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Myofascial pain syndrome (MPS) is difficult to treat. The efficacy and safety of tizanidine, an alpha2-adrenergic agent with effects on spasticity and pain, in treating MPS was evaluated. Female subjects (n = 29) with MPS of 9 to > 52 weeks' duration and mean age 37.5 (range 20-51) years, who also had reduced pressure thresholds, were enrolled. Subjects were titrated up to 12 mg of tizanidine over 3 weeks and maintained for 2 weeks. Sleep was assessed via visual analog scale (VAS), pain intensity via short form McGill questionnaire including VAS, disability/level of function, and pressure threshold (tested by algometry) at baseline, weeks 3 and 5, and 1 week after tizanidine was discontinued. Patient and physician global assessments of treatment were reported at week 5. Twenty-four subjects completed the study. Pain intensity and disability decreased significantly from baseline at weeks 3 and 5 and after washout (P < .001). Pressure threshold and sleep improved for all study periods (P < .001). Tizanidine was rated as good to excellent in relieving pain by 89% of subjects and 79% of physicians. No serious adverse events occurred. Tizanidine was effective in the treatment of MPS.
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Clonidine is an effective spinal analgesic, but it is dose-limited by cardiovascular side effects. We compared the analgesic properties and side effects of clonidine with those of a similar drug, tizanidine. Continuous spinal infusion of tizanidine produced similar analgesia as clonidine, but with fewer adverse effects on blood pressure and heart rate.
In a double-blind, randomized, 2-phase crossover study, 10 healthy volunteers ingested 500 mg ciprofloxacin or placebo twice daily for 3 days. On day 3, a single dose of 4 mg tizanidine was ingested 1 hour after the morning dose of ciprofloxacin. Plasma concentrations of tizanidine and ciprofloxacin and pharmacodynamic variables were measured. A caffeine test was used as a marker for CYP1A2 activity.
All parallel and crossover RCTs including spinal cord injury patients complaining of "severe spasticity". Studies where less than 50% of patients had a spinal cord injury were excluded.
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All three groups had a reduction in pain symptoms and improvement of sleep quality based on a comparison of pretreatment and treatment scores. However, no significant differences among the groups were observed at the posttreatment evaluation.
Spontaneous hemopericardium is a complication of anticoagulant therapy with not only vitamin-K-antagonists, but also with nonvitamin-K-antagonist oral anticoagulants. We report a polymorbid 75-year old male under a therapy with dabigatran, valsartan, amlodipine, nicorandil, furosemide, atorvastatin, bisoprolol, metformin, tizanidine, pantoprazole, and tramadol. He suffered from chest pain for 4 months. Coronary angiography showed only ectatic coronary arteries. He started taking nonsteroidal anti-inflammatory drugs. He was hospitalized because of dyspnea starting 10 days before admission, melena, and renal failure. Hemopericardium was diagnosed and pericardiocentesis yielded 2000 ml hemorrhagic fluid. Review of previous echocardiograms showed a 4 mm echo-free space, epicardial fat or pericardial effusion. A small (<10 mm) echo-free space in a patient on anticoagulant therapy should not be considered as trivial, but additional imaging studies should be carried out. If a pericardial effusion is newly diagnosed in a patient during anticoagulant therapy, the pharmacotherapy should be revised concerning potentially interacting drugs, like nonsteroidal anti-inflammatory drugs, and dosage of the anticoagulant drug. Vitamin-K-antagonists with their possibility of laboratory monitoring and availability of an antidote should be preferred over nonvitamin-K-antagonist oral anticoagulants.
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Post hoc analysis of an enriched-design clinical trial of THC:CBD oromucosal spray versus placebo, using records of patients under previous and current ineffective antispasticity therapies. Subgroups were patients with at least 1 failed therapy attempt with either baclofen or tizanidine (Group 1) or at least 2 failed therapy attempts with both baclofen and tizanidine (Group 2).
Infarction volumes and infarction ratios of the Tizanidine group 1/2 hours before ischemia (143.7+/-6.34 mm3 and 10.1+/-0.43%) and the Tizanidine group 2 hours after ischemia (145.6+/-6.32 mm3 and 10.3+/-0.43%) were found to be significantly lower in favor of the Tizanidine groups when compared with those of the control group (173.9+/-6.38 mm3 and 12,4+/-0.41%). Tizanidine is not effective if used just after reperfusion or later.
