Withdrawal adverse reactions include rebound hypertension, tachycardia, and hypertonia.
Some of the cases resulted in fatality and many of the intentional overdoses were with multiple drugs including CNS depressants.
Monitoring of aminotransferase levels is recommended for baseline and 1 month after maximum dose is achieved, or if hepatic injury is suspected. 70515-594-15, The sedative effects of Zanaflex with CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants) may be additive. Spasm counts were also collected. In these patients, during titration, the individual doses should be reduced.
These patients should be monitored closely for the onset or increase in severity of the common adverse events (dry mouth, somnolence, asthenia and dizziness) as indicators of potential overdose. The following adverse reactions are described elsewhere in other sections of the prescribing information: Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. No effect on fertility was observed at doses of 10 (male) and 3 (female) mg/kg/day, which are approximately 8 and 3 times, respectively, the MRHD on a mg/mTizanidine’s capacity to reduce increased muscle tone associated with spasticity was demonstrated in two adequate and well controlled studies in patients with multiple sclerosis or spinal cord injury (Studies 1 and 2).In Study 1, patients with multiple sclerosis were randomized to receive single oral doses of drug or placebo. The influence of hepatic impairment on the pharmacokinetics of tizanidine has not been evaluated. An overdose of the medication should be avoided as it can increase the risk of dealing with these side effects.If you accidently take an overdose of medication, consult with your doctor immediately or seek emergency medical help.You have to be careful while taking tizanidine or tizanidine HCL. Copy the URL below and paste it into your RSS Reader application.DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed.DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. The case reports suggest that these patients were also misusing narcotics. Cyclobenzaprine is used short-term relief of muscle spasms, while Zanaflex is used for the treatment and management of skeletal muscle spasticity due to chronic conditions such as multiple sclerosis or spinal cord injury. A muscle immobilized by spasticity was given a score of 4. Zanaflex use has been associated with hallucinations. Because tizanidine is extensively metabolized in the liver, hepatic impairment would be expected to have significant effects on pharmacokinetics of tizanidine. Because hypotensive effects may be cumulative, it is not recommended that Zanaflex be used with other αZanaflex has not been studied in pregnant women. (The most common adverse reactions (greater than 2% of 264 patients taking tizanidine and greater than in placebo-treated patients in three multiple dose, placebo-controlled studies) were dry mouth, somnolence, asthenia, dizziness, urinary tract infection, constipation, liver function tests abnormal, vomiting, speech disorder, amblyopia, urinary frequency, flu syndrome, SGPT/ALT increased, dyskinesia, nervousness, pharyngitis, and rhinitis (Zanaflex is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Dispense in containers with child resistant closure.Advise patients they should not take Zanaflex if they are taking fluvoxamine or ciprofloxacin because of the increased risk of serious adverse reactions including severe lowering of blood pressure and sedation. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. Therefore, dialysis is not likely to be an efficient method of removing drug from the body. Adverse reactions such as hypotension, bradycardia, or excessive drowsiness can occur when Zanaflex is taken with other CYP1A2 inhibitors, such as zileuton, fluoroquinolones other than ciprofloxacin (which is contraindicated), antiarrythmics (amiodarone, mexiletine, propafenone), cimetidine, famotidine, oral contraceptives, acyclovir, and ticlopidine). If therapy needs to be discontinued, the dose should be decreased slowly to minimize the risk of withdrawal symptoms Monkeys were shown to self-administer tizanidine in a dose-dependent manner, and abrupt cessation of tizanidine produced transient signs of withdrawal at doses > 35 times the maximum recommended human dose on a mg/mA review of the safety surveillance database revealed cases of intentional and accidental Zanaflex overdose. Concomitant use of Zanaflex with oral contraceptives is not recommended. In all, 264 patients received tizanidine and 261 patients received placebo. Dosage can be gradually increased by 2 mg to 4 mg at each dose, with 1 to 4 days between dosage increases, until a satisfactory reduction of muscle tone is achieved. Single doses greater than 16 mg have not been studied.