Trade Name: Tizanidine

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: NuCare Pharmaceuticals, Inc.

Presentation: TABLET, HUMAN PRESCRIPTION DRUG

Strength: 2 mg/1

Storage and handling

TIZANIDINE HYDROCHLORIDE Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]

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  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
  3. Read more
  • No data
  • These highlights do not include all the information needed to use n- Tizanidine Tablets, USPn- safely and effectively. See full prescribing information for n- Tizanidine Tablets, USPn- .
  • u00a0n n n n n- Tizanidine Tablets, USPn- (tizanidine hydrochloride) tablets, for oral use n n n Initial U.S. Approval: 1996n n n
  • INDICATIONS AND USAGEn- Array
  • Tizanidine Tablets, USP 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, USP should be reserved for those daily activities and times when relief of spasticity is most important. n n n n
  • DOSAGE AND ADMINISTRATIONn- Array
  • DOSAGE FORMS AND STRENGTHSn- Array
  • CONTRAINDICATIONSn- Array
  • WARNINGS AND PRECAUTIONSn- Array
  • ADVERSE REACTIONSn- Array
  • 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. (n n n ) n nn
  • To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. toll free at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • USE IN SPECIFIC POPULATIONSn- Array
  • See 17 for PATIENT COUNSELING INFORMATION.
  • Revised: 09/2014
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  • *n- Sections or subsections omitted from the full prescribing information are not listed.
  • TizanidineTablets, USP is a central alpha-2-adrenergic agonist indicated for themanagement of spasticity. Because of the short duration of therapeutic effect,treatment with Tizanidine Tablets, USP should be reserved for those dailyactivities and times when relief of spasticity is most important [n n n ].n nn
  • Tizanidine Tablets, USPu00a0is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment withu00a0Tizanidine Tablets, USPu00a0should be reserved for those daily activities and times when relief of spasticity is most important. n n n n
  • Arrayn- Array
  • Food has complex effects on tizanidine pharmacokinetics, which differ with the different formulations. Tizanidine Capsules and Tizanidine Tablets, USP are bioequivalent to each other under fasting conditions (more than 3 hours after a meal), but not under fed conditions (within 30 minutes of a meal). These pharmacokinetic differences may result in clinically significant differences when switching administration of tablet and capsules and when switching administration between the fed or fasted state. These changes may result in increased adverse events, or delayed or more rapid onset of activity, depending upon the nature of the switch. For this reason, the prescriber should be thoroughly familiar with the changes in kinetics associated with these different conditions [n n n n ].n nn
  • The recommended starting dose is 2 mg. Because the effect of Tizanidine Tablets, USP peaks at approximately 1 to 2 hours post-dose and dissipates between 3 to 6 hours post-dose, treatment can be repeated at 6 to 8 hour intervals, as needed, to a maximum of three doses in 24 hours.
  • 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. The total daily dose should not exceed 36 mg. Single doses greater than 16 mg have not been studied.
  • Arrayn- Array
  • Tizanidine Tablets, USP should be used with caution in patients with renal insufficiency (creatinine clearance < 25 mL/min), as clearance is reduced by more than 50%. In these patients, during titration, the individual doses should be reduced. If higher doses are required, individual doses rather than dosing frequency should be increased [n n n n ].n nn
  • Arrayn- Array
  • Tizanidine Tablets, USP should be used with caution in patients with any hepatic impairment. In these patients, during titration, the individual doses should be reduced. If higher doses are required, individual doses rather than dosing frequency should be increased. Monitoring of aminotransferase levels is recommended for baseline and 1 month after maximum dose is achieved, or if hepatic injury is suspected. [n n n n ]n nn
