Sanctura XR

Antimuscarinics

Oral Administration Oral Solid Formulations

Tablets:
Administer at least 1 hour before meals or on an empty stomach.
 
Extended-release capsules:
Administer in the morning at roughly the same time each day.
Administer whole; do not cut, crush or chew.
Administer on an empty stomach, at least 1 hour before a meal.
Alcohol should not be consumed within 2 hours of administration.

Severe

visual impairment / Early / Incidence not known
hypertensive crisis / Early / Incidence not known
Stevens-Johnson syndrome / Delayed / Incidence not known
anaphylactoid reactions / Rapid / Incidence not known
angioedema / Rapid / Incidence not known
rhabdomyolysis / Delayed / Incidence not known

Moderate

constipation / Delayed / 8.5-9.6
cystitis / Delayed / 0-1.2
urinary retention / Early / 0-1.2
blurred vision / Early / 0-1.0
sinus tachycardia / Rapid / 0-1.0
gastritis / Delayed / Incidence not known
delirium / Early / Incidence not known
confusion / Early / Incidence not known
hallucinations / Early / Incidence not known
palpitations / Early / Incidence not known
hypertension / Early / Incidence not known
ST-T wave changes / Rapid / Incidence not known
supraventricular tachycardia (SVT) / Early / Incidence not known
chest pain (unspecified) / Early / Incidence not known

Mild

xerostomia / Early / 10.7-20.1
headache / Early / 0-4.2
dyspepsia / Early / 1.0-2.0
abdominal pain / Early / 1.0-2.0
flatulence / Early / 1.0-2.0
nausea / Early / 0-2.0
xerophthalmia / Early / 1.0-1.9
fatigue / Early / 0-1.9
vomiting / Early / 0-1.0
dysgeusia / Early / 0-1.0
xerosis / Delayed / 0-1.0
dizziness / Early / Incidence not known
drowsiness / Early / Incidence not known
syncope / Early / Incidence not known
rash / Early / Incidence not known

Sanctura, Sanctura XR

Rx

Oral non-specific antimuscarinic agent
Used for the treatment of overactive bladder (OAB) in adults
Dry mouth and constipation may occur; limited potential for drug-drug interactions

For the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urinary urgency, and urinary frequency, including neurogenic bladder. Oral dosage (immediate-release) Adults 75 years and older

20 mg PO twice daily. May decrease dose to 20 mg PO once daily based on tolerability.

Adults 18 to 74 years

20 mg PO twice daily.

Children and Adolescents 5 to 17 years†

Dose is not definitively established; however, a study has suggested a dose range of 10 to 25 mg/day PO, given in divided doses twice daily. Only pediatric patients weighing more than 40 kg received 25 mg/day. Fifty-eight pediatric patients with nonneurogenic overactive bladder were randomized into one of 5 groups (daily doses of trospium 10 mg, 15 mg, 20 mg, 25 mg or placebo, given in divided doses twice daily) for 21 days. Trospium therapy resulted in improvement in clinical symptoms (day or nighttime incontinence) in 82% of patients receiving active drug versus 37.5% of patients receiving placebo (p = 0.006). In addition, clinical symptoms and urodynamic parameters (number of uninhibited contractions, volume at first contraction, contraction pressure) improved in 74% of trospium-treated patients. Trospium was well tolerated with 10% of patients experiencing minor side effects. Differences in efficacy or tolerability between the dosage groups were not apparent.

Oral dosage (extended-release) Adults

60 mg PO once daily.

Hepatic Impairment

Specific guidelines for dosage adjustment in hepatic impairment are not available. Caution is advised in patients with moderate or severe hepatic impairment due to possible increased exposure.

Renal Impairment

CrCl less than 30 mL/minute:
Immediate-release tablets: Reduce dosage to 20 mg PO once daily at bedtime.
Extended-release capsules: (e.g., Sanctura XR) : Use is not recommended.

