Drugs Details

Drugs Info of Sanctura, Sanctura XR
Drugs Details
  • Drugs Type  : Multum
  • Date : 27th Mar 2015 04:08 am
  • Brand Name : Sanctura, Sanctura XR
  • Generic Name : trospium (Pronunciation: tros PEE um)
Descriptions

SANCTURA® (trospium chloride) is a quaternary ammonium compound with the chemical name of Spiro [8azoniabicyclo[3.2.1]octane-8,1'-pyrrolidinium], 3-[(hydroxydiphenylacetyl)oxy]-, chloride, (1α, 3β, 5α). The empirical formula of trospium chloride is C25H30ClNO3 and its molecular weight is 427.97. The structural formula of trospium chloride is represented below:

 

SANCTURA® (trospium chloride) Structural Formula Illustration

 

Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. The compound's solubility in water is approximately 1 g per 2 mL.

Each SANCTURA® tablet contains 20 mg of trospium chloride, a muscarinic antagonist, for oral administration. 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.

 

What are the possible side effects of trospium (Sanctura, Sanctura XR)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using trospium and call your doctor at once if you have a serious side effect such as:

  • severe stomach pain or bloating;
  • severe constipation;
  • urinating less than usual or not at all; or
  • confusion, hallucinations.

Less serious side effects may include:

  • dry mouth or throat;
  • headache;
  • mild constipation;
  • upset stomach,...

Read All Potential Side Effects and See Pictures of Sanctura »

What are the precautions when taking trospium chloride tablets (Sanctura)?

Before taking trospium, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain type of glaucoma (uncontrolled narrow-angle type), inability to urinate (urinary retention), delayed or slow emptying of your stomach.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, constipation, other stomach conditions (such as ulcerative colitis, intestinal atony), myasthenia...

Read All Potential Precautions of Sanctura »

 

This monograph has been modified to include the generic and brand name in many instances.

Indications

SANCTURA® is a muscarinic antagonist indicated for the treatment ofoveractive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Dosage Administration

The recommended dose is 20 mg twice daily. SANCTURA® should be dosed at least one hour before meals or given on an empty stomach.

Dosage modification is recommended in the following patient populations:

  • For patients with severe renal impairment (creatinine clearance less than 30 mL/min), the recommended dose is 20 mg once daily at bedtime [see WARNINGS AND PRECAUTIONS, Use In Specific Populations, and CLINICAL PHARMACOLOGY].
  • In geriatric patients greater than or equal to 75 years of age, dose may be titrated down to 20 mg once daily based upon tolerability [see Use In Specific Populations].

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

This monograph has been modified to include the generic and brand name in many instances.

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) 119 (20.1)
  Constipation 27 (4.6) 57 (9.6)
  Abdominal pain upper 7 (1.2) 9 (1.5)
  Constipation aggravated 5 (0.8) 8 (1.4)
  Dyspepsia 2 (0.3) 7 (1.2)
  Flatulence 5 (0.8) 7 (1.2)
Nervous System Disorders
  Headache 12 (2.0) 25 (4.2)
General Disorders
  Fatigue 8 (1.4) 11 (1.9)
Renal and Urinary Disorders
  Urinary retention 2 (0.3) 7 (1.2)
Eye Disorders  
  Dry eyes 2 (0.3) 7 (1.2)

 

Other adverse reactions from the U.S., placebo-controlled trials , occurring in greater than or equal to 0.5% and less than 1.0% of SANCTURA® treated patients, and more common with SANCTURA® than placebo are:tachycardia , vision blurred, abdominal distension, vomiting, dysgeusia, dry throat, and dry skin.

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

Post-marketing Experience

The following adverse reactions have been identified during post-approval use of trospium chloride. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Gastrointestinal – gastritis; Cardiovascular – palpitations, supraventricular tachycardia, chest pain, syncope, “hypertensive crisis”; Immunological –Stevens-Johnson syndrome, anaphylactic reaction, angioedema; Nervous System – dizziness, confusion, vision abnormal, hallucinations, somnolenceand delirium; Musculoskeletal – rhabdomyolysis; General – rash.

