Sulfadiazine (Sulfadiazine) - Summary

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:

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: 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.

IMPORTANT NOTES

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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NEWS HIGHLIGHTS

Published Studies Related to Sulfadiazine

Double-lumen central venous catheters impregnated with chlorhexidine and silver sulfadiazine to prevent catheter colonisation in the intensive care unit setting: a prospective randomised study. [2009.07]
Antimicrobial- and antiseptic-impregnated catheters are strategies recommended to prevent central venous catheter (CVC) colonisation. Few data regarding chlorhexidine/silver sulfadiazine-impregnated catheters in intensive care unit (ICU) patients have been reported... Double-lumen CVCs impregnated with chlorhexidine and silver sulfadiazine were not effective in reducing the incidence of catheter colonisation in ICU patients.

Randomized clinical study of SilvaSorb gel in comparison to Silvadene silver sulfadiazine cream in the management of partial-thickness burns. [2009.03]
This prospective, randomized study assessed the clinical, microbiological, and patient comfort characteristics of two silver-based topical agents in the management of partial-thickness burn wounds. Pediatric patients were randomly assigned to treatment with either SilvaSorb Gel (Medline Industries, Munedelein, IL) or Silvadene silver sulfadiazine cream (King Pharmaceuticals, Bristol, TN) for up to 21 days or to the point of full reepithelialization of the wound...

Aloe versus silver sulfadiazine creams for second-degree burns: a randomized controlled study. [2009]
PURPOSE: Burn injury is associated with a high incidence of death and disability; yet its management remains problematic and costly. We conducted this clinical study to evaluate the efficacy of aloe vera cream for partial thickness burn wounds and compare its results with those of silver sulfadiazine (SSD)... CONCLUSION: These results clearly demonstrated the greater efficacy of aloe cream over SSD cream for treating second-degree burns.

Antimicrobial-coated endotracheal tubes: an experimental study. [2008.06]
OBJECTIVE: Antibiotic-resistant bacterial biofilm may quickly form on endotracheal tubes (ETTs) and can enter the lungs, potentially causing pneumonia. In an attempt to prevent bacterial colonization, we developed and tested in an in-vitro study and animal study several antibacterial-coated ETTs (silver sulfadiazine with and without carbon in polyurethane, silver sulfadiazine and chlorhexidine with and without carbon in polyurethane, silver-platinum with and without carbon in polyurethane, chlorhexidine in polyurethane, and rose bengal for UV light)... CONCLUSION: This study describes several effective and durable antibacterial coatings for ETTs. Particularly, SSD-ETT showed prevention against P. aeruginosa biofilm formation in a 72-h in-vitro study and lower respiratory tract colonization in sheep mechanically ventilated for 24[Symbol: see text]h.

Randomized controlled trial of pyrimethamine plus sulfadiazine versus trimethoprim plus sulfamethoxazole for treatment of toxoplasmic encephalitis in AIDS patients. [2008.03]
Background: Toxoplasmic encephalitis (TE), caused by Toxoplasma gondii, is common in AIDS patients... Conclusions: Available data suggest that of the currently available options, treatment of TE with pyrimethamine at 50 mg/day plus sulfadiazidine at 4 g/day provides the best primary outcome for AIDS patients with TE; however, because this study was terminated prematurely, we suggest that treatment with intravenous TMP-SMX be further evaluated to determine its efficacy.

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Clinical Trials Related to Sulfadiazine

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.

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.

Topical Collagen-Silver Versus Standard Care Following Removal of Ingrown Nails [Recruiting]
This study's purpose is to prospectively determine whether topical therapy with an oxidized regenerated cellulose collagen-silver compound is more effective than the current standard of topical antibiotic therapy for care following the removal of an ingrown toenail. Eighty adult patients with ingrown toenails will be recruited. Each patient will randomly be assigned to apply either topical silver sulfadiazine cream (standard antibiotic) or the novel collagen-silver compound to their nail bed daily, following removal of the ingrown portion of nail. Patients will return for follow up visits weekly, until healing has occurred or twelve weeks have passed. Healing will be defined as resolution of drainage and inflammatory changes surrounding the nail border.

Evaluating the Cost-Effectiveness, Efficacy, Safety and Tolerance of Mepilex® Ag Versus Silvadene® in the Treatment of Partial Thickness Burns. [Recruiting]

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