FDA Approves Sanctura for Overactive Bladder
The Food and Drug Administration (FDA) last week approved the marketing of trospium chloride oral tablets for the treatment of overactive bladder with symptoms of urge incontinence, urgency, and urinary frequency.
Lexington, Mass.-based Indevus Pharmaceuticals announced that the product, Sanctura, will be available from Odyssey Pharmaceuticals Inc., a subsidiary of the Croatian pharmaceutical company Pliva Inc. According to Indevus, trospium should be available in pharmacies by this fall.
Trospium's FDA-approved labeling (PDF) describes the product as an acetylcholine antagonist that acts on muscarinic receptors and relaxes smooth muscle in the bladder.
The recommended starting dosage for trospium is 20 mg taken twice daily on an empty stomach or one hour before meals. For patients with severe kidney impairment, the dosage should be reduced to 20 mg taken once daily at bedtime. The once-daily regimen is also recommended for patients age 75 years or older who do not tolerate the standard twice-daily treatment.
Trospium is contraindicated in patients with urinary or gastric retention or uncontrolled narrow-angle glaucoma or who are at risk for these conditions, according to the labeling.
In clinical trials, about 20 percent of trospium users reported dry mouth, compared with 6 percent who received a placebo. Some 10 percent of patients who took trospium and 5 percent who received placebo became constipated.
Patients who are prescribed trospium should be alert for adverse events associated with anticholinergic drugs, including increased susceptibility to heat prostration during hot weather, according to the product's labeling. Other adverse events associated with anticholinergic agents include dizziness and blurred vision, which may be exacerbated by alcohol use.
Trospium tablets will be supplied in 60- or 500-count bottles and polyvinyl chloride (PVC) or PVC with Aclar film paper-backed foil blister packs with 14 tablets each.