  • Arrayn- 2.4u00a0n Drug Discontinuationu00a0n
  • If therapy needs to be discontinued, particularly in patients who have been receiving high doses (20 mg to 36 mg daily) for long periods (9 weeks or more) or who may be on concomitant treatment with narcotics, the dose should be decreased slowly (2 mg to 4 mg per day) to minimize the risk of withdrawal and rebound hypertension, tachycardia, and hypertonia [n n n n n n
  • Recommended starting dose: 2 mg; dose can be repeated at 6 to 8 hour intervals, up to a maximum of 3 doses in 24 hours (n n n )n n n
  • Dosage can be increased by 2 mg to 4 mg per dose, with 1 to 4 days between increases; total daily dose should not exceed 36 mg (n n n )n n n
  • Tizanidine pharmacokinetics differs between tablets and capsules, and when taken with or without food. These differences could result in a change in tolerability and control of symptoms (n n n , n n n )n n n
  • To discontinue Tizanidine Tablets, USP, decrease dose slowly to minimize the risk of withdrawal and rebound hypertension, tachycardia, and hypertonia (n n n )n n n
  • Tizanidine Tablets, USP 2 mg are white to off-white, round, flat beveled, uncoated tablets debossed with product code u201c502u201d on one side, and bisecting score on the other.
  • Tizanidine Tablets, USP 4 mg are white to off-white, round, flat beveled, uncoated tablets debossed with product code u201c503u201d on one side, and quadrisecting score on the other.
  • Tablets 2 mg and 4 mg. (n n n )n nn
  • Tizanidine Tablets, USP is contraindicated in patientstaking potent inhibitors of CYP1A2, such as fluvoxamine or ciprofloxacin [n n n n n n n ].n nn
  • Concomitant use with potent inhibitors of CYP1A2, such as fluvoxamine or ciprofloxacin (n n n , n n n , n n n , n n n )n nn
  • Arrayn- 5.1 u00a0n u00a0Hypotensionu00a0u00a0u00a0n
  • Tizanidine is an u03b1n n n -adrenergic agonist that can produce hypotension. Syncope has been reported in the post marketing setting. The chance of significant hypotension may possibly be minimized by titration of the dose and by focusing attention on signs and symptoms of hypotension prior to dose advancement. In addition, patients moving from a supine to fixed upright position may be at increased risk for hypotension and orthostatic effects.n nn
  • Monitor for hypotension when Tizanidine Tablets, USP is used in patients receiving concurrent antihypertensive therapy. It is not recommended that Tizanidine Tablets, USP be used with other u03b1n n n -adrenergic agonists. Clinically significant hypotension (decreases in both systolic and diastolic pressure) has been reported with concomitant administration of either fluvoxamine or ciprofloxacin and single doses of 4 mg of Tizanidine Tablets, USP. Therefore, concomitant use of Tizanidine Tablets, USP with fluvoxamine or with ciprofloxacin, potent inhibitors of CYP1A2, is contraindicated [n n n n n n n n n ].n nn
  • Arrayn- 5.2 u00a0n u00a0Risk of Liver Injuryu00a0u00a0n
  • Tizanidine Tablets, USP may cause hepatocellular liver injury. Tizanidine Tablets, USP should be used with caution in patients with any hepatic impairment. Monitoring of aminotransferase levels is recommended for baseline and 1 month after maximum dose is achieved, or if hepatic injury is suspected. [n n n n n n ]n n n n n n
  • Tizanidine Tablets, USP can cause sedation, which may interfere with everyday activity. In the multiple dose studies, the prevalence of patients with sedation peaked following the first week of titration and then remained stable for the duration of the maintenance phase of the study. The CNS depressant effects of Tizanidine Tablets, USP with alcohol and other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants) may be additive. Monitor patients who take Tizanidine Tablets, USP with another CNS depressant for symptoms of excess sedation. [n n n n n n n ] n nn
  • Arrayn- Array
