"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).
NegGram (nalidixic acid, USP) is indicated for the treatment of urinary tract infections caused by susceptible gram-negative microorganisms, including the majority of E. Coli, Enterobacter species, Klebsiella species, and Proteus species. Disc susceptibility testing with the 30 mcg disc should be performed prior to administration of the drug, and during treatment if clinical response warrants.
To reduce the development of drug-resistant bacteria and maintain effectiveness of NegGram and other antibacterial drugs, NegGram 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 when selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
DOSAGE AND ADMINISTRATION
Antacids containing calcium, magnesium, or aluminum; sucralfate; divalent or trivalent cations such as iron; multivitamins containing zinc; or Videx® (Didanosine), chewable/buffered tablets of the pediatric powder for oral solution should not be taken within the two-hour period before or within the two-hour period after taking nalidixic acid.
The recommended dosage for initial therapy in adults is 1 g administered four times daily for one or two weeks (total daily dose, 4 g). For prolonged therapy, the total daily dose may be reduced to 2 g after the initial treatment period. Underdosage during initial treatment may predispose to emergence of bacterial resistance.
The normal dosage of nalidixic acid may be employed in patients with plasma creatinine of less than 300 μmol/L (creatinine clearance more than 20 mL/minute). Dosage should be halved in patients with plasma creatinine of more than 300 μmol/L (creatinine clearance 20 mL/minute or less).
Until further experience is gained, NegGram should not be administered to infants younger than three months. Dosage in pediatric patients 12 years of age and under should be calculated on the basis of body weight. The recommended total daily dosage for initial therapy is 25 mg/lb/day (55 mg/kg/day), administered in four equally divided doses. For prolonged therapy, the total daily dose may be reduced to 15 mg/lb/day (33 mg/kg/day). NegGram Caplets of 250 mg may be used.
NegGram (nalidixic acid, USP) is supplied as:
Caplets of 500 mg, light buff-colored capsule-shaped tablets, bottles of 56 (NDC 0024-1322-03).
Store at room temperature, up to 30° C (86° F).
Manufactured for: sanofi-aventis U.S. LLC Bridgewater, NJ 08807. Revised March 2011
Last reviewed on RxList: 6/10/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional NegGram Caplets Information
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