections
300 mg q12h
10 days
Patients With Renal Insufficiency
For adult patients with creatinine clearance <30 mL/min, the dose of cefdinir should be 300 mg given once daily.

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

Males:              CL cr =      (weight) (140 – age)
                                       (72) (serum creatinine)

Females:           CL cr = 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 (3).

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

CL cr =      K x body length or height
                            serum creatinine

Where K=0.55 for pediatric patients older than 1 year (4) and 0.45 for infants (up to 1 year) (5).

In the above equation, creatinine clearance is in mL/min/1.73 m 2, 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 2, 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.

No Recall
Pd-rx Pharmaceuticals, Inc.

Cefdinir | Pd-rx Pharmaceuticals, Inc.

(See INDICATIONS AND USAGE for Indicated Pathogens.)
Capsules
The recommended dosage and duration of treatment for infections in adults and adolescents are described in the following chart; the total daily dose for all infections is 600 mg. Once-daily dosing for 10 days is as effective as BID dosing. Once-daily dosing has not been studied in pneumonia or skin infections; therefore, cefdinir capsules should be administered twice daily in these infections. Cefdinir capsules may be taken without regard to meals.
Adults and Adolescents (Age 13 Years and Older) Type of Infection Dosage Duration Community-Acquired Pneumonia 300 mg q12h 10 days Acute Exacerbations of Chronic Bronchitis 300 mg q12h 5 to 10 days or 600 mg q24h 10 days Acute Maxillary Sinusitis 300 mg q12h 10 days or 600 mg q24h 10 days Pharyngitis/Tonsillitis 300 mg q12h 5 to 10 days or 600 mg q24h 10 days Uncomplicated Skin and Skin Structure Infections 300 mg q12h 10 days Pediatric Patients
Alternate dosage forms of cefdinir (e.g., cefdinir for oral suspension) may be best suited for pediatric dosing. 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 5 to 10 days or 14 mg/kg q24h 10 days Acute Maxillary Sinusitis 7 mg/kg q12h 10 days or 14 mg/kg q24h 10 days Pharyngitis/Tonsillitis 7 mg/kg q12h 5 to 10 days or 14 mg/kg q24h 10 days Uncomplicated Skin and Skin Structure Infections 7 mg/kg q12h 10 days Pediatric patients who weigh ≥ 43 kg should receive the maximum daily dose of 600 mg. Patients With Renal Insufficiency
For adult patients with creatinine clearance < 30 mL/min, the dose of cefdinir should be 300 mg given once daily.
Creatinine clearance is difficult to measure in outpatients. However, the following formula may be used to estimate creatinine clearance (CLcr) in adult patients. For estimates to be valid, serum creatinine levels should reflect steady-state levels of renal function.
Males: CLcr = (weight) (140 – age) (72) (serum creatinine) Females: CLcr = 0.85 x above value
where creatinine clearance is in mL/min, age is in years, weight is in kilograms, and serum creatinine is in mg/dL.3
The following formula may be used to estimate creatinine clearance in pediatric patients:
CLcr = K × body length or height serum creatinine
where K = 0.55 for pediatric patients older than 1 year4 and 0.45 for infants (up to 1 year).5
In the above equation, creatinine clearance is in mL/min/1.73 m2, body length or height is in centimeters, and serum creatinine is in mg/dL.
For pediatric patients with a creatinine clearance of < 30 mL/min/1.73 m2, the dose of cefdinir should be 7 mg/kg (up to 300 mg) given once daily.
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.

No Recall
Dispensing Solutions, Inc.

Cefdinir | Dispensing Solutions, Inc.

(see INDICATIONS AND USAGE for 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 or
5 to 10 days

14 mg/kg q24h
10 days
Acute Maxillary Sinusitis
7 mg/kg q12h or
10 days

14 mg/kg q24h
10 days
Pharyngitis/Tonsilitis
7 mg/kg q12h or
5 to 10 days

14 mg/kg q24h
10 days
Uncomplicated Skin and Skin Structure Infections
7 mg/kg q12h
10 days
CEFDINIR FOR ORAL SUSPENSION PEDIATRIC DOSAGE CHART 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 a/95 lbs
12 mL q12h or 24 mL q24h
6 mL q12h or 12 mL q24h
a Pediatric patients who weight ≥43 kg should receive the maximum daily dose of 600 mg. Patients With Renal Insufficiency:
For adult patients with creatinine clearance less than 30 mL/min, the dose of cefdinir should be 300 mg given once daily.

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

                                                                                    (weight) (140 – age)

                                                    Males: CLcr =   ————————————

                                                                                    (72) (serum creatinine)

                                                   Females:   CLcr = 0.85 x above value

where creatinine clearance is in mL/min, age is in years, weight is in kilograms, and serum creatinine is in mg/dL.(3)

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

                                                                           body length or height

                                                     CLcr = K x   ———————————

                                                                            serum creatinine

where K = 0.55 for pediatric patients older than 1 year(4) and 0.45 for infants (up to 1 year)(5).

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

For pediatric patients with a creatinine clearance of less than 30 mL/min/1.73 m2, 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 Final Concentration
Final Volume(mL)
Amount of Water
Directions
125 mg/5 mL
60
35 mL
Tap bottle to loosen the powder, then add water in 2

100
58 mL
portions. Shake well after each aliquot.
250 mg/5 mL
60
35 mL
Tap bottle to loosen the powder, then add water in 2

100
58 mL
portions. Shake well after each aliquot.
After mixing, the suspension can be stored at 20°-25°C (68°-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.

