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Randomised controlled trials (RCTs) of anti-spasticity agents were identified using MEDLINE, EMBASE, bibliographies of relevant articles, personal communication, manual searches of relevant journals and information from drug companies.
Breast-feeding has important health and emotional benefits for both mother and infant, and should be encouraged. While there are some data to suggest migraine may improve during breast-feeding, more than half of women experience migraine recurrence with 1 month of delivery. Thus, a thorough knowledge base of the safety and recommended use of common acute and preventive migraine drugs during breast-feeding is vital to clinicians treating migraine sufferers. Choice of treatment should take into account the balance of benefit and risk of medication. For some of the medications commonly used during breast-feeding, there is not good evidence about benefits.
Carbamazepine is still the drug of choice for treating trigeminal neuralgia, being lamotrigine and pimozide indicated for cases refractory to conventional therapy. In addition, further studies are needed to determine future therapeutic options.
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To examine the efficacy and tolerability of tizanidine for the treatment of dysfunctional voiding in children compared with those of doxazosin.
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Tizanidine was shown to be superior to placebo in reducing the overall headache index (P =.0025), as well as mean headache days per week (P =.0193), severe headache days per week (P =.0211), average headache intensity (P =.0108), peak headache intensity (P =.0020), and mean headache duration (P =.0127). The mean percentage improvement during the last 4 weeks of treatment with tizanidine versus placebo was 54% versus 19% for the headache index (P =.0144), 55% versus 21% for severe headache days (P =.0331), 35% versus 19% for headache duration (P =.0142), 35% versus 20% for peak headache intensity (P =.0106), 33% versus 20% for average headache intensity (P =.0281), and 30% versus 22% for total headache days (P =.0593). Patients receiving tizanidine also scored higher ratings of overall headache improvement on a visual analog scale (P =.0069). There was no statistically significant difference in outcome for patients with chronic migraine versus those with only migrainous or tension-type headache. Adverse effects reported by more than 10% of the patients included somnolence (47%), dizziness (24%), dry mouth (23%), and asthenia (19%). Dropouts due to adverse events did not differ significantly between tizanidine and placebo.
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To investigate the effects of intrathecal ouabain and tizanidine injection for treatment of neuropathic pain in rats.
Muscle tone disorders, including poststroke spasticity, is a frequent cause of disability. We studied the efficacy and safety of tizalud (tizanidine) in patients with arm poststroke spasticity.
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Nowadays, based on several epidemiological data, iatrogenic disease is an emerging public health problem, especially in industrialized countries. Adverse drugs reactions (ADRs) are extremely common and, therefore, clinically, socially, and economically worthy of attention. Spontaneous reporting system for suspected ADRs represents the cornerstone of the pharmacovigilance, because it allows rapid detection of potential alarm signals related to drugs use. However, spontaneous reporting system shows several limitations, which are mainly related to under-reporting. In this paper, we describe two particular case reports, which emphasize some reasons of under-reporting and other common criticisms of spontaneous reporting systems.
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Tizanidine, one of the few oral antispastic therapies approved for use in the USA, has a narrow therapeutic index that can often make optimal patient dosing difficult. We surveyed the published literature for data on potential tizanidine dose relationships to pharmacokinetics, drug safety and effectiveness, as well as to provide practical drug dosing advice.
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Chronic migraine is an important public health problem. The aim of treatment should be to reduce migraine frequency and its negative impact on functioning, as well as to limit the use of acute medications. These goals may be accomplished by introducing effective prophylaxis. The aim of the present article is to critically review the published evidence on the pharmacological prophylaxis of chronic migraine, analysing published double-blind, placebo-controlled studies on adult patients. The results of the review indicate that tizanidine, gabapentin, valproic acid, and particularly topiramate are effective prophylactics against chronic migraine, with improvements in several endpoints that were significantly superior to those achieved by placebo. However, the different results found by different trials, as well as several methodological problems inherent in the trials, suggest the need for further research to provide clear indications from large, multicentre, controlled trials with homogeneous inclusion criteria and adequate endpoints.
