neobookRx
DrugsLevel 4 LocalisationS5INJ · INFEML

Midazolam

BenzodiazepineHypnotic, Sedative, Anticonvulsant

Indications

Registered South African indications:

1mg/ml

  • Basal sedation before diagnostic or surgical interventions carried out under local anaesthesia
  • Pre-medication before induction of anaesthesia
  • Induction of anaesthesia, as an induction medicine in inhalation anaesthesia or a sleep-inducing component in combined anaesthesia, including total intravenous anaesthesia
  • Maintenance of anaesthesia where subsequent ICU administration with ventilation is envisaged for the purpose of recovery and stabilisation
  • Long-term sedation in intensive care units

5mg/ml

  • Conscious (basal) sedation before diagnostic or therapeutic procedures with, or without, local anaesthesia
  • Anaesthesia
    - Premedication before induction of anaesthesia, as part of a balanced technique
    - Induction and maintenance of anaesthesia
    - As an induction agent in adults in inhalation anaesthesia or a sedative component in combined anaesthesia, including total intravenous anaesthesia
  • Sedation in intensive care units
    - Long-term sedation in intensive care units

Cautions

Contraindications

South African recommendations

1mg/ml injection

  • Hypersensitivity to midazolam, benzodiazepines or to any of the excipients
  • Conscious sedation in patients with severe respiratory insufficiency or acute respiratory depression
  • Pregnancy
  • Breastfeeding

5mg/ml injection & infusion

  • Known hypersensitivity to midazolam or any medicine from the benzodiazepines group or to any excipient within the medicine
  • Myasthenia gravis
  • Severe hepatic impairment
  • Respiratory insufficiency
  • Sleep apnoea syndrome
  • Pregnancy
  • Lactation

Recommendations in other jurisdictions

  • Hypersensitivity to benzodiazepines or to any of the excipients
  • Conscious sedation in patients with severe respiratory failure or acute respiratory depression

Cautions

  • Pregnancy (Recommendations in other jurisdictions)
  • Breastfeeding (Recommendations in other jurisdictions)
  • Renal impairment
  • Hepatic impairment (1mg/ml) (South African recommendations)
  • Mild to moderate hepatic impairment (5mg/ml) (South African recommendations)
  • Mild to moderate hepatic impairment (Recommendations in other jurisdictions)
  • Elderly
  • Inexperienced physician
  • Rapid IV injection
  • High dosages
  • Long-term sedation
  • Chronically ill or debilitated patients
  • Chronic respiratory insufficiency
  • Impaired cardiac function
  • Low cardiac output
  • Myasthenia gravis
  • History of alcohol or drug abuse
  • Abrupt withdrawal
  • Paediatric patients younger than 6 months
  • Paediatric patients especially those with cardiovascular instability
  • Preterm and former preterm non intubated patients
  • May impair ability to drive and operate machinery

Adult dosage

Forms avail. in SA and covered in this monograph: inj, inf

Dosages below include:

  • South African registered indications and dosages

South African registered indications and dosages

1mg/ml

Basal sedation

  • IV: 1mg, given as a slow injection over 30sec; Takes effect 2min post injection

Basal sedation in diagnostic or surgical interventions carried out under local anaesthesia

  • IV: Initial: 2.5mg (0.04mg/kg), 5-10min before the beginning of the procedure; Further doses of 1mg, may be given when necessary; A total dose >5mg is not usually necessary to reach the desired endpoint

Pre-medication before induction of anaesthesia (before an operation)

  • IM: 0.07-0.1mg/kg body weight, according to the general condition of the patient, administered into a large muscle mass 30-60min before induction of anaesthesia; Usual dose: 5mg

Premedication with midazolam shortly before a procedure produces sedation (induction of sleepiness or drowsiness and relief of apprehension), and pre-operative impairment of memory


Induction of anaesthesia

  • IV: Approx. 2.5mg, given as a slow injection over 10sec for induction of anaesthesia; Desired level of anaesthesia is reached by stepwise titration; Titrate by ≤5mg, given as a slow injection over 20-30sec at intervals of 2min between successive increments; In pre-medicated patients: Dose range: 10-15mg (0.15-0.2mg/kg); Sufficiently deep level of sleep is generally achieved after 2-3 min; In non-pre-medicated patients: Dose requirement may be higher: 0.3-0.35mg/kg body weight

In pre-medicated patients a total dose greater than 15mg is usually not necessary. In non-pre-medicated patients a total dose greater than 20mg is usually not necessary


