"The US Food and Drug Administration (FDA) today approved asfotase alfa (Strensiq, Alexion Pharmaceuticals) as the first-ever therapy for patients who develop hypophosphatasia, a rare metabolic bone disorder, in childhood.
Acute, recurrent or chronic urinary tract infections (primarily pyelonephritis, pyelitis and cystitis) due to susceptible organisms (usually Escherichia coli, Klebsiella-Enterobacter, staphylococcus, Proteus mirabilis and, less frequently, Proteus vulgaris) in the absence of obstructive uropathy or foreign bodies.
Meningococcal meningitis prophylaxis when sulfonamide-sensitive group A strains are known to prevail in family groups or larger closed populations. (The prophylactic usefulness of sulfonamides when group B or C infections are prevalent has not been proven and in closed population groups may be harmful.)
Trachoma. Inclusion conjunctivitis. Nocardiosis. Chancroid. Toxoplasmosis as adjunctive therapy with pyrimethamine. Malaria due to chloroquine-resistant strains of Plasmodium falciparum, when used as adjunctive therapy.
Currently, the increasing frequency of resistant organisms is a limitation of the usefulness of antibacterial agents including the sulfonamides, especially in the treatment of chronic and recurrent urinary tract infections.
Important Note:In vitro sulfonamide susceptibility tests are not always reliable. The test must be carefully coordinated with bacteriologic and clinical response. When the patient is already taking sulfonamides, follow-up cultures should have aminobenzoic acid added to the culture media.
DOSAGE AND ADMINISTRATION
Systemic sulfonamides are contraindicated in infants less than 2 months of age, except in the treatment of congenital toxoplasmosis as adjunctive therapy with pyrimethamine.
Usual Dose for Pediatric Patients Over 2 Months of Age: Initial dose: One half of the 24-hour dose. Maintenance dose: 150 mg/kg/24 hours or 4 gm/M²/24 hours - dose to be divided into 4 to 6 doses/24 hours. The maximum dose should not exceed 6 gm/24 hours.
Pediatric Suspension (raspberry flavored), containing acetyl sulfisoxazole equivalent to approximately 0.5 gm sulfisoxazole per teaspoonful (5 mL) - bottles of 16 oz (1 pint) (NDC 0004-1003-28).
Revised: November 1997. Roche Laboratories Inc. 340 Kingsland Street, Nutley, New Jersey 07110 - 1199. FDA rev date: 12/23/1996This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 9/16/2008
Additional Gantrisin Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.