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TIZANIDINE HYDROCHLORIDE 4 mg Tablet, 72-count — NDC 61919-0196-72 package photo

TIZANIDINE HYDROCHLORIDE 4 mg Tablet, 72-count

by TIZANIDINE HYDROCHLORIDE · 72 TABLET in 1 BOTTLE (61919-196-72)
NDC 61919-0196-72
🏷️ FDA NDC (as labeled) 61919-196-72 billing pads the product segment with a zero
This package
Contains72-count Pack sizes6 compare ↓
Also priced by: Part D plans $0.1130/unit — full pricing hub ↓
Also comes in: 20 tablets 61919-0196-20 30 tablets 61919-0196-30 40 tablets 61919-0196-40 60 tablets 61919-0196-60 90 tablets 61919-0196-90
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 61919-196-72
Product NDC 61919-196
11-digit billing NDC 61919019672
NCPDP billing unit EA — each (per item)
RxCUI 313413
UNII B53E3NMY5C
Application # ANDA091283
SPL Set ID 047c67cd-7a63-49c9-b100-71651d3537ba
Established class (EPC) Central alpha-2 Adrenergic Agonist
Mechanism of action Adrenergic alpha2-Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-01-01
Route ORAL
Dosage form TABLET
Substance TIZANIDINE HYDROCHLORIDE
GPI-14 75100090100320
GPI class tiZANidine HCl
GCN Seq No 030274
GCN 14693
HICL code 011582
Ingredient (HICL) Tizanidine Hcl
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Midbrain
HIC3 code H6H
Therapeutic class — specific (HIC3) Skeletal Muscle Relaxants
AHFS code 12:20.04.00
AHFS class Centrally Acting Skeletal Muscle Relaxnt
FDB label name TIZANIDINE HCL 4 MG TABLET
FDB brand name Tizanidine Hcl
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 61919-196-72 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 61919-0196-72. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Central alpha-2 Adrenergic Agonist class.

Pharmacologic class Central alpha-2 Adrenergic Agonist
Drug family (ATC) Other centrally acting agents
How it works Adrenergic alpha2-Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerTIZANIDINE HYDROCHLORIDE
Application holderUNICHEM LABORATORIES LTD
FDA applicationANDA091283 (ANDA)
Labeler code61919
First marketedJan 2014
Product typeHuman Prescription Drug
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name TIZANIDINE HCL 4 MG TABLET Ingredient Tizanidine Hcl
📗 Our plain-language guide HelloPharmacist
  • Tizanidine is a muscle relaxant prescribed to manage spasticity — that's the uncomfortable muscle stiffness, tightness, or spasms that can come with conditions like multiple sclero...
  • Yes, it actually matters a lot — and it's different depending on whether you're taking a tablet or a capsule. Food increases how much drug your body absorbs from the tablet, but it...
  • Does it matter if I take tizanidine with food or without?
  • Very likely, yes — drowsiness is one of the most common side effects and can be significant, especially when you first start or when the dose is being adjusted. It can interfere wi...
📖 Read our full Tizanidine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color white
ShapeRound
ImprintU;169
Size1 mm
ScoringScored — splits in 4
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.

