Gablofen 500 ug/mL
Baclofen Injection · INJECTION, SOLUTION · Piramal Critical Care Inc
Gablofen is a injection, solution containing baclofen injection at 500 ug/mL, taken intrathecal. Manufactured by Piramal Critical Care Inc.
Key Facts
- Brand Name
- Gablofen
- Generic Name
- Baclofen Injection
- NDC Code (Product)
66794-155- Manufacturer
- Piramal Critical Care Inc
- Strength
- 500 ug/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRATHECAL
- Marketing Status
- Application #
- NDA022462
- Drug Class
- gamma-Aminobutyric Acid-ergic Agonist [EPC]
- Marketing Start
- 04/01/2017
Recall History
Piramal Critical Care, Inc.
Failed Impurities/Degradation Specification -This recall is being initiated as a precaution due to the presence of an unknown impurity observed during shelf life of the product.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE GABLOFEN is indicated for use in the management of severe spasticity in adult and pediatric patients age 4 years and above. 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 GABLOFEN 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. GABLOFEN is intended for use by the intrathecal route in single bolus test doses (via spinal catheter or lumbar puncture) and, for chronic use, only with the Medtronic SynchroMed ® Programmable Pump or other pumps labeled for intrathecal administration of GABLOFEN [see Clinical Studies (14)] . Prior to implantation of a device for chronic intrathecal infusion of GABLOFEN, patients must show a response to GABLOFEN in a screening trial [see Dosage and Administration (2.2)] . GABLOFEN is a gamma-aminobut…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 2.1 Use Only in Medtronic SynchroMed ® Programmable Pump (or other pumps labeled for intrathecal administration of GABLOFEN) GABLOFEN is approved only for use with the Medtronic SynchroMed ® Programmable Pump or other pumps labeled for intrathecal administration of GABLOFEN. Refer to the manufacturer’s manual for specific instructions and precautions for programming the pump and/or refilling the reservoir. It is important to select the appropriate refill kit for the pump used to administer GABLOFEN. GABLOFEN is not to be compounded with other medications. 2.2 Screening Phase Prior to pump implantation and initiation of chronic infusion of GABLOFEN, patients must demonstrate a positive clinical response to a GABLOFEN bolus dose administered intrathecally in a screening trial. The screening trial employs GABLOFEN at a concentration of 50 mcg/mL. A 1 mL syringe (50 mcg/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 ens…
Contraindications
4 CONTRAINDICATIONS GABLOFEN is contraindicated in patients with a hypersensitivity to baclofen. Do not use GABLOFEN for intravenous, intramuscular, subcutaneous or epidural administration. · Hypersensitivity to baclofen (4) · Do not use GABLOFEN for intravenous, intramuscular, subcutaneous or epidural administration. (4)
Drug Interactions
7 DRUG INTERACTIONS There is inadequate systematic experience with the use of intrathecal baclofen in combination with other medications to predict specific drug-drug interactions. Interactions attributed to the combined use of GABLOFEN and epidural morphine include hypotension and dyspnea. Combined use with morphine: hypotension and dyspnea ( 7 )
Adverse Reactions
6 ADVERSE REACTIONS 6.1 Spasticity of Spinal Cord Origin Most Common Adverse Reactions in Patients with Spasticity of Spinal Origin In pre- and post-marketing clinical trials, the most common adverse reactions associated with use of intrathecal baclofen which were not seen at an equivalent incidence among placebo-treated patients were: somnolence, dizziness, nausea, hypotension, headache, convulsions and hypotonia. Adverse Reactions Associated with Discontinuation of Treatment 8/474 patients with spasticity of spinal cord origin receiving long term infusion of intrathecal baclofen in pre- and post-marketing clinical studies in the U.S. discontinued treatment due to adverse reactions. 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 and Precautions ( 5.6 )] . Incidence in Controlled Trials Experience with intrathecal baclofen obtained in …
Frequently Asked Questions
What is Gablofen used for?
Gablofen contains Baclofen Injection. It is a injection, solution taken intrathecal. Consult your doctor for specific uses.
Is Gablofen a controlled substance?
Gablofen is not classified as a controlled substance by the DEA.
What is the generic name for Gablofen?
The generic name for Gablofen is Baclofen Injection. There are no other listed brand versions of Baclofen Injection.
What is the NDC code for Gablofen 500 ug/mL?
The NDC (National Drug Code) for Gablofen 500 ug/mL is 66794-155, listed by Piramal Critical Care Inc.
Other Gablofen Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)