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Tizanidine 4 mg Tablet, 60-count

by REMEDYREPACK INC. · 60 TABLET in 1 BOTTLE, PLASTIC (70518-1598-1)

NDC 70518-1598-01

🏷️ FDA NDC (as labeled) 70518-1598-1 billing pads the package segment with a zero

This package

Contains60-count Pack sizes3 compare ↓

Also comes in: 30 tablets 70518-1598-03 90 tablets 70518-1598-04

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 Dr. Brian Staiger, PharmD

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) 70518-1598-1

Product NDC 70518-1598

11-digit billing NDC 70518159801

RxCUI 313413

UNII B53E3NMY5C

Application # ANDA091283

SPL Set ID b14bd166-9f53-4f2e-be05-c447af04ef69

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 2018-10-26

Route ORAL

Dosage form TABLET

Substance TIZANIDINE HYDROCHLORIDE

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 70518-1598-1 — a 5-4-1 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 package segment → 70518-1598-01. 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

LabelerREMEDYREPACK INC.

Application holderUNICHEM LABORATORIES LTD

FDA applicationANDA091283 (ANDA)

Labeler code70518

First marketedOct 2018

Product typeHuman Prescription Drug

Portfolio1,502 products on file

🔎 All NDCs from REMEDYREPACK INC.

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 →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Tizanidine — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Tizanidine (143 interactions) — ranked by severity →

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.

🧪 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 system	Per each	Per 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 · quarterly	No Part D plan price is available for this NDC in our data.

ℹ️

No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.

Try another pack size: 30 tablets 90 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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price 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 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 mgthis 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

🏛️

2018

On the market since

Oct 2018

📍

2026

Currently FDA-listed

8 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

Male · 24%

Female · 76%

Unknown · 0%

Reports over time (by year) — tap or hover for the count & year

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 NDC	Description	Marketing start	Status
70518-1598-01 You're viewing this	60 TABLET in 1 BOTTLE, PLASTIC (70518-1598-1)	2019-08-01	Active
70518-1598-03	30 TABLET in 1 BOTTLE, PLASTIC (70518-1598-3)	2020-03-06	Active
70518-1598-04	90 TABLET in 1 BOTTLE, PLASTIC (70518-1598-4)	2020-04-03	Active

You're viewing one of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 70518-1598-01?

NDC 70518-1598-01 is a 60-count package — 60 tablet in 1 bottle, plastic.

What is the difference between NDC 70518-1598-01 and NDC 70518-1598-03?

Both are Tizanidine 4 mg Tablet — the drug itself is identical. NDC 70518-1598-01 is the 60-count package, while NDC 70518-1598-03 is the 30 tablets package.

What NDC number is used to bill for this package of Tizanidine 4 mg Tablet?

Bill NDC 70518-1598-01 — the 11-digit billing format is 70518159801. 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 70518-1598-1, 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: 70518-1598-01, written without dashes as 70518159801. 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 70518-1598-01, the first segment (70518) is the labeler code FDA assigned to REMEDYREPACK INC.; the middle segment (1598) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 REMEDYREPACK INC.. 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 2 other package presentations of this same product, including 30 tablets (70518-1598-03), 90 tablets (70518-1598-04). 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?

REMEDYREPACK INC. 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

🎯 Indications and Usage 29 words ▾

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

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Monitoring of aminotransferase levels is recommended at baseline and 1 month 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 every 1 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, decrease dose slowly to minimize the risk of withdrawal adverse reactions ( 2.5 )

2.1Recommended Evaluation and Testing Before and After Initiating Tizanidine 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 dose based 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 between the fed or fasted state [see Clinical Pharmacology ( 12.3 )] . Tizanidine 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 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 lower individual 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 When discontinuing Tizanidine, particularly in patients who have been receiving high doses for long periods or who may be on concomitant treatment with narcotics, decrease the 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 70 words ▾

3. DOSAGE FORMS AND STRENGTHS Tizanidine tablets USP, 4 mg are white to off-white, round, flat, bevel edged uncoated tablets debossed with "U" and "169" on one side and quadrisecting score on other side. Tablets 4 mg ( 3 ) Tablets Tizanidine tablets USP, 4 mg are white to off-white, round, flat, bevel edged uncoated tablets debossed with "U" and "169" on one side and quadrisecting score on other side.