Maintenance of anaesthesia (Additional agent(s) required)

  • IV: 0.03-0.1mg/kg/hr, given as an infusion when used in combination with narcotics or ketamine

In high-risk surgical patients, lower maintenance doses will be required


Midazolam is a potent sedative medicine, requiring slow administration and individualised dosing. The dose should be individualised and titrated to the desired state of sedation according to the clinical need, physical status, age and concomitant medication


Sedation in intensive care units (ICU)

  • IV: Individualised dosages; Loading dose: 0.03-0.3mg/kg, given slowly in increments; For each increment: Titrate by 1-2.5mg, given over 20-30sec at intervals of 2min between successive increments; Maintenance dose range: 0.03-0.2mg/kg/hr

The desired level of sedation is reached by stepwise titration of midazolam, followed by either continuous infusion, or intermittent bolus


For sedation in ICU, the dosage should be individualised and midazolam 1mg/ml titrated to the desired state of sedation according to the clinical need, physical status, age and concomitant medication


A total dose greater than 15mg is usually not necessary. The loading dose should be reduced or omitted in hypovolaemic, vasoconstricted or hypothermic patients


In hypovolaemic, vasoconstricted or hypothermic patients, the maintenance dose should be reduced, at times to as low as 25% of the usual dose. The level of sedation should be assessed regularly if permitted by the patient's condition


5mg/ml

Conscious (basal) sedation before diagnostic or therapeutic procedures with, or without, local anaesthesia

  • IV: Initial: 2.5mg, given as a slow injection at a rate of 1mg/30sec, 5-10min before the beginning of the procedure; Further doses of 1mg, may be given when necessary; Takes effect in about 2min after the injection has been given; Mean time to maximum effect is 2.4min; Total dose: 3.5-7.5mg

A total dose >5mg is not usually necessary to reach the desired endpoint


Midazolam requires slow administration and individualisation of dosage. The dose should be titrated to the desired state of sedation according to the clinical need, physical status, age and concomitant medication


Anaesthesia premedication before induction of anaesthesia, as part of a balanced technique (Additional agent may be required)

  • IM: 0.07-0.1mg/kg bodyweight, according to general condition of the patient 20-60min before induction of anaesthesia; Usual dose: 5mg

Premedication with midazolam given shortly before a procedure produces sedation (induction of sleepiness or drowsiness and relief of apprehension), and pre-operative impairment of memory. Midazolam may be administered in combination with anticholinergics


Induction of anaesthesia (Additional agents may be required)

  • IV: Desired level of anaesthesia is reached by stepwise titration; Titrate by ≤5mg, given as a slow injection over 20-30sec at intervals of 2min between successive increments; In non-pre-medicated patients: Dose requirement may be higher: 0.3-0.35mg/kg body weight given as a slow injection over 20-30sec allowing 2min for effect; To complete induction if needed: Titrate by approx. 25% of the patient’s initial dose OR Induction may instead be completed with volatile liquid inhalation anaesthetics; In resistant patients: Total dose of up to 0.6mg/kg may be used for induction

Large doses of up to 0.6mg/kg may prolong recovery


If midazolam is used for induction of anaesthesia before other anaesthetic agents have been administered, the individual response is variable. The dose of all the agents should be titrated to the desired effect, at times as low as 25% of the usual initial dose of the individual agents


Maintenance of anaesthesia

  • IV: 0.03-0.1mg/kg, given as intermittent small IV doses OR 0.03-0.1mg/kg/hr, given as a continuous infusion typically in combination with analgesics; Dose and the interval between doses vary according to the patient's individual reaction

Sedation in intensive care units (ICU)

  • IV: Loading dose: 0.03-0.3mg/kg, given slowly in increments; For each increment: Titrate by 1-2.5mg, given over 20-30sec at intervals of 2min between successive increments; Maintenance dose range: 0.03-0.2mg/kg/hr

The IV loading dose can range from 0.03-0.3mg/kg, but a total dose greater than 15mg is usually not necessary. The loading dose should be reduced or omitted in hypovolaemic, vasoconstricted or hypothermic patients


When midazolam is given with potent analgesics, the latter should be administered first so that sedative effects of midazolam can safely be titrated on top of any sedation caused by the analgesic


In hypovolaemic, vasoconstricted or hypothermic patients the maintenance dose should be reduced, at times to as low as 25% of the usual dose. The level of sedation should be assessed regularly if the patient's condition permits

