Tizanidine 4 mg Tablets — Generic For Zanaflex — Dr Reddy

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 tablet 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 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)

Dosage Forms And Strengths

Tablets 2 mg and 4 mg (3)1

Contraindications

Concomitant use with strong CYP1A2 inhibitors (4, 7.1)

Patients with a history of hypersensitivity to tizanidine or the ingredientsin tizanidine tablets (4, 5.5)

Warnings And Precautions

• (5.1, 5.2, 5.4, 5.5) 11/2024 INDICATIONS AND USAGE Tizanidine tablet 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 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

• (5.1, 5.2, 5.4, 5.5) 11/2024 INDICATIONS AND USAGE Tizanidine tablet 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 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

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

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

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

Hallucinations: consider discontinuation of tizanidine hydrochloride (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 Dr. Reddy’s Laboratories Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug 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 tizanidine hydrochloride dosage or discontinue. (7.2, 12.3)

Use In Specific Populations

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

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

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 12/2024