Uses
Zanaflex is indicated for the treatment of spasticity in adults. Zanaflex is a central alpha-2-adrenergic agonist indicated for the treatment of spasticity.
Source: US FDA prescribing information
Molecule
Tizanidine
Also known as tizanidine hydrochloride
Available on requestOrphan
- Presentations
- 12
- Brands
- 2
- Manufacturers
- 3
- Available from stock
- 0
Tizanidine is a central alpha-2 adrenergic agonist indicated for the treatment of spasticity in adults. It is available as tablets, capsules and oral solution. MedsAcross supplies Tizanidine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Key facts
- Pharmacological class
- Central alpha-2 Adrenergic Agonist, Adrenergic alpha2-Agonists
- ATC classification
- M03BX02 Tizanidine · Muscle relaxant, subgroup M03BX
- US FDA first approval
- 27 November 1996
- EU status
- Not recorded
- Orphan designation
- Yes
- WHO essential medicine
- Not recorded
- India (CDSCO)
- Not yet confirmed against CDSCO approval lists
- Routes
- Oral
- Dosage forms
- Tablet, Capsule, Oral solution
- Identifiers
- UNII 6AI06C00GWRxCUI 57258CAS 51322-75-9DrugBank DB00697Q423538
Clinical information
From the regulator-approved product information. Each section names its source.
How it works
Tizanidine is a central alpha-2-adrenergic receptor agonist and presumably reduces spasticity by increasing presynaptic inhibition of motor neurons. The effects of tizanidine are greatest on polysynaptic pathways. The overall effect of these actions is thought to reduce facilitation of spinal motor neurons.
Source: US FDA prescribing information
Dosing overview
Monitoring of aminotransferase levels is recommended at baseline and 1 month after maximum dose is achieved. Recommended starting dose: 2 mg by mouth every 6 to 8 hours, as needed, up to a maximum of 3 doses in 24 hours. Dosage can be increased by 2 mg to 4 mg per dose every 1 to 4 days, maximum total daily dosage is 36 mg. Tizanidine pharmacokinetics differs between tablets and capsules, and when taken with or without food. These differences could result in a change in tolerability and control of symptoms. Consistent administration with respect to food is recommended. If substitution between dosage forms is necessary, take into consideration these pharmacokinetic differences. Patients with renal impairment (creatinine clearance <25 mL/min) or hepatic impairment: use lower individual doses during titration.
Source: US FDA prescribing information
Contraindications
Zanaflex is contraindicated in patients taking strong CYP1A2 inhibitors. with a history of hypersensitivity to tizanidine or the ingredients in Zanaflex. Symptoms have included anaphylaxis and angioedema Concomitant use with strong CYP1A2 inhibitors. Patients with a history of hypersensitivity to tizanidine or the ingredients in Zanaflex.
Source: US FDA prescribing information
Warnings and precautions
Hypotension: monitor for signs and symptoms of hypotension, in particular in patients receiving concurrent antihypertensives, Zanaflex should not be used with other α 2 -adrenergic agonists. Risk of liver injury: monitor ALTs, discontinue Zanaflex if liver injury occurs. Sedation: Zanaflex may interfere with everyday activities, sedative effects of Zanaflex, alcohol, and other central nervous system (CNS) depressants are additive. Hallucinations: consider discontinuation of Zanaflex
Source: US FDA prescribing information
Side effects
The following clinically significant adverse reactions are described elsewhere in other sections of the prescribing information: Hypotension Liver Injury Sedation Hallucinosis/Psychotic-Like Symptoms Hypersensitivity Reactions Withdrawal Adverse Reactions The most common adverse reactions (greater than 10% of patients taking tizanidine and greater than in patients taking placebo) were dry mouth, somnolence, asthenia, and dizziness.
Source: US FDA prescribing information
Interactions
Moderate or weak CYP1A2 inhibitors: avoid concomitant use, may cause hypotension, bradycardia, or excessive drowsiness, if concomitant use is necessary and adverse reactions occur, reduce Zanaflex dosage or discontinue.
Source: US FDA prescribing information
Storage
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
All presentations
12 presentations of Tizanidine, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Tizanidine 4 mg tabletOralGeneric name | — | US FDA | Available on request |
| Tizanidine 2 mg tabletOralGeneric name | — | US FDA | Available on request |
| Tizanidine 4 mg capsuleOralGeneric name | — | US FDA | Available on request |
| Tizanidine 6 mg capsuleOralGeneric name | — | US FDA | Available on request |
| Tizanidine 2 mg capsuleOralGeneric name | — | US FDA | Available on request |
| Tizanidine 8 mg capsuleOralGeneric name | — | US FDA | Available on request |
| Zanaflex 2 mg capsuleOral | Legacy Pharma | US FDA | Available on request |
| Zanaflex 4 mg tabletOral | Legacy Pharma | US FDA | Available on request |
| Zanaflex 4 mg capsuleOral | Legacy Pharma | US FDA | Available on request |
| Zanaflex 6 mg capsuleOral | Legacy Pharma | US FDA | Available on request |
| Ontralfy 2 mg/5 mL oral solutionOral | Rosemont Pharmaceuticals | US FDA | Available on request |
| Zanaflex 8 mg capsuleOral | Trifluent Pharma | US FDA | Available on request |
Brands by market
2 brand names across 1 markets.
Manufacturers
Regulatory status
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 27 November 1996 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions
Conditions linked to Tizanidine in public data. This is not a list of approved uses, see the clinical information.
Questions and answers
Is Tizanidine available for export from India?
Yes, on request. MedsAcross lists 12 presentations of Tizanidine and sources them for licensed hospitals, importers and physicians against valid import documents.
What brand names does Tizanidine have?
The catalogue lists 2 brand names for Tizanidine, including Ontralfy, Zanaflex.
Is Tizanidine approved by the US FDA?
Yes. The US FDA first approved Tizanidine on 27 November 1996, according to Drugs@FDA.
Does Tizanidine need cold chain shipping?
No listed presentation of Tizanidine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Which ATC class is Tizanidine in?
Tizanidine is classified under ATC code M03BX02 (Tizanidine).
References
- Zanaflex prescribing information (Legacy Pharma). U.S. National Library of Medicine, DailyMed. Retrieved 2 January 2026
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