Home › NDC Lookup › Ingredients › Tizanidine › 60760-0505-04
Tizanidine 4 mg Tablet, 4-count — NDC 60760-0505-04 package photo

Tizanidine 4 mg Tablet, 4-count

by St. Mary's Medical Park Pharmacy · 4 TABLET in 1 BOTTLE, PLASTIC (60760-505-04)
NDC 60760-0505-04
🏷️ FDA NDC (as labeled) 60760-505-04 billing pads the product segment with a zero
This package
Contains4-count Pack sizes5 compare ↓
Also priced by: Part D plans $0.1130/unit — full pricing hub ↓
Also comes in: 15 tablets 60760-0505-15 30 tablets 60760-0505-30 60 tablets 60760-0505-60 90 tablets 60760-0505-90
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

⚠️
Other active recalls for Tizanidine (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jun 26, 2023 — Failed Stability Specifications (Preferred Pharmaceuticals, Inc.) · FDA recall D-0894-2023
Class II · Jun 21, 2023 — Failed dissolution specification: Out of specification results observed in 24-month long term stability testing. (Dr Reddy's Laboratories Limited) · FDA recall D-0923-2023
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 60760-505-04
Product NDC 60760-505
11-digit billing NDC 60760050504
NCPDP billing unit EA — each (per item)
RxCUI 313413
UNII B53E3NMY5C
Application # ANDA076286
SPL Set ID c6b4486f-e847-64ee-e053-2995a90a855a
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 2021-06-21
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 60760-505-04 — 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 → 60760-0505-04. 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

LabelerSt. Mary's Medical Park Pharmacy
Application holderDR REDDYS LABORATORIES INC
FDA applicationANDA076286 (ANDA)
Labeler code60760
First marketedJun 2021
Product typeHuman Prescription Drug
Portfolio264 products on file
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
📖 What it is MedlinePlus · NLM

Tizanidine is used to relieve muscle spasms, cramping, and tightness caused by certain conditions including multiple sclerosis (MS, a disease in which the nerves do not function properly and patients may experience weakness, numbness, loss of muscle coordination and problems with vision, speech, and bladder control) and spinal injury. Tizanidine is in a class of medications called skeletal muscle relaxants. It works by slowing action in the brain and nervous system to allow the muscles to relax.

Read the full MedlinePlus article ↗
📗 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 →
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
ShapeOval
ImprintR;180
Size11 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 $0.45 / 4 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 mgthis 60760-0505-04 St. 4 tablets — AB FDA listed —
Tizanidine Hydrochloride 4 mg 61919-0196-30 TIZANIDINE 30 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 —
Tizanidine 4 mg 85534-0030-00 HAWAII 10 tablets — AB FDA listed —
tizanidine 4 mg 68788-4159-01 Preferred 100 tablets — AB FDA listed —
Tizanidine 4 mg 84386-0024-77 Aurobindo 150 tablets — — 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

🏛️
2021
On the market since
Jun 2021
📍
2026
Currently FDA-listed
5 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 — the ingredient across all brands.

Top reported reactions

Fatigue3,191
Pain3,038
Nausea3,007
Headache2,695
Fall2,309
Diarrhoea1,970
Dizziness1,915

Reporter sex

41,177 reports
Male · 24%
Female · 76%
Unknown · 0%
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3,614 1,526
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
60760-0505-04 You're viewing this 4 TABLET in 1 BOTTLE, PLASTIC (60760-505-04) 2021-10-04 Active
60760-0505-15 15 TABLET in 1 BOTTLE, PLASTIC (60760-505-15) 2021-06-21 Active
60760-0505-30 30 TABLET in 1 BOTTLE, PLASTIC (60760-505-30) 2021-07-30 Active
60760-0505-60 60 TABLET in 1 BOTTLE, PLASTIC (60760-505-60) 2021-11-10 Active
60760-0505-90 90 TABLET in 1 BOTTLE, PLASTIC (60760-505-90) 2021-12-08 Active

