Diazepam rectal tubes
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Rectal solution containing diazepam.
Drugs List
Therapeutic Indications
Uses
Anxiety state (severe) - short term relief
Control of muscle spasm in tetanus
Febrile convulsions
Premedication - sedative
Status epilepticus
Dosage
Adults
The manufacturer recommends a dose of 0.5mg/kg. As diazepam rectal tubes are provided in fixed unit doses, rounding upward to the next available dose may be required.
It is recommended maximum dose should not exceed 30mg unless monitoring is available by a medical professional. Doses can be repeated every 12 hours.
The following alternative dosing schedule may be suitable:
Status epilepticus and febrile convulsion
10mg to 20mg, repeated after 10 to 15 minutes if required.
If convulsions are not controlled other anticonvulsant measures may be used.
Elderly
The manufacturer recommends a dose of 0.25mg/kg. As diazepam rectal tubes are provided in fixed unit doses, rounding upward to the next available dose may be required.
It is recommended maximum dose should not exceed 30mg unless monitoring is available by a medical professional. Doses can be repeated every 12 hours.
The following alternative dosing schedule may be suitable:
Status epilepticus and febrile convulsion
10mg repeated after 10 to 15 minutes if required.
If convulsions are not controlled other anticonvulsant measures may be used.
Children
Children aged 1 to 18 years
(See Dosage; Adult)
The following alternative dosing schedule may be suitable:
Status epilepticus and febrile convulsion
Children aged 12 to 18 years
10mg to 20mg. Dose may be repeated once after 10 minutes, if considered necessary.
Children aged 2 to 12 years
5mg to 10mg. Dose may be repeated once after 10 minutes, if considered necessary.
Children aged 1 month to 2 years (unlicensed in children below 1 year)
5mg. Dose may be repeated once after 10 minutes, if considered necessary.
Neonates
The following unlicensed dosing schedule may be suitable:
Status epilepticus and febrile convulsion (unlicensed)
1.25mg to 2.5mg. Dose may be repeated once after 10 minutes, if considered necessary.
Additional Dosage Information
During administration, adults should be in the lateral position and children in the prone or lateral position.
Contraindications
Acute porphyria
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 1 year
Debilitation
Elderly
Breastfeeding
Cerebral arteriosclerosis
Chronic respiratory impairment
Hepatic impairment
History of alcohol abuse
History of drug misuse
Organic brain syndrome
Personality disorder
Pregnancy
Renal impairment
Reduce dose in patients with hepatic impairment
Sodium content of formulation may be significant
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 suitable as sole treatment of depression or anxiety with depression
May contain sodium benzoate: mild mucous membrane irritant
Some formulations contain propylene glycol
Some presentations may contain benzyl alcohol
Monitor for mental changes, suicidal depression and antisocial behaviour
Monitor patient for signs and symptoms of respiratory depression
Monitor patients with a history of alcoholism and drug abuse
Monitor patients with marked personality disorders
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
Limit prescribing quantity due to suicide risk
Maintain treatment at the lowest effective dose
Reduce dose in debilitated patients
Reduce dose in elderly
Avoid long term use
Advise that effects are potentiated by CNS depressants (including alcohol)
Advise patient grapefruit products may increase plasma level
Advise patient on possible rebound phenomena on withdrawal
Advise patient to ensure 7- 8 hours of uninterrupted sleep/rest post dose
Care should be taken if switching from diazepam to a benzodiazepine with a shorter duration of action.
Withdrawal symptoms may occur after abrupt discontinuation, patients who have a history of seizures, alcohol or drug abuse may experience convulsions.
Dependence of diazepam increases with duration and dose of treatment, therefore patients must be evaluated before 4 weeks of treatment and regularly thereafter. Treatment should not last longer than 8 to 12 weeks including the tapering off process. If it is necessary to continue treatment re-evaluation must take place.
Monitor patients requiring chronic dosing, dose adjustment may be required due to accumulation.
A reduced dose is recommended for people at risk of chronic respiratory insufficiency.
Pregnancy and Lactation
Pregnancy
Use diazepam with caution during pregnancy.