No Recall
Rebel Distributors Corp

Cefdinir | Rebel Distributors Corp

(see INDICATIONS AND USAGE for 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 or
5 to 10 days

14 mg/kg q24h
10 days
Acute Maxillary Sinusitis
7 mg/kg q12h or
10 days

14 mg/kg q24h
10 days
Pharyngitis/Tonsilitis
7 mg/kg q12h or
5 to 10 days

14 mg/kg q24h
10 days
Uncomplicated Skin and Skin Structure Infections
7 mg/kg q12h
10 days
CEFDINIR FOR ORAL SUSPENSION PEDIATRIC DOSAGE CHART Weight
125 mg/5 mL
250 mg/5 mL
a Pediatric patients who weight ≥43 kg should receive the maximum daily dose of 600 mg.
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 a/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 (CLcr) in adult patients. For estimates to be valid, serum creatinine levels should reflect steady-state levels of renal function.
                                                                                    (weight) (140 – age)
                                                    Males: CLcr =   ————————————
                                                                                    (72) (serum creatinine)
                                                   Females:   CLcr = 0.85 x above value
where creatinine clearance is in mL/min, age is in years, weight is in kilograms, and serum creatinine is in mg/dL.(3)
The following formula may be used to estimate creatinine clearance in pediatric patients:
                                                                           body length or height
                                                     CLcr = K x ———————————
                                                                            serum creatinine
where K = 0.55 for pediatric patients older than 1 year(4) and 0.45 for infants (up to 1 year)(5).
In the above equation, creatinine clearance is in mL/min/1.73 m2, body length or height is in centimeters, and serum creatinine is in mg/dL.
For pediatric patients with a creatinine clearance of <30 mL/min/1.73 m2, the dose of cefdinir should be 7 mg/kg (up to 300 mg) given once daily.
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 Final Concentration
Final Volume(mL)
Amount of Water
Directions
125 mg/5 mL
60
35 mL
Tap bottle to loosen the powder, then add water in 2

100
58 mL
portions. Shake well after each aliquot.
250 mg/5 mL
60
35 mL
Tap bottle to loosen the powder, then add water in 2

100
58 mL
portions. Shake well after each aliquot.
After mixing, the suspension can be stored at 20°-25°C (68°-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.

No Recall
Rebel Distributors Corp

Cefdinir | Rebel Distributors Corp

(See INDICATIONS AND USAGE for Indicated Pathogens.)
Capsules
The recommended dosage and duration of treatment for infections in adults and adolescents are described in the following chart; the total daily dose for all infections is 600 mg. Once-daily dosing for 10 days is as effective as BID dosing. Once-daily dosing has not been studied in pneumonia or skin infections; therefore, cefdinir capsules should be administered twice daily in these infections. Cefdinir capsules may be taken without regard to meals.
Adults and Adolescents (Age 13 Years and Older) Type of Infection Dosage Duration Community-Acquired Pneumonia 300 mg q12h 10 days Acute Exacerbations of Chronic Bronchitis 300 mg q12h 5 to 10 days or 600 mg q24h 10 days Acute Maxillary Sinusitis 300 mg q12h 10 days or 600 mg q24h 10 days Pharyngitis/Tonsillitis 300 mg q12h 5 to 10 days or 600 mg q24h 10 days Uncomplicated Skin and Skin Structure Infections 300 mg q12h 10 days Pediatric Patients
Alternate dosage forms of cefdinir (e.g., cefdinir for oral suspension) may be best suited for pediatric dosing. 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 5 to 10 days or 14 mg/kg q24h 10 days Acute Maxillary Sinusitis 7 mg/kg q12h 10 days or 14 mg/kg q24h 10 days Pharyngitis/Tonsillitis 7 mg/kg q12h 5 to 10 days or 14 mg/kg q24h 10 days Uncomplicated Skin and Skin Structure Infections 7 mg/kg q12h 10 days Pediatric patients who weigh ≥ 43 kg should receive the maximum daily dose of 600 mg. Patients With Renal Insufficiency
For adult patients with creatinine clearance < 30 mL/min, the dose of cefdinir should be 300 mg given once daily.
Creatinine clearance is difficult to measure in outpatients. However, the following formula may be used to estimate creatinine clearance (CLcr) in adult patients. For estimates to be valid, serum creatinine levels should reflect steady-state levels of renal function.
Males: CLcr = (weight) (140 – age) (72) (serum creatinine) Females: CLcr = 0.85 x above value
where creatinine clearance is in mL/min, age is in years, weight is in kilograms, and serum creatinine is in mg/dL.3
The following formula may be used to estimate creatinine clearance in pediatric patients:
CLcr = K × body length or height serum creatinine
where K = 0.55 for pediatric patients older than 1 year4 and 0.45 for infants (up to 1 year).5
In the above equation, creatinine clearance is in mL/min/1.73 m2, body length or height is in centimeters, and serum creatinine is in mg/dL.
For pediatric patients with a creatinine clearance of < 30 mL/min/1.73 m2, the dose of cefdinir should be 7 mg/kg (up to 300 mg) given once daily.
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.

No Recall
Sandoz Inc

Cefdinir | Sandoz Inc

(see INDICATIONS AND USAGE for Indicated Pathogens)
Powder for Oral Suspension
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 b.i.d. 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
or
14 mg/kg q24h
5 to 10 days
10 days
Acute Maxillary Sinusitis
7 mg/kg q12h
or
14 mg/kg q24h
10 days
10 days
Pharyngitis/Tonsillitis
7 mg/kg q12h
or
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 weigh ≥ 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 (CLcr) in adult patients. For estimates to be valid, serum creatinine levels should reflect steady-state levels of renal function.
Males:
CLcr =
(weight) (140 – age)
(72) (serum creatinine)
Females:
CLcr =
0.85 x above value
where creatinine clearance is in mL/min, age is in years, weight is in kilograms, and serum creatinine is in mg/dL.(3)
The following formula may be used to estimate creatinine clearance in pediatric patients:
CLcr = K x
body length or height
serum creatinine
where K=0.55 for pediatric patients older than 1 year(4) and 0.45 for infants (up to 1 year).(5)
In the above equation, creatinine clearance is in mL/min/1.73 m2, body length or height is in centimeters, and serum creatinine is in mg/dL.
For pediatric patients with a creatinine clearance of < 30 mL/min/1.73 m2, the dose of cefdinir should be 7 mg/kg (up to 300 mg) given once daily.
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
60
100
37 mL
62 mL
Tap bottle to loosen powder, then add water in 2 portions. Shake well after each aliquot.
250 mg/5 mL
60
100
37 mL
62 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 controlled room temperature (20°-25°C/68°-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.