The diagnosis of SPG7 is suspected in individuals with characteristic neurologic findings and is confirmed by detection of pathogenic variants in SPG7, the gene encoding the protein paraplegin. SPG7 is the only gene in which pathogenic variants are known to cause SPG7.
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In the studied real-life setting, we found a considerable number of MQAB users with additional risk factors for TdP but no ECG monitoring. However, adverse drug reactions were rarely found, and costs vs. benefits of ECG monitoring have to be weighted. In contrast, avoidable risk factors and selected contraindicated pharmacokinetic interactions are clear targets for implementation as automated alerts in electronic prescribing systems.
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There is a large body of evidence for the effective use of tizanidine monotherapy in the management of spasticity. A case study demonstrates that combination therapy can effectively control spasticity while better managing dose-dependent adverse events, although additional studies need to be performed to confirm these results.
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A double-blind trial with two parallel groups was carried out to compare the antispastic effect and tolerability of a new muscle relaxant, tizanidine (DS 103-282), with those of baclofen in the treatment of spasticity due to multiple sclerosis. Twenty-one hospitalized patients with stable spasticity participated in the 6-week trial. Eleven received tizanidine and 10 baclofen in gradually increasing daily doses. The optimal daily dose of tizanidine was between 8 and 36 mg and that of baclofen between 10 and 80 mg. Overall spastic state, spasms and clonus were similarly improved with both medications. In contrast, muscle strength, bladder function and the activities of daily living were more improved on tizanidine than on baclofen. Tiredness was the most frequent side-effect on tizanidine and muscle weakness on baclofen. The laboratory tests did not show any pathological changes with either medication. According to these results, tizanidine provides a new therapeutic alternative in the treatment of spasticity.
Male Sprague Dawley rats were chronically implanted with lumbar intrathecal catheters. The tail-flick test was used to assess the thermal nociceptive threshold. The ability of intrathecal tizanidine, clonidine, lidocaine, or the combinations of alpha2-adrenergic agonist and lidocaine to alter the tail-flick latency was examined. To characterize the antinociceptive interaction, the isobolographic analysis was applied. Additionally, the motor function, blood pressure and heart rate after intrathecal administration of drugs and combinations were also monitored.
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Muscle tone often exists concomitantly with pain symptoms in different neurological and orthopaedic disease entities. In order to overcome that painful symptom, it is crucial to integrate painkillers with adjunctive therapy using muscle relaxants which decrease the muscle tone. Muscle relaxants available in pharmaceutical trade suppress motor outflow through different mechanisms of action, these include drugs such as: Tizanidine, botulinum toxin, Baclofen, Tolperisone, Methocarbamol. Combining muscle relaxants with analgesics significantly improves the effectiveness of the treatment and allows to reduce drugs doses.
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The effects of tizanidine, a new muscle relaxant, 5-chloro-4-(2-imidazolin-2-yl-amino)-2,1,3-benzothiazole (DS 103-282) were studied on the activity of lumbar dorsal horn convergent neurons in anaesthetized paralysed rats. Following i.v. administration of tizanidine both the A- and C-fibre evoked responses were depressed in a dose-dependent manner in the 0.125-1.0 mg/kg range. The smaller dose employed (0.125 mg/kg) induced a significant depression of the C-fibre evoked responses (39.6 +/- 13.4% of the control responses) and a total recovery was observed 10 min after the injection: when the doses were increased, stronger and longer-lasting depressant effects were obtained. Identical but less powerful effects were observed on A-fibre responses. None of the depressive effects was correlated with variations in blood pressure. Microelectrophoretically applied tizanidine was found to depress current-dependently, the discharges of convergent neurones evoked by microelectrophoretically applied DL-homocysteic acid. In contrast, tizanidine (0.5, 1 mg/kg; i.v.) was found to be ineffective against the activities of non-nociceptive neurones triggered by mechanical stimulation of their receptive fields. It is concluded that tizanidine depresses specifically the activities of dorsal horn convergent neurones, probably in part by a post-synaptic inhibitory action. Owing to the role of convergent neurones in pain processes, the present result could explain, at least partially, the analgesic action of this compound.