4 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.1130 $8.14 / 72 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
tizanidine 4 mg 00904-6418-61 Major 100 tablets $0.032 AB Availability likely —
Tizanidine 4 mg 16714-0172-01 NorthStar 150 tablets $0.032 AB Availability likely —
Tizanidine 4 mg 29300-0169-03 Unichem 300 tablets $0.032 AB Availability likely —
Tizanidine 4 mg 50268-0760-15 AvPAK 50 tablets $0.032 AB Availability likely —
Tizanidine 4 mg 57664-0503-18 Sun 1000 tablets $0.032 AB Availability likely —
Tizanidine 4 mg 68084-0645-01 American 100 tablets $0.032 AB Availability likely —
tizanidine 4 mg 00615-8469-39 NCS 30 tablets — AB FDA listed —
Tizanidine 4 mg 43063-0455-15 PD-Rx 15 tablets — AB FDA listed —
Tizanidine Hydrochloride 4 mg 49999-0347-01 Quality 120 tablets — AB FDA listed —
Tizanidine 4 mg 50090-0840-00 A-S 120 tablets — AB FDA listed —
Tizanidine 4 mg 50090-5767-00 A-S 120 tablets — AB FDA listed —
Tizanidine 4 mg 50090-6756-00 A-S 120 tablets — AB FDA listed —
Tizanidine 4 mg 50090-6757-00 A-S 90 tablets — AB FDA listed —
Tizanidine 4 mg 50090-7889-00 A-S 90 tablets — AB FDA listed —
Tizanidine 4 mg 51655-0603-20 Northwind 20 tablets — AB FDA listed —
Tizanidine 4 mg 51655-0740-26 Northwind 90 tablets — AB FDA listed —
Tizanidine 4 mg 55111-0180-03 Dr. 300 tablets — AB FDA listed —
tizanidine 4 mg 55154-7287-00 Cardinal 10 tablets — AB FDA listed —
tizanidine 4 mg 60505-0252-01 Apotex 100 tablets — AB FDA listed —
Tizanidine 4 mg 60760-0505-04 St. 4 tablets — AB FDA listed —
Tizanidine Hydrochloride 4 mgthis 61919-0196-72 TIZANIDINE 72 tablets — AB FDA listed —
Tizanidine 4 mg 63187-0009-30 Proficient 30 tablets — AB FDA listed —
tizanidine 4 mg 63187-0145-30 Proficient 30 tablets — AB FDA listed —
Tizanidine 4 mg 63187-0493-15 Proficient 15 tablets — AB FDA listed —
Tizanidine 4 mg 63187-0673-14 Proficient 14 tablets — AB FDA listed —
Tizanidine 4 mg 63629-1673-00 Bryant 112 tablets — AB FDA listed —
Tizanidine 4 mg 63629-2371-01 Bryant 1000 tablets — AB FDA listed —
tizanidine 4 mg 64980-0659-03 Rising 30 tablets — AB FDA listed —
tizanidine 4 mg 67046-1444-03 Coupler 30 tablets — AB FDA listed —
Tizanidine 4 mg 67296-2263-02 Redpharm 15 tablets — AB FDA listed —
Tizanidine 4 mg 67877-0614-05 Ascend 500 tablets — AB FDA listed —
tizanidine 4 mg 68071-3719-03 NuCare 30 tablets — AB FDA listed —
Tizanidine 4 mg 68071-4463-03 NuCare 30 tablets — AB FDA listed —
Tizanidine 4 mg 68071-5268-03 NuCare 30 tablets — AB FDA listed —
Tizanidine 4 mg 68788-7781-01 Preferred 100 tablets — AB FDA listed —
tizanidine 4 mg 68788-8741-01 Preferred 100 tablets — AB FDA listed —
Tizanidine 4 mg 68788-8802-01 Preferred 100 tablets — AB FDA listed —
Zanaflex 4 mg 70515-0594-15 Covis 150 tablets — AB FDA listed —
Tizanidine 4 mg 70518-0133-00 REMEDYREPACK 60 tablets — AB FDA listed —
Tizanidine 4 mg 70518-1598-01 REMEDYREPACK 60 tablets — AB FDA listed —
Tizanidine 4 mg 70518-3658-00 REMEDYREPACK 30 tablets — AB FDA listed —
tizanidine 4 mg 70518-4181-00 REMEDYREPACK 90 tablets — AB FDA listed —
tizanidine 4 mg 70771-1336-00 Zydus 1000 tablets — AB FDA listed —
Tizanidine 4 mg 71335-0914-00 Bryant 112 tablets — AB FDA listed —
Tizanidine 4 mg 71335-1016-00 Bryant 112 tablets — AB FDA listed —
Tizanidine 4 mg 71335-2325-00 Bryant 112 tablets — AB FDA listed —
Tizanidine 4 mg 71335-3016-01 Bryant 90 tablets — AB FDA listed —
Tizanidine 4 mg 71610-0228-30 Aphena 30 tablets — AB FDA listed —
tizanidine 4 mg 71610-0776-16 Aphena 6000 tablets — AB FDA listed —
Tizanidine 4 mg 71610-0864-16 Aphena 6000 tablets — AB FDA listed —
Tizanidine 4 mg 72162-1642-00 Bryant 1000 tablets — AB FDA listed —
Tizanidine 4 mg 72189-0602-30 Direct_rx 30 tablets — AB FDA listed —
tizanidine 4 mg 72578-0097-06 Viona 30 tablets — AB FDA listed —
Tizanidine 4 mg 72789-0325-30 PD-Rx 30 tablets — AB FDA listed —
Tizanidine 4 mg 72789-0327-20 PD-Rx 20 tablets — AB FDA listed —
Tizanidine 4 mg 76420-0229-30 Asclemed 30 tablets — AB FDA listed —
Tizanidine 4 mg 76420-0339-00 Asclemed 1000 tablets — AB FDA listed —
Tizanidine 4 mg 76420-0866-00 Asclemed 1000 tablets — AB FDA listed —
tizanidine 4 mg 76420-0886-00 Asclemed 1000 tablets — AB FDA listed —
Tizanidine HCL 4 mg 80425-0022-01 Advanced 60 tablets — AB FDA listed —
Tizanidine HCl 4 mg 80425-0023-01 Advanced 60 tablets — AB FDA listed —
Tizanidine HCL 4 mg 80425-0024-01 Advanced 60 tablets — AB FDA listed —
Tizanidine 4 mg 80425-0453-01 Advanced 30 tablets — AB FDA listed —
tizanidine 4 mg 80425-0454-01 Advanced 30 tablets — AB FDA listed —
Tizanidine 4 mg 82461-0721-60 Medcore 60 tablets — AB FDA listed —
Zanaflex 4 mg 83107-0004-15 Legacy 150 tablets — AB FDA listed —
Tizanidine 4 mg 85509-1180-01 PHOENIX 120 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2014
On the market since
Jan 2014
📍
2026
Currently FDA-listed
12 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Tizanidine hydrochloride — the ingredient across all brands.

