Trospium Chloride Tablets

Name: Trospium Chloride Tablets

How supplied

Dosage Forms And Strengths

SANCTURA® is supplied as 20 mg tablets (brownish yellow, biconvex, glossy coated tablets printed with S in black ink).

Storage And Handling

SANCTURA® tablets 20 mg (brownish yellow, biconvex, glossy coated tablets printed with S in black ink) are supplied as follows: 60 count HDPE bottle -NDC 0023-3513-60

Store at controlled room temperature 20° -25°C (68° -77°F) (see USP).

Manufactured for: Allergan, Inc. Irvine, CA 92612, U.S.A. Manufactured by: Madaus GmbH Troisdorf, Germany. Revised: 07/2012

Warnings

Included as part of the PRECAUTIONS section.

Clinical pharmacology

Mechanism of Action

SANCTURA® is a muscarinic antagonist.

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.

Pharmacodynamics

Placebo-controlled studies employing urodynamic variables were conducted in patients with conditions characterized by involuntary detrusor contractions. The results demonstrate that SANCTURA® increases maximum cystometric bladder capacity and volume at first detrusor contraction.

Electrophysiology

The effect of 20 mg twice daily and up to 100 mg twice daily SANCTURA® on QT interval was evaluated in a single-blind, randomized, placebo and active (moxifloxacin 400 mg once daily) controlled 5 day parallel trial in 170 male and female healthy volunteer subjects aged 18 to 45 years. The QT interval was measured over a 24-hour period at steady state. The 100 mg twice daily dose of SANCTURA® was chosen because this achieves the Cmax expected in severe renal impairment. SANCTURA® was not associated with an increase in individual corrected (QTcI) or Fridericia corrected (QTcF) QT interval at any time during steady state measurement, while moxifloxacin was associated with a 6.4 msec increase in QTcF.

In this study, asymptomatic, non-specific T wave inversions were observed more often in subjects receiving SANCTURA® than in subjects receiving moxifloxacin or placebo following five days of treatment. This finding was not observed during routine safety monitoring in 2 other placebo-controlled clinical trials in 591 SANCTURA® treated overactive bladder patients [see Clinical Studies]. The clinical significance of T wave inversion in this study is unknown. SANCTURA® is associated with an increase in heart rate that correlates with increasing plasma concentrations. In the study described above, SANCTURA® demonstrated a mean increase in heart rate compared to placebo of 9.1 bpm for the 20 mg dose and of 18 bpm for the 100 mg dose. In the two U.S. placebo-controlled trials in patients with overactive bladder, the mean increase in heart rate compared to placebo in Study 1 was observed to be 3 bpm and in Study 2 was 4 bpm.

Pharmacokinetics

Absorption

After oral administration, less than 10% of the dose is absorbed. Mean absolute bioavailability of a 20 mg dose is 9.6% (range: 4-16.1%). Peak plasma concentrations (Cmax) occur between 5 to 6 hours post-dose. Mean Cmax increases greater than dose-proportionally; a 3-fold and 4-fold increase in Cmax was observed for dose increases from 20 mg to 40 mg and from 20 mg to 60 mg, respectively. AUC exhibits dose linearity for single doses up to 60 mg. SANCTURA® exhibits diurnal variability in exposure with a decrease in Cmax and AUC of up to 59% and 33%, respectively, for evening relative to morning doses.

Effect of Food

Administration with a high (50%) fat-content meal resulted in reduced absorption, with AUC and Cmax values 70-80% lower than those obtained when SANCTURA® was administered while fasting. Therefore, it is recommended that SANCTURA® should be taken at least one hour prior to meals or on an empty stomach [see DOSAGE AND ADMINISTRATION].

A summary of mean (± standard deviation) pharmacokinetic parameters for a single 20 mg dose of SANCTURA® is provided in Table 2.

Table 2: Mean (± SD) Pharmacokinetic Parameter Estimates for a Single 20 mg SANCTURA® Dose in Healthy Volunteers

Cmax (ng/mL) AUC0-∞ (ng/mL•hr) Tmax (hr) t½ (hr)
3.5 ± 4.0 36.4 ± 21.8

Patient information

SANCTURA®
[SANK-TOUR-AH]
(trospium chloride) tablets

Read the Patient Information that comes with SANCTURA® before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment.

What is SANCTURA®?

SANCTURA® is a prescription medicine used to treat adults with overactive bladder who have the following symptoms:

  • a strong need to urinate right away;
  • leaking or wetting accidents due to a strong need to urinate right away;
  • a need to urinate often.

