BACLOFEN injection

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Sintetica S.A.

INN (Internationale Bezeichnung):

BACLOFEN

Zusammensetzung:

BACLOFEN 10 mg in 20 mL

Verschreibungstyp:

PRESCRIPTION DRUG

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

BACLOFEN- BACLOFEN INJECTION
SINTETICA S.A.
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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.
CLINICAL PHARMACOLOGY
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