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Parenteral formulations of diazepam.

Drugs List

  • diazepam 10mg/2ml injection (solution)
  • Therapeutic Indications


    Acute alcohol withdrawal
    Anxiety state (severe) - short term relief
    Control of muscle spasm in tetanus
    Epileptic convulsions
    Febrile convulsions
    Muscle spasms
    Premedication for anaesthesia
    Sedation for surgical and diagnostic procedures
    Status epilepticus


    To reduce likelihood of adverse effects, administer intravenous injections slowly (1ml/minute). Keep the patient supine for an hour after administration.

    During prolonged administration, the dose should be decreased after 6 to 7 days to reduce the likelihood of accumulation and prolonged central nervous system depression.

    Doses may vary with age, weight and individual patient response.


    Severe acute anxiety and acute muscle spasms
    10mg administered by intravenous or intramuscular injection. Repeat in intervals of at least 4 hours.
    10mg administered by intravenous injection. Repeat in intervals of at least 4 hours.

    Agitation associated with delirium tremens
    10mg to 20mg administered by intravenous or intramuscular injection.
    10mg administered by intravenous injection. Repeat in intervals of at least 4 hours.

    0.1mg/kg to 0.3mg/kg bodyweight administered intravenously. Repeated at intervals of 1 to 4 hours.
    Or administer by a continuous intravenous infusion of 3mg/kg to 10mg/kg bodyweight over a period of 24 hours.

    Status epilepticus or epileptic convulsions
    Initial dose: 0.15mg/kg to 0.25mg/kg bodyweight (usually 10mg to 20 mg) administered by intravenous injection.
    If considered necessary, the dose may be repeated after 30 to 60 minutes, followed by a slow intravenous infusion of a maximum dose of 3mg/kg bodyweight, over a period of 24 hours to prevent recurrence of seizures.

    The following alternative dosing schedule may be suitable:
    10mg administered intravenously, at a rate of 1ml/minute. If necessary repeat after 10 minutes.

    Pre-operative medication or sedation
    0.1mg/kg to 0.2mg/kg bodyweight (usually 10mg to 20mg) administered by intravenous injection.


    It is recommended doses should not exceed half the adult dosage.


    Some formulations of the injection solution contain benzyl alcohol and are therefore contraindicated in neonates and are considered less suitable for children under 3 years of age. When a parenteral preparation is unavoidable, the emulsion formulation is preferred.

    Status epilepticus, epileptic or febrile convulsions
    0.2mg/kg to 0.3mg/kg bodyweight administered by intravenous or intramuscular injection. Alternatively, administer 1mg per each year of life. Repeat after 30 to 60 minutes.

    The following alternative dosing schedule may be suitable:
    Children aged 12 to 18 years
    10mg, administered intravenously over a period of 3 to 5 minutes. If necessary repeat after 10 minutes.
    Children aged 1 month to 12 years
    300micrograms/kg to 400 micrograms/kg administered intravenously, over a period of 3 to 5 minutes. If necessary repeat after 10 minutes.
    Maximum of 10mg per dose.

    Children aged 1 month to 18 years
    (See Dosage; Adults).

    Pre-operative medication or premedication
    Maximum dose of 0.2mg/kg bodyweight, administered by slow intravenous or intramuscular injection.


    Some formulations of the injection solution contain benzyl alcohol and are therefore contraindicated in neonates, when a parenteral preparation is unavoidable, the emulsion formulation is preferred.

    Status epilepticus, convulsions caused by poisoning and febrile convulsions (unlicensed)
    300micrograms/kg to 400 micrograms/kg administered intravenously, over a period of 3 to 5 minutes. If necessary repeat after 10 minutes.

    Patients with Renal Impairment

    The Renal Drug Handbook makes the following dosage recommendations:

    GFR 20ml/minute to 50 ml/minute: Dose as in normal renal function.
    GFR less than 20 ml/minute: Reduce dose and titrate according to individual patient response.


    Intravenous injection can be irritant and may cause venous thrombosis. The thrombosis may not become apparent until several days after the injection. Intravenous injection should be given slowly at a rate of 1ml per minute into a large vein (for example, the antecubital fossa) whilst the patient is in a supine position.

    It is advisable to keep the patient supine for at least an hour after administration.

    Emulsion injection:
    Can be administered by intravenous injection or intravenous infusion or by injection into the tubing of an ongoing infusion of sodium chloride 0.9% or dextrose 5% or dextrose 10%. Other routes are contraindicated.