You're viewing the smallest of 5 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 60760-0505-04?
NDC 60760-0505-04 is a 4-count package — 4 tablet in 1 bottle, plastic.
What is the difference between NDC 60760-0505-04 and NDC 60760-0505-15?
Both are Tizanidine 4 mg Tablet — the drug itself is identical. NDC 60760-0505-04 is the 4-count package, while NDC 60760-0505-15 is the 15 tablets package.
What NDC number is used to bill for this package of Tizanidine 4 mg Tablet?
Bill NDC 60760-0505-04 — the 11-digit billing format is 60760050504. 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 60760-505-04, 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: 60760-0505-04, written without dashes as 60760050504. 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 60760-0505-04, the first segment (60760) is the labeler code FDA assigned to St. Mary's Medical Park Pharmacy; the middle segment (0505) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 St. Mary's Medical Park Pharmacy. 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 4 other package presentations of this same product, including 15 tablets (60760-0505-15), 30 tablets (60760-0505-30), 60 tablets (60760-0505-60). 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?
St. Mary's Medical Park Pharmacy 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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 31 words ▾

1 INDICATIONS AND USAGE Tizanidine tablets are indicated for the treatment of spasticity in adults. Tizanidine tablet is a central alpha-2-adrenergic agonist indicated for the treatment of spasticity. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Monitoring of aminotransferase levels is recommended at baseline and 1month 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 every1 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)

2.1Recommended Evaluation and Testing Before and After Initiating Tizanidine tablets Monitoring of aminotransferase levels is recommended at baseline and 1 month after maximum dose is achieved [see Warnings and Precautions ( 5.2) ] .

2.2Recommended Dosage The recommended starting dose is 2 mg by mouth every 6 to 8 hours,as needed, to a maximum of three doses in 24 hours. Dosage can be gradually increased every 1 to 4 days by 2 mg to 4 mg at each dosebased on clinical response and tolerability. The maximum total daily dosage is 36 mg.

Single doses greater than 16 mg have not been studied. There are pharmacokinetic differences when administering tizanidine tablets between the fed or fasted state [see Clinical Pharmacology (12.3) ] . Tizanidine tablets may be taken with or without food; however, consistent administration with respect to food is recommended to reduce variability in tizanidine plasma exposure.

Because of the short duration of therapeutic effect, treatment with tizanidine tablets should be reserved for those daily activities and times when relief of spasticity is most important.

2.3Recommended Dosage in Patients with Renal Impairment In patients with creatinine clearance < 25 mL/min, use lower individual doses during titration. If higher doses are required, the individual doses rather than dosing frequency should be increased [see Use in Specific Populations ( 8.6 ) and Clinical Pharmacology ( 12.3) ].

2.4Recommended Dosage in Patients with Hepatic Impairment In patients with hepatic impairment, use lowerindividual doses during titration. If higher doses are required, individual doses rather than dosing frequency should be increased [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3) ].

2.5Discontinuation of Tizanidine Tablets When discontinuing tizanidine tablets, particularly in patients who have been receiving high doses for long periods or who may be on concomitant treatment with narcotics, decreasethe dosage by 2 mg to 4 mg per day to minimize the risk of withdrawal adverse reactions [see Drug Abuse and Dependence (9.3) ].

2.6Switching Between With/Without Food and Different Tizanidine Dosage Forms There are pharmacokinetic differences when: 1) switching between administration of Tizanidine with or without food 2) switching between dosage forms if being administered with food. If these situations occur, monitor patients for therapeutic effect or adverse reactions [see Dosage and Administration ( 2.2 ) and Clinical Pharmacology ( 12.3 )].

💊 Dosage Forms and Strengths 67 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets Tizanidine Tablets USP, 2 mg are white to off white, oval, flat, beveled edged tablets debossed with “R179” on one side and “bisecting score” on other side. Tizanidine Tablets USP, 4 mg are white to off white, oval, flat, beveled edged tablets debossed with “R180” on one side and “quadrisecting score” on other side. Tablets 2 mg and 4 mg (3)

⛔ Contraindications 67 words ▾

4 CONTRAINDICATIONS Tizanidine hydrochloride 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 ingredientsin tizanidine tablets (4, 5.5)

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Hypotension: monitor for signs and symptoms of hypotension, in particular in patients receiving concurrent antihypertensives; tizanidine hydrochloride should not be used with other α 2 -adrenergic agonists ( 5.1 , 7.7 ) Risk of liver injury: monitor ALTs; discontinue tizanidine hydrochloride if liver injury occurs ( 5.2 ) Sedation: tizanidine hydrochloride may interfere with everyday activities; sedative effects of tizanidine hydrochloride, alcohol, and other central nervous system (CNS) depressants are additive ( 5.3 , 7.4 ) Hallucinations: consider discontinuation of tizanidine hydrochloride (5.4)

