Lioresal (baclofen)

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Overview

What is Lioresal (baclofen)?

LIORESAL INTRATHECAL (baclofen injection) 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.

LIORESAL 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 LIORESAL INTRATHECAL contains baclofen U. S. P. 50 mcg, 500 mcg or 2000 mcg and sodium chloride 9 mg in Water for Injection; pH range is 5.0 - 7.0. Each ampule is intended for SINGLE USE ONLY. Discard any unused portion.

What does Lioresal (baclofen) look like?

What are the available doses of Lioresal (baclofen)?

Sorry No records found.

What should I talk to my health care provider before I take Lioresal (baclofen)?

Sorry No records found

How should I use Lioresal (baclofen)?

LIORESAL INTRATHECAL (baclofen injection) 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 LIORESAL 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. LIORESAL 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 LIORESAL INTRATHECAL into the intrathecal space.

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.

What interacts with Lioresal (baclofen)?

Hypersensitivity to baclofen. LIORESAL INTRATHECAL is not recommended for intravenous, intramuscular, subcutaneous or epidural administration.

What are the warnings of Lioresal (baclofen)?

As in the case of other preparations containing CNS-acting drugs, patients receiving Librax should be cautioned about possible combined effects with opioids, alcohol and other CNS depressants. For the same reason, they should be cautioned against hazardous occupations requiring complete mental alertness, such as operating machinery or driving a motor vehicle.

LIORESAL 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 LIORESAL INTRATHECAL injection is adequately evaluated. Evaluation (consisting of a screening procedure: see) requires that LIORESAL 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 surgical implantation of the pump, particularly during the initial phases of pump use, the patient should be monitored closely until it is certain that the patient's response to the infusion is acceptable and reasonably stable.

On each occasion that the dosing rate of the pump and/or the concentration of LIORESAL INTRATHECAL (baclofen injection) in the reservoir is adjusted, close medical monitoring is required until it is certain that the patient's response to the infusion is acceptable and reasonably stable.

It is mandatory that the patient, all patient caregivers, and the physicians responsible for the patient receive adequate information regarding the risks of this mode of treatment. All medical personnel and caregivers should be instructed in 1) the signs and symptoms of overdose, 2) procedures to be followed in the event of overdose and 3) proper home care of the pump and insertion site.

Overdose

Signs of overdose may appear suddenly or insidiously. Acute massive overdose may present as coma. Less sudden and/or less severe forms of overdose may present with signs of drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia and loss of consciousness progressing to coma. Should overdose appear likely, the patient should be taken immediately to a hospital for assessment and emptying of the pump reservoir. In cases reported to date, overdose has generally been related to pump malfunction, inadvertent subcutaneous injection, or dosing error. (Seeand)

Extreme caution must be used when filling an FDA approved implantable pump. Such pumps should only be refilled through the reservoir refill septum. Inadvertent injection into the subcutaneous tissue can occur if the reservoir refill septum is not properly accessed. Some pumps are also equipped with a catheter access port that allows direct access to the intrathecal catheter. Direct injection into this catheter access port or inadvertent injection into the subcutaneous tissue may cause a life-threatening overdose.

Withdrawal

Abrupt withdrawal of intrathecal baclofen, regardless of the cause, has resulted in sequelae that included high fever, altered mental status, exaggerated rebound spasticity and muscle rigidity that in rare cases progressed to rhabdomyolysis, multiple organ-system failure, and death. In the first 9 years of post-marketing experience, 27 cases of withdrawal temporally related to the cessation of baclofen therapy were reported; six patients died. In most cases, symptoms of withdrawal appeared within hours to a few days following interruption of baclofen therapy. Common reasons for abrupt interruption of intrathecal baclofen therapy included malfunction of the catheter (especially disconnection), low volume in the pump reservoir, and end of pump battery life; human error may have played a causal or contributing role in some cases. Cases of intrathecal mass at the tip of the implanted catheter leading to withdrawal symptoms have also been reported, most of them involving pharmacy compounded analgesic admixtures (see).

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.

All patients receiving intrathecal baclofen therapy are potentially at risk for withdrawal. Early symptoms of baclofen withdrawal may include return of baseline spasticity, pruritus, hypotension, and paresthesias. Priapism may develop or recur if treatment with intrathecal baclofen is interrupted. Some clinical characteristics of the advanced intrathecal baclofen withdrawal syndrome may resemble autonomic dysreflexia, infection (sepsis), malignant hyperthermia, neuroleptic-malignant syndrome, or other conditions associated with a hypermetabolic state or widespread rhabdomyolysis.