No Recall
Sandoz Inc

Cefdinir | Sandoz Inc

(see INDICATIONS AND USAGE for Indicated Pathogens)
The recommended dosage and duration of treatment for infections in adults and adolescents are described in the following chart; the total daily dose for all infections is 600 mg. Once-daily dosing for 10 days is as effective as b.i.d. dosing. Once-daily dosing has not been studied in pneumonia or skin infections; therefore, cefdinir capsules should be administered twice daily in these infections. Cefdinir capsules may be taken without regard to meals.
Adults and Adolescents (Age 13 Years and Older)
Type of Infection
Dosage
Duration
Community-Acquired Pneumonia
300 mg q12h
10 days
Acute Exacerbations of Chronic Bronchitis
300 mg q12h
or
600 mg q24h
5 to 10 days
10 days
Acute Maxillary Sinusitis
300 mg q12h
or
600 mg q24h
10 days
10 days
Pharyngitis/Tonsillitis
300 mg q12h
or
600 mg q24h
5 to 10 days
10 days
Uncomplicated Skin and Skin Structure Infections
300 mg q12h
10 days
Patients With Renal Insufficiency
For adult patients with creatinine clearance < 30 mL/min, the dose of cefdinir should be 300 mg given once daily.
Creatinine clearance is difficult to measure in outpatients. However, the following formula may be used to estimate creatinine clearance (CLcr) in adult patients. For estimates to be valid, serum creatinine levels should reflect steady-state levels of renal function.
Males:
CLcr =
(weight) (140 – age)
(72) (serum creatinine)
Females:
CLcr =
0.85 x above value
where creatinine clearance is in mL/min, age is in years, weight is in kilograms, and serum creatinine is in mg/dL.(3)
The following formula may be used to estimate creatinine clearance in pediatric patients:
CLcr = K x
body length or height
serum creatinine
where K=0.55 for pediatric patients older than 1 year(4) and 0.45 for infants (up to 1 year).(5)
In the above equation, creatinine clearance is in mL/min/1.73 m2, body length or height is in centimeters, and serum creatinine is in mg/dL.
For pediatric patients with a creatinine clearance of < 30 mL/min/1.73 m2, the dose of cefdinir should be 7 mg/kg (up to 300 mg) given once daily.
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.

No Recall
Aidarex Pharmaceuticals Llc

Cefdinir | Aidarex Pharmaceuticals Llc

(see INDICATIONS AND USAGE for 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 or
5 to 10 days

14 mg/kg q24h
10 days
Acute Maxillary Sinusitis
7 mg/kg q12h or
10 days

14 mg/kg q24h
10 days
Pharyngitis/Tonsilitis
7 mg/kg q12h or
5 to 10 days

14 mg/kg q24h
10 days
Uncomplicated Skin and Skin Structure Infections
7 mg/kg q12h
10 days
CEFDINIR FOR ORAL SUSPENSION PEDIATRIC DOSAGE CHART Weight
125 mg/5 mL
250 mg/5 mL

a Pediatric patients who weight ≥43 kg should receive the maximum daily dose of 600 mg.
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 a/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 (CLcr) in adult patients. For estimates to be valid, serum creatinine levels should reflect steady-state levels of renal function.
                                                                                    (weight) (140 – age)
                                                    Males: CLcr =   ————————————
                                                                                    (72) (serum creatinine)
                                                   Females:   CLcr = 0.85 x above value
where creatinine clearance is in mL/min, age is in years, weight is in kilograms, and serum creatinine is in mg/dL.(3)
The following formula may be used to estimate creatinine clearance in pediatric patients:
                                                                           body length or height
                                                     CLcr = K x ———————————
                                                                            serum creatinine
where K = 0.55 for pediatric patients older than 1 year(4) and 0.45 for infants (up to 1 year)(5).
In the above equation, creatinine clearance is in mL/min/1.73 m2, body length or height is in centimeters, and serum creatinine is in mg/dL.
For pediatric patients with a creatinine clearance of <30 mL/min/1.73 m2, the dose of cefdinir should be 7 mg/kg (up to 300 mg) given once daily.
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 Final Concentration
Final Volume(mL)
Amount of Water
Directions
125 mg/5 mL
60
35 mL
Tap bottle to loosen the powder, then add water in 2

100
58 mL
portions. Shake well after each aliquot.
250 mg/5 mL
60
35 mL
Tap bottle to loosen the powder, then add water in 2

100
58 mL
portions. Shake well after each aliquot.
After mixing, the suspension can be stored at 20°-25°C (68°-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.

No Recall
Northstar Rx Llc

Cefdinir | Northstar Rx Llc

(see INDICATIONS AND USAGE for 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
or
   14 mg/kg q24h
   5 to 10 days
10 days
   Acute Maxillary Sinusitis
7 mg/kg q12h
or
   14 mg/kg q24h
10 days
10 days
   Pharyngitis/Tonsillitis
7 mg/kg q12h
or
   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 a 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 kga/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 cr) in adult patients. For estimates to be valid, serum creatinine levels should reflect steady-state levels of renal function.

Males:              CL cr =      (weight) (140 – age)
                                       (72) (serum creatinine)

Females:           CL cr = 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. (3)

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

CL cr =      K x body length or height
                            serum creatinine

Where K=0.55 for pediatric patients older than 1 year (4) and 0.45 for infants (up to 1 year) (5).

In the above equation, creatinine clearance is in mL/min/1.73 m 2, 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 2, 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
60
100
38 mL
63 mL
   Tap bottle to loosen powder, then
   add water in 2 portions. Shake well
   after each aliquot.
   250 mg/5 mL
60
100
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.

No Recall
Northstar Rx Llc

Cefdinir | Northstar Rx Llc

(see INDICATIONS AND USAGE for Indicated Pathogens)

The recommended dosage and duration of treatment for infections in adults and adolescents are described in the following chart; the total daily dose for all infections is 600 mg. Once-daily dosing for 10 days is as effective as BID dosing. Once-daily dosing has not been studied in pneumonia or skin infections; therefore, cefdinir capsules should be administered twice daily in these infections. Cefdinir capsules may be taken without regard to meals.
Adults and Adolescents (Age 13 Years and Older) Type of Infection Dosage Duration    Community-Acquired Pneumonia
300 mg q12h
10 days
   Acute Exacerbations of Chronic Bronchitis

300 mg q12h
or
600 mg q24h
5 to 10 days

10 days
   Acute Maxillary Sinusitis

300 mg q12h
or
600 mg q24h
10 days

10 days
   Pharyngitis/Tonsillitis

300 mg q12h
or
600 mg q24h
5 to 10 days

10 days
   Uncomplicated Skin and Skin Structure Infections
300 mg q12h
10 days
Patients With Renal Insufficiency
For adult patients with creatinine clearance <30 mL/min, the dose of cefdinir should be 300 mg given once daily.