  • Tizanidine Tablets, USP use has been associated with hallucinations. Formed, visual hallucinations or delusions have been reported in 5 of 170 patients (3%) in two North American controlled clinical studies. Most of the patients were aware that the events were unreal. One patient developed psychosis in association with the hallucinations. One patient among these 5 continued to have problems for at least 2 weeks following discontinuation of tizanidine. Consider discontinuing Tizanidine Tablets, USP in patients who develop hallucinations.
  • Arrayn- 5.5u00a0u00a0n u00a0u00a0u00a0Interaction with CYP1A2 Inhibitorsu00a0u00a0u00a0u00a0n
  • Because of potential drug interactions, Tizanidine Tablets, USP is contraindicated in patients taking potent CYP1A2 inhibitors, such as fluvoxamine or ciprofloxacin. Adverse reactions such as hypotension, bradycardia, or excessive drowsiness can occur when Tizanidine Tablets, USP 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). Concomitant use should be avoided unless the necessity for Tizanidine Tablets, USP therapy is clinically evident. In such a case, use with caution. [n n n n n n ]n nn
  • Arrayn- 5.6u00a0n Hypersensitivity Reactions
  • Tizanidine Tablets, USP can cause anaphylaxis. Signs and symptoms including respiratory compromise, urticaria, and angioedema of the throat and tongue have been reported. Patients should be informed of the signs and symptoms of severe allergic reactions and instructed to discontinue Tizanidine Tablets, USP and seek immediate medical care should these signs and symptoms occur. [n n n n ] n nn
  • Arrayn- 5.7u00a0u00a0n u00a0Increased Risk of Adverse Reactions in Patients with Renal Impairmentu00a0u00a0n
  • Tizanidine Tablets, USP should be used with caution in patients with renal insufficiency (creatinine clearance < 25 mL/min), as clearance is reduced by more than 50%. In these patients, during titration, the individual doses should be reduced. If higher doses are required, individual doses rather than dosing frequency should be increased. 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. [n n n n n n ] n nn
  • Arrayn- 5.8u00a0n Withdrawal Adverse Reactions
  • Withdrawal adverse reactions include rebound hypertension, tachycardia, and hypertonia. To minimize the risk of these reactions, particularly in patients who have been receiving high doses (20 to 28 mg daily) for long periods of time (9 weeks or more) or who may be on concomitant treatment with narcotics, the dose should be decreased slowly (2 to 4 mg per day). n n n n n n
  • Hypotension: monitor for signs and symptoms of hypotension, in particular in patients receiving concurrent antihypertensives;u00a0Tizanidine Tablets, USPu00a0should not be used with other u03b1n n n -adrenergic agonists (n n n , n n n )n n n
  • Risk of liver injury: monitor ALTs; discontinueu00a0Tizanidine Tablets, USPu00a0if liver injury occurs (n n n )n n n
  • Sedation:u00a0Tizanidine Tablets, USPu00a0may interfere with everyday activities; sedative effects ofu00a0Tizanidine Tablets, USP, alcohol, and other CNS depressants are additive (n n n , n n n , n n n )n n n
  • Hallucinations: consider discontinuation ofu00a0Tizanidine Tablets, USP (n n n )n n n
  • Less potent inhibitors of CYP1A2: may cause hypotension, bradycardia, or excessive drowsiness, use caution ifu00a0Tizanidine Tablets, USPu00a0is used with less potent inhibitors of CYP1A2, e.g., zileuton, other fluoroquinolones, antiarrythmics, cimetidine, famotidine, oral contraceptives, acyclovir, and ticlopidine (n n n , n n n , n n n )n n n
  • Renal impairment (creatinine clearance < 25 mL/min): useu00a0Tizanidine Tablets, USPu00a0with caution, and monitor closely for dry mouth, somnolence, asthenia and dizziness as indicators of potential overdose (n n n )n n n
  • The following adverse reactions are described elsewhere in other sections of the prescribing information:
  • Arrayn- 6.1 u00a0n u00a0Clinical Trials Experienceu00a0u00a0n
  • 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.