Abacavir; Dolutegravir; Lamivudine: (Moderate) Trospium is eliminated by active tubular secretion and has the potential for pharmacokinetic interactions with other drugs that are eliminated by active tubular secretion including lamivudine. In theory, coadministration of trospium with lamivudine may increase the serum concentrations of trospium or lamivudine due to competition for the drug elimination pathway.
Abacavir; Lamivudine, 3TC: (Moderate) Trospium is eliminated by active tubular secretion and has the potential for pharmacokinetic interactions with other drugs that are eliminated by active tubular secretion including lamivudine. In theory, coadministration of trospium with lamivudine may increase the serum concentrations of trospium or lamivudine due to competition for the drug elimination pathway.
Abacavir; Lamivudine, 3TC; Zidovudine, ZDV: (Moderate) Trospium is eliminated by active tubular secretion and has the potential for pharmacokinetic interactions with other drugs that are eliminated by active tubular secretion including lamivudine. In theory, coadministration of trospium with lamivudine may increase the serum concentrations of trospium or lamivudine due to competition for the drug elimination pathway.
Acetaminophen; Aspirin; Diphenhydramine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Acetaminophen; Caffeine; Pyrilamine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Acetaminophen; Chlorpheniramine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Acetaminophen; Chlorpheniramine; Dextromethorphan: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Acetaminophen; Chlorpheniramine; Dextromethorphan; Phenylephrine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Acetaminophen; Chlorpheniramine; Dextromethorphan; Pseudoephedrine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Acetaminophen; Chlorpheniramine; Phenylephrine : (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Acetaminophen; Dextromethorphan; Doxylamine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Acetaminophen; Diphenhydramine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Acetaminophen; Pamabrom; Pyrilamine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Acrivastine; Pseudoephedrine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Adefovir: (Moderate) Adefovir is eliminated renally by a combination of glomerular filtration and active tubular secretion; coadministration of adefovir dipivoxil with drugs that reduce renal function or compete for active tubular secretion like trospium may decrease adefovir elimination by competing for common renal tubular transport systems, therefore increasing serum concentrations of either adefovir and/or trospium. Monitor for side effects of either drug and monitor renal function. For trospium, monitor for dry mouth, constipation or other anticholinergic effects.
Aliskiren; Hydrochlorothiazide, HCTZ: (Minor) Diuretics can increase urinary frequency, which may aggravate bladder symptoms.
Alogliptin; Metformin: (Moderate) Trospium, if used concomitantly with metformin, may increase the risk of lactic acidosis. Cationic drugs that are eliminated by renal tubular secretion like trospium may decrease metformin elimination by competing for common renal tubular transport systems.
Alosetron: (Major) Concomitant use of alosetron and trospium, an antimuscarinic which can decrease GI motility, may seriously worsen constipation, leading to events such as GI obstuction, impaction, or paralytic ileus. Although specific recommendations are not available from the manufacturer, it would be prudent to avoid antimuscarinics in patients taking alosetron.
Amantadine: (Moderate) Additive anticholinergic effects may be seen when drugs with antimuscarinic properties like trospium and amantadine are used concomitantly. In addition, some drugs which are actively secreted by the kidney, such as amantadine, may interact with trospium by competing for renal tubular secretion, further enhancing the possibility for anticholinergic side effects. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Amiloride: (Minor) Amiloride is actively secreted via cationic tubular secretion and may decrease trospium elimination by competing for common renal tubular transport systems. Careful patient monitoring and dose adjustments of both drugs, if needed, is recommended.
Amiloride; Hydrochlorothiazide, HCTZ: (Minor) Amiloride is actively secreted via cationic tubular secretion and may decrease trospium elimination by competing for common renal tubular transport systems. Careful patient monitoring and dose adjustments of both drugs, if needed, is recommended. (Minor) Diuretics can increase urinary frequency, which may aggravate bladder symptoms.
Amlodipine; Valsartan; Hydrochlorothiazide, HCTZ: (Minor) Diuretics can increase urinary frequency, which may aggravate bladder symptoms.
Amoxapine: (Moderate) Additive anticholinergic and CNS effects may be seen when amoxapine is used concomitantly with other antimuscarinics, such as trospium. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients. Monitor for anticholinergic effects such as such as confusion, constipation, dizziness, urinary retention, dry mouth and eyes, blurred vision, or rarely, fast, irregular heartbeat.
Antacids: (Moderate) Antacids may inhibit the oral absorption of antimuscarinics. Simultaneous oral administration should be avoided when feasible; separate dosing by at least 2 hours to limit an interaction.
Anticholinergics: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with other antimuscarinics. When possible, avoid concurrent use, especially in the elderly, who are more susceptible to the anticholinergic effects. Consider alternatives to these other medications, if available. Clinicians should note that antimuscarinic effects might be seen not only on bladder smooth muscle, but also on GI function, the eye, and temperature regulation. Blurred vision, constipation, and dry mouth may be more prominent additive effects. With many of the listed agents, additive drowsiness may also occur when combined with trospium.
Aspirin, ASA; Caffeine; Orphenadrine: (Moderate) Additive anticholinergic effects may be seen when drugs with antimuscarinic properties like trospium are used concomitantly with other commonly used drugs with moderate to significant anticholinergic effects including orphenadrine. Clinicians should note that anticholinergic effects may be seen not only on GI smooth muscle, but also on bladder function, the eye, and temperature regulation.
Aspirin, ASA; Citric Acid; Sodium Bicarbonate: (Moderate) Antacids may inhibit the oral absorption of antimuscarinics. Simultaneous oral administration should be avoided when feasible; separate dosing by at least 2 hours to limit an interaction.
Atenolol; Chlorthalidone: (Minor) Diuretics can increase urinary frequency, which may aggravate bladder symptoms.
Azilsartan; Chlorthalidone: (Minor) Diuretics can increase urinary frequency, which may aggravate bladder symptoms.
Benazepril; Hydrochlorothiazide, HCTZ: (Minor) Diuretics can increase urinary frequency, which may aggravate bladder symptoms.
Bisoprolol; Hydrochlorothiazide, HCTZ: (Minor) Diuretics can increase urinary frequency, which may aggravate bladder symptoms.
Botulinum Toxins: (Moderate) Systemic anticholinergic effects (e.g., blurred vision) may be potentiated if antimuscarinics are administered after administration of botulinum toxins.
Brompheniramine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Brompheniramine; Dextromethorphan; Phenylephrine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Brompheniramine; Phenylephrine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Brompheniramine; Pseudoephedrine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Brompheniramine; Pseudoephedrine; Dextromethorphan: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Bumetanide: (Minor) Diuretics can increase urinary frequency, which may aggravate bladder symptoms.
Buprenorphine: (Moderate) Monitor patients for signs of urinary retention or reduced gastric motility when buprenorphine is used concomitantly with an anticholinergic drug, such as trospium. The concomitant use of buprenorphine and anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus. Opiates increase the tone and decrease the propulsive contractions of the smooth muscle of the gastrointestinal tract. Prolongation of the gastrointestinal transit time may be the mechanism of the constipating effect.
Buprenorphine; Naloxone: (Moderate) Monitor patients for signs of urinary retention or reduced gastric motility when buprenorphine is used concomitantly with an anticholinergic drug, such as trospium. The concomitant use of buprenorphine and anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus. Opiates increase the tone and decrease the propulsive contractions of the smooth muscle of the gastrointestinal tract. Prolongation of the gastrointestinal transit time may be the mechanism of the constipating effect.
