BUTISOL SODIUM- butabarbital sodium tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

BUTABARBITAL SODIUM (UNII: 9WTD50I918) (BUTABARBITAL - UNII:P0078O25A9)

זמין מ:

Meda Pharmaceuticals

INN (שם בינלאומי):

BUTABARBITAL SODIUM

הרכב:

BUTABARBITAL SODIUM 30 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

BUTISOL SODIUM® (butabarbital sodium tablets, USP and butabarbital sodium oral solution, USP) is indicated for use as a sedative or hypnotic. Since barbiturates appear to lose their effectiveness for sleep induction and sleep maintenance after 2 weeks, use of BUTISOL SODIUM® in treating insomnia should be limited to this time (see Clinical Pharmacology above). Barbiturates are contraindicated in patients with known barbiturate sensitivity. Barbiturates are also contraindicated in patients with a history of manifest or latent porphyria. Controlled substance: Schedule III. Abuse and dependence: 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 ad

leaflet_short:

BUTISOL SODIUM® (butabarbital sodium tablets, USP): 30 mg - colored green, scored, imprinted “BUTISOL SODIUM” and 37/113 in bottles of 100 (NDC 0037-0113-60). Contains FD&C Yellow No. 5 (See Precautions). Storage: Store at controlled room temperature 20°-25°C (68°-77°F). Dispense in a tight container. To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-866-210-5952 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . BUTISOL SODIUM is a registered trademark of Meda Pharmaceuticals Inc., a Mylan company. Distributed by: Meda Pharmaceuticals® Meda Pharmaceuticals Inc. Somerset, NJ 08873-4120 Printed in U.S.A. Rev. XX/2018

מצב אישור:

New Drug Application

מאפייני מוצר

BUTISOL SODIUM- BUTABARBITAL SODIUM TABLET
MEDA PHARMACEUTICALS
----------
BUTISOL SODIUM CIII
(BUTABARBITAL SODIUM TABLETS, USP
AND BUTABARBITAL SODIUM ORAL SOLUTION, USP)
TABLETS & ORAL SOLUTION
IN-0110-13 REV. 5/2015
DES CRIPTION
BUTISOL SODIUM (butabarbital sodium tablets, USP and butabarbital
sodium oral solution, USP) is a
non-selective central nervous system depressant which is used as a
sedative or hypnotic. It is available
for oral administration as _Tablets_ containing 30 mg or 50 mg
butabarbital sodium; and as _Oral Solution_
containing 30 mg/5 mL, with alcohol (by volume) 7%. Other ingredients
in the Tablets are: calcium
stearate, corn starch, dibasic calcium phosphate, FD&C Blue No. 1 (30
mg only), FD&C Yellow No. 5
(30 mg and 50 mg — see Precautions), FD&C Yellow No. 6 (50 mg only).
Other ingredients in the Oral
Solution are: D&C Green No. 5, edetate disodium, FD&C Yellow No. 5
(see Precautions), flavors
(natural and artificial), propylene glycol, purified water, saccharin
sodium, sodium benzoate.
Butabarbital sodium occurs as a white, bitter powder which is freely
soluble in water and alcohol, but
practically insoluble in benzene and ether. The structural formula for
butabarbital sodium is:
CLINICAL PHARMACOLOGY
BUTISOL SODIUM (butabarbital sodium tablets, USP and butabarbital
sodium oral solution, USP),
like other barbiturates, is capable of producing all levels of CNS
mood alteration from excitation to
mild sedation, to hypnosis, and deep coma. Overdosage can produce
death. Barbiturates depress the
sensory cortex, decrease motor activity, alter cerebellar function,
and produce drowsiness, sedation,
and hypnosis.
Barbiturate-induced sleep differs from physiological sleep. Sleep
laboratory studies have demonstrated
that barbiturates reduce the amount of time spent in the rapid eye
movement (REM) phase of sleep or
dreaming stage. Also, Stages III and IV sleep are decreased. Following
abrupt cessation of barbiturates
used regularly, patients may experience markedly increased dreaming,
nightmares, a