Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/993
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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 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
maybe 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 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 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.
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Each mL of this sterile injection contains 5 mg diazepam
compounded with 40% propylene glycol, 10% alcohol, 5% sodium benzoate
and benzoic acid as buffers, and 1.5% benzyl alcohol as preservative. Diazepam is a benzodiazepine derivative. Chemically, diazepam
is 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
a molecular weight of 284.74. The solution is clear, colorless to
slightly yellow.
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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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Carpuject sterile cartridge unit 10 mg/2 mL (5 mg/mL in 2 mL cartridge) With Luer Lock, box of 10 (List
1273) Do not use if solution is darker than
slightly yellow or contains a precipitate. Store
at 20 to 25��C (68 to 77��F). [See USP Controlled Room Temperature.] Protect from light. To prevent needle-stick injuries, needles
should not be recapped, purposely bent, or broken by hand.
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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 treatingpatients
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 Tagamet (cimetidine) administration. The clinical
significance of this is unclear.
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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 Levophed (norepinephrine bitartrate) or Aramine (metaraminol). Dialysis is
of a 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 cyclic antidepressant overdose. The complete
flumazenil package insert including CONTRAINDICATIONS, WARNINGS, and
PRECAUTIONS should be consulted prior to use.
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Diazepam
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Diazepam (Injection, Solution)
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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: Central Nervous System: Confusion, depression, dysarthria, headache, hypoactivity, slurred
speech, syncope, tremor, vertigo. Gastrointestinal: Constipation, nausea. Genitourinary: 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 injection 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 respirationshould 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.<br/>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.<br/>Use in Children:: 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).
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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.
(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 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, 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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