Version May 2024
Congenital toxoplasmosis: Oral: 50 mg/kg/dose every 12 hours for 12 months in combination with pyrimethamine and leucovorin (HHS [pediatric OI 2021]).
General dosing: Infants ≥2 months, Children, and Adolescents: Oral: 120 to 150 mg/kg/day in divided doses 4 to 6 times daily; maximum daily dose: 6 g/day (Red Book [AAP 2021]; manufacturer's labeling).
Toxoplasmosis:
Congenital (regardless of HIV status): Infants: Oral: 50 mg/kg/dose every 12 hours for 12 months in combination with pyrimethamine and leucovorin (HHS [pediatric OI 2021]; Red Book [AAP 2021]).
Acquired (including encephalitis):
HIV-exposed/-infected: Note: Use in combination with pyrimethamine and leucovorin for ≥6 weeks, followed by chronic maintenance therapy (secondary prophylaxis); longer duration may be required if incomplete response or extensive disease (HHS [adult OI 2021]; HHS [pediatric OI 2021]).
Infants ≥2 months and Children: Oral: 25 to 50 mg/kg/dose every 6 hours; maximum dose: 1,500 mg/dose (HHS [pediatric OI 2021]).
Adolescents (HHS [adult OI 2021]):
<60 kg: 1,000 mg every 6 hours.
≥60 kg: 1,500 mg every 6 hours.
Non-HIV-exposed/-infected patients: Infants ≥2 months, Children, and Adolescents: Oral: 25 to 50 mg/kg/dose every 6 hours; maximum dose: 1,500 mg/dose; use in combination with pyrimethamine and leucovorin. Continue for ≥2 weeks after resolution of illness in immunocompetent patients and ≥4 to 6 weeks after resolution of illness in immunocompromised patients; longer duration may be necessary based on patient response (Bradley 2021; CDC 2020; Red Book [AAP 2021]).
Chorioretinitis : Note: Use in combination with pyrimethamine and leucovorin for ≥6 weeks, followed by chronic maintenance therapy (secondary prophylaxis); longer duration may be required if incomplete response or extensive disease (HHS [adult OI 2021]; HHS [pediatric OI 2021]).
HIV-exposed/-infected:
Infants ≥2 months and Children: Oral: 25 to 50 mg/kg/dose every 6 hours; maximum dose: 1,500 mg/dose (HHS [pediatric OI 2021]).
Adolescents (HHS [adult OI 2021]):
<60 kg: 1,000 mg every 6 hours.
≥60 kg: 1,500 mg every 6 hours.
Non-HIV-exposed/-infected: Children and Adolescents: Oral: Loading dose: 75 mg/kg once; followed by 50 mg/kg/dose every 12 hours starting 12 hours after loading dose; maximum daily dose: 4,000 mg/day. Use in combination with pyrimethamine and leucovorin for 1 to 2 weeks after resolution of clinical manifestations; usual duration 4 to 6 weeks; however, prolonged therapy (up to 3 months) may be necessary (Red Book [AAP 2021]).
Chronic maintenance therapy (secondary prevention): Note: Use in combination with pyrimethamine and leucovorin. May consider discontinuation when asymptomatic, the patient has completed ≥6 months of stable antiretroviral therapy with CD4 percentage ≥15% (or CD4 count is >200 cells/mm3 for ages ≥6 years) for >6 consecutive months.
HIV-exposed/-infected:
Infants ≥2 months and Children: Oral: 85 to 120 mg/kg/day in 2 to 4 divided doses; maximum daily dose: 4,000 mg/day (HHS [pediatric OI 2021]).
Adolescents: Oral: 2,000 to 4,000 mg/day in 2 to 4 divided doses (HHS [adult OI 2021]).
Rheumatic fever; secondary prevention (AHA [Gerber 2009]; Red Book [AAP 2021):
Infants ≥2 months, Children, and Adolescents:
Weight ≤27 kg: Oral: 500 mg once daily.
Weight >27 kg: Oral: 1,000 mg once daily.
There are no dosage adjustments in the manufacturer's labeling.
There are no dosage adjustments in the manufacturer's labeling.
(For additional information see "Sulfadiazine: Drug information")
Usual dosage range: Oral: 2 to 4 g/day in 3 to 6 divided doses.
Rheumatic fever prophylaxis: Oral:
≤27 kg: 500 mg once daily (AHA [Gerber 2009]).
>27 kg: 1 g once daily (AHA [Gerber 2009]).
Toxoplasma gondii encephalitis: Note: Patients receiving sulfadiazine and pyrimethamine for treatment or suppression of toxoplasmosis do not require additional pneumocystis prophylaxis (HHS [OI adult 2021]).
