buy 60 tabketsDiazepam is a long-acting oral and parenteral benzodiazepine. Diazepam is similar to chlordiazepoxide and clorazepate in that all three generate the same active metabolite. Diazepam is used orally for the short-term management of anxiety dis
In
addition to treating status epilepticus, diazepam has recently been shown
effective in preventing recurrence of febrile seizures. Although diazepam has
been the benzodiazepine of choice for status epilepticus, recent evidence
indicates that lorazepam may be more beneficial because it provides longer
control of seizures and produces less cardiorespiratory depression. Diazepam was
approved by the FDA in November 1963. Phase III data for a rectal formulation of
diazepam in the treatment of acute repetitive seizures was completed April 1995.
The NDA for the rectal formulation (Diastat) is expected to be filed in 1995.
Diazepam is a schedule IV controlled substance.
Diazepam
is an anxiolytic-sedative drug useful in the symptomatic relief of anxiety and
tension states. It has also adjunctive value in the relief of certain
neurospastic conditions. Peak blood levels after oral administration of diazepam
are reached within 1 to 2 hours after single oral dosing. The acute half-life is
6 to 8 hours with a slower decline thereafter, possibly due to tissue storage.
However, after repeated doses, blood levels increase significantly over a period
of 24 to 48 hours.
In
humans, comparable blood levels of diazepam were obtained in maternal and cord
blood indicating placental transfer of the drug.
The
symptomatic management of mild to moderate degrees of anxiety in conditions
dominated by tension, excitation, agitation, fear or aggressiveness, such as may
occur in psychoneurosis, anxiety reactions due to stress conditions and anxiety
states with somatic expression.
In acute alcoholic withdrawal, diazepam may be useful in the symptomatic relief
of acute agitation, tremor and impending acute delirium tremens.
As an adjunct for the relief of skeletal muscle spasm due to reflex spasm to
local pathology, such as inflammation of the muscle and joints or secondary to
trauma; spasticity caused by upper motor neuron disorders, such as cerebral
palsy and paraplegia; athetosis and the rare "stiff man syndrome".
PRECAUTIONS:
Geriatrics:
Elderly and debilitated patients or those with organic brain disorders have been
found to be prone to CNS depression following even low doses. For these patients
it is recommended that the dosage be limited to the smallest effective amount to
preclude development of ataxia, oversedation or other possible adverse effects.
Emotional Disorders: Diazepam is not recommended in the treatment of psychotic
or severely depressed patients. Precautions are indicated for severely depressed
patients or those who show evidence of impending depression, particularly the
recognition that suicidal tendencies may be present and protective measures may
be necessary. Since excitement and other paradoxical reactions may result from
the use of the drug in psychotic patients, it should not be used in ambulatory
patients suspected of having psychotic tendencies.
Epileptic Patients: Careful consideration should be given if diazepam is to be
used in patients with epilepsy as the possibility of an increase in the
frequency and/or severity of grand mal seizures may require an increase in the
doses of standard anticonvulsant medication. An abrupt withdrawal of diazepam is
such cases may also be associated with the temporary increase in the frequency
and/or severity of seizures.
Pregnancy: Diazepam should not be used during the first trimester of pregnancy
except if absolutely necessary.
Potentiation of Drug Effects: Careful consideration should be given if diazepam
is to be combined with other psychotropic agents, phenothiazines, barbiturates,
MAO inhibitors and other antidepressants because the pharmacological action of
these agents might potentiate the action of diazepam. Since diazepam has a CNS
depressant effect, patients should be advised against the simultaneous ingestion
of alcohol and other CNS depressant drugs during diazepam therapy.
Drug Dependence: Abrupt cessation of large doses of diazepam after prolonged
periods may precipitate acute withdrawal symptoms and, in these cases, the drug
should be discontinued gradually. Caution should be exercised when it is
considered necessary to administer diazepam to addiction prone individuals.
General: Patients receiving diazepam should be advised to proceed cautiously
wherever mental alertness and physical coordination are required.
The usual precautions in treating patients with impaired renal and hepatic
functions should be observed. If diazepam is administered for protracted
periods, periodic blood counts and liver function tests would be highly
advisable.
Adverse
Reactions:
The
most common adverse effects reported are drowsiness and ataxia. Other reactions
noted less frequently are fatigue, dizziness, nausea, blurred vision, diplopia,
vertigo, headache, slurred speech, tremors, hypoactivity, dysarthria, euphoria,
impairment of memory, confusion, depression, incontinence or urinary retention,
constipation, skin rash, generalized exfoliative dermatitis, hypotension and
changes in libido.
The more serious adverse reactions occasionally reported are leukopenia,
jaundice, hypersensitivity and paradoxical reactions (such as hyperexcited
states, anxiety, excitement, hallucinations, increased muscle spasticity,
insomnia, rage, as well as sleep disturbances and stimulation). Should these
occur, the drug should be discontinued.
Minor changes in EEG patterns have been observed in patients on diazepam
therapy. These changes consist of low to moderate voltage fast activity, 20 to
30 cycles/second and are of no known significance.
Symptoms
And Treatment Of Overdose:
Symptoms:
Drowsiness, oversedation and ataxia. When the effects of drug overdosage begin
to wear off, the patient exhibits some jitteriness and overstimulation. The
cardinal manifestations of overdosage are drowsiness and confusion, reduced
reflexes and coma. There are minimum effects on respiration, pulse and blood
pressure unless the overdosage is extreme. tag_Treatment
Treatment: Gastric lavage may be beneficial if performed soon after oral
ingestion of diazepam. If necessary, a CNS stimulant such as caffeine or
methylphenidate may be administered with caution. Supportive measures should be
instituted as indicated, such as, maintenance of an adequate airway,
levarterenol or metaraminol bitartrate for hypotension. Dialysis appears to be
of little value.
Dosage
And Administration:
Should
be individualized for maximal beneficial effect. While the usual daily dosages
given below will meet the needs of most patients, there will be some who may
require higher doses. In the first few days of administration a cumulative
effect of the drug may occur, and therefore, the dosage should be increased only
after stabilization is apparent.
Adults: Symptomatic relief of anxiety and tension in psychoneurosis and anxiety
reactions: 2 to 10 mg, 2 to 4 times daily depending upon severity of symptoms.
Symptomatic relief in acute alcohol withdrawal: 10 mg, 3 or 4 times during the
first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed.
Adjunctively for relief of skeletal muscle spasms: 2 to 10 mg, 3 to 4 times
daily.
Elderly and debilitated patients, or in the presence of debilitating disease: 2
mg, 1 or 2 times daily initially; increase gradually as needed and tolerated.
Children: Because of varied responses, initiate therapy with lowest dose and
increase as required. Not for use in children under 6 months (see
Contraindications): 1 to 2.5 mg, 3 or 4 times daily initially; increase
gradually as needed and tolerated.
Availability
And Storage:
10 mg: Each light blue cylindrical, biplane beveled-edged, single scored on one
side and engraved on unscored side contains: diazepam 10 mg. Nonmedicinal
ingredients: cornstarch, indigotine, lactose and magnesium stearate. Energy: 2.8
kJ (0.7 kcal). Gluten-, paraben-, sodium-, sulfite- and tartrazine-free. Bottles
of 100.
Store between 15 and 30 Keep in a tightly closed, light-resistant container.
(Shown in Product Recognition Section)
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