    Solution injection:
    The injection solution may be administered by intramuscular, intravenous injection or intravenous infusion.

    As absorption is painful, slow and erratic, the intramuscular route should only be employed when alternative routes are not possible.


    Acute respiratory impairment
    Chronic psychosis
    Myasthenia gravis
    Obsessional states
    Phobic states
    Respiratory depression
    Severe hepatic impairment
    Severe respiratory impairment
    Sleep apnoea

    Precautions and Warnings

    Children under 3 years
    Females of childbearing potential
    Cardiorespiratory insufficiency
    Cerebral arteriosclerosis
    Chronic respiratory impairment
    History of alcohol abuse
    History of drug misuse
    Mild hepatic impairment
    Organic brain syndrome
    Personality disorder
    Renal impairment

    Reduce dose in patients with hepatic impairment
    Reduce dose in patients with renal impairment
    Advise patient ability to drive or operate machinery may be impaired
    Advise patient not to drive until they know how the medicine affects them
    Advise patient this medicine is subject to driving restrictions
    Not all available brands are licensed for all age groups
    Not all available brands are licensed for all routes of administration
    Not suitable as sole treatment of depression or anxiety with depression
    Some formulations contain egg phospholipids
    Some formulations contain propylene glycol
    Some presentations may contain benzyl alcohol
    Some products may contain soya or soya derivative
    Patient should remain under medical supervision for 1 hour after injection
    Resuscitation facilities must be immediately available
    Refer women considering pregnancy for specialist advice and monitoring
    Tolerance and dependence may occur
    Amnesia may occur
    Potential for withdrawal symptoms
    Psychological adjustment may be impaired in loss or bereavement
    Withdraw gradually after long-term use
    Discontinue if paradoxical reactions occur
    Reduce dose in debilitated patients
    Reduce dose in elderly
    Avoid long term use
    Advise patient not to take St John's wort concurrently
    Advise patient to avoid alcohol during treatment
    Advise patient grapefruit products may increase plasma level
    Advise patient to ensure 7- 8 hours of uninterrupted sleep/rest post dose

    Diazepam may induce anterograde amnesia which occurs most frequently several hours after a dose. To reduce the risk patients should ideally ensure they can have uninterrupted sleep for 7 to 8 hours after a dose.

    Use with caution in patients with cardiorespiratory insufficiency, as the limits of tolerance may be very wide in this patient group and dosage adjustment should be considered.

    Use with caution in patients with organic brain disease, particularly arteriosclerosis as the limits of tolerance may be very wide in this patient group and dosage adjustment should be considered.

    Benzodiazepines should be used to treat insomnia only when it is severe, disabling, or subjecting the individual to extreme distress.

    Emulsion formulation (Diazemuls) caution in children under 3.

    Solution formulation is contraindicated in neonates, as some formulations contain benzyl alcohol.

    Pregnancy and Lactation


    Caution is advised in the use of diazepam during pregnancy.

    Both diazepam and its metabolites cross the placenta and accumulate in the foetus,

    There may be a small increased risk of congenital malformation (such as oral cleft) if benzodiazepines are used during the first trimester of pregnancy.

    Diazepam may alter thermogenesis, cause loss of beat-to-beat variability in the foetal heart rate and decrease foetal movements.

    Animal studies indicate that low dosages may permanently modify downstream responses to benzodiazepine receptors so altering selected behaviours. This raises concerns that long lasting effects on the central nervous system could be possible.

    If, for compelling reasons, diazepam is administered during the late phase of pregnancy or during labour at high doses, effects on the neonate such as hypothermia, hypotonia and moderate respiratory depression can be expected due to the pharmacological action of the drug.

    Infants born to mothers who take benzodiazepines chronically during the latter stages of pregnancy may develop physical dependence and may be at some risk for developing withdrawal symptoms in the postnatal period. This may manifest as intrauterine growth retardation, irritability, restlessness, tremors, muscular hypertonia, vigorous sucking, vomiting, diarrhoea, and convulsions.
    A 'floppy infant syndrome' has also been reported, with hypotonia, lethargy, disturbances of temperature regulation and weak suckling, sometimes lasting for several months.
    A dose-response relationship is considered likely, as complications in the newborn are observed more frequently with higher doses or extended exposure. Exposed newborns should be monitored during the first days of life.

