Oxazepam

Registered South African indications:

• Anxiety
• Alcohol withdrawal syndrome

Contraindications

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

Cautions

• Pregnancy
• Breastfeeding
• End-stage renal impairment (eGFR ≤10ml/min/1.73min²)
• Mild to moderate hepatic impairment
• Elderly
• Substance abuse
• Abrupt withdrawal
• Chronic respiratory impairment
• Psychosis
• Depression
• Narrow angle glaucoma
• Children
• Galactose intolerance
• Lapp lactase deficiency
• Glucose-galactose malabsoprtion
• May affect ability to drive and operate machinery

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

Anxiety
Symptoms of alcohol withdrawal

• Oral (tab): 15-30mg, 6-8hrly; Max treatment duration: 4 weeks

Should only be used if the disorder is severe, disabling or subjecting the individual to extreme distress

Lowest effective dose should be used for shortest time

Not established for use in children

Pregnancy

• Caution
• 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. The infant may also develop withdrawal symptoms during the postnatal period such as hypoactivity, hypotonia, hypothermia, respiratory depression, apnoea, feeding problems, and impaired metabolic response to cold stress
• Women of childbearing potential: If oxazepam is prescribed to a woman of childbearing potential, she should be warned about stopping oxazepam if she intends to become, or suspects that she is, pregnant

Breastfeeding

• Caution; not recommended
• The concentration of oxazepam and its conjugate in human breast milk is approximately 10% of the plasma level. Therefore, oxazepam should not be administered to breastfeeding mothers
• Following maternal use of some benzodiazepines, adverse events including drowsiness, lethargy or weight loss has been observed in breastfeeding infants

Renal Impairment

• eGFR ≥11-89ml/min/1.73min²: No dose adjustment recommended
• eGFR ≤10ml/min/1.73min²: Caution; dose adjustment recommended
  Max: 30mg/24hrs

Hepatic Impairment

• Mild to moderate: Caution; dose adjustment recommended
• Severe: Contraindicated

Elderly 

• Caution; no dose adjustment recommended
  Max: 60mg/24hrs
  Response to therapy may tend to occur slowly (due to tachyphylaxis), therefore treatment duration may be extended to 4-6 weeks
  Treat for the shortest possible therapy period

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Mild drowsiness
• Disorientation
• Nightmares
• Lethargy
• Amnesia 
• Numbed emotions
• Reduced alertness
• Restlessness
• Agitation
• Delusions
• Psychoses
• Inappropriate behaviour
• Paradoxical aggressive outbursts
• Excitement
• Hallucinations
• Confusion
• Unmasking of depression with suicidal tendencies
• Dizziness
• Ataxia
• Vertigo
• Headache
• Syncope
• Slurred speech
• Tremor
• Dysarthria

Cardiovascular Disorders

• Hypotension

Gastrointestinal Disorders

• Nausea
• Salivation changes

Hepatobiliary Disorders

• Increased hepatic enzymes
• Jaundice

Genitourinary Disorders

• Incontinence
• Urinary retention

Endocrine and Metabolic Disorders

• Altered libido

Musculoskeletal Disorders

• Muscle weakness

Skin and Subcutaneous Tissue Disorders

• Minor diffuse skin rashes

Immune, Blood and Lymphatic System Disorders

• Blood dyscrasias
• Leucopenia

Sensory Disorders

• Blurred vision
• Diplopia

• Central nervous system depressants
• CYP450 inhibitors
• Oestrogen-containing contraceptives
• Antibacterials
• Antivirals
• Antiepileptics
• Antihypertensives
• Dopaminergic agents
• Baclofen
• Probenecid

None routine. Specific cases may require

• Renal function
• Hepatic function
• Full blood count

Oxazepam exerts its anxiolytic effects by potentiating the effect of gamma aminobutyric acid (GABA) on GABA-A receptors. GABA receptors produce inhibitory postsynaptic potentials. Benzodiazepines exert their effect by increasing the effect of GABA at its receptor. The α2 subunit of the α2β3γ2 receptor complex mediates the anxiolytic effects of oxazepam while the α1 subunit of the α1β2γ2 receptor complex mediates sedative, anticonvulsant and anterograde amnesia effects of oxazepam.

Tablet 10mg

• Purata (Pharmacare)
• Serepax (Pharmacare)

Tablet 15mg

• Oxazepam (Sandoz)
• Purata (Pharmacare)
• Serepax (Pharmacare)
• Zimtec 15 (Arya Pharma)

Tablet 30mg

• Oxazepam (Sandoz)
• Purata (Pharmacare)
• Serepax Forte (Pharmacare)
• Zimtec 30 (Arya Pharma)