Dormicum Dosage/Direction for Use

Film-coated tablet: Duration of treatment should be as short as possible. Generally, the duration of treatment varies from a few days to a maximum of 2 weeks. The tapering-off process should be tailored to the individual. Treatment with Midazolam (Dormicum) should not be terminated abruptly (see Drug Abuse and Dependence under Precautions).
In certain cases, extension beyond the maximum treatment period may be necessary; if so, it should not take place without re-evaluation of the patient's status. Owing to the rapid onset of action Midazolam (Dormicum) tablets should be taken immediately before going to sleep, and swallowed whole with fluid. Midazolam (Dormicum) can be taken at any time of the day, provided the patient is subsequently assured of at least 7-8 hours undisturbed sleep.
Standard dosage: Dosage range: 7.5-15 mg.
Treatment should be started with the lowest recommended dose. The maximum dose should not be exceeded because of the increased risk of CNS adverse effects possibly including clinically relevant respiratory and cardiovascular depression.
Premedication: In premedication, Midazolam (Dormicum) should be given 30-60 minutes before the procedure.
Special Dosage Instructions: Elderly and/or debilitated patients: In elderly and/or debilitated patients, the recommended dose is 7.5 mg.
Elderly patients showed a larger sedative effect, therefore they may be at increased risk of cardio-respiratory depression as well. Thus, Midazolam (Dormicum) should be used very carefully in elderly patients, and if needed, a lower dose should be considered.
Patients with hepatic impairment: Patients with severe hepatic impairment should not be treated with Midazolam (Dormicum) (see Contraindications). In patients with mild to moderate hepatic impairment, the lowest dose possible should be considered, not exceeding 7.5 mg (see Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations under Actions).
Patients with renal impairment: In patients with severe renal impairment, Midazolam (Dormicum) may be accompanied by more pronounced and prolonged sedation, possibly including clinically relevant respiratory and cardiovascular depression. Midazolam (Dormicum) should therefore be dosed carefully in this patient population and titrated for the desired effect.
The lowest dose should be considered, not exceeding 7.5 mg (see Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations under Actions).
Solution for injection: Midazolam is a potent sedative agent that requires slow administration and individualization of dosage.
The dose should be individualized and titration is strongly recommended to safely obtain the desired state of sedation according to the clinical need, physical status, age and concomitant medication.
In adults over 60 years of age, critically ill patients, high-risk patients and pediatric patients, the dose should be determined with caution and risk factors related to each patient should be taken into account.
The drug takes effect in about 2 minutes after intravenous injection. Maximum effect is obtained in about 5 to 10 minutes.
Standard dosages are provided in the table as follows. Additional details are given in the text following the table. (See Table 1.)

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Conscious sedation: For basal (conscious) sedation prior to diagnostic or surgical intervention, Midazolam (Dormicum) is administered I.V. The dose must be individualized and titrated and should not be administered by rapid or single bolus injection. The onset of sedation may vary individually depending on the physical status of the patient and the detailed circumstances of dosing (e.g. speed of administration, amount of dose). If necessary, subsequent doses may be administered according to the individual need.
Special caution is required for the indication of conscious sedation in patients with impaired respiratory function, see Precautions.
Adults: The I.V. injection of Midazolam (Dormicum) should be given slowly at a rate of approximately 1 mg in 30 seconds.
In adults below the age of 60, the initial dose is 2 to 2.5 mg given 5-10 minutes before the beginning of the procedure. Further doses of 1 mg may be given as necessary. Mean total doses have been found to range from 3.5-7.5 mg.
A total dose greater than 5.0 mg is usually not necessary.
In adults over 60 years of age, critically ill patients, high-risk patients, the initial dose must be reduced to 0.5-1.0 mg and given 5-10 minutes before the beginning of the procedure. Further doses of 0.5-1 mg may be given as necessary. Since in these patients the peak effect may be reached less rapidly, additional Midazolam (Dormicum) should be titrated very slowly and carefully.
A total dose greater than 3.5 mg is not usually necessary.
Pediatrics: I.V. administration: Midazolam (Dormicum) should be titrated slowly to the desired clinical effect. The initial dose of Midazolam (Dormicum) should be administered over 2 to 3 minutes and, it is recommended to wait an additional 2 to 5 minutes to fully evaluate the sedative effect before initiating a procedure or repeating a dose. If further sedation is necessary, continue to titrate with small increments until the appropriate level of sedation is achieved. Infants and young children less than 5 years of age may require substantially higher doses than older children and adolescents.
Pediatric patients less than 6 months of age: Pediatric patients less than 6 months of age are particularly vulnerable to airway obstruction and hypoventilation. For this reason, the use in conscious sedation in children less than 6 months of age is not recommended unless the benefits outweigh the risks. In such cases, titration with small increments to clinical effect and careful monitoring are essential.
