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: 4 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.
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  • No data
  • Tizanidine is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most importantn n n n
  • Tizanidine is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important. n n n n
  • No data
  • 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 u00a0n 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
  • 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
  • To discontinue tizanidine, decrease dose slowly to minimize the risk of withdrawal and rebound hypertension, tachycardia, and hypertonia n n n n
  • Arrayn- Tablets
  • 4 mg- white to off-white, round, scored tablets, imprinted u201cAPOu201d over u201cTI-4u201d on one side and plain with a quadrisect score on the other side.
  • Arrayn- Array
  • Tablets 2 mg and 4 mg n n n n n
  • Tizanidine is contraindicated in patients taking potent inhibitors of CYP1A2, such as fluvoxamine or ciprofloxacin n n n n
  • 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 n n
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  • Hypotension: monitor for signs and symptoms of hypotension, in particular in patients receiving concurrent antihypertensives; tizanidine should not be used with other u03b1n n n -adrenergic agonists n n n n n
  • Risk of liver injury: monitor ALTs; discontinue tizanidine if liver injury occurs n n n n
  • Sedation: Tizanidine may interfere with everyday activities; sedative effects of tizanidine, alcohol, and other CNS depressants are additive n n n n n u00a0n n n
  • Hallucinations: consider discontinuation of tizanidine n n n u00a0n n n
  • Less potent inhibitors of CYP1A2: may cause hypotension, bradycardia, or excessive drowsiness, use caution if tizanidine is 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
  • Renal impairment (creatinine clearance < 25 mL/min): use tizanidine with caution, and monitor closely for dry mouth, somnolence, asthenia and dizziness as indicators of potential overdose n n n n
  • The following adverse reactions are described elsewhere in other sections of the prescribing information:
  • 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 u00a0n nn
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  • Pregnancy: Based on animal data, may cause fetal harm n n n u00a0n n n
  • Geriatric use: tizanidine should be used with caution in elderly patients because clearance is decreased four-fold n n n n
  • No data
  • A review of the safety surveillance database revealed cases of intentional and accidental tizanidine 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.u00a0
  • 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 hydrochloride is a centrally acting u03b1n n n -adrenergic agonist. Tizanidine HCl (tizanidine) 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 hydrochloride. Tizanidineu2019s 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 nn
  • Tizanidine Tablets, USP are supplied as 2, and 4 mg tablets for oral administration. Tizanidine Tablets, USP are composed of the active ingredient, tizanidine hydrochloride (2.288 mg equivalent to 2 mg tizanidine base, and 4.576 mg equivalent to 4 mg tizanidine base), and the inactive ingredients, anhydrous lactose, colloidal silicon dioxide, microcrystalline cellulose and stearic acid.
  • Meets USP Dissolution Test 2
  • No data
  • Carcinogenesis
  • in vitro
  • in vivo
  • Impairment of fertility n n n n
  • u00a0Tizanidineu2019s 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).
  • Arrayn- Single-Dose Study in Patients with Multiple Sclerosis with Spasticity
  • 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.u00a0
  • Assessments were made at 1, 2, 3 and 6 hours after treatment. A statistically significant reduction of the Ashworth score for tizanidine 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 groups was indistinguishable from muscle tone in placebo treated patients. Within a given patient, improvement in muscle tone was correlated with plasma concentration. Plasma concentrationsn n n 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.n nn
  • Arrayn- Seven-Week Study in Patients with Spinal Cord Injury with Spasticity
  • 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.u00a0
  • 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 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 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.
  • Tizanidine Tablets, USP 4 mg are available for oral administration as white to off-white, round, scored tablets, imprinted u201cAPOu201d over u201cTI-4u201d on one side and plain with a quadrisect score on the other side. They are supplied as follows:
  • Bottles of 30 NDC66267-598-30n nBottles of 60 NDC 66267-598-60n nBottles of 84 NDC 66267-598-84n nBottles of 90 NDC 66267-598-90n
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted from 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature].
  • Dispense in a tight, light-resistant container [see USP].
  • Serious Drug Interactionsu00a0
  • Tizanidine Dosing
  • Effects of Tizanidine n- Array
  • APOTEX INC.n- Tizanidine Tablets, USP n- 2 mg and 4 mg
  • Revised: October 2015 n n n Rev. 5 n nn
  • No data

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of tizanidine (tizanidine) which is also known as tizanidine and Manufactured by NuCare Pharmaceuticals, Inc.. It is available in strength of 4 mg/1.

tizanidine (tizanidine) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.

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