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

Males:              CL cr =      (weight) (140 – age)
                                       (72) (serum creatinine)

Females:           CL cr = 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 (3).

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

CL cr =      K x body length or height
                            serum creatinine

Where K=0.55 for pediatric patients older than 1 year (4) and 0.45 for infants (up to 1 year) (5).

In the above equation, creatinine clearance is in mL/min/1.73 m 2, 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 2, 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.

No Recall
Northstar Rx Llc

Cefdinir | Northstar Rx Llc

(see INDICATIONS AND USAGE for 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
or
14 mg/kg q24h 5 to 10 days

10 days Acute Maxillary Sinusitis 7 mg/kg q12h
or
14 mg/kg q24h 10 days

10 days Pharyngitis/Tonsillitis 7 mg/kg q12h
or
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 weigh ≥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 (CLcr) in adult patients. For estimates to be valid, serum creatinine levels should reflect steady-state levels of renal function.
Males:                                CLcr = (weight) (140 – age)
                                                       (72) (serum creatinine)
Females:                            CLcr = 0.85 x above value
where creatinine clearance is in mL/min, age is in years, weight is in kilograms, and serum creatinine is in mg/dL6.
The following formula may be used to estimate creatinine clearance in pediatric patients:
                                    CLcr = K x body length or height
                                                  serum creatinine
where K = 0.55 for pediatric patients older than 1 year7 and 0.45 for infants (up to 1 year)8.
In the above equation, creatinine clearance is in mL/min/1.73 m2, body length or height is in centimeters, and serum creatinine is in mg/dL.
For pediatric patients with a creatinine clearance of <30 mL/min/1.73 m2, the dose of cefdinir should be 7 mg/kg (up to 300 mg) given once daily.
6 Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976; 16:31-41. 7 Schwartz GJ, Haycock GB, Edelmann CM, Spitzer A. A simple estimate of glomerular filtration rate in children derived from body length and plasma creatinine. Pediatrics 1976; 58:259-63. 8 Schwartz GJ, Feld LG, Langford DJ. A simple estimate of glomerular filtration rate in full-term infants during the first year of life. J Pediatrics 1984; 104:849-54. Patients on Hemodialysis
Hemodialysis removes cefdinir from the body. In patients maintained on chronic hemodialysis, the recommended initial dosage regimen is a 300-mg or 7-mg/kg dose every other day. At the conclusion of each hemodialysis session, 300 mg (or 7 mg/kg) should be given. Subsequent doses (300 mg or 7 mg/kg) are then administered every other day.
Directions for Mixing Cefdinir for Oral Suspension Final Concentration Final Volume
(mL) Amount of Water Directions 125 mg/5 mL 60 38 mL Tap bottle to loosen powder, then add water in 2 portions. Shake well after each aliquot. 100 63 mL 250 mg/5 mL 60 38 mL Tap bottle to loosen powder, then add water in 2 portions. Shake well after each aliquot. 100 63 mL
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.

No Recall
A-s Medication Solutions Llc

Cefdinir | A-s Medication Solutions Llc

(see INDICATIONS AND USAGE for Indicated Pathogens)
The recommended dosage and duration of treatment for infections in adults and adolescents are described in the following chart; the total daily dose for all infections is 600 mg. Once-daily dosing for 10 days is as effective as BID dosing. Once-daily dosing has not been studied in pneumonia or skin infections; therefore, cefdinir capsules should be administered twice daily in these infections. Cefdinir capsules may be taken without regard to meals.
Adults and Adolescents (Age 13 years and Older) Type of Infection
Dosage
Duration
Community-Acquired Pneumonia
300 mg q12h
10 days
Acute Exacerbations of Chronic Bronchitis
300 mg q12h
5 to 10 days

or

Acute Maxillary Sinusitis
600 mg q24h
10 days

300 mg q12h
10 days

or

Pharyngitis/Tonsillitis
600 mg q24h
10 days

300 mg q12h
5 to 10 days

or

Uncomplicated Skin and Skin Structure Infections
600 mg q24h
10 days

300 mg q12h
10 days
Patients With Renal Insufficiency:
For adult patients with creatinine clearance <30 mL/min, the dose of cefdinir should be 300 mg given once daily.
Creatinine clearance is difficult to measure in outpatients. However, the following formula may be used to estimate creatinine clearance (CLcr) in adult patients. For estimates to be valid, serum creatinine levels should reflect steady-state levels of renal function.
                                                                                     (weight) (140 – age)
                                                           Males: CLcr = ——————————
                                                                                     (72) (serum creatinine)
                                                           Females: CLcr = 0.85 x above value
where creatinine clearance is in mL/min, age is in years, weight is in kilograms, and serum creatinine is in mg/dL.(3)
The following formula may be used to estimate creatinine clearance in pediatric patients:
                                                                                        body length or height
                                                           CLcr =      K x ——————————
                                                                                        serum creatinine
where K = 0.55 for pediatric patients older than 1 year(4) and 0.45 for infants (up to 1 year)(5).
In the above equation, creatinine clearance is in mL/min/1.73 m2, body length or height is in centimeters, and serum creatinine is in mg/dL.
For pediatric patients with a creatinine clearance of <30 mL/min/1.73 m2, the dose of cefdinir should be 7 mg/kg (up to 300 mg) given once daily.
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.

No Recall
A-s Medication Solutions Llc

Cefdinir | A-s Medication Solutions Llc

(see INDICATIONS AND USAGE for 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 or
5 to 10 days

14 mg/kg q24h
10 days
Acute Maxillary Sinusitis
7 mg/kg q12h or
10 days

14 mg/kg q24h
10 days
Pharyngitis/Tonsilitis
7 mg/kg q12h or
5 to 10 days

14 mg/kg q24h
10 days
Uncomplicated Skin and Skin Structure Infections
7 mg/kg q12h
10 days
CEFDINIR FOR ORAL SUSPENSION PEDIATRIC DOSAGE CHART Weight
125 mg/5 mL
250 mg/5 mL
a Pediatric patients who weight ≥43 kg should receive the maximum daily dose of 600 mg.
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 a/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 (CLcr) in adult patients. For estimates to be valid, serum creatinine levels should reflect steady-state levels of renal function.
                                                                                    (weight) (140 – age)
                                                    Males: CLcr =   ————————————
                                                                                    (72) (serum creatinine)
                                                   Females:   CLcr = 0.85 x above value
where creatinine clearance is in mL/min, age is in years, weight is in kilograms, and serum creatinine is in mg/dL.(3)
The following formula may be used to estimate creatinine clearance in pediatric patients:
                                                                           body length or height
                                                     CLcr = K x ———————————
                                                                            serum creatinine
where K = 0.55 for pediatric patients older than 1 year(4) and 0.45 for infants (up to 1 year)(5).
In the above equation, creatinine clearance is in mL/min/1.73 m2, body length or height is in centimeters, and serum creatinine is in mg/dL.
For pediatric patients with a creatinine clearance of <30 mL/min/1.73 m2, the dose of cefdinir should be 7 mg/kg (up to 300 mg) given once daily.
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 Final Concentration
Final Volume(mL)
Amount of Water
Directions
125 mg/5 mL
60
35 mL
Tap bottle to loosen the powder, then add water in 2

