Baclofen s pharmacological class is a gammaaminobutyric acid gabaergic agonist. Practical protocol for prescribing baclofen in alcohol addiction. It has been written by french prescribers and patient experts, drawing on nearly a decade of experience. Baclofen fda prescribing information, side effects and uses. One important information source that pharmacists as well as other practitioners have access to, but sometimes overlook, is the drugs label, also known as the prescribing information or the package insert pi. Highlights of prescribing information maintenance therapy.
Oct 15, 2018 baclofen is a muscle relaxant and antispastic used for treating spasm of skeletal muscles, muscle clonus, rigidity, and pain caused by multiple sclerosis. Full prescribing information 17 x 11 inch front warning. Highlights of prescribing information these highlights do not include all the information needed to use gablofen safely and effectively. Baclofen is a white to offwhite, odorless or practically odorless crystalline powder, with a molecular weight of 2. See full prescribing information for zofran tablets, zofran odt, and zofran oral solution. Lioresal baclofen is useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis. Baclofen is a muscle relaxant and antispastic used for treating spasm of skeletal muscles, muscle clonus, rigidity, and pain caused by multiple sclerosis.
Sep 20, 2019 a suggested treatment of intrathecal baclofen withdrawal is restoration of treatment at or near the same dosage as before therapy was interrupted. Consult the technical manual of the implantable infusion system for additional postimplant clinician and patient information see warnings. Baclofen is rapidly and extensively absorbed and eliminated. Lioresal intrathecal baclofen injection is administered directly to the intrathecal space surrounding the spinal cord.
The catalog displays all strengths and sizes along with the description, imprint code, ndc and photo for each product. See full prescribing information for complete boxed warning 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 organsystem failure and death. Common side effects of baclofen are low blood pressure, vomiting, nausea, headache, and seizures. Its chemical name is 4amino34chlorophenyl butanoic acid, and its structural formula is. Gablofen, an intrathecal baclofen is available through.
Help drugs pi website grow, register now and become a recognized active member by. Prescribing information 4 67 crossover study in 96 human volunteers, of whom 81 were eligible for the statistical 68 analysis. A suggested treatment of intrathecal baclofen withdrawal is restoration of treatment at or near the same dosage as before therapy was interrupted. Intrathecal baclofen therapy itb therapy sm is delivered by the medtronic synchromed drug infusion system, which consists of an implantable, programmable pump and an intrathecal catheter. Sections or subsections omitted from the full prescribing information are not listed. Highlights of prescribing information these highlights do not include all the information needed to use ozobax safely and effectively. Dec 17, 2019 rx only ndc 16714 baclofen tablets usp, 10 mg 100 tablets northstar each tablet contains 10mg baclofen usp usual dosage. Practical protocol for prescribing baclofen in alcohol.
Health care professionals should limit prescribing opioid pain medicines with. Ozobax is contraindicated in patients with hypersensitivity to baclofen. Help drugs pi website grow, register now and become a recognized active member by adding new content. Highlights of prescribing information dose titration. Baclofen is used to treat pain and certain types of spasticity muscle stiffness and tightness from multiple sclerosis, spinal cord injuries, or other spinal cord diseases. In studies with animals baclofen has been shown to have general cns depressant properties as indicated by the production of sedation with tolerance, somnolence, ataxia, and respiratory and cardiovascular depression. Baclofen is also injected into the spinal cord to treat severe spasticity, spinal cord injuries, and other spinal cord diseases. Jan 01, 2020 baclofen tablets usp are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae. Rx only ndc 16714 baclofen tablets usp, 10 mg 100 tablets northstar each tablet contains 10mg baclofen usp usual dosage. Sep 23, 2019 ozobax baclofen oral solution initial u. Prescribing information, clinical studies, and slide decks all materials are available for download in their original formats as pdf or powerpoint. Avoid prescribing opioid cough medications in patients taking a skeletal muscle relaxant.
Baclofen baclofen is fda approved to treat reversible spasticity associated with multiple sclerosis or spinal cord lesions. If restoration of intrathecal therapy is delayed, treatment with gabaergic agonist drugs should be considered. It may also be used for hiccups and muscle spasms near the end of life. Oral or enteral baclofen alone should not be relied upon to stop intrathecal baclofen. Highlights of prescribing information these highlights do not include all the information needed to use gablofen. See full prescribing information for complete boxed warning. The usual dose is 60120 mg a day divided into 3 doses per day but the dose can vary depending on how well it works for you and. Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal. Please like drugs pis facebook page for even more updates.
Baclofen is fda approved to treat reversible spasticity associated with multiple sclerosis or spinal cord lesions. For long term treatment, the drug is placed into a pump that is surgically placed under the skin of your abdomen. Baclofen official prescribing information for healthcare professionals. Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump. Paul 148x210 7pt accord barnstaple na 4 na version 2 01. Treatment with baclofen is intended to make one indifferent to alcohol, that is to say, to make the. Abrupt discontinuation of baclofen, regardless of the cause, has resulted in adverse reactions that include hallucinations, seizures, high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organsystem failure, and death. This is a practical guide to prescribing baclofen in alcohol addiction.
Baclofen acts on the spinal cord nerves and decreases the number and severity of muscle spasms. Prescribing guide for baclofen in the treatment of alcoholism for use by physicians. Do not discontinue abruptly see full prescribing information for complete boxed warning abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status. Information for the patient continued top of next column continued over page read all of this leaflet carefully before you start taking this medicine because it contains. Baclofen tablets, usp 10 mg are available as a white to off white, round flatfaced, beveled edge tablets debossed with 024 on one side and score on other side, containing 10 mg baclofen usp packaged in bottles of 100, 500 and tablets. Baclofen kemstro, lioresal treatment national hiv curriculum. Prescribing guide for baclofen in the treatment of. Apr 02, 2020 baclofen is a muscle relaxer used to treat muscle symptoms caused by multiple sclerosis, including spasm, pain, and stiffness.