5.1Hypotension Tizanidine is an α 2 -adrenergic agonist that can produce hypotension [see Adverse Reactions ( 6.1 ) and Drug Interactions ( 7.5 )] . Syncope has been reported in patients treated with tizanidine in the postmarketing setting. The risk of hypotension may be minimized by dose titration; monitoring for signs and symptoms of hypotension prior to dosage increase may minimize the risks associated with hypotension..

In addition, patients moving from a supine to fixed upright position may be at increased risk for hypotension and orthostatic effects. Monitor for hypotension when tizanidine hydrochloride is used in patients receiving concurrent antihypertensive therapy. It is not recommended that tizanidine hydrochloride be used with other α 2 -adrenergic agonists.

Clinically significant hypotension (decreases in both systolic and diastolic pressure) has been reported with concomitant administration of tizanidine and strong CYP1A2 inhibitors [see Clinical Pharmacology ( 12.3 )] . Therefore, concomitant use of tizanidine hydrochloride with strong CYP1A2 inhibitors is contraindicated [see Contraindications (4 ) and Drug Interactions (7.1) ].

5.2Liver Injury Tizanidine hydrochloride may cause hepatocellular liver injury. Liver function test abnormality and hepatotoxicity have been observed with tizanidine hydrochloride [see Adverse Reactions ( 6.1 , 6.2 )] . Monitoring of aminotransferase levels is recommended at baseline and 1 month after maximum dose is achieved, or if hepatic injury is suspected [see Dosage and Administration ( 2.1 ) and Use in Specific Populations ( 8.7 )].

5.3Sedation Tizanidine hydrochloride can cause sedation, which may interfere with everyday activity. In the multiple dose studies of tizanidine hydrochloride, the prevalence of patients with sedation peaked following the first week of titration and then remained stable for the duration of the maintenance phase of the study [see Adverse Reactions ( 6.1 )]. The CNS depressant effects of tizanidine hydrochloride with alcohol and other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants) may be additive [see Drug Interactions ( 7.4 )] .

Monitor patients who take tizanidine hydrochloride with another CNS depressant for symptoms of excess sedation.

5.4Hallucinosis/Psychotic-Like Symptoms Tizanidine hydrochloride use has been associated with hallucinations. Formed, visual hallucinations or delusions were reported in 5 of 170 patients (3%) in two North American controlled clinical studies. Most of the patients were aware that the events were unreal.

One patient developed psychosis in association with the hallucinations. One patient among these 5 continued to have problems for at least 2 weeks following discontinuation of tizanidine. Hallucinations have also been reported with tizanidine use in the postmarketing setting.

Consider discontinuing tizanidine hydrochloride in patients who develop hallucinations.

5.5Hypersensitivity Reactions Tizanidine hydrochloride can cause anaphylaxis. Signs and symptoms of hypersensitivity, including respiratory compromise, urticaria, and angioedema of the throat and tongue, have been reported. Tizanidine hydrochloride is contraindicated in patients with a history of hypersensitivity reactions to tizanidine [see Contraindications (4) ] .

5.6 Withdrawal Adverse Reactions Tizanidi…

🤒 Adverse Reactions ~3 min read ▾

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 Dr. Reddy’s Laboratories Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical 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 double-blind, randomized, placebo-controlled clinical studies [see Clinical Studies (14)]. 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 and a 1-week dose tapering period. In all, 264 patients received tizanidine and 261 patients received placebo. Across the three studies approximately 51% of patientswere women, and the median dose during the plateau phase ranged from 20 to 28 mg/day.

The most common adverse reactions (>10% of patients treated with tizanidine) reported in multiple dose, placebo-controlled clinical studies involving 264 patients with spasticity were dry mouth, somnolence/sedation, asthenia (weakness, fatigue and/or tiredness), and dizziness. Three-quarters of the patients rated the reactions as mild to moderate and one-quarter of the patients rated the reactions as being severe. These adverse reactions appeared to be dose related.

