CLOBAZAM solution

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

CLOBAZAM (UNII: 2MRO291B4U) (CLOBAZAM - UNII:2MRO291B4U)

Предлага се от:

Hikma Pharmaceuticals USA Inc.

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Clobazam is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older. Clobazam 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 (5.6)]. 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 to 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. Available data suggest that the class of benzodiazepin

Каталог на резюме:

Clobazam Oral Suspension 2.5 mg per mL is supplied as 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. NDC 0054-0561-50: Bottle of 120 mL 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. Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.]

Статус Оторизация:

Abbreviated New Drug Application

Листовка

Hikma Pharmaceuticals USA Inc.
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MEDICATION GUIDE
Clobazam
Oral Suspension
C-IV
(kloe′ ba zam)
Rx only
What is the most important information I should know about clobazam?
•
Clobazam is a benzodiazepine medicine. Taking benzodiazepines with
opioid medicines, alcohol, or
other central nervous system (CNS) depressants (including street
drugs) can cause severe drowsiness,
breathing problems (respiratory depression), coma, and death. Get
emergency help right away if any of
the following happens:
o
shallow or slowed breathing
o
breathing stops (which may lead to the heart stopping)
o
excessive sleepiness (sedation)
Do not drive or operate heavy machinery until you know how taking
clobazam with opioids affects
you.
•
Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with
benzodiazepines, including clobazam, which can lead to overdose and
serious side effects including
coma and death.
o
Serious side effects including coma and death have happened in people
who have abused or misused
benzodiazepines, including clobazam. These serious side effects may
also include delirium, paranoia,
suicidal thoughts or actions, seizures, and difficulty breathing. Call
your healthcare provider or go to
the nearest hospital emergency room right away if you get any of these
serious side effects.
o
You can develop an addiction even if you take clobazam as prescribed
by your healthcare provider.
o
Take clobazam exactly as your healthcare provider prescribed.
o
Do not share your clobazam with other people.
o
Keep clobazam in a safe place and away from children.
•
Physical dependenceand withdrawal reactions. Clobazam can cause
physical dependence
andwithdrawal reactions.
o
Do not suddenly stop taking clobazam. Stopping clobazam suddenly can
cause serious and life-
threatening side effects, including, unusual movements, responses, or
expressions, seizures, sudden
and severe mental or nervous system changes, depression, seeing or
hearing things that others do not
see or hear, an extreme increas

Данни за продукта

CLOBAZAM- CLOBAZAM SOLUTION
HIKMA PHARMACEUTICALS USA INC.
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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; ABUSE, MISUSE, AND
ADDICTION; AND DEPENDENCE AND WITHDRAWAL REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
RECENT MAJOR CHANGES
•
2/2021
•
2/2021
•
2/2021
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
•
•
•
•
•
•
CONCOMITANT USE OF BENZODIAZEPINES AND OPIOIDS MAY RESULT IN PROFOUND
SEDATION,
RESPIRATORY DEPRESSION, COMA, AND DEATH. 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 (5.1,
7.1).
THE USE OF BENZODIAZEPINES, INCLUDING CLOBAZAM ORAL SUSPENSION,
EXPOSES USERS TO
RISKS OF ABUSE, MISUSE, AND ADDICTION, WHICH CAN LEAD TO OVERDOSE OR
DEATH. BEFORE
PRESCRIBING CLOBAZAM AND THROUGHOUT TREATMENT, ASSESS EACH PATIENT’S
RISK FOR
ABUSE, MISUSE, AND ADDICTION (5.2).
ABRUPT DISCONTINUATION OR RAPID DOSAGE REDUCTION OF CLOBAZAM ORAL
SUSPENSIONAFTER CONTINUED USE MAY PRECIPITATE ACUTE WITHDRAWAL
REACTIONS, WHICH
CAN BE LIFE-THREATENING. TO REDUCE THE RISK OF WITHDRAWAL REACTIONS,
USE A GRADUAL
TAPER TO DISCONTINUE CLOBAZAM ORAL SUSPENSION OR REDUCE THE DOSAGE
(2.2, 5.3).
Boxed Warning
Dosage and Administration (2.2)
Warnings and Precautions (5.2, 5.3)
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. (