Drug Interaction:
Concomittant use with other anticholinergics that produce constipation, dry mouth, - severity increased
Drugs eliminated by tubular secretion eg digoxin, procainamide, pancruronium, morphine, vancomycin. may increase serum concentration of trospium
Indication:
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Trospium Chloride Film Coated 28-05-2009
Tablet 20mg
For the treatment of Overactive Bladder with the symptoms of Urge Urinary
Incontinence, Urgency and urinary frequency
2.Trospium Chloride ER Capsules 60mg 04-09-2009
For the Treatment of Overactive Bladder with the symptoms of Urge Urinary
Incontinence, Urgency and urinary Urgency
Treatment of overactive bladder with symptoms of urinary incontinence , urgency and frequency
Adverse Reaction:
ADVERSE REACTIONS-
CNS Headache 4.
GI Abdominal pain 2 % Constipation 10% Dry mouth 20 %
Dyspepsia 1% Flatulance 1%
GU Urinary retention 1%
OPHTHALMIC - Dry eyes 1 %
MISCELLANEOUS - Fatigue 2 %
Contra-Indications:
Urinary or gastric retention, Uncontrolled narrow-angle glaucoma in patients who are at risk these conditions
Special precautions-
Controlled narrow angle glaucoma- use with caution on patients being treated
Decreased GI motility - administer with caution to patients with GI obstructive disorders because of risk of gastric retention
Hepatic function impairment- observe caution
Renal function impairment - Observe caution
Pregnancy- Administer during pregnancy only if the benefit to the mother outweighs the potential risk to the fetus.
Lactation- Use caution before administering to breast feeding women
Children- Safety and efficacy not established in children
Dosages/ Overdosage Etc:
Indications
Treatment of overactive bladder with symptoms of urinary incontinence , urgency and frequency
Dosage-
20mg twice daily . Trospium should be dosed at least 1 hour before meals or given on an empty stomach
Patient Information:
Heat prostration ( caused by decreased sweating ) can occur , especially when used in hot weather. Observe caution
Can cause blurred vision, diziness. Observe caution before undertaking hazardous tasks.
Inform patients that alcohol may enhance the drowsiness caused by anticholinergics agents
Pharmacology/ Pharmacokinetics:
Ref - Drug Facts And comparison (2010)
Pharmacology
Trospium is an antispasmodic antimuscarine agent.
Trospium antagonises the effect of acetylcholine on muscarinic receptors in cholinergically innervated organs. It parasympathetic action reduces the tonus of smooth muscle in the bladder
Pharmacokinetics-
A summary of mean (=/- standard deviation) pharmacokinetic parameters for a single
20mg trospium dose is provided in the following table
Mean( =/- SD) Pharmacokinetic Parameter Estimates for a
Single 20mg Trospium Dose in Healthy Volunteers
Cmax(ng/mL) AUC 0-x (ng/mL*hr) tmax(hr) t 1/2(hr)
3.5+/- 4 36.4+/- 21.8 5.3=/- 1.2 18.3+/-3.2
Interaction with Food:
Trospium should be dosed at least 1 hour before meals or given on an empty stomach
Pregnancy and lactation:
Pregnancy-
Administer during pregnancy only if the benefit to the mother outweighs the potential risk to the fetus.
Lactation-
Use caution before administering to breast feeding women
Children-
Safety and efficacy not established in children
Manufacturer Details