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Gantrisin Indications, Dosage, Storage, Stability - Acetyl Sulfisoxazole

Gantrisin Indications, Dosage, Storage, Stability - Acetyl Sulfisoxazole

INDICATIONS

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 where the organism has been demonstrated to be susceptible. Haemophilus influenzae meningitis as adjunctive therapy with parenteral streptomycin.

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.)

Acute otitis media due to Haemophilus influenzae when used concomitantly with adequate doses of penicillin or erythromycin (see appropriate labeling for prescribing information).

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.

HOW SUPPLIED

Pediatric Suspension (raspberry flavored), containing acetyl sulfisoxazole equivalent to approximately 0.5 gm sulfisoxazole per teaspoonful (5 mL) — bottles of 16 o (1 pint) (NDC 0004-1003-28).

REFERENCES

1 . Boisvert A, Barbeau G, Belanger PM. Pharmacokinetics of sulfisoxazole in young and elderly subjects. Gerontology. 1984, 30: 125-131.

2. Oie S, Gambertoglio JG, Fleckenstein L. Comparison of the disposition of total and unbound sulfisoxazole after single and multiple dosing. J Pharmacokinet Biopharm. 1982; 10: 157-172.

3. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests. 4th ed. Villanova, PA: April 1990. Approved Standard NCCLS Document M2-A4, Vol . 10, No. 7 NCCLS.

4. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically. 2nd ed. Villanova, PA: April 1990. Approved Standard NCCLS Document M7-A2, Vol. 10, No. 8 NCCLS.

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