Drugs List

Therapeutic Indications

Uses

Short-term relief (2 to 4 weeks only) of disabling or distressing anxiety alone or in association with insomnia.

Administration

For oral use.

Contraindications

Respiratory depression
Acute pulmonary insufficiency
Severe hepatic impairment
Phobic or obsessional states/chronic psychoses
Myasthenia gravis
Sleep apnoea syndrome
Children under 18 years
Galactosaemia

Precautions and Warnings

Prolonged use may result in dependence and/or resistance to treatment. The risk of dependence increases with dose and duration of treatment.
Patients with a history of drug or alcohol abuse are more susceptible to dependence.

Once physical dependence has developed abrupt treatment cessation can result in withdrawal symptoms
The lowest dose should be used to control symptoms to avoid withdrawal phenomena - see Withdrawal symptoms .

Anterograde amnesia may occur. This occurs most often several hours after administration. In order to reduce the risk patients should ensure a good period of uninterrupted sleep (7-8 hours) after the dose.

Oxazepam may impair alertness and cause sedation. Patients should be advised not to drive or operate machinery if affected.

Paradoxical reactions such as restlessness, irritability, aggressiveness, delusion, rage, nightmares, hallucinations, psychoses or inappropriate behaviour may be seen, particularly in children or the elderly. Discontinue oxazepam if such reactions occur.

Alcohol may enhance the sedative effects of oxazepam. Concomitant use should be avoided.

A reduced dose is recommended for patients with chronic respiratory insufficiency due to the risk of respiratory depression.

Elderly patients may be more sensitive to benzodiazepines therefore reduced doses are recommended. See Dosage - Elderly .

Pregnancy - see Pregnancy section.
Breastfeeding - see Lactation section.

Use with caution in renal impairment. See Dosage - Patients with Renal Impairment .

Use with caution hepatic impairment. See Dosage - Patients with Hepatic Impairment .

Oxazepam should not be used alone to treat depressed patients. The use of benzodiazepines may have a disinhibiting effect and may release suicidal tendencies in depressed patients.

Oxazepam is not intended for the primary treatment of psychotic illness.

Use with caution in patients with acute narrow angle glaucoma.

Hypotension is a rare side-effect of oxazepam. Use with caution in patients in whom a drop in blood pressure might lead to cardiovascular or cerebrovascular complications.

Periodic blood and hepatic function assessments are recommended where repeat courses of treatment are considered clinically appropriate.

Tablets contain lactose. Use with caution in patients with glucose-galactose malabsorption syndrome or lactose intolerance.

Pregnancy and Lactation

Pregnancy

Not recommended for use in pregnancy. The manufacturer states that if used in late pregnancy or during labour, adverse effects such as hypothermia, hypotonia and respiratory depression would be expected in the neonate. Physical dependence on benzodiazepines would be expected in infants born to mothers who have taken benzodiazepines chronically during pregnancy, and such infants may be at risk of developing withdrawal symptoms postnatally. Schaefer concludes that benzodiazepines may be used during pregnancy when absolutely necessary ensuring that the lowest possible dose for the shortest duration is prescribed. Observation of the neonate for respiratory depression, withdrawal and adaptation problems is advised. However Briggs (2011) considers that, use of benzodiazepines during pregnancy may cause malformations and growth retardations of the foetus (predominantly cardiac, facial and oral cleft malformations), as a result of benzodiazepines crossing the placenta.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use with caution during breastfeeding.

The manufacturer advises against the use of oxazepam during breastfeeding. Oxazepam is excreted into the breast milk at concentrations approximately 10% of the plasma level.

