SPASMOLYT 20/MG SUGAR COATED TAB 30/TAB

Indications

Approved Uses

Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Off-Label Uses

Used off-label in neurogenic detrusor overactivity (e.g., spinal cord injury)

Dosage & Administration

Dosing by Condition

Overactive bladder (adult): trospium immediate‑release 20 mg orally twice daily on an empty stomach; in severe renal impairment (CrCl <30 mL/min), reduce to 20 mg once daily at bedtime; extended‑release trospium 60 mg once daily is an alternative formulation where available (not this SFDA product).

Initial Dose

20 mg twice daily

Maintenance Dose

20 mg twice daily

Maximum Dose

40mg per day (immediate-release).

Children's Dosage

Not approved for children.

Dose Adjustment Notes

Reduce to 20 mg once daily at bedtime in patients with severe renal impairment (CrCl <30 mL/min). Use with caution in elderly patients ≥75 years; dose reduction may be considered based on tolerability

How to Take

Swallow the 20 mg coated tablet whole with water on an empty stomach, at least 1 hour before meals (or 2 hours after); for immediate‑release trospium, doses are typically taken twice daily (morning and evening) approximately 12 hours apart.

Side Effects

Common Side Effects

Dry mouth, constipation, headache, abdominal pain/dyspepsia, blurred vision, and urinary retention (less commonly: urinary tract infection).

Safety & Warnings

Contraindications

Contraindicated in: urinary retention; gastric retention; uncontrolled narrow-angle glaucoma; hypersensitivity to trospium or any excipient.

Warnings & Precautions

Use with caution in: bladder outflow obstruction; gastrointestinal obstructive disorders (including decreased GI motility/ileus risk); controlled narrow-angle glaucoma; autonomic neuropathy; hiatal hernia with reflux esophagitis; renal impairment (major-may require dose adjustment/avoidance depending on severity); hepatic impairment (limited data in severe); older adults (higher CNS anticholinergic sensitivity). Counsel on decreased sweating and risk of heat prostration in hot environments; may cause dizziness/drowsiness/blurred vision affecting driving.

Age Restriction

Not approved under 18 years.

Drug Interactions

Drug Interactions

Additive anticholinergic effects with other antimuscarinics/anticholinergics (e.g., TCAs, first-generation antihistamines like diphenhydramine, antipsychotics); potential pharmacokinetic interaction with drugs eliminated by active renal tubular secretion (e.g., metformin, procainamide, morphine) which may increase exposure of one or both; digoxin: no clinically meaningful interaction expected but monitor if used together.

Interaction Severity

MODERATE: other anticholinergics (additive anticholinergic toxicity); MODERATE: drugs eliminated by active renal tubular secretion such as metformin, procainamide, and morphine (potentially increased exposure of trospium and/or the co‑administered drug); MINOR to MODERATE: alcohol/CNS depressants (may worsen dizziness/drowsiness in susceptible patients).

Food Interaction

Take on empty stomach (at least 1 hour before meals or on an empty stomach); food significantly reduces absorption

Special Populations

Pregnancy

Consult Doctor

Children

Not approved for children.

Kidney Impairment

CrCl ≥30 mL/min: No adjustment needed (20 mg twice daily). CrCl <30 mL/min: Reduce to 20 mg once daily at bedtime.

Liver Impairment

No dosage adjustment is generally required in mild-to-moderate hepatic impairment; in severe hepatic impairment, use with caution due to limited data.

Storage & Patient Advice

Stopping the Medicine

Can be stopped without tapering; counsel that overactive bladder symptoms may return and advise discussing with the prescriber if stopping due to adverse effects or lack of benefit.

Overdose

Expected overdose manifestations: anticholinergic toxicity (tachycardia, mydriasis/blurred vision, dry/hot skin, hyperthermia, agitation/confusion/hallucinations, ileus, urinary retention). Management: immediate medical evaluation, supportive care and monitoring; consider activated charcoal if early after ingestion; treat severe anticholinergic delirium with physostigmine only in selected cases under expert supervision (with ECG monitoring and contraindication screening).

Patient Counseling

Take on an empty stomach with water at least 1 hour before meals; if prescribed twice daily, take morning and evening about 12 hours apart; expect dry mouth/constipation and manage with fluids/fiber/sugar‑free gum; avoid overheating (reduced sweating) and use caution driving if blurred vision/dizziness occurs; seek care urgently for inability to urinate, severe constipation/abdominal pain, or eye pain/vision changes (possible glaucoma).

Monitoring Requirements

Monitor for anticholinergic adverse effects and urinary retention; assess renal function (baseline and periodically in at‑risk patients, and for dose adjustment in CrCl <30 mL/min); monitor for worsening narrow‑angle glaucoma symptoms in susceptible patients.

Pharmacology

Mechanism of Action

Competitive antagonist of muscarinic receptors (M1, M2, M3) in the bladder, reducing detrusor muscle contractions and increasing bladder capacity by blocking acetylcholine-mediated smooth muscle stimulation

Onset of Action

Pharmacologic onset occurs within a few hours after a dose, but meaningful symptom improvement for overactive bladder is typically assessed over days to 1-2 weeks (and may continue improving over several weeks).

Duration of Effect

For immediate‑release trospium 20 mg, clinical effect is generally maintained with twice‑daily dosing (i.e., roughly a 12‑hour dosing interval).

Half-Life

Approximately 20 hours (reported ranges vary by study and formulation).

Bioavailability

Low oral bioavailability, approximately <10% (commonly cited around 9-10%) and significantly reduced by food.

Metabolism

Minimal metabolism; not significantly CYP450‑mediated, with some hydrolysis/esterase pathways producing metabolites, and elimination is mainly as unchanged drug in urine.

Excretion

Primarily renal excretion with a substantial fraction excreted unchanged in urine via active tubular secretion; unabsorbed drug is eliminated in feces.

Protein Binding

50-85%

Product Information

Available Dosage Forms

Coated tablet (immediate‑release) is the verified dosage form for this SFDA product; trospium is also available in some markets as an extended‑release oral capsule (not part of this specific SFDA product record).

Composition per Dose

Each coated tablet: 20 mg trospium chloride

Generic Availability

Yes

OTC Alternatives

No OTC alternative

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