Table 1 lists adverse reactions that were reported in greater than 2% of patients in three multiple dose, placebo-controlled studies who received tizanidine hydrochloride where the frequency in the tizanidine hydrochloride group was greater than the placebo group. Table 1: Multiple Dose, Placebo-Controlled Studies—Adverse Reactions Reported in >2% of Patients Treated with Tizanidine Tablets and Incidence Greater than Placebo Adverse Reaction 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 Liver test abnormality 2 6 Constipation 1 4 Vomiting 0 3 Speech disorder 0 3 Amblyopia (blurred vision) <1 3 Urinary frequency 2 3 Flu syndrome 2 3 Dyskinesia 0 3 Nervousness <1 3 Pharyngitis 1 3 Rhinitis 2 3 *includes weakness, fatigue, and/or tiredness In the single dose, placebo-controlled study involving 142 patients with spasticity due to multiple sclerosis (Study 1) [see Clinical Studies ( 14 )] , the patients were specifically asked if they had experienced any of the four most common adverse reactions: dry mouth, somnolence (drowsiness), asthenia (weakness, fatigue and/or tiredness) and dizziness.

In addition, hypotension and bradycardia were observed. The occurrence of these reactions is summarized in Table 2. Other events were, in general, reported at a rate of 2% or less.

Table 2: Single Dose, Placebo-Controlled Study—Common Adverse Reactions Reported Adverse Reaction Placebo N = 48 % Tizanidine Tablet, 8mg , N = 45 % Tizanidine Tablet,16 mg, N = 49 % Somnolence 31 78 92 Dry mouth 35 76 88 Asthenia* 40 67 78 Dizziness 4 22 45 Hypotension 0 1…

🔄 Drug Interactions ~2 min read ▾

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 hydrochloride dosage or discontinue. ( 7.2 , 12.3 )

7.1Strong CYP1A2 Inhibitors Concomitant use of tizanidine hydrochloride 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)].

7.2Moderate or Weak CYP1A2 Inhibitors Concomitant use of tizanidine hydrochloride 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 hydrochloride dosage or discontinue tizanidine hydrochloride therapy. [see Clinical Pharmacology (12.3) ].

7.3Oral Contraceptives Concomitant use of tizanidine hydrochloride with oral contraceptives is not recommended. However, if concomitant use is clinically necessary and adverse reactions such as hypotension, bradycardia, or excessive drowsiness occur, reduce or discontinue tizanidine hydrochloride therapy [see Clinical Pharmacology (12.3) ].

7.4Alcohol and Other CNS Depressants Alcohol increases the exposure of tizanidine after administration of tizanidine hydrochloride. This was associated with an increase in adverse reactions of tizanidine hydrochloride. Concomitant use of tizanidine hydrochloride with CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may cause additive CNS depressant effects, including sedation.

Monitor patients who take tizanidine hydrochloride with another CNS depressant for symptoms of excess sedation [see Clinical Pharmacology (12.3) ]. 7.5 α 2 -Adrenergic Agonists Concomitant use of Tizanidine with other α2-adrenergic agonists is not recommended because hypotensive effects may be cumulative [see Warnings and Precautions (5.1) ].

7.6Antihypertensive Medications Concomitant use of Tizanidine with antihypertensive medications may cause additive hypotensive effects [see Warnings and Precautions (5.1) ] . Monitor patients who take Tizanidine with antihypertensive medications for hypotension.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm (8.1) Geriatric use: tizanidine hydrochloride should be used with caution in elderly patients because clearance is decreased four-fold (8.5)

8.1Pregnancy Risk Summary There are no adequate data on the developmental risk associated with use of Tizanidine hydrochloride in pregnant women. In animal studies, administration of tizanidine during pregnancy resulted in developmental toxicity (embryofetal and postnatal offspring mortality and growth deficits) at doses less than those used clinically, which were not associated with maternal toxicity (see Animal Data). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% - 4% and 15% - 20%, respectively.

The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data Oral administration of tizanidine (0.3 to 100 mg/kg/day) to pregnant rats during the period of organogenesis resulted in embryofetal and postnatal offspring mortality and reductions in body weight at doses of 30 mg/kg/day and above. Maternal toxicity was observed at the highest dose tested.

