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Cefdinir (Powder, For Suspension)

Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2510

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Cefdinir (Powder, For Suspension)
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(See INDICATIONS AND USAGE for Indicated Pathogens.)<br/>Powder for Oral Suspension: The recommended dosage and duration of treatment for infections in pediatric patients are described in the following chart; the total daily dose for all infections is 14 mg/kg, up to a maximum dose of 600 mg per day. Once-daily dosing for 10 days is as effective as BID dosing. Once-daily dosing has not been studied in skin infections; therefore, cefdinir for oral suspension should be administered twice daily in this infection. Cefdinir for oral suspension may be administered without regard to meals.<br/>Patients With Renal Insufficiency: For adult patients with creatinine clearance<30 mL/min, the dose of cefdinir should be 300 mg given once daily. Creatinine clearance is difficult to measure in outpatients. However, the following formula may be used to estimate creatinine clearance (CL) in adult patients. For estimates to be valid, serum creatinine levels should reflect steady-state levels of renal function. where creatinine clearance is in mL/min, age is in years, weight is in kilograms, and serum creatinine is in mg/dL. The following formula may be used to estimate creatinine clearance in pediatric patients: where K = 0.55 for pediatric patients older than 1 yearand 0.45 for infants (up to 1 year). In the above equation, creatinine clearance is in mL/min/1.73 m, body length or height is in centimeters, and serum creatinine is in mg/dL. For pediatric patients with creatinine clearance of<30 mL/min/1.73 m, the dose of cefdinir should be 7 mg/kg (up to 300 mg) given once daily.<br/>Patients on Hemodialysis: Hemodialysis removes cefdinir from the body. In patients maintained on chronic hemodialysis, the recommended initial dosage regimen is a 300 mg or 7 mg/kg dose every other day. At the conclusion of each hemodialysis session, 300 mg (or 7 mg/kg) should be given. Subsequent doses (300 mg or 7 mg/kg) are then administered every other day. After mixing, the suspension can be stored at room temperature (25��C/77��F). The container should be kept tightly closed, and the suspension should be shaken well before each administration. The suspension may be used for 10 days, after which any unused portion must be discarded.
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Cefdinir for oral suspension contains the active ingredient cefdinir monohydrate, an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir monohydrate is (6R,7R)-7-[[(2Z)-(2-amino-4-thiazolyl)(hydroxyimino)acetyl] amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate. Cefdinir monohydrate is a white to light yellow crystalline powder. Its solubility is 19.56 mg/mL in 0.1M pH 7 phosphate buffer. Cefdinir monohydrate has the structural formula shown below: CHNOS���HO M.W. 413.44 Cefdinir for oral suspension, after reconstitution, contains 125 mg or 250 mg cefdinir per 5 mL and the following inactive ingredients: artificial cherry-mixed fruit flavor, anhydrous citric acid, colloidal silicon dioxide, guar gum, magnesium stearate, sodium benzoate, sodium citrate, sucrose, and xanthan gum.
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Pharmacokinetics and Drug Metabolism:<br/>Absorption:<br/>Distribution: The mean volume of distribution (Vd) of cefdinir in adult subjects is 0.35 L/kg (��0.29); in pediatric subjects (age 6 months to 12 years), cefdinir Vdis 0.67 L/kg (��0.38). Cefdinir is 60% to 70% bound to plasma proteins in both adult and pediatric subjects; binding is independent of concentration.<br/>Metabolism and Excretion: Cefdinir is not appreciably metabolized. Activity is primarily due to parent drug. Cefdinir is eliminated principally via renal excretion with a mean plasma elimination half-life (t) of 1.7 (��0.6) hours. In healthy subjects with normal renal function, renal clearance is 2.0 (��1.0) mL/min/kg, and apparent oral clearance is 11.6 (��6.0) and 15.5 (��5.4) mL/min/kg following doses of 300 and 600 mg, respectively. Mean percent of dose recovered unchanged in the urine following 300 and 600 mg doses is 18.4% (��6.4) and 11.6% (��4.6), respectively. Cefdinir clearance is reduced in patients with renal dysfunction (see Special Populations, Patients with renal insufficiency). Because renal excretion is the predominant pathway of elimination, dosage should be adjusted in patients with markedly compromised renal function or who are undergoing hemodialysis (see DOSAGE AND ADMINISTRATION).