"The U.S. Food and Drug Administration today approved Zerbaxa (ceftolozane/tazobactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI).
Furadantin is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species.
Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses.
Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with Furadantin are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with Furadantin, other therapeutic agents with broader tissue distribution should be selected. In considering the use of Furadantin, lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.
DOSAGE AND ADMINISTRATION
Furadantin should be given with food to improve drug absorption and, in some patients, tolerance.
50-100 mg four times a day -- the lower dosage level is recommended for uncomplicated urinary tract infections.
5-7 mg/kg of body weight per 24 hours, given in four divided doses (contraindicated under one month of age).
The following table is based on an average weight in each range receiving 5 to 6 mg/kg of body weight per 24 hours, given in four divided doses. It can be used to calculate an average dose of Furadantin Oral Suspension (25 mg/5mL) for pediatric patients.
Table 3: Pediatric Dosing Table
|Weight in Kilograms (kg)||Pediatric Doses (milliliters) and Frequency|
|7 kg to 11 kg||2.5 mL Four times Daily|
|12 kg to 21 kg||5 mL Four times Daily|
|22 kg to 30 kg||7.5 mL Four times Daily|
|31 kg to 41 kg||10 mL Four times Daily|
|42 kg or greater||See Adult Dose|
Therapy should be continued for one week or for at least 3 days after sterility of the urine is obtained. Continued infection indicates the need for reevaluation.
For long-term suppressive therapy in adults, a reduction of dosage to 50-100 mg at bedtime may be adequate. For long-term suppressive therapy in pediatric patients, doses as low as 1 mg/kg per 24 hours, given in a single dose or in two divided doses, may be adequate. SEE WARNINGS SECTION REGARDING RISKS ASSOCIATED WITH LONG TERM THERAPY.
Furadantin Oral Suspension is available in:
NDC 59630-450-08 glass amber bottle of 230 mL
Avoid exposure to strong light which may darken the drug. It is stable when stored between 20°25°C (68°-77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature]. Protect from freezing. Shake vigorously. Dispense in tight, light-resistant, plastic (PET) or glass container. Use within 30 days.
Keep out of reach of children.
Manufactured by : Norwich Pharmaceuticals, Inc., North Norwich, New York 13814. Manufactured for : Shionogi Inc., Florham Park, NJ 07932.
Last reviewed on RxList: 11/14/2013
This monograph has been modified to include the generic and brand name in many instances.
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