Formulary
Midazolam: Indications, Dosing, Side Effects and Interactions
Midazolam clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 6 min read
Midazolam: Indications, Dosing, Side Effects and Interactions
Midazolam clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Status epilepticus, Febrile convulsions for midazolam**
- **Neonate** (By buccal administration): 300 micrograms/kg for 1 dose, then 300 micrograms/kg for 1 dose, to be given 5-10 minutes after first dose if required.
- **Child 1-2 months** (By buccal administration): 300 micrograms/kg for 1 dose (max. per dose 2.5 mg), then 300 micrograms/kg for 1 dose (max. per dose 2.5 mg), to be given 5-10 minutes after first dose if required.
- **Child 3-11 months** (By buccal administration): 2.5 mg for 1 dose, then 2.5 mg for 1 dose, to be given 5-10 minutes after first dose if required.
- **Child 1-4 years** (By buccal administration): 5 mg for 1 dose, then 5 mg for 1 dose, to be given 5-10 minutes after first dose if required.
- **Child 5-9 years** (By buccal administration): 7.5 mg for 1 dose, then 7.5 mg for 1 dose, to be given 5-10 minutes after first dose if required.
- **Child 10-17 years** (By buccal administration): 10 mg for 1 dose, then 10 mg for 1 dose, to be given 5-10 minutes after first dose if required.
- **Neonate** (Initially by intravenous injection): Initially 150-200 micrograms/kg for 1 dose, followed by (by continuous intravenous infusion) 60 micrograms/kg/hour, rate increased in steps of 60 micrograms/kg/hour every 15 minutes until seizure controlled; maximum 300 micrograms/kg/hour.
- **Child** (Initially by intravenous injection): Initially 150-200 micrograms/kg for 1 dose, followed by (by continuous intravenous infusion) 60 micrograms/kg/hour, rate increased in steps of 60 micrograms/kg/hour every 15 minutes until seizure controlled; maximum 300 micrograms/kg/hour.
**Conscious sedation for procedures for midazolam**
- **Child** (By mouth): 500 micrograms/kg for 1 dose (max. per dose 20 mg), to be administered 30-60 minutes before procedure using a liquid special or injection solution given by mouth.
- **Child 6 months-9 years** (By buccal administration): 200-300 micrograms/kg (max. per dose 5 mg).
- **Child 10-17 years (body-weight up to 70 kg)** (By buccal administration): 6-7 mg.
- **Child 10-17 years (body-weight 70 kg and above)** (By buccal administration): 6-7 mg, (max. per dose 8 mg).
- **Child 6 months-11 years** (By rectum): 300-500 micrograms/kg for 1 dose, to be administered 15-30 minutes before procedure.
- **Child 1 month-5 years** (By intravenous injection): Initially 25-50 micrograms/kg for 1 dose, to be administered over 2-3 minutes, 5-10 minutes before procedure, dose can be increased if necessary in small steps to maximum 6 mg per course.
- **Child 6-11 years** (By intravenous injection): Initially 25-50 micrograms/kg for 1 dose, to be administered over 2-3 minutes, 5-10 minutes before procedure, dose can be increased if necessary in small steps to maximum 10 mg per course.
- **Child 12-17 years** (By intravenous injection): Initially 25-50 micrograms/kg for 1 dose, to be administered over 2-3 minutes, 5-10 minutes before procedure, dose can be increased if necessary in small steps to maximum 7.5 mg per course.
**Premedication for midazolam**
- **Child** (By mouth): 500 micrograms/kg for 1 dose (max. per dose 20 mg), to be administered 15-30 minutes before the procedure using a liquid special or injection solution given by mouth.
- **Child 6 months-11 years** (By rectum): 300-500 micrograms/kg for 1 dose, to be administered 15-30 minutes before induction.
**Induction of anaesthesia (but rarely used) for midazolam**
- **Child 7-17 years** (By slow intravenous injection): Initially 150 micrograms/kg (max. per dose 7.5 mg), dose to be given in steps of 50 micrograms/kg (max. 2.5 mg) over 2-5 minutes; wait for 2-5 minutes before subsequent dosing, then 50 micrograms/kg every 2 minutes (max. per dose 2.5 mg) if required; maximum 500 micrograms/kg per course; maximum 25 mg per course.