Paediatric dosage

Paed. forms avail. in SA and covered in this monograph: inj, inf

Dosages below include:

  • South African registered indications and dosages

South African registered indications and dosages

1mg/ml

Pre-medication before induction of anaesthesia (before an operation)

  • Younger than 1 year: No information available
  • Between 1-15 years: IM: 0.08-0.2mg/kg body weight, into a large muscle mass 30-60min before induction of anaesthesia

Premedication with midazolam shortly before a procedure produces sedation (induction of sleepiness or drowsiness and relief of apprehension), and pre-operative impairment of memory


Proportionately higher doses are required than in adults in relation to bodyweight


5mg/ml

Conscious (basal) sedation before diagnostic or therapeutic procedures with, or without, local anaesthesia

IV

  • Younger than 6 months*: Limited information is available in non-intubated paediatric patients less than 6 months of age
  • Between 6 months - 5 years: Initial dose: 0.05-0.1mg/kg, given slowly over 2-3min; Wait an additional 2-3min to fully evaluate the sedative effect before initiating a procedure or repeating dose; If further sedation is necessary, continue to titrate with small increments until the appropriate level of sedation is achieved; Total dose up to 0.6mg/kg may be necessary to reach the desired endpoint; Total dose: ≤6mg
  • Between 6-12 years: Initial dose: 0.025-0.05mg/kg, given slowly over 2-3min; Wait an additional 2-3min to fully evaluate the sedative effect before initiating a procedure or repeating dose; If further sedation is necessary, continue to titrate with small increments until the appropriate level of sedation is achieved; Total dose of up to 0.4mg/kg; Total dose: <10mg
  • Between 12-16 years: See adult dosage

IM

  • Between 1-15 years: 0.1-0.15mg/kg, given 5-10 min before the start of the procedure; For more anxious patients: Up to 0.5mg/kg may be given; A total dose greater than 10mg is not usually necessary

*Limited information is available in non-intubated paediatric patients less than 6 months of age. These patients are particularly vulnerable to airway obstruction and hypoventilation, therefore titration with small increments to the clinical effect and careful monitoring are essential


For conscious sedation prior to diagnostic or surgical intervention, midazolam is administered IV. The dose must be individualised and titrated, and should not be administered by rapid or single bolus injection. If necessary, subsequent doses may be administered according to the individual need


Midazolam should be titrated slowly to the desired clinical effect. Infants and young children <5 years of age may require substantially higher doses (mg/kg) than older children and adolescents


IV administration in paediatric patients less than 6 months of age is not recommended with exception in ICU as they are vulnerable to airway obstruction and hypoventilation


Pre-medication before induction of anaesthesia (before an operation)

  • Younger than 1 year: No information available
  • Between 1-15 years: IM: 0.08-0.2mg/kg, administered into a large muscle mass 30-60min before induction of anaesthesia

Premedication with midazolam shortly before a procedure produces sedation (induction of sleepiness or drowsiness and relief of apprehension), and pre-operative impairment of memory


Proportionally higher doses are required than in adults in relation to bodyweight


Midazolam is not recommended for the induction of anaesthesia in children, as experience is limited


Maintenance of anaesthesia (Additional agent required)

  • IM: 0.15-0.2mg/kg, when receiving ketamine for anaesthesia (ataralgesia); A sufficiently deep level of sleep is generally achieved after 2-3min

Midazolam is a potent sedative medicine, requiring slow administration and individualised dosing. The dose should be individualised and titrated to the desired state of sedation according to the clinical need, physical status, age and concomitant medication


In high-risk surgical patients, lower maintenance doses will be required


Sedation in intensive care units (ICU)

  • Neonates younger than 32 weeks gestational age: IV: 0.03mg/kg/hr (0.5µg/kg/min), given as a continuous infusion
  • Neonates older than 32 weeks gestational age - 6 months: 0.06mg/kg/hr (1µg/kg/min), given as a continuous infusion

Intravenous loading doses should not be used in neonates, rather the infusion may be run more rapidly for the first several hours to establish therapeutic plasma levels. The rate of infusion should be carefully and frequently reassessed, particularly after the first 24 hours so as to administer the lowest possible effective dose and reduce the potential for medicine accumulation


