Cefprozil

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Side Effects & Adverse Reactions

BEFORE THERAPY WITH CEFPROZIL IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFPROZIL, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-SENSITIVITY AMONG ß-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 CEFPROZIL OCCURS, DISCONTINUE THE DRUG. 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 cefprozil, 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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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

Cefprozil for oral suspension is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below:

Upper Respiratory Tract: Pharyngitis/Tonsillitis:

Caused by Streptococcus pyogenes.

NOTE: The usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route. Cefprozil is generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, substantial data establishing the efficacy of cefprozil in the subsequent prevention of rheumatic fever are not available at present.

Otitis Media:

Caused by Streptococcus pneumoniae, Haemophilus influenzae (including ß-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including ß-lactamase-producing strains). (See CLINICAL STUDIES.)

NOTE: In the treatment of otitis media due to ß-lactamase producing organisms, cefprozil had bacteriologic eradication rates somewhat lower than those observed with a product containing a specific ß-lactamase inhibitor. In considering the use of cefprozil, lower overall eradication rates should be balanced against the susceptibility patterns of the common microbes in a given geographic area and the increased potential for toxicity with products containing ß-lactamase inhibitors.

Acute Sinusitis:

Caused by Streptococcus pneumoniae, Haemophilus influenzae (including ß-lactamase producing strains), and Moraxella (Branhamella) catarrhalis (including ß-lactamase-producing strains).

Lower Respiratory Tract: Secondary Bacterial Infection of Acute Bronchitis and Acute Bacterial Exacerbation of Chronic Bronchitis:

Caused by Streptococcus pneumoniae, Haemophilus influenzae (including ß-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including ß-lactamase-producing strains).

Skin And Skin Structure: Uncomplicated Skin and Skin-Structure Infections:

Caused by Staphylococcus aureus (including penicillinase producing strains) and Streptococcus pyogenes. Abscesses usually require surgical drainage.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefprozil for oral suspension and other antibacterial drugs, cefprozil for oral suspension 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.

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History

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Other Information

Cefprozil is a semi-synthetic broad-spectrum cephalosporin antibiotic.

Cefprozil is a cis and trans isomeric mixture (≥90% cis). The chemical name for the monohydrate is (6R,7R)-7-[(R)-2-amino-2-(p-hydroxyphenyl)acetamido]-8-oxo-3-propenyl-5-thia-1-azabicyclo [4.2.0]oct-2-ene-2- carboxylic acid monohydrate, and the structural formula is:

Cefprozil is a white to yellowish powder with a molecular formula for the monohydrate of C18H19N3O5S.H2O and a molecular weight of 407.45.

Cefprozil for oral suspension is intended for oral administration.

Cefprozil for oral suspension contains cefprozil equivalent to 125 mg or 250 mg of anhydrous cefprozil per 5 mL constituted suspension. In addition, the oral suspension contains the following inactive ingredients: aspartame, bubble gum flavor, anhydrous citric acid, colloidal silicon dioxide, FD&C Red No. 40 Aluminum Lake, glycine, microcrystalline cellulose and sodium carboxymethylcellulose, sodium benzoate, sodium chloride and sucrose.

Sources

Cefprozil Manufacturers

Physicians Total Care, Inc.

Cefprozil | Physicians Total Care, Inc.

Cefprozil for oral suspension is administered orally.
Population/Infection Dosage (mg) Duration (days) ADULTS (13 years and older)

    UPPER RESPIRATORY TRACT

        Pharyngitis/Tonsillitis 500 q24h 10 a         Acute Sinusitis 250 q12h or 10         (For moderate to severe infections, the higher dose should be used) 500 q12h
    LOWER RESPIRATORY TRACT

        Secondary Bacterial Infection of Acute Bronchitis and Acute Bacterial
        Exacerbation of Chronic Bronchitis 500 q12h 10     SKIN AND SKIN STRUCTURE

        Uncomplicated Skin and Skin Structure Infections 250 q12h or 10
500 q24h or

500 q12h
CHILDREN (2 years-12 years)

    UPPER RESPIRATORY TRACT b

        Pharyngitis/Tonsillitis 7.5 mg/kg q12h 10 a     SKIN AND SKIN STRUCTURE b

        Uncomplicated Skin and Skin Structure Infections 20 mg/kg q24h 10 INFANTS & CHILDREN (6 months-12 years)

    UPPER RESPIRATORY TRACT b

        Otitis Media 15 mg/kg q12h 10
        (See INDICATIONS AND USAGE and CLINICAL STUDIES)

        Acute Sinusitis 7.5 mg/kg q12h or 10         (For moderate to severe infections, the higher dose should be used) 15 mg/kg q12h
a In the treatment of infections due to Streptococcus pyogenes, cefprozil for oral suspension should be administered for at least 10 days.

b Not to exceed recommended adult doses.

Renal Impairment:
Cefprozil may be administered to patients with impaired renal function. The following dosage schedule should be used.

Creatinine Clearance (mL/min)

Dosage (mg)

Dosing Interval
30-120 standard standard 0-29* 50% of standard standard
*Cefprozil is in part removed by hemodialysis; therefore, cefprozil should be administered after the completion of hemodialysis.

Hepatic Impairment:
No dosage adjustment is necessary for patients with impaired hepatic function.

No Recall
Lupin Pharmaceuticals Inc

Cefprozil | Lupin Pharmaceuticals Inc

Cefprozil for oral suspension is administered orally.
Population/Infection
Dosage (mg)
Duration (days)

a In the treatment of infections due to Streptococcus pyogenes, cefprozil for oral suspension should be administered for at least 10 days.

b Not to exceed recommended adult doses.