Treatment of acute infection (duration of therapy: ≥6 weeks): Oral: 1 g (<60 kg) or 1.5 g (≥60 kg) every 6 hours in combination with pyrimethamine plus leucovorin calcium (preferred) or alternatively, in combination with atovaquone (HHS [OI adult 2021]).
Chronic maintenance: Oral: 2 to 4 g/day in 2 to 4 divided doses in combination with pyrimethamine and leucovorin calcium (preferred) or alternatively, in combination with atovaquone; may discontinue if successfully completed initial treatment, remain asymptomatic of signs/symptoms of T. gondii encephalitis, and CD4 count is >200 cells/mm3 for >6 months in response to antiretroviral therapy (HHS [OI adult 2021]).
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions are derived from product labeling unless otherwise specified.
Postmarketing:
Cardiovascular: Hypersensitivity myocarditis, polyarteritis nodosa
Dermatologic: Erythema multiforme, exfoliative dermatitis, pruritus, skin photosensitivity, skin rash, Stevens-Johnson syndrome (Velter 2018), toxic epidermal necrolysis, urticaria
Endocrine & metabolic: Hypoglycemia (Craft 1977)
Gastrointestinal: Abdominal pain, anorexia, diarrhea, nausea, pancreatitis, stomatitis, vomiting
Genitourinary: Crystalluria (de Sequera 1996), obstructive uropathy (Kabha 2016), toxic nephrosis (with anuria and oliguria) (Craft 1977)
Hematologic & oncologic: Agranulocytosis, aplastic anemia, hemolytic anemia, hypoprothrombinemia, leukopenia, methemoglobinemia, purpuric disease, thrombocytopenia
Hepatic: Hepatic injury (including fulminant hepatitis, hepatitis, hepatorenal syndrome, increased liver enzymes, jaundice) (Khalili 2011)
Hypersensitivity: Drug reaction with eosinophilia and systemic symptoms (Monge-Ortega 2018), hypersensitivity reaction (McLeod 2006), nonimmune anaphylaxis, serum sickness
Nervous system: Ataxia, chills, depression, drug fever, hallucination, headache, insomnia, peripheral neuritis, seizure, vertigo
Neuromuscular & skeletal: Arthralgia, lupus erythematosus (Hogan 2015)
Ophthalmic: Conjunctival injection, injected sclera, periorbital edema
Otic: Tinnitus
Renal: Acute kidney injury (de Sequera 1996), nephrolithiasis (McGettigan 2012), nephrotoxicity (Becker 1996), renal failure syndrome (Marques 1992)
Hypersensitivity to sulfonamides or any component of the formulation; infants <2 months of age unless indicated for the treatment of congenital toxoplasmosis; pregnancy (at term); breastfeeding.
Concerns related to adverse effects:
• Blood dyscrasias: Fatalities associated with severe reactions including agranulocytosis, aplastic anemia and other blood dyscrasias have occurred; discontinue use at first sign of rash or signs of serious adverse reactions.
• Dermatologic reactions: Fatalities associated with severe reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis have occurred; discontinue use at first sign of rash.
• Hepatic necrosis: Fatalities associated with hepatic necrosis have occurred; discontinue use at first sign of rash.
• Sulfonamide (“sulfa”) allergy: Traditionally, concerns for cross-reactivity have extended to all compounds containing the sulfonamide structure (SO2NH2). An expanded understanding of allergic mechanisms indicates cross-reactivity between antibiotic sulfonamides and nonantibiotic sulfonamides may not occur, or at the very least this potential is extremely low (Brackett 2004; Johnson 2005; Slatore 2004; Tornero 2004). In particular, mechanisms of cross-reaction due to antibody production (anaphylaxis) are unlikely to occur with nonantibiotic sulfonamides and antibiotic sulfonamides. A nonantibiotic sulfonamide compound which contains the arylamine structure and therefore may cross-react with antibiotic sulfonamides is sulfasalazine (Zawodniak 2010). T-cell-mediated (type IV) reactions (eg, maculopapular rash) are less understood and it is not possible to completely exclude this potential based on current insights. In cases where prior reactions were severe (Stevens-Johnson syndrome/TEN), some clinicians choose to avoid exposure to these classes.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
Disease-related concerns:
• Allergies/asthma: Use with caution in patients with allergies or asthma.
• Glucose 6-phosphate dehydrogenase (G6PD) deficiency: Use with caution in patients with G6PD deficiency; hemolysis may occur.
• Hepatic impairment: Use with caution in patients with hepatic impairment.
• Renal impairment: Use with caution in patients with renal impairment. Maintain adequate hydration to prevent crystalluria.
Special populations:
• Neonates: Sulfa antibiotics have been shown to displace bilirubin from protein binding sites which may potentially lead to hyperbilirubinemia and kernicterus in neonates and young infants; do not use in neonates; avoid use in infants <2 months unless other options are not available.
Dosage form specific issues:
• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer's labeling.