Rapid, accurate diagnosis and treatment in an emergency-room or intensive-care setting are important in order to prevent the potentially life-threatening central nervous system and systemic effects of intrathecal baclofen withdrawal. The suggested treatment for intrathecal baclofen withdrawal is the restoration of intrathecal baclofen at or near the same dosage as before therapy was interrupted. However, if restoration of intrathecal delivery is delayed, treatment with GABA-ergic agonist drugs such as oral or enteral baclofen, or oral, enteral, or intravenous benzodiazepines may prevent potentially fatal sequelae. Oral or enteral baclofen alone should not be relied upon to halt the progression of intrathecal baclofen withdrawal.

Seizures have been reported during overdose and with withdrawal from LIORESAL INTRATHECAL as well as in patients maintained on therapeutic doses of LIORESAL INTRATHECAL.

Fatalities

Spasticity of Spinal Cord Origin

Spasticity of Cerebral Origin

There were three deaths occurring among the 211 patients treated with LIORESAL INTRATHECAL in pre- marketing studies as of March 1996. These deaths were not attributed to the therapy.

What are the precautions of Lioresal (baclofen)?

Children should be of sufficient body mass to accommodate the implantable pump for chronic infusion. Please consult pump manufacturer's manual for specific recommendations.

Safety and effectiveness in pediatric patients below the age of 4 have not been established.

Screening

Patients should be infection-free prior to the screening trial with LIORESAL INTRATHECAL (baclofen injection) because the presence of a systemic infection may interfere with an assessment of the patient's response to bolus LIORESAL INTRATHECAL.

Pump Implantation

Patients should be infection-free prior to pump implantation because the presence of infection may increase the risk of surgical complications. Moreover, a systemic infection may complicate dosing.

Pump Dose Adjustment and Titration

In most patients, it will be necessary to increase the dose gradually over time to maintain effectiveness; a sudden requirement for substantial dose escalation typically indicates a catheter complication (i. e., catheter kink or dislodgement).

Reservoir refilling must be performed by fully trained and qualified personnel following the directions provided by the pump manufacturer. Inadvertent injection into the subcutaneous tissue can occur if the reservoir refill septum is not properly accessed. Subcutaneous injection may result in symptoms of a systemic overdose or early depletion of the reservoir. Refill intervals should be carefully calculated to prevent depletion of the reservoir, as this would result in the return of severe spasticity and possibly symptoms of withdrawal.

Strict aseptic technique in filling is required to avoid bacterial contamination and serious infection. A period of observation appropriate to the clinical situation should follow each refill or manipulation of the drug reservoir.

Extreme caution must be used when filling an FDA approved implantable pump equipped with an injection port that allows direct access to the intrathecal catheter. Direct injection into the catheter through the catheter access port may cause a life-threatening overdose.

It may be important to titrate the dose to maintain some degree of muscle tone and allow occasional spasms to: 1) help support circulatory function, 2) possibly prevent the formation of deep vein thrombosis, 3) optimize activities of daily living and ease of care.

Except in overdose related emergencies, the dose of LIORESAL INTRATHECAL should ordinarily be reduced slowly if the drug is discontinued for any reason.

An attempt should be made to discontinue concomitant oral antispasticity medication to avoid possible overdose or adverse drug interactions, either prior to screening or following implant and initiation of chronic LIORESAL INTRATHECAL infusion. Reduction and discontinuation of oral anti-spasmotics should be done slowly and with careful monitoring by the physician. Abrupt reduction or discontinuation of concomitant antispastics should be avoided.

Drowsiness

Drowsiness has been reported in patients on LIORESAL INTRATHECAL. Patients should be cautioned regarding the operation of automobiles or other dangerous machinery, and activities made hazardous by decreased alertness. Patients should also be cautioned that the central nervous system depressant effects of LIORESAL INTRATHECAL (baclofen injection) may be additive to those of alcohol and other CNS depressants.

Intrathecal mass

Cases of intrathecal mass at the tip of the implanted catheter have been reported, most of them involving pharmacy compounded analgesic admixtures. The most frequent symptoms associated with intrathecal mass are: 1) decreased therapeutic response (worsening spasticity, return of spasticity when previously well controlled, withdrawal symptoms, poor response to escalating doses, or frequent or large dosage increases), 2) pain, 3) neurological deficit/dysfunction. Clinicians should monitor patients on intraspinal therapy carefully for any new neurological signs or symptoms. In patients with new neurological signs or symptoms suggestive of an intrathecal mass, consider a neurosurgical consultation, since many of the symptoms of inflammatory mass are not unlike the symptoms experienced by patients with severe spasticity from their disease. In some cases, performance of an imaging procedure may be appropriate to confirm or rule-out the diagnosis of an intrathecal mass.