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Systemic pharmacologic treatments may be indicated in conditions in which the distribution of muscle overactivity is diffuse. Antispastic drugs act in the CNS either by suppression of excitation (glutamate) enhancement of inhibition (GABA, glycine), or a combination of the two. Only four drugs are currently approved by the US FDA as antispactic agents: baclofen, diazepam, dantrolene sodium, and tizanidine. However, there are a number of other drugs available with proven antispastic action. This chapter reviews the pharmacology, physiology of action, dosage, and results from controlled clinical trials on side effects, efficacy, and indications for 21 drugs in several categories. Categories reviewed include agents acting through the GABAergic system (baclofen, benzodiazepines, piracetam, progabide); drugs affecting ion flux (dantrolene sodium, lamotrigine, riluzole; drugs acting on monoamines (tizanidine, clonidine, thymoxamine, beta blockers, and cyproheptadine); drugs acting on excitatory amino acids (orphenadrine citrate); cannabinoids; inhibitory neuromediators; and other miscellaneous agents. The technique, advantages and limitations of intrathecal administration of baclofen, morphine, and midazolam are reviewed. Two consistent limitations appear throughout the controlled studies reviewed: the lack of quantitative and sensitive functional assessment and the lack of comparative trials between different agents. In the majority of trials in which meaningful functional assessment was included, the study drug failed to improve function, even though the antispastic action was significant. Placebo-controlled trials of virtually all major centrally acting antispastic agents have shown that sedation, reduction of global performance, and muscle weakness are frequent side effects. It appears preferable to use centrally acting drugs such as baclofen, tizanidine, and diazepam in spasticity of spinal origin (spinal cord injury and multiple sclerosis), whereas dantrolene sodium, due to its primarily peripheral mechanism of action, may be preferable in spasticity of cerebral origin (stroke and traumatic brain injury) where sensitivity to sedating effects is generally higher. Intrathecal administration of antispastic drugs has been used mainly in cases of muscle overactivity occurring primarily in the lower limbs in nonambulatory, severely disabled patients but new indications may emerge in spasticity of cerebral origin. Intrathecal therapy is an invasive procedure involving long-term implantation of a foreign device, and the potential disadvantages must be weighed against the level of disability in each patient and the resistance to other forms of antispastic therapy. In all forms of treatment of muscle overactivity, one must distinguish between two different goals of therapy: improvement of active function and improvement of hygiene and comfort. The risk of global performance reduction associated with general or regional administration of antispastic drugs may be more acceptable when the primary goal of therapy is hygiene and comfort than when active function is a priority.
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The objective was to systematically review the efficacy and tolerability of non-antiepileptic drugs for trigeminal neuralgia.
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[This corrects the article DOI: 10.1155/2015/902914.].
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Methodological quality of studies (allocation concealment, blinding, patients characteristics, inclusion and exclusion criteria; interventions; outcomes; lost to follow up) was independently assessed by two investigators. The heterogeneity among studies did not allow quantitative combination of results.
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Tizanidine was evaluated in a prospective, double-blind, randomized, placebo-controlled trial in 187 patients with MS. Taken orally for 9 weeks and preceded by a titration phase for a period of 3 weeks starting at 2 mg daily, tizanidine produced a significant reduction in spastic muscle tone compared with placebo treatment. Within the effective dose range of 24 to 36 mg given daily in three doses, tizanidine achieved a 20% mean reduction in muscle tone. Approximately 75% of patients, with all degrees of spasticity, reported subjective improvement without an increase in muscle weakness, but there was no improvement in activities of daily living depending on movement. Tizanidine achieved its maximum effect on spasticity within 1 week of the start of treatment; the benefit was maintained for at least 1 week after discontinuation of therapy. A variety of adverse events was recorded by patients taking tizanidine, but these were minor and reversible, and rarely limited treatment. Tizanidine is a well-tolerated and effective drug for symptomatic treatment of spasticity.
We assigned randomly in a double blind study 10 children treated with tizanidine (0.05 mg/kg/day) and 30 with placebo for a 6-month period, after which they were unified in the group of tizanidine. The dependent variables were spasticity, Ashworth scale, posture tone scale, reflex scale and liver function test.
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Based upon the currently available evidence in patients with RA, benzodiazepines (diazepam and triazolam) do not appear to be beneficial in improving pain over 24 hours or one week. The non-benzodiazepine agent zopiclone also did not significantly reduce pain over two weeks. However, even short term muscle relaxant use (24 hours to 2 weeks) is associated with significant adverse events, predominantly drowsiness and dizziness.
