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.
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
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