Careful monitoring of respiratory rate and oxygen saturation is required


  • Older than 6 months: Loading dose: 0.05-0.2mg/kg, given slowly over ≥2-3min to establish the desired clinical effect; Followed by: 0.06-0.12mg/kg/hr (1-2µg/kg/min), given as a continuous infusion; Rate of infusion can be increased or decreased (generally by 25% of the initial or subsequent infusion rate) as required OR supplemental IV doses of midazolam can be administered to increase or maintain the desired effect

When initiating an infusion with midazolam in haemodynamically compromised patients, the usual loading dose should be titrated in small increments and the patient monitored for haemodynamic instability, e.g., hypotension. These patients are also vulnerable to the respiratory depressant effects of midazolam and require careful monitoring of respiratory rate and oxygen saturation


In preterm newborn infants, and paediatrics less than 15kg of body weight, midazolam solutions with concentrations higher than 1mg/ml are not recommended. Higher concentrations should be diluted to 1mg/ml


IV administration in paediatric patients less than 6 months of age is not recommended with exception in ICU as they are vulnerable to airway obstruction and hypoventilation. Midazolam is not indicated in children in induction of anaesthesia and as a sedative component in combined anaesthesia as limited data is available

Special populations

Pregnancy

South African recommendations

1mg/ml

  • Contraindicated
  • Safety in pregnancy has not been established. Midazolam has been shown to cross the placenta and enter foetal circulation
  • Insufficient data are available on midazolam to assess its safety during pregnancy
  • Animal studies do not indicate a teratogenic effect, but fetotoxicity was observed as with other benzodiazepines. No data on exposed pregnancies are available for the first two trimesters of pregnancy
  • The administration of high doses of midazolam in the last trimester of pregnancy, during labour or when used as an induction medicine of anaesthesia for caesarean section has been reported to produce maternal or foetal adverse effects (inhalation risk in mother, irregularities in the foetal heart rate, hypotonia, poor sucking, hypothermia and respiratory depression in the neonate)
  • Infants born from mothers who received benzodiazepines chronically during the latter stage of pregnancy may have developed physical dependence and may be at some risk of developing withdrawal symptoms in the postnatal period. The risk for neonates should be considered in case of administration of midazolam for any surgery near the term

5mg/ml

  • Contraindicated
  • Midazolam has been shown to cross the placenta and to enter foetal circulation. Insufficient data is available on midazolam to assess its safety during pregnancy
  • Benzodiazepines, including midazolam, should be avoided in pregnancy unless there is no safer alternative. An increased risk of congenital malformation associated with the use of midazolam during the first trimester of pregnancy may occur
  • If administered during the last three months of pregnancy, or during labour, effects on the neonate such as irregularities in the foetal heart rate, hypothermia, hypotonia, poor sucking and moderate respiratory depression can be expected
  • 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 of developing withdrawal symptoms in the postnatal period

Recommendations in other jurisdictions

  • Caution; not recommended
  • Insufficient data are available on midazolam to assess its safety during pregnancy. Animal studies do not indicate a teratogenic effect, but foetotoxicity was observed as with other benzodiazepines
  • No data on exposed pregnancies are available for the first two trimesters of pregnancy. It has been suggested that the use of benzodiazepines during the first trimester of pregnancy is associated with an increased risk of congenital abnormalities
  • The administration of high doses of midazolam in the last trimester of pregnancy, during labour or when used as an induction agent of anaesthesia for caesarean section has been reported to produce maternal or foetal adverse effects (inhalation risk in mother, irregularities in the foetal heart rate, hypotonia, poor sucking, hypothermia and respiratory depression in the neonate)
  • Moreover, infants born from mothers who received benzodiazepines chronically during the latter stage of pregnancy may have developed physical dependence and may be at some risk of developing withdrawal symptoms in the postnatal period
  • Consequently, midazolam should not be used during pregnancy unless clearly necessary. It is preferable to avoid using it for caesarean
  • The risk for neonate should be taken into account in case of administration of midazolam for any surgery near the term

Breastfeeding

South African recommendations

1mg/ml

  • Contraindicated
  • Midazolam passes in low quantities into breast milk. Breastfeeding mothers should be advised to discontinue breastfeeding for 24 hours following administration of midazolam

5mg/ml

  • Contraindicated
  • Midazolam is excreted in breast milk. Do not use during lactation

Recommendations in other jurisdictions

  • Caution; not recommended
  • Midazolam passes in low quantities into breast milk. Breastfeeding mothers should be advised to discontinue breastfeeding for 24 hours following administration of midazolam

