SIRDALUD 2MG 30TAB

Indications

Approved Uses

Management of spasticity associated with multiple sclerosis, stroke, or spinal cord injury.

Off-Label Uses

Off-label: chronic musculoskeletal pain (e.g., neck/back pain), headache disorders (e.g., chronic migraine/tension-type), and fibromyalgia (evidence variable).

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 1-4 days between increases; typical effective single doses are 8 mg up to 3 times daily; maximum 36 mg/day.

Initial Dose

2 mg orally every 6-8 hours as needed

Maintenance Dose

Titrated based on patient response, typically up to 8 mg three times daily.

Maximum Dose

36 mg per day (maximum single dose 16 mg)

Children's Dosage

Safety and effectiveness have not been established in pediatric patients.

Dose Adjustment Notes

Increase dose gradually in 2-4 mg increments per dose with 1-4 days between increases; use lower doses and slower titration in renal impairment and avoid/use extreme caution in hepatic impairment; do not stop abruptly-taper to avoid rebound hypertension/tachycardia.

Side Effects

Common Side Effects

Dry mouth, drowsiness/somnolence, dizziness, asthenia/weakness, fatigue; hypotension/bradycardia can occur.

Side Effect Frequency

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

Safety & Warnings

Contraindications

Contraindicated in: hypersensitivity to tizanidine; concomitant use with potent CYP1A2 inhibitors (especially fluvoxamine or ciprofloxacin); significantly impaired hepatic function.

Warnings & Precautions

Key warnings/precautions: monitor liver function (baseline and periodically, especially during the first months and with dose increases); risk of hypotension/bradycardia (greater with antihypertensives/CYP1A2 inhibitors); sedation-avoid alcohol/CNS depressants and caution with driving; taper to discontinue to avoid rebound hypertension/tachycardia; use caution and lower doses in renal impairment and in the elderly.

Age Restriction

Not recommended/established for patients <18 years (safety and efficacy not established).

Driving Warning

Avoid Driving

Drug Interactions

Drug Interactions

Major interactions: fluvoxamine and ciprofloxacin (contraindicated); other CYP1A2 inhibitors (e.g., cimetidine, amiodarone, mexiletine, zileuton, some oral contraceptives) increase tizanidine levels; antihypertensives and other alpha-2 agonists (e.g., clonidine) increase hypotension/bradycardia risk; CNS depressants/alcohol increase sedation; oral contraceptives may reduce clearance.

Food Interaction

No specific food restriction, but food can alter absorption; take consistently with or without food (and avoid switching administration conditions).

Alcohol Interaction

Dangerous

Special Populations

Children

Safety and effectiveness have not been established in pediatric patients.

Elderly

Start at lowest dose (2 mg), titrate slowly with careful monitoring of blood pressure and liver function; renal clearance may be reduced

Liver Impairment

Significant hepatic impairment: contraindicated/avoid; any hepatic impairment: use with extreme caution, consider lower doses and slower titration with LFT monitoring.

Storage & Patient Advice

Stopping the Medicine

Do not stop abruptly after prolonged use or higher doses; taper gradually to reduce risk of withdrawal (rebound hypertension, tachycardia, hypertonia).

Overdose

Symptoms: CNS depression (somnolence/lethargy to coma), bradycardia, hypotension, respiratory depression; may include agitation/confusion and vomiting. Management: urgent emergency care with supportive treatment (airway/ventilation, IV fluids/vasopressors as needed); consider activated charcoal if early after ingestion.

Patient Counseling

Take exactly as prescribed and consistently with respect to meals; 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-taper with prescriber guidance; report signs of liver injury (e.g., jaundice, dark urine, persistent nausea).

Monitoring Requirements

Monitor liver aminotransferases at baseline and periodically (commonly at 1 month after reaching a stable/maximum dose, then periodically thereafter); monitor blood pressure/heart rate especially during initiation and titration.

Pharmacology

Mechanism of Action

Centrally acting alpha-2 adrenergic agonist that reduces excitatory neurotransmitter release in the spinal cord, decreasing facilitation of motor neuron activity and reducing spasticity.

Onset of Action

Peak clinical effect occurs about 1-2 hours after an oral dose.

Duration of Effect

3-6 hours.

Half-Life

Approximately 2.5 hours (range ~2-4 hours)

Bioavailability

Oral bioavailability is about 40% due to extensive first-pass metabolism; food can increase exposure and alter peak concentrations (hence the need for consistent administration).

Excretion

Eliminated mainly as metabolites: predominantly renal (~60%) with a smaller fecal component (~20%).

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

Muscular

Nsaid

No

Opioid

No

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