(sef a drox' il)
P : Caution when used during pregnancy
L : Caution when used during lactation
|| See TERMINOLOGY & ABBREVIATIONS ||
|ATC Classification||J01DB05 - cefadroxil.|
||BEFORE THERAPY WITH CEFADROXIL IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS
HYPERSENSITIVITY REACTIONS TO CEFADROXIL, CEPHALOSPORINS, PENICILLINS OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS,
CAUTION SHOULD BE EXERCISED BECAUSE CROSS-SENSITIVITY AMONG BETA-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 CEFADROXIL 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.
Pseudomembranous colitis has been reported with nearly all antibacterial agents, including cefadroxil and may range from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.
Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by is a primary cause of â€œantibiotic-associated colitisâ€.
After the diagnosis of pseudomembranous has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of the drug alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug effective against C difficile.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefadroxil (cefadroxil hemihydrate) Tablets and Cefadroxil Capsules and other antibacterial drugs, Cefadroxil (cefadroxil hemihydrate) Tablets and Cefadroxil capsules 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.
Cefadroxil is indicated for the treatment of patients with infection caused by susceptible strains of the designated organisms in the following diseases:
Urinary tract infections caused by E. coli, P. mirabilis, and Klebsiella species.
Skin and skin structure infections caused by staphylococci and/or streptococci.
Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes (Group A beta-hemolytic Streptococci).
Note: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Cefadroxil is generally effective in the eradication of streptococci from the oropharynx. However, data establishing the efficacy of cefadroxil for the prophylaxis of subsequent rheumatic fever are not available.
Note: Culture and susceptibility tests should be initiated prior to and during therapy.
Renal function studies should be performed when indicated.
|Dosage & Administration||
Cefadroxil is acid-stable and may be administered orally without regard to meals. Administration with food may be helpful in diminishing potential gastrointestinal complaints occasionally associated with oral cephalosporin therapy.
Urinary Tract Infections: For uncomplicated lower urinary tract infections (i.e., cystitis) the usual dosage is 1 or 2 g per day in single (q.d.) or divided doses (b.i.d).
For all other urinary tract infections the usual dosage is 2 g per day in divided doses (b.i.d).
Skin and Skin Structure Infections: For skin and skin structure infections the usual dosage is 1 g per day in single (q.d.) or divided doses (b.i.d).
Pharyngitis and Tonsillitis: Treatment of group A beta-hemolytic streptococcal pharyngitis and tonsillitis - 1 g per day in single (q.d.) or divided doses (b.i.d) for 10 days.
Cefadroxil oral suspension may be more suitable for pediatric patients.
For urinary tract infections, the recommended daily dosage for children is 30 mg/kg/day in divided doses every 12 hours. For pharyngitis, tonsillitis, and impetigo, the recommended daily dosage for children is 30 mg/kg/day in a single dose or in equally divided doses every 12 hours. For other skin and skin structure infections, the recommended daily dosage is 30 mg/kg/day in equally divided doses every 12 hours. In the treatment of beta-hemolytic streptococcal infections, a therapeutic dosage of cefadroxil should be administered for at least 10 days.
In patients with renal impairment, the dosage of cefadroxil should be adjusted according to creatinine clearance rates to prevent drug accumulation. The following schedule is suggested. In adults, the initial dose is 1000 mg of cefadroxil and the maintenance dose (based on the creatinine clearance rate [mL/min/1.73 M2]) is 500 mg at the time intervals listed below.
Patients with creatinine clearance rates over 50 mL/min may be treated as if they were patients having normal renal function.
A study of children under six years of age suggested that ingestion of less than 250 mg/kg of cephalosporins is not associated with significant outcomes. No action is required other than general support and observation. For amounts greater than 250 mg/kg, induce gastric emptying.
In five anuric patients, it was demonstrated that an average of 63% of a 1 g oral dose is extracted from the body during a 6 to 8 hour hemodialysis session.
|Contraindications||Cefadroxil is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.|
Prescribing Cefadroxil (cefadroxil hemihydrate) Tablets and Cefadroxil Capsules 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.
Cefadroxil should be used with caution in the presence of markedly impaired renal function (creatinine clearance rate of less than 50 mL/min/1.73 M2). In patients with known or suspected renal impairment, careful clinical observation and appropriate laboratory studies should be made prior to and during therapy.