Precautions in special patient populations

Careful dose titration of LIORESAL INTRATHECAL is needed when spasticity is necessary to sustain upright posture and balance in locomotion or whenever spasticity is used to obtain optimal function and care.

Patients suffering from psychotic disorders, schizophrenia, or confusional states should be treated cautiously with LIORESAL INTRATHECAL and kept under careful surveillance, because exacerbations of these conditions have been observed with oral administration.

LIORESAL INTRATHECAL should be used with caution in patients with a history of autonomic dysreflexia. The presence of nociceptive stimuli or abrupt withdrawal of LIORESAL INTRATHECAL (baclofen injection) may cause an autonomic dysreflexic episode.

Because LIORESAL is primarily excreted unchanged by the kidneys, it should be given with caution in patients with impaired renal function and it may be necessary to reduce the dosage.

LABORATORY TESTS

No specific laboratory tests are deemed essential for the management of patients on LIORESAL INTRATHECAL.

DRUG INTERACTIONS

There is inadequate systematic experience with the use of LIORESAL INTRATHECAL in combination with other medications to predict specific drug-drug interactions. Interactions attributed to the combined use of LIORESAL INTRATHECAL and epidural morphine include hypotension and dyspnea.

CARCINOGENESIS, MUTAGENESIS, AND IMPAIRMENT OF FERTILITY

No increase in tumors was seen in rats receiving baclofen orally for two years. Adequate genotoxicity assays of baclofen have not been performed.

PREGNANCY

There are no adequate and well-controlled studies in pregnant women. In animal studies, baclofen had adverse effects on embryofetal development when administered orally to pregnant rats. LIORESAL INTRATHECAL should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Baclofen given orally increased the incidence of fetal structural abnormalities (omphaloceles) in rats. Reductions in food intake and body weight gain were observed in the dams. Fetal structural abnormalities were not observed in mice or rabbits

NURSING MOTHERS

In mothers treated with oral LIORESAL (baclofen USP) in therapeutic doses, the active substance passes into the milk. It is not known whether detectable levels of drug are present in milk of nursing mothers receiving LIORESAL INTRATHECAL. As a general rule, nursing should be undertaken while a patient is receiving LIORESAL INTRATHECAL only if the potential benefit justifies the potential risks to the infant.

PEDIATRIC USE

Children should be of sufficient body mass to accommodate the implantable pump for chronic infusion. Please consult pump manufacturer's manual for specific recommendations.

Safety and effectiveness in pediatric patients below the age of 4 have not been established.

Considerations based on experience with oral LIORESAL (baclofen USP)

A dose-related increase in incidence of ovarian cysts was observed in female rats treated chronically with oral LIORESAL. Ovarian cysts have been found by palpation in about 4% of the multiple sclerosis patients who were treated with oral LIORESAL for up to one year. In most cases these cysts disappeared spontaneously while patients continued to receive the drug. Ovarian cysts are estimated to occur spontaneously in approximately 1% to 5% of the normal female population.

What are the side effects of Lioresal (baclofen)?

Spasticity of Spinal Cord Origin

Spasticity of Cerebral Origin

Postmarketing Experience

The following adverse events have been reported during post-approval use of LIORESAL INTRATHECAL. Because these events are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency.

Musculoskeletal

The onset of scoliosis or worsening of a pre-existing scoliosis has been reported.

Urogenital

Sexual dysfunction in men and women, including decreased libido and orgasm dysfunction, have been reported. Erectile dysfunction in men has also been reported. Priapism has been reported following baclofen withdrawal.

What should I look out for while using Lioresal (baclofen)?

Hypersensitivity to baclofen. LIORESAL INTRATHECAL is not recommended for intravenous, intramuscular, subcutaneous or epidural administration.

LIORESAL 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 LIORESAL INTRATHECAL injection is adequately evaluated. Evaluation (consisting of a screening procedure: see) requires that LIORESAL 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 surgical implantation of the pump, particularly during the initial phases of pump use, the patient should be monitored closely until it is certain that the patient's response to the infusion is acceptable and reasonably stable.

