Monograph: |
BLEPH
BLEPH IS A SULPHONAMIDE, HAS BEEN LIMITED BY THE INCREASING INCIDENCE OF RESISTANT
ORGANISMS. BLEPH HAS A BROAD SPECTRUM OF ACTION, BUT THE DEVELOPMENT OF WIDESPREAD
RESISTANCE HAS GREATLY REDUCED THEIR USEFULNESS, AND SUSCEPTIBILITY OFTEN VARIES
WIDELY EVEN AMONG NOMINALLY SENSITIVE PATHOGENS.
THE PROPERTIES ARE SAME AS SULPHACETAMIDE SOD., SO SEE BELOW AT SULPHACETAMIDE SOD
RECORD FOR THE DETAILS.
SULPHACETAMIDE SOD. :
CONTRAINDICATIONS
Sulfacet-R Lotion is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur, or any other component of this preparation. Sulfacet-R Lotion is not to be used by patients with kidney disease.
WARNINGS
Although rare, sensitivity to sodium sulfacetamide may occur. Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice, and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraded skin are involved.
Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
PRECAUTIONS
General: If irritation develops, use of the product should be discontinued and appropriate therapy instituted. For external use only. Keep away from eyes. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. The object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of epidermis. These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility. Keep out of the reach of children.
Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term studies in animals have not been performed to evaluate carcinogenic potential.
Pregnancy: Category C. Animal reproduction studies have not been conducted with Sulfacet-R Lotion. It is also not known whether Sulfacet-R Lotion can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sulfacet-R Lotion should be given to a pregnant woman only if clearly needed.
Nursing Mothers: It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of Sulfacet-R Lotion. However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when Sulfacet-R Lotion is administered to a nursing woman.
Pediatric Use: Safety and effectiveness in pediatric patients under the age of 12 have not been established.
ADVERSE REACTIONS
Although rare, sodium sulfacetamide may cause local irritation.
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