Dental: Sedation component in I.V. conscious sedation in oral surgery
patients; syrup formulation is used for children to help alleviate anxiety
before a dental procedure
Medical: Preoperative sedation and provides conscious sedation prior to
diagnostic or radiographic procedures
Unlabeled use: Anxiety, status epilepticus
Hypersensitivity to this drug or any component of its formulation, including
benzyl alcohol (cross-sensitivity with other benzodiazepines may exist);
parenteral form is not for intrathecal or epidural injection; narrow-angle
glaucoma (not in product labeling, however, benzodiazepines are
contraindicated); pregnancy; concurrent use with protease inhibitors like
amprenavir and ritonavir
May cause severe respiratory depression, respiratory arrest, or apnea. Use
with extreme caution, particularly in noncritical care settings. Appropriate
resuscitative equipment and qualified personnel must be available for
administration and monitoring. Initial dosing must be cautiously titrated and
individualized, particularly in elderly or debilitated patients, patients with
hepatic impairment (including alcoholics), or in renal impairment, particularly
if other CNS depressants (including opiates) are used concurrently. Initial
doses in elderly or debilitated patients should not exceed 2.5 mg. Use with
caution in patients with respiratory disease or impaired gag reflex. Use during
upper airway procedures may increase risk of hypoventilation. Prolonged
responses have been noted following extended administration by continuous
infusion (possibly due to metabolite accumulation) or in the presence of drugs
which inhibit midazolam metabolism.
Causes CNS depression (dose-related) resulting in sedation, dizziness,
confusion, or ataxia which may impair physical and mental capabilities. Patients
must be cautioned about performing tasks which require mental alertness (ie,
operating machinery or driving). A minimum of 1 day should elapse after
midazolam administration before attempting these tasks. Use with caution in
patients receiving other CNS depressants or psychoactive agents. Effects with
other sedative drugs or ethanol may be potentiated. Benzodiazepines have been
associated with falls and traumatic injury and should be used with extreme
caution in patients who are at risk of these events (especially the elderly).
Midazolam causes anterograde amnesia. Paradoxical reactions, including
hyperactive or aggressive behavior have been reported with benzodiazepines,
particularly in adolescent/pediatric or psychiatric patients. Does not have
analgesic, antidepressant, or antipsychotic properties.
Benzodiazepines have been associated with dependence and acute withdrawal
symptoms on discontinuation or reduction in dose. Acute withdrawal, including
seizures, may be precipitated after administration of flumazenil to patients
receiving long-term benzodiazepine therapy.
>10%: Respiratory: Decreased tidal volume and/or respiratory rate
1% to 10%:
Central nervous system: Drowsiness, oversedation, headache
Gastrointestinal: Nausea, vomiting
Local: Pain and local reactions at injection site (severity less than
Miscellaneous: Physical and psychological dependence with prolonged use,
<1%: PVC, bradycardia, tachycardia, bigeminy, acid taste, excessive
salivation, amnesia, euphoria, hallucinations, confusion, emergence delirium,
agitation, rash, wheezing, laryngospasm, bronchospasm, dyspnea, hyperventilation
Symptoms of overdose include respiratory depression, hypotension, coma,
stupor, confusion, apnea
Treatment for benzodiazepine overdose is supportive. Rarely is mechanical
ventilation required. Flumazenil has been shown to selectively block the binding
of benzodiazepines to CNS receptors, resulting in a reversal of
benzodiazepine-induced CNS depression; respiratory reaction to hypoxia may not
CYP3A3/4 enzyme substrate
Verapamil, troleandomycin, miconazole, itraconazole, nifedipine, grapefruit
juice, diltiazem, fluconazole, ketoconazole, clarithromycin, and erythromycin,
protease inhibitors like amprenavir and ritonavir may increase the serum
concentrations and effects of midazolam via CYP3A4 inhibition
If narcotics or other CNS depressants are administered concomitantly, the
midazolam dose should be reduced by 30% if <65 years of age, or by at least
50% if >65 years of age
Stable for 24 hours at room temperature/refrigeration; admixtures do not
require protection from light for short-term storage; compatible with
Binds to stereospecific benzodiazepine receptors on the postsynaptic GABA
neuron at several sites within the central nervous system, including the limbic
system, reticular formation. Enhancement of the inhibitory effect of GABA on
neuronal excitability results by increased neuronal membrane permeability to
chloride ions. This shift in chloride ions results in hyperpolarization (a less
excitable state) and stabilization.
