Otilonium Bromide

Registered South African indications:

• Symptomatic treatment of established irritable bowel syndrome (IBS) associated with painful, spastic states of distal parts of the intestinal tract (colon and rectum), abdominal pain, distension, and motility disorders

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of its excipients

South African recommendations

Caution in the following patient groups

• Pregnancy
• Breastfeeding
• Glaucoma
• Prostatic hypertrophy
• Pyloric stenosis

Excipient cautions

• The formulation contains lactose. Patients with rare hereditary conditions such as galactose intolerance (e.g., galactosemia), lactase deficiency, or glucose-galactose malabsorption should not take otilonium bromide

Ability to drive and use machines

• Otilonium bromide has no or negligible influence on the ability to drive and use machines

Forms avail. in SA and covered in this monograph: fct

South African registered indications and dosages

Symptomatic treatment of established irritable bowel syndrome (IBS) associated with painful, spastic states of distal parts of the intestinal tract (colon and rectum), abdominal pain, distension, and motility disorders

• Oral (fct): 40mg, 2-3 times daily (80-120mg, daily); Depending on the clinical picture and response to treatment and in accordance with therapeutic guidelines for the treatment of irritable bowel syndrome; Treatment duration: ≤25 weeks

Doctors should periodically assess the need for continued treatment. Safety and efficacy have not been shown beyond 25 weeks

Pharmacological treatment of irritable bowel syndrome should be started only after previously introduced non-pharmacological measures, such as lifestyle changes, dietary modifications, emotional support, and psychotherapy, have been considered and found insufficient in achieving the desired therapeutic effect

Tablets should be swallowed whole, with a glass of water, preferably 20 minutes before meals

Not recommended for use in children below 18 years

Pregnancy

South African recommendations

• Caution
• There is no clinical data about the use of otilonium bromide in pregnant women
• Animal studies did not show embryotoxic, teratogenic or mutagenic effects or reproductive or developmental toxicity
• Otilonium bromide should only be recommended to pregnant women if absolutely necessary and under close medical supervision

Breastfeeding

South African recommendations

• Caution
• There is no clinical data about the use of otilonium bromide in lactating women
• Animal studies did not show embryotoxic, teratogenic or mutagenic effects or reproductive or developmental toxicity
• Otilonium bromide should only be recommended to nursing women if absolutely necessary and under close medical supervision

Fertility

South African recommendations

• No information available

South African recommendations

• No dose adjustment recommended

South African recommendations

• No dose adjustment recommended

South African recommendations

• No dose adjustment recommended

Nervous System Disorders

Uncommon

• Headache

Ear and Labyrinth Disorders

Uncommon

• Vertigo

Gastrointestinal Disorders

Uncommon

• Dry mouth
• Nausea
• Upper abdominal pain

Skin and Subcutaneous Tissue Disorders

Uncommon

• Pruritus
• Erythema

Not known

• Skin hypersensitivity reactions (post-marketing surveillance)
  • Urticaria
  • Angioedema

General Disorders and Administration Site Conditions

Uncommon

• Fatigue
• Asthenia

None known

None routine

Otilonium bromide acts predominantly by modifying Ca²⁺ ion fluxes from cellular and extracellular sites and therefore reduces the trigger of contractile activity. It inhibits opening of L-type Ca-channels and Ca²⁺ ions entry into intestinal smooth muscle cells. The additional pharmacodynamic effect is achieved by inhibition of tachykinin and muscarinic receptors.