  • Three double-blind, randomized, placebo controlled -clinical studies were conducted to evaluate the effect of tizanidine on spasticity control. Two studies were conducted in patients with multiple sclerosis and one in patients with spinal cord injury. Each study had a 13-week active treatment period which included a 3-week titration phase to the maximum tolerated dose up to 36 mg/day in three divided doses, a 9-week plateau phase where the dose of tizanidine was held constant and a 1-week dose tapering. In all, 264 patients received tizanidine and 261 patients received placebo. Across the three studies patient ages ranged from 15u201369 years and 51.4 percent were women. The median dose during the plateau phase ranged from 20u201328 mg/day.
  • The most frequent adverse reactions reported in multiple dose, placebo-controlled clinical studies involving 264 patients with spasticity were dry mouth, somnolence/sedation, asthenia (weakness, fatigue and/or tiredness) and dizziness. Three-quarters of the patients rated the events as mild to moderate and one-quarter of the patients rated the events as being severe. These events appeared to be dose related.
  • Table 1 lists signs and symptoms that were reported in greater than 2% of patients in three multiple dose, placebo-controlled studies who received Tizanidine Tablets, USP where the frequency in the Tizanidine Tablets, USP group was greater than the placebo group. For comparison purposes, the corresponding frequency of the event (per 100 patients) among placebo treated patients is also provided.
  • In the single dose, placebo-controlled study involving 142 patients with spasticity due to multiple sclerosis (Study 1) n n n n n , the patients were specifically asked if they had experienced any of the four most common adverse reactions: dry mouth, somnolence (drowsiness), asthenia (weakness, fatigue and/or tiredness) and dizziness. In addition, hypotension and bradycardia were observed. The occurrence of these reactions is summarized in Table 2. Other events were, in general, reported at a rate of 2% or less.n nn
  • * (weakness, fatigue, and/or tiredness)
  • Arrayn- 6.2u00a0n Post-Marketing Experience
  • The following adverse reactions have been identified during post approval use of Tizanidine Tablets, USP. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • Certain events, such as somnolence, dry mouth, hypotension, decreased blood pressure, bradycardia, dizziness, weakness or asthenia, muscle spasms, hallucinations, fatigue, liver function test abnormality and hepatotoxicity, have been observed in post marketing and clinical trials and are discussed in previous sections of this document.
  • The following adverse reactions have been identified as occurring in the post marketing experience of Tizanidine Tablets, USP. Based on the information provided regarding these reactions, a causal relationship with Tizanidine Tablets, USP cannot be entirely excluded. The events are listed in order of decreasing clinical significance; severity in the post marketing setting is not reported.
  • 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, andu00a0rhinitis. (n n n )n n n n n n
  • Arrayn- 7.1u00a0n Fluvoxamine
  • Concomitant use of fluvoxamine and Tizanidine Tablets, USP is contraindicated. Changes in pharmacokinetics of tizanidine when administered with fluvoxamine resulted in significantly decreased blood pressure, increased drowsiness, and increased psychomotor impairment. [n n n n and n n n ]n nn
  • Arrayn- 7.2u00a0n Ciprofloxacin
  • Concomitant use of ciprofoxacin and Tizanidine Tablets, USP is contraindicated. Changes in pharmacokinetics of tizanidine when administered with ciprofloxacin resulted in significantly decreased blood pressure, increased drowsiness, and increased psychomotor impairment. [n n n n and n n n ]n nn
  • Arrayn- 7.3 n CYP1A2 Inhibitors other than Fluvoxamine and Ciprofloxacin