ADULTS (13 years and older)

    UPPER RESPIRATORY TRACT

        Pharyngitis/Tonsillitis
500 q24h
10 a
        Acute Sinusitis
250 q12h or
10
        (For moderate to severe infections, the higher dose should be used)
500 q12h

    LOWER RESPIRATORY TRACT

        Secondary Bacterial Infection of Acute Bronchitis and Acute Bacterial
        Exacerbation of Chronic Bronchitis
500 q12h
10
    SKIN AND SKIN STRUCTURE

        Uncomplicated Skin and Skin Structure Infections
250 q12h or
10

500 q24h or

500 q12h

CHILDREN (2 years-12 years)

    UPPER RESPIRATORY TRACT b

        Pharyngitis/Tonsillitis
7.5 mg/kg q12h
10 a
    SKIN AND SKIN STRUCTURE b

        Uncomplicated Skin and Skin Structure Infections
20 mg/kg q24h
10
INFANTS & CHILDREN (6 months-12 years)

    UPPER RESPIRATORY TRACT b

        Otitis Media
15 mg/kg q12h
10
        (See INDICATIONS AND USAGE and CLINICAL STUDIES)

        Acute Sinusitis
7.5 mg/kg q12h or
10
        (For moderate to severe infections, the higher dose should be used)
15 mg/kg q12h

Renal Impairment:
Cefprozil may be administered to patients with impaired renal function. The following dosage schedule should be used.
Creatinine Clearance (mL/min)
Dosage (mg)
Dosing Interval
* Cefprozil is in part removed by hemodialysis; therefore, cefprozil should be administered after the completion of hemodialysis. 30-120
standard
standard
0-29*
50% of standard
standard
Hepatic Impairment:
No dosage adjustment is necessary for patients with impaired hepatic function.

No Recall
Redpharm Drug Inc.

Cefprozil | Redpharm Drug Inc.

Cefprozil tablets are administered orally. Population/Infection Dosage (mg) Duration (days) ADULTS (13 years and older)

    UPPER RESPIRATORY TRACT

        Pharyngitis/Tonsillitis 500 q24h 10 a         Acute Sinusitis 250 q12h or 10         (For moderate to severe infections, the higher dose should be used) 500 q12h
    LOWER RESPIRATORY TRACT

        Secondary Bacterial Infection of Acute Bronchitis and Acute Bacterial
        Exacerbation of Chronic Bronchitis 500 q12h 10     SKIN AND SKIN STRUCTURE

        Uncomplicated Skin and Skin Structure Infections 250 q12h or 10
500 q24h or

500 q12h
CHILDREN (2 years-12 years)

    UPPER RESPIRATORY TRACT b

        Pharyngitis/Tonsillitis 7.5 mg/kg q12h 10 a     SKIN AND SKIN STRUCTURE b

        Uncomplicated Skin and Skin Structure Infections 20 mg/kg q24h 10 INFANTS and CHILDREN (6 months-12 years)

    UPPER RESPIRATORY TRACT b

        Otitis Media 15 mg/kg q12h 10
        (See INDICATIONS AND USAGE and CLINICAL STUDIES)

        Acute Sinusitis 7.5 mg/kg q12h or 10         (For moderate to severe infections, the higher dose should be used) 15 mg/kg q12h
a In the treatment of infections due to Streptococcus pyogenes, cefprozil for oral suspension should be administered for at least 10 days.

b Not to exceed recommended adult doses.

Renal Impairment:
Cefprozil may be administered to patients with impaired renal function. The following dosage schedule should be used.

Creatinine Clearance (mL/min)

Dosage (mg)

Dosing Interval
30-120 standard standard 0-29* 50% of standard standard
*Cefprozil is in part removed by hemodialysis; therefore, cefprozil should be administered after the completion of hemodialysis.

Hepatic Impairment:
No dosage adjustment is necessary for patients with impaired hepatic function.

No Recall
H. J. Harkins Company, Inc.

Cefprozil | H. J. Harkins Company, Inc.

Cefprozil tablets are administered orally.
Population/Infection
Dosage (mg)
Duration (days)

a In the treatment of infections due to Streptococcus pyogenes, cefprozil tablets should be administered for at least 10 days.

b Not to exceed recommended adult doses.
ADULTS (13 years and older)

    UPPER RESPIRATORY TRACT

         Pharyngitis/Tonsillitis
500 q24h
10 a
         Acute Sinusitis
250 q12h or
10
         (For moderate to severe infections, the higher dose should be used)
500 q12h

    LOWER RESPIRATORY TRACT

         Secondary Bacterial Infection of Acute Bronchitis and
        Acute Bacterial Exacerbation of Chronic Bronchitis
500 q12h
10
    SKIN AND SKIN STRUCTURE

         Uncomplicated Skin and Skin Structure Infections
250 q12h or
10

500 q24h or

500 q12h

CHILDREN (2 years-12 years)

    UPPER RESPIRATORY TRACT b

        Pharyngitis/Tonsillitis
7.5 mg/kg q12h
10 a
    SKIN AND SKIN STRUCTUREb

        Uncomplicated Skin and Skin Structure Infections
20 mg/kg q24h
10
INFANTS & CHILDREN (6 months-12 years)

    UPPER RESPIRATORY TRACTb

        Otitis Media
15 mg/kg q12h
10
        (See INDICATIONS AND USAGE and CLINICAL STUDIES)

        Acute Sinusitis
7.5 mg/kg q12h or
10
        (For moderate to severe infections, the higher dose should be used)
15 mg/kg q12h

Renal Impairment:
Cefprozil may be administered to patients with impaired renal function. The following dosage schedule should be used.
Creatinine Clearance (mL/min)
Dosage (mg)
Dosing Interval
30-120
standard
standard
0-29
50% of standard
standard
Hepatic Impairment:
No dosage adjustment is necessary for patients with impaired hepatic function.

No Recall
Physicians Total Care, Inc.

Cefprozil | Physicians Total Care, Inc.

Cefprozil tablets are administered orally.
Population/Infection
Dosage (mg)
Duration (days)

a In the treatment of infections due to Streptococcus pyogenes, cefprozil tablets should be administered for at least 10 days.

b Not to exceed recommended adult doses.
ADULTS (13 years and older)

    UPPER RESPIRATORY TRACT

         Pharyngitis/Tonsillitis
500 q24h
10 a
         Acute Sinusitis
250 q12h or
10
         (For moderate to severe infections, the higher dose should be used)
500 q12h

    LOWER RESPIRATORY TRACT

         Secondary Bacterial Infection of Acute Bronchitis and
        Acute Bacterial Exacerbation of Chronic Bronchitis
500 q12h
10
    SKIN AND SKIN STRUCTURE

         Uncomplicated Skin and Skin Structure Infections
250 q12h or
10

500 q24h or

500 q12h

CHILDREN (2 years-12 years)

    UPPER RESPIRATORY TRACT b

        Pharyngitis/Tonsillitis
7.5 mg/kg q12h
10 a
    SKIN AND SKIN STRUCTUREb

        Uncomplicated Skin and Skin Structure Infections
20 mg/kg q24h
10
INFANTS & CHILDREN (6 months-12 years)

    UPPER RESPIRATORY TRACTb

        Otitis Media
15 mg/kg q12h
10
        (See INDICATIONS AND USAGE and CLINICAL STUDIES)

        Acute Sinusitis
7.5 mg/kg q12h or
10
        (For moderate to severe infections, the higher dose should be used)
15 mg/kg q12h

Renal Impairment:
Cefprozil may be administered to patients with impaired renal function. The following dosage schedule should be used.
Creatinine Clearance (mL/min)
Dosage (mg)
Dosing Interval
30-120
standard
standard
0-29
50% of standard
standard
Hepatic Impairment:
No dosage adjustment is necessary for patients with impaired hepatic function.