Read the Sanctura (trospium chloride tablets) Side Effects Center for a complete guide to possible side effects

Learn More »

Interactions

Digoxin

Concomitant use of SANCTURA® and digoxin did not affect the pharmacokinetics of either drug [see CLINICAL PHARMACOLOGY].

Drugs Eliminated by Active Tubular Secretion

Although demonstrated in a drug-drug interaction study not to affect the pharmacokinetics of digoxin, SANCTURA® has the potential for pharmacokinetic interactions with other drugs that are eliminated by active tubular secretion (e.g., procainamide, pancuronium, morphine, vancomycin, and tenofovir). Coadministration of SANCTURA® with these drugs 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 [seeCLINICAL PHARMACOLOGY].

Antimuscarinic Agents

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

Metformin

Co-administration of 500 mg metformin immediate release tablets twice daily with SANCTURA XR® (trospium chloride 60 mg extended release) reduced the steady-state systemic exposure of trospium by approximately 29% for mean AUC0-24 and by 34% for mean Cmax [see CLINICAL PHARMACOLOGY].

Read the Sanctura Drug Interactions Center for a complete guide to possible interactions

Learn More »
 

This monograph has been modified to include the generic and brand name in many instances.

Warnings

Included as part of the PRECAUTIONS section.

Precautions

Risk of Urinary Retention

SANCTURA® should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention [see CONTRAINDICATIONS].

Angioedema

Angioedema of the face, lips, tongue, and/or larynx has been reported with trospium chloride, the active ingredient in SANCTURA®. In one case, angioedema occurred after the first dose of trospium chloride. Angioedema associated with upper airway swelling may be life threatening. If involvement of the tongue, hypopharynx, or larynx occurs, SANCTURA® should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided.

Decreased Gastrointestinal Motility

SANCTURA® should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention [see CONTRAINDICATIONS]. SANCTURA®, like other antimuscarinic agents, may decrease gastrointestinal motility and should be used with caution in patients with conditions such as ulcerative colitis, intestinal atony and myasthenia gravis.

Controlled Narrow-angle Glaucoma

In patients being treated for narrow-angle glaucoma, SANCTURA® should only be used if the potential benefits outweigh the risks and in that circumstance only with careful monitoring [see CONTRAINDICATIONS].

Central Nervous System Effects

SANCTURA® is associated with anticholinergic central nervous system(CNS) effects [see ADVERSE REACTIONS]. A variety of CNS anticholinergic effects have been reported, including dizziness, confusion, hallucinations and somnolence. Patients should be monitored for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing the dose. Advise patients not to drive or operate heavy machinery until they know how SANCTURA® affects them. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered.

Anticholinergic Adverse Reactions in Patients with Moderate Renal Impairment

Trospium is substantially excreted by the kidney. The effects of moderate renal impairment on systemic exposure are not known but systemic exposure is likely increased. Therefore, anticholinergic adverse reactions (including dry mouth, constipation, dyspepsia, urinary tract infection, and urinary retention) are expected to be greater in patients with moderate renal impairment [see DOSAGE AND ADMINISTRATION, and Use in Specific Populations].

Patient Counseling Information

“See FDA-approved Patient Labeling (PATIENT INFORMATION)”

Angioedema

Patients should be informed that trospium chloride, the active ingredient in SANCTURA®, may produce angioedema which could result in life-threatening airway obstruction. Patients should be advised to promptly discontinue SANCTURA® and seek immediate medical attention if they experience edema of the tongue, edema of the laryngopharynx, or difficulty breathing.