Prolonged use of cefadroxil 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.
Cefadroxil should be prescribed with caution in individuals with history of gastrointestinal disease, particularly colitis.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
No long-term studies have been performed to determine carcinogenic potential. No genetic toxicity tests have been performed.
|Adverse Drug Reaction(s)||
Onset of symptoms may occur during or after treatment. , nausea and vomiting have been reported rarely. Diarrhea has also occurred.
Allergies have been observed. These reactions usually subsided upon discontinuation of the drug. has also been reported.
Other reactions have included hepatic dysfunction including cholestasis and elevations in serum transaminase, genital pruritus, genital moniliasis, , moderate transient neutropenia, fever. , thrombocytopenia, idiosyncratic hepatic failure, , , serum sickness, and have been rarely reported.
In addition to the adverse reactions listed above which have been observed in patients treated with cefadroxil, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics:
Toxic epidermal necrolysis, abdominal pain, superinfection, dysfunction, toxic nephropathy, hepatic dysfunction including cholestasis, , , , prolonged , positive Coombsâ€™ test, increased , increased , elevated , elevated ( ), elevated ( ), elevated , elevated , , , neutropenia.
Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment, when the dosage was not reduced. If seizures associated with drug therapy occur, the drug should be discontinued. therapy can be given if clinically indicated.
|Drug Interactions||Positive direct Coombsâ€™ tests have been reported during treatment with the cephalosporin antibiotics. In hematologic studies or in transfusion cross-matching procedures when antiglobulin tests are performed on the minor side or in Coombsâ€™ testing of newborns whose mothers have received cephalosporin antibiotics before parturition, it should be recognized that a positive Coombsâ€™ test may be due to the drug.|
|Pregnancy Category (FDA)||Pregnancy: Pregnancy Category B
Reproduction studies have been performed in mice and rats at doses up to 11 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to cefadroxil . 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
Cefadroxil has not been studied for use during labor and delivery. Treatment should only be given if clearly needed.
Caution should be exercised when cefadroxil is administered to a nursing mother.
Of approximately 650 patients who received cefadroxil for the treatment of urinary tract infections in three clinical trials, 28% were 60 years and older, while 16% were 70 years and older. Of approximately 1000 patients who received cefadroxil for the treatment of skin and skin structure infection in 14 clinical trials, 12% were 60 years and older while 4% were 70 years and over. No overall differences in safety were observed between the elderly patients in these studies and younger patients. Clinical studies of cefadroxil for the treatment for pharyngitis or tonsillitis did not include sufficient numbers of patients 65 years and older to determine whether they respond differently from younger patients. Other reported clinical experience with cefadroxil has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Cefadroxil is substantially excreted by the kidney, and dosage adjustment is indicated for patients with renal impairment. 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).
is rapidly absorbed after oral administration. Following single doses of 500 and 1000 mg, average peak serum concentrations were approximately 16 and 28
mcg/mL, respectively. Measurable levels were present 12 hours after administration. Over 90% of the drug is excreted unchanged in the urine within 24 hours.
Peak urine concentrations are approximately 1800 mcg/mL during the period following a single 500 mg oral dose. Increases in dosage generally produce a
proportionate increase in cefadroxil urinary concentration. The urine concentration, following a 1-g
dose, was maintained well above the MIC of susceptible urinary pathogens for 20 to 22 hours.
tests demonstrate that the cephalosporins are bactericidal because of their inhibition of cell-wall synthesis. Cefadroxil has been shown to be active against the following organisms both and in clinical infections:
including penicillinase-producing strains
Most strains of (formerly ) and (formerly ) are resistant to cefadroxil . It is not active against most strains of species, (formerly ), and . It has no activity against species and (formerly and species).
Susceptibility tests: Diffusion techniques
The use of antibiotic disk susceptibility test methods which measure zone diameter give an accurate estimation of antibiotic susceptibility. One such standard procedurewhich has been recommended for use with disks to test susceptibility of organisms to cefadroxil uses the cephalosporin class (cephalothin) disk. Interpretation involves the correlation of the diameters obtained in the disk test with the minimum inhibitory concentration (MIC) for cefadroxil .