We searched the Cochrane Central Register of Controlled Trials (Issue 7, 2013), MEDLINE (1946 to July week 4, 2013), EMBASE (January 1985 to August week 1, 2013), PsycINFO (1806 to July week 5, 2013) and reference lists of articles. We also contacted manufacturers in the field.
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Reduction in intention myoclonus and change in score on the FIM instrument.
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Intrathecal (IT) administration of opiate analgesics has become a popular method of pain control in patients with pain of both malignant and nonmalignant origin. Therapeutic efficacy for nonmalignant pain states might be improved by having a broader range of available pharmacologic agents for intrathecal administration. Toward this aim, we have applied a new model of neuropathic pain in the rat to evaluate the relative analgesic efficacy and potential cross tolerance of both acutely and chronically administered IT morphine (MS) and tizanidine (TZ), an alpha 2-adrenergic agonist. Under anesthesia, 225 Sprague-Dawley male rats underwent unilateral multiple partial suture ligation of the sciatic nerve. This produces a syndrome similar to human neuropathic pain. Chronic lumbar IT cannulae were placed via the cisterna magna. Seven days after surgery, animals were tested for spontaneous ambulation and paw pinch tolerance. These tests correlate with human clinical observations of chronic pain and hyperpathia. For the acute drug administration, animals were then given saline, 10, 20, or 30 micrograms IT MS or 10, 25 or 50 micrograms IT TZ and testing was repeated. Preliminary results suggest that MS, in a dose-dependent manner, significantly decreased abnormal limb withdrawal from the floor while ambulating and increased paw pinch withdrawal latency to cutoff values (p < or = 0.01 in all tests). IT MS had significant effects on pain sensation in the operated and unoperated limbs, increasing latencies to cutoff and nonspecifically inhibiting pain transmission. IT TZ had a similar effect on decreasing limb withdrawal from the floor, but paw pinch withdrawal latency was increased only to the normal range, not to cutoff values. These effects were also dose-dependent. For chronic drug administration, after baseline testing, osmotic minipumps (Alza, Palo Alto, Calif.) delivering either saline, 60 or 120 micrograms/day MS, or 75 or 150 micrograms/day TZ were attached to the IT catheter. Testing was done on days 1, 4, 7 and 14 after pump attachment. On day 14, the animals were given an IT bolus of the noninfused drug (50 micrograms tizanidine or 30 micrograms morphine) and the tests were repeated to determine degree of cross tolerance. Initially, chronic MS and TZ administration produced a similar degree of analgesia seen with results obtained with acute administration. The animals rapidly became tolerant to these agents so that by day 4, neither drug had an analgesic effect. No significant cross tolerance between MS and TZ was observed. Thus, both IT MS and TZ are analgesic in experimental chronic neuropathic pain.(ABSTRACT TRUNCATED AT 400 WORDS)
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The usual causes of sinusbradycardia like hypothyroidism, hypothermia, intracranial pressure elevation, typhoid fever, sick sinus syndrome, hyperreactive carotid sinus reflex, organic heart disease, electrolyte disorders, and pharmacotherapy with beta-blockers, digitalis, and antiarrhythmics have been excluded in this case. Bradycardia can occur as a side effect of tizanidine. As this substance is metabolized by cytochrome P450 1A2 and rofecoxib inhibits this enzyme, an interaction between these drugs is probable. Liver function disorders and gastrointestinal symptoms, in the present case mainly due to the acute right heart failure, have also been described as side effects under tizanidine, diclofenac as well as rofecoxib. Supposedly, the combination of tizanidine/rofecoxib used to be prescribed frequently for lumbar pain as selective cyclooxygenase-(COX-)2 inhibitors are visibly replacing the nonsteroidal antirheumatics due to their better side effect profile. An augmented risk of cardiovascular events under rofecoxib led to its withdrawal from the market at the end of September 2004.
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Tizanidine HCl is a centrally acting α-2 adrenergic agonist muscle relaxant with a slightly bitter taste having short half-life of 2.5 h. In the present study effect of co-processed excipient bases in formulation of orodispersible tizanidine HCl tablets by direct compression method was investigated. Co-processed excipient of microcrystalline cellulose with SSL-hydroxypropylcellulose was prepared using spray drier in 1:1, 1:2 and 1:3 ratio. Formulated tablets were evaluated for hardness, friability, in vitro disintegration time and in vitro drug release. Formulation F-3 prepared by addition of co-processed excipient base in ratio of 1:3 showed minimum disintegration time of 9.15±0.04 s and higher amount of drug release of 93.75% at the end of 15 min. Granules obtained by spray drying technique were found to be more spherical which improved its flow property and was supported by scanning electron microscope studies. Thermal studies indicated change in amorphous state, compatibility of drug in formulation was confirmed by fourier transform infrared studies. Analyses of drug release data indicated formulation followed first order kinetics. Inclusion of co-processed excipient base in formulation of orodispersible tablets enhanced disintegration significantly.
