Baclofen (Intrathecal) 500 ug/mL
baclofen · INJECTION · MAIA Pharmaceuticals, Inc.
Baclofen intrathecal injection is a prescription medication used to treat muscle spasticity, particularly in patients with spinal cord injuries, multiple sclerosis, or other neurological conditions. It works by acting as a gamma-aminobutyric acid-ergic agonist, which helps reduce muscle stiffness and involuntary muscle contractions.
Key Facts
- Brand Name
- Baclofen (Intrathecal)
- Generic Name
- baclofen
- NDC Code (Product)
70511-122- Manufacturer
- MAIA Pharmaceuticals, Inc.
- Strength
- 500 ug/mL
- Dosage Form
- INJECTION
- Route
- INTRATHECAL
- Marketing Status
- Application #
- ANDA210048
- Drug Class
- gamma-Aminobutyric Acid-ergic Agonist [EPC]
- Marketing Start
- 09/25/2019
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE 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 supporting the efficacy of baclofen injection (intrathecal) was obtained in randomized, controlled investigations that compared the effects of either a singl…
Dosage & Administration
DOSAGE AND ADMINISTRATION Refer to the manufacturer’s manual for the implantable pump approved for intrathecal infusion for specific instructions and precautions for programming the pump and/or refilling the reservoir. There are various pumps with varying reservoir volumes and there are various refill kits available. It is important to be familiar with all of these products in order to select the appropriate refill kit for the particular pump in use. Screening Phase: Prior to pump implantation and initiation of chronic infusion of Baclofen Injection (Intrathecal), patients must demonstrate a positive clinical response to a Baclofen Injection (Intrathecal) bolus dose administered intrathecally in a screening trial. The screening trial employs Baclofen Injection (Intrathecal) at a concentration of 50 mcg per mL. A 1 mL ampule (50 mcg per mL) is available for use in the screening trial. The screening procedure is as follows. An initial bolus containing 50 micrograms in a volume of 1 milliliter is administered into the intrathecal space by barbotage over a period of not less than one minute. The patient is observed over the ensuing 4 to 8 hours. A positive response consists of a signif…
Warnings
WARNINGS Baclofen injection (intrathecal) is for use in single bolus intrathecal injections (via a catheter placed in the lumbar intrathecal space or injection by lumbar puncture) and in implantable pumps approved by the FDA specifically for the intrathecal administration of baclofen. Because of the possibility of potentially life- threatening CNS depression, cardiovascular collapse, and/or respiratory failure, physicians must be adequately trained and educated in chronic intrathecal infusion therapy. The pump system should not be implanted until the patient’s response to bolus baclofen injection (intrathecal) is adequately evaluated. Evaluation (consisting of a screening procedure: see Dosage and Administration) requires that baclofen injection (intrathecal) be administered into the intrathecal space via a catheter or lumbar puncture. Because of the risks associated with the screening procedure and the adjustment of dosage following pump implantation, these phases must be conducted in a medically supervised and adequately equipped environment following the instructions outlined in the Dosage and Administration section. Resuscitative equipment should be available. Following surgica…
Contraindications
CONTRAINDICATIONS Hypersensitivity to baclofen. Baclofen injection (intrathecal) is not recommended for intravenous, intramuscular, subcutaneous or epidural administration.
Adverse Reactions
ADVERSE REACTIONS Spasticity of Spinal Cord Origin Clinical Studies: Commonly Observed in Patients with Spasticity of Spinal Origin - In pre- and post- marketing clinical trials, the most commonly observed adverse events associated with use of Baclofen Injection (Intrathecal) which were not seen at an equivalent incidence among placebo-treated patients were: somnolence, dizziness, nausea, hypotension, headache, convulsions and hypotonia. Associated with Discontinuation of Treatment - 8/474 patients with spasticity of spinal cord origin receiving long term infusion of Baclofen Injection (Intrathecal) in pre- and post- marketing clinical studies in the U.S. discontinued treatment due to adverse events. These include: pump pocket infections (3), meningitis (2), wound dehiscence (1), gynecological fibroids (1) and pump overpressurization (1) with unknown, if any, sequela. Eleven patients who developed coma secondary to overdose had their treatment temporarily suspended, but all were subsequently re-started and were not, therefore, considered to be true discontinuations. Fatalities - See Warnings . Incidence in Controlled Trials - Experience with Baclofen Injection (Intrathecal) obtaine…
Frequently Asked Questions
What is Baclofen (Intrathecal) used for?
Baclofen intrathecal injection is a prescription medication used to treat muscle spasticity, particularly in patients with spinal cord injuries, multiple sclerosis, or other neurological conditions. It works by acting as a gamma-aminobutyric acid-ergic agonist, which helps reduce muscle stiffness and involuntary muscle contractions.
Is Baclofen (Intrathecal) a controlled substance?
Baclofen (Intrathecal) is not classified as a controlled substance by the DEA.
What is the generic name for Baclofen (Intrathecal)?
The generic name for Baclofen (Intrathecal) is baclofen. There are 12 other brand versions of baclofen.
What is the NDC code for Baclofen (Intrathecal) 500 ug/mL?
The NDC (National Drug Code) for Baclofen (Intrathecal) 500 ug/mL is 70511-122, listed by MAIA Pharmaceuticals, Inc..