Product Elements:
Cefadroxil cefadroxil ferrosoferric oxide sodium lauryl sulfate fd&c blue no. 1 magnesium stearate fd&c red no. 40 titanium dioxide gelatin, unspecified lactose monohydrate anhydrous lactose cefadroxil cefadroxil anhydrous d&c red no. 28 maroon opaque white opaque c;97
Indications and Usage:
Indications and usage 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. to reduce the development of drug-resistant bacteria and maint
Read more...ain the effectiveness of cefadroxil and other antibacterial drugs, cefadroxil 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 epidemology and susceptibility patterns may contribute to the empiric selection of therapy.
Warnings:
Warnings 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. clostridium difficile associated diarrhea (cdad) has been reported with use of nearly all antibacterial agents, including cefadroxil, and may range in severity from mild diarrhea to fatal colitis. t
Read more...reatment 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.
Dosage and Administration:
Dosage and 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. adults urinary tract infections: for uncomplicated lower urinary tract infections (i.e., cystitis) the usual dosage is 1 or 2 g per day in a 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 tonsillitisâ1 g per day in single (q.d.) or divided doses (b.i.d.) for 10 days. children for urinary tract infections, the recommended daily dosage for children is 30 mg/kg/day in divided doses every 12 hours. f
Read more...or 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. renal impairment 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. creatinine clearances dosage interval 0 to 10 ml/min 36 hours 10 to 25 ml/min 24 hours 25 to 50 ml/min 12 hours patients with creatinine clearance rates over 50 ml/min may be treated as if they were patients having normal renal function.
Contraindications:
Contraindications cefadroxil is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
Adverse Reactions:
Adverse reactions gastrointestinal onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment (see warnings). dyspepsia, nausea and vomiting have been reported rarely. diarrhea has also occurred. hypersensitivity allergies (in the form of rash, urticaria, angioedema, and pruritus) have been observed. these reactions usually subsided upon discontinuation of the drug. anaphylaxis has also been reported. other other reactions have included hepatic dysfunction including cholestasis and elevations in serum transaminase, genital pruritus, genital moniliasis, vaginitis, moderate transient neutropenia, fever. agranulocytosis, thrombocytopenia, idiosyncratic hepatic failure, erythema multiforme, stevens-johnson syndrome, serum sickness, and arthralgia 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 report
Read more...ed for cephalosporin-class antibiotics: toxic epidermal necrolysis, abdominal pain, superinfection, renal dysfunction, toxic nephropathy, aplastic anemia, hemolytic anemia, hemorrhage, prolonged prothrombin time, positive coombsâ test, increased bun, increased creatinine, elevated alkaline phosphatase, elevated aspartate aminotransferase (ast), elevated alanine aminotransferase (alt), elevated bilirubin, elevated ldh, eosinophilia, pancytopenia, neutropenia. 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.
Overdosage:
Overdosage 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.
Description:
Description cefadroxil, usp is a semisynthetic cephalosporin antibiotic intended for oral administration. it is a white to yellowish-white crystalline powder. it is soluble in water and it is acid-stable. it is chemically designated as 5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[amino(4-hydroxyphenyl)acetyl]amino]-3-methyl-8-oxo-, monohydrate, [6r-[6α,7β(r*)]]-. it has the formula c16h17n3o5s · h2o and the molecular weight of 381.40. it has the following structural formula: cefadroxil capsules contain the following inactive ingredients: lactose monohydrate, magnesium stearate, fd&c blue no.1, d&c red no.28, fd&c red no. 40, titanium dioxide, gelatin, sodium lauryl sulphate, and edible black ink (black iron oxide). cefadroxil
Clinical Pharmacology:
Clinical pharmacology cefadroxil is rapidly absorbed after oral administration. following single doses of 500 mg 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 antibiotic concentration, following a 1 g dose, was maintained well above the mic of susceptible urinary pathogens for 20 to 22 hours. microbiology in vitro 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 in vitroand in clinical infections (see indications and usage): beta-hemolytic streptococ
Read more...ci staphylococci, including penicillinase-producing strains streptococcus (diplococcus) pneumoniae escherichia coli proteus mirabilis klebsiella species moraxella (branhamella) catarrhalis note: most strains of enterococcus faecalis (formerly streptococcus faecalis) and enterococcus faecium(formerly streptococcus faecium) are resistant to cefadroxil. it is not active against most strains of enterobacter species, morganella morganii (formerly proteus morganii), and p. vulgaris. it has no activity against pseudomonas species and acinetobacter calcoaceticus (formerly mima and herelleaspecies). susceptibility testing for specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by fda for this drug, please see: https://www.fda.gov/stic.
How Supplied:
How supplied cefadroxil capsules, usp 500 mg are maroon/white colored, size â0â hard gelatin capsules filled with white to off-white granular free flowing powder and imprinted with âcâ on maroon opaque cap and â97â on white opaque body with black ink. bottles of 50 ndc 65862-085-50 bottles of 100 ndc 65862-085-01 store at 20° to 25°c (68° to 77°f); excursions permitted to 15° to 30°c (59° to 86°f) [see usp controlled room temperature]. distributed by: aurobindo pharma usa, inc. 279 princeton-hightstown road east windsor, nj 08520 manufactured by: aurobindo pharma limited hyderabad-500 038, india revised: 09/2018
Package Label Principal Display Panel:
Package label-principal display panel - 500 mg cerfadroxillabel