Tizanidine

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Monitoring of aminotransferase levels is recommended at baseline and 1month after maximum dose is achieved.
• (2.1) Recommended starting dose:
• 2 mg by mouth every 6 to 8 hours, as needed, up to a maximum of 3 doses in 24 hours (2.2) Dosage can be increased by 2 mg to 4 mg per dose every1 to 4 days; maximum total daily dosage is 36 mg (2.2) 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.
• ( 2.2 , 2.6, 12.3) Patients with renal impairment (creatinine clearance <25 mL/min) or hepatic impairment:
• use lower individual doses during titration.
• If higher doses are required, individual doses rather than dosing frequency should be increased.
• (2.3 , 2.4 ) To discontinue tizanidine tablets, decrease dose slowly to minimize the risk of withdrawal adverse reactions (2.5)
• 2.1 Recommended Evaluation and Testing Before and After Initiating Tizanidine tablets Monitoring of aminotransferase levels is recommended at baseline and 1 month after maximum dose is achieved [see Warnings and Precautions ( 5.2) ] .
• 2.2 Recommended Dosage The recommended starting dose is 2 mg by mouth every 6 to 8 hours,as needed, to a maximum of three doses in 24 hours.
• Dosage can be gradually increased every 1 to 4 days by 2 mg to 4 mg at each dosebased on clinical response and tolerability.
• The maximum total daily dosage is 36 mg.
• Single doses greater than 16 mg have not been studied.
• There are pharmacokinetic differences when administering tizanidine tablets between the fed or fasted state [see Clinical Pharmacology (12.3) ] .
• Tizanidine tablets may be taken with or without food; however, consistent administration with respect to food is recommended to reduce variability in tizanidine plasma exposure.
• Because of the short duration of therapeutic effect, treatment with tizanidine tablets should be reserved for those daily activities and times when relief of spasticity is most important.
• 2.3 Recommended Dosage in Patients with Renal Impairment In patients with creatinine clearance < 25 mL/min, use lower individual doses during titration.
• If higher doses are required, the individual doses rather than dosing frequency should be increased [see Use in Specific Populations ( 8.6 ) and Clinical Pharmacology ( 12.3) ].
• 2.4 Recommended Dosage in Patients with Hepatic Impairment In patients with hepatic impairment, use lowerindividual doses during titration.
• If higher doses are required, individual doses rather than dosing frequency should be increased [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3) ].
• 2.5 Discontinuation of Tizanidine Tablets When discontinuing tizanidine tablets, particularly in patients who have been receiving high doses for long periods or who may be on concomitant treatment with narcotics, decreasethe dosage by 2 mg to 4 mg per day to minimize the risk of withdrawal adverse reactions [see Drug Abuse and Dependence (9.3) ].
• 2.6 Switching Between With/Without Food and Different Tizanidine Dosage Forms There are pharmacokinetic differences when:
• 1) switching between administration of Tizanidine with or without food 2) switching between dosage forms if being administered with food.
• If these situations occur, monitor patients for therapeutic effect or adverse reactions [see Dosage and Administration ( 2.2 ) and Clinical Pharmacology ( 12.3 )].

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Misuse and dependence

Quoted from the official label, section “Drug Abuse and Dependence”.

Use in children

• Safety and effectiveness in pediatric patients have not been established.
• Juvenile Animal Toxicity Data Oral administration of tizanidine (0, 1, 3, and 10 mg/kg/day) to juvenile rats from postnatal day (PND) 7 through PND 70 resulted in delayed sexual maturation in males at all doses, reduced body weight gain, delayed sexual maturation in females, and bilateral corneal crystals at the mid and high doses.
• Corneal crystals were still observed at the mid and high doses after a three-week recovery period.
• Neurobehavioral deficits were observed on a learning and memory task at the high dose.
• A no-effect dose for adverse effects on postnatal development not identified.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• Tizanidine hydrochloride is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function.
• Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
• Clinical studies of tizanidine hydrochloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects.
• Pharmacokinetic data showed that younger subjects cleared tizanidine faster than the elderly subjects [see Clinical Pharmacology (12.3) ] .
• In elderly patients with renal insufficiency (creatinine clearance < 25 mL/min), tizanidine clearance is reduced compared to healthy elderly subjects; this would be expected to lead to a longer duration of clinical effect.
• During titration, the individual doses should be reduced.
• If higher doses are required, individual doses rather than dosing frequency should be increased.
• Monitor elderly patients because they may have an increased risk for adverse reactions associated with tizanidine hydrochloride.

