DRUGS & SUPPLEMENTS
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
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.
caused by Streptococcus pneumoniae, Haemophilusinfluenzae, 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.
caused by Streptococcus pneumoniae, Haemophilusinfluenzae (including β-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including β-lactamase-producing strains).
Lower Respiratory Tract
Secondary Bacterial Infection of Acute Bronchitis and Acute Bacterial Exacerbation of Chronic Bronchitis
caused by Streptococcus pneumoniae, Haemophilus influenza, 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.
Cefprozil is contraindicated in patients with known allergy to the cephalosporin class of antibiotics.
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 β-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 the 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.
Prescribing Cefprozil in the absence of proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
In patients with known or suspected renal impairment, careful clinical observation and appropriate laboratory studies should be done prior to and during therapy. The total daily dose of Cefprozil should be reduced in these patients because high and/or prolonged plasma antibiotic concentrations can occur in such individuals from usual doses. Cephalosporins, including Cefprozil, should be given with caution to patients receiving concurrent treatment with potent diuretics since these agents are suspected of adversely affecting renal function.
Prolonged use of Cefprozil may result in the overgrowth of nonsusceptible organisms. Careful observation of the patient is essential.
If superinfection occurs during therapy, appropriate measures should be taken.
Cefprozil should be prescribed with caution in individuals with a history of gastrointestinal disease particularly colitis.
Positive direct Coombs’ tests have been reported during treatment with cephalosporin antibiotics.
Information for Patients
Cefprozil for oral suspension contains phenylalanine 28 mg per 5 mL constituted suspension for both the 125 mg/5 mL and 250 mg/5 mL dosage forms.
Patients should be counseled that antibacterial drugs including Cefprozil should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Cefprozil is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Cefprozil or other antibacterial drugs in the future.
Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
Nephrotoxicity has been reported following concomitant administration of aminoglycoside antibiotics and cephalosporin antibiotics. Concomitant administration of probenecid doubled the AUC for Cefprozil.
The bioavailability of the capsule formulation of Cefprozil was not affected when administered 5 minutes following an antacid.
Drug/Laboratory Test Interactions
Cephalosporin antibiotics may produce a false positive reaction for glucose in the urine with copper reduction tests, but not with enzyme-based tests for glycosuria (e.g., Clinistix®). A false negative reaction may occur in the ferricyanide test for blood glucose. The presence of Cefprozil in the blood does not interfere with the assay of plasma or urine creatinine by the alkaline picrate method.
Carcinogenesis, Mutagenesis and Impairment of Fertility
Long term in vivo studies have not been performed to evaluate the carcinogenic potential of Cefprozil.
Cefprozil was not found to be mutagenic in either the Ames Salmonella or E. coli WP2 urvA reversion assays or the Chinese hamster ovary cell HGPRT forward gene mutation assay and it did not induce chromosomal abnormalities in Chinese hamster ovary cells or unscheduled DNA synthesis in rat hepatocytes in vitro. Chromosomal aberrations were not observed in bone marrow cells from rats dosed orally with over 30 times the highest recommended human dose based upon mg/m2.
Impairment of fertility was not observed in male or female rats given oral doses of Cefprozil up to 18.5 times the highest recommended human dose based upon mg/m2.
Pregnancy Category B
Reproduction studies have been performed in rabbits, mice, and rats using oral doses of Cefprozil of 0.8, 8.5, and 18.5 times the maximum daily human dose based upon mg/m2, and have revealed no harm to the fetus. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Labor and Delivery
Cefprozil has not been studied for use during labor and delivery. Treatment should only be given if clearly needed.
Small amounts of Cefprozil have been detected in human milk following administration of a single 1 gram dose to lactating women. The average levels over 24 hours ranged from 0.25 to 3.3 mcg/mL. Caution should be exercised when Cefprozil is administered to a nursing woman, since the effect of Cefprozil on nursing infants is unknown.
(See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION .)
The safety and effectiveness of Cefprozil in the treatment of otitis media have been established in the age groups 6 months to 12 years. Use of Cefprozil for the treatment of otitis media is supported by evidence from adequate and well-controlled studies of Cefprozil in pediatric patients. (See CLINICAL STUDIES .)
The safety and effectiveness of Cefprozil in the treatment of pharyngitis/tonsillitis or uncomplicated skin and skin-structure infections have been established in the age groups 2 to 12 years. Use of Cefprozil for the treatment of these infections is supported by evidence from adequate and well-controlled studies of Cefprozil in pediatric patients. The safety and effectiveness of Cefprozil in the treatment of acute sinusitis have been established in the age groups 6 months to 12 years. Use of Cefprozil in these age groups is supported by evidence from adequate and well-controlled studies of Cefprozil in adults.
