Drug Catalog - Product Detail
CEFPROZIL ORAL SUSPENSION SUSP 125MG/5ML 50ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68180-0401-01 | LUPIN PHARMACEUTICALS | 50 | 125MG/5ML | SUSPENSION |
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Description
DESCRIPTION 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 C 18 H 19 N 3 O 5 S.H 2 O 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. cefprozilfos-1
How Supplied
HOW SUPPLIED Cefprozil for oral suspension, USP is a pink coloured powder, forming pink coloured suspension with characteristic odour on constitution. Cefprozil For Oral Suspension, USP 125 mg/5 mL is available as follows: 50 mL Bottle NDC 68180-401-01 75 mL Bottle NDC 68180-401-02 100 mL Bottle NDC 68180-401-03 Cefprozil For Oral Suspension, USP 250 mg/5 mL is available as follows: 50 mL Bottle NDC 68180-402-01 75 mL Bottle NDC 68180-402-02 100 mL Bottle NDC 68180-402-03 All powder formulations for oral suspension contain cefprozil in a 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 36 mL 36 mL 75 mL 53 mL 53 mL 100 mL 70 mL 70 mL Store dry powder at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Store constituted suspension in refrigerator. Discard after 14 days. Preserve in tight containers.
Indications & Usage
INDICATIONS AND USAGE 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.
Dosage and Administration
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 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 30-120 standard standard 0-29 Cefprozil is in part removed by hemodialysis; therefore, cefprozil should be administered after the completion of hemodialysis. 50% of standard standard Hepatic Impairment: No dosage adjustment is necessary for patients with impaired hepatic function.