Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8)
MAlA Pharmaceuticals, Inc.
INTRATHECAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
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 Lire le document complet