Bupropion: (Moderate) Depending on the specific agent, additive anticholinergic effects may be seen when drugs with antimuscarinic properties like trospium and bupropion are used concomitantly. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Bupropion; Naltrexone: (Moderate) Depending on the specific agent, additive anticholinergic effects may be seen when drugs with antimuscarinic properties like trospium and bupropion are used concomitantly. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Butorphanol: (Moderate) Monitor patients for signs of urinary retention or reduced gastric motility when butorphanol is used concomitantly with an anticholinergic drug, such as trospium. The concomitant use of butorphanol and anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus. Opiates increase the tone and decrease the propulsive contractions of the smooth muscle of the gastrointestinal tract. Prolongation of the gastrointestinal transit time may be the mechanism of the constipating effect.
Caffeine: (Minor) Consuming > 400 mg/day caffeine has been associated with the development of urinary incontinence. Caffeine may aggravate bladder symptoms and counteract the effectiveness of drugs used to treat overactive bladder, like trospium, to some degree. Patients with overactive bladder may wish to limit their intake of caffeine including caffeine from drugs, dietary supplements (i.e., guarana), beverages (i.e., teas, coffee, colas), or foods (i.e., chocolate).
Canagliflozin; Metformin: (Moderate) Trospium, if used concomitantly with metformin, may increase the risk of lactic acidosis. Cationic drugs that are eliminated by renal tubular secretion like trospium may decrease metformin elimination by competing for common renal tubular transport systems.
Candesartan; Hydrochlorothiazide, HCTZ: (Minor) Diuretics can increase urinary frequency, which may aggravate bladder symptoms.
Captopril; Hydrochlorothiazide, HCTZ: (Minor) Diuretics can increase urinary frequency, which may aggravate bladder symptoms.
Carbinoxamine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Cetirizine: (Moderate) Dry mouth and drowsiness may occur in patients receiving cetirizine/levocetirizine; caution may be necessary during concomitant use of cetirizine/levocetirizine with the antimuscarinics.
Cetirizine; Pseudoephedrine: (Moderate) Dry mouth and drowsiness may occur in patients receiving cetirizine/levocetirizine; caution may be necessary during concomitant use of cetirizine/levocetirizine with the antimuscarinics.
Chlophedianol; Dexbrompheniramine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Chlophedianol; Dexchlorpheniramine; Pseudoephedrine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Chlorcyclizine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Chlorothiazide: (Minor) Diuretics can increase urinary frequency, which may aggravate bladder symptoms.
Chlorpheniramine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Chlorpheniramine; Codeine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Chlorpheniramine; Dextromethorphan: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Chlorpheniramine; Dextromethorphan; Phenylephrine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Chlorpheniramine; Dextromethorphan; Pseudoephedrine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Chlorpheniramine; Dihydrocodeine; Phenylephrine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Chlorpheniramine; Hydrocodone: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Chlorpheniramine; Ibuprofen; Pseudoephedrine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Chlorpheniramine; Phenylephrine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Chlorpheniramine; Pseudoephedrine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Chlorpromazine: (Moderate) Additive anticholinergic effects may be seen when phenothiazines are used concomitantly with other drugs with antimuscarinic activity, such as trospium.
Chlorthalidone: (Minor) Diuretics can increase urinary frequency, which may aggravate bladder symptoms.
Chlorthalidone; Clonidine: (Minor) Diuretics can increase urinary frequency, which may aggravate bladder symptoms.
Cholinergic agonists: (Moderate) Pharmacologically, parasympathomimetic drugs enhance muscarinic/cholinergic function. Because trospium is an antimuscarinic, the muscarinic actions of drugs known as parasympathomimetics, including direct cholinergic agonists, could be antagonized when used concomitantly with trospium.
Cimetidine: (Moderate) Both trospium and cimetidine are eliminated by active renal tubular secretion; coadministration has the potential to increase serum concentrations of trospium or cimetidine due to competition for the drug elimination pathway. Careful patient monitoring and dosage adjustment of trospium and/or cimetidine is recommended.
Cisapride: (Moderate) The use of drugs that decrease GI motility, such as trospium, may pharmacodynamically oppose the effects of cisapride.
Clemastine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Clozapine: (Moderate) Additive anticholinergic effects may be seen when drugs with antimuscarinic properties like trospium are used concomitantly with other commonly used drugs with moderate to significant anticholinergic effects including clozapine.
Codeine; Phenylephrine; Promethazine: (Moderate) Additive anticholinergic effects may be seen when phenothiazines are used concomitantly with other drugs with antimuscarinic activity, such as trospium.
Codeine; Promethazine: (Moderate) Additive anticholinergic effects may be seen when phenothiazines are used concomitantly with other drugs with antimuscarinic activity, such as trospium.
Cyclizine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Cyclobenzaprine: (Moderate) Cyclobenzaprine possesses antimuscarinic properties, which can cause dry mouth, urinary difficulties and slowing of gastrointestinal motility. If used with other drugs with antimuscarinic properties, anticholinergic side effects can be additive.
Cyproheptadine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Dapagliflozin; Metformin: (Moderate) Trospium, if used concomitantly with metformin, may increase the risk of lactic acidosis. Cationic drugs that are eliminated by renal tubular secretion like trospium may decrease metformin elimination by competing for common renal tubular transport systems.
Dexbrompheniramine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Dexbrompheniramine; Pseudoephedrine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Dexchlorpheniramine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Dexchlorpheniramine; Dextromethorphan; Pseudoephedrine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Dextromethorphan; Bupropion: (Moderate) Depending on the specific agent, additive anticholinergic effects may be seen when drugs with antimuscarinic properties like trospium and bupropion are used concomitantly. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Dextromethorphan; Diphenhydramine; Phenylephrine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Dextromethorphan; Quinidine: (Major) Trospium is eliminated by active tubular secretion and has the potential for pharmacokinetic interactions with other drugs that are eliminated by active tubular secretion, such as quinidine. In theory, coadministration of trospium with quinidine may increase the serum concentrations of trospium or quinidine due to competition for the drug elimination pathway.
Digoxin: (Moderate) Oral formulations of digoxin can produce higher serum concentrations when administered concurrently with antimuscarinics (e.g., propantheline) because of decreased GI motility induced by the antimuscarinic agent. This interaction has mostly occurred in the literature with slowly-dissolving, large-particle formulations of digoxin tablets; the manufacture of oral digoxin products today, utilizing liquid formulations and/or smaller particle sizes, theoretically reduces the potential for absorption interactions. However, there is wide variability expected in individual responses to many digoxin-drug interactions. Other pharmacodynamic and pharmacokinetic systemic interactions are possible between digoxin and select antimuscarinic agents. Both trospium (a selective antimuscarinic) and digoxin are eliminated by active renal tubular secretion; coadministration has the potential to increase serum concentrations of trospium or digoxin due to competition for the drug elimination pathway. Darifenacin (30 mg daily) coadministered with digoxin (0.25 mg daily) resulted in a 16% increase in digoxin exposure. Anticholinergics, because of their ability to cause tachycardia, can also antagonize the beneficial actions of digoxin in atrial fibrillation/flutter. Routine therapeutic monitoring should be continued when an antimuscarinic agent is prescribed with digoxin until the effects of combined use are known.
Dimenhydrinate: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Diphenhydramine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Diphenhydramine; Ibuprofen: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Diphenhydramine; Naproxen: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Diphenhydramine; Phenylephrine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Disopyramide: (Moderate) Additive anticholinergic effects may be seen when drugs with antimuscarinic properties like trospium are used concomitantly with other drugs with moderate to significant anticholinergic effects like disopyramide.
Dofetilide: (Major) Drugs that are actively secreted via cationic secretion (e.g., trospium) should be co-administered with dofetilide with caution since they could increase dofetilide plasma concentrations via potential competition for renal tubular secretion.