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At three months the scores of the placebo and baclofen group differed slightly for the spasm score (effect size=0.20) and substantially for the Ashworth scale (effect size=1.40) and pain score (effect size=0.94); health related quality of life showed no significant differences. Three months after implantation the baclofen group showed a significant, substantial improvement on the SIP "physical health", "mental health", "mobility", and "sleep and rest" subscales and on the HSCL mental health scale; patients receiving placebo showed no change. After one year of baclofen treatment significant (P<0.05) improvement was found on the SIP dimensions "mobility" and "body care and movement" with moderate effect sizes. Improvement on the SIP subscale "physical health" (P<0.05; effect size 0.86), the SIP overall score (without "ambulation"), and the "physical health" and overall scale of the HSCL was also significant, with effect sizes >0.80. Changes in health related behaviour were noted for "sleep and rest" and "recreation and pastimes" (P<0.01, P<0.05; effect size 0.95 and 0.63, respectively). Psychosocial behaviour showed no improvement.
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This pilot study compared the metabolic effects of placebo and 6 mg and 12 mg of oral tizanidine in random double-blind cross-over fashion in five healthy volunteers. The metabolic measurements were made with a portable metabolic chart (Deltatrac, Datex/Instrumentarium, Helsinki, Finland). Heart rate (HR), systolic (BPS), mean (BPM) and diastolic (BPD) blood pressure were measured noninvasively. Subjective assessment of tiredness and dryness of mouth were measured by using visual analogue scales (VAS). There were no statistically significant differences in tiredness or dryness of mouth between the groups. BPD decreased significantly after both doses of tizanidine when compared to placebo (by an average of 12% after 6 mg of tizanidine and 15% after 12 mg of tizanidine from the baseline). Oxygen consumption and energy expenditure decreased significantly after 6 and 12 mg of tizanidine when compared to placebo. The average decrease in oxygen consumption was 3% after 6 mg of tizanidine and 8% after 12 mg of tizanidine, when compared to the baseline. Energy expenditure decreased by an average of 5% after 6 mg of tizanidine and 9% after 12 mg of tizanidine, when compared to the baseline. There were no other statistically significant differences between the groups. This study indicates that 6 and 12 mg of oral tizanidine can be useful for reducing energy expenditure and oxygen consumption without prominent cardiovascular effects.
Analgesic activity of brimonidine, clonidine, and tizanidine was investigated in wild-type C57B/6, alpha-2A, and alpha-2C knockout mice with allodynia induced by N-methyl-D-aspartate or sulprostone. The alpha receptor selectivity of the alpha agonists was assessed using functional in vitro recombinant assays.
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This was a 6-month prospective study where a pharmacy benefit manager distributed evidence-based summaries of 18 different PDDIs that included references and suggested management strategies. Fax alerts were individualized letters sent to the prescriber of the second drug of a PDDI pair for an individual patient. A 16-item questionnaire to assess prescribers' perceptions of the intervention accompanied each individualized PDDI evidence-based summary.
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Reduced stretch reflex activity was observed after the administration of either tizanidine or baclofen. We observed that tizanidine had a stronger inhibitory effect on knee extensors and plantar flexors whereas baclofen had a stronger inhibitory effect on the knee flexors. The effects of these drugs on strength during isometric and isokinetic tasks varied across participants, without a consistent reduction in torque output despite decreased electromyographic activity.
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Multiple sclerosis spasticity (MSS) is a common and disabling symptom for which a number of antispastic agents are available; however, evidence-based guidelines for optimal management are lacking.
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A total of 8,075 fax alerts were distributed with 977 returning questionnaires, yielding a 12.1% response rate. There were 848 (86.8%) responses completed by physicians, and 71 (7.3%) completed by nurse practitioners. The most common PDDI fax alerts sent were for warfarin-statin (3,511, 43.5%) and warfarin-thyroid (2,111, 26.1%) interactions. 42.6% of respondents agreed or strongly agreed that fax alerts were a good way to communicate with them. However, 37.5% of respondents either agreed or strongly agreed that the fax alert was a "waste of my time." In contrast, respondents thought notification of carbamazepine-macrolide (mean 1.5 ± 0.71), ciprofloxacin-tizanidine (mean 2.3 ± 1.0), and statin-macrolide (mean 2.3 ± 1.1) was not a waste of time. Also, 59.1% of respondents either disagreed or strongly disagreed that they would prefer to receive a telephone call when interactions like this occur. Half (50.5%) of the respondents indicated their computer systems provided drug interaction alerts. Prescribers who had previously received alerts and specialists were less likely to respond to the questionnaire (OR = 0.685, P ≤ 0.0001 and OR = 0.851, P = 0.0205, respectively).
