trospium chloride (Rx)

>10%

Dry mouth (20.1%)

1-10%

Constipation (9.6%)

Tachycardia (<2%)

Headache (4.2%)

Fatigue (1.9%)

Rash (<2%)

Dyspepsia (1-2%)

Abdominal pain (1-3%)

Abdominal distention (<2%)

Constipation (9-10%)

Dry eyes (1-2%)

Dyspepsia (1-2%)

Flatulence (1-2%)

Urinary retention (<1%)

Urinary tract infection (1-7%)

Nasopharyngitis (3%)

Nasal dryness (1%)

Postmarketing Reports

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, somnolence and delirium

Skeletal system: Musculoskeletal: Rhabdomyolysis

Dermatology: Rash

Contraindications

Urinary/gastric retention

Uncontrolled narrow-angle glaucoma

Hypersensitivity

Cautions

Use caution in renal impairment, geriatric patients, moderate or severe hepatic dysfunction

Angioedema of the face, lips, tongue and/or larynx reported (including with 1st dose); if involvement of the tongue, hypopharynx, or larynx occurs promptly discontinue; promptly provide appropriate therapy and/or measures necessary to ensure a patent airway function

Administer with caution to patients with clinically significant bladder outflow obstruction or gastrointestinal obstructive disorders due to risk of urinary or gastric retention; use with caution in patients with conditions such as ulcerative colitis, intestinal atony, and myasthenia gravis

To administer, must carefully monitor patients with controlled narrow-angle glaucoma; benefits should outweigh risks

Somnolence reported; advise patients not to drive or operate heavy machinery until they know how therapy affects them

Drug substantially excreted by kidney; effects of moderate renal impairment on systemic exposure are not known but systemic exposure is likely increased; risk of anticholinergic adverse reactions (including dry mouth, constipation, dyspepsia, urinary tract infection, and urinary retention) is expected to be greater in patients with moderate renal impairment

Pregnancy Category: C

Lactation: Excretion in mikl unknown; use with caution

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Reduces the smooth muscle tone of the bladder by antagonizing the effects of acetyl choline on muscarinic receptors.

Pharmacokinetics

Absorption: <10%; reduced when administered with high-fat meal

Half-life: 20 hr (immediate release)

Peak plasma time: 5-6 hr

Protein bound: 45-85%

Metabolism: Not fully elucidated; major pathway is thought to be ester hydrolysis followed by glucuronide conjugation of benzylic acid

Renal clearance: 29.07 L/hr

Excretion: Feces (85.2%); urine (5.8% with 60% unchanged drug)