SODIUM OXYBATE solution

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

SODIUM OXYBATE (UNII: 7G33012534) (4-HYDROXYBUTANOIC ACID - UNII:30IW36W5B2)

から入手可能:

Amneal Pharmaceuticals NY LLC

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Sodium Oxybate Oral Solution is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. Sodium Oxybate Oral Solution is contraindicated for use in: Risk Summary There are no adequate data on the developmental risk associated with the use of sodium oxybate in pregnant women. Oral administration of sodium oxybate to pregnant rats (150, 350, or 1,000 mg/kg/day) or rabbits (300, 600, or 1,200 mg/kg/day) throughout organogenesis produced no clear evidence of developmental toxicity; however, oral administration to rats throughout pregnancy and lactation resulted in increased stillbirths and decreased offspring postnatal viability and growth, at a clinically relevant dose [see Data] . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population

製品概要:

Sodium Oxybate Oral Solution is a clear to slightly opalescent oral solution. Each prescription includes one bottle of Sodium Oxybate Oral Solution with attached press in bottle adaptor, an oral measuring device (plastic syringe), and a Medication Guide. The pharmacy provides two empty containers with child-resistant caps with each Sodium Oxybate Oral Solution shipment. Each amber bottle contains Sodium Oxybate Oral Solution at a concentration of 0.5 g per mL (0.5 g/mL of sodium oxybate equivalent to 0.413 g/mL of oxybate) and has a child-resistant cap. One 180 mL bottle                                       NDC 69238-2391-1 Keep out of reach of children. Sodium Oxybate Oral Solution should be stored at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature). Dispense in tight containers. Solutions prepared following dilution should be consumed within 24 hours. Sodium Oxybate Oral Solution is a Schedule III drug under the Controlled Substances Act. Sodium Oxybate Oral Solution should be handled according to state and federal regulations. It is safe to dispose of Sodium Oxybate Oral Solution down the sanitary sewer.

認証ステータス:

New Drug Application Authorized Generic

情報リーフレット

Amneal Pharmaceuticals NY LLC
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MEDICATION GUIDE
Sodium Oxybate
Oral Solution, CIII
Read this Medication Guide carefully before you start or your child
starts taking Sodium Oxybate Oral
Solution and each time you get or your child gets a refill. There may
be new information. This
information does not take the place of talking to your doctor about
your or your child’s medical
condition or treatment.
What is the most important information I should know about Sodium
Oxybate Oral Solution?
•
Sodium Oxybate Oral Solution is a central nervous system (CNS)
depressant. Taking Sodium
Oxybate Oral Solution with other CNS depressants such as medicines
used to make you or your
child fall asleep, including opioid analgesics, benzodiazepines,
sedating antidepressants,
antipsychotics, sedating anti-epileptic medicines, general
anesthetics, muscle relaxants, alcohol,
or street drugs, may cause serious medical problems, including:
o
trouble breathing (respiratory depression)
o
low blood pressure (hypotension)
o
changes in alertness (drowsiness)
o
fainting (syncope)
o
death
Ask your doctor if you are not sure if you are, or your child is,
taking a medicine listed above.
•
Sodium Oxybate Oral Solution is a federal controlled substance (CIII).
The active ingredient of
Sodium Oxybate Oral Solution is a form of gamma-hydroxybutyrate (GHB)
that is also a federal
controlled substance (CI). Abuse of illegal GHB, either alone or with
other CNS depressants may
cause serious medical problems, including:
o
seizure
o
trouble breathing (respiratory depression)
o
changes in alertness (drowsiness)
o
coma
o
death
Call your doctor right away if you have or your child has any of these
serious side effects.
•
Anyone who takes Sodium Oxybate Oral Solution should not do anything
that requires them to
be fully awake or is dangerous, including driving a car, using heavy
machinery, or flying an
airplane, for at least 6 hours after taking Sodium Oxybate Oral
Solution. Those activities should
not be done until you know how Sodium Oxybate O

製品の特徴

SODIUM OXYBATE- SODIUM OXYBATE SOLUTION
AMNEAL PHARMACEUTICALS NY LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SODIUM OXYBATE ORAL
SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
SODIUM OXYBATE
ORAL SOLUTION.
SODIUM OXYBATE ORAL SOLUTION, CIII
INITIAL U.S. APPROVAL: 2002
WARNING: CENTRAL NERVOUS SYSTEM (CNS) DEPRESSION AND ABUSE AND MISUSE.
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
CENTRAL NERVOUS SYSTEM DEPRESSION
•
ABUSE AND MISUSE
•
SODIUM OXYBATE ORAL SOLUTION IS AVAILABLE ONLY THROUGH A RESTRICTED
PROGRAM CALLED THE
XYWAV AND XYREM REMS (5.3)
INDICATIONS AND USAGE
Sodium Oxybate Oral Solution is a central nervous system depressant
indicated for the treatment of
cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of
age and older with narcolepsy (1).
DOSAGE AND ADMINISTRATION
Dosage for Adult Patients
•
•
•
TOTAL NIGHTLY DOSE
TAKE AT BEDTIME
TAKE 2.5 TO 4 HOURS LATER
4.5 g per night
2.25 g
2.25 g
6 g per night
3 g
3 g
7.5 g per night
3.75 g
3.75 g
9 g per night
4.5 g
4.5 g
Dosage for Pediatric Patients (7 years of Age and Older)
•
Important Administration Information
•
•
•
Patients with Hepatic Impairment
SODIUM OXYBATE ORAL SOLUTION IS A CNS DEPRESSANT, AND RESPIRATORY
DEPRESSION CAN
OCCUR WITH SODIUM OXYBATE ORAL SOLUTION USE (5.1, 5.4)
SODIUM OXYBATE IS THE SODIUM SALT OF GAMMA-HYDROXYBUTYRATE (GHB).
ABUSE OR
MISUSE OF ILLICIT GHB IS ASSOCIATED WITH CNS ADVERSE REACTIONS,
INCLUDING SEIZURE,
RESPIRATORY DEPRESSION, DECREASED CONSCIOUSNESS, COMA, AND DEATH (5.2,
9.2)
Initiate dosage at 4.5 g per night orally, divided into two doses
(2.1).
Titrate to effect in increments of 1.5 g per night at weekly intervals
(0.75 g at bedtime and 0.75 g
taken 2.5 to 4 hours later) (2.1).
Recommended dosage range: 6 g to 9 g per night orally (2.1).
The recommended starting dosage, titration regimen, and maximum total
nightly dosage are based
on body weight (2.2).
Prepare both