BACLOFEN (INTRATHECAL)- baclofen injection BACLOFEN (INTRATHECAL)- baclofen injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

MAIA Pharmaceuticals, Inc.

Administration route:

INTRATHECAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Spasticity of Spinal Cord Origin: Evidence su

Product summary:

Baclofen injection (intrathecal), USP 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 (Intrathecal) is packaged in single-dose vials containing 10 mg/20 mL (500 mcg/mL) or 40 mg/20 mL (2000 mcg/mL) supplied as follows: One vial containing 10 mg/20 mL (500 mcg/mL) (NDC 70511-122-10). One vial containing 40 mg/20 mL (2000 mcg/mL) (NDC 70511-124-10). 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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BACLOFEN (INTRATHECAL) - BACLOFEN INJECTION
MAIA PHARMACEUTICALS, INC.
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BACLOFEN INJECTION (INTRATHECAL), USP
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), USP 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), USP 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 U. S. P., 500 mcg
or 2,000 mcg and sodium chloride 9 mg in Water for Injection; pH range
is 5.0 to 7.0.
Each vial is intended for SINGLE USE ONLY. Discard any unused portion.
DO NOT
AUTOCLAVE