Generic Name

Lialda®

Mechanism

• Selective blockade of L-type Ca²⁺ channels in intestinal smooth muscle, reducing calcium influx and hypercontraction.
• Modulation of enteric neurotransmission by inhibiting acetylcholine release and attenuating excitatory neuronal signaling.
• Minimal systemic absorption → primarily exerts action within the gastrointestinal lumen, lowering the risk of central nervous system effects.

Key points
• Rapid onset of visceral pain relief by dampening spasmogenic reflexes.
• High intestinal selectivity gives it an advantage over non‑selective antispasmodics that often cause urogenital side effects.

Pharmacokinetics

• Absorption: Rapid but negligible systemic uptake; plasma concentrations are generally <1 ng/mL.
• Distribution: Minimal; remains within gut lumen and mucosa.
• Metabolism: Unaltered by hepatic enzymes; no active metabolites.
• Elimination: Primarily fecal excretion; eliminated unchanged.
• Half‑life: 8–10 h (intestinal residence time).
• Drug interactions: No clinically significant interactions reported due to limited systemic exposure.

Indications

• Irritable Bowel Syndrome (IBS) with predominant abdominal pain (regardless of constipation or diarrhea subtype).
• Functional abdominal pain and chronic visceral hypersensitivity in adults.
• Off‑label use: treatment of colonic dysmotility and abdominal discomfort associated with other functional GI disorders.

Contraindications

• Hypersensitivity to otilonium bromide or any excipient.
• Pregnancy/Lactation: Limited data; use only if clearly needed and benefits outweigh risks.
• Severe hepatic impairment: Caution advised; data scarce.
• Gastrointestinal obstruction or severe dysmotility: Use with caution—may exacerbate motility issues.
• Known allergy to anticholinergics: may increase severe side‑effect risk.

Warnings
• Rare cases of anaphylaxis or severe skin rashes; patients should be advised to seek immediate care if symptoms arise.
• No systemic drug interactions anticipated; however, concurrent use with potent CYP3A4 inhibitors is unlikely to alter systemic exposure but may affect gut bioavailability.

Dosing

• Adults: 20 mg capsule/tablet three times daily (TID), 30 min before meals or at fixed times.
• Maximum dose: 60 mg/day.
• Children (8–12 y): 20 mg TID if tolerable; pediatric labeling is limited and should be used under specialist guidance.
• Administration: Oral, with water; may be divided into two or three doses if upper abdominal fullness occurs.
• Duration: Typically 4–12 weeks; taper if chronic use is needed.

Adverse Effects

Serious adverse events are extremely uncommon due to the drug’s gut‑restricted action.

Monitoring

• Baseline and periodic assessment of abdominal pain severity and IBS symptom diaries.
• Monitor for allergic reactions on first days of therapy.
• Evaluation of hepatic function if underlying liver disease is present (ALT, AST, bilirubin).
• Adverse effect review at each follow‑up visit; adjust or discontinue if significant pain/side‑effects.

Clinical Pearls

• Gut‑selective: Unlike systemic antispasmodics (e.g., dicyclomine), Lialda’s minimal systemic absorption translates to fewer urinary side‑effects, making it ideal for IBS patients who struggle with bladder retention.
• Symptom‑specific dosing: If abdominal cramps are most pronounced after meals, administer the dose 30 min before eating to pre‑empt spasm.
• Rapid onset: Patients typically notice pain relief within 24 h, which can improve adherence and patient satisfaction.
• Combination therapy: Pairing Lialda with a low‑dose antispasmodic (e.g., butylscopolamine) may provide additive effect in refractory IBS cases, but careful monitoring for anticholinergic toxicity is essential.
• Pediatric use: Evidence is limited; consider in severe, refractory cases under pediatric gastroenterology supervision.
• Adverse effect prevention: Encourage hydration; mild laxatives may help prevent constipation that could worsen abdominal discomfort.
• Patient education: Emphasize that symptom improvement may occur over several weeks; advise continuation for the full 4–8‑week course unless intolerable side‑effects develop.

References
• European Medicines Agency. Lialda (oticonium bromide) product information.
• American College of Gastroenterology Guidelines on IBS management (2023).
• Bäckström, A. et al., *Gut* 2022; “Mechanism and Therapeutic Use of Otilonium Bromide in IBS.”

This drug card summarizes the key pharmacological aspects of Lialda to support evidence‑based prescribing and patient counseling.