Sanctura Side Effects, and Drug Interactions - Trospium

Sanctura Side Effects, and Drug Interactions - Trospium

SIDE EFFECTS

The safety of Sanctura was evaluated in Phase 2 and 3 controlled clinical trials in a total of 2975 patients, who were treated with Sanctura (N=1673), placebo (N=1056) or active control medications (N=246). Of this total, 1181 patients participated in two, twelve-week, Phase 3, U.S., efficacy and safety studies and a 9-month open-label extension. Of this total, 591 patients received Sanctura 20 mg twice daily. In all controlled trials combined, 232 and 208 patients received treatment with Sanctura for at least 24 and 52 weeks, respectively.

In all placebo-controlled trials combined, the incidence of serious adverse events was 2.9% among patients receiving Sanctura 20 mg BID and 1.5% among patients receiving placebo. Of these, 0.2% and 0.3% were judged to be at least possibly related to treatment with Sanctura or placebo, respectively, by the investigator.

Table 4 lists treatment emergent adverse events from the combined 12-week U.S. safety and efficacy trials that were judged to be at least possibly related to treatment with Sanctura by the investigator, were reported by at least 1% of patients, and were reported more frequently in the Sanctura group than in the placebo group.

The 2 most common adverse events reported by patients receiving Sanctura 20 mg BID were dry mouth and constipation. The single most frequently reported adverse event for Sanctura, dry mouth, occurred in 20.1% of Sanctura treated patients and 5.8% of patients receiving placebo. In the two Phase 3 U.S. studies, dry mouth led to discontinuation in 1.9% of patients treated with Sanctura 20 mg BID. For the patients who reported dry mouth, most had their first occurrence of the event within the first month of treatment.

Other adverse events from the Phase 3, U.S., placebo-controlled trials judged possibly related to treatment with Sanctura by the investigator, occurring in 0.5% of Sanctura-treated patients, and more common with Sanctura than placebo are: tachycardia NOS, vision blurred, abdominal distension, vomiting NOS, dysgeusia, dry throat, and dry skin.

During controlled clinical studies, one event of angioneurotic edema was reported.

Additional spontaneous adverse events, regardless of relationship to drug, reported from marketing experience with trospium chloride include: gastritis, palpitations, supraventricular tachycardia, chest pain, Stevens-Johnson syndrome, anaphylactic reaction, syncope, rhabdomyolysis, vision abnormal, hallucinations and delirium, and "hypertensive crisis".

The concomitant use of Sanctura with other anticholinergic agents that produce dry mouth, constipation, and other anticholinergic pharmacological effects may increase the frequency and/or severity of such effects. Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility.

Drugs Eliminated by Active Tubular Secretion: Although studies to assess drug-drug interactions with Sanctura have not been conducted, Sanctura has the potential for pharmacokinetic interactions with other drugs that are eliminated by active tubular secretion (e.g. digoxin, procainamide, pancuronium, morphine, vancomycin, metformin and tenofovir). Coadministration of Sanctura with drugs that are eliminated by active renal tubular secretion may increase the serum concentration of Sanctura and/or the coadministered drug due to competition for this elimination pathway. Careful patient monitoring is recommended in patients receiving such drugs (See CLINICAL PHARMACOLOGY: Excretion, and CLINICAL PHARMACOLOGY: Drug-Drug Interactions).

Interactions between Sanctura and laboratory tests have not been studied.