Seconal Sodium Capsules 100mg-100 Capsules
Posology and Method of Administration
For oral administration to adults only. Normal dosage is 100 mg at bedtime.
THE ELDERLY
Seconal Sodium is not recommended for use in elderly or debilitated patients.
CHILDREN
Seconal should not be administered to children or young adults.
In studies, Secobarbital sodium has been found to lose most of its
effectiveness for both inducing and maintaining sleep by the end of two weeks
of continued drug administration, even with the use of multiple doses.
4.3
SECONAL SODIUM CAPSULES 100MG
Contraindications
Hypersensitivity to barbiturates, a history of manifest or latent porphyria, marked
impairment of liver function or respiratory disease in which dyspnoea or obstruction
is evident.
Barbiturates should not be administered to children, young adults, patients with a
history of drug or alcohol addiction or abuse, the elderly and the debilitated.
Seconal Sodium Capsules 100mg
4.4
Seconal Sodium Capsules 100mg
Special warnings and precautions for use
Addiction potential: Secobarbital sodium may be habit forming. Tolerance and
psychological and physical dependence may occur with continued use. Patients who
have psychological dependence on barbiturates may increase the dosage or decrease
the dosage interval without consulting a doctor and, subsequently, may develop a
physical dependence on barbiturates.
To minimise the possibility of overdosage or development of dependence, the amount
prescribed should be limited to that required for the interval until the next
appointment.
Withdrawal symptoms occur after long term normal use (and particularly after abuse)
on rapid cessation of barbiturate treatment. Symptoms include nightmares, irritability
and insomnia and, in severe cases,tremors, delirium, convulsions and death.
Barbiturates should be withdrawn gradually from any patient known to be taking
excessive doses over long periods.
Caution should be exercised when barbiturates are administered in the presence of
acute or chronic pain, because paradoxical excitement could be induced or important
symptoms could be masked.
Information for patients: The following information should be given to patients
receiving Secobarbital:
The use of Secobarbital carries with it an associated risk of psychological and/or
physical dependence. The patient should be warned against increasing the dose of
the drug without consulting a doctor.
Secobarbital may impair the mental and/or physical abilities required for the
SECONAL SODIUM CAPSULES 100MG
performance of potentially hazardous tasks, such as driving a car or operating
machinery. The patient should be cautioned accordingly.
Alcohol should not be consumed while taking Secobarbital. The concurrent use of
Secobarbital with other CNS depressants (eg alcohol, narcotics, tranquillisers and
antihistamines) may result in additional CNS depressant effects.
Drug abuse and dependence: Barbiturates may be habit forming;
tolerance,psychological and physical dependence may occur especially following
prolonged use of high doses. Daily administration in excess of 400 mg Secobarbital,
for approximately 90 days, is likely to produce some degree of physical dependence.
A dosage of 600 – 800 mg, for at least 35 days, is sufficient to produce withdrawal
seizures. The average daily dose for the barbiturate addict is usually about 1.5g.
As tolerance to barbiturates develops, the amount needed to maintain the same level
of intoxication increases; tolerance to a fatal dosage, however, does not increase more
than twofold. As this occurs, the margin between intoxicating dosage and fatal
dosage becomes smaller. The lethal dose of a barbiturate is far less if alcohol is also
ingested. SECONAL SODIUM CAPSULES 100MG
Symptoms of acute intoxication include unsteady gait, slurred speech and sustained
nystagmus. Mental signs of chronic intoxication include confusion, poor judgement,
irritability, insomnia and somatic complaints.
The symptoms of barbiturate withdrawal can be severe and may cause death. Minor
withdrawal symptoms may appear 8 to 12 hours after the last dose of a barbiturate.
These symptoms usually appear in the following order: anxiety, muscle twitching,
tremor of hands and fingers, progressive weakness, dizziness, distortion in visual
perception, nausea, vomiting, insomnia and orthostatic hypotension. Major
withdrawal symptoms (convulsions and delirium) may occur within 16 hours and last
up to five days after abrupt cessation of barbiturates. Intensity of withdrawal
symptoms gradually declines over a period of approximately 15 days. Individuals
susceptible to barbiturate abuse and dependence include alcoholics and opiate
abusers, as well as other sedative-hypnotic and amphetamine abusers.
Dependence on barbiturates arises from repeated administration on a continuous
basis, generally in amounts exceeding therapeutic dose levels. Treatment of
dependence consists of cautious and gradual withdrawal of the drug. Barbituratedependent patients can be withdrawn by using a number of withdrawal regimens. In SECONAL SODIUM CAPSULES 100MG
all cases, withdrawal takes an extended period. One method involves substituting a
30 mg dose of Phenobarbital for each 100 – 200 mg dose of barbiturate that the
patient has been taking. The total daily amount of Phenobarbital is then administered
in three or four divided doses, not to exceed 600 mg daily. Should signs of
withdrawal occur on the first day of treatment, a loading dose of 100 to 200 mg of
Phenobarbital may be administered intramuscularly in addition to the oral dose. After
stabilisation on Phenobarbital, the total daily dose is decreased by 30 mg a day as
long as withdrawal is proceeding smoothly. A modification of this regimen involves
initiating treatment at the patient’s regular dosage level and decreasing the daily
dosage by 10% as tolerated by the patient.
SECONAL SODIUM CAPSULES 100MG
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