BACLOFEN injection

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8)

Disponível em:

MAlA Pharmaceuticals, Inc.

Via de administração:

INTRATHECAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Baclofen injection is indicated for use in the management of severe spasticity in adult and pediatric patients age 4 years and above. Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump. For spasticity of spinal cord origin, chronic infusion of baclofen injection via an implantable pump should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable CNS side effects at effective doses. Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long term intrathecal baclofen therapy.  Baclofen injection is intended for use by the intrathecal route in single bolus test doses (via spinal catheter or lumbar puncture) and, for chronic use, only with the Medtronic SynchroMed® II Programmable Pump or other pumps labeled for intrathecal administration of baclofen injection [see Clinical Studies (14)] . Prior to implan

Resumo do produto:

Baclofen injection is a clear, colorless, sterile, pyrogen-free, isotonic solution consisting of the active ingredient, Baclofen USP, and the excipients Sodium Chloride USP and Water for Injection USP in single-dose clear glass vials. Baclofen injection is packaged in single-dose vials supplied as follows: One vial containing 20,000 mcg/20 mL (1,000 mcg/mL) (NDC 70511-123-20). Storage Does not require refrigeration. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Do not freeze. Do not heat sterilize.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

BACLOFEN- BACLOFEN INJECTION
MALA PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BACLOFEN INJECTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BACLOFEN
INJECTION.INITIAL U.S.
APPROVAL: 1992
WARNING: DO NOT DISCONTINUE ABRUPTLY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
ABRUPT DISCONTINUATION OF INTRATHECAL BACLOFEN, REGARDLESS OF THE
CAUSE, HAS RESULTED IN
SEQUELAE THAT INCLUDE HIGH FEVER, ALTERED MENTAL STATUS, EXAGGERATED
REBOUND
SPASTICITY, AND MUSCLE RIGIDITY, THAT IN RARE CASES HAS ADVANCED TO
RHABDOMYOLYSIS,
MULTIPLE ORGAN-SYSTEM FAILURE AND DEATH.
​PREVENTION OF ABRUPT DISCONTINUATION OF INTRATHECAL BACLOFEN
REQUIRES CAREFUL ATTENTION
TO PROGRAMMING AND MONITORING OF THE INFUSION SYSTEM, REFILL
SCHEDULING AND
PROCEDURES, AND PUMP ALARMS. PATIENTS AND CAREGIVERS SHOULD BE ADVISED
OF THE
IMPORTANCE OF KEEPING SCHEDULED REFILL VISITS AND SHOULD BE EDUCATED
ON THE EARLY
SYMPTOMS OF BACLOFEN WITHDRAWAL. SPECIAL ATTENTION SHOULD BE GIVEN TO
PATIENTS AT
APPARENT RISK (E.G., SPINAL CORD INJURIES AT T-6 OR ABOVE,
COMMUNICATION DIFFICULTIES,
HISTORY OF WITHDRAWAL SYMPTOMS FROM ORAL OR INTRATHECAL BACLOFEN).
CONSULT THE
TECHNICAL MANUAL OF THE IMPLANTABLE INFUSION SYSTEM FOR ADDITIONAL
POST-IMPLANT
CLINICIAN AND PATIENT INFORMATION. (5.4)
INDICATIONS AND USAGE
Baclofen injection is a gamma-aminobutyric acid (GABA) ergic agonist
indicated for use in the
management of severe spasticity of cerebral or spinal origin in adult
and pediatric patients age 4 years
and above (1)
Baclofen injection should be reserved for patients unresponsive to
oral baclofen therapy, or those who
experience intolerable central nervous system side effects at
effective doses (1)
Patients should first respond to a screening dose of intrathecal
baclofen prior to consideration for long
term infusion via an implantable pump. (1)
Spasticity due to traumatic brain injury: wait at least one year after
injury before considerin