No Recall
Teva Pharmaceuticals Usa Inc

Cefprozil | Wal-mart Stores Inc

• do not take more than directed unless advised by your doctor • the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line (white section in cap) • adults and children 17 years of age and older: • fill to top of white section in cap which is marked to indicate the correct dose (17 g) • stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink • use once a day • use no more than 7 days • children 16 years of age or under: ask a doctor

No Recall
Teva Pharmaceuticals Usa Inc

Cefprozil | Teva Pharmaceuticals Usa Inc

Cefprozil for oral suspension is administered orally.
* In the treatment of infections due to Streptococcus pyogenes, cefprozil should be administered for at least 10 days. † Not to exceed recommended adult doses. Population/Infection Dosage (mg) Duration (days) ADULTS (13 years and older) UPPER RESPIRATORY TRACT Pharyngitis/Tonsillitis 500 q24h 10* Acute Sinusitis (For moderate to severe infections, the higher dose should be used) 250 q12h or 500 q12h 10 LOWER RESPIRATORY TRACT Secondary Bacterial Infection of Acute Bronchitis and Acute Bacterial Exacerbation of Chronic Bronchitis 500 q12h 10 SKIN AND SKIN STRUCTURE Uncomplicated Skin and Skin Structure Infections 250 q12h or 500 q24h or 500 q12h 10 CHILDREN (2 years to 12 years) UPPER RESPIRATORY TRACT† Pharyngitis/Tonsillitis 7.5 mg/kg q12h 10* SKIN AND SKIN STRUCTURE† Uncomplicated Skin and Skin Structure Infections 20 mg/kg q24h 10 INFANTS & CHILDREN (6 months to 12 years) UPPER RESPIRATORY TRACT† Otitis Media (See INDICATIONS AND USAGE and CLINICAL STUDIES) 15 mg/kg q12h 10 Acute Sinusitis (For moderate to severe infections, the higher dose should be used) 7.5 mg/kg q12h or 15 mg/kg q12h 10 Renal Impairment
Cefprozil may be administered to patients with impaired renal function. The following dosage schedule should be used.
* Cefprozil is in part removed by hemodialysis; therefore, cefprozil should be administered after the completion of hemodialysis. Creatinine Clearance (mL/min) Dosage (mg) Dosing Interval 30 to 120 standard standard 0 to 29* 50% of standard standard Hepatic Impairment
No dosage adjustment is necessary for patients with impaired hepatic function.

No Recall
Wockhardt Usa Llc.

Cefprozil | Wockhardt Usa Llc.

Cefprozil tablets are administered orally.

a In the treatment of infections due to Streptococcus pyogenes, Cefprozil tablets should be administered for at least 10 days.

b Not to exceed recommended adult doses.
Population/Infection
Dosage
(mg)
Duration (days)
ADULTS (13 years and older)
     UPPER RESPIRATORY TRACT
            Pharyngitis/Tonsillitis

500 q24h

10a
            Acute Sinusitis
            (For moderate to severe infections, the higher dose should be used)
250 q12h or
500 q12h
10
     LOWER RESPIRATORY TRACT
              Secondary Bacterial Infection of Acute Bronchitis
              and Acute Bacterial Exacerbation of Chronic Bronchitis

500 q12h

10
              SKIN AND SKIN STRUCTURE
              Uncomplicated Skin and Skin Structure Infections

250 q12h or
500 q24h or
500 q12h

10
CHILDREN (2 years-12 years)
     UPPER RESPIRATORY TRACTb
              Pharyngitis/Tonsillitis

7.5 mg/kg q12h

10a
     SKIN AND SKIN STRUCTUREb
              Uncomplicated Skin and Skin  Structure Infections

20 mg/kg q24h

10
INFANTS & CHILDREN (6 months-12 years)
     UPPER RESPIRATORY TRACTb
              Otitis Media (See INDICATIONS AND USAGE and
              CLINICAL STUDIES)

15 mg/kg q12h

10
              Acute Sinusitis
              (For moderate to severe infections, the higher dose should be used)
7.5 mg/kg q12h or
15 mg/kg q12h
10
Renal Impairment
Cefprozil may be administered to patients with impaired renal function. The following dosage schedule should be used.

*Cefprozil is in part removed by hemodialysis; therefore, cefprozil should be administered after the completion of hemodialysis.
Creatinine Clearance
(mL/min)
Dosage
(mg)
Dosing Interval
30-120
standard
standard
0-29*
50% of standard
standard
Hepatic Impairment
No dosage adjustment is necessary for patients with impaired hepatic function.