Reports from the laboratory giving results of the standard single-disk susceptibility test with a 30 mcg cephalothin disk should be interpreted according to the following criteria:
A report of â€œ;Susceptibleâ€ indicates that theis likely to be inhibited by generally achievable blood levels. A report of â€œintermediate susceptibilityâ€ suggests that the organism would be susceptible if high dosage is used or if the infection is confined to tissue and fluids (e.g., urine) in which high antibiotic levels are attained. A report of â€œResistantâ€ indicates that achievable concentrations of the antibiotic are unlikely to be inhibitory and other therapy should be selected.
Standardized procedures require the use of laboratory control organisms. The 30 mcg cephalothin disk should give the following zone diameters:
When using the NCCLS agar dilution or broth dilution (including microdilution) methodor equivalent, a bacterial isolate may be considered susceptible if the MIC (minimum inhibitory concentration) value for cephalothin is 8 mcg/mL or less. Organisms are considered resistant if the MIC is 32 mcg/mL or greater. Organisms with an MIC value of less than 32 mcg/mL but greater than 8 mcg/mL are intermediate.
As with standard diffusion methods, dilution procedures require the use of laboratory control organisms. Standard cephalothin powder should give MIC values in the range of 0.12 mcg/mL and 0.5 mcg/mL for ATCC 29213. For ATCC 25922, the MIC range should be between 4 mcg/mL and 16 mcg/mL. For ATCC 29212, the MIC range should be between 8 and 32 mcg/mL.
1. National Committee for Clinical Laboratory Standards, Approved Standard, 4th Edition, Vol. 10(7): M2-A4, Villanova, PA, April, 1990.
2. National Committee for Clinical Laboratory Standards, Approved Standard: 2nd Edition, Vol. 10(8): M7-A2, Villanova, PA, April, 1990.
|Brand Name||Manufacturer/Marketer||Composition||Dosage Form||Pack Size & Price|
|ADOCEF||Ziska Pharmaceuticals Ltd.||Cefadroxil monohydrate 125mg/5ml||Suspension||100ml: 70.00 MRP|
|ADOCEF-500||Ziska Pharmaceuticals Ltd.||Cefadroxil monohydrate USP 500mg||Capsule||20's: 240.00 MRP|
|ADOCIL||Kemiko Pharmaceuticals Ltd||Cefadroxil monohydrate 125mg/5ml||Suspension||100ml: 70.00 MRP|
|ADOCIL-500||Kemiko Pharmaceuticals Ltd||Cefadroxil monohydrate USP 500mg||Capsule||20's: 240.00 MRP|
|Adora 100ml||Incepta Pharmaceuticals Limited||Cefadroxil Monohydrate USP equivalent to Cefadroxil 125 mg/5ml||Suspension||100ml:MRP 70 Tk|
|Adora 500||Incepta Pharmaceuticals Limited||Cefadroxil Monohydrate USP equivalent to Cefadroxil 500mg||Capsule||4x5's:MRP 240 Tk|
|Adora 60ml||Incepta Pharmaceuticals Limited||Cefadroxil Monohydrate USP equivalent to Cefadroxil 125 mg/5ml||Suspension||60ml:MRP 50 Tk|
|Adora Drop||Incepta Pharmaceuticals Limited||Cefadroxil Monohydrate USP equivalent to Cefadroxil 125 mg/1.25ml||Paed. Drop||15ml:MRP 50 Tk|
|AROCEF||Eskayef Bangladesh Ltd||Cefadroxil Monohydrate USP equivalent to Cefadroxil 500mg||Capsule||500mg x24's MRP: 288.00|
|AROCEF Drop||Eskayef Bangladesh Ltd||Cefadroxil Monohydrate USP equivalent to Cefadroxil 125mg/1.25ml||Drop||15ml MRP: 50.00|