When Not to Use

Prior to treatment, patients should fully understand the risks and benefits of SANCTURA®. In particular, patients should be informed not to take SANCTURA® tablets if they:

  • have urinary retention;
  • gastric retention;
  • uncontrolled narrow-angle glaucoma;
  • are allergic to any component of SANCTURA®.

Administration

Patients should be instructed regarding the recommended dosing and administration of SANCTURA®:

  • Take one SANCTURA® tablet twice daily with water.
  • Take SANCTURA® on an empty stomach or at least 1 hour before a meal.

Adverse Reactions

Patients should be informed that the most common side effects with SANCTURA® are dry mouth and constipation and that other less common side effects include trouble emptying the bladder, blurred vision, and heat prostration. Because anticholinergics, such as SANCTURA®, may produce dizziness or blurred vision, patients should be advised to exercise caution in decisions to engage in potentially dangerous activities until the drug's effects have been determined. Patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

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.

Mutagenesis

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 vivo in the rat micronucleus test.

Impairment of Fertility

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).

Use In Specific Populations

Pregnancy

Teratogenic Effects

Pregnancy Category C: There are no adequate and well-controlled studies of SANCTURA® in pregnant women. SANCTURA® should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the patient and fetus. Women who become pregnant during SANCTURA® treatment are encouraged to contact their physician.

Risk Summary

Based on animal data, trospium chloride is predicted to have a low probability of increased risk of adverse developmental outcomes, above background risk. Adverse developmental findings were not observed to correlate with dose in rats or in rabbits. No increased risk above background was observed in rats and rabbits treated at an exposure approximately equivalent to the maximal recommended human dose (MRHD) of 40 mg.

Animal Data

In a rat embryo/fetal development study, pregnant rats received doses of trospium chloride up to 200 mg/kg/day, from implantation to closure of the fetal hard palate, with maternal systemic exposures corresponding to approximately nine times the exposure of women treated at the MRHD of 40 mg, based on AUC. No malformations or fetal toxicity were observed.

The offspring of female rats exposed orally, pre-and post-natally, to trospium chloride up to 200 mg/kg/day showed no increased developmental toxicity over background in surviving pups. However, maternal toxicity (death, irregular breathing, increased excitability) was observed at 200 mg/kg/day. A no-effect level for maternal and pup toxicity (survival to Day 4) was 20 mg/kg/day, an exposure approximately equivalent to the maximal recommended human dose (MRHD) of 40 mg.

In a rabbit embryo/fetal development study, pregnant rabbits received doses of trospium chloride up to 200 mg/kg/day, from implantation to closure of the fetal hard palate. At 200 mg/kg/day, maternal systemic exposures corresponded to approximately 16 times the exposure of women treated at the MRHD of 40 mg, based on AUC. However, one fetus in each of the three treated dose groups (0.3 to 16 times exposures at the MRHD) demonstrated multiple malformations, including umbilical hernia and skeletal malformations. A maternal no-effect level was set at 20 mg/kg/day, at an exposure approximately equivalent to the maximal recommended human dose (MRHD) of 40 mg, due to clinical signs (reduced feces, hunched posture, diarrhea) observed in a pharmacokinetic study at 200 mg/kg/day.

Labor and Delivery

The effect of SANCTURA® tablets on labor and delivery is unknown.

Nursing Mothers

Trospium chloride (2 mg/kg orally and 50 mcg/kg intravenously) was excreted, to a limited extent (less than 1%), into the milk of lactating rats (primarily as parent compound). It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, SANCTURA® should be used during lactation only if the potential benefit justifies the potential risk to the newborn.

Pediatric Use

The safety and effectiveness of SANCTURA® in pediatric patients have not been established.

Geriatric Use

Of the 591 patients with overactive bladder who received treatment with SANCTURA® in the two U.S., placebo-controlled, efficacy and safety studies, 249 patients (42%) were 65 years of age and older. Eighty-eight SANCTURA® treated patients (15%) were greater than or equal to 75 years of age.