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Randomized controlled clinical trials on the analgesic effects of drugs prescribed for trigeminal neuralgia were evaluated. All of them were published until July 2003. Statistical analysis was accomplished with the support of Review Manager 4.2.2 software (Cochrane Collaboration, 2003).
The effects of intravenous clonidine and tizanidine on nociceptive neurons in the nucleus ventralis posterolateralis (VPL) of the thalamus, a key station in the lateral system of ascending pain pathways, were evaluated in urethane-chloralose anesthetized cats. Intravenous clonidine and tizanidine produced a dose-dependent (5 and 10 micrograms/kg, and 25 and 50 micrograms/kg, respectively) suppression of responses of nociceptive specific (NS) and wide dynamic range (WDR) neurons in the VPL to high threshold splanchnic input. In contrast, the responses of both NS and WDR units to electrical stimulation of spinothalamic tract fibers in the ventrolateral funiculus (VLF) were little affected. We conclude that a site of suppressive action of the alpha 2-adrenoceptor agonists, as observed in nociceptive VPL neurons, is at the level of the spinal dorsal horn rather than in the VPL itself.
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Walking requires a constant adaptation of locomotor output from sensory afferent feedback mechanisms to ensure efficient and stable gait. We investigated the nature of the sensory afferent feedback contribution to the soleus motoneuronal drive and to the corrective stretch reflex by manipulating body load and ankle joint angle. The volunteers walked on a treadmill ( approximately 3.6 km/h) connected to a body weight support (BWS) system. To manipulate the load sensitive afferents the level of BWS was switched between 5 and 30% of body weight. The effect of transient changes in BWS on the soleus stretch reflex was measured by presenting dorsiflexion perturbations ( approximately 5 degrees, 360-400 degrees/s) in mid and late stances. Short (SLRs) and medium latency reflexes (MLRs) were quantified in a 15 ms analysis window. The MLR decreased with decreased loading (P = 0.045), but no significant difference was observed for the SLR (P = 0.13). Similarly, the effect of the BWS was measured on the unload response, i.e., the depression in soleus activity following a plantar-flexion perturbation ( approximately 5.6 degrees, 203-247 degrees/s), quantified over a 50 ms analysis window. The unload response decreased with decreased load (P > 0.001), but was not significantly affected (P = 0.45) by tizanidine induced depression of the MLR (P = 0.039, n = 6). Since tizanidine is believed to depress the group II afferent pathway, these results are consistent with the idea that force-related afferent feedback contributes both to the background locomotor activity and to the medium latency stretch reflex. In contrast, length-related afferent feedback may contribute to only the medium latency stretch reflex.
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Among nonsmokers, the peak concentration (C(max)) and area under concentration-time curve from 0 to infinity [AUC(0-infinity)] of tizanidine did not differ significantly between females and males. However, the half-life (t(1/2)) was 9% shorter in female nonsmokers than in male nonsmokers (P < 0.05). In male smokers, the t(1/2) was 10% shorter and the weight-adjusted AUC(0-infinity) 33% smaller than in male nonsmokers (P < 0.05). The caffeine/paraxanthine ratio was 35-40% smaller (P = 0.001) in male smokers than in nonsmoking males or females, but did not differ between males and females. Tizanidine lowered blood pressure and caused drowsiness significantly (P < 0.05) more in females than in either male groups. The effects on blood pressure were smallest in male smokers (P < 0.05).
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Tizanidine is an imidazoline with central alpha(2)-adrenoceptor agonist activity at both spinal and supraspinal levels, which is indicated as a short-acting drug for the management of spasticity. Despite being used in pediatric populations, there is no adequate information or well controlled studies to document the safety and efficacy of tizanidine in this group.
