Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/367
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Diazepam (Injection)
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Dosage should be individualized
for maximum beneficial effect. The usual recommended dose in older children and adults
ranges from 2 mg to 20 mg IM or IV, depending on the indication and its severity. In
some conditions, e.g., tetanus, larger doses may be required. (See dosage for specific
indications.) In acute conditions the injection may be repeated within one hour
although an interval of 3 to4 hours is usually satisfactory. Lower doses (usually 2
mg to 5 mg) and slow increase in dosage should be used for elderly or debilitated
patients and when other sedative drugs are administered. For dosage in infants above the
age of 30 days and children, see the specific indications below. When intravenous use
is indicated, facilities for respiratory assistance should be readily
available.<br/>Intramuscular: Diazepam Injection should
be injected deeply into the muscle.<br/>Intravenous Use: (See WARNINGS,
particularly for use in children.) 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 flask. If it is not feasible to
administer diazepam directly IV, it may be injected slowly through the infusion
tubing as close as possible to the vein insertion. Once the acute
symptomatology has been properly controlled with Diazepam Injection, the patient
may be placed on oral therapy with diazepam if further treatment is required. Parenteral drug products should be inspected visually
for particulate matter and discoloration prior to administration, whenever
solution and container permit. NOTE: Solution may appear colorless to light yellow.
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Each mL of Diazepam Injection,
USP, an anxiolytic, contains diazepam 5 mg, propylene glycol 0.4 mL, alcohol 0.1 mL,
benzyl alcohol 0.015 mL and sodium benzoate/benzoic acid, a total of 50 mg, in Water
for Injection. pH 6.2���6.9. Sealed under nitrogen. NOTE: Solution may appear colorless to light yellow. Diazepam is a benzodiazepine
derivative, identified chemically as
7-Chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless
crystalline compound, insoluble in water and has the following structural formula:
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In animals, diazepam appears to
act on parts of the limbic system, the thalamus and hypothalamus, and induces calming
effects. Diazepam, unlike chlorpromazine and reserpine, has no demonstrable peripheral
autonomic blocking action, nor does it produce extrapyramidal side effects; however,
animals treated with diazepam do have a transient ataxia at higher doses. Diazepam was
found to have transient cardiovascular depressor effects in dogs. Long-term
experiments in rats revealed no disturbances of endocrine function. Injections into animals have
produced localized irritation of tissue surrounding injection sites and some
thickening of veins after intravenous use.
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Diazepam Injection is
contraindicated in patients with a known hypersensitivity to this drug; acute narrow
angle glaucoma; and open angle glaucoma unless patients are receiving appropriate
therapy.
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Diazepam Injection, USP 5 mg/mL 10 mL amber Multiple Dose vials
packaged in 10s (NDC 0641-2289-43)<br/>Storage: Store at 20��-25��C (68��-77��F), excursions permitted to
15��-30��C (59��-86��F) [See USP Controlled Room Temperature]. PROTECT FROM
LIGHT.
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Although seizures may be brought under control promptly, a significant proportion of patients experience a
return to seizure activity, presumably due to the short-lived effect of diazepam after
IV administration. The physician should be prepared to readminister the drug. However,
diazepam is not recommended for maintenance, and once seizures are brought under
control, consideration should be given to the administration of agents useful in
longer term control of seizures. If diazepam is to be combined with other psychotropic
agents or anticonvulsant drugs, careful consideration should be given to the
pharmacology of the agents to be employed���particularly with known compounds which may
potentiate the action of diazepam, such as phenothiazines, narcotics, barbiturates,
MAO inhibitors and other antidepressants. In highly anxious patients with evidence of
accompanying depression, particularly those who may have suicidal tendencies,
protective measures may be necessary. The usual precautions in treating patients with
impaired hepatic function should be observed. Metabolites of diazepam are excreted by
the kidney; to avoid their excess accumulation, caution should be exercised in the
administration to patients with compromised kidney function. Since an increase in cough
reflex and laryngospasm may occur with peroral endoscopic procedures, the use of a
topical anesthetic agent and the availability of necessary countermeasures are
recommended. Diazepam Injection has produced
hypotension or muscular weakness in some patients particularly when used with
narcotics, barbiturates or alcohol. Lower doses (usually 2 mg to 5 mg) should be used
for elderly and debilitated patients. The clearance of diazepam and
certain other benzodiazepines can be delayed in association with Tagamet' (cimetidine)
administration. The clinical significance of this is unclear.<br/>Labor and Delivery: 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.
