Drug Catalog - Product Detail
CEFPROZIL TB 500MG 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00781-5044-01 | SANDOZ | 100 | 500MG | TABLET |
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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 407.44. Cefprozil Tablets and Cefprozil for Oral Suspension are intended for oral administration. Each cefprozil tablet contains cefprozil equivalent to 250 mg or 500 mg of anhydrous cefprozil. In addition each tablet contains the following inactive ingredients: hypromellose, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol 400, polysorbate 80, sodium starch glycolate and titanium dioxide. The 500 mg tablets also contain ferric oxide. Cefprozil for oral suspension contains cefprozil equivalent to 125 mg or 250 mg anhydrous cefprozil per 5 mL constituted suspension. In addition, the oral suspension contains the following inactive ingredients: aspartame, carboxymethylcellulose sodium, citric acid anhydrous, colloidal silicon dioxide, FD & C Yellow No. 6, glycine, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate 80, simethicone, sodium benzoate, sodium chloride, sucrose, and Tutti-Frutti flavor. Cefprozil Chemical Structure
How Supplied
HOW SUPPLIED Cefprozil Tablets USP, 250 mg are oval-shaped, white to cream tinged, unscored, film-coated tablets, debossed 347 on one side and 250 on the reverse side and are supplied as follows: NDC 0781-5043-01 in bottles of 100 tablets Cefprozil Tablets USP, 500 mg are oval-shaped, beige, unscored, film-coated tablets, debossed 348 on one side and 500 on the reverse side and are supplied as follows: NDC 0781-5044-50 in bottles of 50 tablets NDC 0781-5044-01 in bottles of 100 tablets Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Cefprozil for Oral Suspension, USP, 125 mg/5 mL is supplied as follows: NDC 0781-6202-91 50 mL bottle NDC 0781-6202-57 75 mL bottle NDC 0781-6202-46 100 mL bottle Cefprozil for Oral Suspension, USP, 250 mg/5 mL is supplied as follows: NDC 0781-6203-91 50 mL bottle NDC 0781-6203-57 75 mL bottle NDC 0781-6203-46 100 mL bottle All powder formulations for oral suspension contain cefprozil in a fruity flavored mixture. Cefprozil powder is slightly cream tinged to beige. After reconstitution the suspension is light orange and of a fruity odor and flavor.
Indications & Usage
INDICATIONS AND USAGE Cefprozil 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 β-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including β-lactamase-producing strains). (See CLINICAL STUDIES .) NOTE: In the treatment of otitis media due to β-lactamase-producing organisms, cefprozil had bacteriologic eradication rates somewhat lower than those observed with a product containing a specific β-lactamase inhibitor. In considering the use of ceprozil, 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 β-lactamase inhibitors. Acute Sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including β-lactamase-producing strains). Lower Respiratory Tract Acute Bacterial Exacerbation of Chronic Bronchitis caused by Streptococcus pneumoniae, Haemophilus influenza (including β-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including β-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 and other antibacterial drugs, cefprozil 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 is administered orally. Population/Infection Dosage (mg) Duration (days) ADULTS (13 years and older) UPPER RESPIRATORY TRACT Pharyngitis/Tonsillitis 500 q24h 10 In the treatment of infections due to Streptococcus pyogenes , cefprozil should be administered for at least 10 days. Acute Sinusitis (For moderate to severe infections, the higher dose should be used) 250 q12h or 500 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 or 500 q24h or 500 q12h 10 CHILDREN (2 years – 12 years) UPPER RESPIRATORY TRACT Not to exceed recommended adult doses. 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 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. 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