Pediatric patients >6 months to 5 years of age: Initial dose 0.05 to 0.1 mg/kg. A total dose up to 0.6 mg/kg may be necessary to reach the desired endpoint but the total dose should not exceed 6 mg. Prolonged sedation and risk of hypoventilation may be associated with the higher doses (see Precautions).
Pediatric patients 6 to 12 years of age: Initial dose 0.025 to 0.05 mg/kg. A total dose up to 0.4 mg/kg to a maximum of 10 mg may be necessary. Prolonged sedation and risk of hypoventilation may be associated with the higher doses (see Precautions).
Pediatric patients 13 to 16 years of age: Should be dosed as adults.
Rectal administration (pediatrics >6 months): The total dose of Midazolam (Dormicum) ranges from 0.3-0.5 mg/kg.
Total dose should be administered at once and repeated rectal administration avoided. The use in pediatrics less than 6 months of age is not recommended, as available data in this population are limited.
For rectal administration of Midazolam (Dormicum) see Special Instructions for Use, Handling and Disposal under Cautions for Usage.
I.M. administration (pediatrics 1-16 years): The recommended dose range is 0.05 to 0.15 mg/kg given 5-10 minutes before the beginning of the procedure. A total dose greater than 10.0 mg is not usually necessary. This route should only be used in exceptional cases.
Rectal administration should be preferred as I.M. injection may be painful.
In pediatrics less than 15 kg of body weight, midazolam solutions with concentrations higher than 1 mg/mL are not recommended. Higher concentrations should be diluted to 1 mg/mL.
Anesthesia-premedication: Premedication with Midazolam (Dormicum) given shortly before a procedure produces sedation (induction of sleepiness or drowsiness and relief of apprehension) and preoperative impairment of memory. Midazolam (Dormicum) can also be administered in combination with anticholinergics. For this indication, Midazolam (Dormicum) should be administered I.V., or I.M. (deep into a large muscle mass 20-60 minutes before induction of anesthesia), or preferably via the rectal route in pediatrics (see as follows). Adequate observation of the patient after administration is mandatory as inter-individual sensitivity varies and symptoms of overdose may occur.
Adults: For preoperative sedation and to impair memory of preoperative events, the recommended dose for adults of ASA Physical Status I & II and below 60 years is 1-2 mg I.V. repeated as needed, or 0.07-0.1 mg/kg I.M.
The dose must be reduced and individualized when Midazolam (Dormicum) is administered to adults over 60 years of age, critically ill, high-risk patients.
The recommended initial I.V. dose is 0.5 mg and should be slowly uptitrated as needed. Allow 2-3 minutes to fully evaluate the effect between doses. An I.M. dose of 0.025-0.05 mg/kg is recommended if there is no concomitant administration of narcotics. The usual dose is 2-3 mg.
Pediatrics: Rectal administration (>6 months): The total dose of Midazolam (Dormicum), usually 0.4 mg/kg, ranging from 0.3-0.5 mg/kg, should be administered 20-30 minutes before induction of anesthesia.
For rectal administration of Midazolam (Dormicum) see Special Instructions for Use, Handling and Disposal under Cautions for Usage.
The use in pediatrics less than 6 months of age is not recommended as available data are limited.
I.M. administration (1-15 years): As I.M. injection may be painful, this route should only be used in exceptional cases. Rectal administration should be preferred. However, a dose range from 0.08-0.2 mg/kg of Midazolam (Dormicum) administered I.M. has been shown to be effective and safe.
In children between ages 1 and 15, proportionally higher doses are required than in adults in relation to body weight. It is recommended that Midazolam (Dormicum) should be administered deep into a large muscle mass 30-60 minutes prior to the induction of anesthesia.
In pediatrics less than 15 kg of body weight, midazolam solutions with concentrations higher than 1 mg/mL are not recommended. Higher concentrations should be diluted to 1 mg/mL.
Induction of anesthesia: Adults: If Midazolam (Dormicum) is used for induction of anesthesia before other anesthetic agents have been administered, the individual response is variable. The dose should be titrated to the desired effect according to the patient's age and clinical status. When Midazolam (Dormicum) is used before or in combination with other I.V. or inhalation agents for induction of anesthesia, the initial dose of each agent may be significantly reduced, at times to as low as 25% of the usual initial dose of the individual agents.
The desired level of anesthesia is reached by stepwise titration. The I.V. induction dose of Midazolam (Dormicum) should be given slowly in increments. Each increment of not more than 5 mg should be injected over 20-30 seconds allowing 2 minutes between successive increments.
Adults below the age of 60 years: A dose of 0.2 mg/kg, administered I.V. over 20-30 seconds and allowing 2 minutes for effect, will usually suffice.