Dolutegravir; Lamivudine: (Moderate) Trospium is eliminated by active tubular secretion and has the potential for pharmacokinetic interactions with other drugs that are eliminated by active tubular secretion including lamivudine. In theory, coadministration of trospium with lamivudine may increase the serum concentrations of trospium or lamivudine due to competition for the drug elimination pathway.
Donepezil: (Moderate) The therapeutic benefits of the cholinesterase inhibitors for dementia or other neurologic conditions may be diminished during chronic coadministration with antimuscarinics or medications with potent anticholinergic activity. Some of the common selective antimuscarinic drugs for bladder problems, (such as trospium), do not routinely cause problems with medications used for dementia, but may cause anticholinergic side effects in some patients. When concurrent use is not avoidable, the patient should be monitored for cognitive decline and anticholinergic side effects. Clinicians should generally avoid multiple medications with anticholinergic activity in the patient with dementia.
Donepezil; Memantine: (Moderate) Memantine is excreted in part by renal tubular secretion. Competition of memantine for excretion with other drugs that are also eliminated by tubular secretion, such as trospium, could result in elevated serum concentrations of one or both drugs. (Moderate) The therapeutic benefits of the cholinesterase inhibitors for dementia or other neurologic conditions may be diminished during chronic coadministration with antimuscarinics or medications with potent anticholinergic activity. Some of the common selective antimuscarinic drugs for bladder problems, (such as trospium), do not routinely cause problems with medications used for dementia, but may cause anticholinergic side effects in some patients. When concurrent use is not avoidable, the patient should be monitored for cognitive decline and anticholinergic side effects. Clinicians should generally avoid multiple medications with anticholinergic activity in the patient with dementia.
Doravirine; Lamivudine; Tenofovir disoproxil fumarate: (Moderate) Trospium is eliminated by active tubular secretion and has the potential for pharmacokinetic interactions with other drugs that are eliminated by active tubular secretion including lamivudine. In theory, coadministration of trospium with lamivudine may increase the serum concentrations of trospium or lamivudine due to competition for the drug elimination pathway. (Minor) Both trospium and tenofovir are eliminated by active renal tubular secretion; coadministration has the potential to increase serum concentrations of trospium or tenofovir due to competition for the drug elimination pathway. Careful patient monitoring and dosage adjustment of trospium and/or tenofovir, PMPA is recommended.
Doxylamine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Doxylamine; Pyridoxine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Dronabinol: (Moderate) Use caution if coadministration of dronabinol with an anticholinergic drug like trospium is necessary. Concurrent use of dronabinol, THC with anticholinergics may result in additive drowsiness, hypertension, tachycardia, and possibly cardiotoxicity.
Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate: (Minor) Both trospium and tenofovir are eliminated by active renal tubular secretion; coadministration has the potential to increase serum concentrations of trospium or tenofovir due to competition for the drug elimination pathway. Careful patient monitoring and dosage adjustment of trospium and/or tenofovir, PMPA is recommended.
Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate: (Moderate) Trospium is eliminated by active tubular secretion and has the potential for pharmacokinetic interactions with other drugs that are eliminated by active tubular secretion including lamivudine. In theory, coadministration of trospium with lamivudine may increase the serum concentrations of trospium or lamivudine due to competition for the drug elimination pathway. (Minor) Both trospium and tenofovir are eliminated by active renal tubular secretion; coadministration has the potential to increase serum concentrations of trospium or tenofovir due to competition for the drug elimination pathway. Careful patient monitoring and dosage adjustment of trospium and/or tenofovir, PMPA is recommended.
Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Disoproxil Fumarate: (Minor) Both trospium and tenofovir are eliminated by active renal tubular secretion; coadministration has the potential to increase serum concentrations of trospium or tenofovir due to competition for the drug elimination pathway. Careful patient monitoring and dosage adjustment of trospium and/or tenofovir, PMPA is recommended.
Empagliflozin; Linagliptin; Metformin: (Moderate) Trospium, if used concomitantly with metformin, may increase the risk of lactic acidosis. Cationic drugs that are eliminated by renal tubular secretion like trospium may decrease metformin elimination by competing for common renal tubular transport systems.
Empagliflozin; Metformin: (Moderate) Trospium, if used concomitantly with metformin, may increase the risk of lactic acidosis. Cationic drugs that are eliminated by renal tubular secretion like trospium may decrease metformin elimination by competing for common renal tubular transport systems.
Emtricitabine; Rilpivirine; Tenofovir Disoproxil Fumarate: (Minor) Both trospium and tenofovir are eliminated by active renal tubular secretion; coadministration has the potential to increase serum concentrations of trospium or tenofovir due to competition for the drug elimination pathway. Careful patient monitoring and dosage adjustment of trospium and/or tenofovir, PMPA is recommended.
Emtricitabine; Tenofovir Disoproxil Fumarate: (Minor) Both trospium and tenofovir are eliminated by active renal tubular secretion; coadministration has the potential to increase serum concentrations of trospium or tenofovir due to competition for the drug elimination pathway. Careful patient monitoring and dosage adjustment of trospium and/or tenofovir, PMPA is recommended.
Enalapril; Hydrochlorothiazide, HCTZ: (Minor) Diuretics can increase urinary frequency, which may aggravate bladder symptoms.
Entecavir: (Moderate) Both entecavir and trospium are secreted by active tubular secretion. In theory, coadministration of entecavir with trospium may increase the serum concentrations of either drug due to competition for the drug elimination pathway. The manufacturer of entecavir recommends monitoring for adverse effects when these drugs are coadministered.
Eprosartan; Hydrochlorothiazide, HCTZ: (Minor) Diuretics can increase urinary frequency, which may aggravate bladder symptoms.
Ertugliflozin; Metformin: (Moderate) Trospium, if used concomitantly with metformin, may increase the risk of lactic acidosis. Cationic drugs that are eliminated by renal tubular secretion like trospium may decrease metformin elimination by competing for common renal tubular transport systems.
Erythromycin: (Minor) The antimuscarinics can antagonize the stimulatory effects of erythromycin on the GI tract when erythromycin is used therapeutically for improving GI motility.
Ethacrynic Acid: (Minor) Diuretics can increase urinary frequency, which may aggravate bladder symptoms.
Ethanol: (Major) Advise patients to avoid alcohol and alcohol-containing products while taking trospium. Alcohol consumption may result in additive CNS depression. Alcohol should not be consumed within 2 hours of trospium extended-release capsules. (Moderate) Advise patients not to consume alcoholic beverages within 2 hours of trospium extended-release capsules. Alcohol may also enhance drowsiness caused by trospium.
Fluphenazine: (Moderate) Additive anticholinergic effects may be seen when phenothiazines are used concomitantly with other drugs with antimuscarinic activity, such as trospium.
Food: (Moderate) Trospium is minimally absorbed after oral administration (< 10%). Administration with food (a high fat meal) significantly reduces absorption. Patients should be advised to take trospium at least 1 hour before meals on an empty stomach.
Fosinopril; Hydrochlorothiazide, HCTZ: (Minor) Diuretics can increase urinary frequency, which may aggravate bladder symptoms.
Furosemide: (Minor) Diuretics can increase urinary frequency, which may aggravate bladder symptoms.
Galantamine: (Moderate) The therapeutic benefits of the cholinesterase inhibitors for dementia or other neurologic conditions may be diminished during chronic co-administration with antimuscarinics or medications with potent anticholinergic activity. Some of the common selective antimuscarinic drugs for bladder problems, (such as trospium), do not routinely cause problems with medications used for dementia, but may cause anticholinergic side effects in some patients. When concurrent use is not avoidable, the patient should be monitored for cognitive decline and anticholinergic side effects. Clinicians should generally avoid multiple medications with anticholinergic activity in the patient with dementia.
Glipizide; Metformin: (Moderate) Trospium, if used concomitantly with metformin, may increase the risk of lactic acidosis. Cationic drugs that are eliminated by renal tubular secretion like trospium may decrease metformin elimination by competing for common renal tubular transport systems.
Glyburide; Metformin: (Moderate) Trospium, if used concomitantly with metformin, may increase the risk of lactic acidosis. Cationic drugs that are eliminated by renal tubular secretion like trospium may decrease metformin elimination by competing for common renal tubular transport systems.
