Bromazepam

Registered South African indications:

• Anxiety

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Severe hepatic impairment
• Myasthenia gravis
• Narrow angle glaucoma
• Severe respiratory insufficiency
• Sleep apnoea syndrome
• Coadministration with benzodiazepines

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Mild to moderate hepatic impairment
• Elderly
• Cerebrovascular disease
• Depression
• Psychosis
• Suicidal ideation
• Substance abuse
• Chronic respiratory disease
• Debilitated patients
• Abrupt withdrawal
• Galactose intolerance
• Lapp lactase deficiency
• Glucose-galactose malabsorption
• May impair the ability to drive and operate machinery

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

Anxiety

• Oral (tab): Initial: 3mg, 8-12hrly; Titrate at intervals of 1 week; Maintenance: 6-30mg/day, in 2-3 divided doses

---

Only indicated when the disorder is severe, disabling or subjecting the individual to extreme stress

---

Treatment should be as short as possible and should not exceed 8-12 weeks

Not established for use in children

Pregnancy

• Caution; positive evidence of risk
• Studies in animals have revealed adverse effects on the foetus
• Benzodiazepines should not be used during pregnancy, especially during the first and last trimesters. Benzodiazepines may cause foetal damage when administered to pregnant women
• There is a possibility that infants born to mothers who take benzodiazepines chronically during the later stages of pregnancy may develop physical dependence. Infants of mothers who ingested benzodiazepines for several weeks or more preceding delivery have been reported to have withdrawal symptoms during the postnatal period. Symptoms such as hypoactivity, hypotonia, hypothermia, respiratory depression, apnoea, feeding problems, and impaired metabolic response to cold stress have been reported in neonates born of mothers who have received benzodiazepines during the late phase of pregnancy or at delivery

Breastfeeding

• Caution; not recommended
• Excretion of bromazepam and its metabolites in breast milk is expected. Mothers who are breastfeeding should not take benzodiazepines. Sedation and inability to suckle have occurred in neonates of breastfeeding mothers taking benzodiazepines

Renal Impairment

• Caution; no dose adjustment recommended
  Initiate at lower end of dosage range; titrate cautiously

Hepatic Impairment

• Mild to moderate: Caution; no dose adjustment recommended
  Initiate at lower end of dosage range; titrate cautiously
• Severe: Contraindicated

Elderly

• Caution; dose adjustment recommended
  Initial: 3mg daily; Titrate gradually according to response and tolerability

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Physical and psychological dependence
• Depressed level of consciousness
• Headache
• Dizziness
• Ataxia
• Anterograde amnesia
• Confusion
• Disordered libido
• Depression
• Restlessness
• Irritability
• Emotional lability
• Aggression
• Psychotic symptoms
• Nightmares
• Increased risk for hazardous sleep-related activities
• Fatigue
• Seizures

Cardiovascular Disorders

• Cardiac arrest
• Hypotension
• Palpitations
• Tachycardia

Respiratory Disorders

• Respiratory depression

Gastrointestinal Disorders

• Gastrointestinal distress
• Nausea and vomiting
• Xerostomia

Hepatobiliary Disorders

• Increased serum alkaline phosphatase
• Increased serum alanine aminotransferase
• Increased serum aspartate aminotransferase
• Increased serum bilirubin

Genitourinary Disorders

• Urinary incontinence

Endocrine and Metabolic Disorders

• Decreased serum glucose
• Increased serum glucose

Musculoskeletal Disorders

• Muscular weakness
• Increased risk for falls and fractures 
• Muscle spasm

Skin and Subcutaneous Tissue Disorders

• Pruritus
• Skin rash

Immune, Blood and Lymphatic System Disorders

• Decreased haematocrit
• Anaemia
• Decreased white cell count
• Increased white cell count

Sensory Disorders

• Diplopia
• Blurred vision

• Central nervous system depressants
• Oral anticoagulants
• Cimetidine
• Clozapine
• CYP1A2 inhibitors
• Fluvoxamine
• Olanzapine
• Theophylline derivatives
• Vemurafenib

None routine. Specific cases may require

• ECG
• Respiratory function
• Hepatic function 
• Full blood count

Bromazepam potentiates the activity of gamma aminobutyric acid, the major inhibitory neurotransmitter in the central nervous system.  This results in increased inhibition of the ascending reticular activating system, thereby blocking cortical and limbic arousal that occurs following stimulation of the reticular pathways  

Tablet 3mg

• Bromazepam 3 Kiara (Kiara Health)
• Brazepam (Pharmacare)
• Lexotan (Roche) originator
• Sandoz Bromazepam (Sandoz)

Tablet 6mg

• Bromazepam 6 Kiara (Kiara Health)
• Brazepam (Pharmacare)
• Bromaze (Sandoz)
• Lexotan (Roche) originator
• Sandoz Bromazepam (Sandoz)