However, the American Drugs and Lactation Database LactMed concludes that the low level of oxazepam in breast milk is not expected to cause any adverse effects in breastfed infants with usual maternal dosages and no special precautions are required.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Dependence
Drowsiness
Light headedness
Dizziness
Ataxia
Vertigo
Headache
Syncope
Hypotension
Blurred Vision
Disorientation
Vivid dreams
Fever
Excitation
Morbilliform rash
Gastro intestinal disturbances
Urinary incontinence
Aggressive outbursts
Confusion
Depression
Urticaria
Rash
Altered libido
Nausea
Oedema
Slurred speech
Tremor
Blood dyscrasias
Increased liver enzymes
Jaundice
Leucopenia
Amnesia
Muscle weakness
Salivation changes
Dysarthria
Urinary retention
Hallucinations
Suicidal tendencies
Lethargy
Fatigue
Reduced alertness
Numbed emotions
Changes in appetite
Sleep disturbances
Visual disturbances
Restlessness
Agitation
Irritability
Delusion
Rage
Nightmares
Psychoses
Abnormal behaviour
Memory impairment

Presentation

Tablets containing oxazepam 10mg
Tablets containing oxazepam 15mg

Drugs List

Therapeutic Indications

Uses

Short-term relief (2 to 4 weeks only) of disabling or distressing anxiety alone or in association with insomnia.

Dosage

Adults

Elderly

Children

Patients with Renal Impairment

Patients with Hepatic Impairment

Additional Dosage Information

Administration

For oral use.

Contraindications

Respiratory depression
Acute pulmonary insufficiency
Severe hepatic impairment
Phobic or obsessional states/chronic psychoses
Myasthenia gravis
Sleep apnoea syndrome
Children under 18 years
Galactosaemia

Precautions and Warnings

Prolonged use may result in dependence and/or resistance to treatment. The risk of dependence increases with dose and duration of treatment.
Patients with a history of drug or alcohol abuse are more susceptible to dependence.

Once physical dependence has developed abrupt treatment cessation can result in withdrawal symptoms
The lowest dose should be used to control symptoms to avoid withdrawal phenomena - see Withdrawal symptoms .

Anterograde amnesia may occur. This occurs most often several hours after administration. In order to reduce the risk patients should ensure a good period of uninterrupted sleep (7-8 hours) after the dose.

Oxazepam may impair alertness and cause sedation. Patients should be advised not to drive or operate machinery if affected.

Paradoxical reactions such as restlessness, irritability, aggressiveness, delusion, rage, nightmares, hallucinations, psychoses or inappropriate behaviour may be seen, particularly in children or the elderly. Discontinue oxazepam if such reactions occur.

Alcohol may enhance the sedative effects of oxazepam. Concomitant use should be avoided.

A reduced dose is recommended for patients with chronic respiratory insufficiency due to the risk of respiratory depression.

Elderly patients may be more sensitive to benzodiazepines therefore reduced doses are recommended. See Dosage - Elderly .

Pregnancy - see Pregnancy section.
Breastfeeding - see Lactation section.

Use with caution in renal impairment. See Dosage - Patients with Renal Impairment .

Use with caution hepatic impairment. See Dosage - Patients with Hepatic Impairment .

Oxazepam should not be used alone to treat depressed patients. The use of benzodiazepines may have a disinhibiting effect and may release suicidal tendencies in depressed patients.

Oxazepam is not intended for the primary treatment of psychotic illness.

Use with caution in patients with acute narrow angle glaucoma.

Hypotension is a rare side-effect of oxazepam. Use with caution in patients in whom a drop in blood pressure might lead to cardiovascular or cerebrovascular complications.

Periodic blood and hepatic function assessments are recommended where repeat courses of treatment are considered clinically appropriate.

Tablets contain lactose. Use with caution in patients with glucose-galactose malabsorption syndrome or lactose intolerance.

Pregnancy and Lactation

Pregnancy

Not recommended for use in pregnancy. The manufacturer states that if used in late pregnancy or during labour, adverse effects such as hypothermia, hypotonia and respiratory depression would be expected in the neonate. Physical dependence on benzodiazepines would be expected in infants born to mothers who have taken benzodiazepines chronically during pregnancy, and such infants may be at risk of developing withdrawal symptoms postnatally. Schaefer concludes that benzodiazepines may be used during pregnancy when absolutely necessary ensuring that the lowest possible dose for the shortest duration is prescribed. Observation of the neonate for respiratory depression, withdrawal and adaptation problems is advised. However Briggs (2011) considers that, use of benzodiazepines during pregnancy may cause malformations and growth retardations of the foetus (predominantly cardiac, facial and oral cleft malformations), as a result of benzodiazepines crossing the placenta.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use with caution during breastfeeding.

