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Sulfadiazine (Sulfadiazine) - Summary



Sulfadiazine is an oral sulfonamide anti-bacterial agent. Each tablet, for oral administration, contains 500 mg sulfadiazine.

Sulfadiazine tablets are indicated in the following conditions:



Inclusion conjunctivitis


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: Escherichia 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.

Prophylaxis of meningococcal meningitis when sul fonamide-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 is not proved and may be harmful in closed population groups).

Meningococcal meningitis, when the organism has been demonstrated to be susceptible.

Acute otitis media due to Haemophilus influenzae, when used concomitantly with adequate doses of penicillin.

Prophylaxis against recurrences of rheumatic fever, as an alternative to penicillin.

H. influenzae meningitis, as adjunctive therapy with parental streptomycin.


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.

Currently, the increasing frequency of resistant organisms limits the usefulness of antibacterial agents, including the sulfonamides, especially in the treatment of recurrent and complicated urinary tract infections.

Wide variation in blood levels may result with identical doses. Blood levels should be measured in patients receiving sulfonamides for serious infections. Free sulfonamide blood levels of 5 to 15 mg per 100 mL may be considered therapeutically effective for most infections, and blood levels of 12 to 15 mg per 100 mL may be considered optimal for serious infections. Twenty mg per 100 mL should be the maximum total sulfonamide level, since adverse reactions occur more frequently above this level.

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Published Studies Related to Sulfadiazine

Topical silver sulfadiazine for the prevention of acute dermatitis during irradiation for breast cancer. [2011.10.19]
PURPOSE: This study aimed to evaluate the effectiveness of topical silver sulfadiazine (SSD) in preventing acute radiation dermatitis in women receiving radiotherapy for breast cancer... CONCLUSIONS: SSD cream reduced the severity of radiation-induced skin injury compared with general skin care alone. Further studies in patients with other types of cancer and also comparing SSD cream with other topical agents are warranted.

Randomized controlled single center study comparing a polyhexanide containing bio-cellulose dressing with silver sulfadiazine cream in partial-thickness dermal burns. [2011.08]
OBJECTIVE: A prospective, randomized, controlled single center study was designed to evaluate clinical efficacy of a polyhexanide containing bio-cellulose dressing (group B) compared to a silver-sulfadiazine cream (group A) in sixty partial-thickness burn patients... CONCLUSION: Group B demonstrated a better and faster pain reduction in the treated partial-thickness burns, compared to group A. The results indicate the polyhexanide containing bio-cellulose dressing to be a safe and cost effective treatment for partial-thickness burns. Copyright (c) 2011 Elsevier Ltd and ISBI. All rights reserved.

Prevalence of pin-site infection: the comparison between silver sulfadiazine and dry dressing among open tibial fracture patients. [2011.05]
CONCLUSION: There was no significant difference in prevalence of pin-site infection between both groups (p = 0.97). Therefore, either silver sulfadiazine or dry dressing could be advocated.

The efficacy of silver mesh dressing compared with silver sulfadiazine cream for the treatment of pressure ulcers. [2011.05]
CONCLUSION: Silver mesh dressings is one of the choices for pressure ulcer treatment with good healing rate, minimal care and lower overall cost.

Comparisons of the effects of biological membrane (amnion) and silver sulfadiazine in the management of burn wounds in children. [2011.03]
This prospective study was conducted on 102 children with second-degree thermal burns to assess qualitative differences between topical silver sulfadiazine (SD) and oven-dried, radiation-sterilized human amnion as wound dressing. The patients were divided into silver SD and amniotic membrane (AM) group by random sampling technique...

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Clinical Trials Related to Sulfadiazine

An Open, Randomized, Multi-centre Investigation With Mepilex Ag Versus Silver Sulfadiazine in the Treatment of Deep Partial Thickness Burn Injuries. [Recruiting]
The purpose is to compare time to healing using absorbent foam silver dressing (Mepilex Ag) compared to a silver sulfadiazine (SSD) 1% cream in the treatment of partial thickness burn injuries. 284 in-patients in 8-12 centres in China will be evaluated. Treatment period will be up to 4 weeks with either Mepilex Ag or SSD.

SSD vs Collagenase in Pediatric Burn Patients [Recruiting]
The objective of this study is to evaluate the outcomes of children with burn injury with regard to the utilization of Silver sulfadiazine (SSD) cream and Collagenase ointment. The primary outcome variable will be need for skin grafting. The specific aim of the study is to prospectively collect data to determine if SSD is superior to Collagenase with regard to avoiding the need for skin grafting.

Prevention of Congenital Toxoplasmosis With Pyrimethamine + Sulfadiazine Versus Spiramycine During Pregnancy [Recruiting]
Background : When a mother contracts toxoplasmosis during pregnancy, the parasite may be transmitted from to her unborn child. This results in congenital toxoplasmosis, which may cause damage to the eyes and nervous system of the child. To date, no method has been proved effective to prevent this transmission. In France, spiramycin is usually prescribed to women who have toxoplasma seroconversion in pregnancy, however its efficacy has not been determined. The standard treatment for toxoplasmosis is the combination of the antiparasitic drugs pyrimethamine and sulfadiazine, but this strategy has not been evaluated for the prevention of mother-to-child transmission. Purpose : Randomized phase 3 trial to determine whether pyrimethamine + sulfadiazine is more effective than spiramycin to prevent congenital toxoplasmosis.

Pyrimethamine, Sulfadiazine, and Leucovorin in Treating Patients With Congenital Toxoplasmosis [Recruiting]
RATIONALE: Congenital toxoplasmosis is an infection caused by the parasitic organism Toxoplasma gondii, and it may be passed from an infected mother to her unborn child. The mother may have mild symptoms or no symptoms; the fetus, however, may experience damage to the eyes, nervous system, skin, and ears. The newborn may have a low birth weight, enlarged liver and spleen, jaundice, anemia, petechiae, and eye damage. Giving the antiparasitic drugs pyrimethamine and sulfadiazine is standard treatment for congenital toxoplasmosis, but it is not yet known which regimen of pyrimethamine is most effective for the disease. PURPOSE: Randomized phase IV trial to determine which regimen of pyrimethamine is most effective when combined with sulfadiazine and leucovorin in treating patients who have congenital toxoplasmosis.

Evaluation of Phage Therapy for the Treatment of Escherichia Coli and Pseudomonas Aeruginosa Wound Infections in Burned Patients [Not yet recruiting]
The objective of PHAGOBURN is to assess tolerance and efficacy of local bacteriophage treatment of E. coli or P. aeruginosa wound infections in burned patients.

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Reports of Suspected Sulfadiazine Side Effects

Fall (10)Stevens-Johnson Syndrome (10)Drug Rash With Eosinophilia and Systemic Symptoms (10)Hyperhidrosis (9)Loss of Consciousness (9)Gastric Ulcer Haemorrhage (9)Drug Hypersensitivity (6)Renal Failure (6)Cytolytic Hepatitis (5)Myocarditis (4)more >>

Page last updated: 2011-12-09

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