Tizanidine 4 mg Tablets — Generic For Zanaflex — Unichem

These highlights do not include all the information needed to use TIZANIDINE TABLETS safely and effectively. See full prescribing information for TIZANIDINE TABLETS.

TIZANIDINE tablets, for oral use

Initial U.S. Approval:1996

Recent Major Changes

Indications and Usage (1) 11/2024

Dosage and Administration (2.1, 2.2, 2.3, 2.4, 2.5, 2.6) 11/2024

Contraindications (4) 11/2024

Warnings and Precautions (5.1, 5.2, 5.4, 5.5) 11/2024

Indications And Usage

Tizanidine is a central alpha-2-adrenergic agonist indicated for the treatment of spasticity. (1)

Dosage And Administration

Monitoring of aminotransferase levels is recommended at baseline and 1 month 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 every 1 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, decrease dose slowly to minimize the risk of withdrawal adverse reactions (2.5)

Dosage Forms And Strengths

Tablets 2 mg and 4 mg (3)

Contraindications

Concomitant use with strong CYP1A2 inhibitors (4, 7.1)

Patients with a history of hypersensitivity to tizanidine or the ingredients in Tizanidine (4, 5.5)

Warnings And Precautions

• (5.1, 5.2, 5.4, 5.5) 11/2024 INDICATIONS AND USAGE Tizanidine is a central alpha-2-adrenergic agonist indicated for the treatment of spasticity. (1) DOSAGE AND ADMINISTRATION
• Monitoring of aminotransferase levels is recommended at baseline and 1 month 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 every 1 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, decrease dose slowly to minimize the risk of withdrawal

• (5.1, 5.2, 5.4, 5.5) 11/2024 INDICATIONS AND USAGE Tizanidine is a central alpha-2-adrenergic agonist indicated for the treatment of spasticity. (1) DOSAGE AND ADMINISTRATION
• Monitoring of aminotransferase levels is recommended at baseline and 1 month 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 every 1 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, decrease dose slowly to minimize the risk of withdrawal

Hypotension: monitor for signs and symptoms of hypotension, in particular in patients receiving concurrent antihypertensives; tizanidine should not be used with other α2-adrenergic agonists (5.1, 7.7)

Risk of liver injury: monitor ALTs; discontinue tizanidine if liver injury occurs (5.2)

Sedation: tizanidine may interfere with everyday activities; sedative effects of tizanidine, alcohol, and other central nervous system (CNS) depressants are additive (5.3, 7.4)

Hallucinations: consider discontinuation of tizanidine (5.4)

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 (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Unichem Pharmaceuticals (USA) Inc. at 1-866-562-4616 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Use In Specific Populations

● Pregnancy: Based on animal data, may cause fetal harm (8.1)

● Geriatric use: Tizanidine should be used with caution in elderly patients because clearance is decreased four-fold (8.5)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 5/2025