Glycopyrronium: (Moderate) Although glycopyrronium is minimally absorbed into the systemic circulation after topical application, there is the potential for glycopyrronium to have additive anticholinergic effects when administered with trospium. Per the manufaturer, avoid concomitant administration of glycopyrronium with other anticholinergic medications.
Green Tea: (Minor) Some green tea products contain caffeine, which may aggravate bladder symptoms and counteract the effectiveness of drugs used to treat overactive bladder like trospium.
Hydrochlorothiazide, HCTZ: (Minor) Diuretics can increase urinary frequency, which may aggravate bladder symptoms.
Hydrochlorothiazide, HCTZ; Methyldopa: (Minor) Diuretics can increase urinary frequency, which may aggravate bladder symptoms.
Hydrochlorothiazide, HCTZ; Moexipril: (Minor) Diuretics can increase urinary frequency, which may aggravate bladder symptoms.
Hydroxyzine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Irbesartan; Hydrochlorothiazide, HCTZ: (Minor) Diuretics can increase urinary frequency, which may aggravate bladder symptoms.
Itraconazole: (Moderate) Antimuscarinic drugs including trospium can raise intragastric pH. This effect may decrease the oral bioavailability of itraconazole. Trospium should be used cautiously in patients receiving itraconazole.
Ketoconazole: (Moderate) Antimuscarinic drugs, including trospium, can raise intragastric pH. This effect may decrease the oral bioavailability of ketoconazole. In addition, because both trospium and ketoconazole are eliminated by active tubular secretion, concurrent use may result in increased effects of either drug; however, studies have not been conducted.
Lamivudine, 3TC: (Moderate) Trospium is eliminated by active tubular secretion and has the potential for pharmacokinetic interactions with other drugs that are eliminated by active tubular secretion including lamivudine. In theory, coadministration of trospium with lamivudine may increase the serum concentrations of trospium or lamivudine due to competition for the drug elimination pathway.
Lamivudine, 3TC; Zidovudine, ZDV: (Moderate) Trospium is eliminated by active tubular secretion and has the potential for pharmacokinetic interactions with other drugs that are eliminated by active tubular secretion including lamivudine. In theory, coadministration of trospium with lamivudine may increase the serum concentrations of trospium or lamivudine due to competition for the drug elimination pathway.
Lamivudine; Tenofovir Disoproxil Fumarate: (Moderate) Trospium is eliminated by active tubular secretion and has the potential for pharmacokinetic interactions with other drugs that are eliminated by active tubular secretion including lamivudine. In theory, coadministration of trospium with lamivudine may increase the serum concentrations of trospium or lamivudine due to competition for the drug elimination pathway. (Minor) Both trospium and tenofovir are eliminated by active renal tubular secretion; coadministration has the potential to increase serum concentrations of trospium or tenofovir due to competition for the drug elimination pathway. Careful patient monitoring and dosage adjustment of trospium and/or tenofovir, PMPA is recommended.
Levocetirizine: (Moderate) Dry mouth and drowsiness may occur in patients receiving cetirizine/levocetirizine; caution may be necessary during concomitant use of cetirizine/levocetirizine with the antimuscarinics.
Levoketoconazole: (Moderate) Antimuscarinic drugs, including trospium, can raise intragastric pH. This effect may decrease the oral bioavailability of ketoconazole. In addition, because both trospium and ketoconazole are eliminated by active tubular secretion, concurrent use may result in increased effects of either drug; however, studies have not been conducted.
Linagliptin; Metformin: (Moderate) Trospium, if used concomitantly with metformin, may increase the risk of lactic acidosis. Cationic drugs that are eliminated by renal tubular secretion like trospium may decrease metformin elimination by competing for common renal tubular transport systems.
Lisinopril; Hydrochlorothiazide, HCTZ: (Minor) Diuretics can increase urinary frequency, which may aggravate bladder symptoms.
Loop diuretics: (Minor) Diuretics can increase urinary frequency, which may aggravate bladder symptoms.
Losartan; Hydrochlorothiazide, HCTZ: (Minor) Diuretics can increase urinary frequency, which may aggravate bladder symptoms.
Lurasidone: (Moderate) Antipsychotic agents may disrupt core temperature regulation; therefore, caution is recommended during concurrent use of lurasidone and medications with anticholinergic activity such as antimuscarinics. Concurrent use of lurasidone and medications with anticholinergic activity may contribute to heat-related disorders. Monitor patients for heat intolerance, decreased sweating, or increased body temperature if lurasidone is used with antimuscarinics.
Maprotiline: (Moderate) Additive anticholinergic effects may be seen when drugs with antimuscarinic properties like trospium are used concomitantly with other drugs with moderate to significant anticholinergic effects including maprotiline.
Meclizine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Megestrol: (Minor) Trospium is metabolized by ester hydrolysis and excreted by the kidneys through a combination of tubular secretion and glomerular filtration. Some drugs which are actively secreted by the kidney, including megestrol, may interact with trospium by competing for renal tubular secretion. Be alert for increased effect of either trospium ( anticholinergic effects) or megestrol.
Memantine: (Moderate) Memantine is excreted in part by renal tubular secretion. Competition of memantine for excretion with other drugs that are also eliminated by tubular secretion, such as trospium, could result in elevated serum concentrations of one or both drugs.
Metformin: (Moderate) Trospium, if used concomitantly with metformin, may increase the risk of lactic acidosis. Cationic drugs that are eliminated by renal tubular secretion like trospium may decrease metformin elimination by competing for common renal tubular transport systems.
Metformin; Repaglinide: (Moderate) Trospium, if used concomitantly with metformin, may increase the risk of lactic acidosis. Cationic drugs that are eliminated by renal tubular secretion like trospium may decrease metformin elimination by competing for common renal tubular transport systems.
Metformin; Rosiglitazone: (Moderate) Trospium, if used concomitantly with metformin, may increase the risk of lactic acidosis. Cationic drugs that are eliminated by renal tubular secretion like trospium may decrease metformin elimination by competing for common renal tubular transport systems.
Metformin; Saxagliptin: (Moderate) Trospium, if used concomitantly with metformin, may increase the risk of lactic acidosis. Cationic drugs that are eliminated by renal tubular secretion like trospium may decrease metformin elimination by competing for common renal tubular transport systems.
Metformin; Sitagliptin: (Moderate) Trospium, if used concomitantly with metformin, may increase the risk of lactic acidosis. Cationic drugs that are eliminated by renal tubular secretion like trospium may decrease metformin elimination by competing for common renal tubular transport systems.
Methyclothiazide: (Minor) Diuretics can increase urinary frequency, which may aggravate bladder symptoms.
Metolazone: (Minor) Diuretics can increase urinary frequency, which may aggravate bladder symptoms.
Metoprolol; Hydrochlorothiazide, HCTZ: (Minor) Diuretics can increase urinary frequency, which may aggravate bladder symptoms.
Midodrine: (Moderate) Both trospium and midodrine are eliminated by active renal tubular secretion; coadministration has the potential to increase serum concentrations of trospium or midodrine due to competition for the drug elimination pathway. Careful patient monitoring and dosage adjustment of trospium and/or midodrine is recommended.
Mirabegron: (Moderate) Mirabegron should be administered with caution in patients taking antimuscarinic medications for the treatment of overactive bladder, such as oxybutynin, because of the risk of urinary retention. Monitor for symptoms of urinary difficulties or urinary retention. Patients may note constipation or dry mouth with use of these drugs together.
Mirtazapine: (Moderate) Mirtazapine exhibits weak anticholinergic activity that is not expected to be clinically significant. However, the anticholinergic effects may be additive to the antimuscarinics. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function, the CNS, the eye, and temperature regulation.
Nabilone: (Moderate) Concurrent use of oral cannabinoids, such as nabilone, with anticholinergics such as trospium may result in pronounced tachycardia and drowsiness.
Nalbuphine: (Moderate) Monitor patients for signs of urinary retention or reduced gastric motility when nalbuphine is used concomitantly with an anticholinergic drug, such as trospium. The concomitant use of nalbuphine and anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus. Opiates increase the tone and decrease the propulsive contractions of the smooth muscle of the gastrointestinal tract. Prolongation of the gastrointestinal transit time may be the mechanism of the constipating effect.
Olanzapine: (Moderate) Additive anticholinergic effects may be seen w

hen drugs with antimuscarinic properties like trospium and olanzapine are used concomitantly. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Olanzapine; Fluoxetine: (Moderate) Additive anticholinergic effects may be seen when drugs with antimuscarinic properties like trospium and olanzapine are used concomitantly. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Olanzapine; Samidorphan: (Moderate) Additive anticholinergic effects may be seen when drugs with antimuscarinic properties like trospium and olanzapine are used concomitantly. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Olmesartan; Amlodipine; Hydrochlorothiazide, HCTZ: (Minor) Diuretics can increase urinary frequency, which may aggravate bladder symptoms.
Olmesartan; Hydrochlorothiazide, HCTZ: (Minor) Diuretics can increase urinary frequency, which may aggravate bladder symptoms.
Omeprazole; Sodium Bicarbonate: (Moderate) Antacids may inhibit the oral absorption of antimuscarinics. Simultaneous oral administration should be avoided when feasible; separate dosing by at least 2 hours to limit an interaction.
Opiate Agonists: (Moderate) Monitor patients for signs of urinary retention or reduced gastric motility when trospium, an anticholinergic drug for overactive bladder, is used with opiate agonists. The concomitant use of these drugs together may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus. Opiates increase the tone and decrease the propulsive contractions of the smooth muscle of the gastrointestinal tract. Prolongation of the gastrointestinal transit time may be the mechanism of the constipating effect. Both agents may also cause drowsiness or blurred vision, and patients should use care in driving or performing other hazardous tasks until the effects of the drugs are known.
Orphenadrine: (Moderate) Additive anticholinergic effects may be seen when drugs with antimuscarinic properties like trospium are used concomitantly with other commonly used drugs with moderate to significant anticholinergic effects including orphenadrine. Clinicians should note that anticholinergic effects may be seen not only on GI smooth muscle, but also on bladder function, the eye, and temperature regulation.
Pancuronium: (Moderate) Monitor patients receiving pancuronium and trospium closely. Coadministration may increase serum concentrations of either drug due to competition for elimination via active tubular secretion.
Pentazocine: (Moderate) Monitor patients for signs of urinary retention or reduced gastric motility when pentazocine is used concomitantly with an anticholinergic drug, such as trospium. The concomitant use of pentazocine and anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus. Opiates increase the tone and decrease the propulsive contractions of the smooth muscle of the gastrointestinal tract. Prolongation of the gastrointestinal transit time may be the mechanism of the constipating effect.
Pentazocine; Naloxone: (Moderate) Monitor patients for signs of urinary retention or reduced gastric motility when pentazocine is used concomitantly with an anticholinergic drug, such as trospium. The concomitant use of pentazocine and anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus. Opiates increase the tone and decrease the propulsive contractions of the smooth muscle of the gastrointestinal tract. Prolongation of the gastrointestinal transit time may be the mechanism of the constipating effect.
Perphenazine: (Moderate) Additive anticholinergic effects may be seen when phenothiazines are used concomitantly with other drugs with antimuscarinic activity, such as trospium.
Perphenazine; Amitriptyline: (Moderate) Additive anticholinergic effects may be seen when phenothiazines are used concomitantly with other drugs with antimuscarinic activity, such as trospium.
Phenothiazines: (Moderate) Additive anticholinergic effects may be seen when phenothiazines are used concomitantly with other drugs with antimuscarinic activity, such as trospium.
Phentermine; Topiramate: (Moderate) Oligohidrosis and hyperthermia have been reported in post-marketing experience with topiramate. Use caution when topiramate is prescribed with agents known to predispose patients to similar heat-related disorders such as trospium.
Pioglitazone; Metformin: (Moderate) Trospium, if used concomitantly with metformin, may increase the risk of lactic acidosis. Cationic drugs that are eliminated by renal tubular secretion like trospium may decrease metformin elimination by competing for common renal tubular transport systems.
Procainamide: (Major) Both trospium and procainamide are eliminated by active renal tubular secretion; coadministration has the potential to increase serum concentrations of trospium or procainamide due to competition for the drug elimination pathway. Careful patient monitoring and dosage adjustment of trospium and/or procainamide is recommended.
Prochlorperazine: (Moderate) Additive anticholinergic effects may be seen when phenothiazines are used concomitantly with other drugs with antimuscarinic activity, such as trospium.
Promethazine: (Moderate) Additive anticholinergic effects may be seen when phenothiazines are used concomitantly with other drugs with antimuscarinic activity, such as trospium.
Promethazine; Dextromethorphan: (Moderate) Additive anticholinergic effects may be seen when phenothiazines are used concomitantly with other drugs with antimuscarinic activity, such as trospium.
Promethazine; Phenylephrine: (Moderate) Additive anticholinergic effects may be seen when phenothiazines are used concomitantly with other drugs with antimuscarinic activity, such as trospium.
Propranolol; Hydrochlorothiazide, HCTZ: (Minor) Diuretics can increase urinary frequency, which may aggravate bladder symptoms.
Proton pump inhibitors: (Moderate) The American College of Gastroenterology states that the effectiveness of proton pump inhibitors (PPIs) may be theoretically decreased if given with other antisecretory agents (e.g., anticholinergics). Proton pump inhibitors (PPIs) inhibit only actively secreting H+-pumps.
Pseudoephedrine; Triprolidine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Pyrilamine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Quetiapine: (Moderate) When coadministering quetiapine and trospium, monitor for additive anticholinergic effects such as constipation, blurred vision, urinary retention, xerostomia, and tachycardia. Constipation is a commonly reported adverse effect of quetiapine and anticholinergic agents such as trospium. Constipation may lead to ileus. Intestinal obstruction has been reported with quetiapine, including fatal cases in patients who were receiving multiple concomitant medications that decrease intestinal motility. Anticholinergic effects observed during therapeutic use of quetiapine are thought to be associated with norquetiapine, an active metabolite of quetiapine which has demonstrated a moderate to strong in vitro binding affinity for several muscarinic receptor subtypes.
Quinapril; Hydrochlorothiazide, HCTZ: (Minor) Diuretics can increase urinary frequency, which may aggravate bladder symptoms.
Quinidine: (Major) Trospium is eliminated by active tubular secretion and has the potential for pharmacokinetic interactions with other drugs that are eliminated by active tubular secretion, such as quinidine. In theory, coadministration of trospium with quinidine may increase the serum concentrations of trospium or quinidine due to competition for the drug elimination pathway.
Quinine: (Moderate) Both trospium and quinine are eliminated by active renal tubular secretion; coadministration has the potential to increase serum concentrations of trospium or quinine due to competition for the drug elimination pathway. Careful patient monitoring and dosage adjustment of trospium and/or quinine is recommended.
Ranitidine: (Moderate) Both trospium and ranitidine are eliminated by active renal tubular secretion; coadministration has the potential to increase serum concentrations of trospium or ranitidine due to competition for the drug elimination pathway. Careful patient monitoring and dosage adjustment of trospium and/or ranitidine is recommended.
Rasagiline: (Moderate) MAOIs exhibit secondary anticholinergic actions. Additive anticholinergic effects may be seen when MAOIs are used concomitantly with antimuscarinics. Clinicians should note that antimuscarinic effects might be seen not only on GI smooth muscle, but also on bladder function, the eye, and temperature regulation. Additive CNS effects are also possible when many of these drugs are combined with MAOIs.