Fertility

  • Animal studies did not show an impairment of fertility

Renal Impairment

  • Caution; no dose adjustment recommended
  • In severe renal impairment (CrCl <30ml/min) midazolam may be accompanied by more pronounced and prolonged sedation including clinically relevant respiratory and cardiovascular depression. Midazolam should therefore be dosed carefully in this patient population and titrated for the desired effect

Hepatic Impairment

South African recommendations

1mg/ml

  • Caution; no dose adjustment recommended
    The elimination half-life in patients with cirrhosis can be prolonged, and the clearance, shorter than in healthy test subjects

5mg/ml

  • Mild to moderate: Caution; dose adjustment recommended
    Hepatic impairment reduces the clearance of IV midazolam with a subsequent increase in terminal half-life
    The clinical effects in patients with hepatic impairment may be stronger and prolonged. In patients with mild to moderate hepatic impairment the dose of midazolam may have to be reduced and vital signs should be monitored
  • Severe: Contraindicated
    Patients with severe hepatic impairment should not be treated with midazolam

Recommendations in other jurisdictions

  • Caution; dose adjustment recommended
    Hepatic impairment reduces the clearance of IV midazolam with a subsequent increase in terminal half-life
    Therefore the clinical effects in patients with hepatic impairment may be stronger and prolonged. The required dose of midazolam may have to be reduced and proper monitoring of vital signs should be established
    Benzodiazepines may precipitate or exacerbate encephalopathy in patients with severe hepatic impairment

Elderly

South African recommendations

  • >60 years: Caution; dose adjustment recommended

    1mg/ml
    For basal sedation in diagnostic or surgical interventions carried out under local anaesthesia: Initial: 1-1.5mg, given over 5-10min before the beginning of a procedure;  Further doses of 0.5-1mg, may be given when necessary; Total doses greater than 3.5mg are not usually necessary
    Pre-medication before an operation: IM: 0.025 – 0.05mg/kg body weight; Usual dose: 2-3mg
    Induction of anaesthesia: Lower doses will be required
    Maintenance of anaesthesia: Lower maintenance doses will be requires

    5mg/ml
    Conscious (basal) sedation before diagnostic or therapeutic procedures with, or without, local anaesthesia (IV administration): Initial and further doses must be halved; Additional midazolam should be titrated very slowly and carefully; Total dose of >3.5mg is not usually necessary
    Anaesthesia induction: IV: Non-premedicated: Initial: 0.3mg/kg; Non-premedicated patients with severe systemic disease or other debilitation: 0.2-0.25mg/kg will usually suffice; In some cases: 0.15mg/kg may suffice
    In adults over 60 years of age, debilitated and chronically ill patients: Lower doses will be required
    Anaesthesia maintenance: IV: Lower doses than recommended for adults <60 years
    Sedation in ICU: No dose adjustment recommended

Recommendations in other jurisdictions

  • Caution; dose adjustment recommended
    Conscious sedation: IV: Initial dose: 0.5-1mg; Titration doses: 0.5-1mg, given 5-10min before the beginning of the procedure. Further doses of 0.5-1mg may be given as necessary. Since in these patients the peak effect may be reached less rapidly, additional midazolam should be titrated very slowly and carefully. Total dose: <3.5mg (A total dose >3.5mg is usually not necessary)
    Anaesthesia premedication: IV: Initial dose: 0.5mg; Slow up-titration as needed OR IM: 0.025-0.05mg/kg; In case of concomitant administration of narcotics the midazolam dose should be reduced. The usual dose is 2-3mg
    Anaesthesia induction: IV: In premedicated patients: 0.05-0.15mg/kg, given over 20-30secs and allowing 2min for effect; In non-premedicated patients: Initial: 0.15-0.3mg/kg; Non-premedicated patients with severe systemic disease or other debilitation usually require less midazolam for induction: 0.15-0.25mg/kg will usually suffice
    Sedative component in combined anaesthesia: IV: Lower doses than recommended for adults <60 years
    Sedation in ICU: No dose adjustment recommended