⛔ Contraindications 71 words ▾

4 CONTRAINDICATIONS Concomitant use with strong CYP1A2 inhibitors ( 4 , 7.1 ) Patients with a history of hypersensitivity to tizanidine or the ingredients in Tizanidine ( 4 , 5.5 ) Tizanidine 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. Symptoms have included anaphylaxis and angioedema [see Warnings and Precautions ( 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 should not be used with other α 2 -adrenergic agonists ( 5.1 , 7.7 ) Risk of liver injury: monitor ALTs; discontinue tizanidine if liver injury occurs ( 5.2 ) Sedation: tizanidine may interfere with everyday activities; sedative effects of tizanidine, alcohol, and other central nervous system (CNS) depressants are additive ( 5.3 , 7.4 ) Hallucinations: consider discontinuation of tizanidine ( 5.4 )

5.1Hypotension Tizanidine is an α2-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 is used in patients receiving concurrent antihypertensive therapy. It is not recommended that Tizanidine be used with other α2-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 with strong CYP1A2 inhibitors is contraindicated [see Contraindications ( 4 ) and Drug Interactions ( 7.1 )] . ( 7.1 )] .

5.2Liver Injury Tizanidine may cause hepatocellular liver injury. Liver function test abnormality and hepatotoxicity have been observed with Tizanidine [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 can cause sedation, which may interfere with everyday activity. In the multiple dose studies of Tizanidine, 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 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 with another CNS depressant for symptoms of excess sedation.

5.4Hallucinosis/Psychotic-Like Symptoms Tizanidine 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 in patients who develop hallucinations.

5.6Hypersensitivity Reactions Tizanidine can cause anaphylaxis. Signs and symptoms of hypersensitivity, including respiratory compromise, urticaria, and angioedema of the throat and tongue, have been reported. Tizanidine is contraindicated in patients with a history of hypersensitivity reactions to tizanidine [see Contraindications ( 4 )] .

5.8Withdrawal Adverse Reactions Tizanidine can cause withdrawal adverse reactions, which include rebound hypertension, tachycardia, and hypertonia. To minimize the risk of these reactions, particularly in patients who have been receiving high doses of Tizanidine (20 to 28 mg dai…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS 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 Unichem Pharmaceuticals (USA) Inc. at 1-866-562-4616 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.5 )] Withdrawal Adverse Reactions [see Warnings and Precautions ( 5.6 )]

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 patients were 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 where the frequency in the Tizanidine group was greater than the placebo group. 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 1: Multiple Dose, Placebo-Controlled Studies-Adverse Reactions Reported in >2% of Patients Treated with Tizanidine Tablets and Incidence Greater than Placebo *(includes weakness, fatigue, and/or tiredness) 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 Table 2: Single Dose, Placebo-Controlled Study—Common Adverse Reactions Reported *includes weakness, fatigue, and/or tiredness A dverse 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 16 33 Bradycardia 0 2 10

6.2 Postmarketing Experi…

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS

7.1Strong CYP1A2 Inhibitors Concomitant use of Tizanidine 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 )] .

7.3Moderate or Weak CYP1A2 Inhibitors Concomitant use of Tizanidine 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 dosage or discontinue Tizanidine therapy [see Clinical Pharmacology ( 12.3 )] .

7.4Oral Contraceptives Concomitant use of Tizanidine 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 therapy. [see Clinical Pharmacology ( 12.3 )]

7.5Alcohol and Other CNS Depressants Alcohol increases the exposure of tizanidine after administration of Tizanidine. This was associated with an increase in adverse reactions of Tizanidine. Concomitant use of Tizanidine with CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may cause additive CNS depressant effects, including sedation.

Monitor patients who take Tizanidine with another CNS depressant for symptoms of excess sedation [see Clinical Pharmacology ( 12.3 )] 7.6 a2-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 )] .

7.7Antihypertensive 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 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 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/m 2 ) 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/m 2 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/m 2 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 and any potential adverse effects on the breastfed infant from tizanidine 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 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 is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patie…

🤰 Pregnancy ~1 min read ▾

🧒 Pediatric Use 108 words ▾

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 172 words ▾

8.5Geriatric Use Tizanidine 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 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.

🆘 Overdosage 176 words ▾

10 OVERDOSAGE 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 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 monitor cardiovascular 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 not under 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 with respect 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 Tablets – Fed Capsules – Fed Capsule Content Sprinkled on Applesauce Compared to administration of an intact capsule while fasting: 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 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, however, showed that gender had no effect on the pharmacokinetics of tizanidine. Drug Interactions CYP1A2 Inhibitors The effects of coadministration of fluvoxamine or ciprofloxacin, both str…

🧬 Mechanism of Action 46 words ▾

📦 How Supplied / Storage and Handling 140 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Tizanidine tablets, USP are available as white to off-white, round, flat, bevel edged uncoated tablets containing 4 mg of tizanidine. Tizanidine tablets USP, 4 mg white to off white, round, flat, beveledged uncoated tablet with "U" on one side and "169" debossed on one side and quadrisecting score on other side. NDC: 70518-1598-00 NDC: 70518-1598-01 NDC: 70518-1598-02 NDC: 70518-1598-03 NDC: 70518-1598-04 PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 60 in 1 BOTTLE PLASTIC PACKAGING: 15 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BOTTLE PLASTIC PACKAGING: 90 in 1 BOTTLE PLASTIC Store at 20° - 25°C (68° - 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Dispense in tight, light-resistant container [see USP]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr.