We report a case of profound symptomatic bradycardia after a single dose of tizanidine.
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Significant relief from the systemic muscle hypertonia was obtained in 4 of the 5 patients with improvement of the quality of life of the patients, e. g., they could get adequate sleep. There were no serious side effects in any of the cases.
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Rifampicin moderately decreases the plasma concentrations of tizanidine. The strong inducing effects of rifampicin on other CYP enzymes, e.g. CYP3A4, may have contributed to the findings, and the inducibility of CYP1A2-mediated presystemic (tizanidine) and systemic (tizanidine, caffeine) metabolism by rifampicin is weak at the most. Compared to CYP3A4 substrate drugs, substrates of CYP1A2 are much less susceptible to drug interactions caused by enzyme inducers of the rifampicin type.
We report a case of delirium accompanied by extrapyramidal symptoms and autonomic dysfunction in a 59-year-old man following abrupt cessation of baclofen and tizanidine. An extensive search for the etiology was undertaken, but it was only after a careful history was taken that suspicion for baclofen and tizanidine withdrawal was raised. The delirium and motor disturbances resolved within 24 h of reintroduction of baclofen. Withdrawal from muscle relaxants requires a high index of suspicion but should be considered in patients who manifest signs and symptoms of withdrawal from the medications, particularly visual hallucinations, rigidity and autonomic dysfunction.
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Spasticity is a common problem in paediatric neurology and its management constitutes a real professional challenge. There are numerous therapeutic options available and their advantages and disadvantages should be carefully weighed up for each individual patient. It is true that we do not have one single final option, but experience and knowledge of the therapeutic possibilities favour the functional improvement of patients suffering from spasticity. In this paper, we analyse the different drugs available for oral administration in the treatment of spasticity. Special attention is given to the side effects and interactions of these drugs in multiple deficiency patients, who are usually already receiving other medication. We review the mechanism of action, the forms of presentation and dosage, the side effects and interactions of baclofen, diazepam, clonidine, tizanidine, modafilin, gabapentin and dantrolene. Finally, other drugs that may be useful in improving spasticity are also analysed.
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Comparator studies that assess treatment effects in a clinical setting have improved the understanding of the efficacy and tolerability of prophylactic treatments for chronic migraine (CM). It is premature to recommend device-based treatments, such as occipital nerve stimulation, vagal nerve stimulation, and patent foramen ovale closure for CM, because clinical trials are in the preliminary stages. Physical therapy techniques, like applying heat or cold packs, ultrasonography, and electrical stimulation, have been shown to lessen pain. Nonpharmacologic treatments, including cognitive behavioral therapy, stress management, and biofeedback, have been investigated and proved effective in some areas of pain management, including migraine. However, pharmacologic interventions may be necessary for effective, long-term prophylaxis. Several medications under investigation, including topiramate, gabapentin, tizanidine, and amitriptyline, have proved efficacious in reducing the number of migraine episodes and the pain associated with migraine, although adverse events may prevent continued use of some agents. Evidence supports the use of botulinum toxin type A (BoNT-A) for CM, with or without medication overuse, to achieve a significant reduction in headache episodes. Efficacy of BoNT-A for CM is comparable with or better than that of valproate and topiramate, with better tolerability. Predictors of response to BoNT-A for CM appear to include predominantly unilateral location of the headache and the presence of cutaneous or muscle allodynia. BoNT-A has been demonstrated to be safe and well tolerated, with rare discontinuations due to adverse events. Recent clinical trials indicate that rational combination therapy may have a place in treating refractory CM. Well-controlled multicenter trials are awaited.
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Dysfunction of nervous system plays the main role in this pain syndrome. The efficacy of the drugs in the early/late recovery period was estimated as follows: nonsteroidal anti-inflammatory drugs - 33%/12%, amitriptyline - 24%/42%, gabapentin - 10%/13%, lidocaine - 95%/100%, tizanidine - 29%/33%. Seventy-six percent of patients were free of pain after treatment using a regimen suggested by the authors.