100
58 mL
portions. Shake well after each aliquot.
250 mg/5 mL
60
35 mL
Tap bottle to loosen the powder, then add water in 2

100
58 mL
portions. Shake well after each aliquot.
After mixing, the suspension can be stored at 20°-25°C (68°-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.

No Recall
A-s Medication Solutions Llc

Cefdinir | A-s Medication Solutions Llc

(see INDICATIONS AND USAGE for 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
or
14 mg/kg q24h 5 to 10 days

10 days Acute Maxillary Sinusitis 7 mg/kg q12h
or
14 mg/kg q24h 10 days

10 days Pharyngitis/Tonsillitis 7 mg/kg q12h
or
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 weigh ≥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 (CLcr) in adult patients. For estimates to be valid, serum creatinine levels should reflect steady-state levels of renal function.
Males:                                CLcr = (weight) (140 – age)
                                                       (72) (serum creatinine)
Females:                            CLcr = 0.85 x above value
where creatinine clearance is in mL/min, age is in years, weight is in kilograms, and serum creatinine is in mg/dL6.
The following formula may be used to estimate creatinine clearance in pediatric patients:
                                    CLcr = K x body length or height
                                                  serum creatinine
where K = 0.55 for pediatric patients older than 1 year7 and 0.45 for infants (up to 1 year)8.
In the above equation, creatinine clearance is in mL/min/1.73 m2, body length or height is in centimeters, and serum creatinine is in mg/dL.
For pediatric patients with a creatinine clearance of <30 mL/min/1.73 m2, the dose of cefdinir should be 7 mg/kg (up to 300 mg) given once daily.
6 Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976; 16:31-41. 7 Schwartz GJ, Haycock GB, Edelmann CM, Spitzer A. A simple estimate of glomerular filtration rate in children derived from body length and plasma creatinine. Pediatrics 1976; 58:259-63. 8 Schwartz GJ, Feld LG, Langford DJ. A simple estimate of glomerular filtration rate in full-term infants during the first year of life. J Pediatrics 1984; 104:849-54. Patients on Hemodialysis
Hemodialysis removes cefdinir from the body. In patients maintained on chronic hemodialysis, the recommended initial dosage regimen is a 300-mg or 7-mg/kg dose every other day. At the conclusion of each hemodialysis session, 300 mg (or 7 mg/kg) should be given. Subsequent doses (300 mg or 7 mg/kg) are then administered every other day.
Directions for Mixing Cefdinir for Oral Suspension Final Concentration Final Volume
(mL) Amount of Water Directions 125 mg/5 mL 60 38 mL Tap bottle to loosen powder, then add water in 2 portions. Shake well after each aliquot. 100 63 mL 250 mg/5 mL 60 38 mL Tap bottle to loosen powder, then add water in 2 portions. Shake well after each aliquot. 100 63 mL
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.

No Recall
Pd-rx Pharmaceuticals, Inc.

Cefdinir | Deseret Biologicals, Inc.

1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

No Recall
Orchidpharma Inc

Cefdinir | Army And Air Force Exchange Service

adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
children under 12 years: do not use this product in children under 12 years of age

No Recall
Clinical Solutions Wholesale

Cefdinir | Clinical Solutions Wholesale

(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
or
   14 mg/kg q24h
   5 to 10 days

10 days
   Acute Maxillary Sinusitis
7 mg/kg q12h
or
   14 mg/kg q24h
10 days

10 days
   Pharyngitis/Tonsillitis
7 mg/kg q12h
or
   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 a 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 kga/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 (CLcr) in adult patients. For estimates to be valid, serum creatinine levels should reflect steady-state levels of renal function.

Males:              CLcr =     (weight) (140 – age)
                                       (72) (serum creatinine)

Females:           CLcr = 0.85 x above value

where creatinine clearance is in mL/min, age is in years, weight is in kilograms, and serum creatinine is in mg/dL(3).

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

CLcr =      K x  body length or height
                            serum creatinine

Where K=0.55 for pediatric patients older than 1 year(4) and 0.45 for infants (up to 1 year)(5).

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

For pediatric patients with a creatinine clearance of <30 mL/min/1.73 m2, the dose of cefdinir should be 7 mg/kg (up to 300 mg) given once daily.
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
60
100
38 mL
63 mL
   Tap bottle to loosen powder, then
   add water in 2 portions. Shake well
   after each aliquot.
   250 mg/5 mL
60
100
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.