Suite #4 Indiana, PA 1-724-465-8762

📋 Description 124 words ▾

11 DESCRIPTION Tizanidine Tablets contains tizanidine hydrochloride as the active ingredient, which is a central alpha 2 -adrenergic agonist. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3- benzothiadiazole monohydrochloride. It has a molecular formula of C 9 H 8 ClN 5 S-HCl and a molecular weight of 290.2.

Its structural formula is: Tizanidine hydrochloride is a white to off-white, fine crystalline powder, which is odorless or with a faint characteristic odor. Tizanidine hydrochloride is slightly soluble in water and methanol; solubility in water decreases as the pH increases Tizanidine tablets, are for oral administration and contain 2 or 4 mg tizanidine (equivalent to 2.288 mg and 4.576 mg tizanidine hydrochloride, respectively), and the inactive ingredients anhydrous lactose, colloidal silicon dioxide, microcrystalline cellulose, and stearic acid. molecular structure

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

sedative: A substance with a calming effect that can also cause drowsiness.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

abuse: Using a medicine in a way it was not meant to be used, such as taking more than prescribed to feel a high.

Active ingredient: The part of a medicine that produces its intended effect on the body.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agonist: A substance that switches on a specific target in the body to produce an effect, the way a key turns a lock.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

angioedema: Rapid swelling deep under the skin, often around the eyes, lips, tongue, or throat.

asthenia: Unusual weakness or lack of physical strength and energy.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

bradycardia: A slower-than-normal heart rate, usually under 60 beats per minute.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

creatinine clearance: An estimate of how fast the kidneys filter waste from the blood, often used to choose the right medicine dose.

crossover: A study design in which each person takes one treatment for a time, then switches to the other, acting as their own comparison.

CYP1A2: A liver enzyme that breaks down certain medicines and whose activity can be changed by cigarette smoke.

cytochrome P450: A large family of enzymes, mostly in the liver, that break down many medicines so the body can remove them.

depression: A lasting low mood with loss of interest that affects everyday life.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dosage form: The physical form a medicine comes in, such as a tablet, capsule, liquid, patch, or injection.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

Drug Abuse and Dependence: A label section describing a medicine's potential to be misused and to cause the body to rely on it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dyskinesia: Involuntary, uncontrolled movements of the face, arms, legs, or body.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

fertility: The natural ability to become pregnant or to father a child.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

hepatic metabolism: The breakdown of a medicine by the liver into other substances the body can use or remove.

hepatotoxicity: Damage to the liver caused by a medicine or other substance.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

lactation: The making and release of milk from a mother's breasts after giving birth.

lethargy: A state of tiredness and sluggishness, often with slowed thinking or movement.

linear pharmacokinetics: When blood levels of a medicine rise in direct proportion to the size of the dose.

maximum tolerated dose: The highest dose people can take in a study without unacceptable side effects.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

Nonclinical Toxicology: The label section summarizing safety findings from laboratory and animal studies, rather than from studies in people.

open-label: A study in which both the patients and their doctors know which treatment each person is receiving.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

psychosis: A state of losing touch with reality, such as seeing or hearing things that are not there or holding false beliefs.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

rebound: The return of symptoms, sometimes worse than before, after a medicine that was controlling them is stopped.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

reproductive potential: The ability to have children, meaning a person who could become pregnant or could father a child.

respiratory depression: Breathing that becomes too slow or too shallow to move enough air, so the body may not get enough oxygen.

sedation: A calm, sleepy, slowed-down state caused by a medicine that relaxes the brain and body.

somnolence: Feeling very sleepy or drowsy, with trouble staying awake during the day.

steady state: The point where the amount of medicine going in equals the amount leaving, so blood levels stay fairly even.

syncope: The medical term for fainting, a brief loss of consciousness from a temporary drop in blood flow to the brain.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

titration: Slowly adjusting a medicine's dose up or down in small steps to find the amount that works best with the fewest side effects.

urticaria: Raised, itchy welts on the skin, commonly called hives.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

withdrawal: Uncomfortable physical or mental symptoms that appear when a medicine the body has gotten used to is reduced or stopped.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

← 70518-1588-00 · REMEDYREPACK 70518-1599-00 · REMEDYREPACK →

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.

Tizanidine 4 mg Tablet, 60-count

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7 DRUG INTERACTIONS

12 CLINICAL PHARMACOLOGY

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