Top reported reactions

Fatigue1,518
Pain1,453
Nausea1,450
Headache1,410
Fall1,030
Dizziness926
Diarrhoea880

Age at onset

Neonate3
Infant4
Child6
Adolescent8
Adult2,057
Elderly825

Reporter sex

17,971 reports
Male · 21%
Female · 78%
Unknown · 0%

Serious outcomes

Hospitalization5,265
Death889
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,262 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
61919-0196-30 30 TABLET in 1 BOTTLE (61919-196-30) 2015-01-01 Active
61919-0196-40 40 TABLET in 1 BOTTLE (61919-196-40) 2014-01-01 Active
61919-0196-60 60 TABLET in 1 BOTTLE (61919-196-60) 2015-01-01 Active
61919-0196-72 You're viewing this 72 TABLET in 1 BOTTLE (61919-196-72) 2015-01-01 Active
61919-0196-90 90 TABLET in 1 BOTTLE (61919-196-90) 2015-01-01 Active
61919-0196-20 20 TABLET in 1 BOTTLE (61919-196-20) 2014-01-01 Active

You're viewing one of 6 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 61919-0196-72?
NDC 61919-0196-72 is a 72-count package — 72 tablet in 1 bottle.
What is the difference between NDC 61919-0196-72 and NDC 61919-0196-20?
Both are TIZANIDINE HYDROCHLORIDE 4 mg Tablet — the drug itself is identical. NDC 61919-0196-72 is the 72-count package, while NDC 61919-0196-20 is the 20 tablets package.
What NDC number is used to bill for this package of TIZANIDINE HYDROCHLORIDE 4 mg Tablet?
Bill NDC 61919-0196-72 — the 11-digit billing format is 61919019672. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 61919-196-72, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 61919-0196-72, written without dashes as 61919019672. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 61919-0196-72, the first segment (61919) is the labeler code FDA assigned to TIZANIDINE HYDROCHLORIDE; the middle segment (0196) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (72) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by TIZANIDINE HYDROCHLORIDE. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 5 other package presentations of this same product, including 20 tablets (61919-0196-20), 30 tablets (61919-0196-30), 40 tablets (61919-0196-40). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
TIZANIDINE HYDROCHLORIDE is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 45 words ▾

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 and Administration ~1 min read ▾

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 [1] switching administration of the tablet between the fed or fasted state, [2] switching administration of the capsule between the fed or fasted state, [3] switching between the tablet and capsule in the fed state, or [4] switching between the intact capsule and sprinkling the contents of the capsule on applesauce. These changes may result in increased adverse events or delayed/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: Pharmacokinetics).

⛔ Contraindications 79 words ▾

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.

⚠️ Warnings ~3 min read ▾

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 dosing and was associated, at times, with bradycardia, orthostatic hypotension, lightheadedness/dizziness and rarely syncope. The hypotensive effect is dose related and has been measured following single doses of ≥ 2 mg.

The chance of significant hypotension may possibly be minimized by titration of the dose and by focusing attention on signs and symptoms of hypotension prior to dose advancement. In addition, patients moving from a supine to a fixed upright position may be at increased risk for hypotension and orthostatic effects. Caution is advised when tizanidine is to be used in patients receiving concurrent antihypertensive therapy and should not be used with other α2-adrenergic agonists.

Clinically significant hypotension (decreases in both systolic and diastolic pressure) has been reported with concomitant administration of either fluvoxamine or ciprofloxacin and single doses of 4 mg of tizanidine. Therefore, concomitant use of tizanidine with fluvoxamine or with ciprofloxacin, potent inhibitors of CYP1A2, is contraindicated (see CONTRAINDICATIONS and CLINICAL PHARMACOLOGY: Drug Interactions). RISK OF LIVER INJURY Tizanidine occasionally causes liver injury, most often hepatocellular in type.

In controlled clinical studies, approximately 5% of patients treated with tizanidine had elevations of liver function tests (ALT/SGPT, AST/SGOT) to greater than 3 times the upper limit of normal (or 2 times if baseline levels were elevated) compared to 0.4% in the control patients. Most cases resolved rapidly upon drug withdrawal with no reported residual problems. In occasional symptomatic cases, nausea, vomiting, anorexia and jaundice have been reported.

Based upon postmarketing experience, death associated with liver failure has been a rare occurrence reported in patients treated with tizanidine. Monitoring of aminotransferase levels is recommended during the first 6 months of treatment (e.g., baseline, 1, 3 and 6 months) and periodically thereafter, based on clinical status. Because of the potential toxic hepatic effect of tizanidine, the drug should ordinarily be avoided or used with extreme caution in patients with impaired hepatic function.

SEDATION In the multiple doses, controlled clinical studies, 48% of patients receiving any dose of tizanidine reported sedation as an adverse event. In 10% of these cases, the sedation was rated as severe compared to < 1% in the placebo treated patients. Sedation may interfere with everyday activity.

The effect appears to be dose related. In a single dose study, 92% of the patients receiving 16 mg, when asked, reported that they were drowsy during the 6 hour study. This compares to 76% of the patients on 8 mg and 35% of the patients on placebo.

Patients began noting this effect 30 minutes following dosing. The ef…

🤒 Adverse Reactions ~2 min read ▾

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-quarters of the patients rated the events as mild to moderate and one-quarter of the patients rated the events as being severe. These events appeared to be dose related. ADVERSE EVENTS REPORTED IN CONTROLLED STUDIES The events cited reflect experience gained under closely monitored conditions of clinical studies in a highly selected patient population.