No Recall
Teva Pharmaceuticals Usa Inc

Cefdinir | Teva Pharmaceuticals Usa Inc

(See INDICATIONS AND USAGE for Indicated Pathogens.)
Powder for Oral Suspension
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 USP should be administered twice daily in this infection. Cefdinir for oral suspension USP 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
5 to 10 days
or
14 mg/kg q24h
10 days
Acute Maxillary Sinusitis
7 mg/kg q12h
10 days
or
14 mg/kg q24h
10 days
Pharyngitis/Tonsillitis
7 mg/kg q12h
5 to 10 days
or
14 mg/kg q24h
10 days
Uncomplicated Skin and Skin Structure Infections
7 mg/kg q12h
10 days
CEFDINIR FOR ORAL SUSPENSION PEDIATRIC DOSAGE CHART * Pediatric patients who weigh ≥ 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 7.5mL 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 (CLcr) in adult patients. For estimates to be valid, serum creatinine levels should reflect steady-state levels of renal function.
Males:
CLcr =
(weight) (140 − age)
(72) (serum creatinine)
Females:
CLcr =
0.85 × above value
where creatinine clearance is in mL/min, age is in years, weight is in kilograms, and serum creatinine is in mg/dL.3
The following formula may be used to estimate creatinine clearance in pediatric patients:
CLcr = K ×
body length or height
serum creatinine
where K = 0.55 for pediatric patients older than 1 year4 and 0.45 for infants (up to 1 year).5
In the above equation, creatinine clearance is in mL/min/1.73 m2, body length or height is in centimeters, and serum creatinine is in mg/dL.
For pediatric patients with a creatinine clearance of < 30 mL/min/1.73 m2, the dose of cefdinir should be 7 mg/kg (up to 300 mg) given once daily.
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 USP
Final Concentration
Final Volume (mL)
Amount of Water
Directions
125 mg/5 mL
60
50 mL
Tap bottle to loosen powder, then add water in 2 portions. Shake well after each aliquot.
100
80 mL
250 mg/5 mL
60
49 mL
Tap bottle to loosen powder, then add water in 2 portions. Shake well after each aliquot.
100
80 mL

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.

No Recall
Bluepoint Laboratories

Cefdinir | Procter & Gamble Manufacturing Company

apply to underarms only apply 2-3 clicks as needed

No Recall
Aurobindo Pharma Limited

Cefdinir | Aurobindo Pharma Limited

(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
or
   14 mg/kg q24h
   5 to 10 days

10 days
   Acute Maxillary Sinusitis
7 mg/kg q12h
or
   14 mg/kg q24h
10 days

10 days
   Pharyngitis/Tonsillitis
7 mg/kg q12h
or
   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 a 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 kga/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 (CLcr) in adult patients. For estimates to be valid, serum creatinine levels should reflect steady-state levels of renal function.

Males:              CLcr =     (weight) (140 – age)
                                       (72) (serum creatinine)

Females:           CLcr = 0.85 x above value

where creatinine clearance is in mL/min, age is in years, weight is in kilograms, and serum creatinine is in mg/dL(3).

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

CLcr =      K x  body length or height
                            serum creatinine

Where K=0.55 for pediatric patients older than 1 year(4) and 0.45 for infants (up to 1 year)(5).

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

For pediatric patients with a creatinine clearance of <30 mL/min/1.73 m2, the dose of cefdinir should be 7 mg/kg (up to 300 mg) given once daily.
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
60
100
38 mL
63 mL
   Tap bottle to loosen powder, then
   add water in 2 portions. Shake well
   after each aliquot.
   250 mg/5 mL
60
100
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.

No Recall
Dava Pharmaceuticals Inc

Cefdinir | Dava Pharmaceuticals Inc

(see INDICATIONS AND USAGE for Indicated Pathogens)
Powder for Oral Suspension
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 b.i.d. 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
or
14 mg/kg q24h
5 to 10 days
10 days
Acute Maxillary Sinusitis
7 mg/kg q12h
or
14 mg/kg q24h
10 days
10 days
Pharyngitis/Tonsillitis
7 mg/kg q12h
or
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 weigh ≥ 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 (CLcr) in adult patients. For estimates to be valid, serum creatinine levels should reflect steady-state levels of renal function.
Males:
CLcr =
(weight) (140 – age)
(72) (serum creatinine)
Females:
CLcr =
0.85 x above value
where creatinine clearance is in mL/min, age is in years, weight is in kilograms, and serum creatinine is in mg/dL.(3)
The following formula may be used to estimate creatinine clearance in pediatric patients:
CLcr = K x
body length or height
serum creatinine
where K=0.55 for pediatric patients older than 1 year(4) and 0.45 for infants (up to 1 year).(5)
In the above equation, creatinine clearance is in mL/min/1.73 m2, body length or height is in centimeters, and serum creatinine is in mg/dL.
For pediatric patients with a creatinine clearance of < 30 mL/min/1.73 m2, the dose of cefdinir should be 7 mg/kg (up to 300 mg) given once daily.
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
60
100
37 mL
62 mL
Tap bottle to loosen powder, then add water in 2 portions. Shake well after each aliquot.
250 mg/5 mL
60
100
37 mL
62 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 controlled room temperature (20°-25°C/68°-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.

No Recall
Dava Pharmaceuticals Inc

Cefdinir | Dava Pharmaceuticals Inc

(see INDICATIONS AND USAGE for Indicated Pathogens)
The recommended dosage and duration of treatment for infections in adults and adolescents are described in the following chart; the total daily dose for all infections is 600 mg. Once-daily dosing for 10 days is as effective as b.i.d. dosing. Once-daily dosing has not been studied in pneumonia or skin infections; therefore, cefdinir capsules should be administered twice daily in these infections. Cefdinir capsules may be taken without regard to meals.
Adults and Adolescents (Age 13 Years and Older)
Type of Infection
Dosage
Duration
Community-Acquired Pneumonia
300 mg q12h
10 days
Acute Exacerbations of Chronic Bronchitis
300 mg q12h
or
600 mg q24h
5 to 10 days
10 days
Acute Maxillary Sinusitis
300 mg q12h
or
600 mg q24h
10 days
10 days
Pharyngitis/Tonsillitis
300 mg q12h
or
600 mg q24h
5 to 10 days
10 days
Uncomplicated Skin and Skin Structure Infections
300 mg q12h
10 days
Patients With Renal Insufficiency
For adult patients with creatinine clearance < 30 mL/min, the dose of cefdinir should be 300 mg given once daily.
Creatinine clearance is difficult to measure in outpatients. However, the following formula may be used to estimate creatinine clearance (CLcr) in adult patients. For estimates to be valid, serum creatinine levels should reflect steady-state levels of renal function.
Males:
CLcr =
(weight) (140 – age)
(72) (serum creatinine)
Females:
CLcr =
0.85 x above value
where creatinine clearance is in mL/min, age is in years, weight is in kilograms, and serum creatinine is in mg/dL.(3)
The following formula may be used to estimate creatinine clearance in pediatric patients:
CLcr = K x
body length or height
serum creatinine
where K=0.55 for pediatric patients older than 1 year(4) and 0.45 for infants (up to 1 year).(5)
In the above equation, creatinine clearance is in mL/min/1.73 m2, body length or height is in centimeters, and serum creatinine is in mg/dL.
For pediatric patients with a creatinine clearance of < 30 mL/min/1.73 m2, the dose of cefdinir should be 7 mg/kg (up to 300 mg) given once daily.
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.