In these 2 studies, the incidence of commonly reported anticholinergic adverse reactions in patients treated with SANCTURA® (including dry mouth, constipation, dyspepsia, urinary tract infection, 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 CLINICAL PHARMACOLOGY]. Therefore, based upon tolerability, the dose frequency of SANCTURA® may be reduced to 20 mg once daily in patients 75 years of age and older.

Renal Impairment

Severe renal impairment (creatinine clearance less than 30 mL/minute) significantly altered the disposition of SANCTURA®. A 4.2-fold and 1.8-fold increase in mean AUC(0-∞) and Cmax, respectively, and the appearance of an additional elimination phase with a long half-life (~33 hr) were detected in patients with severe renal impairment compared with nearly age-matched subjects with creatinine clearance equal to or higher than 80 mL/min. The different pharmacokinetic behavior of SANCTURA® in patients with severe renal impairment necessitates adjustment of dosage frequency [seeDOSAGE AND ADMINISTRATION]. The pharmacokinetics of trospium have not been studied in patients with creatinine clearance ranging from 30-80 mL/min.

Trospium is known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function.

Hepatic Impairment

There is no information regarding the effect of severe hepatic impairment on exposure to SANCTURA®. In a study of patients with mild and with moderate hepatic impairment, given 40 mg of immediate-release trospium chloride, mean Cmax increased 12% and 63%, respectively, and mean AUC(0-∞) decreased 5% and 15%, respectively, compared to healthy subjects. The clinical significance of these findings is unknown. Caution should be used when administering SANCTURA® to patients with moderate and severe hepatic impairment.

This monograph has been modified to include the generic and brand name in many instances.

 

OverDose

Overdosage with antimuscarinic agents, including SANCTURA®, can result in severe antimuscarinic effects. Supportive treatment should be provided according to symptoms. In the event of overdosage, electrocardiographic monitoring is recommended.

A 7-month-old baby experienced tachycardia and mydriasis after administration of a single dose of trospium 10 mg given by a sibling. The baby's weight was reported as 5 kg. Following admission into the hospital and about 1 hour after ingestion of the trospium, medicinal charcoal was administered for detoxification. While hospitalized, the baby experienced mydriasis and tachycardia up to 230 beats per minute. Therapeutic intervention was not deemed necessary. The baby was discharged as completely recovered the following day.

 
 

ContrainDications

SANCTURA® is contraindicated in patients with:

  • urinary retention
  • gastric retention
  • uncontrolled narrow-angle glaucoma.
  • known hypersensitivity to the drug or its ingredients. Angioedema, rash and anaphylactic reaction have been reported.

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

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 [seeClinical 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 5.3 ± 1.2 18.3 ± 3.2

 

The mean plasma concentration-time (+ SD) profile for SANCTURA® is shown in Figure 1.

Figure 1 : Mean (+ SD) Concentration-Time Profile for a Single 20 mg Oral Dose of SANCTURA® in Healthy Volunteers

View Enlarged Table

 

Distribution

Protein binding ranged from 50 to 85% when concentration levels of trospium chloride (0.5-50 ng/mL) were incubated with human serum in vitro.

The 3H-trospium chloride ratio of plasma to whole blood was 1.6:1. This ratio indicates that the majority of 3H-trospium chloride is distributed in plasma.

The apparent volume of distribution for a 20 mg oral dose is 395 (± 140) liters.

Metabolism

The metabolic pathway of trospium in humans has not been fully defined. Of the 10% of the dose absorbed, metabolites account for approximately 40% of the excreted dose following oral administration. The major metabolic pathway is hypothesized as ester hydrolysis with subsequent conjugation of benzylic acid to form azoniaspironortropanol with glucuronic acid. Cytochrome P450 (CYP) is not expected to contribute significantly to the elimination of trospium. Data taken from in vitro human liver microsomes investigating the inhibitory effect of trospium on seven CYP isoenzyme substrates (CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1, and 3A4) suggest a lack of inhibition at clinically relevant concentrations.