Onset of sedation: Within 15 minutes
Peak effect: 0.5-1 hour
Duration: 2 hours mean, up to 6 hours
I.V.: Onset of action: Within 1-5 minutes
Absorption: Oral: Rapid
Distribution: Vd: 0.8-2.5 L/kg; increased with congestive heart
failure (CHF) and chronic renal failure
Protein binding: 95%
Metabolism: Extensively in the liver (microsomally)
Bioavailability: 45% mean
Half-life, elimination: 1-4 hours, increased with cirrhosis, CHF, obesity,
Elimination: As glucuronide conjugated metabolites in urine, ~2% to 10%
excreted in feces
The dose of midazolam needs to be individualized based on the patient's age,
underlying diseases, and concurrent medications. Decrease dose (by ~30%) if
narcotics or other CNS depressants are administered concomitantly. Personnel
and equipment needed for standard respiratory resuscitation should be
immediately available during midazolam administration.
Infants <2 months and Children: Status epilepticus refractory to standard
therapy: I.V.: Loading dose: 0.15 mg/kg followed by a continuous infusion of 1
mcg/kg/minute; titrate dose upward every 5 minutes until clinical seizure
activity is controlled; mean infusion rate required in 24 children was 2.3
mcg/kg/minute with a range of 1-18 mcg/kg/minute
I.M.: 0.07-0.08 mg/kg 30-60 minutes presurgery
I.V.: 0.035 mg/kg/dose, repeat over several minutes as required to achieve
the desired sedative effect up to a total dose of 0.1-0.2 mg/kg
Conscious sedation during mechanical ventilation: I.V.: Loading dose:
0.05-0.2 mg/kg then follow with initial continuous infusion: 1-2 mcg/kg/minute;
titrate to the desired effect; usual range: 0.4-6 mcg/kg/minute
Conscious sedation for procedures:
Oral, Intranasal: 0.2-0.4 mg/kg (maximum: 15 mg) 30-45 minutes before the
I.V.: 0.05 mg/kg 3 minutes before procedure
Adolescents >12 years: I.V.: 0.5 mg every 3-4 minutes until effect
Preoperative sedation: I.M.: 0.07-0.08 mg/kg 30-60 minutes presurgery; usual
dose: 5 mg
Conscious sedation: I.V.: Initial: 0.5-2 mg slow I.V. over at least 2
minutes; slowly titrate to effect by repeating doses every 2-3 minutes if
needed; usual total dose: 2.5-5 mg; use decreased doses in elderly
Healthy Adults <60 years: Some patients respond to doses as low as 1 mg;
no more than 2.5 mg should be administered over a period of 2 minutes.
Additional doses of midazolam may be administered after a 2-minute waiting
period and evaluation of sedation after each dose increment. A total dose >5
mg is generally not needed. If narcotics or other CNS depressants are
administered concomitantly, the midazolam dose should be reduced by 30%.
Elderly: I.V.: Conscious sedation: Initial: 0.5 mg slow I.V.; give no more
than 1.5 mg in a 2-minute period; if additional titration is needed, give no
more than 1 mg over 2 minutes, waiting another 2 or more minutes to evaluate
sedative effect; a total dose >3.5 mg is rarely necessary
Sedation in mechanically intubated patients: I.V. continuous infusion: 100 mg
in 250 mL D5W or NS, (if patient is fluid-restricted, may concentrate
up to a maximum of 0.5 mg/mL); initial dose: 1 mg/hour; titrate to reach desired
level of sedation
Hemodialysis: Supplemental dose is not necessary
Peritoneal dialysis: Significant drug removal is unlikely based on
No data reported
Oral: Do not mix with any liquid (such as grapefruit juice) prior to
Parenteral: Administer by slow I.V. injection over at least 2-5 minutes at a
concentration of 1-5 mg/mL or by I.V. infusion
Respiratory and cardiovascular status, blood pressure, blood pressure monitor
required during I.V. administration
|Dental Health: Local
No information available to require special precautions
Effects on Dental Treatment|
No effects or complications reported
Avoid use of alcohol or prescription or OTC sedatives or hypnotics for a
minimum of 24 hours after administration. Avoid driving or engaging in any tasks
that require alertness for 24 hours following administration. You may experience
some loss of memory following administration. Pregnancy/breast-feeding
precautions: Advise prescriber if you are pregnant; this medication is
contraindicated for pregnant women. Breast-feeding is not
Midazolam is a short-acting benzodiazepine; recovery occurs within 2 hours in
most patients, however, may require up to 6 hours in some
Injection, as hydrochloride: 1 mg/mL (2 mL, 5 mL, 10 mL); 5 mg/mL (1 mL, 2
mL, 5 mL, 10 mL)
Syrup: 2 mg/mL (118 mL)
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