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MINT-TIZANIDINE is a brand name for Tizanidine, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE .............................................................................................. 3 CONTRAINDICATIONS ................................................................................................................... 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
General Hypotension Tizanidine HCl is an α2-adrenergic agonist (like clonidine) and can produce hypotension. In a single dose study where blood pressure was monitored closely after dosing, two thirds of patients treated with 8 mg of tizanidine had a 20% reduction in either the diastolic or systolic BP.
The reduction was seen within 1 hour after dosing, peaked 2 to 3 hours after dosing and was associated, at times, with bradycardia, orthostatic hypotension, lightheadedness/dizziness and rarely syncope. The hypotensive effect is dose related and has been measured following single doses of ≥ 2 mg.
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 a fixed upright position may be at increased risk for hypotensive and orthostatic effects.
Caution is advised when MINT-TIZANIDINE is to be used in patients who have a history of orthostatic hypotension or labile blood pressure or who are receiving concurrent antihypertensive therapy. MINT-TIZANIDINE should not be used with other α2-adrenergic agonists.
Risk of Liver Injury Tizanidine use occasionally causes drug induced liver injury, most often hepatocellular in type. In controlled clinical studies, approximately 5% of patients treated with tizanidine had elevations of liver function tests (ALT/SGPT, AST/SGOT) to greater than 3 times the upper limit of normal (or 2 times if baseline levels were elevated).
The patients usually remain asymptomatic despite increased aminotransferases. In occasional symptomatic cases, nausea, vomiting, anorexia and jaundice have been reported. The onset of the elevated liver enzymes typically occurred within the first 6 months of treatment with tizanidine and most resolved rapidly upon drug withdrawal with no reported residual problems.
In post-marketing experience, three deaths associated with liver failure have been reported in patients treated with tizanidine, including one case of fatal fulminant hepatitis. , baseline, 1, 3 and 6 months) and periodically thereafter, based on clinical status.
Because of the potential toxic hepatic effect of tizanidine, the drug should be used only with extreme caution in patients with impaired hepatic function. Sedation In the multiple dose, controlled clinical studies, 48% of patients receiving any dose of tizanidine reported sedation as an adverse event.
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In 10% of these cases, the sedation was rated as severe compared to <1% in the placebo treated patients. Sedation may interfere with everyday activity. The effect appears to be dose related. In a single dose study, 92% of the patients receiving 16 mg, when asked, reported that they were drowsy during the 6-hour study.
This compares to 76% Page 5 of 27 of the patients on 8 mg and 35% of the patients on placebo. Patients began noting this effect 30 minutes following dosing. 5 hours following dosing. Of the patients who received a single dose of 16 mg, 51% continued to report drowsiness 6 hours following dosing compared to 13% in the patients receiving placebo or 8 mg of tizanidine.
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. Hallucinations Tizanidine 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 psychoses in association with the hallucinations.
One patient continued to have problems for at least 2 weeks following discontinuation of tizanidine. Dosage reduction or discontinuation should be considered for patients who experience hallucinations while receiving MINT- TIZANIDINE.
Particular caution should be observed if MINT-TIZANIDINE is administered to patients with a prior history of psychotic illness. Limited Database for Chronic Use of Single Doses Above 8 mg and Multiple Doses Above 24 mg per day Clinical experience with long-term use of tizanidine at single doses of 8 to 16 mg or total daily doses of 24 to 36 mg is limited.
Approximately 75 patients have been exposed to individual doses of 12 mg or more for at least one year and approximately 80 patients have been exposed to total daily doses of 30 to 36 mg/day for at least one year. There is essentially no long-term experience with single, daytime doses of 16 mg.
Because long-term clinical study experience at high doses is limited, only those adverse events with a relatively high incidence are likely to have been identified. Discontinuation of Treatment with MINT-TIZANIDINE If therapy needs to be discontinued, especially in patients who have been receiving high doses for long periods, the dose should be decreased slowly to minimize the risk of withdrawal and rebound hypertension, tachycardia, and hypertonia.
The following additional precautions are listed alphabetically. Carcinogenesis and Mutagenesis Only animal carcinogenesis data and mutagenesis data from in vitro and in vivo assays are available (see TOXICOLOGY). Cardiovascular Prolongation of the QT interval and bradycardia were noted in chronic toxicity studies in dogs at doses equal to the maximum human dose on a mg/m2 basis.
ECG evaluation was not performed in the controlled clinical studies. There have been post-market reports of QT prolongation and a small number of reports of Torsades de Pointes, none of them fatal, during tizanidine treatment. Caution should be exercised when MINT-TIZANIDINE is prescribed with drugs known to prolong the QT interval.
Page 6 of 27 Tizanidine HCl can produce hypotension associated, at times, with bradycardia and orthostatic […]