<br/>Special Populations:<br/>Microbiology: As with other cephalosporins, bactericidal activity of cefdinir results from inhibition of cell wall synthesis. Cefdinir is stable in the presence of some, but not all,��-lactamase enzymes. As a result, many organisms resistant to penicillins and some cephalosporins are susceptible to cefdinir. Cefdinir has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in INDICATIONS AND USAGE.<br/>Aerobic Gram-Positive Microorganisms: Staphylococcus aureus (including��-lactamase producing strains) NOTE: Cefdinir is inactive against methicillin-resistant staphylococci. Streptococcus pneumoniae (penicillin-susceptible strains only) Streptococcus pyogenes<br/>Aerobic Gram-Negative Microorganisms: Haemophilus influenzae (including��-lactamase producing strains) Haemophilus parainfluenzae (including��-lactamase producing strains) Moraxella catarrhalis (including��-lactamase producing strains) The following in vitro data are available, but their clinical significance is unknown. Cefdinir exhibits in vitro minimum inhibitory concentrations (MICs) of 1 mcg/mL or less against (���90%) strains of the following microorganisms; however, the safety and effectiveness of cefdinir in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials.<br/>Aerobic Gram-Positive Microorganisms: Staphylococcus epidermidis (methicillin-susceptible strains only) Streptococcus agalactiae Viridans group streptococci NOTE: Cefdinir is inactive against Enterococcus and methicillin-resistant Staphylococcus species.<br/>Aerobic Gram-Negative Microorganisms: Citrobacter diversus Escherichia coli Klebsiella pneumoniae Proteus mirabilis NOTE: Cefdinir is inactive against Pseudomonas and Enterobacter species.<br/>Susceptibility Tests:
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Cefdinir for oral suspension is contraindicated in patients with known allergy to the cephalosporin class of antibiotics.
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Cefdinir for oral suspension is a white to off-white powder formulation that, when reconstituted as directed, contains either 125 mg cefdinir/5 mL or 250 mg cefdinir/5 mL. The reconstituted suspension has a white to off-white color and cherry flavor. The powder is available as follows: 125 mg/5 mL���in bottles of 60 mL and 100 mL. 250 mg/5 mL���in bottles of 60 mL and 100 mL. Store the unsuspended powder at 20��to 25��C (68��to 77��F) [See USP Controlled Room Temperature]. Once reconstituted, the oral suspension can be stored at controlled room temperature for 10 days.
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General: Prescribing cefdinir for oral suspension in the absence of a 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. As with other broad-spectrum antibiotics, prolonged treatment may result in the possible emergence and overgrowth of resistant organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate alternative therapy should be administered. Cefdinir, as with other broad-spectrum antimicrobials (antibiotics), should be prescribed with caution in individuals with a history of colitis. In patients with transient or persistent renal insufficiency (creatinine clearance<30 mL/min), the total daily dose of cefdinir should be reduced because high and prolonged plasma concentrations of cefdinir can result following recommended doses (see DOSAGE AND ADMINISTRATION).<br/>Information for Patients: Patients should be counseled that antibacterial drugs including cefdinir for oral suspension should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When cefdinir for oral suspension 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 cefdinir for oral suspension or other antibacterial drugs in the future. Antacids containing magnesium or aluminum interfere with the absorption of cefdinir. If this type of antacid is required during cefdinir for oral suspension therapy, cefdinir for oral suspension should be taken at least 2 hours before or after the antacid. Iron supplements, including multivitamins that contain iron, interfere with the absorption of cefdinir. If iron supplements are required during cefdinir for oral suspension therapy, cefdinir for oral suspension should be taken at least 2 hours before or after the supplement. Iron-fortified infant formula does not significantly interfere with the absorption of cefdinir. Therefore, cefdinir for oral suspension can be administered with iron-fortified infant formula. Diabetic patients and caregivers should be aware that the oral suspension, 250 mg/5 mL contains 1.37 g of sucrose per teaspoon and 125 mg/5 mL contains 1.50 g of sucrose per teaspoon. 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 assoon as possible.