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Participants with an incomplete SCI were assigned to 3 groups: no intervention, Lokomat, or tizanidine. Outcome measures were the 10-m walk test, 6-minute walk test, and the Timed Up and Go. Participants were classified in 2 ways: (1) based on achieving an improvement above the minimally important difference (MID) and (2) using growth mixture modeling (GMM). Functional levels of participants who achieved the MID were compared and random coefficient regression (RCR) was used to assess recovery in GMM classes.
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Nine trials of different non-antiepileptic drugs involving 223 participants were included. Each trial investigated one non-antiepileptic drug. Two trials tested baclofen. In one, more people gained 50% reduction from baseline than with placebo (relative risk 15.00, 95% CI 0.97 to 231.84, P value = 0.05). In the other, slightly more participants on baclofen had a 75% reduction in attacks on the 10th day compared with carbamazepine (relative risk 2.38, 95% CI 0.83 to 6.85, P value = 0.11). One trial showed no significant difference in reduction in average daily frequency of attacks with L-Baclofen compared with racemic baclofen. Tizanidine was investigated in two trials. In one, the proportion of people with reduction in the average number of paroxysms per day increased with tizanidine compared with placebo (relative risk 8.00, 95% CI 1.21 to 52.69, P value = 0.03). In the other, one of five participants improved in visual analog scale score with tizanidine and four of six with carbamazepine (relative risk 0.30, 95% CI 0.05 to 1.89, P value = 0.20). One study showed that the improvement in mean values of pain scores with tocainide was similar to that of carbamazepine. In one study more participants improved during the pimozide than the carbamazepine period (relative risk 1.78, 95% CI 1.39 to 2.28). In one study, proparacaine hydrochloride 0.5% instillation into the eyes was not significantly different from placebo (relative risk 1.06, 95% CI 0.37 to 2.99, P value = 0.92). In another, there was moderate or marked improvement in seven of nine participants treated with clomipramine and three of nine with amitriptyline after a 12-week treatment (RR 2.33, 95% CI 0.87 to 6.27).
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Trigeminal neuralgia is a syndrome of chronic pain, characterized by paroxysms of excruciating pain which dramatically affect patients' quality of life. Systemic drug therapy is the first line treatment for this disease. This study aimed at evaluating efficacy, safety and tolerability of several pharmacologic treatments offered to trigeminal neuralgia patients, trying to supply evidences for clinical practice recommendations and to identify the needs for further research.
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Tizanidine and aceclofenac individually have shown efficacy in the treatment of low back pain. The efficacy and tolerability of the combination have not yet been established. The objective of the study was to evaluate the efficacy and safety of aceclofenac-tizanidine fixed dose combination against aceclofenac alone in patients with acute low back pain. This double-blind, double-dummy, randomized, comparative, multicentric, parallel group study enrolled 197 patients of either sex in the age range of 18-70 years with acute low back pain. The patients were randomized to receive either aceclofenac (100 mg)-tizanidine (2 mg) b.i.d or aceclofenac (100 mg) alone b.i.d for 7 days. The primary efficacy outcomes were pain intensity (on movement, at rest and at night; on VAS scale) and pain relief (on a 5-point verbal rating scale). The secondary efficacy outcomes measures included functional impairment (modified Schober's test and lateral body bending test) and patient's and investigator's global efficacy assessment. aceclofenac-tizanidine was significantly superior to aceclofenac for pain intensity (on movement, at rest and at night; P < 0.05) and pain relief (P = 0.00) on days 3 and 7. There was significant increase in spinal flexion in both the groups from baseline on days 3 and 7 with significant difference in favour of the combination group (P < 0.05). There were significantly more number of patients with excellent to good response for the aceclofenac-tizanidine treatment as compared to aceclofenac alone (P = 0.00). Both the treatments were well tolerated. In this study, aceclofenac-tizanidine combination was more effective than aceclofenac alone and had a favourable safety profile in the treatment of acute low back pain.