Quoted from the official label, section “Geriatric Use”.

Side effects

• The following clinically significant adverse reactions are described elsewhere in other sections of the prescribing information:
• Hypotension [see Warnings and Precautions ( 5.1 )] Liver Injury [see Warnings and Precautions ( 5.2 )] Sedation [see Warnings and Precautions ( 5.3 )] Hallucinosis/Psychotic-Like Symptoms [see Warnings and Precautions ( 5.4 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.5 )] Withdrawal Adverse Reactions [see Warnings and Precautions ( 5.6 )] 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.
• ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Dr.
• Reddy’s Laboratories Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
• 6.1 Clinical 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 clinical practice.
• The safety of tizanidine has been evaluated in three double-blind, randomized, placebo-controlled clinical studies [see Clinical Studies (14)].
• Two studies were conducted in patients with multiple sclerosis and one in patients with spinal cord injury.
• Each study had a 13-week active treatment period which included a 3-week titration phase to the maximum tolerated dose up to 36 mg/day in three divided doses, a 9-week plateau phase where the dose of tizanidine was held constant and a 1-week dose tapering period.
• In all, 264 patients received tizanidine and 261 patients received placebo.
• Across the three studies approximately 51% of patientswere women, and the median dose during the plateau phase ranged from 20 to 28 mg/day.
• 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 hydrochloride where the frequency in the tizanidine hydrochloride 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 Adverse Reaction Placebo N = 261 % Tizanidine Tablet N = 264 % Dry mouth 10 49 Somnolence 10 48 Asthenia* 16 41 Dizziness 4 16 UTI 7 10 Infection 5 6 Liver test abnormality 2 6 Constipation 1 4 Vomiting 0 3 Speech disorder 0 3 Amblyopia (blurred vision) <1 3 Urinary frequency 2 3 Flu syndrome 2 3 Dyskinesia 0 3 Nervousness <1 3 Pharyngitis 1 3 Rhinitis 2 3 *includes weakness, fatigue, and/or tiredness In the single dose, placebo-controlled study involving 142 patients with spasticity due to multiple sclerosis (Study 1) [see Clinical Studies ( 14 )] , the patients were specifically asked if they had experienced any of the four most common adverse reactions:
• dry mouth, somnolence (drowsiness), asthenia (weakness, fatigue and/or tiredness) and dizziness.
• In addition, hypotension and bradycardia were observed.
• The occurrence of these reactions is summarized in Table 2.
• Other events were, in general, reported at a rate of 2% or less.
• Table 2:
• Single Dose, Placebo-Controlled Study—Common Adverse Reactions Reported Adverse Reaction Placebo N = 48 % Tizanidine Tablet, 8mg , N = 45 % Tizanidine Tablet,16 mg, N = 49 % Somnolence 31 78 92 Dry mouth 35 76 88 Asthenia* 40 67 78 Dizziness 4 22 45 Hypotension 0 16 33 Bradycardia 0 2 10 *includes weakness, fatigue, and/or tiredness
• 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tizanidine hydrochloride.
• 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 [see Warnings and Precautions (5.2)] hepatitis Musculoskeletal and Connective Tissue Disorders:
• arthralgia Nervous System Disorders:
• Convulsion, paresthesia, tremor, muscle spasms Psychiatric Disorders:
• Hallucinations [see Warnings and Precautions (5.4)], depression Skin and Subcutaneous Tissue Disorders:
• Stevens Johnson Syndrome, anaphylactic reaction [seeWarnings and Precautions (5.5)], exfoliative dermatitis, rash