Other warnings/precautions:
• Appropriate use: Not for the treatment of group A beta-hemolytic streptococcal infections.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Generic: 500 mg
Yes
Tablets (sulfADIAZINE Oral)
500 mg (per each): $20.04
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200 mg/mL Oral Suspension:
A 200 mg/mL oral suspension may be made with sulfadiazine powder and sterile water. Place 50 g sulfadiazine powder in a glass mortar. Add small portions of sterile water and mix to a uniform paste; mix while incrementally adding sterile water to almost 250 mL; transfer to a calibrated bottle, rinse mortar with sterile water, and add sufficient quantity of sterile water to make 250 mL. Label "shake well" and "refrigerate". Stable for 3 days refrigerated. Note: Suspension may also be prepared by crushing one-hundred 500 mg tablets; however, it is stable for only 2 days.
Oral: Administer with at least 8 ounces of water and around-the-clock to promote less variation in peak and trough serum levels.
Oral: Administer with at least 8 ounces of water and around-the-clock to promote less variation in peak and trough serum levels. Oral sodium bicarbonate may be used to alkalinize the urine of patients unable to maintain adequate fluid intake (in order to prevent crystalluria, azotemia, oliguria) (Lerner 1996).
Store at controlled room temperature of 20°C to 25°C (68°F to 77°F). Protect from light.
Adjunctive treatment in toxoplasmosis with pyrimethamine (FDA approved in ages ≥2 months and adults [may be used in ages <2 months for treatment of congenital toxoplasmosis]); prophylaxis of rheumatic fever in penicillin-allergic patient (FDA approved in ages ≥2 months and adults).
Although FDA approved for the following indications, sulfadiazine use has been replaced by other agents: Treatment of chancroid, trachoma, inclusion conjunctivitis, urinary tract infections, and nocardiosis (not first line), treatment and prophylaxis of meningococcal meningitis, treatment of Haemophilus influenzae meningitis, adjunctive treatment of uncomplicated attack of malaria due to chloroquine-resistant Plasmodium falciparum (FDA approved in ages ≥2 months and adults).
SulfADIAZINE may be confused with sulfaSALAzine
The Institute for Safe Medication Practices (ISMP) includes this medication (when used in pregnancy at term) among its list of drugs that have a heightened risk of causing significant patient harm when used in error.
KIDs List: Sulfonamides, when used in neonates, are identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list and should be avoided due to risk of kernicterus except sulfadiazine as adjunctive therapy with pyrimethamine as a treatment of congenital toxoplasmosis (weak recommendation; very low quality of evidence) (PPA [Meyers 2020]).
Substrate of CYP2C9 (minor), CYP2E1 (minor), CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Ajmaline: Sulfonamides may enhance the adverse/toxic effect of Ajmaline. Specifically, the risk for cholestasis may be increased. Risk C: Monitor therapy
Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Risk X: Avoid combination
Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Risk C: Monitor therapy
Androgens: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy
Antidiabetic Agents: May enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Risk C: Monitor therapy
Bacillus clausii: Antibiotics may diminish the therapeutic effect of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider therapy modification
BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: Monitor therapy
Chloroprocaine (Systemic): May diminish the therapeutic effect of Sulfonamide Antibiotics. Management: Avoid concurrent use of chloroprocaine and systemic sulfonamide-based antimicrobials whenever possible. Risk D: Consider therapy modification
Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid combination
CycloSPORINE (Systemic): Sulfonamide Antibiotics may enhance the nephrotoxic effect of CycloSPORINE (Systemic). Sulfonamide Antibiotics may decrease the serum concentration of CycloSPORINE (Systemic). Risk C: Monitor therapy
Dapsone (Topical): May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Risk C: Monitor therapy
Dexketoprofen: May enhance the adverse/toxic effect of Sulfonamides. Risk C: Monitor therapy
Fecal Microbiota (Live) (Oral): May diminish the therapeutic effect of Antibiotics. Risk X: Avoid combination
Fecal Microbiota (Live) (Rectal): Antibiotics may diminish the therapeutic effect of Fecal Microbiota (Live) (Rectal). Risk X: Avoid combination
Fosphenytoin-Phenytoin: SulfADIAZINE may increase the serum concentration of Fosphenytoin-Phenytoin. Risk C: Monitor therapy
Herbal Products with Glucose Lowering Effects: May enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Risk C: Monitor therapy
Hypoglycemia-Associated Agents: May enhance the hypoglycemic effect of other Hypoglycemia-Associated Agents. Risk C: Monitor therapy
Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor therapy
Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy
Local Anesthetics: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased. Risk C: Monitor therapy
Maitake: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy
Mecamylamine: Sulfonamides may enhance the adverse/toxic effect of Mecamylamine. Risk X: Avoid combination