Excretion

The plasma half-life for SANCTURA® following oral administration is approximately 20 hours. After oral administration of an immediate-release formulation of 14C-trospium chloride, the majority of the dose (85.2%) was recovered in feces and a smaller amount (5.8% of the dose) was recovered in urine; 60% of the radioactivity excreted in urine was unchanged trospium.

The mean renal clearance for trospium (29.07 L/hour) is 4-fold higher than average glomerular filtration rate, indicating that active tubular secretion is a major route of elimination for trospium. There may be competition for elimination with other compounds that are also renally eliminated [see DRUG INTERACTIONS].

Drug Interactions

Digoxin: Concomitant use of 20 mg SANCTURA® (trospium chloride immediate release) twice daily at steady state and a single dose of 0.5 mg digoxin in a  with 40 male and female subjects did not affect the pharmacokinetics of either drug.

Metformin: A drug interaction study was conducted in which SANCTURA XR® 60 mg once daily was coadministered with Glucophage® (metformin hydrochloride) 500 mg twice daily under steady-state conditions in 44 healthy subjects. Co-administration of 500 mg metformin immediate release tablets twice daily reduced the steady-state systemic exposure of trospium by approximately 29% for mean AUC0-24 and by 34% for mean Cmax. The effect of decrease in trospium exposure on the efficacy of SANCTURA XR® is unknown. The steady-state pharmacokinetics of metformin were comparable when administered with or without 60 mg SANCTURA XR® once daily under fasted condition. The effect of metformin at higher doses on trospium PK is unknown.

Specific Populations

Age: Age did not appear to significantly affect the pharmacokinetics of SANCTURA®, however, increased anticholinergic side effects unrelated to drug exposure were observed in patients greater than or equal to 75 years of age [see Use In Specific Populations].

Pediatric: The pharmacokinetics of SANCTURA® were not evaluated in pediatric patients.

Race: Pharmacokinetic differences due to race have not been studied.

Gender: Studies comparing the pharmacokinetics in different genders had conflicting results. When a single 40 mg SANCTURA® dose was administered to 16 elderly subjects, exposure was 45% lower in elderly females compared to elderly males. When 20 mg SANCTURA® was dosed twice daily for 4 days to 6 elderly males and 6 elderly females (60 to 75 years), AUC and Cmax were 26% and 68% higher, respectively, in females without hormone replacement therapy than in males.

Renal Impairment: In a clinical pharmacokinetic study where a single dose of 40 mg immediate release trospium chloride was administered to 12 healthy males and 12 males with severe renal impairment, severe renal impairment (creatinine clearance less than 30 mL/minute) significantly altered the disposition of SANCTURA®. A 4.2-fold and 1.8-fold increase in mean AUC(0-∞) and Cmax, respectively, and the appearance of an additional elimination phase with a long half-life (~33 hours vs. 18 hours) were detected in patients with severe renal impairment compared with nearly age-matched subjects with creatinine clearance equal to or higher than 80 mL/min. The different pharmacokinetic behavior of SANCTURA® in patients with severe renal impairment necessitates adjustment of dosage frequency [see DOSAGE AND ADMINISTRATION]. The pharmacokinetics of trospium have not been studied in patients with creatinine clearance ranging from 30-80 mL/min.

Hepatic Impairment: In a clinical pharmacokinetic study in patients with mild (Child-Pugh score 5-6) and with moderate (Child-Pugh score 7-8) hepatic impairment, given a single dose of 40 mg immediate-release trospium chloride, mean Cmax increased 12% and 63%, respectively, and mean AUC(0-∞) decreased 5% and 15%, respectively, compared to healthy subjects. There is no information regarding the effect of severe hepatic impairment on exposure to SANCTURA®.

