CLOBAZAM suspension

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

clobazam (UNII: 2MRO291B4U) (clobazam - UNII:2MRO291B4U)

Tilgjengelig fra:

Taro Pharmaceuticals U.S.A., Inc.

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Clobazam oral suspension is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older. Clobazam oral suspension is contraindicated in patients with a history of hypersensitivity to the drug or its ingredients. Hypersensitivity reactions have included serious dermatological reactions [see Warnings and Precautions (5.5)]. Pregnancy Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, such as clobazam, during pregnancy. Physicians are advised to recommend that pregnant patients taking clobazam oral suspension enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll-free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/. Risk Summary There are no adequate and well-controlled studies of clobazam in pregnant women. Availabl

Produkt oppsummering:

Clobazam oral suspension is a berry flavored off-white liquid supplied in a bottle with child-resistant closure. The oral suspension is packaged with a dispenser set which contains two calibrated oral dosing syringes and a bottle adapter. Store and dispense clobazam oral suspension in its original bottle in an upright position. Use within 90 days of first opening the bottle, then discard any remainder. NDC 51672-4210-8: 2.5 mg/mL supplied in a bottle containing 120 mL of suspension. Store oral suspension at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

Taro Pharmaceuticals U.S.A., Inc.
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MEDICATION GUIDE
CLOBAZAM (KLOE BA ZAM) ORAL SUSPENSION
CIV
This Medication Guide has been approved by the U.S. Food and
Drug Administration
Issued: September 2018
21133-0918-0
What is the most important information I should know about clobazam
oral suspension?
•
Do not stop taking clobazam oral suspension without first talking to
your healthcare provider.
Stopping clobazam oral suspension suddenly can cause serious side
effects.
•
Clobazam is a benzodiazepine medicine. Benzodiazepines can cause
severe drowsiness, breathing
problems (respiratory depression), coma, and death when taken with
opioid medicines.
•
Clobazam oral suspension can make you sleepy or dizzy and can slow
your thinking and motor
skills. This may get better over time.
•
Do not drive, operate heavy machinery, or do other dangerous
activities until you know
how clobazam oral suspension affects you.
•
Clobazam oral suspension may cause problems with your coordination,
especially when
you are walking or picking things up.
•
Do not drink alcohol or take other drugs that may make you sleepy or
dizzy while taking
clobazam oral suspension until you talk to your healthcare provider.
When taken with alcohol or
drugs that cause sleepiness or dizziness, clobazam oral suspension may
make your sleepiness or
dizziness much worse.
•
Clobazam oral suspension can cause withdrawal symptoms.
•
Do not stop taking clobazam oral suspension all of a sudden without
first talking to a
healthcare provider. Stopping clobazam oral suspension suddenly can
cause seizures that
will not stop (status epilepticus), hearing or seeing things that are
not there
(hallucinations), shaking, nervousness, and stomach and muscle cramps.
•
Talk to your healthcare provider about slowly stopping clobazam oral
suspension to avoid
withdrawal symptoms.
•
Clobazam oral suspension can be abused and cause dependence.
•
Physical dependence is not the same as drug addiction. Your healthcare
provider can tell
you more about the diffe

Preparatomtale

CLOBAZAM- CLOBAZAM SUSPENSION
TARO PHARMACEUTICALS U.S.A., INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLOBAZAM ORAL SUSPENSION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CLOBAZAM ORAL
SUSPENSION.
CLOBAZAM ORAL SUSPENSION, CIV
INITIAL U.S. APPROVAL: 2011
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
CONCOMITANT USE OF BENZODIAZEPINES AND OPIOIDS MAY RESULT IN PROFOUND
SEDATION, RESPIRATORY
DEPRESSION, COMA, AND DEATH (5.1, 7.1).
RESERVE CONCOMITANT PRESCRIBING OF THESE DRUGS FOR USE IN PATIENTS FOR
WHOM ALTERNATIVE TREATMENT
OPTIONS ARE INADEQUATE.
LIMIT DOSAGES AND DURATIONS TO THE MINIMUM REQUIRED.
FOLLOW PATIENTS FOR SIGNS AND SYMPTOMS OF RESPIRATORY DEPRESSION AND
SEDATION.
INDICATIONS AND USAGE
Clobazam is a benzodiazepine indicated for adjunctive treatment of
seizures associated with Lennox-Gastaut syndrome
(LGS) in patients 2 years of age or older (1)
DOSAGE AND ADMINISTRATION
For doses above 5 mg/day administer in two divided doses (2.1)
Patients ≤30 kg body weight: Initiate at 5 mg daily and titrate as
tolerated up to 20 mg daily (2.1)
Patients >30 kg body weight: Initiate at 10 mg daily and titrate as
tolerated up to 40 mg daily (2.1)
Dosage adjustment needed in following groups:
Geriatric patients (2.4, 8.5)
Known CYP2C19 poor metabolizers (2.5)
Mild or moderate hepatic impairment; no information for severe hepatic
impairment (2.7, 8.8)
Reduce dose, or discontinue drug gradually (2.2)
Measure prescribed amount of oral suspension using provided adapter
and dosing syringe (2.3)
Can be taken with or without food (2.3)
DOSAGE FORMS AND STRENGTHS
2.5 mg/mL in 120 mL bottles (3)
CONTRAINDICATIONS
History of hypersensitivity to the drug or its ingredients (4)
WARNINGS AND PRECAUTIONS
Somnolence or Sedation: Monitor for central nervous system (CNS)
depression. Risk may be increased with
concomitant use of other CNS depressants (5.2, 5.3)
Withdrawal: S