Chlordiazepoxide

Registered South African indications:

• Anxiety
• Muscle spasm

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Severe hepatic impairment
• Myasthenia gravis
• Severe pulmonary insufficiency
• Respiratory depression
• Sleep apnoea syndrome
• Phobic or obsessional states
• Chronic psychosis
• Spinal or cerebral ataxia

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Mild to moderate hepatic impairment
• Elderly
• Tolerance
• High doses
• Prolonged use
• Abrupt withdrawal
• History of alcoholism or drug abuse
• Personality disorders
• Children
• Psychotic, phobic or obsessive-compulsive disorders
• Depression
• Loss or bereavement
• Galactose intolerance
• Lapp lactase deficiency
• Glucose-galactose malabsorption

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

Anxiety
- Mild stress

• Oral (tab): 5-10mg, 8-12hrly; Max: 30mg/24hrs in divided doses

- Severe symptoms

• Oral (tab): 20mg, 6-12hrly; Max: 100mg/24hrs in divided doses

Insomnia associated with anxiety

• Oral (tab): 10-30mg, dly before bedtime

Symptomatic relief of acute alcohol withdrawal

• Oral (tab): Initial: 25-100mg; Repeated if necessary in 2-4hrs; Max: 300mg/24hrs

Muscle spasm
- Neurogenic or psychogenic

• Oral (tab): 10-30mg/day, in divided doses

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Duration of treatment should not exceed 4 weeks, including dose tapering

Paed. forms avail. in SA and covered in this monograph: tab

Anxiety

Younger than 6 years

• Not established for use

Older than 6 years

• Oral (tab): 5mg, 6-12hrly; Titrate to 10mg, 8-12hrly if needed

Pregnancy

• Caution; positive evidence of risk
• Chlordiazepoxide crosses the placenta
• There is a limited amount of data from the use of chlordiazepoxide in pregnant women
• Studies in animals have shown reproductive toxicity
• Chlordiazepoxide should not be used during pregnancy, especially during the first and last trimester unless the clinical condition of the woman requires treatment with chlordiazepoxide
• If the product is is prescribed to a woman of childbearing potential, she should be warned to contact her physician to discuss discontinuation of chlordiazepoxide if she intends to become or suspects that she is pregnant
• The administration of high doses or prolonged administration of low doses of benzodiazepines in the last trimester of pregnancy or during labour have been reported to produce irregularities in the foetal heart rate, moderate respiratory depression, hypotonia, poor sucking and hypothermia in the neonate. Moreover, infants born to mothers who chronically took benzodiazepines during the later stages of pregnancy may have developed physical dependence and may be at some risk for developing withdrawal symptoms in the postnatal period

Breastfeeding

• Caution; not recommended
• Chlordiazepoxide may appear in breast milk. If possible the use of chlordiazepoxide should be avoided during breastfeeding

Renal Impairment

• CrCl≥10 mL/minute: no dose adjustment recommended
• CrCl<10 mL/minute: Caution; dose adjustment recommended
  Reduce dose by 50%

Hepatic Impairment

• Mild (Child-Pugh Class A): No dose adjustment recommended
  Limit the use for acute (short) use
• Moderate (Child-Pugh Class B): Caution; dose adjustment recommended
  Limit the use to a maximum daily dose of 2-3 tablets/24 hrs
• Severe (Child-Pugh Class C): Contraindicated
  Use is not recommended
• Avoid the use of Chlordiazepoxide/ Clidinium preparations

Elderly

• Caution; dose adjustment recommended
  Limit use to the maximum of 2-3 tablets per day

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warning

Central Nervous System Disorders

• Amnesia
• Fatigue
• Hallucinations
• Dependence
• Depression
• Restlessness
• Agitation
• Irritability
• Depressed level of consciousness
• Aggression
• Delusion
• Nightmares
• Psychotic disorder
• Abnormal behaviour
• Emotional disturbances
• Paradoxical drug reaction
• Anxiety
• Sleep disorders
• Insomnia
• Suicide attempt
• Suicidal ideation
• Sedation
• Dizziness
• Unsteadiness
• Somnolence
• Ataxia
• Balance disorder
• Confusion
• Headache
• Vertigo
• Dysarthria
• Gait disturbance
• Extrapyramidal disorder
• Libido disorders

Cardiovascular Disorders

• Hypotension

Respiratory Disorders

• Respiratory depression

Gastrointestinal Disorders

• Changes in salivation
• Gastrointestinal upsets

Hepatobiliary Disorders

• Jaundice
• Increased blood bilirubin
• Increased transaminases
• Increased blood alkaline phosphatase

Genitourinary Disorders

• Urinary retention
• Incontinence
• Erectile dysfunction
• Menstrual disorder

Endocrine and Metabolic Disorders

• Increased appetite

Musculoskeletal Disorders

• Falls
• Fractures
• Muscle weakness

Skin and Subcutaneous Tissue Disorders

• Rash

Immune, Blood and Lymphatic System Disorders

• Bone marrow depression
• Thrombocytopenia
• Leukopenia
• Agranulocytosis
• Pancytopenia
• Anaphylactic reactions
• Angioedema
• Hypersensitivity

Sensory Disorders

• Visual impairment
• Diplopia

• Central nervous system depressants
• Sodium oxybate
• Antiepileptic agents
• Cimetidine
• Omeprazole
• Macrolide antiobiotics
• Disulfiram 
• Hormonal contraceptives 
• Enzyme inducers
• Centrally acting antihypertensive agents
• Beta blockers
• Anticoagulant agents
• Cardiac glycosides
• Levodopa
• Moxonidine
• Theophylline

None routine

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.

Film - coated tablet 25mg

• Librium 25 (Mylan) originator

COMBINATION PREPARATIONS

Chlordiazepoxide/ Clidinium

Tablet 5mg/2.5mg

• Librax (Meda) originator