No Recall
Wockhardt Limited

Cefprozil | Wockhardt Limited

Cefprozil tablets are administered orally.

a In the treatment of infections due to Streptococcus pyogenes, Cefprozil tablets should be administered for at least 10 days.

b Not to exceed recommended adult doses.
Population/Infection
Dosage
(mg)
Duration (days)
ADULTS (13 years and older)
     UPPER RESPIRATORY TRACT
            Pharyngitis/Tonsillitis

500 q24h

10a
            Acute Sinusitis
            (For moderate to severe infections, the higher dose should be used)
250 q12h or
500 q12h
10
     LOWER RESPIRATORY TRACT
              Secondary Bacterial Infection of Acute Bronchitis
              and Acute Bacterial Exacerbation of Chronic Bronchitis

500 q12h

10
              SKIN AND SKIN STRUCTURE
              Uncomplicated Skin and Skin Structure Infections

250 q12h or
500 q24h or
500 q12h

10
CHILDREN (2 years-12 years)
     UPPER RESPIRATORY TRACTb
              Pharyngitis/Tonsillitis

7.5 mg/kg q12h

10a
     SKIN AND SKIN STRUCTUREb
              Uncomplicated Skin and Skin  Structure Infections

20 mg/kg q24h

10
INFANTS & CHILDREN (6 months-12 years)
     UPPER RESPIRATORY TRACTb
              Otitis Media (See INDICATIONS AND USAGE and
              CLINICAL STUDIES)

15 mg/kg q12h

10
              Acute Sinusitis
              (For moderate to severe infections, the higher dose should be used)
7.5 mg/kg q12h or
15 mg/kg q12h
10
Renal Impairment
Cefprozil may be administered to patients with impaired renal function. The following dosage schedule should be used.

*Cefprozil is in part removed by hemodialysis; therefore, cefprozil should be administered after the completion of hemodialysis.
Creatinine Clearance
(mL/min)
Dosage
(mg)
Dosing Interval
30-120
standard
standard
0-29*
50% of standard
standard
Hepatic Impairment
No dosage adjustment is necessary for patients with impaired hepatic function.

No Recall
Northstar Rx Llc

Cefprozil | Northstar Rx Llc

Cefprozil is administered orally.
Population/Infection Dosage
(mg) Duration
(days) * In the treatment of infections due to Streptococcus pyogenes, cefprozil should be administered for at least 10 days. † Not to exceed recommended adult doses. ADULTS (13 years and older) UPPER RESPIRATORY TRACT Pharyngitis/Tonsillitis 500 q24h 10* Acute Sinusitis
(For moderate to severe infections, the higher dose should be used) 250 q12h or
500 q12h 10 LOWER RESPIRATORY TRACT Secondary Bacterial Infection
of Acute Bronchitis and Acute
Bacterial Exacerbation of Chronic
Bronchitis 500 q12h 10 SKIN AND SKIN STRUCTURE Uncomplicated Skin and
Skin Structure Infections 250 q12h or
500 q24h or
500 q12h 10 CHILDREN (2 years – 12 years) UPPER RESPIRATORY TRACT† Pharyngitis/Tonsillitis 7.5 mg/kg q12h 10* SKIN AND SKIN STRUCTURE† Uncomplicated Skin and
Skin Structure Infections 20 mg/kg q24h 10 INFANTS & CHILDREN (6 months – 12 years) UPPER RESPIRATORY TRACT† Otitis Media (See INDICATIONS AND USAGE and
CLINICAL STUDIES) 15 mg/kg q12h 10 Acute Sinusitis
(For moderate to severe infections,
the higher dose should be used) 7.5 mg/kg q12h or 15 mg/kg q12h 10
Renal Impairment

Cefprozil may be administered to patients with impaired renal function. The following dosage schedule should be used.
Creatinine Clearance (mL/min) Dosage (mg) Dosing Interval * Cefprozil is in part removed by hemodialysis; therefore, cefprozil should be administered after the completion of hemodialysis. 30-120 standard standard 0- 29* 50% of standard standard
Hepatic Impairment

No dosage adjustment is necessary for patients with impaired hepatic function.

No Recall
Lupin Pharmaceuticals, Inc.

Cefprozil | Lupin Pharmaceuticals, Inc.

Cefprozil tablets are administered orally.
Population/Infection
Dosage (mg)
Duration (days)

a In the treatment of infections due to Streptococcus pyogenes, cefprozil tablets should be administered for at least 10 days.

b Not to exceed recommended adult doses.
ADULTS (13 years and older)

    UPPER RESPIRATORY TRACT

         Pharyngitis/Tonsillitis
500 q24h
10 a
         Acute Sinusitis
250 q12h or
10
         (For moderate to severe infections, the higher dose should be used)
500 q12h

    LOWER RESPIRATORY TRACT

         Secondary Bacterial Infection of Acute Bronchitis and
        Acute Bacterial Exacerbation of Chronic Bronchitis
500 q12h
10
    SKIN AND SKIN STRUCTURE

         Uncomplicated Skin and Skin Structure Infections
250 q12h or
10

500 q24h or

500 q12h

CHILDREN (2 years-12 years)

    UPPER RESPIRATORY TRACT b

        Pharyngitis/Tonsillitis
7.5 mg/kg q12h
10 a
    SKIN AND SKIN STRUCTUREb

        Uncomplicated Skin and Skin Structure Infections
20 mg/kg q24h
10
INFANTS & CHILDREN (6 months-12 years)

    UPPER RESPIRATORY TRACTb

        Otitis Media
15 mg/kg q12h
10
        (See INDICATIONS AND USAGE and CLINICAL STUDIES)

        Acute Sinusitis
7.5 mg/kg q12h or
10
        (For moderate to severe infections, the higher dose should be used)
15 mg/kg q12h

Renal Impairment:
Cefprozil may be administered to patients with impaired renal function. The following dosage schedule should be used.
Creatinine Clearance (mL/min)
Dosage (mg)
Dosing Interval
* Cefprozil is in part removed by hemodialysis; therefore, cefprozil should be administered after the completion of hemodialysis. 30-120
standard
standard
0-29 *
50% of standard
standard
Hepatic Impairment:
No dosage adjustment is necessary for patients with impaired hepatic function.

