Renal Dose Adjustment (Based on CrCl)
- <25 mL/min: Reduce dose; amount not defined
Hepatic Dose Adjustment
- Hepatic impairment: Extreme caution advised; dose adjustments not defined
See Supplemental Patient Information
- Clinical experience with chronic use of single doses of tizanidine at 8-16 mg or total daily doses of 24-36 mg is limited
- Tablets and capsules are bioequivalent under fasted conditions
- Food has complex effects on tizanidine pharmacokinetics. Food increases absorption for both tablets and capsules. The increase with tablet is approx. 30% and with capsule approx. 10%
- Dose-related hypotension may occur. Hypotension starts within 1 hr of administration and peaks 2-3 hrs after administration; may be associated with bradycardia, orthostatic hypotension, light-headedness/dizziness, and syncope (rarely). Use with caution in patients receiving concurrent antihypertensive therapy; do not use with other a2-adrenergic agonists
- Use with caution when spasticity is utilized to sustain posture, balance in locomotion, or increased function
- Hepatocellular liver injury reported; elevations of LFTs to >3 times the UNL (or 2 times if baseline levels were elevated) have occurred
- Dose-related sedation has occurred in 48% of the patients. Drowsiness may be noted within 0.5 hrs of dosing and peaks at 1.5 hrs following dose. Advise patients not to engage in hazardous activities (driving, operating machinery)
- Hallucinations, delusions, or psychotic-like symptoms may occur
- Avoid abrupt withdrawal of therapy; taper slowly to minimize risk of withdrawal, rebound hypertension, tachycardia, and hypertonia, particularly in patients receiving high doses for prolonged periods
- Monitor patients with CrCl <25 mL/min for onset or increase in severity of common adverse reactions
- Monitor creatinine at baseline; AST/ALT at baseline, 1,3 and 6 months, then periodically
- Monitor temperature and vital signs. Watch for orthostatic hypotension, bradycardia, and signs and symptoms of infection
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- Prolongation of the QT interval and bradycardia
- Concurrent antihypertensive therapy
- Pregnancy
- Lactation
- Women taking oral contraceptives
- Elderly
Supplemental Patient Information
- Patients should be advised of the limited clinical experience with tizanidine both in regard to duration of use and the higher doses required to reduce muscle tone
- Patients should be warned about the risk of clinically significant orthostatic hypotension
- Because of the possibility of sedation, patients should be warned about performing activities requiring alertness
- Patients should also be instructed that the sedation may be additive when tizanidine hydrochloride tablets are taken in conjunction with drugs or substances (e.g., alcohol) that act as CNS depressants
- Patients should be advised of the change in the absorption profile of tizanidine if taken with food and the potential changes in efficacy and adverse effect profiles that may result
- Patients should be advised not to stop tizanidine suddenly as rebound hypertension and tachycardia may occur
- Tizanidine hydrochloride tablets should be used with caution where spasticity is utilized to sustain posture and balance in locomotion or whenever spasticity is utilized to obtain increased function
- Tizanidine should not be used with either fluvoxamine or ciprofloxacin. Because of the potential for interaction with other CYP1A2 inhibitors, patients should be instructed to inform their physicians and pharmacists when any medication is added or removed from their regimen
Pregnancy Category:C
Breastfeeding: Safety unknown; caution advised.
Pricing data from www.DrugStore.com in U.S.A.
- Zanaflex 4 MG CAPS [Bottle] (ACORDA THERAPEUTICS)
150 mg = $551.73
450 mg = $1597.11 - Zanaflex 4 MG TABS [Bottle] (ACORDA THERAPEUTICS)
90 mg = $249.99
270 mg = $730.01 - Zanaflex 2 MG CAPS [Bottle] (ACORDA THERAPEUTICS)
150 mg = $428
450 mg = $1213.92 - Zanaflex 6 MG CAPS [Bottle] (ACORDA THERAPEUTICS)
150 mg = $799.96
450 mg = $2299.88
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
