TILAX 2/MG TAB 30/TAB

Indications

Approved Uses

Management of spasticity (e.g., due to multiple sclerosis or spinal cord injury/other spinal cord disorders).

Off-Label Uses

Off-label: musculoskeletal pain/spasm (e.g., acute or chronic back/neck pain), headache disorders (e.g., tension-type or migraine adjunct; medication-overuse/rebound headache), and fibromyalgia (adjunct).

Dosage & Administration

Dosing by Condition

Spasticity: start 2 mg orally up to every 6-8 hours as needed; increase by 2-4 mg per dose with intervals of about 1-4 days between increases; usual max 36 mg/day (in divided doses).

Initial Dose

2 mg orally every 6-8 hours as needed

Maintenance Dose

Titrate gradually in 2-4 mg increments per dose; usual maintenance 4-8 mg orally up to three times daily (maximum 36 mg/day in divided doses) based on patient response and tolerability.

Maximum Dose

36 mg per 24 hours.

Children's Dosage

Not approved for children.

Dose Adjustment Notes

Titrate gradually; in renal impairment (CrCl <25 mL/min) use lower doses and increase dose less frequently; avoid or use extreme caution in hepatic impairment with dose reduction and close monitoring; in older adults use cautious dosing and slower titration.

How to Take

Swallow tablet with water; may be taken with or without food, but take consistently the same way each time (with food or without food).

Side Effects

Common Side Effects

Drowsiness/somnolence, dizziness, dry mouth, asthenia/fatigue, hypotension (including orthostatic), and bradycardia.

Safety & Warnings

Contraindications

Contraindicated in: (1) known hypersensitivity to tizanidine; (2) concomitant use with potent CYP1A2 inhibitors-especially fluvoxamine or ciprofloxacin.

Warnings & Precautions

Key warnings/precautions: avoid concomitant potent CYP1A2 inhibitors; monitor for hypotension/bradycardia (caution with antihypertensives and position changes); monitor liver function (baseline and periodically) and stop if significant LFT elevation/hepatitis symptoms; sedation-avoid alcohol/CNS depressants and caution driving; use caution in renal/hepatic impairment; taper gradually to avoid rebound hypertension/tachycardia; monitor for hallucinations.

Age Restriction

Pediatric use: safety and efficacy have not been established; generally not recommended in patients <18 years unless specialist-directed.

Driving Warning

Avoid Driving

Drug Interactions

Drug Interactions

Major/contraindicated: fluvoxamine, ciprofloxacin (potent CYP1A2 inhibitors). Other clinically important interactions: other CYP1A2 inhibitors (e.g., zileuton, some fluoroquinolones) ↑ tizanidine; antihypertensives (incl. clonidine) ↑ hypotension/bradycardia; CNS depressants/alcohol ↑ sedation/respiratory depression risk; oral contraceptives ↑ tizanidine exposure.

Interaction Severity

MAJOR/Contraindicated: ciprofloxacin and fluvoxamine (strong CYP1A2 inhibitors). MODERATE: other CYP1A2 inhibitors (e.g., oral contraceptives, cimetidine, amiodarone, verapamil, some fluoroquinolones), antihypertensives, alcohol and other CNS depressants (additive hypotension/sedation).

Food Interaction

Food affects absorption; tablets and capsules are not bioequivalent with food-take consistently with or without food and avoid switching formulation/food state without clinician guidance.

Alcohol Interaction

Dangerous

Special Populations

Children

Not approved for children.

Elderly

Start at lowest dose (2 mg), titrate slowly with close monitoring of blood pressure and renal function

Kidney Impairment

CrCl <25 mL/min: use with caution-start low, titrate slowly; reduce individual doses and/or extend dosing interval based on response and tolerability. CrCl ≥25 mL/min: no specific adjustment but monitor for excess effects.

Liver Impairment

Hepatic impairment: avoid if possible; if used, start at the lowest dose and titrate cautiously with close LFT monitoring. Severe hepatic impairment: generally avoid/contraindicated per labeling/clinical guidance.

Storage & Patient Advice

Missed Dose

Take as soon as remembered; skip if near the time of the next scheduled dose; do not double the dose

Stopping the Medicine

Do not stop abruptly; taper dose gradually to avoid withdrawal symptoms like rebound hypertension and tachycardia.

Overdose

Overdose: CNS depression (somnolence/lethargy, confusion/coma), bradycardia, hypotension, dizziness; may include agitation, vomiting and respiratory depression. Management: urgent medical evaluation, supportive care (airway/ventilation as needed), IV fluids/vasopressors for hypotension, cardiac monitoring; consider activated charcoal if early and airway protected.

Patient Counseling

Take exactly as prescribed and consistently with or without food; may cause drowsiness/dizziness-avoid driving until effects known; avoid alcohol/CNS depressants; rise slowly to reduce orthostatic symptoms; do not stop abruptly (taper to avoid rebound hypertension/tachycardia); report liver injury symptoms (e.g., jaundice, dark urine, persistent nausea); check with a clinician before starting interacting drugs, especially ciprofloxacin or fluvoxamine.

Monitoring Requirements

Monitor liver function tests at baseline and periodically (commonly at 1, 3, and 6 months or after dose escalation to higher doses), and monitor blood pressure/heart rate especially during initiation and titration; assess renal function in renal impairment.

Pharmacology

Mechanism of Action

Central alpha-2 adrenergic agonist that reduces excitatory neurotransmitter release and polysynaptic spinal reflex activity, producing decreased spasticity and skeletal muscle relaxation.

Onset of Action

Onset/peak effect: about 1-2 hours after an oral dose.

Duration of Effect

3-6 hours.

Half-Life

2-2.5 hours

Metabolism

Extensive hepatic metabolism, primarily via CYP1A2.

Protein Binding

Approximately 30% protein bound.

Product Information

Available Dosage Forms

Tablet, Capsule.

Composition per Dose

Each tablet: 2 mg tizanidine (as tizanidine hydrochloride)

Generic Availability

Yes

Pain Type

Spasticity

Nsaid

No

Opioid

No

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