When used intravenously,
the following procedures should be undertaken to reduce the possibility
of venous thrombosis, phlebitis, local irritation, swelling, and,
rarely, vascular impairment; the solution should be injected slowly,
taking at least one minute for each 5 mg (1 mL) given; do not use
small veins, such as those on the dorsum of the hand or wrist; extreme
care should be taken to avoid intra-arterial administration or extravasation.
Do not mix or
dilute diazepam with other solutions or drugs in syringe or infusion
container. If it is not feasible to administer diazepam directly I.V.,
it may be injected slowly through the infusion tubing as close as
possible to the vein insertion.
Extreme
care must be used in administering Diazepam Injection, particularly
by the I.V. route, to the elderly, to very ill patients and to those
with limited pulmonary reserve because of the possibility that apnea
and/or cardiac arrest may occur. Concomitant use of barbiturates,
alcohol or other central nervous system depressants increases depression
with increased risk of apnea. Resuscitative equipment including that
necessary to support respiration should be readily available.
When diazepam is used with a narcotic analgesic, the dosage
of the narcotic should be reduced by at least one-third and administered
in small increments. In some cases the use of a narcotic may not be
necessary.
Diazepam Injection should not be
administered to patients in shock, coma, or in acute alcoholic intoxication
with depression of vital signs. As is true of most CNS-acting drugs,
patients receiving diazepam should be cautioned against engaging in
hazardous occupations requiring complete mental alertness, such as
operating machinery or driving a motor vehicle.
Tonic status epilepticus has been precipitated in patients treated
with I.V. diazepam for petit mal status or petit mal variant status.
Usage in Pregnancy:
An increased risk
of congenital malformations associated with the use of minor tranquilizers
(diazepam, meprobamate and chlordiazepoxide) during the first trimester
of pregnancy has been suggested in several studies. Because use of
these drugs is rarely a matter of urgency, their use during this period
should almost always be avoided. The possibility that a woman of childbearing
potential may be pregnant at the time of institution of therapy should
be considered. Patients should be advised that if they become pregnant
during therapy or intend to become pregnant they should communicate
with their physicians about the desirability of discontinuing the
drug.
In humans, measurable amounts
of diazepam were found in maternal and cord blood, indicating placental
transfer of the drug. Until additional information is available, diazepam
injection is not recommended for obstetrical use.
Pediatric Use:
Efficacy and safety of parenteral diazepam has not been established
in the neonate (30 days or less of age).
Prolonged
central nervous system depression has been observed in neonates, apparently
due to inability to biotransform diazepam into inactive metabolites.
In pediatric use, in order to obtain maximal clinical
effect with the minimum amount of drug and thus to reduce the risk
of hazardous side effects, such as apnea or prolonged periods of somnolence,
it is recommended that the drug be given slowly over a three-minute
period in a dosage not to exceed 0.25 mg/kg. After an interval of
15 to 30 minutes the initial dosage can be safely repeated. If, however,
relief of symptoms is not obtained after a third administration, adjunctive
therapy appropriate to the condition being treated is recommended.
Withdrawal symptoms of the barbiturate type have occurred
after the discontinuation of benzodiazepines (see DRUG ABUSE AND DEPENDENCE
section).
Benzyl alcohol has been reported to
be associated with a fatal gasping syndrome in premature infants.