Rivastigmine: (Moderate) The therapeutic benefits of the cholinesterase inhibitors for dementia or other neurologic conditions may be diminished during chronic co-administration with antimuscarinics or medications with potent anticholinergic activity. Some of the common selective antimuscarinic drugs for bladder problems, (such as trospium), do not routinely cause problems with medications used for dementia, but may cause anticholinergic side effects in some patients. When concurrent use is not avoidable, the patient should be monitored for cognitive decline and anticholinergic side effects. Clinicians should generally avoid multiple medications with anticholinergic activity in the patient with dementia.
Secretin: (Major) Discontinue anticholinergic medications, including trospium, at least 5 half-lives before administering secretin. Patients who are receiving anticholinergics at the time of stimulation testing may be hyporesponsive to secretin stimulation and produce a false result. Consider additional testing and clinical assessments for aid in diagnosis.
Sedating H1-blockers: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Sodium Bicarbonate: (Moderate) Antacids may inhibit the oral absorption of antimuscarinics. Simultaneous oral administration should be avoided when feasible; separate dosing by at least 2 hours to limit an interaction.
Solifenacin: (Major) Additive anticholinergic effects may be seen when solifenacin is used concomitantly with other antimuscarinics, such as trospium. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function, the CNS, the eye, and temperature regulation. Additive drowsiness may also occur, depending on the interacting agent.
Spironolactone; Hydrochlorothiazide, HCTZ: (Minor) Diuretics can increase urinary frequency, which may aggravate bladder symptoms.
Sulfamethoxazole; Trimethoprim, SMX-TMP, Cotrimoxazole: (Moderate) Both trospium and trimethoprim are eliminated by active renal tubular secretion; coadministration has the potential to increase serum concentrations of trospium or trimethoprim due to competition for the drug elimination pathway. Careful patient monitoring is recommended. For trospium, monitor for anticholinergic effects, such as dry mouth, constipation, blurred vision, urinary retention, or increased CNS effects which are not frequent when the drug is used alone. Trimethoprim dose-related side effects include nausea, vomiting, dizziness, headaches, mental depression/confusion, palpitations, and bone marrow depression. In some patients, a dosage reduction may be required.
Tegaserod: (Major) Trospium is an antagonist at muscarinic cholinergic receptors and decreases gastrointestinal motility. Trospium, therefore, may potentially antagonize the actions of drugs that enhance gastrointestinal motility, like tegaserod.
Telmisartan; Hydrochlorothiazide, HCTZ: (Minor) Diuretics can increase urinary frequency, which may aggravate bladder symptoms.
Tenofovir Alafenamide: (Moderate) Tenofovir-containing products should be avoided with concurrent trospium administration as both are eliminated by active renal tubular secretion; coadministration has the potential to increase serum concentrations of either drug due to competition for the elimination pathway and patients should be carefully monitored.
Tenofovir Disoproxil Fumarate: (Minor) Both trospium and tenofovir are eliminated by active renal tubular secretion; coadministration has the potential to increase serum concentrations of trospium or tenofovir due to competition for the drug elimination pathway. Careful patient monitoring and dosage adjustment of trospium and/or tenofovir, PMPA is recommended.
Thiazide diuretics: (Minor) Diuretics can increase urinary frequency, which may aggravate bladder symptoms.
Thioridazine: (Moderate) Additive anticholinergic effects may be seen when phenothiazines are used concomitantly with other drugs with antimuscarinic activity, such as trospium.
Thiothixene: (Moderate) Additive anticholinergic effects may be seen when thiothixene is used concomitantly with other drugs having anticholinergic activity such as trospium. Monitor for anticholinergic-related adverse effects such as constipation, blurred vision, and urinary retention during concurrent use.
Topiramate: (Moderate) Oligohidrosis and hyperthermia have been reported in post-marketing experience with topiramate. Use caution when topiramate is prescribed with agents known to predispose patients to similar heat-related disorders such as trospium.
Torsemide: (Minor) Diuretics can increase urinary frequency, which may aggravate bladder symptoms.
Triamterene: (Minor) In theory, coadministration of trospium with drugs which are eliminated by renal cationic secretion, such as triamterene, may increase the serum concentrations of trospium or triamterene due to competition for the drug elimination pathway.
Triamterene; Hydrochlorothiazide, HCTZ: (Minor) Diuretics can increase urinary frequency, which may aggravate bladder symptoms. (Minor) In theory, coadministration of trospium with drugs which are eliminated by renal cationic secretion, such as triamterene, may increase the serum concentrations of trospium or triamterene due to competition for the drug elimination pathway.
Tricyclic antidepressants: (Moderate) Additive anticholinergic and CNS effects may be seen when tricyclic antidepressants (TCAs) are used concomitantly with other antimuscarinics, such as trospium. Antimuscarinic effects might be seen on GI smooth muscle, bladder function, the eye, and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients. Monitor for anticholinergic effects such as such as confusion, constipation, dizziness, urinary retention, dry mouth and eyes, blurred vision, or rarely, fast, irregular heartbeat.
Trifluoperazine: (Moderate) Additive anticholinergic effects may be seen when phenothiazines are used concomitantly with other drugs with antimuscarinic activity, such as trospium.
Trimethobenzamide: (Moderate) The concurrent use of trimethobenzamide with other medications that cause CNS depression, like the anticholinergics, may potentiate the effects of either trimethobenzamide or the anticholinergic.
Trimethoprim: (Moderate) Both trospium and trimethoprim are eliminated by active renal tubular secretion; coadministration has the potential to increase serum concentrations of trospium or trimethoprim due to competition for the drug elimination pathway. Careful patient monitoring is recommended. For trospium, monitor for anticholinergic effects, such as dry mouth, constipation, blurred vision, urinary retention, or increased CNS effects which are not frequent when the drug is used alone. Trimethoprim dose-related side effects include nausea, vomiting, dizziness, headaches, mental depression/confusion, palpitations, and bone marrow depression. In some patients, a dosage reduction may be required.
Triprolidine: (Moderate) Additive anticholinergic effects may be seen when trospium is used concomitantly with drugs that are known to possess relatively significant antimuscarinic properties, including sedating H1-blockers. Clinicians should note that additive antimuscarinic effects may be seen not only on GI smooth muscle, but also on bladder function and temperature regulation. While CNS-related side effects such as drowsiness and blurred vision are not typically noted with trospium, they may occur in some patients.
Valsartan; Hydrochlorothiazide, HCTZ: (Minor) Diuretics can increase urinary frequency, which may aggravate bladder symptoms.
Vancomycin: (Moderate) Both trospium and vancomycin are eliminated by active renal tubular secretion; coadministration has the potential to increase serum concentrations of trospium or vancomycin due to competition for the drug elimination pathway. Careful patient monitoring and dosage adjustment of trospium and/or vancomycin is recommended.
Vibegron: (Moderate) Vibegron should be administered with caution in patients taking antimuscarinic medications for the treatment of overactive bladder, such as trospium, because of the risk of urinary retention. Monitor for symptoms of urinary difficulties or urinary retention. Patients may note constipation or dry mouth with use of these drugs together.
Zonisamide: (Moderate) Zonisamide use is associated with case reports of decreased sweating, hyperthermia, heat intolerance, or heat stroke and should be used with caution with other drugs that may also predispose patients to heat-related disorders like anticholiinergics.

