A fixed-dose combination of a high-dose benzodiazepine (Diazepam) and an anticholinergic/antispasmodic agent (Dicyclomine). Diazepam acts as a central nervous system depressant, producing anxiolytic, sedative, muscle relaxant, and anticonvulsant effects. Dicyclomine acts peripherally to relieve smooth muscle spasm in the gastrointestinal and genitourinary tracts. The combination is primarily used for severe, acute anxiety states with pronounced somatic symptoms, particularly gastrointestinal spasms. The 80mg dose of Diazepam is exceptionally high and is intended for severe, acute conditions under strict medical supervision, not for chronic management.
Adult: ONE tablet (Diazepam 80mg + Dicyclomine 10mg/20mg) as a single dose. May be repeated ONLY under direct medical supervision, not more than once in 24 hours. Duration should not exceed 3-5 days. This is a crisis dose, not for maintenance.
Note: Take orally with a full glass of water. Can be taken with or without food, but food may delay absorption. Tablet should be swallowed whole. Do not crush or chew. Administer at bedtime or when patient can remain sedentary for 8-12 hours due to profound sedation. Do not operate machinery for at least 24 hours.
Diazepam potentiates the effects of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA) at the GABA-A receptor complex in the central nervous system, leading to neuronal hyperpolarization and reduced neuronal excitability. Dicyclomine competitively antagonizes acetylcholine at muscarinic receptors (M1, M2, M3) on smooth muscle cells in the gastrointestinal and genitourinary tracts, directly relaxing spasms and reducing motility and secretions.
Pregnancy: CATEGORY D (Diazepam). Evidence of human fetal risk. Contraindicated, especially in first trimester (risk of cleft lip/palate) and near term (risk of floppy infant syndrome, withdrawal in neonate).
Driving: SEVERELY IMPAIRED. Do not drive or operate heavy machinery for at least 24-48 hours after a dose. Judgment, reaction time, and motor coordination are significantly affected.
| Alcohol, Opioids (e.g., Codeine, Tramadol) | Profound additive CNS and respiratory depression. Potentially fatal. | Contraindicated |
| Other CNS Depressants (Antipsychotics, Antihistamines, Barbiturates) | Increased sedation, dizziness, respiratory risk. | Major |
| CYP3A4 Inhibitors (Ketoconazole, Clarithromycin, Ritonavir) | Markedly increased Diazepam levels, toxicity risk. | Major |
| CYP2C19 Inhibitors (Omeprazole, Fluoxetine) | Increased Diazepam levels. | Moderate |
| Anticholinergics (Amitriptyline, Oxybutynin) | Additive anticholinergic effects (dry mouth, constipation, urinary retention, confusion). | Moderate |
| Levodopa | Dicyclomine may reduce gastric motility and absorption of Levodopa. | Moderate |
Same composition (Diazepam (80mg) + Dicyclomine (NA)), different brands: