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Buy Tizanidine 4mg Tablets

  • 1 INDICATIONS AND USAGE

     

    Best Quality Tizanidine for sale, Buy Tizanidine 4mg Tablets, 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 [see Dosage and Administration(2.1)]. Buy Tizanidine 4mg Tablets


  • 2 DOSAGE AND ADMINISTRATION

     

    2.1 Dosing Information

    Tizanidine Tablets, USP  tablets may be prescribed with or without food. Once the formulation has been selected and the decision to take with or without food has been made, this regimen should not be altered.

    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 [see  Clinical Pharmacology (12.3)]. Buy Tizanidine 4mg Tablets, Best Quality Tizanidine for sale

    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.

    2.2 Dosing in Patients with Renal Impairment

    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 [see  Warnings and Precautions (5.7)]. Buy Tizanidine 4mg Tablets

    2.3 Dosing in Patients with Hepatic Impairment

    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. [see  Use in Specific Populations (8.7)]

    2.4 Drug Discontinuation

    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 [see  Drug Abuse and Dependence (9.3)]. Buy Tizanidine 4mg Tablets


  • 3 DOSAGE FORMS AND STRENGTHS

    Tizanidine Tablets, USP 2 mg are white to off-white, round, flat beveled, uncoated tablets debossed with product code “502” 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 “503” on one side, and quadrisecting score on the other.


  • 4 CONTRAINDICATIONS

    Tizanidine Tablets, USP is contraindicated in patientstaking potent inhibitors of CYP1A2, such as fluvoxamine or ciprofloxacin [see Drug Interactions (7.1 , 7.2 )]. Buy Tizanidine 4mg Tablets


  • 5 WARNINGS AND PRECAUTIONS

    5.1 Hypotension

    Tizanidine is an α2-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.

    Monitor for hypotension when Tizanidine Tablets, USP is used in patients receiving concurrent antihypertensive therapy. It is not recommended thatTizanidine Tablets, USP be used with other α2-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 [see  Contraindications  (4)andDrug Interactions (7.1,7.2)]. Buy Tizanidine 4mg Tablets

    5.2 Risk of Liver Injury

    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. [see  Dosage and Administration (2.3)and Use in Specific Populations (8.7)]

    5.3 Sedation

    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. [see  Drug Interactions (7.5,  7.6 )] Buy Tizanidine 4mg Tablets

    5.4 Hallucinosis/Psychotic-Like Symptoms

    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.

    5.5 Interaction with CYP1A2 Inhibitors

    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. [see  Drug Interactions (7.3)and Clinical Pharmacology (12.3)] Buy Tizanidine 4mg Tablets

    5.6 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. [see  Contraindications (4)], Best Quality Tizanidine for sale

    5.7 Increased Risk of Adverse Reactions in Patients with Renal Impairment

    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. [see  Dosage and Administration (2.2)and Use in Specific Populations (8.6)] Buy Tizanidine 4mg Tablets

    5.8 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). [see  Dosage and Administration (2.2)],Best Quality Tizanidine for sale

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