Sanctura XR/Trospium Chloride Oral Cap ER: 60mg
Sanctura/Trospium Chloride Oral Tab: 20mg

Adults

40 mg/day PO IR tablets; 60 mg/day PO for ER capsules.

Geriatric

40 mg/day PO IR tablets; 60 mg/day PO for ER capsules.

Adolescents

Safety and efficacy have not been established.

Children

Safety and efficacy have not been established.

Infants

Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

Trospium is an antispasmodic, competitive antimuscarinic agent used in the treatment of patients with overactive bladder. Trospium chloride antagonizes the effect of acetylcholine on muscarinic receptors in cholinergically innervated organs. Its actions reduce the tonus of smooth muscle in the bladder. Trospium chloride decreases the frequency of voluntary and involuntary detrusor contractions and increases maximum cystometric bladder capacity and volume at first detrusor contraction. Clinically, trospium decreases urinary urgency, frequency, and incontinence. When used at therapeutic doses, trospium chloride has negligible affinity for nicotinic receptors. Trospium is a quaternary amine and does not cross the blood-brain barrier or conjunctiva like oxybutynin, a tertiary amine.

Trospium is administered orally.
 
Protein binding ranges from 48—85% depending on formulation and assay used; the majority of trospium is distributed in plasma with an apparent mean volume of distribution of 395 liters for a 20 mg dose of the tablets or > 600 liters for a 60 mg dose of the extended-release capsules. Trospium is a quaternary amine and does not readily cross the conjunctiva or the blood-brain barrier.
The metabolic pathway of trospium is not fully established. Of the absorbed dose, metabolites account for approximately 40% of the excreted dose. The major metabolic pathway is hypothesized to be ester hydrolysis and subsequent conjugation of benzylic acid to form azoniaspironortropanol with glucuronic acid. Cytochrome P-450 does not contribute significantly to the elimination of trospium. Trospium is an inhibitor of CYP2D6; however, the inhibition constant is 1000-fold higher than the Cmax that is achieved with the usual oral regimen. Drug interactions via cytochrome P-450 pathways are not expected to be significant for trospium.
After oral administration, 85.2% of the dose is recovered in the feces. Of the proportion of trospium that is absorbed, 60% is excreted unchanged in the urine. Active tubular secretion is a major elimination route for trospium; the mean renal clearance for trospium is 4-fold higher than average glomerular filtration rate. The plasma half-life of trospium following oral administration is approximately 20 hours for the tablets and 35 hours for the extended-release capsules.

Oral Route

After oral administration of either the immediate-release tablets or extended-release capsules, less than 10% of the dose is absorbed. Peak plasma concentrations (Cmax) occur between 5—6 hours post-dose. The pharmacokinetics of trospium are not dose dependent; the increase in Cmax for dosage increases of 20—40 mg and 20—60 mg is 3-fold and 4-fold, respectively. However, increases in AUC are dose proportional for single doses of up to 60 mg. Trospium exhibits diurnal variability in drug exposure, with a decrease in Cmax and AUC of up to 59% and 33%, respectively, for evening doses compared to morning doses. Concomitant administration of the immediate-release tablets with a high fat meal results in reduced absorption, with AUC and Cmax values 70—80% lower than those obtained during a fasting state. A 35% reduction in the AUC and a 60% reduction in the Cmax is observed when the extended-release capsules are given with a high-fat meal. It is recommended, therefore, that trospium be administered at least one hour before meals or on an empty stomach.

Pregnancy

There are no studies of trospium during human pregnancy. Trospium should only be used in pregnancy if the potential benefit justifies the potential risk to the fetus. Trospium was not teratogenic at statistically significant levels in rats or rabbits administered doses up to 200 mg/kg/day; this dose corresponds to systemic exposures up to approximately 16 and 32 times, respectively (based on AUC), the clinical exposure at the maximum recommended human dose (MRHD) of 60 mg. However, in rabbits, one fetus in each of the 3 treated dose groups (1, 1, and 32 times the MRHD) demonstrated multiple malformations, including umbilical hernia and skeletal malformations. A no effect level for maternal and fetal toxicity was observed at levels approximately equivalent to the clinical exposure at the MRHD (20 mg/kg/day in rats and rabbits). No developmental toxicity was observed in the offspring of female rats exposed pre- and post-natally to up to 200 mg/kg/day.

Use trospium with caution during breast-feeding. Trospium, as a quaternary amine anticholinergic, is expected to have limited distribution into breast milk. Trospium (2 mg/kg PO and 50 mcg/kg IV) is excreted, to a limited extent (less than 1%, primarily the parent compound), into the milk of lactating rats. It is not known if this drug is excreted into human milk. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition.