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Apo-Diazepam
Diazepam Tablets USP 2mg, 5mg and 10mg
Pharmacology:
Diazepam possesses anxiolytic and sedative properties which
may be of value in the symptomatic relief of manifest anxiety and tension
states in psychoneurotic patients. It has also and adjunctive value in the
relief of certain neurospastic conditions. Peak blood levels after oral
administration of diazepam are reached within one or two hours after single
oral dosing. The acute half-life is six to eight hours with a slower decline
thereafter, possibly due to tissue storage. However, after repeated doses,
blood levels increase significantly over a period of 24 - 48 hours. In
humans, comparable blood levels of diazepam were obtained in maternal and
cord blood indicating placental transfer of the drug.
Indications
Diazepam is useful in symptomatic relief of excessive anxiety
and tension in psychoneurotic patients, including those with somatic
manifestations. In acute alcoholic withdrawal, diazepam may be useful in the
symptomatic relief of acute agitation, tremor and impending acute delirium
tremens. Diazepam is a useful adjunct to the relief of spasticity in
neuromuscular disorders, such as cerebral palsy and athetosis.
Contraindications
Diazepam is contraindicated in patients with myasthenia
gravis, glaucoma or known hypersensitivity to the drug.
Precautions
Use in Elderly: Elderly and debilitated patients or those with
organic brain disorders have been found to be prone to central nervous
system 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.
Use In 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.
Use in Epileptic Patients: Since diazepam may
exacerbate grand mal seizures in some patients, caution is required when it
is used in epileptic patients. An adjustment may be necessary in their
anti-convulsive medication. Abrupt withdrawal of diazepam in these patients
should also be avoided.
Drug Dependence: Abrupt cessation of large doses of diazepam after prolonged
periods may precipitate acute withdrawal symptoms, including convulsions,
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 are advisable.
Anaphylaxis (severe allergic reaction) and angioedema (severe facial
swelling) which can occur as early as the first time the product is taken.
Complex sleep-related behaviors which may include sleep driving, making
phone calls, preparing and eating food (while asleep).
Drug Interactions
Careful consideration should be given if diazepam is to
be combined with other psychotropic agents (phenothiazines, barbiturates,
and MAO inhibitors and other anti-depressants) because the pharmacological
action of these agents might potentiate the action of diazepam. Since this
drug has a central nervous system depressant effect, patients should be
advised against the simultaneous ingestion
of alcohol and other central nervous system depressant drugs during diazepam
therapy.
Adverse Reactions
The most common adverse reactions reported for diazepam
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 most serious adverse reaction occasionally reported
are leucopenia, 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 per second and are of no known significance.
Symptoms & Treatment of Overdosage
The main symptoms of diazepam overdosage
are drowsiness, oversedation and ataxia. When the effects of the 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.
There is no specific antidote known. 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: maintenance
of an adequate airway, levarterinol or metaraminol bitartrate for
hypotension. Dialysis appears to be of little value.
Dosage & Administration
The average dosage of diazepam in adults is from
4-40mg daily in divided doses. However, the dosage must be individualized
for maximal therapeutic effect depending on diagnosis, severity of symptoms
and patient's response. A cumulative effect of the drug may occur in the
first few days after initiation of treatment.
Usual Oral Dose In Adults
Symptomatic relief of excessive anxiety and
tension in psychoneurotic patients. The recommended dose is 4-40mg daily
administered in divided doses 2-3 times daily. Adjunctively for the relief
of spasticity in neuromuscular disorders, such as cerebral palsy and
athetosis. The recommended dose is 6-30mg daily in divided doses. Elderly
and debilitated patients. The recommended initial dose is 2mg, once or twice
daily. Increase gradually as needed and tolerated.
Mode of Administration: Oral
Availability:
APO-DIAZEPAM TABLETS - each round, flat-faced, bevelled edge, scored tablet
contains diazepam 2mg, white, identified "APO" over "2"; 5mg - yellow,
identified "APO" over "5"; 10mg - blue, identified "APO" over "10:.
Available in PVC Blisters of 1000 tablets.
Storage Conditions: Store between 15-30°C.
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