  • Because of potential drug interactions, concomitant use of Tizanidine Tablets, USP with other CYP1A2 inhibitors, such as zileuton, fluoroquinolones other than strong CYP1A2 inhibitors (which are contraindicated), antiarrythmics (amiodarone, mexiletine, propafenone, and verapamil), cimetidine, famotidine, oral contraceptives, acyclovir, and ticlopidine) should be avoided. If their use is clinically necessary, therapy should be initiated with 2 mg dose and increased in 2u20134 mg steps daily based on patient response to therapy. If adverse reactions such as hypotension, bradycardia, or excessive drowsiness occur, reduce or discontinue Tizanidine Tablets, USP therapy. [n n n n n n ]n nn
  • Arrayn- 7.4u00a0n Oral Contraceptivesu00a0n
  • Concomitant use of Tizanidine Tablets, USP with oral contraceptives is not recommended. However, if concomitant use is clinically necessary, initiate Tizanidine Tablets, USP with a single 2 mg dose and increase in 2u20134 mg steps daily based on patient response to therapy. If adverse reactions such as hypotension, bradycardia, or excessive drowsiness occur, reduce or discontinue Tizanidine Tablets, USP therapy. [n n n n ] n nn
  • Arrayn- 7.5u00a0n Alcohol
  • Alcohol increases the overall amount of drug in the bloodstream after a dose of Tizanidine Tablets, USP. This was associated with an increase in adverse reactions of Tizanidine Tablets, USP. The CNS depressant effects of Tizanidine Tablets, USP and alcohol are additive. [n n n n ]n nn
  • Arrayn- 7.6u00a0n Other CNS Depressants
  • The sedative effects of Tizanidine Tablets, USP with CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants) may be additive. Monitor patients who take Tizanidine Tablets, USP with another CNS depressant for symptoms of excess sedation. [n n n n ]n nn
  • 7n n n u00a0u03b1n n n -n adrenergic agonistsn n
  • Because hypotensive effects may be cumulative, it is not recommended that Tizanidine Tablets, USP be used with other u03b1n n n -adrenergic agonists. [n n n n ]n nn
  • u00a0n
  • See 17 for PATIENT COUNSELING INFORMATION.
  • Revised: 09/2014
  • Pregnancy: Based on animal data, may cause fetalu00a0harm (n n n )n n n
  • Geriatric use:u00a0Tizanidine Tablets, USPu00a0should be used with caution in elderly patients because clearance is decreased four-fold (n n n )n n n
  • No data
  • A review of the safety surveillance database revealed cases of intentional and accidental Tizanidine Tablets, USP overdose. Some of the cases resulted in fatality and many of the intentional overdoses were with multiple drugs including CNS depressants. The clinical manifestations of tizanidine overdose were consistent with its known pharmacology. In the majority of cases a decrease in sensorium was observed including lethargy, somnolence, confusion and coma. Depressed cardiac function is also observed including most often bradycardia and hypotension. Respiratory depression is another common feature of tizanidine overdose.
  • Should overdose occur, basic steps to ensure the adequacy of an airway and the monitoring of cardiovascular and respiratory systems should be undertaken. Tizanidine is a lipid-soluble drug, which is only slightly soluble in water and methanol. Therefore, dialysis is not likely to be an efficient method of removing drug from the body. In general, symptoms resolve within one to three days following discontinuation of tizanidine and administration of appropriate therapy. Due to the similar mechanism of action, symptoms and management of tizanidine overdose are similar to that following clonidine overdose. For the most recent information concerning the management of overdose, contact a poison control center.
  • Tizanidine Tablets, USP u00a0(tizanidine hydrochloride) is a central alphan n n -adrenergic agonist. Tizanidine HCl is a white to off-white, fine crystalline powder, which is odorless or with a faint characteristic odor. Tizanidine is slightly soluble in water and methanol; solubility in water decreases as the pH increases. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. Tizanidine's molecular formula is Cn n n Hn n n ClNn n n S-HCl, its molecular weight is 290.2 and its structural formula is:n n n n n
  • Tizanidine Tablets, USP are supplied as 2 mg and 4 mg tablets for oral administration. Tizanidine Tablets, USP contain the active ingredient, tizanidine hydrochloride (2.288 mg equivalent to 2 mg tizanidine base andu00a0 4.576 mg equivalent to 4 mg tizanidine base), and the inactive ingredients, colloidal silicon dioxide, stearic acid, microcrystalline cellulose, lactose monohydrate and anhydrous lactose.
