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Clonidine .17 mg Tablet, Extended Release, 30-count — NDC 68134-0603-30 package photo

Clonidine .17 mg Tablet, Extended Release, 30-count

by PALMETTO PHARMACEUTICALS INC. · 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68134-603-30)
NDC 68134-0603-30
🏷️ FDA NDC (as labeled) 68134-603-30 billing pads the product segment with a zero
Rx only Brand 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 Clonidine (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 19, 2026 — CGMP Deviations: use of an unapproved raw material (Teva Pharmaceuticals USA, Inc) · FDA recall D-0473-2026
Class II · Mar 19, 2026 — CGMP Deviations: use of an unapproved raw material (Teva Pharmaceuticals USA, Inc) · FDA recall D-0472-2026
Class II · Mar 19, 2026 — CGMP Deviations: use of an unapproved raw material (Teva Pharmaceuticals USA, Inc) · FDA recall D-0474-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 68134-603-30
Product NDC 68134-603
11-digit billing NDC 68134060330
NCPDP billing unit EA — each (per item)
RxCUI 885880
UNII MN3L5RMN02
UPC 0368134603307
Application # NDA022500
SPL Set ID e93324f1-ad83-7bbe-e053-2995a90a8c9e
Established class (EPC) Central alpha-2 Adrenergic Agonist
Mechanism of action Adrenergic alpha2-Agonists
DEA schedule Non-controlled
Marketing category NDA AUTHORIZED GENERIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-03-01
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance CLONIDINE
GCN Seq No 066917
GCN 29347
HICL code 000113
Ingredient (HICL) Clonidine Hcl
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A4
Therapeutic class — intermediate (HIC2) Antihypertensives
HIC3 code A4B
Therapeutic class — specific (HIC3) Antihypertensives, Sympatholytic
AHFS code 24:24.00.00
AHFS class Central Alpha-Agonists
FDB label name CLONIDINE HCL ER 0.17 MG TAB
FDB brand name Clonidine Hcl Er
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 68134-603-30 — 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 → 68134-0603-30. 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) Imidazoline receptor agonists, Other antimigraine preparations, Sympathomimetics in glaucoma therapy
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

LabelerPALMETTO PHARMACEUTICALS INC.
Application holderROSEMONT PHARMACEUTICALS LLC
FDA applicationNDA022500 (NDA AUTHORIZED GENERIC)
Labeler code68134
First marketedMar 2022
Product typeHuman Prescription Drug
Portfolio2 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 CLONIDINE HCL ER 0.17 MG TAB Ingredient Clonidine Hcl
📖 What it is MedlinePlus · NLM

Clonidine is used alone or in combination with other medications to treat high blood pressure. Clonidine is also used alone or in combination with other medications as part of a treatment program to control symptoms of attention deficit hyperactivity disorder (ADHD; more difficulty focusing, controlling actions, and remaining still or quiet than other people who are the same age) in children 6 years of age and older. Clonidine is in a class of medications called centrally acting alpha-agonist hypotensive agents. Clonidine treats high blood pressure by decreasing your heart rate and relaxing th...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • You're right that it's used for several different conditions — that can be confusing. Depending on the product, clonidine is prescribed to lower high blood pressure in adults, to t...
  • What exactly is clonidine used for — I've seen it mentioned for totally different things?
  • Drowsiness is one of the most common side effects, especially when you first start or when your dose goes up. Many people find it eases a bit over time. Until you know how it affec...
  • Will clonidine make me too sleepy to function?
📖 Read our full Clonidine guide →
1
Nutrient depletion considerations

Clonidine may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Clonidine nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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
ImprintNP2
Size13 mm
ScoringScored — splits in 2
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 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 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII U076Q6Q621
    Polyethylene glycol 1000 is a synthetic compound made from ethylene oxide. It serves as a solvent, lubricant, and humectant in medicines, helping dissolve active ingredients and improve how the product flows and feels.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII 1699G8679Z
    A synthetic polymer that acts as a binder and helps hold tablet or capsule ingredients together. It may also be used to improve how the medicine dissolves or is absorbed in the digestive system.
  • UNII IJF18F77L3
    Sodium silicate is a glassy, water-soluble compound made from silica and sodium. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help tablets break apart, and sometimes as an absorbent or anti-caking agent.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII XHX3C3X673
    Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.
  • UNII L9MK238N77
    Vinyl acetate is a synthetic polymer used primarily as a film-coating agent in tablets and capsules. It helps create a smooth, protective outer layer that controls how quickly the medicine dissolves and improves appearance.