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Serious Drug Interactions Advise patients they should not take tizanidine hydrochloride if they are taking fluvoxamine or ciprofloxacin because of the increased risk of serious adverse reactions including severe lowering of blood pressure and sedation.
• Instruct patients to inform their healthcare providers when they start or stop taking any medication because of the risks associated with interaction between tizanidine hydrochloride and other medicines [see Contraindications ( 4 ) and Drug Interactions ( 7 )].
• Tizanidine hydrochloride Dosing and Administration Tell patients to take tizanidine hydrochloride exactly as prescribed (consistently either with or without food) and not to switch between tablets and capsules [see Dosage and Administration ( 2) ].
• Inform patients that they should not take more tizanidine hydrochloride than prescribed because of the risk of adverse events at single doses greater than 8 mg or total daily doses greater than 36 mg.
• Tell patients that they should not suddenly discontinue tizanidine hydrochloride, because rebound hypertension and tachycardia may occur [see Warnings and Precautions ( 5.6 )].
• Hypotension Warn patients that they may experience hypotension and to be careful when changing from a lying or sitting to a standing position. [see Warnings and Precautions (5.1) ] .
• Sedation Tell patients that tizanidine hydrochloride may cause them to become sedated or somnolent and they should be careful when performing activities that require alertness, such as driving a vehicle or operating machinery [see Warnings and Precautions ( 5.3 )] .
• Tell patients that the sedation may be additive when tizanidine hydrochloride is taken in conjunction with drugs (baclofen, benzodiazepines) or substances (e.g., alcohol) that act as CNS depressants.
• Remind patients that if they depend on their spasticity to sustain posture and balance in locomotion, or whenever spasticity is utilized to obtain increased function, that Tizanidine hydrochloride decreases spasticity and caution should be used.
• Hypersensitivity Reactions Inform patients of the signs and symptoms of severe allergic reactions and instruct them to discontinue Tizanidine and seek immediate medical care should these signs and symptoms occur [see Warnings and Precautions (5.5) ].
• Rx Only Distributor: Dr.
• Reddy's Laboratories, Inc., Princeton, NJ 08540.
• Made in India Revised: 12/24

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Tablets Tizanidine Tablets USP, 2 mg are white to off white, oval, flat, beveled edged tablets debossed with “R179” on one side and “bisecting score” on other side.
• Tizanidine Tablets USP, 4 mg are white to off white, oval, flat, beveled edged tablets debossed with “R180” on one side and “quadrisecting score” on other side.
• Tablets 2 mg and 4 mg (3)

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• 16.1 How Supplied Tizanidine Tablets USP, 4 mg are white to off white, oval, flat, beveled edged tablets debossed with “R180” on one side and “quadrisecting score” on other side.
• The tablets are available in bottles of 4,15,30,60,90 Bottles of 4 NDC 60760-505-04 Bottles of 15 NDC 60760-505-15 Bottles of 30 NDC 60760-505-30 Bottles of 60 NDC 60760-505-60 Bottles of 90 NDC 60760-505-90
• Storage and Handling
• Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
• Dispense in containers with child resistant closure.

Quoted from the official label, section “How Supplied”.

What is in it

• Tizanidine hydrochloride USP, is a central α 2 -adrenergic agonist.
• Tizanidine hydrochloride USP is almost white to slightly yellow crystalline powder, which is slightly soluble in water and methanol.
• Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiodiazole monohydrochloride.
• Tizanidine’s molecular formula is C 9 H 8 ClN 5 S.HCl, its molecular weight is 290.2 and its structural formula is:
• Tizanidine tablets USP, are supplied as 2 mg and 4 mg tablets for oral administration.
• Tizanidine tablets USP, contain the active ingredient, tizanidine hydrochloride USP (2.288 mg equivalent to 2 mg tizanidine base and 4.576 mg equivalent to 4 mg tizanidine base), and the inactive ingredients, anhydrous lactose, microcrystalline cellulose, colloidal silicon dioxide and stearic acid. structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

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Same active substance

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