Safety and effectiveness in pediatric patients below the age of 6 months have not been established for the treatment of otitis media or acute sinusitis, or below the age of 2 years for the treatment of pharyngitis/tonsillitis or uncomplicated skin and skin-structure infections. However, accumulation of other cephalosporin antibiotics in newborn infants (resulting from prolonged drug half-life in this age group) has been reported.
Of the more than 4500 adults treated with Cefprozil in clinical studies, 14% were 65 years and older, while 5% were 75 years and older. When geriatric patients received the usual recommended adult doses, their clinical efficacy and safety were comparable to clinical efficacy and safety in nongeriatric adult patients. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals to the effects of Cefprozil cannot be excluded (see CLINICAL PHARMACOLOGY ).
Cefprozil is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function. See DOSAGE AND ADMINISTRATION for dosing recommendations for patients with impaired renal function.
The adverse reactions to Cefprozil are similar to those observed with other orally administered cephalosporins. Cefprozil was usually well tolerated in controlled clinical trials. Approximately 2% of patients discontinued Cefprozil therapy due to adverse events.
The most common adverse effects observed in patients treated with Cefprozil are:
Diarrhea, nausea (3.5%), vomiting (1%), and abdominal pain (1%).
Elevations of AST (SGOT) (2%), ALT (SGPT) (2%), alkaline phosphatase (0.2%), and bilirubin values (<0.1%). As with some penicillins and some other cephalosporin antibiotics, cholestatic jaundice has been reported rarely.
Rash, urticaria (0.1%). Such reactions have been reported more frequently in children than in adults. Signs and symptoms usually occur a few days after initiation of therapy and subside within a few days after cessation of therapy.
Dizziness (1%). Hyperactivity, headache, nervousness, insomnia, confusion, and somnolence have been reported rarely (<1%). All were reversible.
Decreased leukocyte count, eosinophilia (2.3%).
Elevated BUN (0.1%), serum creatinine (0.1%).
Diaper rash and superinfection, genital pruritus and vaginitis (1.6%).
The following adverse events, regardless of established causal relationship to Cefprozil, have been rarely reported during postmarketing surveillance: anaphylaxis, angioedema, colitis (including pseudomembranous colitis), erythema multiforme, fever, serum-sickness like reactions, Stevens-Johnson syndrome, and thrombocytopenia.
Cephalosporin Class Paragraph
In addition to the adverse reactions listed above which have been observed in patients treated with Cefprozil, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics:
Aplastic anemia, hemolytic anemia, hemorrhage, renal dysfunction, toxic epidermal necrolysis, toxic nephropathy, prolonged prothrombin time, positive Coombs’ test, elevated LDH, pancytopenia, neutropenia, agranulocytosis.
Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment, when the dosage was not reduced. (See DOSAGE AND ADMINISTRATION and OVERDOSAGE .) If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.
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 is administered orally.
Cefprozil may be administered to patients with impaired renal function.
The following dosage schedule should be used.
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.
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) prior to constitution.
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
Ceprozil 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).
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.
In a controlled clinical study of acute otitis media performed in the United States where significant rates of β-lactamase-producing organisms were found, Cefprozil was compared to an oral antimicrobial agent that contained a specific β-lactamase inhibitor. In this study, using very strict evaluability criteria and microbiologic and clinical response criteria at the 10 to 16 days post-therapy follow-up, the following presumptive bacterial eradication/clinical cure outcomes and safety results were obtained:
In a controlled clinical study of acute otitis media performed in Europe, Cefprozil was compared to an oral antimicrobial agent that contained a specific β-lactamase inhibitor. As expected in a European population, this study population had a lower incidence of β-lactamase-producing organisms than usually seen in U.S. trials. In this study, using very strict evaluability criteria and microbiologic and clinical response criteria at the 10 to 16 days post-therapy follow-up, the following presumptive bacterial eradication/clinical cure outcomes (ie clinical success) were obtained:
Clinitest® and Clinistix® are registered trademarks of the Bayer HealthCare LLC.
Manufactured in Austria by Sandoz GmbH
for Sandoz Inc., Princeton, NJ 08540
125 mg/5 mL*
according to directions
250 mg/5 mL*
according to directions
Cefprozil pharmaceutical active ingredients containing related brand and generic drugs:
Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.
Cefprozil available forms, composition, doses:
Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.
Cefprozil destination | category:
Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.
Cefprozil Anatomical Therapeutic Chemical codes:
A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.
Cefprozil pharmaceutical companies:
Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.
Frequently asked QuestionsCan i drive or operate heavy machine after consuming Cefprozil?
Depending on the reaction of the Cefprozil after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Cefprozil not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Cefprozil addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
ReviewsDrugs.com conducted a study on Cefprozil, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Cefprozil consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.
One visitor reported age
The information was verified by Dr. Arunabha Ray, MD Pharmacology