    Schaefer concludes that exposure to benzodiazepines such as diazepam, is not an indication for termination of pregnancy, noting that in cases of long term abuse or high doses during organogenesis a detailed foetal ultrasound should be offered. In later pregnancy, monitoring of foetal motor patterns can be performed (Schaefer 2007).

    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 ( ) or if this is unavailable at the backup site ( ).


    Diazepam is not recommended for use during breastfeeding.

    Diazepam, and its active metabolite nordiazepam are present in breast milk and accumulate in the serum of breastfed infants with repeated doses. Effects reported as seen in exposed infants include: weight loss, lethargy and a depressed EEG consistent with sedation, mild jaundice, sedation.

    Both diazepam and nordiazepam have long half lives, therefore, timing of breastfeeding in relation to dosing will not usually reduce infant exposure.

    Most authors conclude that single maternal doses (for example, for sedation before a procedure) should not affect an infant but advise caution and possible delay of resumption of breastfeeding by 6-8 hours.

    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

    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

    Side Effects

    Accidental injury
    Anterograde amnesia
    Behavioural disturbances
    Blood dyscrasias
    Cardiac arrest
    Changes in libido
    Chest pain
    Dry mouth
    Erythema at injection site
    Gastro-intestinal disturbances
    Hangover effects
    Hypersensitivity reactions
    Increases in hepatic enzymes
    Muscle weakness
    Numbed emotions
    Paradoxical reactions
    Reduced alertness
    Reproductive disorders
    Respiratory depression
    Salivation changes
    Skin reactions
    Sleep disturbances
    Slurred speech
    Urinary retention
    Venous thrombosis
    Visual disturbances
    Withdrawal symptoms


    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 ( ) or if this is unavailable at the backup site ( ).

    The MHRA have produced 'generic' overdose sections for the top ten drugs for which the NPIS received the greatest number of queries about management of overdose in 2002. This information is attached below:

    Signs and Symptoms

    Benzodiazepines commonly cause drowsiness, ataxia, dysarthria and nystagmus. Coma, hypotension and respiratory depression occasionally occur but are seldom serious if these drugs are taken alone. Coma usually lasts only a few hours but in elderly people it may be more protracted and cyclical. Benzodiazepine respiratory depressant effects are more serious in patients with severe chronic respiratory disease.

    Benzodiazepines potentiate the effects of other central nervous system depressants, including alcohol.


    Consider activated charcoal in adults or children who have taken more than 1 mg/kg within 1 hour, provided they are not too drowsy. Gastric lavage is unnecessary if these drugs have been taken alone. Patients who are asymptomatic at four hours are unlikely to develop symptoms. Institute supportive measures as indicated by the patient's clinical state.

    If CNS depression is severe consider the use of flumazenil (Anexate), a benzodiazepine antagonist. This should rarely be required. It has a short half-life (about an hour) and should NOT TO BE USED IN MIXED OVERDOSE OR AS A "DIAGNOSTIC" TEST. It is contraindicated in the presence of drugs that reduce seizure threshold (e.g. tricyclic antidepressants).

    Further Information

    Last Full Review Date: September 2014

    Reference Sources

    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

    Injectable Medicines Administration Guide, 3rd edition (2010) UCL NHS Foundation Trust. Wiley-Blackwell, Oxford.

    Summary of Product Characteristics: Diazemuls. Actavis. Revised May 2017.

    Summary of Product Characteristics: Diazepam injection. Wockhardt. Revised May 2017.

    Summary of Product Characteristics: Diazepam injection. Hameln Pharmaceuticals. Revised December 2015.

    The Renal Drug Handbook. 3rd edition. (2009) ed. Ashley, C and Currie, Radcliffe Publishing Ltd, Abingdon.

    Drugs in Lactation Database, LactMed, diazepam record, Revised 27 December 2007.
    Available at :
    Accessed 4 September 2014.

    European Porphyria Network
    Available at:
    Last accessed: September 4, 2014. 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: Last accessed: 6 January 2015

    MHRA ( Generic Overdose sections based on Toxbase for Diazepam/Temazepam
    Available at:
    Last updated 19 September 2005, accessed September 2014.

    NICE - Evidence Services
    Available at:
    Last accessed: 27 June 2017.

    The Drug Data Base for Acute Porphyria
    Available at:
    Diazepam last revised: March 21, 2012
    Last accessed: 4 September, 2014.

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