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more than doubled) when the substance is taken in
combination with erythromycin. This results in potenti-
ation of the sedative effect of midazolam. In vitro data
show that the hydroxylation of midazolam is inhibited
by many other substances that specifically inhibit the
isozyme cytochrome P-450 3 A. Clinically relevant
potentiation of the effect of midazolam has been dem-
onstrated with erythromycin, diltiazem, verapamil,
ketoconazole, itraconazole, cimetidine and ranitidine,
but not with cyclosporin or nitrendipine.
When Dormicum is used concomitantly with erythro-
mycin or cimetidine its oral dose should be reduced,
in the case of erythromycin to a half to a quarter,
and in that of cimetidine to about two thirds, of the
usual dose.
A much smaller change in plasma concentration,
but no potentiation of the sedative effect, has been
observed after I.V. administration of midazolam.
Nevertheless, caution is advised.
With concomitant intake of other CNS depressant
medications (e.g. neuroleptics, narcotics) or alcohol
there is a risk of life-threatening respiratory depres-
sion.
During the clinical trials Dormicum was given togeth-
er with various medications including oral antidia-
betics and anticoagulants. No interactions were
observed.
Dosage and Administration
In general the lowest effective dose should be given
for as short a time as possible.
Standard Dosage
The standard dose for adults is 7.5 to 15 mg.
Because of its rapid onset of action, Dormicum
should be swallowed whole with fluid immediately
before retiring. An uninterrupted period of at least six
hours of sleep must be available thereafter. The risk
of anterograde amnesia should be borne in mind
(see Side Effects).
Special Dosage Instructions
The standard dose for elderly or frail patients is
7.5 mg.
This dose may also be suitable for patients with mild
impairment of liver and/or renal function. Where
appropriate, treatment can be initiated with half a
7.5 mg tablet. A dose of 7.5 mg is generally also suf-
ficient for situational sleep disturbances. The above
doses may be increased to a maximum of 15 mg if
treatment with the recommended dose and other
measures such as improved sleep hygiene and
treatment of sleep-disturbing underlying disease are
unsuccessful.
For premedication of adults, 7.5 to 15 mg of
Dormicum should be administered orally 30 to 60
minutes before the procedure, unless the parenteral
route is preferred (see Dormicum Ampoules).
The duration of treatment should generally not
exceed two weeks. In some cases a shorter period
of treatment may be adequate; in other cases a lon-
ger period of treatment may be necessary, but this
requires a careful re-evaluation.
At the end of treatment the dose of Dormicum
should be tapered off. The tapering-off process
should be tailored to the individual.