Oxazepam

If the product is prescribed to a woman of childbearing potential, she should be warned to contact her physician regarding discontinuance of the product if she intends to become or suspects that she is pregnant.

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 took 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.

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 breast-feeding mothers.

Sedation, amnesia, dizziness and impaired muscular function may adversely affect the ability to drive or use machines. If insufficient sleep occurs, the likelihood of impaired alertness may be increased.

This medicine can impair cognitive function and can affect a patient’s ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told:

*The medicine is likely to affect your ability to drive

• Do not drive until you know how the medicine affects you
• It is an offence to drive while under the influence of this medicine
• However, you would not be committing an offence (called ‘statutory defence’) if:
  • The medicine has been prescribed to treat a medical or dental problem and
  • You have taken it according to the instructions given by the prescriber and in the information provided with the medicine and
  • It was not affecting your ability to drive safely

Blood and lymphatic system disorders: Blood dyscrasias, leucopenia

Psychiatric disorders: Mild drowsiness*, disorientation, dreams, †nightmares, lethargy, amnesia (see below), mild excitatory effects with stimulation of effect**, numbed emotions, reduced alertness, †restlessness, †agitation, †irritability, †delusions, †rages, †psychoses, †inappropriate behaviour, behavioural adverse effects including paradoxical †aggressive outbursts, excitement, †hallucinations, confusion, uncovering of depression with suicidal tendencies***.

^† These are more likely to occur in children and the elderly.

Nervous system disorders: Dizziness, light-headedness*, ataxia, vertigo, headache, syncope, slurred speech, tremor, dysarthria.

Eye disorders: Blurred vision, double vision.

Vascular disorders: Hypotension.

Gastrointestinal disorders: Nausea, salivation changes, gastro-intestinal disturbances.

Hepatobiliary disorders: Increased liver enzymes, jaundice.

Skin and subcutaneous tissue disorders: Minor diffuse skin rashes (morbilliform, urticarial and maculopapular).

Musculoskeletal and connective tissue disorders: Muscle weakness.

Renal and urinary disorders: Incontinence, urinary retention.

Reproductive system and breast disorders: Altered libido.

General disorders and administration site conditions: Fever, oedema, fatigue.

Injury, poisoning and procedural complications: Fall.

^* Commonly seen in the first few days of therapy. If this becomes troublesome dosage should be reduced.
^** Reported in psychiatric patients and usually occur within the first few weeks of therapy.
^*** Extreme caution should therefore be exercised in prescribing benzodiazepines to patients with personality disorders.

Amnesia

Anterograde amnesia may occur using therapeutic dosages, the risk increasing at higher dosages. Amnesic effects may be associated with inappropriate behaviour.

Dependence

When used at the appropriate recommended dosage for short term treatment of anxiety the dependence potential of oxazepam is low. However, the risk of dependence increases with higher doses and longer-term use and is further increased in patients with a history of alcoholism, drug abuse or in patients with marked personality disorders.

Withdrawal

As with all benzodiazepines, withdrawal may be associated with physiological and psychological symptoms including depression, persistent tinnitus, involuntary movements, paraesthesia, perceptual changes, confusion, convulsions, muscle cramps, abdominal cramps and vomiting.

Symptoms such as anxiety, depression, headache, insomnia, tension and sweating have been reported following abrupt discontinuation of benzodiazepines and these symptoms may be difficult to distinguish from the original symptoms of anxiety.