<br/>Drug Interactions:<br/>Antacids (Aluminum- or Magnesium-Containing): Concomitant administration of 300 mg cefdinir capsules with 30 mL Maalox TC suspension reduces the rate (C) and extent (AUC) of absorption by approximately 40%. Time to reach Cis also prolonged by 1 hour. There are no significant effects on cefdinir pharmacokinetics if the antacid is administered 2 hours before or 2 hours after cefdinir. If antacids are required during cefdinir for oral suspension therapy, cefdinir for oral suspension should be taken at least 2 hours before or after the antacid.<br/>Probenecid: As with other��-lactam antibiotics, probenecid inhibits the renal excretion of cefdinir, resulting in an approximate doubling in AUC, a 54% increase in peak cefdinir plasma levels, and a 50% prolongation in the apparent elimination t.<br/>Iron Supplements and Foods Fortified With Iron: Concomitant administration of cefdinir with a therapeutic iron supplement containing 60 mg of elemental iron (as FeSO) or vitamins supplemented with 10 mg of elemental iron reduced extent of absorption by 80% and 31%, respectively. If iron supplements are required during cefdinir for oral suspension therapy, cefdinir for oral suspension should be taken at least 2 hours before or after the supplement. The effect of foods highly fortified with elemental iron (primarily iron-fortified breakfast cereals) on cefdinir absorption has not been studied. Concomitantly administered iron-fortified infant formula (2.2 mg elemental iron/6 oz) has no significant effect on cefdinir pharmacokinetics. Therefore, cefdinir for oral suspension can be administered with iron-fortified infant formula. There have been reports of reddish stools in patients receiving cefdinir. In many cases, patients were also receiving iron-containing products. The reddish color is due to the formation of a nonabsorbable complex between cefdinir or its breakdown products and iron in the gastrointestinal tract.<br/>Drug/Laboratory Test Interactions: A false-positive reaction for ketones in the urine may occur with tests using nitroprusside, but not with those using nitroferricyanide. The administration of cefdinir may result in a false-positive reaction for glucose in urine using Clinitest, Benedict's solution, or Fehling's solution. It is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix or Tes-Tape) be used. Cephalosporins are known to occasionally induce a positive direct Coombs' test.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: The carcinogenic potential of cefdinir has not been evaluated. No mutagenic effects were seen in the bacterial reverse mutation assay (Ames) or point mutation assay at the hypoxanthine-guanine phosphoribosyltransferase locus (HGPRT) in V79 Chinese hamster lung cells. No clastogenic effects were observed in vitro in the structural chromosome aberration assay in V79 Chinese hamster lungcells or in vivo in the micronucleus assay in mouse bone marrow. In rats, fertility and reproductive performance were not affected by cefdinir at oral doses up to 1000 mg/kg/day (70 times the human dose based on mg/kg/day, 11 times based on mg/m/day).<br/>Pregnancy:<br/>Teratogenic Effects:<br/>Labor and Delivery: Cefdinir has not been studied for use during labor and delivery.<br/>Nursing Mothers: Following administration of single 600 mg doses, cefdinir was not detected in human breast milk.<br/>Pediatric Use: Safety and efficacy in neonates and infants less than 6 months of age have not been established. Use of cefdinir for the treatment of acute maxillary sinusitis in pediatric patients (age 6 months through 12 years) is supported by evidence from adequate and well-controlled studies in adults and adolescents, the similar pathophysiology of acute sinusitis in adult and pediatric patients, and comparative pharmacokinetic data in the pediatric population.<br/>Geriatric Use: Efficacy is comparable in geriatric patients and younger adults. While cefdinir has been well-tolerated in all age groups, in clinical trials geriatric patients experienced a lower rate of adverse events, including diarrhea, than younger adults. Dose adjustment in elderly patients is not necessary unless renal function is markedly compromised (see DOSAGE AND ADMINISTRATION).
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Information on cefdinir overdosage in humans is not available. In acute rodent toxicity studies, a single oral 5600 mg/kg dose produced no adverse effects. Toxic signs and symptoms following overdosage with other��-lactam antibiotics have included nausea, vomiting, epigastric distress, diarrhea, and convulsions. Hemodialysis removes cefdinir from the body. This may be useful in the event of a serious toxic reaction from overdosage, particularly if renal function is compromised.