**Sedation of patient receiving intensive care for midazolam**
- **Child 6 months-11 years** (Initially by slow intravenous injection): Initially 50-200 micrograms/kg, to be administered over at least 3 minutes, followed by (by continuous intravenous infusion) 30-120 micrograms/kg/hour, adjusted according to response, initial dose may not be required and lower maintenance doses needed if opioid analgesics also used; reduce dose (or reduce or omit initial dose) in hypovolaemia, vasoconstriction, or hypothermia.
- **Child 12-17 years** (Initially by slow intravenous injection): Initially 30-300 micrograms/kg, dose to be given in steps of 1-2.5 mg every 2 minutes, followed by (by continuous intravenous infusion) 30-200 micrograms/kg/hour, adjusted according to response, initial dose may not be required and lower maintenance doses needed if opioid analgesics also used; reduce dose (or reduce or omit initial dose) in hypovolaemia, vasoconstriction, or hypothermia.
- **Neonate up to 32 weeks corrected gestational age** (By continuous intravenous infusion): 60 micrograms/kg/hour for 24 hours, then reduced to 30 micrograms/kg/hour, adjusted according to response for maximum treatment duration of 4 days.
- **Neonate 32 weeks corrected gestational age and above** (By continuous intravenous infusion): 60 micrograms/kg/hour, adjusted according to response for maximum treatment duration of 4 days.
- **Child 1-5 months** (By continuous intravenous infusion): 60 micrograms/kg/hour, adjusted according to response.
**Conscious sedation for procedures, Premedication for Miprosed**
- **Child 6 months-14 years** (By mouth): 250-500 micrograms/kg for 1 dose (max. per dose 20 mg), to be administered 15 to 30 minutes before procedure or anaesthesia.
**Conscious sedation for procedures, Premedication for Ozalin**
- **Child 6 months-17 years** (By mouth): 250 micrograms/kg for 1 dose (max. per dose 20 mg), to be administered 30 minutes before procedure or anaesthesia.
Interactions
**Severe interactions:**
- Interactions with CYP450 substrates In a Phase I study in patients with moderate to severe plaque psoriasis, changes in systemic exposures (C max and AUC inf ) of midazolam, Swarfarin, omeprazole,...
- Other concomitant therapies No clinically significant pharmacokinetic or pharmacodynamic interactions were observed when rivaroxaban was co-administered with midazolam (substrate of CYP3A4), digoxin...
- In patients with moderate to severe plaque psoriasis, a single subcutaneous dose of 210 mg brodalumab increased the exposure of midazolam, a CYP3A4/3A5 substrate by 24%.
- Interactions with cytochrome P450 The effects of nemolizumab on the pharmacokinetics of midazolam (CYP3A4/5 substrate), warfarin (CYP2C9 substrate), omeprazole (CYP2C19 substrate), metoprolol...
- Potential for Cibinqo to affect pharmacokinetics of other medicinal products No clinically significant effects of Cibinqo were observed in drug interaction studies with oral contraceptives (e.g.
- Benzodiazepines (midazolam): Diltiazem significantly increases plasma concentrations of midazolam and prolongs its half-life.
- CYP3A4 substrates Results of pharmacokinetic studies with CYP3A4 probe-substrates, i.e.
- Additionally, co-administration of valdecoxib had no clinically significant effect on the hepatic or intestinal CYP 3A4-mediated metabolism of orally administered midazolam.
**Other interactions (106):**
- After co-administration with daily 40 -mg doses of relugolix, the AUC and C max of midazolam, a sensitive CYP3A4 substrate, were decreased by 18% and 26%, respectively.
- Benzodiazepines (Midazolam, Triazolam): Following oral administration of midazolam, fluconazole resulted in substantial increases in midazolam concentrations and psychomotor effects.
- Concomitant intake of fluconazole 200 mg and midazolam 7.5 mg orally increased the midazolam AUC and half-life 3.7-fold and 2.2-fold, respectively.
- Effect of raltegravir on the pharmacokinetics of other medicinal products In drug interaction studies performed using raltegravir 400 mg twice daily, raltegravir did not have a clinically meaningful...
- SEDATIVE midazolam (raltegravir 400 mg twice daily) midazolam AUC 8 % midazolam C max 3 % No dosage adjustment required for raltegravir (400 mg twice daily and 1,200 mg once daily) or midazolam.
- Sedatives midazolam (0.075 mg/kg single dose, maribavir 400 mg twice daily for 7 days) midazolam AUC 0.89 (0.79, 1.00) C max 0.82 (0.70, 0.96) No dose adjustment is required.
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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