Sanctura Information
Sanctura (Trospium chloride) Description
Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. The compound's solubility in water is approximately 1 g/2 mL.
Each
tablet contains 20 mg of trospium chloride and is to be given orally. Each tablet also contains the following inactive ingredients: sucrose, wheat starch, microcrystalline cellulose, talc, lactose monohydrate, calcium carbonate, titanium dioxide, stearic acid, croscarmellose sodium, povidone, polyethylene glycol 8000, colloidal silicon dioxide, ferric oxide, carboxymethylcellulose sodium, white wax, magnesium stearate, and carnauba wax.
Sanctura (Trospium chloride) Clinical Pharmacology
Trospium chloride antagonizes the effect of acetylcholine on muscarinic receptors in cholinergically innervated organs including the bladder. Its parasympatholytic action reduces the tonus of smooth muscle in the bladder. Receptor assays showed that trospium chloride has negligible affinity for nicotinic receptors as compared to muscarinic receptors at concentrations obtained from therapeutic doses.
Sanctura (Trospium chloride) Indications And Usage
Sanctura (Trospium chloride)
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Sanctura (Trospium chloride) Warnings
Angioedema of the face, lips, tongue, and/or larynx has been reported with trospium chloride. In one case, angioedema occurred after the first dose. Angioedema associated with upper airway swelling may be life threatening. If involvement of the tongue, hypopharynx, or larynx occurs, trospium chloride should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided.
Sanctura (Trospium chloride) Precautions
Patients should be informed that trospium chloride may produce angioedema which could result in life-threatening airway obstruction. Patients should be advised to promptly discontinue trospium chloride and seek immediate medical attention if they experience edema of the tongue, edema of the laryngopharynx, or difficulty breathing.
Patients should be informed that anticholinergic agents, such as
, may produce clinically significant adverse effects related to anticholinergic pharmacological activity. For example, heat prostration (fever and heat stroke due to decreased sweating) can occur when anticholinergics such as
are used in a hot environment. Because anticholinergics such as
may also produce dizziness or blurred vision, patients should be advised to exercise caution. Patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents.
Sanctura (Trospium chloride)
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The concomitant use of
with other antimuscarinic agents that produce dry mouth, constipation, and other anticholinergic pharmacological effects may increase the frequency and/or severity of such effects.
may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility.
Concomitant use of
and digoxin did not affect the pharmacokinetics of either drug.
Carcinogenicity studies with trospium chloride were conducted in mice and rats for 78 weeks and 104 weeks, respectively, at maximally tolerated doses. No evidence of a carcinogenic effect was found in either mice or rats administered up to 200 mg/kg/day, approximately 9 times the expected clinical exposure levels at the maximum recommended human dose (MRHD) of 40 mg.
Trospium chloride was not mutagenic nor genotoxic in tests in vitro in bacteria (Ames test) and mammalian cells (L5178Y mouse lymphoma and CHO cells) or in the rat micronucleus test.
No evidence of impaired fertility was observed in rats administered doses up to 200 mg/kg/day (about 16 times the expected clinical exposure at the MRHD, based on AUC).
Of the 591 patients with overactive bladder who received treatment with
in the two U.S., placebo-controlled, efficacy and safety studies, 249 patients (42%) were 65 years of age and older. Eighty-eight
treated patients (15%) were greater than or equal to 75 years of age.
In these 2 studies, the incidence of commonly reported anticholinergic adverse events in patients treated with
(including dry mouth, constipation, dyspepsia, UTI, and urinary retention) was higher in patients 75 years of age and older as compared to younger patients. This effect may be related to an enhanced sensitivity to anticholinergic agents in this patient population (see and ). Therefore, based upon tolerability, the dose frequency of
may be reduced to 20 mg once daily in patients 75 years of age and older.
Sanctura (Trospium chloride) Adverse Reactions
The safety of
was evaluated in Phase 2 and 3 controlled clinical trials in a total of 2975 patients, who were treated with
(N=1673), placebo (N=1056) or active control medications (N=246). Of this total, 1181 patients participated in two, 12-week, Phase 3, U.S., efficacy and safety studies and a 9-month open-label extension. Of this total, 591 patients received
20 mg twice daily. In all controlled trials combined, 232 and 208 patients received treatment with
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
20 mg twice daily 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
or placebo, respectively, by the investigator.
The two most common adverse events reported by patients receiving
20 mg twice daily were dry mouth and constipation. The single most frequently reported adverse event for
, dry mouth, occurred in 20.1% of
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
20 mg twice daily. 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
by the investigator, occurring in greater than or equal to 0.5% of
treated patients, and more common with
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.
Sanctura (Trospium chloride) Dosage And Administration
The recommended dose is 20 mg twice daily.
should be dosed at least one hour before meals or given on an empty stomach.
Dosage modification is recommended in the following patient populations:
Sanctura (Trospium chloride) How Supplied
Store at controlled room temperature 20° to 25°C (68° to 77°F) (see USP).
Rx only
Manufactured for:Allergan, Inc.Irvine, CA92612
Manufactured by:Madaus GmbHTroisdorf, Germany
Address Medical Inquiries to:1-800-433-8871
© 2011 Allergan, Inc., Irvine, CA 92612, U.S.A.® marks owned by Allergan, Inc.
72157US12C
Sanctura (Trospium chloride)
