Sulfadiazine

Indications

INDICATIONS AND USAGE sulfADIAZINE Tablets, USP are indicated in the following conditions: Chancroid Trachoma Inclusion conjunctivitis Nocardiosis Urinary tract infections (primarily pyelonephritis, pyelitis and cystitis) in the absence of obstructive uropathy or foreign bodies, when these infections are caused by susceptible strains of the following organisms: Esch erichia coli, Klebsiella species, Enterobacter species, Staphylococcus aureus, Proteus mirabilis and P. vulgaris . Sulfadiazine should be used for urinary tract infections only after use of more soluble sulfonamides has been unsuccessful. Toxoplasmosis encephalitis in patients with and without acquired immunodeficiency syndrome, as adjunctive therapy with pyrimethamine. Malaria due to chloroquine-resistant strains of Plasmodium falciparum , when used as adjunctive therapy.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION SYSTEMIC SULFONAMIDES ARE CONTRAINDICATED IN INFANTS UNDER 2 MONTHS OF AGE except as adjunctive therapy with pyrimethamine in the treatment of congenital toxoplasmosis. Usual Dosage for Infants over 2 Months of Age and Children Initially, one-half the 24-hour dose. Maintenance, 150 mg/kg or 4 g/m 2 , divided into 4 to 6 doses, every 24 hours, with a maximum of 6 g every 24 hours. Rheumatic fever prophylaxis, under 30 kg (66 pounds), 500 mg every 24 hours; over 30 kg (66 pounds), 1 g every 24 hours. Usual Adult Dosage Initially, 2 g to 4 g. Maintenance, 2 g to 4 g, divided into 3 to 6 doses, every 24 hours.

Contraindications

CONTRAINDICATIONS Sulfadiazine is contraindicated in the following circumstances: Hypersensitivity to sulfonamides. In infants less than 2 months of age (except as adjunctive therapy with pyrimethamine in the treatment of congenital toxoplasmosis). In pregnancy at term and during the nursing period, because sulfonamides cross the placenta and are excreted in breast milk and may cause kernicterus.

Warnings and precautions

WARNINGS The sulfonamides should not be used for the treatment of group A betahemolytic streptococcal infections. In an established infection, they will not eradicate the streptococcus and, therefore, will not prevent sequelae such as rheumatic fever and glomerulonephritis. Deaths associated with the administration of sulfonamides have been reported from hypersensitivity reactions, agranulocytosis, aplastic anemia and other blood dyscrasias. The presence of such clinical signs as sore throat, fever, pallor, purpura or jaundice may be early indications of serious blood disorders.

Pregnancy

Pregnancy Teratogenic Effects The safe use of sulfonamides in pregnancy has not been established. The teratogenic potential of most sulfonamides has not been thoroughly investigated in either animals or humans.

Storage and supply

HOW SUPPLIED sulfADIAZINE Tablets, USP for oral administration are available as 500 mg White, unscored, capsule-shaped tablets, debossed “ E 757” on one face and supplied as: NDC 42806-757-60 bottles of 60 Storage Store at 20° to 25°C (68° to 77°F) . Protect from moisture.

Source: Sulfadiazine (Sulfadiazine) — US FDA prescribing information, 2023-11-08, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.