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Cefdinir
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Cefdinir (Powder, For Suspension)
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Clinical Trials:<br/>Cefdinir for Oral Suspension (Pediatric Patients): In clinical trials, 2289 pediatric patients (1783 U.S. and 506 non-U.S.) were treated with the recommended dose of cefdinir suspension (14 mg/kg/day). Most adverse events were mild and self-limiting. No deaths or permanent disabilities were attributed to cefdinir. Forty of 2289 (2%) patients discontinued medication due to adverse events considered by the investigators to be possibly, probably, or definitely associated with cefdinir therapy. Discontinuations were primarily for gastrointestinal disturbances, usually diarrhea. Five of 2289 (0.2%) patients were discontinued due to rash thought related to cefdinir administration. In the U.S., the following adverse events were thought by investigators to be possibly, probably, or definitely related to cefdinir suspension in multiple-dose clinical trials (N = 1783 cefdinir-treated patients): NOTE: In both cefdinir- and control-treated patients, rates of diarrhea and rash were higher in the youngest pediatric patients. The incidence of diarrhea in cefdinir-treated patients���2 years of age was 17% (95/557) compared with 4% (51/1226) in those>2 years old. The incidence of rash (primarily diaper rash in the younger patients) was 8% (43/557) in patients���2 years of age compared with 1% (8/1226) in those>2 years old. The following laboratory value changes of possible clinical significance, irrespective of relationship to therapy with cefdinir, were seen during clinical trials conducted in the U.S.:<br/>Postmarketing Experience: The following adverse experiences and altered laboratory tests, regardless of their relationship to cefdinir, have been reported during extensive postmarketing experience, beginning with approval in Japan in 1991: shock, anaphylaxis with rare cases of fatality, facial and laryngeal edema, feeling of suffocation, serum sickness-like reactions, conjunctivitis, stomatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, erythema multiforme, erythema nodosum, acute hepatitis, cholestasis, fulminant hepatitis, hepatic failure, jaundice, increased amylase, acute enterocolitis, bloody diarrhea, hemorrhagic colitis, melena, pseudomembranous colitis, pancytopenia, granulocytopenia, leucopenia, thrombocytopenia, idiopathic thrombocytopenic purpura, hemolytic anemia, acute respiratory failure, asthmatic attack, drug-induced pneumonia, eosinophilic pneumonia, idiopathic interstitial pneumonia, fever, acute renal failure, nephropathy, bleeding tendency, coagulation disorder, disseminated intravascular coagulation, upper GI bleed, peptic ulcer, ileus, loss of consciousness, allergic vasculitis, possible cefdinir-diclofenac interaction, cardiac failure, chest pain, myocardial infarction, hypertension, involuntary movements, and rhabdomyolysis.<br/>Cephalosporin Class Adverse Events: The following adverse events and altered laboratory tests have been reported for cephalosporin-class antibiotics in general: Allergic reactions, anaphylaxis, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, renal dysfunction, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemolytic anemia, hemorrhage, false-positive test for urinary glucose, neutropenia, pancytopenia, and agranulocytosis. Pseudomembranous colitis symptoms may begin during or after antibiotic treatment (see WARNINGS). 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.
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BEFORE THERAPY WITH CEFDINIR FOR ORAL SUSPENSION IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFDINIR, OTHER CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF CEFDINIR IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG��-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 CEFDINIR OCCURS, THE DRUG SHOULD BE DISCONTINUED. 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 cefdinir, 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.
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To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir for oral suspension and other antibacterial drugs, cefdinir 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. Cefdinir 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.<br/>Adults and Adolescents:<br/>Community-Acquired Pneumonia: Caused by Haemophilus influenzae (including��-lactamase producing strains), Haemophilus parainfluenzae (including��-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including��-lactamase producing strains) (see CLINICAL STUDIES).<br/>Acute Exacerbations of Chronic Bronchitis: Caused by Haemophilus influenzae (including��-lactamase producing strains), Haemophilus parainfluenzae (including��-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including��-lactamase producing strains).<br/>Acute Maxillary Sinusitis: Caused by Haemophilus influenzae (including��-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including��-lactamase producing strains). NOTE: For information on use in pediatric patients, see Pediatric Use and DOSAGE AND ADMINISTRATION.<br/>Pharyngitis/Tonsillitis: Caused by Streptococcus pyogenes (see CLINICAL STUDIES). NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.<br/>Uncomplicated Skin and Skin Structure Infections: Caused by Staphylococcus aureus (including��-lactamase producing strains) and Streptococcus pyogenes.<br/>Pediatric Patients: Acute Bacterial Otitis Media caused by Haemophilus influenzae (including��-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including��-lactamase producing strains).<br/>Pharyngitis/Tonsillitis: Caused by Streptococcus pyogenes (see CLINICAL STUDIES). NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.<br/>Uncomplicated Skin and Skin Structure Infections: Caused by Staphylococcus aureus (including��-lactamase producing strains) and Streptococcus pyogenes.
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Cefdinir