DROXIFAL

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: [Chemical Structure] 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).

Different types of bacterial infection, especially caused by the nostril bacteria (Streptococcus bacteria) such as lymphocytes, various skin infections, almonditis and urinary tract infections, and used to prevent heart-fuse infection in patients expected to undergo certain surgeries.

The treatment (in small quantities) is given to breast-feeding milk, so the doctor must be consulted in case the patient is a nurse.

The doctor should be informed that if there are signs of kidney infestation or disease, certain cases may require special precautionary procedures or modified doses.

If the patient is sensitive to penicillin, the doctor must be informed before treatment begins.

Cefadroxil is rapidly absorbed after oral administration.

Following single doses of 500 mg and 1000 mg, average peak serum concentrations were approximately 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 to 22 hours.

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 vitro and in clinical infections: Beta-hemolytic streptococci 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 Herellea species).

Sevdroxyl is a bio-reactive first generation cyvalosporin group that is effective against many positive airbrows (Staphylococcus aerobic Gram-positive).

But it has limited effectiveness against negative genomics (gram negative).

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.

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 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 reported for cephalosporin-class antibiotics: Toxic epidermal necrolysis, abdominal pain, superinfection, renal dysfunction, toxic nephropathy, aplastic anemia, hemolytic anemia, hemorrhage, prolonged prothrombin time, positive Coombs’ 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.

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 to 8 hour hemodialysis session.

10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY.

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.

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.

Cefadroxil is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

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.

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).

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).

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.

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.

Interval to 10 mL/min 36 hours to 25 mL/min 24 hours 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.

Capsules, USP 500 mg are maroon/white colored, size “0” hard gelatin capsules filled with white to off-white granular free flowing powder and imprinted with “C” on maroon opaque cap and “97” on white opaque body with black ink.

Bottles of 20 NDC 72189-506-20.

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) .

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