Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1956
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Diazepam (Injection, Solution)
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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 I.M. or I.V., 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 to 4 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. (See WARNINGS and
ADVERSE REACTIONS.) 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. Intramuscular: Diazepam Injection,
USP should be injected deeply into the muscle. 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 I.V., 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 (see PRECAUTIONS). NOTE: Solution may
appear colorless to light yellow.
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| dailymed-instance:descripti... |
Diazepam Injection, USP is a sterile, nonpyrogenic
solution intended for intramuscular or intravenous administration.
Each milliliter (mL) contains 5 mg diazepam; 40% propylene glycol;
10% alcohol; 5% sodium benzoate and benzoic acid added as buffers;
and 1.5% benzyl alcohol added as a preservative. pH 6.6 (6.2 to 6.9).
Note: Solution may appear colorless to light yellow. Diazepam is a benzodiazepine derivative chemically designated 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, with the
following molecular structure:
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| dailymed-instance:clinicalP... |
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 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 is supplied as follows: 10 mL multiple dose vials containing 50 mg (5 mg/mL) Box of 10 NDC 0409���3213���12 Store at 20 to 25��C (68 to 77��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
I.V. administration. The physician should be prepared to re-administer
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. Until additional information is available, diazepam injection
is not recommended for obstetrical use. 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 cimetidine
administration. The clinical significance of this is unclear.
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Diazepam
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Diazepam (Injection, Solution)
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| dailymed-instance:adverseRe... |
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
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.
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| dailymed-instance:indicatio... |
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.
(See WARNINGS.) 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 is a useful adjunct in
status epilepticus and severe recurrent convulsive seizures. Diazepam is a useful premedication (the I.M. route is
preferred) for relief of anxiety and tension in patients who are to
undergo surgical procedures. Intravenously, 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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