No Recall
Orchidpharma Inc

Cefdinir | Orchidpharma Inc

(see INDICATIONS AND USAGE for Indicated Pathogens)
The recommended dosage and duration of treatment for infections in adults and adolescents are described in the following chart; the total daily dose for all infections is 600 mg. Once-daily dosing for 10 days is as effective as BID dosing. Once-daily dosing has not been studied in pneumonia or skin infections; therefore, Cefdinir Capsules should be administered twice daily in these infections. Cefdinir Capsules may be taken without regard to meals.
Adults and Adolescents (Age 13 Years and Older) Type of Infection Dosage Duration Community-Acquired Pneumonia 300 mg q12h 10 days Acute Exacerbations of Chronic Bronchitis 300 mg q12h
or
600 mg q24h 5 to 10 days

10 days Acute Maxillary Sinusitis 300 mg q12h
or
600 mg q24h 10 days

10 days Pharyngitis/Tonsillitis 300 mg q12h
or
600 mg q24h 5 to 10 days

10 days Uncomplicated Skin and Skin Structure Infections 300 mg q12h 10 days Patients With Renal Insufficiency
For adult patients with creatinine clearance <30 mL/min, the dose of cefdinir should be 300 mg given once daily.
Creatinine clearance is difficult to measure in outpatients. However, the following formula may be used to estimate creatinine clearance (CLcr) in adult patients. For estimates to be valid, serum creatinine levels should reflect steady-state levels of renal function.
Males:                    CLcr = (weight) (140 – age)
                                          (72) (serum creatinine)
Females:                CLcr = 0.85 x above value
where creatinine clearance is in mL/min, age is in years, weight is in kilograms, and serum creatinine is in mg/dL6.
The following formula may be used to estimate creatinine clearance in pediatric patients:
                            CLcr = K x body length or height
                                          serum creatinine
where K = 0.55 for pediatric patients older than 1 year7 and 0.45 for infants (up to 1 year)8.
In the above equation, creatinine clearance is in mL/min/1.73 m2, body length or height is in centimeters, and serum creatinine is in mg/dL.
For pediatric patients with a creatinine clearance of <30 mL/min/1.73 m2, the dose of cefdinir should be 7 mg/kg (up to 300 mg) given once daily.
6 Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976; 16:31-41. 7 Schwartz GJ, Haycock GB, Edelmann CM, Spitzer A. A simple estimate of glomerular filtration rate in children derived from body length and plasma creatinine. Pediatrics 1976; 58:259-63. 8 Schwartz GJ, Feld LG, Langford DJ. A simple estimate of glomerular filtration rate in full-term infants during the first year of life. J Pediatrics 1984; 104:849-54. Patients on Hemodialysis
Hemodialysis removes cefdinir from the body. In patients maintained on chronic hemodialysis, the recommended initial dosage regimen is a 300 mg or 7 mg/kg dose every other day. At the conclusion of each hemodialysis session, 300 mg (or 7 mg/kg) should be given. Subsequent doses (300 mg or 7 mg/kg) are then administered every other day.

No Recall
Citron Pharma Llc

Cefdinir | Citron Pharma Llc

(see INDICATIONS AND USAGE for Indicated Pathogens)

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

Adults and Adolescents (Age 13 Years and Older) Type of Infection Dosage Duration    Community-Acquired Pneumonia
300 mg q12h
10 days
   Acute Exacerbations of Chronic Bronchitis

300 mg q12h
or
600 mg q24h
5 to 10 days
10 days
   Acute Maxillary Sinusitis

300 mg q12h
or
600 mg q24h
10 days
10 days
   Pharyngitis/Tonsillitis

300 mg q12h
or
600 mg q24h
5 to 10 days
10 days
   Uncomplicated Skin and Skin Structure Infections
300 mg q12h
10 days
Patients With Renal Insufficiency
For adult patients with creatinine clearance <30 mL/min, the dose of cefdinir should be 300 mg given once daily.

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

Males:              CLcr =     (weight) (140 – age)
                                       (72) (serum creatinine)

Females:           CLcr = 0.85 x above value

where creatinine clearance is in mL/min, age is in years, weight is in kilograms, and serum creatinine is in mg/dL(3).

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

CLcr =      K x  body length or height
                            serum creatinine

Where K=0.55 for pediatric patients older than 1 year(4) and 0.45 for infants (up to 1 year)(5).

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

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

No Recall
Aurobindo Pharma Limited

Cefdinir | Aurobindo Pharma Limited

(see INDICATIONS AND USAGE for Indicated Pathogens)

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

Adults and Adolescents (Age 13 Years and Older) Type of Infection Dosage Duration    Community-Acquired Pneumonia
300 mg q12h
10 days
   Acute Exacerbations of Chronic Bronchitis

300 mg q12h
or
600 mg q24h
5 to 10 days
10 days
   Acute Maxillary Sinusitis

300 mg q12h
or
600 mg q24h
10 days
10 days
   Pharyngitis/Tonsillitis

300 mg q12h
or
600 mg q24h
5 to 10 days
10 days
   Uncomplicated Skin and Skin Structure Infections
300 mg q12h
10 days
Patients With Renal Insufficiency
For adult patients with creatinine clearance <30 mL/min, the dose of cefdinir should be 300 mg given once daily.

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

Males:              CLcr =     (weight) (140 – age)
                                       (72) (serum creatinine)

Females:           CLcr = 0.85 x above value

where creatinine clearance is in mL/min, age is in years, weight is in kilograms, and serum creatinine is in mg/dL(3).

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

CLcr =      K x  body length or height
                            serum creatinine

Where K=0.55 for pediatric patients older than 1 year(4) and 0.45 for infants (up to 1 year)(5).

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

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

No Recall
Northwind Pharmaceuticals, Llc

Cefdinir | Northwind Pharmaceuticals, Llc

Capsules
The recommended dosage and duration of treatment for infections in adults and adolescents are described in the following chart; the total daily dose for all infections is 600 mg. Once-daily dosing for 10 days is as effective as BID dosing. Once-daily dosing has not been studied in pneumonia or skin infections; therefore, cefdinir capsules USP should be administered twice daily in these infections. Cefdinir capsules USP may be taken without regard to meals.
Please visit the FDA site to view the manufacturer's complete drug information including the dosage recommendations:
http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=de3441e3-7fd2-4d29-a8b7-0f9b66e35c9c&CFID=19698&CFTOKEN=609ac8b08c4f1e1e-30173D7B-F4DA-D75D-F59581A3FE4C3FFD
Pediatric Patients
Alternate dosage forms of cefdinir (e.g., cefdinir for oral suspension) may be best suited for pediatric dosing. 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.

