BACLOFEN (INTRATHECAL)- baclofen injection

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Emerald International Limited

طريقة التعاطي:

INTRATHECAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Baclofen Injection (Intrathecal) 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 Baclofen Injection (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. Baclofen Injection (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 Baclofen Injection (Intrathecal) into the intrathecal space. Evidence supporting the efficacy of intratheca

ملخص المنتج:

Baclofen Injection (Intrathecal) is packaged in single use ampules of 0.05 mg/mL (50 mcg/mL), 10 mg/20 mL (500 mcg/mL) or 40 mg/20 mL (2000 mcg/mL) supplied as follow: Screening dose: Baclofen Injection (Intrathecal) 0.05 mg/mL (50 mcg/mL) in shelf carton of 10 ampules Baclofen Injection (Intrathecal) 10 mg/20 mL (500 mcg/mL) in individual packaging of 1 ampule Baclofen Injection (Intrathecal) 40 mg/20 mL (2000 mcg/mL) in individual packaging of 1 ampule Does not require refrigeration. Store at 20° to 25°C (68° to 77°F) [See USP controlled room temperature]. Do not freeze. Do not heat sterilize.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

BACLOFEN (INTRATHECAL)- BACLOFEN INJECTION
EMERALD INTERNATIONAL LIMITED
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BACLOFEN INJECTION (INTRATHECAL)
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
Baclofen Injection (Intrathecal) 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.
Baclofen Injection (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 Baclofen Injection
(Intrathecal) contains baclofen 50 mcg, 500 mcg or 2000 mcg and sodium
chloride 8.8 mg in Water for
Injection; pH range is 5.5–6.8. Each ampule is intended for SINGLE
USE ONLY. Discard any unused
portion. DO NOT AUTOCLAVE.
CLINIC