On each occasion that the dosing rate of the pump and/or the concentration of LIORESAL INTRATHECAL (baclofen injection) in the reservoir is adjusted, close medical monitoring is required until it is certain that the patient's response to the infusion is acceptable and reasonably stable.

It is mandatory that the patient, all patient caregivers, and the physicians responsible for the patient receive adequate information regarding the risks of this mode of treatment. All medical personnel and caregivers should be instructed in 1) the signs and symptoms of overdose, 2) procedures to be followed in the event of overdose and 3) proper home care of the pump and insertion site.

What might happen if I take too much Lioresal (baclofen)?

Special attention must be given to recognizing the signs and symptoms of overdosage, especially during the initial screening and dose-titration phase of treatment, but also during re-introduction of LIORESAL INTRATHECAL after a period of interruption in therapy.

How should I store and handle Lioresal (baclofen)?

LIORESAL INTRATHECAL (baclofen injection) is packaged in single use ampules containing 0.05 mg/1 mL (50 mcg/mL), 10 mg/20 mL (500 mcg/mL), 10 mg/5 mL (2000 mcg/mL), or 40 mg/20 mL (2000 mcg/mL) supplied as follows:Screening dose (Model 8563s): five ampules each containing 0.05 mg/1 mL (50 mcg/mL) (NDC 70257-562-55).LIORESAL INTRATHECAL (baclofen injection) Refill Kits. Each refill kit includes the indicated amount of LIORESAL INTRATHECAL, a drug preparation kit, a pump refill kit with accessories that are compatible with Medtronic SynchroMedInfusion Systems, and associated instructions.Model 8561: one ampule containing 10 mg/20 mL (500 mcg/mL) (NDC 70257-560-01). Model 8562: two ampules, each contains 10 mg/5 mL (2000 mcg/mL) (NDC 70257-561-02). Model 8564: one ampule containing 40 mg/20 mL (2000 mcg/mL) (NDC 70257-563-01). Model 8565: two ampules, each contains 10 mg/20 mL (500 mcg/mL) (NDC 70257-560-02).Model 8566: two ampules, each contains 40 mg/20 mL (2000 mcg/mL) (NDC 70257-563-02).LIORESAL INTRATHECAL (baclofen injection) is packaged in single use ampules containing 0.05 mg/1 mL (50 mcg/mL), 10 mg/20 mL (500 mcg/mL), 10 mg/5 mL (2000 mcg/mL), or 40 mg/20 mL (2000 mcg/mL) supplied as follows:Screening dose (Model 8563s): five ampules each containing 0.05 mg/1 mL (50 mcg/mL) (NDC 70257-562-55).LIORESAL INTRATHECAL (baclofen injection) Refill Kits. Each refill kit includes the indicated amount of LIORESAL INTRATHECAL, a drug preparation kit, a pump refill kit with accessories that are compatible with Medtronic SynchroMedInfusion Systems, and associated instructions.Model 8561: one ampule containing 10 mg/20 mL (500 mcg/mL) (NDC 70257-560-01). Model 8562: two ampules, each contains 10 mg/5 mL (2000 mcg/mL) (NDC 70257-561-02). Model 8564: one ampule containing 40 mg/20 mL (2000 mcg/mL) (NDC 70257-563-01). Model 8565: two ampules, each contains 10 mg/20 mL (500 mcg/mL) (NDC 70257-560-02).Model 8566: two ampules, each contains 40 mg/20 mL (2000 mcg/mL) (NDC 70257-563-02).LIORESAL INTRATHECAL (baclofen injection) is packaged in single use ampules containing 0.05 mg/1 mL (50 mcg/mL), 10 mg/20 mL (500 mcg/mL), 10 mg/5 mL (2000 mcg/mL), or 40 mg/20 mL (2000 mcg/mL) supplied as follows:Screening dose (Model 8563s): five ampules each containing 0.05 mg/1 mL (50 mcg/mL) (NDC 70257-562-55).LIORESAL INTRATHECAL (baclofen injection) Refill Kits. Each refill kit includes the indicated amount of LIORESAL INTRATHECAL, a drug preparation kit, a pump refill kit with accessories that are compatible with Medtronic SynchroMedInfusion Systems, and associated instructions.Model 8561: one ampule containing 10 mg/20 mL (500 mcg/mL) (NDC 70257-560-01). Model 8562: two ampules, each contains 10 mg/5 mL (2000 mcg/mL) (NDC 70257-561-02). Model 8564: one ampule containing 40 mg/20 mL (2000 mcg/mL) (NDC 70257-563-01). Model 8565: two ampules, each contains 10 mg/20 mL (500 mcg/mL) (NDC 70257-560-02).Model 8566: two ampules, each contains 40 mg/20 mL (2000 mcg/mL) (NDC 70257-563-02).LIORESAL INTRATHECAL (baclofen injection) is packaged in single use ampules containing 0.05 mg/1 mL (50 mcg/mL), 10 mg/20 mL (500 mcg/mL), 10 mg/5 mL (2000 mcg/mL), or 40 mg/20 mL (2000 mcg/mL) supplied as follows:Screening dose (Model 8563s): five ampules each containing 0.05 mg/1 mL (50 mcg/mL) (NDC 70257-562-55).LIORESAL INTRATHECAL (baclofen injection) Refill Kits. Each refill kit includes the indicated amount of LIORESAL INTRATHECAL, a drug preparation kit, a pump