Clinical Studies

SANCTURA® was evaluated for the treatment of patients with overactive bladder who had symptoms of urinary frequency, urgency, and urge incontinence in two U.S. 12-week, placebo-controlled studies and one 9-month open label extension.

Study 1 was a randomized, double-blind, placebo-controlled, parallel-group study in 523 patients. A total of 262 patients received SANCTURA® 20 mg twice daily and 261 patients received placebo. The majority of patients were Caucasian (85%) and female (74%) with a mean age of 61 years (range: 21 to 90 years). Entry criteria required that patients have urge or mixedincontinence (with a predominance of urge), urge incontinence episodes of at least 7 per week, and greater than 70 micturitions per week. The patient's medical history and urinary diary during the treatment-free baseline confirmed the diagnosis. Reductions in urinary frequency, urge incontinence episodes and urinary void volume for placebo and SANCTURA® treatment groups are summarized in Table 3 and Figures 2 and 3.

Table 3: Mean (SE) change from baseline to end of treatment (Week 12 or last observation carried forward) for urinary frequency, urge incontinence episodes, and void volume in Study 1

EFFICACY ENDPOINT PLACEBO N=256 SANCTUR A® N=253 P-VALUE
Urinary frequency/24 hours a,*
  Mean baseline 12.9 12.7  
  Mean change from baseline -1.3 (0.2) -2.4 (0.2) < 0.001
Urge incontinence episodes/week b,*
  Mean baseline 30.1 27.3  
  Mean change from baseline -13.9 (1.2) -15.4 (1.1) 0.012
Urinary void volume/toilet void (mL)a,c
  Mean baseline 156.6 155.1  
  Mean change from baseline 7.7 (3.1) 32.1 (3.1) < 0.001
a Treatment differences assessed by analysis of variance for ITT:LOCF data set. 
b Treatment differences assessed by ranked analysis of variance for ITT:LOCF data set. 
c Placebo N=253, SANCTURA® N=248. 
* Denotes co-primary endpoint 
ITT=intent-to-treat, LOCF=last observation carried forward.

 

Figure 2 : Mean Change from Baseline in Urinary Frequency/24 Hours, by Visit: Study 1 

Mean Change from Baseline in Urinary Frequency/24 Hours, by Visit - Illustration

 

Figure 3 : Mean Change from Baseline in Urge Incontinence/Week, by Visit: Study 1

Mean Change from Baseline in Urge Incontinence/Week, by Visit - Illustration

 

Study 2 was nearly identical in design to Study 1. A total of 329 patients received SANCTURA® 20 mg twice daily and 329 patients received placebo. The majority of patients were Caucasian (88%) and female (82%) with a mean age of 61 years (range: 19 to 94 years). Entry criteria were identical to Study 1. Reductions in urinary frequency, urge incontinence episodes, and urinary void volume for placebo and SANCTURA® treatment groups are summarized in Table 4 and Figures 4 and 5.

Table 4: Mean (SE) change from baseline to end of treatment (Week 12 or last observation carried forward) for urinary frequency, urge incontinence episodes, and void volume in Study 2

EFFICACY ENDPOINT PLACEBO N=325 SANCTUR A® N=323 P-VALUE
Urinary frequency/24 hoursa,*
  Mean baseline 13.2 12.9  
  Mean change from baseline -1.8 (0.2) -2.7 (0.2) < 0.001
Urge incontinence episodes/weekb
  Mean baseline 27.3 26.9  
  Mean change from baseline -12.1 (1.0) -16.1 (1.0) < 0.001
Urinary void volume/toilet void (mL)a,c
  Mean baseline 154.6 154.8  
  Mean change from baseline 9.4 (2.8) 35.6 (2.8) < 0.001
a Treatment differences assessed by analysis of variance for ITT:LOCF data set. 
b Treatment differences assessed by ranked analysis of variance for ITT:LOCF data set. 
c Placebo N=320, SANCTURA® N=319. 
* Denotes primary endpoint 
ITT=intent-to-treat, LOCF=last observation carried forward.