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Diazepam
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Diazepam (Injection)
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Side effects most commonly
reported were drowsiness, fatigue and ataxia; venous thrombosis and phlebitis at the
site of injection. Other adverse reactions less frequently reported include: CNS:
confusion, depression, dysarthria, headache, hypoactivity, slurred speech, syncope,
tremor, vertigo. G.I.: constipation, nausea. G.U.: incontinence, changes in libido,
urinary retention. Cardiovascular: bradycardia, cardiovascular collapse, hypotension.
EENT: blurred vision, diplopia, nystagmus. Skin: urticaria, skin rash. Other: hiccups,
changes in salivation, neutropenia, jaundice. Paradoxical reactions such as acute
hyperexcited states, anxiety, hallucinations, increased muscle spasticity, insomnia,
rage, sleep disturbances and stimulation have been reported; should these occur, use
of the drug should be discontinued. Minor changes in EEG patterns, usually low-voltage
fast activity, have been observed in patients during and after diazepam therapy and
are of no known significance. In peroral endoscopic
procedures, coughing, depressed respiration, dyspnea, hyperventilation, laryngospasm
and pain in throat or chest have been reported. Because of isolated reports of
neutropenia and jaundice, periodic blood counts and liver function tests are advisable
during long-term therapy.
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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 flask. If it is not feasible to administer diazepam
directly IV, 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 IV 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 IV diazepam for petit mal status or petit
mal variant status. Withdrawal symptoms of the
barbiturate type have occurred after the discontinuation of benzodiazepines (seeDRUG ABUSE AND
DEPENDENCE).<br/>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.<br/>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.<br/>Management of Overdosage: Manifestations of diazepam overdosage include
somnolence, confusion, coma, and diminished reflexes. Respiration, pulse and
blood pressure should be monitored, as in all cases of drug overdosage,
although, in general, these effects have been minimal. General supportive
measures should be employed, along with intravenous fluids, and an adequate
airway maintained. Hypotension may be combated by the use of norepinephrine or
metaraminol. Dialysis is of limited value. Flumazenil, a specific
benzodiazepine receptor antagonist, is indicated for the complete or partial
reversal of the sedative effects of benzodiazepines and may be used in situations
when an overdose with a benzodiazepine is known or suspected. Prior to the
administration of flumazenil, necessary measures should be instituted to secure
airway, ventilation and intravenous access. Flumazenil is intended as an adjunct
to, not as a substitute for, proper management of benzodiazepine overdose.
Patients treated with flumazenil should be monitored for resedation, respiratory
depression and other residual benzodiazepine effects for an appropriate period
after treatment. The prescriber should be aware of a
risk of seizure in association with flumazenil treatment, particularly in
long-term benzodiazepine users and in cyclic antidepressant overdose.
The complete flumazenil package insert including CONTRAINDICATIONS,WARNINGS andPRECAUTIONS should
be consulted prior to use.
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Diazepam is indicated for the
management of anxiety disorders or for the short-term relief of the symptoms of
anxiety. Anxiety or tension associated with the stress of everyday life usually does
not require treatment with an anxiolytic. In acute alcohol withdrawal,
diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending
or acute delirium tremens and hallucinosis. As an adjunct prior to
endoscopic procedures if apprehension, anxiety or acute stress reactions are present,
and to diminish the patient's recall of the procedures. Diazepam is a useful adjunct
for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such
as inflammation of the muscles or joints, or secondary to trauma); spasticity caused
by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis;
stiff-man syndrome; and tetanus. Diazepam Injection is a useful
adjunct in status epilepticus and severe recurrent convulsive seizures. Diazepam is a useful
premedication (the IM route is preferred) for relief of anxiety and tension in
patients who are to undergo surgical procedures. Intravenously, it is used prior to
cardioversion for the relief of anxiety and tension and to diminish the patient's
recall of the procedure.
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Diazepam
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