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Neggram Indications, Dosage, Storage, Stability - Nalidixic Acid
INDICATIONS
AND USES
NegGram 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.
Antacids containing calcium, magnesium, or aluminum; sucralfate; divalent or trivalent cations such as iron; multivitamins contaning 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.
Adults. 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.
Pediatric Patients. 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 Suspension or NegGram Caplets of 250 mg may be used. One 250 mg tablet is equivalent to one teaspoon (5 mL) of the suspension.
HOW SUPPLIED
Suspension (250 mg/5 mL tsp), raspberry flavored, bottles of 1 pint (NDC 0024-1318-06)
Caplets of 1 g, light buff-colored capsule-shaped tablets, bottles of 100 (NDC 0024-1323-04)
Caplets of 500 mg, light buff-colored capsule-shaped tablets, bottles of 56 (NDC 0024-1322-03) 500 (NDC 0024-1322-06)
Caplets of 250 mg, light buff-colored capsule-shaped tablets, bottles of 56 (NDC 0024-1321-03)
Store suspension at room temperature up to 25°C (77°F). Store caplets at room temperature, up to 30°C (86°F).
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