Chlordiazepoxide/ Clidinium

Registered South African indications:

• Irritable bowel syndrome

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Myasthenia gravis
• Glaucoma
• Prostatic hyperplasia 
• Benign bladder neck obstruction
• Paralytic ileus
• Psychosis

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Hot weather and/or exercise
• Depression
• History of drug or alcohol abuse
• Impaired gag reflex
• Respiratory disease
• Debilitated patients
• Risk of falls
• Abrupt withdrawal
• Children
• Prolonged use
• May impair ability to drive and operate machinery

Forms avail. in SA and covered in this monograph: tab

Irritable bowel syndrome - severe
- Short term treatment of non-ulcerated irritable bowel syndrome associated with anxiety, tension or apprehension in adults

Chlordiazepoxide/ Clidinium
5/2.5 (mg)

• Oral (tab): 1 tab, 6-8hrly; Max: 8 tabs/24hrs

Administer before meals and at bedtime

The overall duration of treatment should not generally exceed 8-12 weeks, including a tapering off process

Not established for use in children

Pregnancy

• Caution
• In animals studies, reproductive toxicity was not observed. Safety in human pregnancy has not been established. Clidinium/chlordiazepoxide should only be considered if benefits of treatment of the mother outweigh any potential risks to the infant

Breastfeeding

• Caution; not recommended
• Chlordiazepoxide is known to be excreted in breast milk. As with other antihistamines, clidinium may have an inhibitory effect on the production of breast milk

Renal Impairment

• Caution; no dose adjustment recommended

Hepatic Impairment

• Caution; no dose adjustment recommended

Elderly

• Caution; dose adjustment recommended
  Initial: Dosage should not exceed 2 tabs daily; Titrate gradually as needed and tolerated

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Ataxia
• Confusion
• Drowsiness
• Extrapyramidal reactions
• Syncope

Gastrointestinal Disorders

• Constipation
• Nausea
• Xerostomia

Hepatobiliary Disorders

• Hepatic insufficiency
• Jaundice

Immune, Blood and Lymphatic System Disorders

• Agranulocytosis
• Haematologic disease

• Aclidinium
• Azelastine
• Blonanserin
• Buprenorphine
• Chlormethiazole
• Cimetropium
• Clozapine
• Conivaptan
• CYP3A4 inducers
• CYP3A4 inhibitors
• Dabrafenib
• Droperidol
• Eluxadoline
• Enzalutamide
• Flunitrazepam
• Fusidic acid
• Glucagon
• Glycopyrrolate
• Hydrocodone
• Idelalisib
• Ipratropium
• Levosulpiride
• Methadone
• Methotrimeprazine
• Mifepristone
• Mitotane
• Olanzapine
• Opioid analgesics
• Orphenadrine
• Oxatomide
• Oxomemazine
• Oxycodone
• Paraldehyde
• Perampanel
• Potassium chloride
• Potassium citrate
• Pramlintide
• Secretin
• Sodium oxybate
• St John's wort
• Stiripentol
• Suvorexant
• Tapentadol
• Thalidomide
• Theophylline derivatives
• Tiotropium
• Umeclidinium
• Zolpidem

• Full blood count
• Hepatic function
• Mental status

Chlordiazepoxide
Chlordiazepoxide binds to gamma-aminobutyric acid (GABA) receptor complexes in the limbic system and reticular formation of the brain. This enhances the inhibitory activity of GABA, and results in the sedative, hypnotic, anxiolytic, and muscle relaxant properties of chlordiazepoxide.

Clidinium
Clidinium antagonises M1 muscarinic receptors at postganglionic parasympathetic neuroeffector sites, inhibiting the muscarinic actions of acetylcholine.

COMBINATION PREPARATIONS

Chlordiazepoxide/ Clidinium

Tablet 5mg/2.5mg

• Librax (Mylan) originator