The no-effect dose for embryofetal developmental toxicity in rats (3 mg/kg/day) is similar to the maximum recommended human dose (MRHD) of 36 mg/day on a body surface area (mg/m2) basis. Oral administration of tizanidine (1 to 100 mg/kg/day) to pregnant rabbits during the period of organogenesis resulted in embryofetal and postnatal offspring mortality at all doses. Maternal toxicity was observed at the highest dose tested.

Oral administration of tizanidine (10 and 30 mg/kg/day) during the perinatal period of pregnancy (2-6 days prior to delivery) resulted in increased postnatal offspring mortality at both doses. A no-effect dose for embryofetal developmental toxicity in rabbit was not identified. The lowest dose tested (1 mg/kg/day) is less than the MRHD on a mg/m2 basis.

In a pre- and postnatal development study in rats, oral administration of tizanidine (3 to 30 mg/kg/day) resulted in increased postnatal offspring mortality. A no-effect dose for pre- and postnatal developmental toxicity was not identified. The lowest dose tested (3 mg/kg/day) is similar to the MRHD on a mg/m2 basis, respectively.

8.2Lactation Risk Summary There are no data on the presence of tizanidine in human milk, the effects on the breastfed infant, or the effects on human milk production. Animal studies have reported the presence of tizanidine in the milk of lactating animals. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for tizanidine hydrochloride and any potential adverse effects on the breastfed infant from Tizanidine hydrochloride or from the underlying maternal condition.

8.3Females and Males of Reproductive Potential There are no adequate and well-controlled studies in humans on the effect of tizanidine hydrochloride on female or male reproductive potential. Oral administration of tizanidine to male and female rats resulted in adverse effects on fertility [see Nonclinical Toxicology (13.1)].

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established. Juvenile Animal Toxicity Data Oral administration of tizanidine (0, 1, 3, and 10 mg/kg/day) to juvenile rats from postnatal day (PND) 7 through PND 70 resulted in delayed sexual maturation in males at all doses, reduced body weight gain, delayed sexual maturation in females, and bilateral corneal crystals at the mid and high doses. Corneal crystals were still observed at the mid and high doses after a three-week recovery period.

Neurobehavioral deficits were observed on a learning and memory task at the high dose. A no-effect dose for adverse effects on postnatal development not identified.

8.5Geriatric Use Tizanidine hydrochloride is known to be substantially excreted by the kidney,…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary There are no adequate data on the developmental risk associated with use of Tizanidine hydrochloride in pregnant women. In animal studies, administration of tizanidine during pregnancy resulted in developmental toxicity (embryofetal and postnatal offspring mortality and growth deficits) at doses less than those used clinically, which were not associated with maternal toxicity (see Animal Data). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% - 4% and 15% - 20%, respectively.

The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data Oral administration of tizanidine (0.3 to 100 mg/kg/day) to pregnant rats during the period of organogenesis resulted in embryofetal and postnatal offspring mortality and reductions in body weight at doses of 30 mg/kg/day and above. Maternal toxicity was observed at the highest dose tested.

The no-effect dose for embryofetal developmental toxicity in rats (3 mg/kg/day) is similar to the maximum recommended human dose (MRHD) of 36 mg/day on a body surface area (mg/m2) basis. Oral administration of tizanidine (1 to 100 mg/kg/day) to pregnant rabbits during the period of organogenesis resulted in embryofetal and postnatal offspring mortality at all doses. Maternal toxicity was observed at the highest dose tested.

Oral administration of tizanidine (10 and 30 mg/kg/day) during the perinatal period of pregnancy (2-6 days prior to delivery) resulted in increased postnatal offspring mortality at both doses. A no-effect dose for embryofetal developmental toxicity in rabbit was not identified. The lowest dose tested (1 mg/kg/day) is less than the MRHD on a mg/m2 basis.

In a pre- and postnatal development study in rats, oral administration of tizanidine (3 to 30 mg/kg/day) resulted in increased postnatal offspring mortality. A no-effect dose for pre- and postnatal developmental toxicity was not identified. The lowest dose tested (3 mg/kg/day) is similar to the MRHD on a mg/m2 basis, respectively.