No Recall
Northstar Rx Llc

Cefprozil | Northstar Rx Llc

Cefprozil is administered orally.
Population/Infection Dosage
(mg)    Duration
(days) a In the treatment of infections due to Streptococcus pyogenes, cefprozil should be administered for at least 10 days.
b Not to exceed recommended adult doses.
ADULTS (13 years and older)

     UPPER RESPIRATORY TRACT

     Pharyngitis/Tonsillitis
500 q24h
10a
     Acute Sinusitis
     (For moderate to severe infections, the higher dose should be used)
250 q12h or
500 q12h
10
     LOWER RESPIRATORY TRACT

     Secondary Bacterial Infection of Acute Bronchitis and Acute Bacterial Exacerbation of
     Chronic Bronchitis
500 q12h
10
     SKIN AND SKIN STRUCTURE

     Uncomplicated Skin and Skin Structure Infections
250 q12h or
500 q24h or
500 q12h
10
CHILDREN (2 years to 12 years)

     UPPER RESPIRATORY TRACTb

     Pharyngitis/Tonsillitis
7.5 mg/kg q12h
10a
     SKIN AND SKIN STRUCTUREb

     Uncomplicated Skin and Skin Structure Infections
20 mg/kg q24h
10
INFANTS & CHILDREN (6 months to 12 years)

     UPPER RESPIRATORY TRACTb

     Otitis Media
     (See INDICATIONS AND USAGE and CLINICAL STUDIES)
15 mg/kg q12h
10
     Acute Sinusitis
     (For moderate to severe infections, the higher dose should be used)
7.5 mg/kg q12h or
15 mg/kg q12h
10
Renal Impairment
Cefprozil may be administered to patients with impaired renal function. The following dosage schedule should be used.
Creatinine Clearance
(mL/min) Dosage
(mg) Dosing Interval * Cefprozil is in part removed by hemodialysis; therefore, cefprozil should be
   administered after the completion of   hemodialysis.
30–120
0–29*
standard
50% of standard
standard
standard
Hepatic Impairment
No dosage adjustment is necessary for patients with impaired hepatic function.

No Recall
Northstar Rx Llc

Cefprozil | Northstar Rx Llc

Cefprozil tablets are administered orally.
Population/Infection Dosage
(mg) Duration
(days) a In the treatment of infections due to Streptococcus pyogenes, cefprozil should be administered for at least 10 days.
b Not to exceed recommended adult doses.
   ADULTS (13 years and older)

      UPPER RESPIRATORY TRACT

         Pharyngitis/Tonsillitis
500 q 24 h
10a
         Acute Sinusitis
         (For moderate to severe infections, the higher dose should be used)
250 q 12 h or
500 q 12 h
10
      LOWER RESPIRATORY TRACT

         Secondary Bacterial Infection of Acute Bronchitis and
         Acute Bacterial Exacerbation of Chronic Bronchitis
500 q 12 h
10
      SKIN AND SKIN STRUCTURE

         Uncomplicated Skin and Skin Structure Infections
250 q 12 h or
500 q 24 h or
500 q 12 h
10
   CHILDREN (2 years–12 years)

      UPPER RESPIRATORY TRACTb

         Pharyngitis/Tonsillitis
7.5 mg/kg q 12 h
10a
      SKIN AND SKIN STRUCTUREb

         Uncomplicated Skin and Skin Structure Infections
20 mg/kg q 24 h
10
   INFANTS & CHILDREN (6 months–12 years)

      UPPER RESPIRATORY TRACTb

         Otitis Media
         (See INDICATIONS AND USAGE and CLINICAL STUDIES)
15 mg/kg q 12 h
10
         Acute Sinusitis
         (For moderate to severe infections, the higher dose should be used)
7.5 mg/kg q 12 h or
15 mg/kg q 12 h
10
Renal Impairment
Cefprozil may be administered to patients with impaired renal function. The following dosage schedule should be used.
Creatinine Clearance
(mL/min) Dosage
(mg) Dosing Interval * Cefprozil is in part removed by hemodialysis; therefore, cefprozil should be administered after the completion of hemodialysis.
30–120
0–29*
standard
50% of standard
standard
standard
Hepatic Impairment
No dosage adjustment is necessary for patients with impaired hepatic function.

No Recall
Apotex Corp

Cefprozil | Apotex Corp

Cefprozil Tablets USP are administered orally.
Population/Infection Dosage (mg) Duration (days) ADULTS (13 years and older) UPPER RESPIRATORY TRACT      Pharyngitis/Tonsillitis 500 q 24h     10 a      Acute Sinusitis 250 q 12h or 10     (For moderate to severe infections, the higher dose should be used) 500 q 12h     LOWER RESPIRATORY TRACT      Secondary Bacterial Infection of Acute Bronchitis and Acute Bacterial Exacerbation of Chronic Bronchitis 500 q 12h     10 SKIN AND SKIN STRUCTURE      Uncomplicated Skin and Skin Structure Infections 250 q 12h or 500 q 24h or 500 q 12h     10 CHILDREN (2 years to 12 years) UPPER RESPIRATORY TRACT b      Pharyngitis/Tonsillitis 7.5 mg/kg q 12h 10 a SKIN AND SKIN STRUCTURE b      Uncomplicated Skin and Skin Structure Infections 20 mg/kg q 24h 10 INFANTS & CHILDREN (6 months to 12 years) UPPER RESPIRATORY TRACT b      Otitis Media 15 mg/kg q 12h 10     (See INDICATIONS AND USAGE and CLINICAL STUDIES )      Acute Sinusitis 7.5 mg/kg q 12h 10     (For moderate to severe infections, the higher dose should be used) or 15 mg/kg q 12h
a    In the treatment of infections due to Streptococcus pyogenes, cefprozil should be administered for at least 10 days.

b    Not to exceed recommended adult doses
Renal Impairment
Cefprozil may be administered to patients with impaired renal function. The following dosage schedule should be used.
Creatinine Clearance (mL/min) Dosage(mg) Dosing Interval 30 to 120 standard standard 0 to 29* 50% of standard standard
*Cefprozil is in part removed by hemodialysis; therefore, cefprozil should be administered after the completion of hemodialysis.
Hepatic Impairment
No dosage adjustment is necessary for patients with impaired hepatic function.

No Recall
A-s Medication Solutions Llc

Cefprozil | A-s Medication Solutions Llc

Cefprozil for oral suspension is administered orally.
Population/Infection
Dosage (mg)
Duration (days)

a In the treatment of infections due to Streptococcus pyogenes, cefprozil for oral suspension should be administered for at least 10 days.

b Not to exceed recommended adult doses.

