A fixed-dose combination (FDC) of a benzodiazepine (Diazepam) and an anticholinergic/antispasmodic (Dicyclomine). Primarily used for the short-term management of anxiety disorders and for the symptomatic relief of conditions involving smooth muscle spasm of the gastrointestinal tract, particularly when anxiety is a significant co-factor. The combination aims to provide both anxiolytic and antispasmodic effects, targeting the brain-gut axis. Its use is restricted due to the risk of dependence, sedation, and anticholinergic side effects.
Adult: One tablet (Diazepam 2mg + Dicyclomine 20mg) two to three times daily. The lowest effective dose for the shortest duration should be used. Maximum: 3 tablets per day. Duration should not exceed 2-4 weeks without re-evaluation.
Note: Take orally with or without food. Food may delay absorption but does not significantly affect overall bioavailability. Swallow whole with a glass of water. Do not crush or chew. Avoid taking immediately before bedtime if only daytime anxiety/spasm is targeted, due to drowsiness.
The combination exerts synergistic effects on symptoms arising from anxiety-induced visceral hypersensitivity and smooth muscle spasm. Diazepam potentiates the effect of the inhibitory neurotransmitter GABA at the GABA-A receptor in the CNS, leading to anxiolysis, sedation, and muscle relaxation. Dicyclomine acts as a competitive antagonist at muscarinic (M1, M3) receptors on smooth muscle cells in the gastrointestinal tract, inhibiting acetylcholine-mediated contractions, thereby relieving spasm and associated pain.
Pregnancy: CONTRANDICATED, especially first trimester. Diazepam: FDA Pregnancy Category D. Risk of fetal malformations (cleft lip/palate), neonatal flaccidity, withdrawal symptoms. Dicyclomine: Associated with fetal harm. Use only if potential benefit justifies extreme risk to fetus.
Driving: STRONGLY NOT ADVISED. Causes drowsiness, dizziness, blurred vision, and impaired judgment and motor coordination. Patients should not drive or operate heavy machinery until effect is known.
| Alcohol, Opioids (e.g., Codeine, Tramadol) | Profound additive CNS and respiratory depression. Risk of coma and death. | Major |
| Other CNS Depressants (Antipsychotics, Antihistamines, Barbiturates) | Increased sedation, dizziness, impaired motor skills. | Major |
| CYP3A4 Inhibitors (Ketoconazole, Itraconazole, Clarithromycin, Ritonavir) | Increased Diazepam levels, prolonged sedation and side effects. | Major |
| CYP3A4 Inducers (Rifampicin, Carbamazepine, Phenytoin, St. John's Wort) | Decreased Diazepam levels, reduced efficacy. | Moderate |
| Other Anticholinergics (Amitriptyline, Oxybutynin, Trihexyphenidyl) | Additive anticholinergic side effects (dry mouth, constipation, urinary retention, confusion). | Major |
| Levodopa | Dicyclomine may reduce gastric motility and absorption of Levodopa. | Moderate |
| Digoxin | Anticholinergics may increase serum Digoxin levels by decreasing gut motility. | Moderate |
| Metoclopramide | Pharmacological antagonism; Dicyclomine opposes prokinetic effect. | Moderate |
Same composition (Diazepam (2mg) + Dicyclomine (20mg)), different brands: