Veron

Approved Indications:

• Irritable Bowel Syndrome (IBS):
  Symptomatic treatment of abdominal pain, bowel spasm, bloating, and diarrhea or constipation associated with IBS.
• Spastic Colitis / Mucous Colitis / Spastic Constipation:
  Relief of colonic spasm and associated symptoms.
• Diverticular Disease:
  Management of symptoms caused by muscular spasm in diverticular disease of the colon.

Clinically Accepted Off-label Uses:

• Biliary Tract Spasm:
  Sometimes used to relieve spasm in biliary disorders (as adjunct therapy).

Route: Oral. Swallow tablets/capsules whole with water; do not chew or crush.

Adults and Elderly:

• 135 mg Tablets:
  135 mg three times daily, preferably 20 minutes before meals.
• 200 mg Modified-release Capsules:
  200 mg twice daily, usually morning and evening.

Pediatric Use:

• Children under 10 years: Not recommended due to lack of safety data.
• Children aged ≥10 years: Use only under specialist supervision; adult dosage may be considered in adolescents.

Renal Impairment:

• No dosage adjustment generally required; monitor in severe impairment.

Hepatic Impairment:

• Use with caution in severe hepatic impairment; no dosage adjustment needed in mild to moderate cases.

Mebeverine is a musculotropic antispasmodic agent that acts directly on the smooth muscle of the gastrointestinal tract. It relieves painful muscle spasms without affecting normal gut motility. It achieves this by modulating calcium influx and inhibiting sodium channels in smooth muscle cells, leading to membrane stabilization and muscle relaxation. Unlike anticholinergic agents, it does not produce systemic anticholinergic side effects such as dry mouth, blurred vision, or urinary retention.

• Absorption: Rapid and complete absorption after oral administration.
• Distribution: Primarily confined to the gastrointestinal tract; plasma protein binding is high.
• Metabolism: Undergoes extensive first-pass metabolism in the liver to inactive metabolites (including veratric acid).
• Half-life: Approximately 2.5 hours (for active metabolites).
• Excretion: Excreted mainly via the kidneys as metabolites; negligible unchanged drug in urine.
• Bioavailability: Not significantly altered by food; modified-release form ensures sustained plasma levels.

• Pregnancy: No formal FDA pregnancy category assigned. Animal studies have not shown teratogenic effects, but human data are limited. Use only if clearly needed and under medical supervision.
• Lactation: Unknown whether excreted into human milk. Due to low systemic levels, risk to nursing infant is likely low; use caution.

• Primary Class: Antispasmodic
• Subclass: Musculotropic gastrointestinal smooth muscle relaxant (non-anticholinergic)

• Known hypersensitivity to mebeverine or any component of the formulation
• Paralytic ileus
• Intestinal obstruction
• Galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption (with lactose-containing formulations)

• Rule out Organic Disease: Ensure no serious underlying pathology (e.g., colorectal cancer or IBD) before initiating therapy.
• Abrupt Symptom Change: New or worsening symptoms (e.g., rectal bleeding, weight loss) should prompt reassessment.
• Children under 10 years: Safety and efficacy not established.
• Driving & Machinery: No known effects; drug is non-sedative.

Gastrointestinal:

• Nausea
• Indigestion
• Abdominal discomfort

Allergic Reactions:

• Rash
• Urticaria
• Angioedema
• Anaphylactic reactions (very rare)

Neurological (rare):

• Dizziness
• Headache

Adverse effects are generally mild and transient.

• No significant drug-drug interactions known.
• Does not affect or inhibit cytochrome P450 enzymes (e.g., CYP3A4).
• Can be used safely with most commonly prescribed drugs, including proton pump inhibitors, antibiotics, and antidepressants.

• No recent FDA or EMA warnings or safety alerts.
• Continues to be supported in updated NICE and ACG guidelines as a preferred antispasmodic option in IBS treatment.
• Preferred over anticholinergic drugs due to better tolerability and absence of systemic side effects.

• Temperature: Store below 25°C.
• Humidity: Protect from moisture.
• Light: Store in original packaging to protect from light.
• Handling: No special precautions.
• Oral Suspension (if applicable): Shake well before use; follow label instructions for shelf life post-opening.