Tizanidine HCL 4 mg/1
Tizanidine HCL · TABLET · Advanced Rx of Tennessee, LLC
Tizanidine HCL is a tablet containing tizanidine hcl at 4 mg/1, taken oral. Manufactured by Advanced Rx of Tennessee, LLC.
Key Facts
- Brand Name
- Tizanidine HCL
- Generic Name
- Tizanidine HCL
- NDC Code (Product)
80425-0024- Manufacturer
- Advanced Rx of Tennessee, LLC
- Strength
- 4 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA091283
- Marketing Start
- 04/01/2013
Recall History
Dr. Reddy's Laboratories, Inc.
Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets .
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.
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.
Aidapak Services, LLC
Labeling:Label Mixup; tiZANidine HCL Tablet, 2 mg may be potentially mislabeled as NICOTINE POLACRILEX, Lozenge, 2 mg, NDC 37205098769, Pedigree: AD70700_4, EXP: 5/29/2014; NIFEdipine ER, Tablet, 60 mg, NDC 00591319401, Pedigree: W003729, EXP: 6/26/2014.
Aidapak Services, LLC
Labeling:Label Mixup; tiZANidine HCl Tablet, 2 mg may be potentially mislabeled as RIBAVIRIN, Capsule, 200 mg, NDC 68382026007, Pedigree: AD21790_37, EXP: 4/30/2014; CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00904421713, Pedigree: AD46257_59, EXP: 5/15/2014; NIACIN, Tablet, 100 mg, NDC 00904227160, Pedigree: W002661, EXP: 6/5/2014; PANTOPRAZOLE SODIUM DR, Tablet, 20 mg, NDC 00008060601, Pedigree
Full Prescribing Information
Indications & Usage
1. Indications and Usage Section 1 INDICATIONS AND USAGE Tizanidine Tablets, USP is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with Tizanidine Tablets, USP should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration(2.1)].
Dosage & Administration
2. Dosage and Administration Section 2.1 Dosing Information Tizanidine Tablets, USP tablets may be prescribed with or without food. Once the formulation has been selected and the decision to take with or without food has been made, this regimen should not be altered. Food has complex effects on tizanidine pharmacokinetics, which differ with the different formulations. Tizanidine Capsules and Tizanidine Tablets, USP are bioequivalent to each other under fasting conditions (more than 3 hours after a meal), but not under fed conditions (within 30 minutes of a meal). These pharmacokinetic differences may result in clinically significant differences when switching administration of tablet and capsules and when switching administration between the fed or fasted state. These changes may result in increased adverse events, or delayed or more rapid onset of activity, depending upon the nature of the switch. For this reason, the prescriber should be thoroughly familiar with the changes in kinetics associated with these different conditions [SEE CLINICAL PHARMACOLOGY (12.3)]. The recommended starting dose is 2 mg. Because the effect of Tizanidine Tablets, USP peaks at approximately 1 to 2 hou…
Contraindications
4. Contraindications Tizanidine Tablets, USP is contraindicated in patientstaking potent inhibitors of CYP1A2, such as fluvoxamine or ciprofloxacin [SEE DRUG INTERACTIONS (7.1 , 7.2 )].
Drug Interactions
7. Drug Interactions 7.1 Fluvoxamine Concomitant use of fluvoxamine and Tizanidine Tablets, USP is contraindicated. Changes in pharmacokinetics of tizanidine when administered with fluvoxamine resulted in significantly decreased blood pressure, increased drowsiness, and increased psychomotor impairment. [SEE CONTRAINDICATIONS (4) and CLINICAL PHARMACOLOGY (12.3)] 7.2 Ciprofloxacin Concomitant use of ciprofoxacin and Tizanidine Tablets, USP is contraindicated. Changes in pharmacokinetics of tizanidine when administered with ciprofloxacin resulted in significantly decreased blood pressure, increased drowsiness, and increased psychomotor impairment. [SEE CONTRAINDICATIONS (4) and CLINICAL PHARMACOLOGY (12.3)] 7.3 CYP1A2 Inhibitors other than Fluvoxamine and Ciprofloxacin Because of potential drug interactions, concomitant use of Tizanidine Tablets, USP with other CYP1A2 inhibitors, such as zileuton, fluoroquinolones other than strong CYP1A2 inhibitors (which are contraindicated), antiarrythmics (amiodarone, mexiletine, propafenone, and verapamil), cimetidine, famotidine, oral contraceptives, acyclovir, and ticlopidine) should be avoided. If their use is clinically necessary, therapy s…
Adverse Reactions
6. Adverse Reactions The following 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 (5.6)] 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. Three double-blind, randomized, placebo controlled -clinical studies were conducted to evaluate the effect of tizanidine on spasticity control. 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 an…
Frequently Asked Questions
What is Tizanidine HCL used for?
Tizanidine HCL contains Tizanidine HCL. It is a tablet taken oral. Consult your doctor for specific uses.
Is Tizanidine HCL a controlled substance?
Tizanidine HCL is not classified as a controlled substance by the DEA.
What is the generic name for Tizanidine HCL?
The generic name for Tizanidine HCL is Tizanidine HCL. There are 2 other brand versions of Tizanidine HCL.
What is the NDC code for Tizanidine HCL 4 mg/1?
The NDC (National Drug Code) for Tizanidine HCL 4 mg/1 is 80425-0024, listed by Advanced Rx of Tennessee, LLC.