SECONAL SODIUM® (secobarbital sodium) CAPSULES, USP CII Rx only

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

SECOBARBITAL SODIUM (UNII: XBP604F6UM) (SECOBARBITAL - UNII:1P7H87IN75)

Saatavilla:

Bausch Health US, LLC

INN (Kansainvälinen yleisnimi):

SECOBARBITAL SODIUM

Koostumus:

SECOBARBITAL SODIUM 100 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Seconal Sodium is contraindicated in patients who are hypersensitive to barbiturates. It is also contraindicated in patients with a history of manifest or latent porphyria, marked impairment of liver function, or respiratory disease in which dyspnea or obstruction is evident. Abuse and addiction are separate and distinct from physical dependence and tolerance. Abuse is characterized by misuse of the drug for non-medical purposes, often in combination with other psychoactive substances. Physical dependence is a state of adaptation that is manifested by a specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug and/or administration of an antagonist. Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug's effects over time. Tolerance may occur to both the desired and undesired effects of drugs and may develop at different rates for different effects. Addiction is

Tuoteyhteenveto:

Seconal Sodium (secobarbital sodium) capsules are orange and imprinted with RX679 on both the cap and the body: NDC 0187-4220-10           100 mg            Bottles of 100 Store at 20° - 25° C (68° - 77° F) [See USP Controlled Room Temperature]. Dispense in a tight container. Distributed by: Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA November 2015 9478800 Seconal and Seconal Sodium are trademarks of Valeant Pharmaceuticals International, Inc. or its affiliates ©Valeant Pharmaceuticals North America LLC

Valtuutuksen tilan:

Abbreviated New Drug Application

Pakkausseloste

SECONAL SODIUM- SECOBARBITAL SODIUM CAPSULE
Valeant Pharmaceuticals North America LLC
----------
MEDICATION GUIDE
SEDATIVE-HYPNOTIC/CAPSULES C-II
SECONAL SODIUM™
(secobarbital sodium)
Capsules, USP
Rx only
Read this Medication Guide before you start taking a SEDATIVE-HYPNOTIC
and each time you get a
refill. There may be new information. This Medication Guide does not
take the place of talking to your
doctor about your medical condition or treatment. You and your doctor
should talk about the
SEDATIVE-HYPNOTIC when you start taking it and at regular checkups.
What is the most important information I should know about
SEDATIVE-HYPNOTICS?
After taking a SEDATIVE-HYPNOTIC, you may get up out of bed while not
being fully awake and do
an activity that you do not know you are doing. The next morning, you
may not remember that you did
anything during the night. You have a higher chance for doing these
activities if you drink alcohol or take
other medicines that make you sleepy with a SEDATIVE-HYPNOTIC.
Reported activities include:
•
driving a car ("sleep-driving")
•
making and eating food
•
talking on the phone
•
having sex
•
sleep-walking
Important:
1.
Take SEDATIVE-HYPNOTICS exactly as prescribed
•
Do not take more SEDATIVE-HYPNOTICS than prescribed.
•
Take the SEDATIVE-HYPNOTIC right before you get in bed, not sooner.
2.
Do not take SEDATIVE-HYPNOTICS if you:
•
drink alcohol
•
take other medicines that can make you sleepy. Talk to your doctor
about all of your
medicines. Your doctor will tell you if you can take
SEDATIVE-HYPNOTICS with your
other medicines
1.
cannot get a full night's sleep
3.
Call your doctor right away if you find out that you have done any of
the above activities after
taking the SEDATIVE-HYPNOTIC.
What are SEDATIVE-HYPNOTICS?
SEDATIVE-HYPNOTICS are sleep medicines. SEDATIVE-HYPNOTICS are used in
adults for the
short-term treatment of the symptom of trouble falling asleep from
insomnia. SEDATIVE-HYPNOTICS
do not treat other symptoms of insomnia which include waking up too
early i

Valmisteyhteenveto

SECONAL SODIUM- SECOBARBITAL SODIUM CAPSULE
VALEANT PHARMACEUTICALS NORTH AMERICA LLC
----------
SECONAL SODIUM
(SECOBARBITAL SODIUM)
CAPSULES, USP
CII
RX ONLY
DESCRIPTION
The barbiturates are nonselective central nervous system (CNS)
depressants that are primarily used as
sedative hypnotics. In subhypnotic doses, they are also used as
anticonvulsants. The barbiturates and
their sodium salts are subject to control under the Federal Controlled
Substances Act.
Seconal Sodium (Secobarbital Sodium Capsules, USP) is a barbituric
acid derivative and occurs as a
white, odorless, bitter powder that is very soluble in water, soluble
in alcohol, and practically insoluble
in ether. Chemically, the drug is sodium 5-allyl-5-(1-methylbutyl)
barbiturate, with the molecular
formula C
H N NaO . Its molecular weight is 260.27. The structural formula is as
follows:
Each capsule contains 100 mg (0.38 mmol) of secobarbital sodium. It
also contains dimethicone, FD&C
Red No. 3, FD&C Yellow No. 10, gelatin, magnesium stearate,
pregelatinized starch, and titanium
dioxide.
CLINICAL PHARMACOLOGY
Barbiturates are capable of producing all levels of CNS mood
alteration, from excitation to mild
sedation, hypnosis, and deep coma. Overdosage can produce death. In
high enough therapeutic doses,
barbiturates induce anesthesia. Barbiturates depress the sensory
cortex, decrease motor activity, alter
cerebellar function, and produce drowsiness, sedation, and hypnosis.
Barbiturate-induced sleep differs from physiologic sleep. Sleep
laboratory studies have demonstrated
that barbiturates reduce the amount of time spent in the rapid eye
movement (REM) phase, or dreaming
stage of sleep. Also, Stages III and IV sleep are decreased. Following
abrupt cessation of regularly
used barbiturates, patients may experience markedly increased
dreaming, nightmares, and/or insomnia.
Therefore, withdrawal of a single therapeutic dose over 5 or 6 days
has been recommended to lessen
the REM rebound and disturbed sleep that contribute to drug withdrawal
syndrome (for examp