ADULTS (13 years and older)

    UPPER RESPIRATORY TRACT

        Pharyngitis/Tonsillitis
500 q24h
10 a
        Acute Sinusitis
250 q12h or
10
        (For moderate to severe infections, the higher dose should be used)
500 q12h

    LOWER RESPIRATORY TRACT

        Secondary Bacterial Infection of Acute Bronchitis and Acute Bacterial
        Exacerbation of Chronic Bronchitis
500 q12h
10
    SKIN AND SKIN STRUCTURE

        Uncomplicated Skin and Skin Structure Infections
250 q12h or
10

500 q24h or

500 q12h

CHILDREN (2 years-12 years)

    UPPER RESPIRATORY TRACT b

        Pharyngitis/Tonsillitis
7.5 mg/kg q12h
10 a
    SKIN AND SKIN STRUCTURE b

        Uncomplicated Skin and Skin Structure Infections
20 mg/kg q24h
10
INFANTS & CHILDREN (6 months-12 years)

    UPPER RESPIRATORY TRACT b

        Otitis Media
15 mg/kg q12h
10
        (See INDICATIONS AND USAGE and CLINICAL STUDIES)

        Acute Sinusitis
7.5 mg/kg q12h or
10
        (For moderate to severe infections, the higher dose should be used)
15 mg/kg q12h

Renal Impairment:
Cefprozil may be administered to patients with impaired renal function. The following dosage schedule should be used.
Creatinine Clearance (mL/min)
Dosage (mg)
Dosing Interval
* Cefprozil is in part removed by hemodialysis; therefore, cefprozil should be administered after the completion of hemodialysis. 30-120
standard
standard
0-29*
50% of standard
standard
Hepatic Impairment:
No dosage adjustment is necessary for patients with impaired hepatic function.

No Recall
Aurobindo Pharma Limited

Cefprozil | Aurobindo Pharma Limited

Cefprozil is administered orally.

Population/Infection Dosage
(mg)    Duration
(days) a In the treatment of infections due to Streptococcus pyogenes, cefprozil should be administered for at least 10 days.
b Not to exceed recommended adult doses.
ADULTS (13 years and older)

     UPPER RESPIRATORY TRACT

     Pharyngitis/Tonsillitis
500 q24h
10a
     Acute Sinusitis
     (For moderate to severe infections, the higher dose should be used)
250 q12h or
500 q12h
10
     LOWER RESPIRATORY TRACT

     Secondary Bacterial Infection of Acute Bronchitis and Acute Bacterial Exacerbation of
     Chronic Bronchitis
500 q12h
10
     SKIN AND SKIN STRUCTURE

     Uncomplicated Skin and Skin Structure Infections
250 q12h or
500 q24h or
500 q12h
10
CHILDREN (2 years to 12 years)

     UPPER RESPIRATORY TRACTb

     Pharyngitis/Tonsillitis
7.5 mg/kg q12h
10a
     SKIN AND SKIN STRUCTUREb

     Uncomplicated Skin and Skin Structure Infections
20 mg/kg q24h
10
INFANTS & CHILDREN (6 months to 12 years)

     UPPER RESPIRATORY TRACTb

     Otitis Media
     (See INDICATIONS AND USAGE and CLINICAL STUDIES)
15 mg/kg q12h
10
     Acute Sinusitis
     (For moderate to severe infections, the higher dose should be used)
7.5 mg/kg q12h or
15 mg/kg q12h
10
Renal Impairment

Cefprozil may be administered to patients with impaired renal function. The following dosage schedule should be used.

Creatinine Clearance
(mL/min) Dosage
(mg) Dosing Interval * Cefprozil is in part removed by hemodialysis; therefore, cefprozil should be administered after the completion of   hemodialysis.
30–120
0–29*
standard
50% of standard
standard
standard
Hepatic Impairment

No dosage adjustment is necessary for patients with impaired hepatic function.

No Recall
Aurobindo Pharma Limited

Cefprozil | Aurobindo Pharma Limited

Cefprozil tablets are administered orally.

Population/Infection Dosage
(mg) Duration
(days) a In the treatment of infections due to Streptococcus pyogenes, cefprozil should be administered for at least 10 days.
b Not to exceed recommended adult doses.
   ADULTS (13 years and older)

      UPPER RESPIRATORY TRACT

         Pharyngitis/Tonsillitis
500 q24h
10a
         Acute Sinusitis
         (For moderate to severe infections, the higher dose should be used)
250 q12h or
500 q12h
10
      LOWER RESPIRATORY TRACT

         Secondary Bacterial Infection of Acute Bronchitis and
         Acute Bacterial Exacerbation of Chronic Bronchitis
500 q12h
10
      SKIN AND SKIN STRUCTURE

         Uncomplicated Skin and Skin Structure Infections
250 q12h or
500 q24h or
500 q12h
10
   CHILDREN (2 years–12 years)

      UPPER RESPIRATORY TRACTb

         Pharyngitis/Tonsillitis
7.5 mg/kg q12h
10a
      SKIN AND SKIN STRUCTUREb

         Uncomplicated Skin and Skin Structure Infections
20 mg/kg q24h
10
   INFANTS & CHILDREN (6 months–12 years)

      UPPER RESPIRATORY TRACTb

         Otitis Media
         (See INDICATIONS AND USAGE and CLINICAL STUDIES)
15 mg/kg q12h
10
         Acute Sinusitis
         (For moderate to severe infections, the higher dose should be used)
7.5 mg/kg q12h or
15 mg/kg q12h
10
Renal Impairment
Cefprozil may be administered to patients with impaired renal function. The following dosage schedule should be used.

Creatinine Clearance
(mL/min) Dosage
(mg) Dosing Interval * Cefprozil is in part removed by hemodialysis; therefore, cefprozil should be administered after the completion of hemodialysis.
30–120
0–29*
standard
50% of standard
standard
standard
Hepatic Impairment
No dosage adjustment is necessary for patients with impaired hepatic function.

No Recall
Citron Pharma Llc

Cefprozil | Citron Pharma Llc

Cefprozil tablets are administered orally.