  • No data
  • Carcinogenesis
  • Tizanidine was administered to mice for 78 weeks at oral doses up to 16 mg/kg/day, which is 2 times the maximum recommended human dose (MRHD) on a mg/mn n n basis. Tizanidine was administered to rats for 104 weeks at oral doses up to 9 mg/kg/day, which is 2.5 times the MRHD on a mg/mn n n basis. There was no increase in tumors in either species.n nn
  • Mutagenesis
  • Tizanidine was negative in n n n (bacterial reverse mutation [Ames], mammalian gene mutation, and chromosomal aberration test in mammalian cells) and n n n (bone marrow micronucleus, and cytogenetics) assay.n nn
  • Impairment of fertility
  • Oral administration of tizanidine resulted in reduced fertility in male and female rats following doses of 30 and 10 mg/kg/day, respectively. 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/mn n n basis).n nn
  • Tizanidine'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).
  • Single-Dose Study in Patients with Multiple Sclerosis with Spasticity
  • In Study 1, patients with multiple sclerosis were randomized to receive single oral doses of drug or placebo. Patients and assessors were blind to treatment assignment and efforts were made to reduce the likelihood that assessors would become aware indirectly of treatment assignment (e.g., they did not provide direct care to patients and were prohibited from asking questions about side effects). In all, 140 patients received placebo, 8 mg or 16 mg of Tizanidine Tablets, USP.
  • Response was assessed by physical examination; muscle tone was rated on a 5 point scale (Ashworth score), with a score of 0 used to describe normal muscle tone. A score of 1 indicated a slight spastic catch while a score of 2 indicated more marked muscle resistance. A score of 3 was used to describe considerable increase in tone, making passive movement difficult. A muscle immobilized by spasticity was given a score of 4. Spasm counts were also collected.
  • Assessments were made at 1, 2, 3 and 6 hours after treatment. A statistically significant reduction of the Ashworth score for Tizanidine Tablets, USP compared to placebo was detected at 1, 2 and 3 hours after treatment. Figure 2 below shows a comparison of the mean change in muscle tone from baseline as measured by the Ashworth scale. The greatest reduction in muscle tone was 1 to 2 hours after treatment. By 6 hours after treatment, muscle tone in the 8 and 16 mg Tizanidine Tablets, USP groups was indistinguishable from muscle tone in placebo treated patients. Within a given patient, improvement in muscle tone was correlated with plasma concentration. Plasma concentrations were variable from patient to patient at a given dose. Although 16 mg produced a larger effect, adverse events including hypotension were more common and more severe than in the 8 mg group. There were no differences in the number of spasms occurring in each group.
  • Figure 2: Single Dose Studyu2014Mean Change in Muscle Tone from Baseline as Measured by the Ashworth Scale u00b1 95% Confidence Interval (A Negative Ashworth Score Signifies an Improvement in Muscle Tone from Baseline)
  • Seven-Week Study in Patients with Spinal Cord Injury with Spasticity
  • In a 7-week study (Study 2), 118 patients with spasticity secondary to spinal cord injury were randomized to either placebo or Tizanidine Tablets, USP. Steps similar to those taken in the first study were employed to ensure the integrity of blinding.
  • Patients were titrated over 3 weeks up to a maximum tolerated dose or 36 mg daily given in three unequal doses (e.g., 10 mg given in the morning and afternoon and 16 mg given at night). Patients were then maintained on their maximally tolerated dose for 4 additional weeks (i.e., maintenance phase). Throughout the maintenance phase, muscle tone was assessed on the Ashworth scale within a period of 2.5 hours following either the morning or afternoon dose. The number of daytime spasms was recorded daily by patients.
