TILAX 4/MG TAB 30/TAB

Indications

Approved Uses

Management of spasticity (e.g., associated with multiple sclerosis or spinal cord injury).

Off-Label Uses

Off-label: musculoskeletal pain/spasm (e.g., acute or chronic low back/neck pain) and certain headache disorders (e.g., chronic migraine/medication-overuse headache) in selected patients.

Dosage & Administration

Dosing by Condition

Spasticity: start 2 mg up to every 6-8 hours as needed; increase by 2-4 mg per dose at intervals of 1-4 days; usual effective single doses often 8 mg up to three times daily; maximum 36 mg/day.

Initial Dose

2-4 mg orally every 6-8 hours as needed

Maintenance Dose

Up to 36 mg/day in 3 divided doses

Maximum Dose

36mg per 24 hours.

Children's Dosage

Safety and efficacy not established in children.

Dose Adjustment Notes

Titrate slowly in 2-4 mg increments; use lower doses and slower titration in renal impairment (CrCl <25 mL/min) and avoid/use extreme caution in hepatic impairment; consider lower starting doses in older adults.

How to Take

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

Side Effects

Common Side Effects

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

Side Effect Frequency

Very common (>10%): somnolence/drowsiness, dizziness, dry mouth, asthenia/fatigue. Common (1-10%): hypotension, bradycardia, constipation, increased liver enzymes (transaminases).

Safety & Warnings

Contraindications

Contraindicated with fluvoxamine or ciprofloxacin (potent CYP1A2 inhibitors) and in patients with hypersensitivity to tizanidine; avoid use in severe hepatic impairment.

Warnings & Precautions

Monitor liver function (baseline and periodically); risk of hypotension/bradycardia-caution with antihypertensives and in patients prone to syncope; sedation-avoid alcohol/CNS depressants and caution with driving; hallucinations/psychotic-like symptoms; use caution and adjust/titrate carefully in renal impairment and in hepatic impairment; taper to discontinue to avoid rebound hypertension/tachycardia.

Driving Warning

Avoid Driving

Drug Interactions

Drug Interactions

Contraindicated: fluvoxamine, ciprofloxacin. Avoid/Use caution: other CYP1A2 inhibitors (e.g., zileuton, mexiletine, cimetidine, some antiarrhythmics) and oral contraceptives (reduced clearance); additive effects with antihypertensives (hypotension/bradycardia) and CNS depressants/alcohol (sedation/respiratory depression).

Interaction Severity

MAJOR/Contraindicated: ciprofloxacin and fluvoxamine (strong CYP1A2 inhibitors). MODERATE: other CYP1A2 inhibitors (e.g., zileuton, mexiletine), oral contraceptives (reduced clearance), antihypertensives (additive hypotension/bradycardia), alcohol and other CNS depressants (additive sedation/hypotension).

Food Interaction

Food can alter absorption/exposure; take consistently either always with food or always without food.

Alcohol Interaction

Dangerous

Special Populations

Pregnancy

C

Children

Safety and efficacy not established in children.

Elderly

Start at lower doses (2 mg), titrate slowly, monitor blood pressure and renal function closely

Kidney Impairment

CrCl <25 mL/min: start with a low dose and titrate cautiously; increase the individual dose rather than dosing frequency; monitor closely for adverse effects.

Liver Impairment

Hepatic impairment: use with extreme caution; start low and titrate slowly with LFT monitoring; avoid in severe hepatic impairment.

Storage & Patient Advice

Stopping the Medicine

Do not stop abruptly; taper gradually (especially after high doses or prolonged use) to reduce risk of rebound hypertension and tachycardia.

Overdose

Symptoms: marked somnolence, confusion, bradycardia, hypotension, respiratory depression, coma (may include miosis). Management: urgent emergency care; supportive treatment with 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; take consistently with or without food; may cause drowsiness/dizziness-avoid driving/operating machinery until effects are known; avoid alcohol and other sedatives; rise slowly to reduce dizziness/fainting; do not stop abruptly (risk rebound hypertension/tachycardia); report signs of liver injury (e.g., jaundice, dark urine, persistent nausea) and inform clinicians about all medicines-especially ciprofloxacin or fluvoxamine.

Monitoring Requirements

Monitor liver aminotransferases at baseline and periodically (commonly at ~1 month after reaching/near maximum dose and thereafter as clinically indicated); monitor blood pressure/heart rate during titration and dose increases; assess renal function in patients with renal impairment.

Pharmacology

Mechanism of Action

Centrally acting alpha-2 adrenergic agonist that increases presynaptic inhibition in the spinal cord, reducing release of excitatory neurotransmitters and decreasing spasticity/muscle tone.

Onset of Action

Approximately 1 hour (range ~30-90 minutes) after an oral dose.

Duration of Effect

3-6 hours.

Half-Life

Approximately 2.5 hours (range commonly cited ~2-3 hours).

Bioavailability

Oral absolute bioavailability is approximately 20-40% (commonly cited around ~34%) due to extensive first-pass metabolism; food can increase exposure and alter absorption.

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: 4 mg tizanidine (as tizanidine hydrochloride)

Generic Availability

Yes

Pain Type

Spasticity

Nsaid

No

Opioid

No

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