Methenamine: May enhance the adverse/toxic effect of Sulfonamide Antibiotics. Specifically, the combination may result in the formation of an insoluble precipitate in the urine. Risk X: Avoid combination
Methotrexate: Sulfonamide Antibiotics may enhance the adverse/toxic effect of Methotrexate. Management: Consider avoiding concomitant use of methotrexate and therapeutic doses of sulfonamides (eg, trimethoprim/sulfamethoxazole). Patients receiving prophylactic doses of trimethoprim/sulfamethoxazole and methotrexate should be carefully monitored. Risk D: Consider therapy modification
Methoxsalen (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Methoxsalen (Systemic). Risk C: Monitor therapy
Monoamine Oxidase Inhibitors: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy
Nitric Oxide: May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Risk C: Monitor therapy
Pegvisomant: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy
Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Risk C: Monitor therapy
Potassium P-Aminobenzoate: May diminish the therapeutic effect of Sulfonamide Antibiotics. Risk X: Avoid combination
Prilocaine: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Prilocaine. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Management: Monitor patients for signs of methemoglobinemia (e.g., hypoxia, cyanosis) when prilocaine is used in combination with other agents associated with development of methemoglobinemia. Avoid lidocaine/prilocaine in infants receiving such agents. Risk C: Monitor therapy
Procaine: May diminish the therapeutic effect of Sulfonamide Antibiotics. Risk X: Avoid combination
Prothionamide: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy
Pyrimethamine: May enhance the adverse/toxic effect of Sulfonamide Antibiotics. Risk C: Monitor therapy
Quinolones: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Quinolones may diminish the therapeutic effect of Agents with Blood Glucose Lowering Effects. Specifically, if an agent is being used to treat diabetes, loss of blood sugar control may occur with quinolone use. Risk C: Monitor therapy
Salicylates: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy
Selective Serotonin Reuptake Inhibitors: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy
Sodium Nitrite: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Sodium Nitrite. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Risk C: Monitor therapy
Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider therapy modification
Sulfonylureas: Sulfonamide Antibiotics may enhance the hypoglycemic effect of Sulfonylureas. Risk C: Monitor therapy
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider therapy modification
Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Risk C: Monitor therapy
Vitamin K Antagonists (eg, warfarin): Sulfonamide Antibiotics may enhance the anticoagulant effect of Vitamin K Antagonists. Management: Consider reducing the vitamin K antagonist dose by 10% to 20% prior to starting the sulfonamide antibiotic. Monitor INR closely to further guide dosing. Risk D: Consider therapy modification
Vitamin C or acidifying agents (cranberry juice) may cause crystalluria. Management: Avoid large quantities of vitamin C or acidifying agents (cranberry juice).
Supplemental leucovorin calcium should be administered to reverse symptoms or prevent problems due to folic acid deficiency.
Sulfadiazine crosses the placenta (Speert 1943).
A systematic review of 8 studies (860 pregnancies) and 10 case reports did not find a consistent pattern of adverse fetal or neonatal outcomes following in utero exposure to sulfadiazine. Exposures during the first trimester was limited. Jaundice was reported in some infants; however, data were too limited to calculate a risk of progression to kernicterus in the newborn (Yu 2020).
Due to pregnancy-induced physiologic changes, some pharmacokinetic properties of sulfadiazine may be altered; serum levels may be decreased during pregnancy (Reiter-Owona 2020).
Sulfadiazine is recommended for use in pregnant patients to prevent Toxoplasmosis gondii infection of the fetus, and for the maternal treatment of T. gondii encephalitis (HHS [OI adult 2021]). Sulfadiazine is an alternative agent for the secondary prevention of rheumatic fever in pregnant patients; however, use is not recommended during the third trimester (AHA [Gerber 2009]).
Use with caution in patients with G6PD deficiency; hemolysis may occur. Due to the theoretical increased risk for hyperbilirubinemia and kernicterus, sulfadiazine is contraindicated by the manufacturer for use near term. Neonatal health care providers should be informed if maternal sulfonamide therapy is used near the time of delivery (HHS [OI adult 2021]).
CBC, renal function tests, urinalysis; signs of serious blood disorders (sore throat, fever, pallor, purpura, jaundice); CD4+ count in HIV-exposed/-positive patients treated for toxoplasmosis; observe for change in bowel frequency
Interferes with bacterial growth by inhibiting bacterial folic acid synthesis through competitive antagonism of PABA
Absorption: Well absorbed
Distribution: Throughout body tissues and fluids including pleural, peritoneal, synovial, and ocular fluids; throughout total body water; readily diffused into CSF
Protein binding: 38% to 48%
Metabolism: Via N-acetylation
Half-life elimination: 10 hours
Time to peak: Within 3-6 hours
Excretion: Urine (43% to 60% as unchanged drug, 15% to 40% as metabolites)
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