In actual clinical practice or in other clinical studies, these frequency estimates may not apply, as the conditions of use, reporting behavior, and the kinds of patients treated may differ. Table 1 lists treatment emergent signs and symptoms that were reported in greater than 2% of patients in three multiple dose, placebo-controlled studies who received tizanidine where the frequency in the tizanidine group was at least as common as in the placebo group. These events are not necessarily related to tizanidine treatment.

For comparison purposes, the corresponding frequency of the event (per 100 patients) among placebo treated patients is also provided. Table 1: Multiple Dose, Placebo-Controlled Studies—Frequent (> 2%) Adverse Events Reported for Which Tizanidine Tablets Incidence is Greater than Placebo * (weakness, fatigue, and/or tiredness) Event Placebo N = 261 % Tizanidine Tablet N = 264 % Dry mouth 10 49 Somnolence 10 48 Asthenia* 16 41 Dizziness 4 16 UTI 7 10 Infection 5 6 Constipation 1 4 Liver function tests abnormal <1 3 Vomiting 0 3 Speech disorder 0 3 Amblyopia (blurred vision) <1 3 Urinary frequency 2 3 Flu symptom 2 3 SGPT/ALT increased <1 3 Dyskinesia 0 3 Nervousness <1 3 Pharyngitis 1 3 Rhinitis 2 3 Close

🆘 Overdosage 163 words ▾

OVERDOSAGE SECTION A review of the safety surveillance database revealed cases of intentional and accidental tizanidine overdose. Some of the cases resulted in fatality and many of the intentional overdoses were with multiple drugs including CNS depressants. The clinical manifestations of tizanidine overdose were consistent with its known pharmacology.

In the majority of cases a decrease in sensorium was observed including lethargy, somnolence, confusion and coma. Depressed cardiac function are also observed including most often bradycardia and hypotension. Respiratory depression is another common feature of tizanidine overdose.

Should overdose occur, basic steps to ensure the adequacy of an airway and the monitoring of cardiovascular and respiratory systems should be undertaken. In general, symptoms resolve within one to three days following discontinuation of tizanidine and administration of appropriate therapy. Due to the similar mechanism of action, symptoms and management of tizanidine overdose are similar to those following clonidine overdose.

For the most recent information concerning the management of overdose, contact a poison control center.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY SECTION Mechanism Of Action Tizanidine is an agonist at α2-adrenergic receptor sites and presumably reduces spasticity by increasing presynaptic inhibition of motor neurons. In animal models, tizanidine has no direct effect on skeletal muscle fibers or the neuromuscular junction, and no major effect on monosynaptic spinal reflexes. The effects of tizanidine are greatest on polysynaptic pathways.

The overall effect of these actions is thought to reduce facilitation of spinal motor neurons. The imidazoline chemical structure of tizanidine is related to that of the anti-hypertensive drug clonidine and other α2-adrenergic agonists. Pharmacological studies in animals show similarities between the two compounds, but tizanidine was found to have one-tenth to one-fiftieth (1/50) of the potency of clonidine in lowering blood pressure.

Pharmacokinetics Absorption and Distribution Following oral administration, tizanidine is essentially completely absorbed. The absolute oral bioavailability of tizanidine is approximately 40% (CV = 24%), due to extensive first-pass hepatic metabolism. Tizanidine is extensively distributed throughout the body with a mean steady state volume of distribution of

2.4L/kg (CV = 21%) following intravenous administration in healthy adult volunteers. Tizanidine is approximately 30% bound to plasma proteins. Pharmacokinetics, Metabolism and Excretion Tizanidine has linear pharmacokinetics over a dose of 1 to 20 mg.

Tizanidine has a half-life of approximately 2.5 hours (CV=33%). Approximately 95% of an administered dose is metabolized. The primary cytochrome P450 isoenzyme involved in tizanidine metabolism is CYP1A2.

Tizanidine metabolites are not known to be active; their half-lives range from 20 to 40 hours. Following single and multiple oral dosing of 14C-tizanidine, an average of 60% and 20% of total radioactivity was recovered in the urine and feces, respectively. Pharmacokinetic differences between Tizanidine Capsules and Tizanidine Tablets Tizanidine Capsules and Tizanidine tablets are bioequivalent to each other under fasted conditions, but not under fed conditions.

A single dose of either two 4 mg tablets or two 4 mg capsules was administered under fed and fasting conditions in an open label, four period, randomized crossover study in 96 human volunteers, of whom 81 were eligible for the statistical analysis. Following oral administration of either the tablet or capsule (in the fasted state), tizanidine has peak plasma concentrations occurring 1.0 hours after dosing with a half-life of approximately 2 hours. When two 4 mg tablets are administered with food the mean maximal plasma concentration is increased by approximately 30%, and the median time to peak plasma concentration is increased by 25 minutes, to 1 hour and 25 minutes.

In contrast, when two 4 mg capsules are administered with food the mean maximal plasma concentration is decreased by 20%, the median time to peak plasma concentration is increased by 2 hours to 3 hours. Consequently, the mean Cmax for the capsule when administered with food is approximately 2/3's the Cmax for the tablet when administered with food. Food also increases the extent of absorption for both the tablets and capsules.

The increase with the tablet (~30%) is significantly greater than with the capsule (~10%). Consequently when each is administered with food, the amount absorbed from the capsule is about 80% of the amount absorbed from the tablet (See Figure 1). Administration of the capsule contents sprinkled on applesauce is not bioequivalent to administration of an intact capsule under fasting conditions.

Administration of the capsule contents on applesauce results in a 15% - 20% increase in Cmax and AUC of tizanidine compared to administration of an intact capsule while fasting, and a 15 minute decrease in the median lag time and time to peak concentration. Figure 1: Mean Tizanidine Concentration vs. Time Profiles For Tizanidine Tablets and Capsules…

📦 How Supplied / Storage and Handling 112 words ▾

HOW SUPPLIED SECTION Tizanidine tablets USP are available as white to off-white, round, flat, beveledged uncoated tablets containing 2 mg or 4 mg of tizanidine. Tizanidine tablets USP 2 mg are debossed with "U" and "168" on one side and bisecting score on other side. Bottles of 150: NDC 29300-168-15 Bottles of 500: NDC 29300- 168-05 Bottles of 1000: NDC 29300- 168-10 Tizanidine tablets USP 4 mg are debossed with "U" and "169" on one side and quadrisecting score on other side.

Bottles of 150: NDC 29300- 169-15 Bottles of 300: NDC 29300- 169-03 Bottles of 500: NDC 29300- 169-05 Bottles of 1000: NDC 29300-169-10 Dispense in tight, light-resistant container [see USP].

📋 Description 126 words ▾

DESCRIPTION SECTION Tizanidine hydrochloride is a centrally acting α2-adrenergic agonist. Tizanidine HCl (tizanidine) is a white to off-white, fine crystalline powder, which is odorless or with a faint characteristic odor. Tizanidine is slightly soluble in water and methanol; solubility in water decreases as the pH increases.

Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiodiazole hydrochloride. Tizanidine's molecular formula is C9H8CIN5S-HCl, its molecular weight is 290.2 and its structural formula is: Tizanidine tablets USP are supplied as 2 and 4 mg tablets for oral administration. Tizanidine tablets USP are composed of the active ingredient, tizanidine hydrochloride USP (2.288 mg equivalent to 2 mg tizanidine base and 4.576 mg equivalent to 4 mg tizanidine base), and the inactive ingredients, colloidal silicon dioxide, stearic acid, microcrystalline cellulose and anhydrous lactose. image description

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 61919-0171-30 · Direct 61919-0213-30 · C →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.