refill kit with accessories that are compatible with Medtronic SynchroMedInfusion Systems, and associated instructions.Model 8561: one ampule containing 10 mg/20 mL (500 mcg/mL) (NDC 70257-560-01). Model 8562: two ampules, each contains 10 mg/5 mL (2000 mcg/mL) (NDC 70257-561-02). Model 8564: one ampule containing 40 mg/20 mL (2000 mcg/mL) (NDC 70257-563-01). Model 8565: two ampules, each contains 10 mg/20 mL (500 mcg/mL) (NDC 70257-560-02).Model 8566: two ampules, each contains 40 mg/20 mL (2000 mcg/mL) (NDC 70257-563-02).LIORESAL INTRATHECAL (baclofen injection) is packaged in single use ampules containing 0.05 mg/1 mL (50 mcg/mL), 10 mg/20 mL (500 mcg/mL), 10 mg/5 mL (2000 mcg/mL), or 40 mg/20 mL (2000 mcg/mL) supplied as follows:Screening dose (Model 8563s): five ampules each containing 0.05 mg/1 mL (50 mcg/mL) (NDC 70257-562-55).LIORESAL INTRATHECAL (baclofen injection) Refill Kits. Each refill kit includes the indicated amount of LIORESAL INTRATHECAL, a drug preparation kit, a pump refill kit with accessories that are compatible with Medtronic SynchroMedInfusion Systems, and associated instructions.Model 8561: one ampule containing 10 mg/20 mL (500 mcg/mL) (NDC 70257-560-01). Model 8562: two ampules, each contains 10 mg/5 mL (2000 mcg/mL) (NDC 70257-561-02). Model 8564: one ampule containing 40 mg/20 mL (2000 mcg/mL) (NDC 70257-563-01). Model 8565: two ampules, each contains 10 mg/20 mL (500 mcg/mL) (NDC 70257-560-02).Model 8566: two ampules, each contains 40 mg/20 mL (2000 mcg/mL) (NDC 70257-563-02).LIORESAL INTRATHECAL (baclofen injection) is packaged in single use ampules containing 0.05 mg/1 mL (50 mcg/mL), 10 mg/20 mL (500 mcg/mL), 10 mg/5 mL (2000 mcg/mL), or 40 mg/20 mL (2000 mcg/mL) supplied as follows:Screening dose (Model 8563s): five ampules each containing 0.05 mg/1 mL (50 mcg/mL) (NDC 70257-562-55).LIORESAL INTRATHECAL (baclofen injection) Refill Kits. Each refill kit includes the indicated amount of LIORESAL INTRATHECAL, a drug preparation kit, a pump refill kit with accessories that are compatible with Medtronic SynchroMedInfusion Systems, and associated instructions.Model 8561: one ampule containing 10 mg/20 mL (500 mcg/mL) (NDC 70257-560-01). Model 8562: two ampules, each contains 10 mg/5 mL (2000 mcg/mL) (NDC 70257-561-02). Model 8564: one ampule containing 40 mg/20 mL (2000 mcg/mL) (NDC 70257-563-01). Model 8565: two ampules, each contains 10 mg/20 mL (500 mcg/mL) (NDC 70257-560-02).Model 8566: two ampules, each contains 40 mg/20 mL (2000 mcg/mL) (NDC 70257-563-02).LIORESAL INTRATHECAL (baclofen injection) is packaged in single use ampules containing 0.05 mg/1 mL (50 mcg/mL), 10 mg/20 mL (500 mcg/mL), 10 mg/5 mL (2000 mcg/mL), or 40 mg/20 mL (2000 mcg/mL) supplied as follows:Screening dose (Model 8563s): five ampules each containing 0.05 mg/1 mL (50 mcg/mL) (NDC 70257-562-55).LIORESAL INTRATHECAL (baclofen injection) Refill Kits. Each refill kit includes the indicated amount of LIORESAL INTRATHECAL, a drug preparation kit, a pump refill kit with accessories that are compatible with Medtronic SynchroMedInfusion Systems, and associated instructions.Model 8561: one ampule containing 10 mg/20 mL (500 mcg/mL) (NDC 70257-560-01). Model 8562: two ampules, each contains 10 mg/5 mL (2000 mcg/mL) (NDC 70257-561-02). Model 8564: one ampule containing 40 mg/20 mL (2000 mcg/mL) (NDC 70257-563-01). Model 8565: two ampules, each contains 10 mg/20 mL (500 mcg/mL) (NDC 70257-560-02).Model 8566: two ampules, each contains 40 mg/20 mL (2000 mcg/mL) (NDC 70257-563-02).LIORESAL INTRATHECAL (baclofen injection) is packaged in single use ampules containing 0.05 mg/1 mL (50 mcg/mL), 10 mg/20 mL (500 mcg/mL), 10 mg/5 mL (2000 mcg/mL), or 40 mg/20 mL (2000 mcg/mL) supplied as follows:Screening dose (Model 8563s): five ampules each containing 0.05 mg/1 mL (50 mcg/mL) (NDC 70257-562-55).LIORESAL INTRATHECAL (baclofen injection) Refill Kits. Each refill kit includes the indicated amount of LIORESAL INTRATHECAL, a drug preparation kit, a pump refill kit with accessories that are compatible with Medtronic SynchroMedInfusion Systems, and associated instructions.Model 8561: one ampule containing 10 mg/20 mL (500 mcg/mL) (NDC 70257-560-01). Model 8562: two ampules, each contains 10 mg/5 mL (2000 mcg/mL) (NDC 70257-561-02). Model 8564: one ampule containing 40 mg/20 mL (2000 mcg/mL) (NDC 70257-563-01). Model 8565: two ampules, each contains 10 mg/20 mL (500 mcg/mL) (NDC 70257-560-02).Model 8566: two ampules, each contains 40 mg/20 mL (2000 mcg/mL) (NDC 70257-563-02).