Who should not take SANCTURA®?

Do not take SANCTURA® if you:

  • have trouble emptying your bladder;
  • have delayed or slow emptying of your stomach;
  • have an eye problem called “uncontrolled narrow-angle glaucoma”;
  • are allergic to SANCTURA® or any of its ingredients. See the end of this leaflet for a complete list of ingredients.

SANCTURA® has not been studied in children under the age of 18 years.

What should I tell my doctor before starting SANCTURA®?

Tell your doctor about all of your medical conditions including if you:

  • have any stomach or intestinal problems or problems with constipation;
  • have trouble emptying your bladder or have a weak urine stream;
  • have an eye problem called narrow-angle glaucoma;
  • have kidney problems;
  • have liver problems;
  • are pregnant or planning to become pregnant. It is not known if SANCTURA® can harm your unborn baby.
  • are breastfeeding. It is not known if SANCTURA® passes into breast milk and if it can harm your baby. You should talk to your doctor about the best way to feed your baby if you are taking SANCTURA®.

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. SANCTURA® and certain other medicines can interact and make some side effects worse. SANCTURA® can affect how other medicines are handled by the body.

Know all the medicines you take. Keep a list of them with you to show your doctor and pharmacist each time you get a new medicine.

How should I take SANCTURA®?

Take SANCTURA® exactly as prescribed.

  • Take one SANCTURA® tablet twice daily with water.
  • Take SANCTURA® on an empty stomach or at least 1 hour before a meal.
  • If you take too much SANCTURA®, call your local Poison Control Center or go to an emergency room right away.

What are the possible side effects of SANCTURA®?

SANCTURA® may cause allergic reactions that may be serious. Symptoms of a serious allergic reaction may include swelling of the face, lips, throat or tongue. If you experience these symptoms, you should stop taking SANCTURA® and get emergency medical help right away.

The most common side effects with SANCTURA® are:

  • dry mouth;
  • constipation;
  • headache.

SANCTURA® may cause other less common side effects, including:

  • trouble emptying the bladder;
  • blurred vision; and drowsiness. Do not drive or operate heavy machinery until you know how SANCTURA® affects you. Alcohol can worsen the drowsiness caused by drugs such as SANCTURA®.
  • heat prostration. Due to decreased sweating, heat prostration can occur when drugs such as SANCTURA® are used in a hot environment.

Tell your doctor if you have any side effects that bother you or that do not go away.

These are not all possible side effects of SANCTURA®. For more information, ask your doctor, healthcare professional or pharmacist.

How should I store SANCTURA®?

  • Keep SANCTURA® and all other medicines out of the reach of children.
  • Store SANCTURA® at room temperature, 68° to 77°F (20° to 25°C).
  • Safely dispose of SANCTURA® tablets that are out of date or that you no longer need.

General information about SANCTURA®

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use SANCTURA® for a condition for which it was not prescribed. Do not give SANCTURA® to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about SANCTURA®. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about SANCTURA® that is written for health professionals. You can also call Allergan's product information department at 1-800433-8871.

What are the ingredients in SANCTURA®?

Active Ingredient: trospium chloride.

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.

What happens if i miss a dose (sanctura, sanctura xr)?

Take the missed dose 1 hour before your next meal. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Side effects

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The safety of SANCTURA® was evaluated in 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, 12-week, 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 twice daily and 1.5% among patients receiving placebo. Table 1 lists adverse reactions from the combined 12-week U.S. safety and efficacy trials were reported by at least 1% of patients, and were reported more frequently in the SANCTURA® group than in the placebo group.

The two most common adverse reactions reported by patients receiving SANCTURA® 20 mg twice daily were dry mouth and constipation. The single most frequently reported adverse reaction for SANCTURA®, dry mouth, occurred in 20.1% of SANCTURA® treated patients and 5.8% of patients receiving placebo. In the two U.S. studies, dry mouth led to discontinuation in 1.9% of patients treated with SANCTURA® 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.

Table 1: Incidence (%) of adverse reactions with SANCTURA®, reported in greater than or equal to 1% of all patients treated with SANCTURA® and more frequent with SANCTURA® (20 mg twice daily) than placebo in Studies 1 and 2 combined

Adverse Reaction Placebo
(N=590) 		SANCTURA® 20 mg twice daily
(N=591)
Gastrointestinal Disorders
  Dry mouth 34 ( 5.8)
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