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Presentation

Oral formulations of lorazepam.

Drugs List

  • lorazepam 1mg tablets
  • lorazepam 1mg/ml oral solution sugar-free
  • lorazepam 2.5mg tablets
  • lorazepam 500microgram tablets
  • Therapeutic Indications

    Uses

    Anxiety disorders: short term management
    Insomnia (short-term treatment)
    Premedication - sedative

    Unlicensed Uses

    Nausea and vomiting following cancer chemotherapy or irradiation

    Dosage

    Treatment duration should not exceed four weeks including a tapering off period. Use beyond four weeks should not take place without re-evaluation of the patients need for continued therapy.

    Adults

    Moderate to severe anxiety
    1mg to 4mg daily in divided doses.

    For orodispersible tablets the maximum daily dose is 7.5mg.

    Insomnia
    1mg to 2mg before retiring.

    For orodispersible tablets the maximum daily dose is 7.5mg.

    Premedication before surgery
    2mg to 3mg the night before the operation, and then 2mg to 4mg one to two hours before surgery.

    Elderly

    Initially use half the normal adult dose and adjust according to individual patient response.

    Children

    Premedication Before Surgery
    Children aged 12 to 18 years
    1mg to 4mg at least 1 hour before surgery.
    The same dose may be administered the night before in addition to or to replace the dose before surgery.

    Children aged 5 to 13 years
    Tablets are unlicensed for use in children under 5 years.

    50 micrograms/kg to a maximum of 2.5mg at least 1 hour before surgery.

    The following dosing schedule may also be suitable:
    Children aged 1 month to 12 years
    Tablets are unlicensed for use in children under 5 years.
    50 micrograms/kg to 100 micrograms/kg at least 1 hour before surgery. The same dose may be administered the night before in addition to or to replace the dose before surgery. Maximum of 4mg per dose.

    Lorazepam is not recommended for the treatment of anxiety or insomnia in children.

    Contraindications

    Acute pulmonary disease
    Breastfeeding
    History of alcohol abuse
    History of drug misuse
    Myasthenia gravis
    Obsessional states
    Pregnancy
    Respiratory depression
    Severe hepatic impairment
    Sleep apnoea

    Precautions and Warnings

    Children under 18 years
    Debilitation
    Elderly
    Females of childbearing potential
    Suicidal ideation
    Acute narrow angle glaucoma
    Depression
    Galactosaemia
    Glucose-galactose malabsorption syndrome
    Hypotension
    Lactose intolerance
    Mild hepatic impairment
    Personality disorder
    Renal impairment

    Reduce dose in patients with hepatic impairment
    Reduce dose in patients with renal impairment
    Advise impaired alertness may affect ability to drive or operate machinery
    Advise patient not to drive until they know how the medicine affects them
    Advise patient this medicine is subject to driving restrictions
    For use only under medical supervision
    Not suitable as sole treatment of depression or anxiety with depression
    Oral solution contains alcohol
    Some formulations contain lactose
    Evaluate treatment efficacy regularly
    Monitor haematological parameters periodically
    Potential for drug abuse
    Tolerance and dependence may occur
    Amnesia may occur
    Psychological adjustment may be impaired in loss or bereavement
    Avoid abrupt withdrawal
    Discontinue if paradoxical reactions occur
    Limit prescribing quantity due to suicide risk
    Maintain treatment at the lowest effective dose
    Not licensed for all indications in all age groups
    Reduce dose in elderly
    Avoid repeated or prolonged use
    Not recommended for use longer than 4 weeks
    Only recommended for short term use
    Advise patient to avoid alcohol during treatment
    Advise that effects are potentiated by CNS depressants (including alcohol)
    Advise patient to avoid grapefruit products
    Female: Ensure adequate contraception during treatment
    Advise patient of increased risk of falls
    Advise patient on possible rebound phenomena on withdrawal

    Patients treated for insomnia due to anxiety, should ensure they have a period of uninterrupted sleep (7 to 8 hours).

    Pregnancy and Lactation

    Pregnancy

    Lorazepam is contraindicated during pregnancy.

    The manufacturers do not recommend using lorazepam during pregnancy, particularly during the first and last trimester.

    Women of childbearing potential should contact their physician regarding the continued use of lorazepam if she is or wishes to become pregnant.

    At the time of writing, infants born to mothers taking lorazepam during the later stages of pregnancy may develop physical dependence or withdrawal symptoms during the postnatal period. Symptoms like hypoactivity, hypotonia, hypothermia, respiratory depression, apnea, feeding problems and impaired metabolic response to cold stress have been reported.

    Lactation

    Lorazepam is contraindicated during breastfeeding.

    The manufacturers do not recommend the use of lorazepam during breastfeeding due to the risk of sedation and inability to suckle in neonates of lactating mothers.

    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

    Side Effects

    Aggression
    Agitation
    Agranulocytosis
    Allergic dermatitis
    Altered liver function tests
    Anaphylactoid reaction
    Anaphylaxis
    Anterograde amnesia
    Apnoea
    Asthenia
    Ataxia
    Behavioural disturbances
    Blurred vision
    Changes in libido
    Coma
    Confusion
    Constipation
    Daytime sedation
    Delusions
    Dependence
    Depression
    Diplopia
    Disinhibition
    Disturbances of appetite
    Dizziness
    Drowsiness
    Dysarthria
    Euphoria
    Exacerbation of obstructive pulmonary disease
    Extrapyramidal effects
    Fatigue
    Hallucinations
    Headache
    Hypersensitivity reactions
    Hyponatraemia
    Hypotension
    Hypothermia
    Impaired memory
    Impotence
    Inappropriate secretion of antidiuretic hormone
    Insomnia
    Irritability
    Leucopenia
    Muscle weakness
    Nausea
    Nightmares
    Numbed emotions
    Orgasmic dysfunction
    Pancytopenia
    Paradoxical reactions
    Pre-existing depression may be unmasked
    Psychosis
    Rages
    Rash
    Reduced alertness
    Respiratory depression
    Restlessness
    Salivation changes
    Sedation
    Sleep apnoea
    Sleep disturbances
    Slurred speech
    Suicidal tendencies
    Thrombocytopenia
    Tremor
    Visual disturbances
    Withdrawal symptoms

    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 ).

    Further Information

    Last Full Review Date: April 2020

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

    Summary of Product Characteristics: Lorazepam 0.5mg tablets. Advanz Pharma. Revised April 2019.

    Summary of Product Characteristics: Lorazepam 1mg/ml Oral Solution. Thame Laboratories. Revised November 2016.

    Summary of Product Characteristics: Lorazepam 1mg tablets. Genus Pharmaceuticals. Revised October 2019.

    Summary of Product Characteristics: Lorazepam 1mg orodispersible tablets. Aristo Pharma GmbH. Revised March 2019.

    Summary of Product Characteristics: Lorazepam 2.5mg orodispersible tablets. Aristo Pharma GmbH. Revised March 2019.

    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: 12 June 2019

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 15 April 2021

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