Drugplain

Tizanidne hydrochloride 2 mg/1

Tizanidne hydrochloride · CAPSULE · Ascend Laboratories, LLC

No Recall History
Plain English

Tizanidne hydrochloride is a capsule containing tizanidne hydrochloride at 2 mg/1, taken oral. Manufactured by Ascend Laboratories, LLC.

Key Facts

Brand Name
Tizanidne hydrochloride
Generic Name
Tizanidne hydrochloride
NDC Code (Product)
67877-610
Manufacturer
Ascend Laboratories, LLC
Strength
2 mg/1
Dosage Form
CAPSULE
Route
ORAL
Marketing Status
Application #
ANDA212196
Marketing Start
03/29/2019

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Tizanidine hydrochloride is indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine hydrochloride should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration ( 2.1 )]. Tizanidine hydrochloride is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine hydrochloride capsules should be reserved for those daily activities and times when relief of spasticity is most important. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Recommended starting dose: 2 mg; dose can be repeated at 6- to 8-hour intervals, up to a maximum of 3 doses in 24 hours ( 2.1 ) Dosage can be increased by 2 mg to 4 mg per dose, with 1 to 4 days between increases; total daily dose should not exceed 36 mg ( 2.1 ) 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 ( 2.1 , 12.3 ) To discontinue tizanidine hydrochloride capsules, decrease dose slowly to minimize the risk of withdrawal and rebound hypertension, tachycardia, and hypertonia ( 2.2 ) 2.1 Dosing Information Tizanidine hydrochloride capsules 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 hydrochloride capsules and tizanidine tablets 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 mea…

Contraindications

4 CONTRAINDICATIONS Tizanidine hydrochloride capsules is contraindicated in patients taking potent inhibitors of CYP1A2, such as fluvoxamine or ciprofloxacin [see Drug Interactions ( 7.1 , 7.2 )]. Concomitant use with potent inhibitors of CYP1A2, such as fluvoxamine or ciprofloxacin( 4 , 5.5 , 7.1 , 7.2 )

Drug Interactions

7 DRUG INTERACTIONS 7.1 Fluvoxamine Concomitant use of fluvoxamine and tizanidine 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 ciprofloxacin and tizanidine 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 with other CYP1A2 inhibitors, such as zileuton, fluoroquinolones other than strong CYP1A2 inhibitors (which are contraindicated), antiarrhythmics (amiodarone, mexiletine, propafenone, and verapamil), cimetidine, famotidine, oral contraceptives, acyclovir, and ticlopidine) should be avoided. If their use is clinically necessary, therapy should be initiated with 2 mg d…

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 )] The most common adverse reactions (greater than 2% of 264 patients taking tizanidine and greater than in placebo-treated patients in three multiple dose, placebo-controlled studies) were dry mouth, somnolence, asthenia, dizziness, urinary tract infection, constipation, liver function tests abnormal, vomiting, speech disorder, amblyopia, urinary frequency, flu syndrome, SGPT/ALT increased, dyskinesia, nervousness, pharyngitis, and rhinitis ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-ASC-RX01 (877-272-7901) 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 canno…

Frequently Asked Questions

What is Tizanidne hydrochloride used for?

Tizanidne hydrochloride contains Tizanidne hydrochloride. It is a capsule taken oral. Consult your doctor for specific uses.

Is Tizanidne hydrochloride a controlled substance?

Tizanidne hydrochloride is not classified as a controlled substance by the DEA.

What is the generic name for Tizanidne hydrochloride?

The generic name for Tizanidne hydrochloride is Tizanidne hydrochloride. There are no other listed brand versions of Tizanidne hydrochloride.

What is the NDC code for Tizanidne hydrochloride 2 mg/1?

The NDC (National Drug Code) for Tizanidne hydrochloride 2 mg/1 is 67877-610, listed by Ascend Laboratories, LLC.

Product NDC

67877-610

Package NDC

67877-610-05

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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