Generic Name
TiZANidine
Brand Names
Ontralfy, Tizandine, Tizanidne, Zanaflex
FDA approval date: July 03, 2002
Classification: Central alpha-2 Adrenergic Agonist
Form: Tablet, Capsule, Solution
What is Ontralfy (TiZANidine)?
Ontralfy is indicated for the treatment of spasticity in adults. Ontralfy is a central alpha-2-adrenergic agonist indicated for the treatment of spasticity in adults.
Approved To Treat
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Brand Information
Ontralfy (Tizanidine Hydrochloride)
1INDICATIONS AND USAGE
Ontralfy is indicated for the treatment of spasticity in adults.
2DOSAGE FORMS AND STRENGTHS
Oral Solution: 2 mg/5 mL of tizanidine as a clear, colorless to pale yellow solution with a strawberry flavor.
3CONTRAINDICATIONS
Ontralfy is contraindicated in patients:
- taking strong CYP1A2 inhibitors
- with a history of hypersensitivity to tizanidine or the ingredients in Ontralfy. Symptoms have included anaphylaxis and angioedema
4ADVERSE REACTIONS
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
4.1Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
The safety of Ontralfy has been established from adequate and well-controlled studies of tizanidine tablets in adult patients with spasticity
The safety of tizanidine has been evaluated in three double-blind, randomized, placebo-controlled clinical studies
The most common adverse reactions (>10% of patients treated with tizanidine) reported in multiple dose, placebo-controlled clinical studies involving 264 patients with spasticity were dry mouth, somnolence/sedation, asthenia (weakness, fatigue and/or tiredness), and dizziness. Three-quarters of the patients rated the reactions as mild to moderate and one-quarter of the patients rated the reactions as being severe. These adverse reactions appeared to be dose related.
Table 1 lists adverse reactions that were reported in greater than 2% of patients in three multiple dose, placebo-controlled studies who received tizanidine where the frequency in the tizanidine group was greater than the placebo group.
Table 1: Multiple Dose, Placebo-Controlled Studies Adverse Reactions Reported in >2% of Patients Treated with Tizanidine Tablets and Incidence Greater than Placebo
* includes weakness, fatigue, and/or tiredness
In the single dose, placebo-controlled study involving 142 patients with spasticity due to multiple sclerosis (Study 1)
Table 2: Single Dose, Placebo-Controlled Study—Common Adverse Reactions Reported
* includes weakness, fatigue, and/or tiredness
4.2Postmarketing Experience
The following adverse reactions have been identified during post approval use of tizanidine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiac Disorders: Ventricular tachycardia, decreased blood pressure
Hepatobiliary Disorders: Hepatotoxicity
Musculoskeletal and Connective Tissue Disorders: arthralgia
Nervous System Disorders: Convulsion, paresthesia, tremor, muscle spasms
Psychiatric Disorders: Hallucinations
Skin and Subcutaneous Tissue Disorders: Stevens Johnson Syndrome, anaphylactic reaction
5OVERDOSAGE
A review of the safety surveillance database revealed cases of intentional and accidental tizanidine overdose. Some of the cases resulted in fatality and many of the intentional overdoses were with multiple drugs including CNS depressants. The clinical manifestations of tizanidine overdose were consistent with its known pharmacology. In the majority of cases a decrease in sensorium was observed including lethargy, somnolence, confusion and coma. Depressed cardiac function is also observed including most often bradycardia and hypotension. Respiratory depression is another common feature of tizanidine overdose.
Should overdose occur, ensure the adequacy of an airway and monitor cardiovascular and respiratory function. Dialysis is not likely to be an efficient method of removing tizanidine from the body
6DESCRIPTION
Ontralfy contains tizanidine hydrochloride as the active ingredient, which is a central alpha2-adrenergic agonist. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. It has a molecular formula of C
Tizanidine hydrochloride is a white to off-white, fine crystalline powder, which is odorless or with a faint characteristic odor. Tizanidine hydrochloride is slightly soluble in water and methanol; solubility in water decreases as the pH increases.
Ontralfy is supplied as an oral solution. Each 5 mL contains 2 mg tizanidine (equivalent to 2.29 mg tizanidine hydrochloride), and the inactive ingredients anhydrous citric acid, edetate disodium dihydrate, flavor, methylparaben sodium, propylparaben sodium, purified water, sodium citrate anhydrous, and sucralose. Each 5 mL of Ontralfy contains 2 mg of sodium.
7CLINICAL STUDIES
The efficacy of Ontralfy is supported by evidence from a relative bioavailability study in healthy adult subjects comparing Ontralfy to tizanidine tablets under fasted and fed conditions
The efficacy of tizanidine for the treatment of spasticity was demonstrated in two adequate and well-controlled studies in patients with multiple sclerosis or spinal cord injury (Studies 1 and 2).
8PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
NDC 69528-310-16
Ontralfy™
16 fl. oz. (473 mL)