|AROCEF Suspension||Eskayef Bangladesh Ltd||Cefadroxil Monohydrate USP equivalent to Cefadroxil 125mg/5ml||Suspension||100ml MRP: 70.00|
|BEXAN||NIPRO JMI Pharma Ltd.||Cefadroxil monohydrate USP 500mg||Capsule||24's: 241.00 MRP|
|BEXAN Suspension||NIPRO JMI Pharma Ltd.||Cefadroxil monohydrate 125mg/5ml||Suspension||100ml: 70.26 & 70.00 MRP|
|CEFADOR||Somatec Pharmaceuticals Ltd.||Cefadroxil monohydrate 100mg/1ml||Drop||15ml: 50.19 MRP|
|CEFADOR Capsule||Somatec Pharmaceuticals Ltd.||Cefadroxil monohydrate USP 500mg||Capsule||20's: 241.00 MRP|
|CEFADOR Suspension||Somatec Pharmaceuticals Ltd.||Cefadroxil monohydrate 125mg/5ml||Suspension||100ml: 70.26 MRP|
|CEFCARE||Navana Pharmaceuticals Limited||Cefadroxil monohydrate 100mg/1ml||Drop||15ml: 50.19 MRP|
|CEFCARE Suspension||Navana Pharmaceuticals Limited||Cefadroxil monohydrate 125mg/5ml||Suspension||100ml: 70.26 MRP|
|CEFCARE-500||Navana Pharmaceuticals Limited||Cefadroxil monohydrate USP 500mg||Capsule||12's: 144.60 MRP|
|DROXIL||Rangs Pharmaceuticals Ltd.||Cefadroxil monohydrate 100mg/1ml||Drop||15ml: 50.00 MRP|
|DROXIL 500||Rangs Pharmaceuticals Ltd.||Cefadroxil monohydrate USP 500mg||Capsule||20's: 240.00 MRP|
|DROXIL Suspension||Rangs Pharmaceuticals Ltd.||Cefadroxil monohydrate 125mg/5ml||Suspension||100ml: 70.00 MRP|
|FICEF||UniDerma Pharmaceuticals Ltd.||Cefadroxil monohydrate 100mg/1ml||Drop||15ml: 50.00 MRP|
|FICEF Capsule||UniDerma Pharmaceuticals Ltd.||Cefadroxil monohydrate USP 500mg||Capsule||20's: 240.00 MRP|
|FICEF Suspension||UniDerma Pharmaceuticals Ltd.||Cefadroxil monohydrate 125mg/5ml||Suspension||100ml: 70.00 MRP|
|FODEXIL 500||Square Pharmaceuticals Ltd.||Cefadroxil 500mg||Capsule||3x6's: 270.90 MRP|
|SEFADOL||Techno Drugs||Cefadroxil monohydrate USP 500mg||Capsule||18's: 180.00 MRP|
|SEFADOL Suspension||Techno Drugs||Cefadroxil monohydrate 125mg/5ml||Suspension||100ml: 65.00 MRP|
|SEFANID||Drug International Ltd||Cefadroxil monohydrate USP 500mg||Capsule||50's: 600.00 MRP|
|SEFANID Suspension||Drug International Ltd||Cefadroxil monohydrate 125mg/5ml||Suspension||100ml: 70.00 MRP|
|TRUBID||Opsonin Pharma Limited||Cefadroxil monohydrate USP 100mg/1ml||Drop||15ml: 50.00 MRP|
|TRUBID Capsule||Opsonin Pharma Limited||Cefadroxil monohydrate USP 500mg||Capsule||24's: 288.00 MRP|
|TRUBID DS||Opsonin Pharma Limited||Cefadroxil monohydrate 250mg/5ml||Suspension||100ml: 120.00 MRP|
|TRUBID Suspension||Opsonin Pharma Limited||Cefadroxil monohydrate 125mg/5ml||Suspension||60ml,100ml: 50.00 & 70.00 MRP|
|TWICEF||The Acme Laboratories Ltd.||Cefadroxil monohydrate USP 100mg/1ml||Drop||15ml: 50.20 MRP|
|TWICEF Capsule||The Acme Laboratories Ltd.||Cefadroxil monohydrate USP 500mg||Capsule||20's: 241.00 MRP|
|TWICEF DS||The Acme Laboratories Ltd.||Cefadroxil monohydrate 250mg/5ml||Suspension||100ml: 120.46 MRP|
|TWICEF Suspension||The Acme Laboratories Ltd.||Cefadroxil monohydrate 125mg/5ml||Suspension||100ml: 70 76 MRP|
|| See FDA approved Prescribing Information from Brand Manufacturer |||Manufacturer's|
| | Latest mph edition: 09 Dec 2013 |
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*Trademark name & prescribing information are the property of their respective Manufacturers.