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Tizanidine

Sirdalud, Tizagelan, Tizanidin Actavis · ATC code M03BX02

Also known as: Tizanidin · Brand names: Sirdalud, Tizagelan, Tizanidin Actavis, Tizanidin Ascend, Tizanidin Teva, Santadine, Simvacor, Ontralfy, Zanaflex

Key facts
Active substance
Tizanidine
Drug class
Muscle relaxant
ATC code
M03BX02
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-27

Key facts

Tizanidine is a central alpha-2-adrenergic agonist. Per the US label it is used to manage spasticity, reserved for the daily activities and times when relief matters most.

What it is used for

  • Management of spasticity

Dosing

  • Starting dose 2 mg; may repeat at 6 to 8 hour intervals as needed, up to three doses in 24 hours
  • Increase by 2 mg to 4 mg per dose with 1 to 4 days between increases; total daily dose not above 36 mg
  • Take with or without food, but keep the chosen regimen (tablets and capsules differ in the fed state)
  • Renal insufficiency (creatinine clearance < 25 mL/min) and hepatic impairment: reduce individual doses
  • After high doses, discontinue slowly (2 mg to 4 mg per day) to avoid rebound hypertension and tachycardia

Contraindications

  • Concomitant potent CYP1A2 inhibitors such as fluvoxamine or ciprofloxacin

Important warnings

  • Hypotension and syncope; caution with antihypertensives
  • Hepatocellular liver injury; check aminotransferases at baseline and 1 month after reaching the maximum dose
  • Sedation
  • Hallucinations and psychotic-like symptoms
  • Withdrawal reactions on abrupt discontinuation

Side effects

  • Most common: dry mouth, somnolence/sedation, asthenia and dizziness
  • Hypotension and bradycardia
  • Liver injury, hallucinations, hypersensitivity reactions

Interactions

  • Fluvoxamine and ciprofloxacin: contraindicated (marked blood pressure drop, increased drowsiness)
  • Other CYP1A2 inhibitors (e.g. oral contraceptives, acyclovir, ticlopidine) should be avoided
  • Other alpha-2 agonists not recommended; antihypertensives: monitor for hypotension

Pregnancy and breastfeeding

  • Not studied in pregnant women; use only if the benefit outweighs the risk to the fetus
  • Unknown whether excreted in human milk; caution when nursing

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Patient information (US)

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Austria

  • SirdaludSandoz Gmbh · 2 register entries
  • TizagelanG.L. Pharma Gmbh · 1 register entry
  • Tizanidin ActavisActavis Group Ptc Ehf. · 2 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • SirdaludHexal Ag · 1 register entry
  • Tizanidin AscendAscend Gmbh · 1 register entry
  • Tizanidin TevaTeva Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • SantadineSANTA FARMA İLAÇ SAN. A.Ş. · 1 register entry
  • SimvacorGÜREL İLAÇ TİC. A.Ş. · 1 register entry
  • SirdaludSANDOZ İLAÇ SAN. VE TİC. A.Ş. · 2 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

USA

  • OntralfyRosemont Pharmaceuticals, LLC · 1 register entry
  • ZanaflexCovis Pharma US, Inc, Legacy Pharma USA, Inc., Trifluent Pharma, LLC · 3 register entries

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-28

Brand names in 20 more European countries
Belgium
Sirdalud
Bulgaria
Tizanidine Teva, Тизанидин Tева
Croatia
Tizanidin Altamedics
Czechia
Sirdalud
Denmark
Sirdalud Retard, Tizanidin Teva
Estonia
Sirdalud
Finland
Sirdalud, Tizagelan, Tizanidin Orion
Greece
Sirdalud
Hungary
Sirdalud, Tizagelan
Ireland
Tizanidine Teva
Italy
Navizan, Sirdalud, Tizagelan, Tizanidina Doc
Latvia
Sirdalud
Lithuania
Sirdalud
Luxembourg
Sirdalud
Netherlands
Chordyna, Sirdalud, Tizagelan, Tizanidine Ascend, Tizanidine Focus Care, Tizanidine Teva
Poland
Chordyna, Sirdalud, Tizagelan, Tizanor
Portugal
Sirdalud, Tizanidina Teva, Tizanidine Teva
Slovakia
Sirdalud
Slovenia
Sirdalud
Spain
Sirdalud

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

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Sources

  1. U.S. Food and Drug Administration. Tizanidine (AvPAK) – Prescribing Information, 2026-01-11. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b694225c-1fa9-4726-89a6-fd3f87084248
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-28. https://dailymed.nlm.nih.gov/dailymed/
  6. Wikidata (CC0): ATC M03BX.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.