The manufacturer advises against the use of oxazepam during breastfeeding. Oxazepam is excreted into the breast milk at concentrations approximately 10% of the plasma level.

However, the American Drugs and Lactation Database LactMed concludes that the low level of oxazepam in breast milk is not expected to cause any adverse effects in breastfed infants with usual maternal dosages and no special precautions are required.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Effects on Ability to Drive and Operate Machinery

This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988 (England and Wales). This medicine may be subject to police testing and has specified maximum blood levels for driving. When prescribing this medicine: Advise patient the medicine can affect cognitive function and is likely to affect ability to drive. Advise patient not to drive until they know how the medicine affects them. It is an offence to drive while under the influence of this medicine. However, a patient is not committing an offence (called 'statutory defence') if: 1.The medicine has been prescribed to treat a medical or dental problem and 2.The medicine has been taken according to the instructions given by the prescriber and/or in the information provided with the medicine and 3.The medicine was not affecting the ability to drive safely. For further guidance see https://www.gov.uk

Counselling

Advise patient that treatment is a short term and that the dosage will be gradually reduced before stopping completely.

Patients should also be made aware that there is a possibility of rebound phenomena, and withdrawal symptoms.

Oxazepam may impair alertness and cause sedation. Patients should be advised not to drive or operate machinery if affected.

Alcohol may enhance the sedative effects of oxazepam. Concomitant use should be avoided.

Side Effects

Dependence
Drowsiness
Light headedness
Dizziness
Ataxia
Vertigo
Headache
Syncope
Hypotension
Blurred Vision
Disorientation
Vivid dreams
Fever
Excitation
Morbilliform rash
Gastro intestinal disturbances
Urinary incontinence
Aggressive outbursts
Confusion
Depression
Urticaria
Rash
Altered libido
Nausea
Oedema
Slurred speech
Tremor
Blood dyscrasias
Increased liver enzymes
Jaundice
Leucopenia
Amnesia
Muscle weakness
Salivation changes
Dysarthria
Urinary retention
Hallucinations
Suicidal tendencies
Lethargy
Fatigue
Reduced alertness
Numbed emotions
Changes in appetite
Sleep disturbances
Visual disturbances
Restlessness
Agitation
Irritability
Delusion
Rage
Nightmares
Psychoses
Abnormal behaviour
Memory impairment

Withdrawal Symptoms and Signs

Symptoms may be difficult to distinguish from the original symptoms of anxiety as they can manifest as:-
Rebound anxiety
Rebound depression
Headache
Insomnia
Tension
Sweating
Persistent tinnitus
Involuntary movements
Paraesthesia
Perceptual changes
Confusion
Convulsions
Muscle cramps
Abdominal cramps
Vomiting
Muscle pain
Restlessness
Irritability
Mood changes

In severe cases symptoms of withdrawal can be seen as:-
Derealisation
Depersonalisation
Numbness and tingling of extremities
Hypersensitivity to light, noise and physical contact
Hallucinations
Epileptic seizures
Hyperacusis

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Shelf Life and Storage

Store in a dry place below 25 degrees C.

Further Information

Last Full Review Date: August 2012

Reference Sources

British National Formulary, 63rd Edition (2012) Pharmaceutical Press, London.

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Summary of Product Characteristics: Oxazepam Tablets BP 10mg. Actavis UK Ltd. Revised May 2011.
Summary of Product Characteristics: Oxazepam Tablets BP 15mg. Actavis UK Ltd. Revised May 2011.

Summary of Product Characteristics: Oxazepam Tablets 10mg. Genus Pharmaceuticals Holdings Limited. Revised September 2011.
Summary of Product Characteristics: Oxazepam Tablets 15mg. Genus Pharmaceuticals Holdings Limited. Revised February 2009.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Oxazepam. Last revised: May 3, 2012
Last accessed: August 3, 2012

Gov.uk. Government departments. Department for Transport. Publications. Drug driving and medicine: advice for healthcare professionals. Drug driving: Guidance for healthcare professionals on drug driving. Available at: https://www.gov.uk Last accessed: 6 January 2015