Population/Infection Dosage
(mg) Duration
(days) a In the treatment of infections due to Streptococcus pyogenes, cefprozil should be administered for at least 10 days.
b Not to exceed recommended adult doses.
   ADULTS (13 years and older)

      UPPER RESPIRATORY TRACT

         Pharyngitis/Tonsillitis
500 q24h
10a
         Acute Sinusitis
         (For moderate to severe infections, the higher dose should be used)
250 q12h or
500 q12h
10
      LOWER RESPIRATORY TRACT

         Secondary Bacterial Infection of Acute Bronchitis and
         Acute Bacterial Exacerbation of Chronic Bronchitis
500 q12h
10
      SKIN AND SKIN STRUCTURE

         Uncomplicated Skin and Skin Structure Infections
250 q12h or
500 q24h or
500 q12h
10
   CHILDREN (2 years–12 years)

      UPPER RESPIRATORY TRACTb

         Pharyngitis/Tonsillitis
7.5 mg/kg q12h
10a
      SKIN AND SKIN STRUCTUREb

         Uncomplicated Skin and Skin Structure Infections
20 mg/kg q24h
10
   INFANTS & CHILDREN (6 months–12 years)

      UPPER RESPIRATORY TRACTb

         Otitis Media
         (See INDICATIONS AND USAGE and CLINICAL STUDIES)
15 mg/kg q12h
10
         Acute Sinusitis
         (For moderate to severe infections, the higher dose should be used)
7.5 mg/kg q12h or
15 mg/kg q12h
10
Renal Impairment
Cefprozil may be administered to patients with impaired renal function. The following dosage schedule should be used.

Creatinine Clearance
(mL/min) Dosage
(mg) Dosing Interval * Cefprozil is in part removed by hemodialysis; therefore, cefprozil should be administered after the completion of hemodialysis.
30–120
0–29*
standard
50% of standard
standard
standard
Hepatic Impairment
No dosage adjustment is necessary for patients with impaired hepatic function.

No Recall
Citron Pharma Llc

Cefprozil | Citron Pharma Llc

Cefprozil is administered orally.

Population/Infection Dosage
(mg)    Duration
(days) a In the treatment of infections due to Streptococcus pyogenes, cefprozil should be administered for at least 10 days.
b Not to exceed recommended adult doses.
ADULTS (13 years and older)

     UPPER RESPIRATORY TRACT

     Pharyngitis/Tonsillitis
500 q24h
10a
     Acute Sinusitis
     (For moderate to severe infections, the higher dose should be used)
250 q12h or
500 q12h
10
     LOWER RESPIRATORY TRACT

     Secondary Bacterial Infection of Acute Bronchitis and Acute Bacterial Exacerbation of
     Chronic Bronchitis
500 q12h
10
     SKIN AND SKIN STRUCTURE

     Uncomplicated Skin and Skin Structure Infections
250 q12h or
500 q24h or
500 q12h
10
CHILDREN (2 years to 12 years)

     UPPER RESPIRATORY TRACTb

     Pharyngitis/Tonsillitis
7.5 mg/kg q12h
10a
     SKIN AND SKIN STRUCTUREb

     Uncomplicated Skin and Skin Structure Infections
20 mg/kg q24h
10
INFANTS & CHILDREN (6 months to 12 years)

     UPPER RESPIRATORY TRACTb

     Otitis Media
     (See INDICATIONS AND USAGE and CLINICAL STUDIES)
15 mg/kg q12h
10
     Acute Sinusitis
     (For moderate to severe infections, the higher dose should be used)
7.5 mg/kg q12h or
15 mg/kg q12h
10
Renal Impairment
Cefprozil may be administered to patients with impaired renal function. The following dosage schedule should be used.

Creatinine Clearance
(mL/min) Dosage
(mg) Dosing Interval * Cefprozil is in part removed by hemodialysis; therefore, cefprozil should be administered after the completion of   hemodialysis.
30–120
0–29*
standard
50% of standard
standard
standard
Hepatic Impairment
No dosage adjustment is necessary for patients with impaired hepatic function.

No Recall
Dava Pharmaceuticals Inc

Cefprozil | Dava Pharmaceuticals Inc

Cefprozil is administered orally.
Population/Infection Dosage
(mg) Duration
(days) * In the treatment of infections due to Streptococcus pyogenes, cefprozil should be administered for at least 10 days. † Not to exceed recommended adult doses.
ADULTS (13 years and older)

UPPER RESPIRATORY TRACT

Pharyngitis/Tonsillitis

500 q24h

10*

Acute Sinusitis
(For moderate to severe infections, the higher dose
should be used)

250 q12h or
500 q12h

10

LOWER RESPIRATORY TRACT

Secondary Bacterial Infection of Acute Bronchitis
and Acute Bacterial Exacerbation of Chronic
Bronchitis

500 q12h

10

SKIN AND SKIN STRUCTURE

Uncomplicated Skin and Skin Structure Infections

250 q12h or
500 q24h or
500 q12h

10

CHILDREN (2 years – 12 years)

UPPER RESPIRATORY TRACT†

Pharyngitis/Tonsillitis

7.5 mg/kg
q12h

10*

SKIN AND SKIN STRUCTURE†

Uncomplicated Skin and Skin Structure Infections

20 mg/kg
q24h

10

INFANTS ( CHILDREN (6 months – 12 years)

UPPER RESPIRATORY TRACT†

Otitis Media (See INDICATIONS AND USAGE and
CLINICAL STUDIES)

15 mg/kg
q12h

10

Acute Sinusitis
(For moderate to severe infections, the higher dose
should be used)

7.5 mg/kg
q12h or
15 mg/kg
q12h

10
Renal Impairment
Cefprozil may be administered to patients with impaired renal function.

The following dosage schedule should be used.
* Cefprozil is in part removed by hemodialysis; therefore, cefprozil should be administered after the completion of hemodialysis.
Creatinine Clearance
(mL/min)

Dosage
(mg)

Dosing Interval

30–120

Standard

standard

0–29*

50% of standard

standard
Hepatic Impairment
No dosage adjustment is necessary for patients with impaired hepatic function.
Reconstitution Directions for Oral Suspension
Prepare the suspension at the time of dispensing; for ease in preparation, add water in two portions and shake well after each aliquot.
Total Amount of Water Required for Reconstitution
Bottle Size

Final Concentration

125 mg/5 mL

Final Concentration

250 mg/5 mL

50 mL

36 mL

36 mL

75 mL

54 mL

54 mL

100 mL

72 mL

72 mL

After mixing, store in a refrigerator and discard unused portion after 14 days.

Store dry powder at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] prior to constitution.