Manufacturers recommend not using diazepam during the 1st and 3rd trimesters of pregnancy unless the benefits outweigh the risks.
Advise women of child bearing potential requiring regular diazepam to discuss withdrawal of diazepam if they should wish to become, or discover they are, pregnant.
Available reports indicate a small increased risk of congenital malformation, such as oral cleft, if benzodiazepines are used during the first trimester of pregnancy. Exposure in the later stages of pregnancy or during labour at high doses may have effects on the neonate such as hypothermia, hypotonia, moderate respiratory depression, foetal heart irregularities and poor suckling can be expected due to the pharmacological action of the drug. Infants born to mothers who took benzodiazepines chronically during the latter stages of pregnancy may have developed physical dependence and may be at some risk for developing withdrawal symptoms in the postnatal period.
Lactation
Use diazepam with caution during breastfeeding.
Manufacturers do not recommend breastfeeding whilst taking diazepam. Available data indicates diazepam is expressed in the milk of breast feeding mothers, the quantity is unknown. As such, diazepam may be used with caution when breastfeeding. LactMed suggests using alternative treatments but allows breastfeeding to be resumed if only a single dose of diazepam has been taken before a procedure or for a seizure.
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
Abdominal cramps
Aggression
Agitation
Anaphylaxis
Angioedema
Anterograde amnesia
Anxiety
Apnoea
Ataxia
Behavioural disturbances
Blood dyscrasias
Blurred vision
Bradycardia
Cardiac failure
Changes in libido
Chest pain
Concentration disturbances
Confusion
Constipation
Convulsions
Decreased appetite
Delirium
Delusions
Dependence
Depression
Diarrhoea
Diplopia
Disinhibition
Dizziness
Drowsiness
Dry mouth
Dysarthria
Dystonia
Epigastric pain
Epileptic seizures
Euphoria
Excitation
Fatigue
Gastro-intestinal disturbances
Gynaecomastia
Hallucinations
Hangover effects
Headache
Hostility
Hyperkinesia
Hypersensitivity reactions
Hypotension
Impotence
Incontinence
Increased appetite
Increased bronchial secretions
Increases in hepatic enzymes
Insomnia
Irritability
Jaundice
Laryngeal spasm
Light-headedness
Malaise
Menstrual disturbances
Motor disturbances
Muscle spasm
Muscle weakness
Myasthenia
Nausea
Nightmares
Numbed emotions
Nystagmus
Obstipation
Palpitations
Paradoxical reactions
Psychosis
Rash
Reduced alertness
Respiratory arrest
Respiratory depression
Restlessness
Salivation changes
Sedation
Sensory disturbances
Skin reactions
Sleep disturbances
Slurred speech
Suicidal tendencies
Sweating
Syncope
Tachycardia
Taste disturbances
Thrombocytopenia
Tinnitus
Tremor
Unconsciousness
Unsteady gait
Urinary retention
Urticaria
Vertigo
Visual disturbances
Vomiting
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: July 2018
Reference Sources
Summary of Product Characteristics: Diazepam RecTubes 2.5 mg. Wockhardt UK Ltd. Revised January 2020.
Summary of Product Characteristics: Diazepam RecTubes 5 mg. Wockhardt UK Ltd. Revised January 2020.
Summary of Product Characteristics: Diazepam RecTubes 10 mg. Wockhardt UK Ltd. Revised January 2020.
Summary of Product Characteristics: Diazepam Desitin 5 mg rectal solution. Desitin Pharma Ltd. Revised December 2011.
Summary of Product Characteristics: Diazepam Desitin 10 mg rectal solution. Desitin Pharma Ltd. Revised December 2011.
Summary of Product Characteristics: Stesolid Rectal Tubes 5 mg. Actavis UK Ltd. Revised November 2017.
Summary of Product Characteristics: Stesolid Rectal Tubes 10 mg. Actavis UK Ltd. Revised November 2017.
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.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 26 July 2018.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922
Diazepam Last revised: 11 May 2020
Last accessed: 17 June 2020.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.