Cefprozil (Page 4 of 5)

OVERDOSAGE

Single 5000 mg/kg oral doses of cefprozil caused no mortality or signs of toxicity in adult, weanling, or neonatal rats, or adult mice. A single oral dose of 3000 mg/kg caused diarrhea and loss of appetite in cynomolgus monkeys, but no mortality.Cefprozil is eliminated primarily by the kidneys. In case of severe overdosage, especially in patients with compromised renal function, hemodialysis will aid in the removal of cefprozil from the body.

DOSAGE AND ADMINISTRATION

Cefprozil for oral suspension 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 or500 q12h 10
LOWER RESPIRATORY TRACT
Acute Bacterial Exacerbation of Chronic Bronchitis 500 q12h 10
SKIN AND SKIN STRUCTURE
Uncomplicated Skin and Skin Structure Infections 250 q12h or500 q24h or500 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 to 1200 to 29* standard50% of standard standard standard

Hepatic Impairment

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

HOW SUPPLIED

Cefprozil for Oral Suspension, USP 125 mg/5 mL: Each 5 mL of reconstituted suspension contains cefprozil USP equivalent to anhydrous cefprozil 125 mg.
50 mL Bottle NDC 65862-099-50
75 mL Bottle NDC 65862-099-75
100 mL Bottle NDC 65862-099-01
Cefprozil for Oral Suspension, USP 250 mg/5 mL: Each 5 mL of reconstituted suspension contains cefprozil USP equivalent to anhydrous cefprozil 250 mg.
50 mL Bottle NDC 65862-100-50
75 mL Bottle NDC 65862-100-75
100 mL Bottle NDC 65862-100-01
All powder formulations for oral suspension contain cefprozil in light pink granular powder with bubble-gum flavored mixture.
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 35 mL 35 mL
75 mL 52 mL 52 mL
100 mL 70 mL 70 mL

After mixing, store at 2° to 8°C [36° to 46° F] in a refrigerator and discard unused portion after 14 days.
Store dry powder at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] prior to constitution.

CLINICAL STUDIES

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.