Tizanidine 4 mg/1
Tizanidine · TABLET · A-S Medication Solutions
Tizanidine is a prescription muscle relaxer taken by mouth that helps reduce muscle tightness and spasms caused by conditions like multiple sclerosis or spinal cord injury. It works by calming nerve activity in the muscles to provide relief from muscle stiffness.
Key Facts
- Brand Name
- Tizanidine
- Generic Name
- Tizanidine
- NDC Code (Product)
50090-6757- Manufacturer
- A-S Medication Solutions
- Strength
- 4 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA076286
- Marketing Start
- 06/15/2021
Recall History
Dr. Reddy's Laboratories, Inc.
Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets .
Stat Rx USA
Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label.
Dr. Reddy's Laboratories, Inc.
Failed Tablet/Capsule Specification: Some tablets are shaved
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Aidapak Services, LLC
Labeling:Label Mixup; tiZANidine HCl Tablet, 1 mg (1/2 of 2 mg) may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 00536440801, Pedigree: AD60428_10, EXP: 5/22/2014.
Dr Reddy's Laboratories Limited
Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
Aidapak Services, LLC
Labeling: Label Mixup: tiZANidine HCl, Tablet, 2 mg may have potentially been mislabeled as the following drug: NIACIN TR, Tablet, 500 mg, NDC 00904434260, Pedigree: W002969, EXP: 6/11/2014.
Dr. Reddy'S Laboratories
Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details.
Ascend Laboratories LLC
Failed Dissolution Specifications; Out of Specification (low) results were obtained.
Preferred Pharmaceuticals, Inc.
Failed Stability Specifications
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Tizanidine is indicated for the treatment of spasticity in adults. Tizanidine is a central alpha-2-adrenergic agonist indicated for the treatment of spasticity. (1)
Dosage & Administration
2 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 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 Monit…
Contraindications
4 CONTRAINDICATIONS Tizanidine is contraindicated in patients: • taking strong CYP1A2 inhibitors [see Drug Interactions ( 7.1 )]. • with a history of hypersensitivity to tizanidine or the ingredients in tizanidine tablets. Symptoms have included anaphylaxis and angioedema [see Warnings and Precautions ( 5.5 )]. Concomitant use with strong CYP1A2 inhibitors ( 4 , 7.1 ) Patients with a history of hypersensitivity to tizanidine or the ingredients in tizanidine tablets ( 4 , 5.5 )
Drug Interactions
7 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 dosage or discontinue. ( 7.2 , 12.3 ) 7.1 Strong CYP1A2 Inhibitors Concomitant use of tizanidine with strong cytochrome P450 1A2 (CYP1A2) inhibitors (e.g., fluvoxamine, ciprofloxacin) is contraindicated. Changes in pharmacokinetics of tizanidine when administered with a strong CYP1A2 inhibitor resulted in significantly decreased blood pressure, increased drowsiness, and increased psychomotor impairment [see Contraindications ( 4 ) and Clinical Pharmacology ( 12.3 )]. 7.2 Moderate or Weak CYP1A2 Inhibitors Concomitant use of tizanidine with moderate or weak CYP1A2 inhibitors (e.g., zileuton, antiarrhythmics [amiodarone, mexiletine, propafenone, and verapamil], cimetidine, famotidine, oral contraceptives, acyclovir, and ticlopidine) should be avoided. If concomitant use is clinically necessary, and adverse reactions such as hypotension, bradycardia, or excessive drowsiness occur, reduce tizanidine dosage or discontinue tizanidine therapy [see Clinical Pharmacology ( 12…
Adverse Reactions
6 ADVERSE REACTIONS 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 Apotex Corp. at 1-800-706-5575 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 do…
Frequently Asked Questions
What is Tizanidine used for?
Tizanidine is a prescription muscle relaxer taken by mouth that helps reduce muscle tightness and spasms caused by conditions like multiple sclerosis or spinal cord injury. It works by calming nerve activity in the muscles to provide relief from muscle stiffness.
Is Tizanidine a controlled substance?
Tizanidine is not classified as a controlled substance by the DEA.
What is the generic name for Tizanidine?
The generic name for Tizanidine is Tizanidine. There are 7 other brand versions of Tizanidine.
What is the NDC code for Tizanidine 4 mg/1?
The NDC (National Drug Code) for Tizanidine 4 mg/1 is 50090-6757, listed by A-S Medication Solutions.