1. Clinical Overview
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.
| Onset | Duration | Bioavailability |
|---|---|---|
| Diazepam: Oral: 30 to 60 minutes. Dicyclomine: Oral: 1 to 2 hours. | Diazepam: Variable, active metabolites prolong effect to 24-48 hours or more. Dicyclomine: 4 to 6 hours. | Diazepam: Oral: 93-100%. Dicyclomine: Oral: ~67%. |
2. Mechanism of Action
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.
3. Indications & Uses
- Severe acute anxiety disorders with pronounced somatic (especially GI) symptoms
- Acute panic attacks with severe autonomic hyperactivity and GI spasms
- Pre-procedural sedation and anxiolysis in highly anxious patients (short-term)
4. Dosage & Administration
Adult Dosage: 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.
Administration: 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.
5. Side Effects
Common side effects may include:
- Drowsiness, sedation, fatigue
- Dizziness, lightheadedness
- Dry mouth
- Blurred vision
- Constipation
- Ataxia (unsteadiness)
- Muscle weakness
6. Drug Interactions
| Drug | Effect | Severity |
|---|---|---|
| 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 |
7. Patient Counselling
- DO take exactly as prescribed, never increase dose or frequency.
- DO NOT consume alcohol or other sedatives.
- DO NOT drive, operate machinery, or engage in hazardous activities for 24-48 hours.
- DO inform all doctors and dentists about this medication.
- DO NOT stop abruptly after prolonged use; taper under medical guidance to avoid withdrawal.
- DO store in a safe place, away from others, especially children and individuals with substance abuse history.
8. Toxicology & Storage
Overdose: Manifestations of Diazepam overdose (dominant): Profound sedation, confusion, coma, diminished reflexes, respiratory depression, apnea, hypotension, cardiac arrest. Dicyclomine contributes: Flushed skin, hyperthermia, tachycardia, urinary retention, dilated pupils.
Storage: Store below 30°C, in a cool, dry place. Protect from light and moisture. Keep in the original container, tightly closed. Keep out of reach of children and in a locked cabinet if possible due to abuse potential. Do not use after the expiry date.