Drugplain

TIZANIDINE HYDROCHLORIDE 4 mg/1

tizanidine hydrochloride · CAPSULE · Ingenus Pharmaceuticals, LLC

1 Recall on Record
Plain English

TIZANIDINE HYDROCHLORIDE is a capsule containing tizanidine hydrochloride at 4 mg/1, taken oral. Manufactured by Ingenus Pharmaceuticals, LLC.

Key Facts

Brand Name
TIZANIDINE HYDROCHLORIDE
Generic Name
tizanidine hydrochloride
NDC Code (Product)
50742-225
Manufacturer
Ingenus Pharmaceuticals, LLC
Strength
4 mg/1
Dosage Form
CAPSULE
Route
ORAL
Marketing Status
Application #
ANDA210267
Marketing Start
03/20/2019

Recall History

1 Recall on Record
Class II06/26/2023

Preferred Pharmaceuticals, Inc.

Failed Stability Specifications

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fatigue585 reports
headache539 reports
nausea479 reports
pain463 reports
drug ineffective449 reports
product dose omission issue432 reports
somnolence366 reports
diarrhoea334 reports
dyspnoea324 reports
fall316 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS & USAGE SECTION Tizanidine tablet is a short-acting drug for the management of spasticity. Because of the short duration of effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important (see DOSAGE AND ADMINISTRATION).

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION A single dose of 8 mg of tizanidine reduces muscle tone in patients with spasticity for a period of several hours. The effect peaks at approximately 1 to 2 hours and dissipates between 3 to 6 hours. Effects are dose-related. Although single doses of less than 8 mg have not been demonstrated to be effective in controlled clinical studies, the dose-related nature of tizanidine's common adverse events make it prudent to begin treatment with single oral doses of 4 mg. Increase the dose gradually (2 to 4 mg steps) to optimum effect (satisfactory reduction of muscle tone at a tolerated dose). The dose can be repeated at 6 to 8 hour intervals, as needed, to a maximum of three doses in 24 hours. The total daily dose should not exceed 36 mg. Experience with single doses exceeding 8 mg and daily doses exceeding 24 mg is limited. There is essentially no experience with repeated, single, daytime doses greater than 12 mg or total daily doses greater than 36 mg (see WARNINGS). Food has complex effects on tizanidine pharmacokinetics, which differ with the different formulations. These pharmacokinetic differences may result in clinically significant differences when…

Warnings

WARNINGS SECTION LIMITED DATA BASE FOR CHRONIC USE OF SINGLE DOSES ABOVE 8 MG AND MULTIPLE DOSES ABOVE 24 MG PER DAY Clinical experience with long-term use of tizanidine at doses of 8 to 16 mg single doses or total daily doses of 24 to 36 mg (see Dosage and Administration) is limited. In safety studies, approximately 75 patients have been exposed to individual doses of 12 mg or more for at least one year or more and approximately 80 patients have been exposed to total daily doses of 30 to 36 mg/day for at least one year or more. There is essentially no long-term experience with single, daytime doses of 16 mg. Because long-term clinical study experience at high doses is limited, only those adverse events with a relatively high incidence are likely to have been identified (see WARNINGS, PRECAUTIONS and ADVERSE REACTIONS). HYPOTENSION Tizanidine is a α2-adrenergic agonist (like clonidine) and can produce hypotension. In a single dose study where blood pressure was monitored closely after dosing, two-thirds of patients treated with 8 mg of tizanidine had a 20% reduction in either the diastolic or systolic BP. The reduction was seen within 1 hour after dosing, peaked 2 to 3 hours after …

Contraindications

CONTRAINDICATIONS SECTION Concomitant use of tizanidine with fluvoxamine or with ciprofloxacin, potent inhibitors of CYP1A2, is contraindicated. Significant alterations of pharmacokinetic parameters of tizanidine including increased AUC, t1/2, Cmax, increased oral bioavailability and decreased plasma clearance have been observed with concomitant administration of either fluvoxamine or ciprofloxacin. This pharmacokinetic interaction can result in potentially serious adverse events (See WARNINGS and CLINICAL PHARMACOLOGY: Drug Interactions). Tizanidine tablets is contraindicated in patients with known hypersensitivity to Tizanidine tablets or its ingredients.

Adverse Reactions

ADVERSE REACTIONS SECTION In multiple doses, placebo-controlled clinical studies, 264 patients were treated with tizanidine and 261 with placebo. Adverse events, including severe adverse events, were more frequently reported with tizanidine than with placebo. COMMON ADVERSE EVENTS LEADING TO DISCONTINUATION Forty-five of 264 (17%) patients receiving tizanidine and 13 of 261 (5%) of patients receiving placebo in three multiple dose, placebo-controlled clinical studies, discontinued treatment for adverse events. When patients withdrew from the study, they frequently had more than one reason for discontinuing. The adverse events most frequently leading to withdrawal of tizanidine treated patients in the controlled clinical studies were asthenia (weakness, fatigue and/or tiredness) (3%), somnolence (3%), dry mouth (3%), increased spasm or tone (2%), and dizziness (2%). MOST FREQUENT ADVERSE CLINICAL EVENTS SEEN IN ASSOCIATION WITH THE USE OF TIZANIDINE In multiple dose, placebo-controlled clinical studies involving 264 patients with spasticity, the most frequent adverse effects were dry mouth, somnolence/sedation, asthenia (weakness, fatigue and/or tiredness) and dizziness. Three-quart…

Frequently Asked Questions

What is TIZANIDINE HYDROCHLORIDE used for?

TIZANIDINE HYDROCHLORIDE contains tizanidine hydrochloride. It is a capsule taken oral. Consult your doctor for specific uses.

Is TIZANIDINE HYDROCHLORIDE a controlled substance?

TIZANIDINE HYDROCHLORIDE is not classified as a controlled substance by the DEA.

What is the generic name for TIZANIDINE HYDROCHLORIDE?

The generic name for TIZANIDINE HYDROCHLORIDE is tizanidine hydrochloride. There are 10 other brand versions of tizanidine hydrochloride.

What is the NDC code for TIZANIDINE HYDROCHLORIDE 4 mg/1?

The NDC (National Drug Code) for TIZANIDINE HYDROCHLORIDE 4 mg/1 is 50742-225, listed by Ingenus Pharmaceuticals, LLC.

Product NDC

50742-225

Package NDC

50742-225-15

Other Tizanidine Brands

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

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