  • At endpoint (the protocol-specified time of outcome assessment), there was a statistically significant reduction in muscle tone and frequency of spasms in the Tizanidine Tablets, USP treated group compared to placebo. The reduction in muscle tone was not associated with a reduction in muscle strength (a desirable outcome) but also did not lead to any consistent advantage of Tizanidine Tablets, USP treated patients on measures of activities of daily living. Figure 3 below shows a comparison of the mean change in muscle tone from baseline as measured by the Ashworth scale.
  • Figure 3: Seven Week Studyu2014Mean Change in Muscle Tone 0.5u20132.5 Hours After Dosing as Measured by the Ashworth Scale u00b1 95% Confidence Interval (A Negative Ashworth Score Signifies an Improvement in Muscle Tone from Baseline)
  • Arrayn- Tizanidine Tablets, USPn- Tablets
  • Tizanidine Tablets, USP 2 mg are available as; white to off-white, round, flat beveled, uncoated tablets debossed with product code u201c502u201d on one side, and bisecting score on the other.
  • 2 mg Bottles of 30 NDC 66267-749-30
  • Store at 25u00b0C (77u00b0F); excursions permitted 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature]. Dispense in containers with child resistant closure.
  • Serious Drug Interactions
  • Advise patients they should not take Tizanidine Tablets, USP if they are taking fluvoxamine or ciprofloxacin because of the increased risk of serious adverse reactions including severe lowering of blood pressure and sedation. Instruct patients to inform their physicians or pharmacists when they start or stop taking any medication because of the risks associated with interaction between Tizanidine Tablets, USP and other medicines.
  • Tizanidine Tablets, USP Dosing
  • Tell patients to take Tizanidine Tablets, USP exactly as prescribed (consistently either with or without food) and not to switch between tablets and capsules. Inform patients that they should not take more Tizanidine Tablets, USP than prescribed because of the risk of adverse events at single doses greater than 8 mg or total daily doses greater than 36 mg. Tell patients that they should not suddenly discontinue Tizanidine Tablets, USP, because rebound hypertension and tachycardia may occur.
  • Effects of Tizanidine Tablets, USP
  • Warn patients that they may experience hypotension and to be careful when changing from a lying or sitting to a standing position. Tell patients that Tizanidine Tablets, USP may cause them to become sedated or somnolent and they should be careful when performing activities that require alertness, such as driving a vehicle or operating machinery. Tell patients that the sedation may be additive when Tizanidine Tablets, USP is taken in conjunction with drugs (baclofen, benzodiazepines) or substances (e.g., alcohol) that act as CNS depressants. Remind patients that if they depend on their spasticity to sustain posture and balance in locomotion, or whenever spasticity is utilized to obtain increased function, that Tizanidine Tablets, USP decreases spasticity and caution should be used.
  • Distributed by:
  • Sun Pharmaceutical Industries, Inc.
  • Cranbury, NJ 08512
  • Revised: 09/2014
  • No data

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BENZALKONIUM CHLORIDE - 1 (nickelodeon bright bubble gum scented hand sanitizer)

BENZALKONIUM CHLORIDE - 1 (nickelodeon bright bubble gum scented hand sanitizer)

Liposomal Amphotericin - B for Injection IP (AmBisome)

Liposomal Amphotericin - B for Injection IP (AmBisome)

Beclomethasone Dipropionate and Levosalbutamol Inhaler (Aerocort)

Beclomethasone Dipropionate and Levosalbutamol Inhaler (Aerocort)

Monobenzone Cream USP 20% (Albaquin)

Monobenzone Cream USP 20% (Albaquin)

Melphalan Injection IP 50mg (Alkacel)

Melphalan Injection IP 50mg (Alkacel)

Edatate Calcium Disodium Injection USP 200mg/ml (Cal-Rsodate)

Edatate Calcium Disodium Injection USP 200mg/ml (Cal-Rsodate)

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