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Clinical Information

Chemical Structure

No Image found

Clinical Pharmacology

The precise mechanism of action of baclofen as a muscle relaxant and antispasticity agent is not fully understood. Baclofen inhibits both monosynaptic and polysynaptic reflexes at the spinal level, possibly by decreasing excitatory neurotransmitter release from primary afferent terminals, although actions at supraspinal sites may also occur and contribute to its clinical effect. Baclofen is a structural analog of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), and may exert its effects by stimulation of the GABAreceptor subtype.

LIORESAL INTRATHECAL when introduced directly into the intrathecal space permits effective CSF concentrations to be achieved with resultant plasma concentrations 100 times less than those occurring with oral administration.

In people, as well as in 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.

Non-Clinical Toxicology

Hypersensitivity to baclofen. LIORESAL INTRATHECAL is not recommended for intravenous, intramuscular, subcutaneous or epidural administration.

LIORESAL 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 LIORESAL INTRATHECAL injection is adequately evaluated. Evaluation (consisting of a screening procedure: see) requires that LIORESAL 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 surgical implantation of the pump, particularly during the initial phases of pump use, the patient should be monitored closely until it is certain that the patient's response to the infusion is acceptable and reasonably stable.

On each occasion that the dosing rate of the pump and/or the concentration of LIORESAL INTRATHECAL (baclofen injection) in the reservoir is adjusted, close medical monitoring is required until it is certain that the patient's response to the infusion is acceptable and reasonably stable.

It is mandatory that the patient, all patient caregivers, and the physicians responsible for the patient receive adequate information regarding the risks of this mode of treatment. All medical personnel and caregivers should be instructed in 1) the signs and symptoms of overdose, 2) procedures to be followed in the event of overdose and 3) proper home care of the pump and insertion site.

There is inadequate systematic experience with the use of LIORESAL INTRATHECAL in combination with other medications to predict specific drug-drug interactions. Interactions attributed to the combined use of LIORESAL INTRATHECAL and epidural morphine include hypotension and dyspnea.

Children should be of sufficient body mass to accommodate the implantable pump for chronic infusion. Please consult pump manufacturer's manual for specific recommendations.

Safety and effectiveness in pediatric patients below the age of 4 have not been established.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Review

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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