Debilitated or chronically ill patients

  • See elderly

Porphyria Information

Drugs in Sport

  • Permitted - No warnings

Adverse reactions

Central Nervous System Disorders

  • Confusion
  • Disorientation
  • Emotional
  • Libido disorder
  • Mood disturbances
  • Physical drug dependence and withdrawal syndrome
  • Abuse
  • Involuntary movements (including tonic/clonic movements and muscle tremor)
  • Hyperactivity
  • Sedation (prolonged and postoperative)
  • Decreased alertness
  • Headache
  • Somnolence
  • Dizziness
  • Ataxia
  • Anterograde amnesia
  • Seizures (premature infants and neonates)
  • Drug withdrawal seizures
  • Depression
  • Fatigue
  • Paradoxical reactions
    - Restlessness
    - Agitation
    - Irritability
    - Nervousness
    - Hostility
    - Anger
    - Aggressiveness
    - Anxiety
    - Nightmares
    - Abnormal dreams
    - Hallucinations
    - Psychoses
    - Inappropriate behaviour
    - Paroxysmal excitement

Cardiovascular Disorders

  • Cardiac arrest
  • Bradycardia
  • Hypotension
  • Vasodilation
  • Thrombophlebitis
  • Thrombosis

Respiratory Disorders

  • Respiratory depression
  • Respiratory arrest
  • Apnoea
  • Dyspnoea
  • Laryngospasm
  • Hiccups

Gastrointestinal Disorders

  • Nausea and vomiting
  • Constipation
  • Dry mouth

Musculoskeletal Disorders

  • Falls
  • Fractures

Skin and Subcutaneous Tissue Disorders

  • Rash
  • Urticaria
  • Pruritis
  • Injection site erythema
  • Injection site pain

Immune, Blood and Lymphatic System Disorders

  • Hypersensitivity
  • Angioedema
  • Anaphylactic shock

Interactions

  • CYP3A4 inhibitors
  • CYP3A4 inducers
  • Central nervous system depressants
  • Centrally acting antihypertensives
  • Inhalational anaesthetics
  • Azole antifungals
  • Ketoconazole
  • Voriconazole
  • Fluconazole
  • Itraconazole
  • Posaconazole
  • Macrolide antibiotics
  • Erythromycin
  • Clarithromycin
  • Telithromycin
  • Roxithromycin
  • Propofol
  • Protease inhibitors
  • Saquinavir 
  • Ritonavir-boosted lopinavir
  • Boceprevir
  • Telaprevir
  • Calcium-channel blockers
  • Diltiazem
  • Verapamil
  • Atorvastatin
  • Fentanyl
  • Nefazodone
  • Aprepitant
  • Ticagrelor
  • Valproic acid
  • Analgesics
  • Antitussives
  • Antipsychotics
  • Other benzodiazepines
  • Anxiolytics
  • Hypnotics
  • Barbiturates
  • Ketamine
  • Etomidate
  • Sedative antidepressants
  • Non-recent H1-antihistamines
  • St John's wort
  • Quercetin
  • Ginkgo biloba
  • Panax ginseng
  • Alcohol

Monitoring

  • Respiratory function
  • Pulse oximetry
  • Vital signs
  • Heart rate
  • Blood pressure

Mechanism of action

The central actions of benzodiazepines are mediated through an enhancement of the GABAergic neurotransmission at inhibitory synapses. In the presence of benzodiazepines the affinity of the GABA receptor for the neurotransmitter is enhanced through positive allosteric modulation resulting in an increased action of released GABA on the postsynaptic transmembrane chloride ion flux. Chemically midazolam is a derivative of the imidazobenzodiazepine group. Although the free base is a lipophilic substance with low solubility in water, the basic nitrogen in position 2 of the imidazobenzodiazepine ring system enables the active ingredient of midazolam to form water-soluble salts with acids, producing a stable and well tolerated injection solution. This together with rapid metabolic transformation is the reason for rapid onset and short duration of effects. Due to its low toxicity, midazolam has a wide therapeutic range. 

Dosage forms

  • Injection
  • Infusion

Formulation

Injection (per ml) 5mg

  • Midacum (Sandoz)

Injection (per 5ml) 5mg

  • Accord midazolam (Accord)
  • Dormicum (Roche) originator
  • Midanium (Pharmacare)
  • Midacum (Sandoz)
  • Midazoject (Thebe)
  • Pharma-Q midazolam (Pharma-Q)
  • Sabax midazolam (Adcock Ingram) originator

Injection (per 3ml) 15mg

  • Accord midazolam (Accord)
  • Dormicum (Roche) originator
  • Micro-midazolam (Micro)
  • Midanium (Pharmacare)
  • Midacum (Sandoz)
  • Midazoject (Thebe)
  • Midazolam Specpharm (Specpharm)
  • Pharma-Q midazolam (Pharma-Q)
  • Sabax midazolam (Adcock Ingram) originator

