LIORESAL (BACLOFEN)- baclofen injection

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

baclofen (UNII: H789N3FKE8) (baclofen - UNII:H789N3FKE8)

Доступна з:

Saol Therapeutics Inc.

ІПН (Міжнародна Ім'я):

baclofen

Склад:

baclofen 10 mg in 20 mL

Адміністрація маршрут:

INTRATHECAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

LIORESAL INTRATHECAL (baclofen injection) is indicated for use in the management of severe spasticity. 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 LIORESAL INTRATHECAL 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. LIORESAL INTRATHECAL is intended for use by the intrathecal route in single bolus test doses (via spinal catheter or lumbar puncture) and, for chronic use, only in implantable pumps approved by the FDA specifically for the administration of LIORESAL INTRATHECAL into the intrathecal space. Spasticity of Spinal Cord Origin: Evidence supporting the efficacy of LI

Огляд продуктів:

LIORESAL INTRATHECAL (baclofen injection) is packaged in single use ampules containing 0.05 mg/1 mL (50 mcg/mL), 10 mg/20 mL (500 mcg/mL), 10 mg/5 mL (2000 mcg/mL), or 40 mg/20 mL (2000 mcg/mL) supplied as follows: Screening dose (Model 8563s): five ampules each containing 0.05 mg/1 mL (50 mcg/mL) (NDC 70257-562-55). LIORESAL INTRATHECAL (baclofen injection) Refill Kits. Each refill kit includes the indicated amount of LIORESAL INTRATHECAL, a drug preparation kit, a pump refill kit with accessories that are compatible with Medtronic SynchroMed ® Infusion Systems, and associated instructions. Model 8561: one ampule containing 10 mg/20 mL (500 mcg/mL) (NDC 70257-560-01). Model 8562: two ampules, each contains 10 mg/5 mL (2000 mcg/mL) (NDC 70257-561-02). Model 8564: one ampule containing 40 mg/20 mL (2000 mcg/mL) (NDC 70257-563-01). Model 8565: two ampules, each contains 10 mg/20 mL (500 mcg/mL) (NDC 70257-560-02). Model 8566: two ampules, each contains 40 mg/20 mL (2000 mcg/mL) (NDC 70257-563-02). Does not require refrigeration. Do not store above 86° F (30° C). Do not freeze. Do not heat sterilize.

Статус Авторизація:

New Drug Application

Характеристики продукта

LIORESAL (BACLOFEN)- BACLOFEN INJECTION
SAOL THERAPEUTICS INC.
----------
LIORESAL INTRATHECAL
(BACLOFEN INJECTION)
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
postimplant clinician and patient information (see WARNINGS ).
DESCRIPTION
LIORESAL INTRATHECAL (baclofen injection) is a muscle relaxant and
antispastic. Its
chemical name is 4-amino-3-(4-chlorophenyl) butanoic acid, and its
structural formula is:
Baclofen is a white to off-white, odorless or practically odorless
crystalline powder, with
a molecular weight of 213.66. It is slightly soluble in water, very
slightly soluble in
methanol, and insoluble in chloroform.
LIORESAL INTRATHECAL is a sterile, pyrogen-free, isotonic solution
free of antioxidants,
®
preservatives or other potentially neurotoxic additives indicated only
for intrathecal
administration. The drug is stable in solution at 37° C and
compatible with CSF. Each
milliliter of LIORESAL INTRATHECAL contains baclofen U. S. P. 50 mcg,
500 mcg or 2000
mcg and sodium chloride 9 mg in Water for Injection; pH range is 5.0 -
7.0. Each ampule
is intended for SINGLE USE ONLY. Discard any unused portion. DO NOT
AUTOCLAVE.
CLINICAL PHARMAC