RxIndia
Loading clinical data...
Loading clinical data...
Authoritative Clinical Reference
| Formulation | Strengths | Availability Status |
| Clidinium bromide tablets (single entity) | — | NOT AVAILABLE in India |
| Clidinium + Chlordiazepoxide tablets (FDC) | 2.5 mg + 5 mg | Available |
Important Note: Clidinium is NOT available as a single-entity formulation in India. It is marketed ONLY as a fixed-dose combination (FDC) with chlordiazepoxide. All dosing information below refers to this FDC.
Using FDC: Clidinium 2.5 mg + Chlordiazepoxide 5 mg
| Parameter | Recommendation |
| Starting dose | 1 tablet (Clidinium 2.5 mg + Chlordiazepoxide 5 mg) orally twice daily before meals |
| Titration | May increase to three times daily based on tolerance and symptom response |
| Usual maintenance dose | 1 tablet orally 2–3 times daily, before meals and at bedtime |
| Maximum dose | 4 tablets/day (Clidinium 10 mg/day) |
| Parameter | Recommendation |
| Starting dose | 1 tablet orally twice daily |
| Titration | Increase to 3 times daily if required |
| Usual maintenance dose | 1 tablet 2–3 times daily before meals |
| Maximum dose | 4 tablets/day |
| Indication | Dose | Duration | Notes |
| Peptic ulcer disease – adjunctive (OFF-LABEL) | 1 tablet 2–3 times daily before meals | Short-term (1–2 weeks) | Largely obsolete; PPIs and H. pylori eradication are first-line; historical use only |
| Functional dyspepsia with anxiety (OFF-LABEL) | 1 tablet 2–3 times daily | Short-term trial (2–4 weeks) | Specialist only; consider when psychogenic overlay suspected |
| Renal Function | Recommendation |
| Mild impairment (eGFR 60–89) | No specific adjustment; use with caution |
| Moderate impairment (eGFR 30–59) | Use with caution; increased risk of anticholinergic and CNS effects |
| Severe impairment (eGFR <30) | Avoid; poor clearance may lead to drug accumulation |
| Dialysis | Avoid; no specific data available |
| Hepatic Function | Recommendation |
| Mild impairment | Use with caution; monitor for enhanced sedation (chlordiazepoxide component) |
| Moderate impairment | Avoid unless essential; significantly reduced benzodiazepine clearance |
| Severe impairment | Contraindicated — risk of hepatic encephalopathy from benzodiazepine component |
| Aspect | Recommendation |
| Overall safety | Avoid — benzodiazepine component associated with potential fetal harm |
| Risk category | Not formally classified; benzodiazepines are generally Category D equivalent |
| First trimester | Contraindicated — risk of congenital malformations with benzodiazepines |
| Third trimester/peripartum | Risk of neonatal withdrawal syndrome, floppy infant syndrome |
| Preferred alternatives | Mebeverine; hyoscine butylbromide (short-term) |
| Monitoring | Fetal movements; neonatal observation if inadvertent exposure near delivery |
| Aspect | Recommendation |
| Compatibility | Not recommended |
| Reason | Chlordiazepoxide excreted in breast milk; may cause infant sedation |
| Clidinium in milk | Limited data; anticholinergic effects possible |
| Effect on lactation | May suppress milk production (anticholinergic effect) |
| Preferred alternatives | Mebeverine; hyoscine butylbromide (if short-term antispasmodic needed) |
| Infant monitoring | Sedation, poor feeding, lethargy, poor weight gain |
| Aspect | Recommendation |
| Starting dose | 1 tablet once daily (lowest effective dose) |
| Titration | Very slow; increase only after 3–5 days if tolerated |
| Key risks | Confusion, delirium, hallucinations, falls, urinary retention, constipation, paradoxical agitation |
| Benzodiazepine concerns | Increased sensitivity; higher risk of falls and cognitive impairment |
| General guidance | Avoid if possible; prefer mebeverine or hyoscine butylbromide as alternatives |
| Interacting Drug/Class | Effect | Management |
| CNS depressants (opioids, alcohol, other benzodiazepines, sedating antihistamines) | Additive CNS and respiratory depression | Avoid combination; if essential, use lowest doses with close monitoring |
| MAO inhibitors | Risk of enhanced CNS effects; potential hypertensive crisis | Avoid combination |
| Other anticholinergics (TCAs, antihistamines, antipsychotics) | Additive anticholinergic toxicity | Avoid combination; assess total anticholinergic burden |
| Ketoconazole, itraconazole, erythromycin (CYP3A4 inhibitors) | Increased chlordiazepoxide levels | Monitor for enhanced sedation; consider dose reduction |
| Interacting Drug/Class | Effect | Management |
| Prokinetics (metoclopramide, domperidone) | Pharmacodynamic antagonism (opposing GI effects) | Avoid co-prescription for same indication |
| Warfarin | Possible altered INR (chlordiazepoxide interaction) | Monitor INR more frequently |
| Antacids | May reduce clidinium absorption | Separate administration by 1–2 hours |
| Rifampicin | May reduce chlordiazepoxide efficacy (CYP induction) | Monitor for reduced effect |
| Levodopa | Reduced levodopa efficacy (anticholinergic effect) | Avoid in Parkinson’s patients |
| Adverse Effect | Clinical Notes |
| Acute angle-closure glaucoma | Medical emergency; discontinue immediately; urgent ophthalmology referral |
| Severe urinary retention | May require catheterisation; discontinue drug |
| Toxic megacolon | Rare but serious; discontinue; surgical consultation |
| Confusion, delirium, hallucinations | More common in elderly; discontinue immediately |
| Paradoxical reactions (agitation, aggression) | Discontinue; more common in elderly and children |
| Benzodiazepine dependence | Risk with use >4 weeks; gradual taper required on discontinuation |
| Withdrawal syndrome | Seizures, rebound anxiety if abruptly stopped after prolonged use |
| Hepatic dysfunction | Rare; discontinue if jaundice or elevated LFTs occur |
| Phase | Parameters |
| Baseline | Rule out glaucoma, prostatic hypertrophy, GI obstruction; assess mental status; LFTs if prolonged use planned |
| After initiation | Response assessment at 1–2 weeks; monitor bowel habits, CNS effects, urinary symptoms |
| Long-term (if used >4 weeks) | LFTs periodically; assess for dependence; plan tapering strategy; reassess continued need |
| Brand Name | Manufacturer | Composition |
| Librax® | Abbott | Clidinium 2.5 mg + Chlordiazepoxide 5 mg |
| Spaslibrax® | Sun Pharma | Clidinium 2.5 mg + Chlordiazepoxide 5 mg |
| Normaxin® | Intas | Clidinium 2.5 mg + Chlordiazepoxide 5 mg |
| Clidium Plus® | Various | Clidinium 2.5 mg + Chlordiazepoxide 5 mg |
Note: All marketed products in India are FDCs. Single-entity clidinium is NOT available.
| Formulation | Approximate Price |
| Clidinium + Chlordiazepoxide tablet (FDC) | ₹4–₹10 per tablet |
This platform is designed strictly for healthcare professionals. Data provided is synthesized from authoritative pharmacological sources and clinical registries. Do not use for consumer medical decisions. Always verify critical dosing and contraindications with official institutional protocols and peer-reviewed journals.
Help us improve our clinical database for the medical community.