Injection (per 10ml) 50mg

  • Accord midazolam (Accord)
  • Aspen midazolam (Pharmacare)
  • Dormicum (Roche) originator
  • Midazoject (Thebe)
  • Midazolam PharmC (Pharmacorp)
  • Midazolam Specpharm (Specpharm)
  • Pharma-Q midazolam (Pharma-Q)
  • Sabax midazolam (Adcock Ingram) originator

References

1. SAMF_12th Edition_Page 490 2. SmPC: Midazolam 5 mg/ml solution for injection/ =infusion, hameln pharmaceuticals ltd; Last updated on eMC: 23 Jul 2018; accessed online 20 August 2018 [https://www.medicines.org.uk/emc/product/6420/smpc] 3. https://drive.google.com/drive/folders/0B27NqM_vidrmU19DMmozMFBJdXM (17/02/2006_Pharma Q_Midazolam_5,15,50mg_inj) 4. https://drive.google.com/drive/folders/0B27NqM_vidrmU19DMmozMFBJdXM (01/10/2010_Roche_Dormicum_tab) 5. https://drive.google.com/drive/folders/0B27NqM_vidrmU19DMmozMFBJdXM (26/11/2010_Roche_Dormicum_5, 15, 50mg_inj) 6. U2D: Midazolam: Drug information; Uptodate, Downloaded online 20 August 2018 [https://www.uptodate.com/contents/midazolam-drug-information] 7. Drugs.com: Midazolam, Medically reviewed on 29 November 2016; Downloaded online 20 August 2018 [https://www.drugs.com/pregnancy/midazolam.html] 8. NAPOS The Drug Database for Acute Porphyria: Midazolam; Accessed online 20 August 2018 [http://www.drugs-porphyria.org/languages/UnitedKingdom/s3.php?l=gbr&atc_code=N05CD08] 9. South African Institute for Drug-Free Sport: Midazolam Specpharm Injection; Accessed online 2018 [http://www.drugfreesport.org.za/online-medication-check/]_inj) 10. Clinical Pharmacologist - Dr. M Irhuma. 10.1 Spina SP and Ensom MHH, “Clinical Pharmacokinetic Monitoring of Midazolam in Critically Ill Patients,” Pharmacotherapy, 2007, 27(3):389-98. 11. Afritox: Midazolam; Accessed online 9 October 2019 [https://www.afritox.co.za/hp/SingleToxin/SingleToxin.aspx?SingleToxinID=5215] 12. Clinical Pharmacologist - A/Prof(Dr). M Irhuma 12.1 27 May 2020 : Midazolam 5mg/ml, solution for injection / infusion (hameln pharma ltd) - SmPC 12.2 01 Nov 2017 : Dormicum® Midazolam maleate 7.5 mg and 15 mg (F. Hoffmann -La Roche Ltd) 13. SmPC: Midazolam 5mg/ml, solution for injection / infusion, hameln pharmaceuticals ltd; Last updated on eMC: 05 Aug 2020; Downloaded online 01 September 2020 14. SmPC: BUCCOLAM 10 mg oromucosal solution, Shire Pharmaceuticals Limited; Last updated on eMC: 11 Aug 2020; Downloaded online 01 September 2020 Downloaded just to have as an option not used in this monograph) 15. PI - Midazolam 1 mg/ml Accord, Accord Healthcare (Pty) Ltd - Date of first Authoorisation - 13 September 2022 - Downloaded online 05 May 2023 [https://pi-pil-repository.sahpra.org.za/wp-content/uploads/2023/01/Final_PI_Midazolam_Applicant.pdf] 16. PI - DORMICUM® 15 mg/3 mL Ampoules, DORMICUM® 5 mg/5 mL Ampoules, DORMICUM® 50 mg/10 mL Ampoules, Pharmaco Distribution (Pty) Ltd. - Date of Revision of Text 25 August 2022 - Downloaded 05 May 2023 [https://pi-pil-repository.sahpra.org.za/wp-content/uploads/2022/08/DORMICUM-Injection-PI-2022-07-25.pdf] 17. SmPC - Midazolam 1mg/ml, solution for injection / infusion Summary of Product Characteristics Updated 09-Nov-2022 | hameln pharma ltd Downloaded online 05 May 2023 18. SmPC - Midazolam 5mg/ml, solution for injection/infusion, Summary of Product Characteristics Updated 09-Nov-2022 | hameln pharma ltd Downloaded online 05 May 2023

