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Cefadroxil

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Cefadroxil

Warnings
Precautions

WARNINGS

BEFORE THERAPY WITH CEFADROXIL (cefadroxil (cefadroxil hemihydrate) hemihydrate) IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFADROXIL (cefadroxil (cefadroxil hemihydrate) hemihydrate) , 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 (cefadroxil (cefadroxil hemihydrate) hemihydrate) 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 (cefadroxil (cefadroxil hemihydrate) hemihydrate) , 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 Clostridium difficile is a primary cause of “antibiotic-associated colitis”.

After the diagnosis of pseudomembranous colitis 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 Clostridium difficile.

PRECAUTIONS

General:

Prescribing Cefadroxil (cefadroxil hemihydrate) Tablets and Cefadroxil (cefadroxil (cefadroxil hemihydrate) hemihydrate) 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 (cefadroxil (cefadroxil hemihydrate) hemihydrate) 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) (See DOSAGE AND ADMINISTRATION). 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 (cefadroxil (cefadroxil hemihydrate) hemihydrate) 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 (cefadroxil (cefadroxil hemihydrate) hemihydrate) 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.

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 (cefadroxil (cefadroxil hemihydrate) hemihydrate) . 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 (cefadroxil (cefadroxil hemihydrate) hemihydrate) has not been studied for use during labor and delivery. Treatment should only be given if clearly needed.

Nursing Mothers

Caution should be exercised when cefadroxil (cefadroxil (cefadroxil hemihydrate) hemihydrate) is administered to a nursing mother.

Geriatric Use

Of approximately 650 patients who received cefadroxil (cefadroxil (cefadroxil hemihydrate) hemihydrate) 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 (cefadroxil (cefadroxil hemihydrate) hemihydrate) 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 (cefadroxil (cefadroxil hemihydrate) hemihydrate) 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 (cefadroxil (cefadroxil hemihydrate) hemihydrate) has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Cefadroxil (cefadroxil (cefadroxil hemihydrate) hemihydrate) is substantially excreted by the kidney, and dosage adjustment is indicated for patients with renal impairment (see DOSAGE AND ADMINISTRATION: 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.

Pediatric Use

(See DOSAGE AND ADMINISTRATION).

Last reviewed on RxList: 7/31/2007
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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