FDA Approvals 2006

January 1, 2007

Trospium chloride (Sanctura) recentlybecame available for the treatmentof overactive bladder and urge urinaryincontinence. This drug, fromIndevus Pharmaceuticals, is a muscarinicreceptor antagonist that relaxesthe smooth muscle tissue of thebladder, thereby decreasing contractionsand counteracting overactive orunstable detrusor muscle function.

New Medication forUrinary Incontinence/Overactive Bladder
Trospium chloride (Sanctura) recentlybecame available for the treatmentof overactive bladder and urge urinaryincontinence. This drug, fromIndevus Pharmaceuticals, is a muscarinicreceptor antagonist that relaxesthe smooth muscle tissue of thebladder, thereby decreasing contractionsand counteracting overactive orunstable detrusor muscle function.The recommended dosage isone 20-mg tablet bid. The drug iscontraindicated in patients with urinaryor gastric retention or uncontrollednarrow-angle glaucoma--andin patients at risk for these conditions.The most common side effectsare dry mouth, constipation, andheadacheIntestinal Parasites
Tinidazole (Tindamax), from PresuttiLaboratories, Inc., has been approvedfor treatment of trichomoniasis, giardiasis,intestinal amebiasis, and amebicliver abscess. A single 2-g doseis recommended for patients with trichomoniasisor giardiasis; in amebicdysentery, the recommended dosageis 2 g/d for 3 days. Patients with amebicabscess from amebic hepatitis require2 g/d for 3 to 5 days.Contraindications are similar tothose for metronidazole. The safety ofthis medication during pregnancy hasyet to be established. Patients shouldnot consume alcohol within 72 hoursof their final dose of tinidazole.Traveler's Diarrhea
The FDA has approved rifaximin(Xifaxan), from Salix Pharmaceuticals,Inc., for treatment of traveler'sdiarrhea caused by noninvasive strains of Escherichia coli. Rifaximinis a nonsystemic, GI-selective, oralantibiotic; the recommended dosageis 200 mg tid for 3 days.Rifaximin is not effective in patientswith diarrhea complicated byfever and/or blood in the stool or diarrheacaused by pathogens otherthan E coli. The medication should bediscontinued if diarrhea symptomsintensify or persist for longer than 24to 48 hours: in this setting, alternativeantibiotic treatments should be considered.The most common side effectsare flatulence, headache, abdominalpain, and tenesmus.New Agent CombatsRespiratory Tract Infection
Telithromycin (Ketek) from AventisPharmaceuticals Inc., is now availableto treat acute exacerbations of chronicbronchitis, acute bacterial sinusitis,and mild to moderately severe community-acquired RTI--includingthose caused by multidrug-resistantStreptococcus pneumoniae. Telithromycin,the first available ketolide, selectivelytargets common respiratorybacteria without significant effects onbacteria not normally associated withRTIs.The recommended dosage is800 mg/d. Telithromycin is not approvedfor those younger than 18years. The most common side effectsare diarrhea, nausea, headache, dizziness,and vomiting.Osteoporosis Prophylaxis
The FDA has approved the use ofan estradiol transdermal system(Menostar), from Berlex LaboratoriesInc., to prevent osteoporosis in postmenopausalwomen. The hormoneis impregnated in a dime-sized, oncea-week patch that delivers 14 g/d ofestradiol: this dosage is half that ofother currently available transdermalestrogen patches. No supplementaryprogestin therapy is generally needed.This product can be prescribed for women who are without a uterus.The most common side effects areirritation at the patch site, joint pain,and leukorrhea.Vasomotor Symptomsof Menopause
The FDA has approved a new syntheticconjugated estrogen formulation(Enjuvia), from Duramed Pharmaceuticals,for the management ofmenopausal vasomotor symptoms.This product is the only plant-derivedsynthetic conjugated estrogen compoundthat includes the componentdelta 8,9-dehydroestrone--an activeestrogenic compound.Clinical studies demonstrate thatthis formulation can reduce the frequencyand severity of hot flashes inmenopausal women. Although dosesas low as 0.3 mg have been reportedto be effective, the FDA has approvedthis product for use in doses of 0.625and 1.25 mg; it is often prescribed inconjunction with a progestin.