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GABLOFEN（巴氯芬）鞘内注射液-供鞘内注射治疗中枢神经系统
GABLOFEN（巴氯芬）50mcg/mL，500mcg/mL，2000微克/供鞘内注射治疗中枢神经系统毫升
美国食品药物管理局已批准Gablofen（巴氯芬鞘内注射用于治疗由中枢神经系统），中央积极的肌肉松弛剂，对严重痉挛的管理。 Gablofen预计将在50mcg/mL，500mcg/mL可用，并且在2000微克准备使用的小瓶或预充式注射器/毫升的浓度由初期至中期，2010年12月
The FDA has approved Gablofen (baclofen for intrathecal injection, from CNS Therapeutics), a centrally active muscle relaxant, for the management of severe spasticity. Gablofen is expected to be available in 50mcg/mL, 500mcg/mL, and 2,000mcg/mL concentrations in ready-to-use vials or pre-filled syringes by early to mid-December 2010.
2010年11月23日，CNS Therapeutics宣布，美国食品药品管理局(FDA)已批准GABLOFEN(巴氯芬)用于治疗重度脑源性或脊髓源性痉挛。重度痉挛是一种运动障碍，通常与多发性硬化症、脑性瘫痪、脊髓损伤、脑外伤以及卒中有关。
根据Gablofen的处方信息，该药是一种抑制性神经递质γ-氨基丁酸的结构类似物，适用于通过椎管或腰椎穿刺以单剂试验剂量给药，若长期用药，则可通过使用美敦力公司的SynchroMed II-可编程泵系统或其他标明用于Gablofen鞘内给药的泵系统给药。
FDA批准Gablofen是基于已发表的关于巴氯芬鞘内注射液安全性和疗效的临床数据。脊髓源性痉挛患者使用Gablofen最常见的不良反应是嗜睡、头晕、恶心、低血压、头痛、惊厥和肌张力减退。在脑源性痉挛患者中最常见的不良反应是烦躁不安、便秘、嗜睡、白细胞增多症、寒战、尿潴留和肌张力减退。
无论是何种原因，突然停用巴氯芬鞘内注射液均会产生后遗症，其中包括高热、神志状态改变、痉挛反弹加重和肌强直，有少数病例会进展至横纹肌溶解症、多器官系统衰竭和死亡。
Gablofen包装在即用型药瓶内和预灌封注射器内。使用时需要密切监测以下情况：输注系统的编程与监测、再注满的时间安排与过程以及泵警报器。应告知患者和护理人员保持按时就诊进行再注满的重要性，并应针对巴氯芬撤药后的早期症状对其进行教育。
美国食品和药物管理局（FDA）已经批准Gablofen（巴氯芬注射剂）用于在严重痉挛的管理使用，运动障碍往往带来的多发性硬化症，脑性麻痹，脊髓损伤，脑外伤和中风
Gablofen Medication Guide
Read this leaflet before you start receiving Gablofen and before each injection. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
What is Gablofen?
Gablofen is a muscle relaxer and an antispastic agent.
Gablofen is used to treat severe spasticity, a movement disorder often brought on by multiple sclerosis, cerebral palsy, spinal cord injury, brain trauma and stroke.
Gablofen may also be used for other purposes not listed in this medication guide
Important information about Gablofen
Sudden withdrawal of Gablofen may result in serious complications that include high fever, confusion, muscle stiffness, organ failure and death. Early symptoms of Gablofen withdrawal may include increased spasticity, itching, and tingling of extremities.
If Gablofen withdrawal or a pump malfunction is suspected, you should be taken immediately to a hospital for assessment and treatment.
Sudden withdrawal occurs most frequently due to a delivery problem with the catheter or the pump, or failure to refill the pump on schedule. Pay careful attention to infusion system alarms. If you miss your scheduled pump refill, you should immediately contact your doctor or healthcare provider to reschedule the refill before the pump runs out of drug.
Gablofen can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of Gablofen. Do not use Gablofen at a time when muscle tone is needed to assure safe balance and movement for certain activities. In some situations, it may endanger your physical safety to be in a state of reduced muscle tone.
Before receiving Gablofen
Do not use this medication if you are allergic to Gablofen.
Before taking Gablofen, tell your doctor if you are allergic to any drugs, or if you have:
kidney disease;
epilepsy or other seizure disorder; or
a history of stroke or blood clots.
If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.
FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether Gablofen passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
See also: Gablofen pregnancy and breastfeeding warnings (in more detail)
Older adults may be more sensitive to the effects of this medicine.
Do not give this medication to a child younger than 4 years old.
How should I use Gablofen?
Gablofen is given as an injection into the space around your spinal cord (intrathecal injection) using a computerized, portable infusion pump to control the rate of medication you receive. You may need to use this medication for a long period of time.
Gablofen must be given only as an intrathecal injection through an infusion pump and should not be injected directly into a vein or other part of the body. Your doctor, nurse, or other healthcare provider will give you this injection.
Your doctor may occasionally change your dose or infusion pump flow rate to make sure you get the best results from this medication.
You may have withdrawal symptoms such as seizures or hallucinations, when you stop using Gablofen after using it over a long period of time. Do not stop using this medication suddenly. Always talk to your doctor. You may need to use less and less before you stop the medication completely.
Store Gablofen at room temperature away from moisture and heat.
What happens if I miss a dose?
Since Gablofen dosing and infusion pump programming is administered by a healthcare professional, you are not likely to miss a dose.
What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine or if your infusion pump is not working properly.
Signs of overdose include drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, hypotonia and loss of consciousness progressing to coma.
What should I avoid while taking Gablofen?
Gablofen can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of Gablofen.
Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by Gablofen.
Gablofen side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:
seizure (convulsions);
confusion, hallucinations; or
an uneven heartbeat.
Less serious side effects may include:
drowsiness, dizziness, weakness, tired feeling;
agitation;
low blood pressure;
headache;
confusion;
sleep problems (insomnia);
nausea, constipation; or
increased urinary frequency or urinary retention.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
See also: Gablofen side effects (in more detail)
What other drugs will affect Gablofen?
There may be other drugs that can affect Gablofen. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor
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