A fixed-dose combination (FDC) of three distinct pharmacological agents used primarily for the management of functional gastrointestinal disorders (FGIDs) like Irritable Bowel Syndrome (IBS) and related conditions. Clidinium and Dicyclomine are anticholinergic/antispasmodic agents that reduce gastrointestinal smooth muscle spasms and secretions. Chlordiazepoxide is a benzodiazepine anxiolytic that addresses the psychosomatic and anxiety components often associated with these disorders. This combination is indicated for conditions where both visceral hypersensitivity and psychological stress are contributing factors. Its use is now more restricted due to the risk of dependence from the benzodiazepine component.
Adult: One tablet three or four times daily, preferably 30-60 minutes before meals and at bedtime. The dose should be individualized. Maximum: 4 tablets per day. Therapy should be initiated at the lowest effective dose and for the shortest duration possible (typically 2-4 weeks).
Note: Take orally with a full glass of water. Can be taken with or without food, but taking before meals may improve symptom control during digestion. Do not crush or chew. Avoid taking with alcohol or grapefruit juice.
This combination exerts a dual therapeutic effect: 1) Peripheral anticholinergic/antispasmodic action on the GI smooth muscle and glands (Clidinium & Dicyclomine), and 2) Central anxiolytic and mild sedative action (Chlordiazepoxide). The anticholinergics competitively inhibit acetylcholine at muscarinic receptors in the GI tract, reducing tone, amplitude, and frequency of peristaltic contractions, and decreasing gastric secretions. Chlordiazepoxide potentiates the effect of the inhibitory neurotransmitter GABA at the GABA-A receptor in the CNS, producing calming effects which can break the brain-gut axis dysfunction common in functional GI disorders.
Pregnancy: Category D (US FDA). Contraindicated, especially in first trimester. Benzodiazepines may cause fetal harm (risk of cleft lip/palate, floppy infant syndrome if used near term). Anticholinergics may cause fetal tachycardia, meconium ileus. Use only if potential benefit justifies clear risk to fetus.
Driving: Patients should NOT drive or operate heavy machinery, especially when starting therapy or if experiencing drowsiness, dizziness, or blurred vision. Effects may be potentiated by alcohol.
| Alcohol, Opioids, Barbiturates, other CNS Depressants | Additive CNS and respiratory depression. Increased risk of sedation, dizziness, and accidents. | Major |
| Other Anticholinergics (e.g., Atropine, TCAs, Antihistamines, Antipsychotics) | Additive anticholinergic side effects (dry mouth, constipation, urinary retention, confusion, tachycardia). | Major |
| Potent CYP3A4 Inhibitors (Ketoconazole, Itraconazole, Clarithromycin, Ritonavir) | Increased plasma levels and toxicity of Chlordiazepoxide (prolonged sedation, ataxia). | Major |
| CYP3A4 Inducers (Rifampicin, Carbamazepine, Phenytoin, St. John's Wort) | Decreased plasma levels and efficacy of Chlordiazepoxide. | Moderate |
| Levodopa | Reduced gastrointestinal absorption and efficacy of Levodopa. | Moderate |
| Digoxin | Increased bioavailability of Digoxin due to reduced GI motility. | Moderate |
| Metoclopramide | Pharmacological antagonism; reduces prokinetic effect. | Moderate |
Same composition (Clidinium (2.5mg) + Chlordiazepoxide (5mg) + Dicyclomine (10mg)), different brands: