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Pharmacodynamics of the drug Lioresal
Baclofen is an analogue of GABA, the main mediator involved in the processes of central inhibition. By stimulating presynaptic GABABreceptors in the spinal cord, baclofen suppresses mono- and polysynaptic reflexes. The drug does not affect the transmission of impulses in the neuromuscular synapses. In addition to its muscle relaxant properties, baclofen has an antinociceptive effect.
In patients with chronic spasticity associated with damage to the brain or spinal cord, baclofen reduces the intensity of muscle twitching, painful involuntary muscle spasms, reduces motor automatisms and clonic convulsions. As a result, patients' physical activity increases, their ability to self-care improves, and also facilitates rehabilitation therapy. When painful muscle spasms are weakened in patients, the range of active movements increases, which prevents the formation and accelerates healing of pressure ulcers, as well as improves patients' sleep. Also, in patients, normalization of the function of the bladder is noted, which in turn facilitates its catheterization and improves the quality of life of patients. Providing a general depressing effect on the central nervous system, baclofen can cause sedation, drowsiness and inhibit the functions of the respiratory and cardiovascular systems.
Intrathecal baclofen is an effective treatment for muscle spasticity, with doses at least 100 times lower than oral doses. Drug treatment can be considered as an alternative to destructive neurosurgical operations.
After a single intrathecal injection of the drug, the onset of its action is usually observed in 0.5-1 hours. The maximum antispastic effect develops after about 4 hours, and the duration of action is from 4 to 8 hours. The maximum severity and duration of action of baclofen in individual patients can vary significantly in depending on the dose, the severity of the symptoms, the method of administration and the rate of administration of the drug.
With long-term intrathecal infusion of baclofen, the onset of antispastic action is observed after 6-8 hours. The maximum effect develops within 24-48 hours.
The pharmacokinetic parameters of baclofen given below should be considered taking into account the route of administration (intrathecal) and slow circulation of cerebrospinal fluid (CSF) ...
Infusion of the drug directly into the subarachnoid space of the spinal cord excludes the absorption process as such and ensures the effect of the drug directly on the receptor zones of the posterior horns of the spinal cord.
Distribution. After a single intrathecal injection of the drug by bolus injection or short-term infusion, VSS, calculated from the determination of baclofen concentrations in the CSF at the lumbar level, is from 22 to 157 ml.
When carrying out a long-term continuous intrathecal infusion of the drug in a daily dose of 50 to 1200 μg, the equilibrium concentrations of baclofen in the CSF are from 130 to 1240 ng / ml. Taking into account the known duration of Т1/ 2 of baclofen in the CSF, its equilibrium concentration should be reached within 1–2 days. There is no such data for children.
During intrathecal infusion of baclofen, its plasma concentration does not exceed 5 ng / ml, which confirms the slow penetration of the drug through the BBB. In children, the corresponding plasma concentrations of the drug are ≤10 ng / ml.
After a single intrathecal administration of the drug by bolus injection or short-term infusion at a dose of 50 to 136 μg T1/2 of baclofen from CSF is 1 to 5 hours. The T1/2 of baclofen when its equilibrium concentrations in CSF are reached has not yet been established.
Both after a single injection and after prolonged subarachnoid infusion at the level of the lumbar spinal cord (carried out using an implantable pump), Cl of baclofen from CSF averages about 30 ml / h.
During continuous infusion of the drug, upon reaching an equilibrium state, the ratio of baclofen concentrations in CSF obtained by lumbar puncture and extracted from subarachnoid cisterns was 1.8: 1–8.7: 1 (on average 4: 1). This fact is of great clinical importance, since it confirms the possibility of effective treatment of spasticity, mainly of the lower extremities, with a simultaneous weakly pronounced effect on the muscle tone of the upper extremities and an insignificant number of adverse reactions from the central nervous system caused by the effect of the drug on the centers of the brain.
Indications of the drug Lioresal® Intrathecal
Severe chronic spasticity in spinal lesions (for example, due to trauma, in multiple sclerosis) or the brain in case of ineffectiveness or intolerance of therapy with muscle relaxants for oral administration.
Dosage and administration of the drug Lioresal
Intrathecal, for the introduction of single test doses (through a catheter located in the spinal canal, or by lumbar puncture) and long-term use with an implantable pump that provides continuous administration of this drug into the subarachnoid space.
The drug is intended for intrathecal administration only!
In case of spasticity caused by TBI, it is not recommended to resort to long-term intrathecal administration of the drug until the symptoms of spasticity stabilize (at least 1 year after injury).
Each ampoule of Lioresal® Intrathecal is intended for single use only. After a single use of the drug, the rest of the contents of the ampoule cannot be used.
The drug should not be used if the color changes and the appearance of undissolved visible particles.
The drug can be mixed only with 0.9% sodium chloride solution for injection, provided that the concentration of baclofen required by the patient is not 50 μg / ml, 500 μg / ml or 2000 μg / ml. The drug should not be mixed with any other solutions for infusion or injection.
Treatment with the drug in each patient should be carried out in several stages. In order to develop the optimal dosing regimen, before switching to maintenance therapy, a single intrathecal injection of the drug is mandatory (the initial phase of treatment), and then a careful selection of the dose. This is necessary due to the significant individual variability of the drug effect.
Intrathecal administration of the drug using implantable infusion systems should be carried out only by doctors with the necessary knowledge and experience. Specific instructions for programming and / or refilling the reservoir of an implantable pump (which must be strictly adhered to) are provided by the manufacturers of those systems. The clinical efficacy of Liorezal® Intrathecal was established when the drug was administered using the programmable infusion system SynchroMed, implanted under the skin.
Initial phase of treatment
Before administration of the drug, you should make sure that the patient has no infectious diseases, since the presence of an infectious disease may affect the assessment of the patient's response to a single bolus injection of Lioresal® Intrathecal.
Before starting a long intrathecal infusion of the drug, it is necessary to make sure that the patient has a response to a single administration of the drug (initial phase of treatment).
A positive result of intrathecal administration of the drug is a significant decrease in muscle tone and / or the frequency or severity of seizures. A test dose of the drug is usually given by lumbar puncture or using a catheter in the spinal canal.
The initial test dose in adults is usually 25 or 50 mcg. In children, the recommended starting test dose is 25 mcg. The test dose should be administered over a period of at least 1 min by bubbling (mixing with cerebrospinal fluid). A solution with a low concentration of the drug (0.05 mg / ml) is intended for dose testing. In the absence of a positive result, the test dose can be increased stepwise by 25 μg every 24 hours until the effect is achieved, which persists for about 4-8 hours.
In cases where a positive result is not observed with the introduction of a test dose of 100 μg, a further increase in the dose as well as continuous intrathecal administration should not be performed.
Before the introduction (especially the first) of the drug, it is necessary to prepare in advance the appropriate resuscitation equipment and drugs necessary for the relief of life-threatening conditions or severe side effects. The sensitivity to Liorezal® Intrathecal is very variable. There is one known case of coma in an adult patient after a single injection of a test dose of the drug, which was 25 μg.
Dose selection phase (adults and children over the age of 4 years)
After confirmation of the effect in response to the use of single test doses, intrathecal administration of the drug is carried out using an implantable system.
If the clinical effect of the test dose established in the initial phase of treatment lasted up to 12 hours, a double test dose should be used for administration using an implantable infusion system, which caused a positive effect. It is administered over 24 hours.
When the duration of the test dose effect (established in the initial phase of treatment) is more than 12 hours, the daily initial dose for administration over 24 hours using an implantable infusion system is equal to the effective test dose. In the first 24 hours after the start of prolonged intrathecal administration, the dose of baclofen should not be increased.
Spasticity due to spinal cord injury. In order to achieve the desired clinical effect, after the first 24 hours of treatment, a slow daily increase in the dose of the drug should be started. To avoid possible overdose, the dose should not be increased by more than 5-10% for children and 10-30% for adult patients.
Spasticity due to brain damage. In order to achieve the desired clinical effect, after the first 24 hours of treatment, a slow daily increase in the dose of the drug should be started. To avoid possible overdose, do not increase the dose by more than 5-15%.
When using programmable infusion pumps, the dose of the drug should be increased only 1 time during 24 hours. When using non-programmable infusion pumps equipped with a 76 cm catheter (through which 1 ml of the drug flows during the day), it is recommended that the time intervals necessary for assessing the effect be 48 hours. In cases where, with a significant increase in the daily dose of the drug, clinical the effect is not achieved, the correct functioning of the infusion pump and the patency of the catheter should be checked. Experience with drug doses exceeding 1000 mcg / day is limited. During the initial phase and the phase of selection of the dose of the drug, which follows immediately after the installation of the implant, the condition of the patients should be carefully monitored in a properly equipped facility and in the presence of trained personnel. Resuscitation equipment should be readily available in the event that life-threatening or severe side effects develop. To minimize the risk of postoperative complications, implantation of infusion pumps should only be performed in centers where there is relevant experience.
The clinical goal of this drug is to maintain muscle tone as close to normal as possible and to minimize the severity and frequency of spastic reactions without causing severe side effects. In the case of using the drug in patients with spasticity with brain damage, in addition, it is necessary to select such a dose of the drug that would provide the level of muscle tone desired for the optimal functioning of the patient. The smallest dose of the drug should be used, causing an adequate effect. To maintain optimal effect during long-term treatment in most patients, a gradual increase in the dose of the drug is required over time due to the gradually weakening of the drug effect or the progression of the disease.
Adults and children over 12 years of age
In patients with spasticity with spinal cord injury, to maintain an adequate effect, the daily dose can be gradually increased (by 10–30%) by changing the dosing rate of the infusion pump and / or the concentration of the drug in the reservoir. In the event of side effects, the daily dose may be reduced by 10–20%.
In patients with spasticity with brain damage, to maintain an adequate effect, the daily dose can be gradually increased (by 5–20%, but not more than 20%) by changing the dosing rate of the infusion pump and / or the concentration of the drug in the reservoir. In the event of side effects, the daily dose may be reduced by 10–20%.
A sudden need for a significant increase in the dose of the drug indicates problems with the catheter (for example, torsion or displacement) or a malfunction of the infusion pump. In patients with spasticity with spinal cord injury, the maintenance dose of the drug with long-term continuous administration is from 12 to 2003 μg / day, in most of them the adequate effect is maintained when using 300-800 μg / day.
In patients with spasticity with brain damage, the maintenance dose of the drug with prolonged continuous administration is from 22 to 1400 μg / day; the average daily dose for 12 months is 276 μg, and for 24 months - 307 μg.
<12 years of age Children <12 years of age usually require lower doses of the drug than older patients; the dose range is 24–1199 mcg / day, and the average daily dose is 274 mcg / day.
During long-term treatment, about 5% of patients develop refractoriness to increasing doses of the drug. There is no sufficient experience to give clear recommendations regarding therapy in the development of tolerance to the drug. Nevertheless, it is known that in this category of patients, interruptions in the use of the drug (gradual cessation of administration within 2–4 weeks) and the transition to another antispastic therapy are effective. Sensitivity to the drug Lioresal® Intrathecal can recover in a few days. In order to avoid overdose, drug treatment should be resumed with the use of the dose that was administered at the beginning of the continuous infusion, then the dose selection must be repeated. This method of eliminating tolerance should be used in a hospital setting. The need for regular clinical observation of patients to assess the required dose of the drug, the functioning of the infusion system, control for possible side effects or detect infections remains throughout the entire period of treatment.
Termination of treatment
Termination of treatment should always be carried out gradually, by successively reducing the dose of the drug. Exceptions are cases of sudden overdose or serious side effects when urgent drug withdrawal is required.
The sudden withdrawal of the drug Liorezal®, Intrathecal especially when applied dose exceeded the recommended average range, leads to a drastic deterioration of the patient's condition (occurrence of frequent, uncontrolled muscle spasms, increased rigidity to intolerable levels), which lasts for several days. There are reports of the development of confusion, hallucinations, psychotic, manic or paranoid states, seizures (status epilepticus), as well as a temporary increase in spasticity (the phenomenon of "rebound") and after a sudden withdrawal of therapy with oral baclofen (especially after a long period of its use).
Instructions for use of the infusion system
The ampoules of Lioresal® Intrathecal, containing 10 mg of baclofen in 5 ml and 10 mg of baclofen in 20 ml, are manufactured specifically for use with an infusion pump. The specific concentration of the drug that should be applied using the infusion pump depends on the required total daily dose, as well as on the infusion rate. For specific recommendations, it is necessary to read the instructions of the manufacturer of the infusion system.
Immediately after the installation of the infusion system, the drug is most often used in a continuous infusion regimen. Once stabilization is achieved and the patient is picked up the daily dose can be started more complex mode of administration Lioresal Drug,® Intrathecal allowing to provide optimal control of spasticity in individual intervals of day (if available model allows infusion pump). For example, those patients whose spasticity increases at night may need to increase the hourly infusion rate by 20%. Changes in the rate of infusion of the drug should be programmed to occur 2 hours before the onset of the desired clinical effect.
Stability of the drug
It was found that the stability of the drug Lioresal® Intrathecal in the SynchroMed implantable infusion system is maintained for 11 weeks.
Lioresal® Intrathecal can be mixed only with 0.9% sodium chloride solution for injection, provided that the required baclofen concentration for the patient is not 50 μg / ml, 500 μg / ml or 2000 μg / ml. The drug should not be mixed with any other solutions for infusion or injection.
Since baclofen enters into a chemical interaction with dextrose, Lioresal® Intrathecal should not be mixed with solutions containing dextrose.
Signs and symptoms of overdose should be paid special attention to constantly, especially during the initial phase and the phase of selection of the dose of the drug, as well as during the resumption of the drug after a break in treatment. Overdose manifestations can develop suddenly or gradually.
Symptoms: Excessive muscle hypotension, drowsiness, staggering, dizziness, seizure, blurred consciousness, hypothermia, excessive salivation, nausea and vomiting.
Significant overdose leads to respiratory depression, apnea and coma. A serious overdose may occur, for example, if the contents of the catheter accidentally leave the catheter while checking its patency or clarifying its position, other possible causes of an overdose may be errors in programming the infusion pump, an excessively rapid dose increase and the simultaneous use of baclofen inside. Potential malfunctions of the infusion pump should also be analyzed.
Treatment: there is no specific antidote. It is necessary to withdraw the remaining baclofen solution from the infusion pump as soon as possible. In patients with respiratory depression, if necessary, intubation should be performed (in this state, the patient should remain until the drug is completely removed). Some reports indicate that the reverse development of side effects from the central nervous system, especially drowsiness and respiratory depression, can cause physostigmine used in / in.
Caution should be exercised with intravenous administration of physostigmine, as this may be accompanied by the occurrence of seizures, bradycardia and intracardiac conduction disorders.
In adults, intravenous administration of physostigmine can be undertaken in a total dose of 1–2 mg for 5–10 minutes. During this period of time, careful monitoring of patients is necessary. If there is a positive effect, physostigmine can be reused at a dose of 1 mg at intervals of 30-60 minutes in order to maintain adequate respiration and consciousness of the patient.
In children, an attempt at intravenous administration of physostigmine at a dose of 0.02 mg / kg at a rate of no more than 0.5 mg / min is possible. Physostigmine at this dose can be reused until a beneficial effect is obtained or until a maximum dose of 2 mg is reached.
Physostigmine may not be effective if overdose is significant. In these cases, mechanical ventilation may be required as maintenance therapy.
At an early stage of an overdose, if a lumbar puncture is not contraindicated, consideration should be given to removing 30–40 ml of cerebrospinal fluid (in order to reduce the concentration of baclofen).
It is necessary to carry out therapy in order to maintain the functions of the cardiovascular system. If seizures develop, diazepam should be administered intravenously with caution.
Necessary medical support. The implantation of the infusion system should be carried out only after careful assessment of the patient's response to a single administration of the drug Liorezal® Intrathecal and / or selection of the dose. Since there is a risk of complications associated with the initial administration and selection of the dose of Lioresal® Intrathecal (general depressive effect on the central nervous system, vascular collapse and / or respiratory depression), these stages of drug use should be carried out under medical supervision, with the proper equipment and in accordance with the instructions set out in the section "Dosage and Administration". In case of a severe, life-threatening overdose of the drug, it is necessary to prepare the appropriate resuscitation equipment and medicines in advance. Adequate training of physicians in the conduct of continuous intrathecal fluid therapy is required.
Patient monitoring. After surgical implantation of the pump, the patient's condition should be carefully monitored until it is clear that his response to the drug is acceptable and reasonably stable. This is especially necessary during the initial phase of use of the infusion set and whenever the dosing rate and / or the concentration of baclofen in the pump reservoir changes.
The patient and doctors, as well as all persons involved in providing care to the patient, must be sure to receive full information about the possible dangers of this method of therapy. Everyone involved in treating and caring for a patient should be instructed about the signs and symptoms of drug overdose, the steps to take if it occurs, and the necessary home care for the infusion system and its implantation site.
Dose testing phase. During the use of the first test dose of Lioresal® Intrathecal (initial phase of treatment), especially in patients with heart disease, lungs, respiratory muscle weakness, as well as with the simultaneous use of benzodiazepine drugs or opiates (i.e., in the presence of an increased risk of respiratory depression ), it is necessary to carefully monitor the functions of the respiratory and cardiovascular systems.
Implantation of an infusion pump. Before implanting the infusion pump, make sure that the patient does not have any infectious diseases. they can increase the risk of surgical complications. In addition, the presence of an infectious process can make it difficult to select a dose of the drug.
Refill the reservoir of the infusion pump. Refilling of the reservoir of an infusion pump must be performed by appropriately experienced and qualified personnel and in accordance with the instructions provided by the manufacturer of the pump. In order to prevent complete emptying of the reservoir of the infusion pump (which can lead to a recurrence of severe spasticity), the intervals between its refills should be carefully calculated.
Additional precautions regarding dose selection. In order to avoid the development of excessive muscle weakness and the resulting falls in the patient, the drug should be used with caution in cases where maintaining a certain degree of spasticity is necessary to maintain an upright position and balance while walking, as well as in other situations when muscle spasticity is necessary to ensure optimal patient activity and his ability to take care of himself.
Maintaining muscle tone and allowing spasticity to increase intermittently can be important in maintaining peripheral circulation and possibly helping to prevent deep vein thrombosis. In order to avoid a possible overdose of the drug Lioresal® Intrathecal or the development of adverse drug interactions, it is advisable, under the close supervision of a physician, to attempt to stop the ingestion of simultaneously used antispastic drugs (preferably before starting intrathecal administration of the drug). During the period of continuous intrathecal infusion therapy of Lioresal® Intrathecal, a rapid dose reduction or sudden cancellation of concurrently used antispastic drugs should be avoided.
Influence on the ability to drive vehicles and work with mechanisms. It was reported that a number of patients treated with the drug developed drowsiness. Patients should be warned that during the period of treatment, care must be taken when driving and engaging in potentially hazardous activities that require increased attention.
Application during pregnancy and lactation
In experimental studies, when taking baclofen orally at doses approximately 13 times higher than the maximum oral dose (per mg / kg) recommended in clinical practice, an increase in the frequency of umbilical (ventral) hernias was noted. There have been no adequate and well-controlled studies in pregnant women. Baclofen crosses the placenta. Lioresal® Intrathecal should not be used during pregnancy, unless the expected positive effect of therapy for the mother outweighs the potential risk to the fetus.
In women taking oral baclofen in therapeutic doses, the drug passes into breast milk, but in an amount insufficient to anticipate the development of adverse reactions in children. It is not known whether baclofen is excreted in breast milk after intrathecal administration. During the period of use of the drug, breastfeeding should be discontinued.
Hypersensitivity to baclofen or any other components of the drug;
children's age ≤4 years (the effectiveness and safety of the drug in children under 4 years of age have not been established).
This drug should not be used IV, IM, SC or epidural!
- Children ≤18 years of age - Sufficient body weight is a prerequisite for installing an implantable infusion system in children (see “Instructions for use of an implantable infusion system”). Clinical data on the use of the drug in children under 6 years of age are limited;
- patients aged ≥65 years - in the course of clinical studies when using the drug Lioresal® Intrathecal in patients aged ≥65 years, the tolerance of the drug was similar to that in patients of young age. In patients aged ≥65 years, receiving oral baclofen, in some cases, there was an increase in the frequency of adverse events (AEs), especially during the dose selection period. When using the drug in this category of patients, the possibility of an increased risk of developing AE cannot be excluded. However, with an individual selection of the dose of the drug, an increase in the frequency of AEs in elderly patients is unlikely;
- impaired circulation of cerebrospinal fluid (CSF) - the antispastic activity of the drug may differ from that in patients with normal CSF circulation, due to the uneven distribution of baclofen in the subarachnoid space;
- mental disorders, incl. schizophrenia, confusion and Parkinson's disease; there are cases of exacerbation of these diseases (conditions) when using baclofen orally (careful observation of patients is necessary);
- epilepsy - since there are known cases of the development of seizures with an overdose of the drug, as well as during maintenance therapy and after its termination;
- a history of autonomic dysfunction (dysreflexia) - the occurrence of a paroxysm of autonomic dysfunction can be triggered by a pain stimulus or a sudden cessation of drug administration;
- cerebrovascular or respiratory failure - because baclofen can worsen the course of these conditions;
- ulcerative lesions of the gastrointestinal tract (including in history), hypertonicity of the sphincters, impaired renal function - a worsening of the course of concomitant diseases not associated with pathology of the central nervous system is unlikely against the background of drug therapy, because with intrathecal administration, the systemic effect of baclofen is much less pronounced compared with its intake. However, care should be taken when prescribing the drug;
When using the drug in patients with spinal or brain damage, the assessment of adverse events (AE) is difficult due to a number of symptoms associated with the disease itself. Nevertheless, it is likely that some of the most common adverse events (drowsiness / somnolence, dizziness, headache, nausea, hypotension, muscle hypotonia), due to the use of Lioresal.® Intrathecal
Some of the AEs listed below have been identified in patients with spasticity from spinal cord injury, but may also occur in patients with spasticity from brain injury. The following are the most common AEs, regardless of the nature of the disease.
The incidence of adverse reactions is estimated as follows: very often (≥1 / 10); often (≥1 / 100, <1/10); sometimes (≥1 / 1000, <1/100); rarely (≥1 / 10000, <1/1000); very rare (<1/10000), including isolated messages.
From the side of the central nervous system: very often - drowsiness; often - sedation, dizziness / staggering, convulsions, headache, paresthesia, accommodation disturbances / blurred vision / double vision, dysarthria, lethargy, asthenia, respiratory depression, insomnia, confusion / disorientation, anxiety / agitation, depression; sometimes - hypothermia, nystagmus, dysphagia, ataxia, memory impairment, suicidal thoughts and attempts, euphoria, dysphoria, hallucinations, paranoid reactions. Seizures and headache are more common in patients with spasticity of cerebral origin than in patients with spasticity of spinal cord origin.
From the side of the cardiovascular system: often - arterial hypotension; sometimes - arterial hypertension, bradycardia, deep vein thrombosis, redness or blanching of the skin (of various localization).
From the respiratory system: often - shortness of breath, bradypnea, pneumonia.
On the part of the digestive system: often - nausea / vomiting, constipation, dry mouth, diarrhea, decreased appetite, increased salivation; sometimes - dehydration, intestinal obstruction, taste disturbances. Nausea and vomiting are more common in patients with cerebral spasticity than in patients with spasticity of spinal cord origin.
Dermatological reactions: often - urticaria / itching, facial edema / peripheral edema; sometimes - alopecia, profuse sweating.
From the genitourinary system: often - urinary incontinence, urinary retention, various violations of sexual function. Urinary retention is more common in patients with spasticity of cerebral origin than in patients with spasticity of spinal cord origin.
On the part of the musculoskeletal system: very often - muscle hypotension; often - increased muscle tone.
Others: often - pain, fever / chills.
This list does not include AEs associated with the infusion set (eg catheter displacement, implantation site infection, meningitis, overdose due to device mishandling).
When taking baclofen orally, rare cases of increased AST and ALP activity in the blood plasma and hyperglycemia have been reported.