🧒 Pediatric Use 108 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established. Juvenile Animal Toxicity Data Oral administration of tizanidine (0, 1, 3, and 10 mg/kg/day) to juvenile rats from postnatal day (PND) 7 through PND 70 resulted in delayed sexual maturation in males at all doses, reduced body weight gain, delayed sexual maturation in females, and bilateral corneal crystals at the mid and high doses. Corneal crystals were still observed at the mid and high doses after a three-week recovery period.

Neurobehavioral deficits were observed on a learning and memory task at the high dose. A no-effect dose for adverse effects on postnatal development not identified.

🧓 Geriatric Use 175 words ▾

8.5Geriatric Use Tizanidine hydrochloride is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Clinical studies of tizanidine hydrochloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects.

Pharmacokinetic data showed that younger subjects cleared tizanidine faster than the elderly subjects [see Clinical Pharmacology (12.3) ] . In elderly patients with renal insufficiency (creatinine clearance < 25 mL/min), tizanidine clearance is reduced compared to healthy elderly subjects; this would be expected to lead to a longer duration of clinical effect. During titration, the individual doses should be reduced.

If higher doses are required, individual doses rather than dosing frequency should be increased. Monitor elderly patients because they may have an increased risk for adverse reactions associated with tizanidine hydrochloride.

🆘 Overdosage 175 words ▾

10 OVERDOSAGE A review of the safety surveillance database revealed cases of intentional and accidental tizanidine hydrochloride 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 is also observed including most often bradycardia and hypotension. Respiratory depression is another common feature of tizanidine overdose.

Should overdose occur ensure the adequacy of an airway and monitorcardiovascular and respiratory function. Dialysis is not likely to be an efficient method of removing tizanidine from the body [see Description (11) ] . In general, symptoms resolve within one to three days following discontinuation of tizanidine and administration of appropriate therapy.

Because of the similar mechanism of action, symptoms and management of tizanidine overdose are similar to that following clonidine overdose. For the most recent information concerning the management of overdose, contact a poison control center.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Tizanidine is a central alpha-2-adrenergic receptor agonist and presumably reduces spasticity by increasing presynaptic inhibition of motor neurons. The effects of tizanidine are greatest on polysynaptic pathways. The overall effect of these actions is thought to reduce facilitation of spinal motor neurons.

12.2Pharmacodynamics The CNS depressant effects of tizanidine and alcohol are additive [see Warnings and Precautions (5.3 ) and Drug Interactions (7.4) ].

12.3Pharmacokinetics Tizanidine has linear pharmacokinetics over the doses studied in clinical development [1 mg (half the recommended dosage) to 20 mg]. Tizanidine capsules and tablets are bioequivalent to each other under fasting conditions, but notunder fed conditions (see Absorption, Effect of Food). Absorption 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. Effect of Food There are pharmacokinetic differences between Tizanidine capsules and Tizanidine tablets withrespect to administration with food. 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 volunteers, of whom 81 were eligible for the statistical analysis.

Pharmacokinetics under fed conditions were different than under fasting conditions and vary by dosage form. Tablets or Capsules - Fasting Tmax was 1.0 hours after dosing T ½ was approximately 2 hours. Tablets - Fed Mean Cmax was increased by approximately 30% Median Tmax was increased by 25 minutes, to 1 hour and 25 minutes.

Extent of absorption was increased approximately 30% Figure 1: Mean Tizanidine Concentration vs. Time Profiles For Tizanidine Tablets and Capsules (2 × 4 mg) Under Fasted and Fed Conditions Distribution 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. Elimination Metabolism 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.

Excretion Following single and multiple oral dosing of 14 C-tizanidine, an average of 60% and 20% of total radioactivity was recovered in the urine and feces, respectively. Specific Populations Geriatric Patients No specific pharmacokinetic study was conducted to investigate age effects. Cross study comparison of pharmacokinetic data following single dose administration of 6 mg tizanidine hydrochloride showed that younger subjects cleared the drug four times faster than the elderly subjects. [see Use in Specific Populations (8.5 ].

Patients with Hepatic Impairment The influence of hepatic impairment on the pharmacokinetics of tizanidine has not been evaluated. Because tizanidine is extensively metabolized in the liver, hepatic impairment would be expected to have significant effects on pharmacokinetics of tizanidine [see Use in Specific Populations (8.7) ]. Patients with Renal Impairment Tizanidine clearance is reduced by more than 50% in elderly patients with renal insufficiency (creatinine clearance < 25 mL/min) compared to healthy elderly subjects; this would be expected to lead to a longer duration of clinical effect [see Use in Specific Populations (8.6)] .