 

Figure 4 : Mean Change from Baseline in Urinary Frequency/24 Hours, by Visit: Study 2

Mean Change from Baseline in Urinary Frequency/24 Hours, by Visit - Illustration

 

Figure 5 : Mean Change from Baseline in Urge Incontinence/Week, by Visit: Study 2

Mean Change from Baseline in Urge Incontinence/Week -  Illustration

 

This monograph has been modified to include the generic and brand name in many instances.

 

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.


This monograph has been modified to include the generic and brand name in many instances. 

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

TROSPIUM - ORAL

 

(TROSE-pee-um)

 

COMMON BRAND NAME(S): Sanctura

 

USES: This medication is used to treat an overactive bladder. By relaxing the muscles in the bladder, trospium improves your ability to control your urination. It helps to reduce leaking of urine, feelings of needing to urinate right away, and frequent trips to the bathroom. Trospium belongs to a class of drugs known as antispasmodics. It is also known as an antimuscarinic.

 

HOW TO USE: Take this medication by mouth, usually twice daily, 1 hour before a meal or on an empty stomach.

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time(s) each day. Dosage is based on your age, medical condition, and response to therapy.

Tell your doctor if your condition does not improve or if it worsens.

Consumer Overview Side Effect

SIDE EFFECTS: Dry mouth, constipation, stomach upset, headache, dry eyes, dizziness, blurred vision, or drowsiness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water or use a saliva substitute.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: eye pain, difficulty urinating, fast heartbeat, mental/mood changes (such as hallucinations, confusion).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Sanctura (trospium chloride tablets) Side Effects Center for a complete guide to possible side effects

Learn More »
 

PRECAUTIONS: Before taking trospium, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain type of glaucoma (uncontrolled narrow-angle type), inability to urinate (urinary retention), delayed or slow emptying of your stomach.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, constipation, other stomach conditions (such as ulcerative colitis, intestinal atony), myasthenia gravis.

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication can reduce sweating, making you more likely to develop a serious condition called heat stroke. Avoid strenuous work or exercise in hot weather.

Older adults may be more sensitive to the side effects of this drug, especially constipation, dry mouth, drowsiness, confusion, or trouble urinating. Drowsiness and confusion can increase the risk of falling.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other drugs that are also removed by the kidneys (such as metformin, morphine, procainamide, tenofovir, vancomycin), certain anti-Parkinson's drugs (such as benztropine, trihexyphenidyl), other antimuscarinic drugs (such as dicyclomine, oxybutynin, scopolamine, tolterodine), potassium tablets/capsules, pramlintide.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness, including alcohol, certain antihistamines (such as cetirizine, diphenhydramine), anti-seizure drugs (such as carbamazepine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and narcotic pain relievers (such as codeine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: fast heartbeat, widened pupils.

 

NOTES: Do not share this medication with others.

 

MISSED DOSE: If you miss a dose, use it as soon as you remember. Take the missed dose at least 2 hours after a meal or 1 hour before your next meal. If it is near the time of your next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Information last revised December 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Sanctura, Sanctura XR

Generic Name: trospium (Pronunciation: tros PEE um)

  • What is trospium (Sanctura)?
  • What are the possible side effects of trospium (Sanctura)?
  • What is the most important information I should know about trospium (Sanctura)?
  • What should I discuss with my healthcare provider before taking trospium (Sanctura)?
  • How should I take trospium (Sanctura)?
  • What happens if I miss a dose (Sanctura)?
  • What happens if I overdose (Sanctura)?
  • What should I avoid while taking trospium (Sanctura)?
  • What other drugs will affect trospium (Sanctura)?
  • Where can I get more information?

What is trospium (Sanctura)?

 

Trospium relieves spasms of the bladder.