No Recall
Teva Pharmaceuticals Usa Inc

Cefdinir | Teva Pharmaceuticals Usa Inc

(See INDICATIONS AND USAGE for Indicated Pathogens.)
Capsules
The recommended dosage and duration of treatment for infections in adults and adolescents are described in the following chart; the total daily dose for all infections is 600 mg. Once-daily dosing for 10 days is as effective as BID dosing. Once-daily dosing has not been studied in pneumonia or skin infections; therefore, cefdinir capsules USP should be administered twice daily in these infections. Cefdinir capsules USP may be taken without regard to meals.
Adults and Adolescents (Age 13 Years and Older)
Type of Infection
Dosage
Duration
Community-Acquired Pneumonia
300 mg q12h
10 days
Acute Exacerbations of Chronic Bronchitis
300 mg q12h
5 to 10 days
or
600 mg q24h
10 days
Acute Maxillary Sinusitis
300 mg q12h
10 days
or
600 mg q24h
10 days
Pharyngitis/Tonsillitis
300 mg q12h
5 to 10 days
or
600 mg q24h
10 days
Uncomplicated Skin and Skin Structure Infections
300 mg q12h
10 days
Pediatric Patients
Alternate dosage forms of cefdinir (e.g., cefdinir for oral suspension) may be best suited for pediatric dosing. 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
5 to 10 days
or
14 mg/kg q24h
10 days
Acute Maxillary Sinusitis
7 mg/kg q12h
10 days
or
14 mg/kg q24h
10 days
Pharyngitis/Tonsillitis
7 mg/kg q12h
5 to 10 days
or
14 mg/kg q24h
10 days
Uncomplicated Skin and Skin Structure Infections
7 mg/kg q12h
10 days
Pediatric patients who weigh ≥ 43 kg should receive the maximum daily dose of 600 mg.
Patients With Renal Insufficiency
For adult patients with creatinine clearance < 30 mL/min, the dose of cefdinir should be 300 mg given once daily.
Creatinine clearance is difficult to measure in outpatients. However, the following formula may be used to estimate creatinine clearance (CLcr) in adult patients. For estimates to be valid, serum creatinine levels should reflect steady-state levels of renal function.
Males:
CLcr =
(weight) (140 – age)
(72) (serum creatinine)
Females:
CLcr = 0.85 x above value
where creatinine clearance is in mL/min, age is in years, weight is in kilograms, and serum creatinine is in mg/dL.3
The following formula may be used to estimate creatinine clearance in pediatric patients:
CLcr = K ×
body length or height
serum creatinine
where K = 0.55 for pediatric patients older than 1 year4 and 0.45 for infants (up to 1 year).5
In the above equation, creatinine clearance is in mL/min/1.73 m2, body length or height is in centimeters, and serum creatinine is in mg/dL.
For pediatric patients with a creatinine clearance of < 30 mL/min/1.73 m2, the dose of cefdinir should be 7 mg/kg (up to 300 mg) given once daily.
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.

No Recall
Preferred Pharmaceuticals Inc.

Cefdinir | Preferred Pharmaceuticals Inc.

(see INDICATIONS AND USAGE for Indicated Pathogens)
The recommended dosage and duration of treatment for infections in adults and adolescents are described in the following chart; the total daily dose for all infections is 600 mg. Once-daily dosing for 10 days is as effective as BID dosing. Once-daily dosing has not been studied in pneumonia or skin infections; therefore, Cefdinir Capsules should be administered twice daily in these infections. Cefdinir Capsules may be taken without regard to meals.
Adults and Adolescents (Age 13 Years and Older)
Type of Infection
Dosage
Duration
Community-Acquired Pneumonia
300 mg q12h
10 days
Acute Exacerbations of Chronic Bronchitis
300 mg q12h
or
600 mg q24h
5 to 10 days

10 days
Acute Maxillary Sinusitis
300 mg q12h
or
600 mg q24h
10 days

10 days
Pharyngitis/Tonsillitis
300 mg q12h
or
600 mg q24h
5 to 10 days

10 days
Uncomplicated Skin and Skin Structure Infections
300 mg q12h
10 days
Patients With Renal Insufficiency
For adult patients with creatinine clearance <30 mL/min, the dose of cefdinir should be 300 mg given once daily.
Creatinine clearance is difficult to measure in outpatients. However, the following formula may be used to estimate creatinine clearance (CLcr) in adult patients. For estimates to be valid, serum creatinine levels should reflect steady-state levels of renal function.
Males:                    CLcr = (weight) (140 – age)
                                          (72) (serum creatinine)
Females:                CLcr = 0.85 x above value
where creatinine clearance is in mL/min, age is in years, weight is in kilograms, and serum creatinine is in mg/dL6.
The following formula may be used to estimate creatinine clearance in pediatric patients:
                            CLcr = K x body length or height
                                          serum creatinine
where K = 0.55 for pediatric patients older than 1 year7 and 0.45 for infants (up to 1 year)8.
In the above equation, creatinine clearance is in mL/min/1.73 m2, body length or height is in centimeters, and serum creatinine is in mg/dL.
For pediatric patients with a creatinine clearance of <30 mL/min/1.73 m2, the dose of cefdinir should be 7 mg/kg (up to 300 mg) given once daily.
6 Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976; 16:31-41. 7 Schwartz GJ, Haycock GB, Edelmann CM, Spitzer A. A simple estimate of glomerular filtration rate in children derived from body length and plasma creatinine. Pediatrics 1976; 58:259-63. 8 Schwartz GJ, Feld LG, Langford DJ. A simple estimate of glomerular filtration rate in full-term infants during the first year of life. J Pediatrics 1984; 104:849-54. Patients on Hemodialysis
Hemodialysis removes cefdinir from the body. In patients maintained on chronic hemodialysis, the recommended initial dosage regimen is a 300 mg or 7 mg/kg dose every other day. At the conclusion of each hemodialysis session, 300 mg (or 7 mg/kg) should be given. Subsequent doses (300 mg or 7 mg/kg) are then administered every other day.

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