In non-premedicated patients, the dose may be higher (0.3-0.35 mg/kg), administered I.V. over 20-30 seconds and allowing about 2 minutes for effect. If needed to complete induction, increments of approximately 25% of the patient's initial dose may be used. Induction may instead be completed with volatile liquid inhalational anesthetics. In resistant cases, a total dose of up to 0.6 mg/kg may be used for induction, but such larger doses may prolong recovery.
Adults above the age of 60 years and/or critically ill and/or high-risk patients: In non-premedicated patients the lowest initial dose of 0.15-0.2 mg/kg is recommended.
In premedicated patients, a dose of 0.05-0.15 mg/kg administered I.V. over 20-30 seconds and allowing 2 minutes for effect, will usually suffice.
Pediatrics: The use of Midazolam (Dormicum) for the induction of anesthesia is limited to adults only as there is very limited experience in children.
Sedative component in combined anesthesia: Adults: Midazolam (Dormicum) can be given as a sedative component in combined anesthesia by either further intermittent small I.V. doses (range between 0.03 and 0.1 mg/kg) or continuous infusion of I.V. Midazolam (Dormicum) (range between 0.03 and 0.1 mg/kg/h) typically in combination with analgesics.
The dose and the intervals between doses vary according to the patient's individual reaction.
In adults over 60 years of age, critically ill and/or, high-risk patients, lower maintenance doses will be required.
Pediatrics: The use of Midazolam (Dormicum) as sedative component in combined anesthesia is limited to adults only as there is very limited experience in children.
Sedation in intensive care units: The desired level of sedation is reached by stepwise titration of Midazolam (Dormicum) followed by either continuous infusion or intermittent bolus, according to the clinical need, physical status, age and concomitant medication (see Interactions).
Adults: I.V. loading dose: 0.03-0.3 mg/kg should be given slowly in increments.
Each increment of 1-2.5 mg should be injected over 20-30 seconds allowing 2 minutes between successive increments.
In hypovolemic, vasoconstricted or hypothermic patients the loading dose should be reduced or omitted.
When Midazolam (Dormicum) is given with potent analgesics, the latter should be administered first so that the sedative effects of Midazolam (Dormicum) can be safely titrated on top of any sedation caused by the analgesic.
I.V. maintenance dose: Doses can range from 0.03-0.2 mg/kg/h. In hypovolemic, vasoconstricted or hypothermic patients the maintenance dose should be reduced. The level of sedation should be assessed regularly if the patient's condition permits. With long-term sedation, tolerance may develop and the dose may have to be increased.
Pediatrics: In preterm newborn infants, term newborn infants, and pediatrics less than 15 kg of body weight, midazolam solutions with concentrations higher than 1 mg/mL are not recommended. Higher concentrations should be diluted to 1 mg/mL.
Pediatrics up to 6 months of age: Midazolam (Dormicum) should be given as a continuous I.V. infusion: Pediatrics ≤32 weeks of gestational age: starting dose at 0.03 mg/kg/h (0.5 µg/kg/min).
Pediatrics >32 weeks of gestational age up to 6 months of age: starting dose 0.06 mg/kg/h (1 µg/kg/min).
Intravenous loading doses should not be used 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 drug accumulation.
Careful monitoring of respiratory rate and oxygen saturation is required.
Pediatrics over 6 months of age: In intubated and ventilated patients, a loading dose of 0.05 to 0.2 mg/kg I.V. should be administered slowly over at least 2 to 3 minutes to establish the desired clinical effect. Midazolam (Dormicum) should not be administered as a rapid intravenous dose. The loading dose is followed by a continuous I.V. infusion at 0.06 to 0.12 mg/kg/h (1 to 2 μg/kg/min). The rate of infusion can be increased or decreased (generally by 25% of the initial or subsequent infusion rate) as required, or supplemental I.V. doses of Midazolam (Dormicum) can be administered to increase or maintain the desired effect.
When initiating an infusion with Midazolam (Dormicum) in hemodynamically compromised patients, the usual loading dose should be titrated in small increments and the patient monitored for hemodynamic instability, e.g., hypotension. These patients are also vulnerable to the respiratory depressant effects of Midazolam (Dormicum) and require careful monitoring of respiratory rate and oxygen saturation.
Special Dosage Instructions: Patients with renal impairment: In patients with severe renal impairment, Midazolam (Dormicum) may be accompanied by more pronounced and prolonged sedation possibly including clinically relevant respiratory and cardiovascular depression. Midazolam (Dormicum) should therefore be dosed carefully in this patient population and titrated for the desired effect (see as previously mentioned and Use in Special Populations under Precautions).
Hepatic Impairment: The clinical effects in patients with hepatic impairment may be stronger and prolonged. The dose of midazolam may have to be reduced and vital signs should be monitored (see Precautions and Pharmacology: Pharmacokinetics in Special Populations under Actions).