Trospium is used to treat overactive bladder and symptoms of urinary incontinence, frequency, and urgency.

Trospium may also be used for purposes not listed in this medication guide.

What are the possible side effects of trospium (Sanctura)?

 

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using trospium and call your doctor at once if you have a serious side effect such as:

  • severe stomach pain or bloating;
  • severe constipation;
  • urinating less than usual or not at all; or
  • confusion, hallucinations.

Less serious side effects may include:

  • dry mouth or throat;
  • headache;
  • mild constipation;
  • upset stomach, gas;
  • dizziness, drowsiness, or
  • dry eyes.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Sanctura (trospium chloride tablets) Side Effects Center for a complete guide to possible side effects

Learn More »
 

What is the most important information I should know about trospium (Sanctura)?

 

You should not take this medicine if you are allergic to trospium, or if you have untreated or uncontrolled narrow-angle glaucoma, a blockage in your digestive system, or if you are unable to urinate.

Take trospium on an empty stomach, at least 1 hour before a meal.

Avoid drinking alcohol within 2 hours before or after you take trospium. Drinking alcohol can increase certain side effects of trospium.

This medication may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Trospium can decrease sweating, which makes it easier for you to have heat stroke. Drink plenty of fluids while you are taking this medication.

Before using trospium, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by trospium.

Side Effects Centers
  • Sanctura
  • Sanctura XR

Patient Detailed How Take

What should I discuss with my healthcare provider before taking trospium (Sanctura)?

 

You should not use trospium if you are allergic to it, or if you have:

  • untreated or uncontrolled narrow-angle glaucoma;
  • a blockage in your digestive system; or
  • if you are unable to urinate.

To make sure you can safely take trospium, tell your doctor if you have any of these other conditions:

  • glaucoma;
  • liver disease;
  • kidney disease;
  • a stomach or intestinal disorder such as ulcerative colitis;
  • a muscle disorder such as myasthenia gravis; or
  • an enlarged prostate.

FDA pregnancy category C. It is not known whether trospium will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether trospium passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults may be more likely to have side effects from this medicine.

How should I take trospium (Sanctura)?

 

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take trospium on an empty stomach, at least 1 hour before a meal. Extended-release trospium (Sanctura XR) should be taken once each morning, at least 1 hour before a meal.

Do not crush, chew, break, or open an extended-release capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

Store at room temperature away from moisture and heat.

Side Effects Centers
  • Sanctura
  • Sanctura XR

Patient Detailed Avoid Taking

What happens if I miss a dose (Sanctura)?

 

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.

What happens if I overdose (Sanctura)?

 

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

What should I avoid while taking trospium (Sanctura)?

 

This medication may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Avoid drinking alcohol within 2 hours before or after you take trospium. Drinking alcohol can increase certain side effects of trospium.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Trospium can decrease sweating, which makes it easier for you to have heat stroke. Drink plenty of fluids while you are taking this medication.

What other drugs will affect trospium (Sanctura)?

 

Before using trospium, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by trospium.

Tell your doctor about all other medicines you use, especially:

  • atropine (Atreza, Sal-Tropine, and others);
  • belladonna (Donnatal, and others);
  • benztropine (Cogentin);
  • dimenhydrinate (Dramamine);
  • metformin (Actoplus Met, Avandamet, Glucophage, Glucovance, Janumet, Kombiglyze, Metaglip, PrandiMet);
  • morphine (Kadian, MS Contin, Oramorph);
  • procainamide (Procanbid, Pronestyl);
  • tenofovir (Viread);
  • vancomycin (Vancocin);
  • bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);
  • bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);
  • irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Hyomax), or propantheline (Pro Banthine); or
  • ulcer medications such as glycopyrrolate (Robinul) or mepenzolate (Cantil).

This list is not complete and other drugs may interact with trospium. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

 

Your pharmacist can provide more information about trospium.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 3.02. Revision date: 8/21/2012.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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