"The cystic fibrosis (CF) drug Orkambi (Vertex Pharmaceuticals) has received a green light from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
Orkambi is a fixed-dose oral combination "...
(Generic versions may still be available.)
Because sulfonamides may be absorbed from the vaginal mucosa, the usual precautions for oral sulfonamides apply. Patients should be observed for skin rash or evidence of systemic toxicity, and if these develop, the medications should be discontinued.
Laboratory tests: Standard office diagnostic procedures for vaginitis are usually sufficient to establish the diagnosis of Haemophilus (Gardnerella) vaginalis and to rule out a trichomonal or monilial infection. These include noting a fish-like odor upon addition of 10% KOH to vaginal discharge and microscopic identification of "clue cells" in a wet mount preparation. If cultures are obtained, care must be taken to use appropriate media and methods for Haemophilus (Gardnerella) vaginalis.
Carcinogenesis, mutagenesis, impairment of fertility: The sulfonamides bear certain chemical similarities to some goitrogens. Rats appear to be especially susceptible to the goitrogenic effects of sulfonamides, and long-term administration has produced thyroid malignancies in this species.
Teratogenic Effects: Pregnancy Category C: The safe use of sulfonamides in pregnancy has not been established. The teratogenicity potential of most sulfonamides has not been thoroughly investigated in either animals or humans. However, a significant increase in the incidence of cleft palate and other bony abnormalities of offspring has been observed when certain sulfonamides of the short, intermediate and long-acting types were given to pregnant rats and mice at high oral doses (7 to 25 times the human therapeutic dose).
Nursing Mothers: Because of the potential for serious adverse reactions in nursing infants from SULTRIN (sulfathiazole, sulfacetamide and sulfabenzamide) , a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. See CONTRAINDICATIONS .
Pediatric use: Safety and effectiveness in children have not been established.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/8/2004
Additional Sultrin Information
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