Gender Effects No specific pharmacokinetic study was conducted to investigate gender effects. Retrospective analysis of pharmacokinetic data following single and multiple dose administration of 4 mg tizanidine hydrochloride,however showed that gender had no effect on the pharmacokinet…

🧬 Mechanism of Action 46 words ▾

12.1Mechanism of Action Tizanidine is a central alpha-2-adrenergic receptor agonist and presumably reduces spasticity by increasing presynaptic inhibition of motor neurons. The effects of tizanidine are greatest on polysynaptic pathways. The overall effect of these actions is thought to reduce facilitation of spinal motor neurons.

📦 How Supplied / Storage and Handling 97 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Tizanidine Tablets USP, 4 mg are white to off white, oval, flat, beveled edged tablets debossed with “R180” on one side and “quadrisecting score” on other side. The tablets are available in bottles of 4,15,30,60,90 Bottles of 4 NDC 60760-505-04 Bottles of 15 NDC 60760-505-15 Bottles of 30 NDC 60760-505-30 Bottles of 60 NDC 60760-505-60 Bottles of 90 NDC 60760-505-90

16.2Storage and Handling Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in containers with child resistant closure.

📋 Description 115 words ▾

11 DESCRIPTION Tizanidine hydrochloride USP, is a central α 2 -adrenergic agonist. Tizanidine hydrochloride USP is almost white to slightly yellow crystalline powder, which is slightly soluble in water and methanol. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiodiazole monohydrochloride.

Tizanidine’s molecular formula is C 9 H 8 ClN 5 S.HCl, its molecular weight is 290.2 and its structural formula is: Tizanidine tablets USP, are supplied as 2 mg and 4 mg tablets for oral administration. Tizanidine tablets USP, contain 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, anhydrous lactose, microcrystalline cellulose, colloidal silicon dioxide and stearic acid. structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Serious Drug Interactions Advise patients they should not take tizanidine hydrochloride if they are taking fluvoxamine or ciprofloxacin because of the increased risk of serious adverse reactions including severe lowering of blood pressure and sedation. Instruct patients to inform their healthcare providers when they start or stop taking any medication because of the risks associated with interaction between tizanidine hydrochloride and other medicines [see Contraindications ( 4 ) and Drug Interactions ( 7 )].

Tizanidine hydrochloride Dosing and Administration Tell patients to take tizanidine hydrochloride exactly as prescribed (consistently either with or without food) and not to switch between tablets and capsules [see Dosage and Administration ( 2) ]. Inform patients that they should not take more tizanidine hydrochloride than prescribed because of the risk of adverse events at single doses greater than 8 mg or total daily doses greater than 36 mg. Tell patients that they should not suddenly discontinue tizanidine hydrochloride, because rebound hypertension and tachycardia may occur [see Warnings and Precautions ( 5.6 )].

Hypotension Warn patients that they may experience hypotension and to be careful when changing from a lying or sitting to a standing position. [see Warnings and Precautions (5.1) ] . Sedation Tell patients that tizanidine hydrochloride may cause them to become sedated or somnolent and they should be careful when performing activities that require alertness, such as driving a vehicle or operating machinery [see Warnings and Precautions ( 5.3 )] . Tell patients that the sedation may be additive when tizanidine hydrochloride is taken in conjunction with drugs (baclofen, benzodiazepines) or substances (e.g., alcohol) that act as CNS depressants.

Remind patients that if they depend on their spasticity to sustain posture and balance in locomotion, or whenever spasticity is utilized to obtain increased function, that Tizanidine hydrochloride decreases spasticity and caution should be used. Hypersensitivity Reactions Inform patients of the signs and symptoms of severe allergic reactions and instruct them to discontinue Tizanidine and seek immediate medical care should these signs and symptoms occur [see Warnings and Precautions (5.5) ]. Rx Only Distributor: Dr.

Reddy's Laboratories, Inc., Princeton, NJ 08540. Made in India Revised: 12/24

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 60760-0495-30 · St. 60760-0507-60 · St. →
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.