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Tizanidine (Tizanidine Hydrochloride) - Summary

 
 



TIZANIDINE SUMMARY

Tizanidine hydrochloride USP, is a central α2-adrenergic agonist. Tizanidine hydrochloride USP is almost white to slightly yellow crystalline powder, which is slightly soluble in water and methanol. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiodiazole monohydrochloride.

Tizanidine tablet is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine tablets should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration].


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NEWS HIGHLIGHTS

Published Studies Related to Tizanidine

Nightly sublingual tizanidine HCl in multiple sclerosis: clinical efficacy and safety. [2010.05]
BACKGROUND: Approximately 90% of patients with multiple sclerosis (MS) experience spasticity during their lifetime. Tizanidine HCl is an alpha2 adrenergic agonist indicated for treating spasticity due to MS or spinal cord injury. OBJECTIVES: To compare the clinical efficacy and safety of once-nightly sublingual versus oral tizanidine HCl (8 mg) or placebo in MS patients with spasticity requiring treatment... CONCLUSIONS: Overnight sublingual tizanidine provides improvement in next-day spasticity compared with placebo, without increasing next-day somnolence. The Epworth somnolence score improved significantly with sublingual tizanidine treatment. This is contrary to the reported day-dose tizanidine use, in which increased somnolence is the most cited cause for patient dissatisfaction and noncompliance.

Nightly sublingual tizanidine HCl in multiple sclerosis: clinical efficacy and safety. [2010]
spasticity requiring treatment... CONCLUSIONS: Overnight sublingual tizanidine provides improvement in next-day

Aceclofenac-tizanidine in the treatment of acute low back pain: a double-blind, double-dummy, randomized, multicentric, comparative study against aceclofenac alone. [2009.12]
Tizanidine and aceclofenac individually have shown efficacy in the treatment of low back pain... 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.

Botulinum neurotoxin versus tizanidine in upper limb spasticity: a placebo-controlled study. [2009.04]
BACKGROUND: While spasticity is commonly treated with oral agents or botulinum neurotoxin (BoNT) injection, these treatments have not been systematically compared... CONCLUSIONS: BoNT is safer and more effective than TZD in reducing tone and disfigurement in upper-extremity spasticity, and may be considered as first-line therapy for this disorder.

Botulinum Neurotoxin vs Tizanidine in Upper Limb Spasticity: A Placebo-Controlled Study. [2008.10.31]
BACKGROUND: While spasticity is commonly treated with oral agents or botulinum neurotoxin (BoNT) injection, these treatments have not been systematically compared... CONCLUSIONS: BoNT is safer and more effective than TZD in reducing tone and disfigurement in upper extremity spasticity, and may be considered as first line therapy for this disorder.

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Clinical Trials Related to Tizanidine

Tizanidine and Pain After Herniorrhaphy [Completed]
Herniorrhaphy is the most frequent general surgical procedure. There are moderate pain complaints after herniorrhaphy. Besides causing discomfort to the patients, pain, can delay recovery and discharge and cause cognitive dysfunction and difficulty with returning to normal daily activity. A combination of analgesics with different effect sites can reduce the doses needed and analgesic related side effects which is called multimodal analgesia . Opioids, acetaminophen, nonsteroid anti-inflammatory drugs and cox-2 inhibitors, alfa-2 receptor agonists, steroids, gabapentin and pregabalin have been used for this purpose(4). Tizanidine is an alfa-2 receptor agonist, and is used for musculoskeletal pain conditions. Tizanidine reduced the local anesthetic requirement in spinal anesthesia. The aim of this study is to investigate the hypothesis that: Tizanidine can reduce the pain scores, analgesic consumption, analgesic related side effects and provide early return to normal daily activity compared to placebo after inguinal herniorrhaphy.

Bioequivalence Study of Tizanidine HCl 4mg Tablets of Dr.Reddy's Under Fed Conditions [Completed]
The purpose of this bioequivalence study is to compare the test tizanidine Hydrochloride 4mg tablets of Dr. Reddys Laboratories Limited with reference zanaflex® 4mg tablets of Elan in healthy adult subjects under fed conditions.

Phase 1b Study of Tizanidine in Pediatric Patients With Cerebral Palsy [Terminated]

Bioequivalence Study of Tizanidine HCl Tablets 4 mg of Dr.Reddys Under Fasting Conditions [Completed]
The purpose of this bioequivalence study is to compare the test Tizanidine Hydrochloride 4mg tablets of Dr. Reddys Laboratories Limited with reference zanaflex® 4mg tablets of Elan in healthy adult subjects under fasting conditions.

A Study to Define the ECG Effects of Tizanidine Compared to Placebo and the Positive Control, Moxifloxacin, in Healthy Men and Women Using a Blinded ECG Evaluator: A Thorough ECG Trial [Completed]
This is a single-center, partial-blind, randomized, placebo-controlled, parallel design study with a nested crossover comparison to define the ECG effects of tizanidine compared to placebo and the positive control, moxifloxacin, in healthy men and women. The study will be conducted in a Phase 1 unit with sufficient facilities to house subjects as required by the protocol.

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Page last updated: 2013-02-10

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