Composition:
Application:
Utilisé dans le traitement:
Examiné médicalement par Fedorchenko Olga Valeryevna, Pharmacie Dernière mise à jour le 05.04.2022
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Lizor (cefprozil) est indiqué pour le traitement des patients atteints d'infections légères à modérées causées par des souches sensibles des micro-organismes désignés dans les conditions énumérées ci-dessous:
Tract respiratoire supérieur
Pharyngite / tonsillite causé par Streptococcus pyogenes.
REMARQUE: Le médicament habituel de choix dans le traitement et la prévention des infections à streptocoques, y compris la prophylaxie de la fièvre rhumatismale, est la pénicilline administrée par voie intramusculaire. Le céfprozil est généralement efficace pour l'éradication de Streptococcus pyogenes du nasopharynx; cependant, des données substantielles établissant l'efficacité du céfprozil dans la prévention ultérieure de la fièvre rhumatismale ne sont pas disponibles à l'heure actuelle.
Otite Media causé par Streptococcus pneumoniae, Haemophilus influenzae (y compris les souches productrices de β-lactamase), et Catarrhalis de Moraxella (Branhamella) (y compris les souches productrices de β-lactamase). (Voir ÉTUDES CLINIQUES.)
REMARQUE: Dans le traitement de l'otite moyenne due à des organismes producteurs de β-lactamase, le céfprozil avait des taux d'éradication bactériologique quelque peu inférieurs à ceux observés avec un produit contenant un inhibiteur spécifique de la β-lactamase. En tenant compte de l'utilisation du céfprozil, des taux d'éradication globaux inférieurs devraient être mis en balance avec les schémas de sensibilité des microbes communs dans une zone géographique donnée et le potentiel accru de toxicité avec les produits contenant des inhibiteurs de la β-lactamase.
Sinusite aiguë causé par Streptococcus pneumoniae, Haemophilus influenzae (y compris les souches productrices de β-lactamase), et Catarrhalis de Moraxella (Branhamella) (y compris les souches productrices de β-lactamase).
Tract respiratoire inférieur
Infection bactérienne secondaire de la bronchite aiguë et exacerbation bactérienne aiguë de la bronchite chronique causé par Streptococcus pneumoniae, Haemophilus influenzae (y compris les souches productrices de β-lactamase), et Catarrhalis de Moraxella (Branhamella) (y compris les souches productrices de β-lactamase).
Structure de la peau et de la peau
Infections non compliquées de la peau et de la structure cutanée causé par Staphylococcus aureus (y compris les souches productrices de pénicillinase) et Streptococcus pyogenes Les abcès nécessitent généralement un drainage chirurgical.
Pour réduire le développement de bactéries résistantes aux médicaments et maintenir l'efficacité de Lizor (cefprozil) et d'autres médicaments antibactériens, Lizor (cefprozil) ne doit être utilisé que pour traiter ou prévenir les infections qui sont prouvées ou fortement suspectées d'être causées par des bactéries sensibles. Lorsque des informations sur la culture et la sensibilité sont disponibles, elles doivent être prises en compte lors de la sélection ou de la modification du traitement antibactérien. En l'absence de telles données, l'épidémiologie locale et les schémas de sensibilité peuvent contribuer à la sélection empirique de la thérapie.
Lizor (cefprozil) is administered orally.
Population/Infection | Dosage(mg) | Duration(days) |
ADULTS (13 years and older) | ||
UPPER RESPIRATORY TRACT | ||
Pharyngitis/Tonsillitis | 500 q24h | 10a |
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 500 q24h or 500 q12h | 10 |
CHILDREN (2 years-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-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 |
a In the treatment of infections due to Streptococcus pyogenes, Lizor (cefprozil) should be administered for at least 10 days. b Not to exceed recommended adult doses. |
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* | 50% of standard | standard |
* Cefprozil is in part removed by hemodialysis; therefore, cefprozil should be administered after the completion of hemodialysis. |
Hepatic Impairment
No dosage adjustment is necessary for patients with impaired hepatic function.
Lizor (cefprozil) est contre-indiqué chez les patients allergiques connus à la classe d'antibiotiques céphalosporine.
WARNINGS
BEFORE THERAPY WITH Lizor (cefprozil) IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO Lizor (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 Lizor (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 Lizor (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 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.
PRECAUTIONS
General
Prescribing Lizor (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 (see DOSAGE AND ADMINISTRATION), careful clinical observation and appropriate laboratory studies should be done prior to and during therapy. The total daily dose of Lizor (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 Lizor (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 Lizor (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.
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
Teratogenic Effects: 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 (1000 mg) 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.
Nursing Mothers
Small amounts of cefprozil ( < 0.3% of dose) 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 µg/mL. Caution should be exercised when Lizor (cefprozil) is administered to a nursing woman, since the effect of cefprozil on nursing infants is unknown.
Pediatric Use
(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 Lizor (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 Lizor (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 Lizor (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.
Geriatric Use
Of the more than 4500 adults treated with Lizor (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 Lizor cannot be excluded (see CLINICAL PHARMACOLOGY).
Lizor (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:
Gastrointestinal: Diarrhea (2.9%), nausea (3.5%), vomiting (1%), and abdominal pain (1%).
Hepatobiliary: 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.
Hypersensitivity: Rash (0.9%), 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.
CNS: Dizziness (1%), hyperactivity, headache, nervousness, insomnia, confusion, and somnolence have been reported rarely ( < 1%). All were reversible.
Hematopoietic: Decreased leukocyte count (0.2%), eosinophilia (2.3%).
Renal: Elevated BUN (0.1%), serum creatinine (0.1%).
Other: Diaper rash and superinfection (1.5%), genital pruritus and vaginitis (1.6%).
The following adverse events, regardless of established causal relationship to Lizor (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.
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