No Recall
Sandoz Inc

Cefprozil | Sandoz Inc

Cefprozil is administered orally.
Population/Infection Dosage
(mg) Duration
(days) * In the treatment of infections due to Streptococcus pyogenes, cefprozil should be administered for at least 10 days. † Not to exceed recommended adult doses.
ADULTS (13 years and older)

UPPER RESPIRATORY TRACT

Pharyngitis/Tonsillitis

500 q24h

10*

Acute Sinusitis
(For moderate to severe infections, the higher dose
should be used)

250 q12h or
500 q12h

10

LOWER RESPIRATORY TRACT

Secondary Bacterial Infection of Acute Bronchitis
and Acute Bacterial Exacerbation of Chronic
Bronchitis

500 q12h

10

SKIN AND SKIN STRUCTURE

Uncomplicated Skin and Skin Structure Infections

250 q12h or
500 q24h or
500 q12h

10

CHILDREN (2 years – 12 years)

UPPER RESPIRATORY TRACT†

Pharyngitis/Tonsillitis

7.5 mg/kg
q12h

10*

SKIN AND SKIN STRUCTURE†

Uncomplicated Skin and Skin Structure Infections

20 mg/kg
q24h

10

INFANTS ( CHILDREN (6 months – 12 years)

UPPER RESPIRATORY TRACT†

Otitis Media (See INDICATIONS AND USAGE and
CLINICAL STUDIES)

15 mg/kg
q12h

10

Acute Sinusitis
(For moderate to severe infections, the higher dose
should be used)

7.5 mg/kg
q12h or
15 mg/kg
q12h

10
Renal Impairment
Cefprozil may be administered to patients with impaired renal function.

The following dosage schedule should be used.
* Cefprozil is in part removed by hemodialysis; therefore, cefprozil should be administered after the completion of hemodialysis.
Creatinine Clearance
(mL/min)

Dosage
(mg)

Dosing Interval

30–120

Standard

standard

0–29*

50% of standard

standard
Hepatic Impairment
No dosage adjustment is necessary for patients with impaired hepatic function.
Reconstitution Directions for Oral Suspension
Prepare the suspension at the time of dispensing; for ease in preparation, add water in two portions and shake well after each aliquot.
Total Amount of Water Required for Reconstitution
Bottle Size

Final Concentration

125 mg/5 mL

Final Concentration

250 mg/5 mL

50 mL

36 mL

36 mL

75 mL

54 mL

54 mL

100 mL

72 mL

72 mL

After mixing, store in a refrigerator and discard unused portion after 14 days.

Store dry powder at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] prior to constitution.

No Recall
Orchidpharma Inc

Cefprozil | Orchidpharma Inc

Cefprozil is administered orally.
Population/Infection Dosage
(mg) Duration
(days) ADULTS (13 years and older) UPPER RESPIRATORY TRACT Pharyngitis/Tonsillitis 500 q24h 10a Acute Sinusitis
(For moderate to severe infections, the higher dose should be used)
250 q12h or

500 q12h
10 LOWER RESPIRATORY TRACT Secondary Bacterial Infection of Acute Bronchitis and Acute Bacterial Exacerbation of Chronic
Bronchitis 500 q12h 10 SKIN AND SKIN STRUCTURE Uncomplicated Skin and Skin Structure Infections 250 q12h or
500 q24h or
500 q12h 10 CHILDREN (2 years to 12 years) UPPER RESPIRATORY TRACTb Pharyngitis/Tonsillitis 7.5 mg/kg q12h 10a SKIN AND SKIN STRUCTUREb Uncomplicated Skin and Skin Structure Infections 20 mg/kg q24h 10 INFANTS & CHILDREN (6 months to 12 years) UPPER RESPIRATORY TRACT Otitis Media (See INDICATIONS AND USAGE and CLINICAL STUDIES) 15 mg/kg q12h 10 Acute Sinusitis (For moderate to severe infections, the higher dose should be used) 7.5 mg/kg q12h or 15 mg/kg q12h 10
aIn the treatment of infections due to Streptococcus pyogenes, cefprozil should be administered for at least 10 days.
bNot to exceed recommended adult doses.

Renal Impairment: Cefprozil may be administered to patients with impaired renal function. The following dosage schedule should be used.
Creatinine Clearance (mL/min) Dosage(mg) Dosing Interval 30 to 120 standard standard 0 to 20* 50% of standard standard
*Cefprozil is in part removed by hemodialysis; therefore, cefprozil should be administered after the completion of hemodialysis.

Hepatic Impairment: No dosage adjustment is necessary for patients with impaired hepatic function.

No Recall
Medsource Pharmaceuticals

Cefprozil | Medsource Pharmaceuticals

Cefprozil tablets are administered orally.

Population/Infection Dosage
(mg) Duration
(days) a In the treatment of infections due to Streptococcus pyogenes, cefprozil should be administered for at least 10 days.
b Not to exceed recommended adult doses.
   ADULTS (13 years and older)

      UPPER RESPIRATORY TRACT

         Pharyngitis/Tonsillitis
500 q24h
10 a
         Acute Sinusitis
         (For moderate to severe infections, the higher dose should be used)
250 q12h or
500 q12h
10
      LOWER RESPIRATORY TRACT

         Secondary Bacterial Infection of Acute Bronchitis and
         Acute Bacterial Exacerbation of Chronic Bronchitis
500 q12h
10
      SKIN AND SKIN STRUCTURE

         Uncomplicated Skin and Skin Structure Infections
250 q12h or
500 q24h or
500 q12h
10
   CHILDREN (2 years–12 years)

      UPPER RESPIRATORY TRACT b

         Pharyngitis/Tonsillitis
7.5 mg/kg q12h
10 a
      SKIN AND SKIN STRUCTURE b

         Uncomplicated Skin and Skin Structure Infections
20 mg/kg q24h
10
   INFANTS & CHILDREN (6 months–12 years)

      UPPER RESPIRATORY TRACT b

         Otitis Media
         (See INDICATIONS AND USAGE and CLINICAL STUDIES)
15 mg/kg q12h
10
         Acute Sinusitis
         (For moderate to severe infections, the higher dose should be used)
7.5 mg/kg q12h or
15 mg/kg q12h
10
Renal Impairment
Cefprozil may be administered to patients with impaired renal function. The following dosage schedule should be used.

Creatinine Clearance
(mL/min) Dosage
(mg) Dosing Interval * Cefprozil is in part removed by hemodialysis; therefore, cefprozil should be administered after the completion of hemodialysis.
30–120
0–29*
standard
50% of standard
standard
standard
Hepatic Impairment
No dosage adjustment is necessary for patients with impaired hepatic function.

No Recall