See package insert for full prescribing information. Lioresal, baclofen usp, is a muscle relaxant and antispastic, available as 10mg and 20mg tablets for oral administration. Because baclofen is excreted unchanged through the kidneys it may be necessary to reduce the dosage in patients with impaired renal function. Lioresal intrathecal baclofen injection is indicated for use in the management of severe spasticity. Prescribing guide for baclofen in the treatment of alcoholism page. Lioresal fda prescribing information, side effects and uses. Gablofen baclofen injection, for intrathecal use initial u. Mar 23, 2020 lioresal, baclofen usp, is a muscle relaxant and antispastic, available as 10mg and 20mg tablets for oral administration. The efficacy of baclofen in stroke, cerebral palsy, and parkinsons disease has not been established and, therefore, it is not recommended for these conditions. Baclofen tablets usp, 20 mg are available as an offwhite, to beige, round, flatfaced tablet with a beveled edge debossed with a c22 on top of bisect on one side and plain on the other side. See full prescribing information for complete boxed warning injec abrupt discontinuation of intrathecal baclofen, regardless of the. Highlights of prescribing information these highlights. Intrathecal baclofen therapy itb is a treatment using lioresal intrathecal baclofen that is delivered into the fluid around your spinal cord intrathecal to help manage severe spasticity.
Fda approved indications gablofen and lioresal intrathecal are indicated for use in the management of severe spasticity. In cerebrospinal fluid, the active substance attains concentrations approx. Prescribing guide for baclofen in the treatment of alcoholism. Nov 08, 2019 baclofen tablets, usp 10 mg are available as a white to off white, round flatfaced, beveled edge tablets debossed with 024 on one side and score on other side, containing 10 mg baclofen usp packaged in bottles of 100, 500 and tablets. Dispense in a wellclosed container as defined in the usp. Dexilant is indicated for healing of all grades of erosive esophagitis ee for up to 8. Do not discontinue abruptly see full prescribing information for complete boxed warning. Spach, md principal investigator mountain west aetc professor of medicine division of infectious diseases.
Dexilant is indicated for healing of all grades of erosive esophagitis ee for up to 8 weeks. Gablofen prescribing information pdf gablofen baclofen injection is a gammaaminobutyric acid gaba ergic agonist indicated for use in the management of severe spasticity of cerebral or spinal origin in adult and pediatric patients age 4 years and above. Prescribing information gablofen for healthcare providers. For more information, including box warning, refer to lioresal intrathecal baclofen injection prescribing information in brochure pocket, or attached to this. Baclofen is a muscle relaxer and an antispasmodic agent. Includes baclofen side effects, interactions and indications. This is the new guide to baclofen treatment for alcohol addiction 2017 prescribing guide, updating the previous 2012 version. Baclofen usp is a white to offwhite, odorless or practically odorless crystalline powder, with a molecular weight of 2. Patients should have reversible spasticity so that baclofen tablet treatment will aid in restoring residual function.
Highlights of prescribing information these highlights do not include all the information needed to use zofran tablets, zofran odt, and zofran oral solution safely and effectively. Baclofen is in a class of medications called skeletal muscle relaxants. The related drug information index provides comprehensive access to all drug information related to a specific drug types of content include full prescribing information, drug summaries, full prescribing information continuing medication education full pi cme, medication guides, risk evaluation and mitigation strategies rems summaries, rems continuing medication education rems cme, and. All the information in this module is available in written form including protocols for prescribing and dose adjustment and an information pack to give patients. Baclofen tablets usp are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. It is taken by mouth or by delivery into the spinal canal. Stelax product information page 2 of 7 distribution. May 15, 2015 one important information source that pharmacists as well as other practitioners have access to, but sometimes overlook, is the drugs label, also known as the prescribing information or the package insert pi. Baclofen lioresal, kemstro is a muscle relaxant drug used for treating muscle spasms, rigidity, and pain from conditions such as multiple sclerosis ms. Baclofen, sold under the brand name lioresal among others, is a medication used to treat muscle spasticity such as from a spinal cord injury or multiple sclerosis. 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 organsystem failure and death. Baclofen injection fda prescribing information, side. Treatment with baclofen is intended to make one indifferent to alcohol, that is to say, to make the preoccupation with alcohol disappear from ones mind. Special attention should be given to patients at apparent risk e.
It is given intrathecally directly into the spinal cord or orally by mouth. Baclofen baclofen dose, indications, adverse effects. See important risk information on back cover and in accompanying full prescribing information. Consult the technical manual of the implantable infusion system for additional postimplant clinician and patient information. Gablofen prescribing information pdf indications and usage gablofen baclofen injection is a gammaaminobutyric acid gaba ergic agonist indicated for use in the management of severe spasticity of cerebral or spinal origin in adult and pediatric patients age 4 years and above. Intrathecal baclofen therapy full prescribing information. Pdr drug summaries are concise pointofcare prescribing, dosing and administering information to help phsyicans more efficiently and accurately prescribe in their practice pdr s drug summaries are available free of charge and serve as a great resource for us based mds, dos, nps and pas in patient practice. Maximum dosage information is not available for intrathecal baclofen.