Brands & products

26 products · cached snapshot
Trade names (10)
  • Dormicum
  • Micro-Midazolam
  • Midanium
  • Midacum
  • Midazolam PharmC
  • Midazolam Specpharm
  • Midazoject
  • Pharma-Q Midazolam
  • Sabax Midazolam
  • Accord Midazolam

INJInjection· 25 products

from R62.91
ProductStrengthPackApplicantMin price
Midazolam 50mg/10ml PharmC50 mg/10ml10Pharmacorp (Pty) LtdR62.91
Accord Midazolam 50mg/10ml50 mg/10ml10Accord Healthcare (Pty) LtdR66.97
Midacum 5mg/ml5 mg/ml1Sandoz SA (Pty) LtdR72.78
Accord Midazolam 5mg/5ml5 mg/5ml5Accord Healthcare (Pty) LtdR136.71
Dormicum5 mg/5ml5Pharmaco Distribution (Pty) LtdR167.71
Midazoject 5mg/5ml5 mg/5ml5Thebe MedicareR181.56
Pharma-Q Midazolam Injection 5mg/5ml5 mg/5ml1Pharma-Q Holdings (Pty) LtdR191.93
Accord Midazolam 15mg/3ml15 mg/3ml3Accord Healthcare (Pty) LtdR203.88
Sabax Midazolam Injection 5mg/5ml5 mg/5ml5Adcock Ingram Critical Care (Pty) LtdR204.49
Dormicum15 mg/3ml3Pharmaco Distribution (Pty) LtdR213.59
Pharma-Q Midazolam Injection 15mg/3ml15 mg/3ml1Pharma-Q Holdings (Pty) LtdR218.29
Midacum 15mg/3ml15 mg/3ml1Sandoz SA (Pty) LtdR218.54
Midazoject 15mg/3ml15 mg/3ml3Thebe MedicareR263.89
Midanium15 mg/3ml3Pharmacare Limited, WoodmeadR278.62
Midazolam Specpharm 5mg/5ml5 mg/5ml5Specpharm (Pty) LtdR299.30
Midanium5 mg/5ml5Pharmacare Limited, WoodmeadR303.11
Sabax Midazolam Injection 50mg/10ml50 mg/10ml10Adcock Ingram Critical Care (Pty) LtdR433.36
Sabax Midazolam Injection 15mg/3ml15 mg/3ml3Adcock Ingram Critical Care (Pty) LtdR480.14
Midazolam 50mg/10ml PharmC50 mg/10ml10Pharmacorp (Pty) LtdR629.11
Midazolam Specpharm 50mg/10ml50 mg/10ml10Specpharm (Pty) LtdR697.76
Midazoject 50mg/10ml50 mg/10ml10Thebe MedicareR959.69
Dormicumdiscontinued5 mg/5ml5Roche Products (Pty) LtdR1246.51
Micro-Midazolamdiscontinued15 mg/3ml3Micro HealthcareR1331.49
Pharma-Q Midazolam Injection 50mg/10ml50 mg/10ml1Pharma-Q Holdings (Pty) LtdR1422.06
Dormicumdiscontinued15 mg/3ml3Roche Products (Pty) LtdR1875.31

INFInfusion· 1 product

from R130.91
ProductStrengthPackApplicantMin price
Dormicum 10ml50 mg/10ml10Pharmaco Distribution (Pty) LtdR130.91

Medical aid coverage

data not yet integrated
Discovery Health
not yet integrated
  • Comprehensive Series—
  • Executive Plan—
  • KeyCare Series—
  • Priority Series—
  • Saver Series—

Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.

Bonitas Medical Fund
not yet integrated
  • BonClassic—
  • BonComprehensive—
  • BonEssential—
  • BonFit Select—
  • BonSave—
  • BonStart—

Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.

GEMS — Government Employees Medical Scheme
not yet integrated
  • Beryl—
  • Emerald—
  • Onyx—
  • Ruby—
  • Sapphire—
  • Tanzanite One—

Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.

POLMED — Police Medical Aid Scheme
not yet integrated
  • Aquarium Option—
  • Efficiency Option—
  • Marine Option—

Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.

Interacts with 54 known drugs

Check against other drugs →

Cited in 60+ documents

NeoHealth® ID 35167 · updated 6/2/2023