12 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 · 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.
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
Clonidine .17 mg 52817-0375-30 TruPharma, 30 tablets $15.236 — Availability likely —
Clonidine .17 mgthis 68134-0603-30 PALMETTO 30 tablets — — FDA listed —
Nexiclon XR .17 mg 71511-0503-30 Rosemont 30 tablets — — FDA listed —
About this product: this is an authorized generic — the brand-name product marketed without its brand name. 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

🏛️
2009
First FDA approval
Dec 2009
📍
2026
Currently FDA-listed
17 years listed
🛡️
2031
Latest patent/protection listed
not a guaranteed launch date
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Sep 2031. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Dec 3, 2009 RLD RS ⏳ ~5 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 8337890 — drug product
US 8623409 — drug product
US 8337890 — drug product
US 8623409 — drug product
2009 2011 2013 2015 2017 2019 2021 2023 2025 2027 2029 2031
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (4)
PatentTypeUse codeExpires
US 8337890 ↗ Drug product — Apr 17, 2027
US 8623409 ↗ Drug product — Sep 8, 2031
US 8337890 ↗ Drug product — Apr 17, 2027
US 8623409 ↗ Drug product — Sep 8, 2031
Common questions
Is there a generic version of CLONIDINE HCL ER 0.17 MG TAB?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for CLONIDINE HCL ER 0.17 MG TAB. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Clonidine — the program that covers self-administered drugs. 4 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Clonidine. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$13.31M
Claims incl. refills
123.2K
Beneficiaries
66.1K
Spend / beneficiary
$201.20
Spend / claim
$108.02
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 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 Clonidine — the ingredient across all brands.

Top reported reactions

Fatigue3,519
Pain3,514
Nausea3,475
Headache3,432
Hypertension3,275
Dyspnoea2,748
Diarrhoea2,666

Age at onset

Neonate74
Infant109
Child656
Adolescent326
Adult3,815
Elderly2,595

Reporter sex

57,112 reports
Male · 40%
Female · 60%
Unknown · 0%

Serious outcomes

Hospitalization19,920
Disabling1,368
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4,032 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
68134-0603-30 You're viewing this 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68134-603-30) 2022-03-01 Active

🧭 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 68134-603-30, 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: 68134-0603-30, written without dashes as 68134060330. 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 68134-0603-30, the first segment (68134) is the labeler code FDA assigned to PALMETTO PHARMACEUTICALS INC.; the middle segment (0603) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) 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 PALMETTO PHARMACEUTICALS INC.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
PALMETTO PHARMACEUTICALS 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 43 words ▾

1 INDICATIONS AND USAGE Clonidine extended-release tablets are indicated in the treatment of hypertension. Clonidine extended-release tablets may be employed alone or concomitantly with other antihypertensive agents. Clonidine extended-release tablets are a central alpha-adrenergic agonist indicated for: Treatment of hypertension ( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION The dose of clonidine extended-release tablets must be adjusted according to the patient's individual blood pressure response. The following is a general guide to its administration in adults. Initial dose: 0.17 mg once daily.

Elderly patients may benefit from a lower initial dose. Initial dose is recommended to be administered at bedtime. ( 2.1 ) Maintenance dose: Further increments of 0.09 mg once daily may be made at weekly intervals if necessary until the desired response is achieved.

The therapeutic doses most commonly employed have ranged from 0.17 mg to 0.52 mg once daily. ( 2.2 ) Patients with renal impairment: Up-titrate slowly (2.4)

2.1Initial Dose Dosing with clonidine extended-release tablets should be initiated at 0.17 mg once daily. Elderly patients may benefit from a lower initial dose [ see Use in Specific Populations (8.4) ]. Initial dose is recommended to be administered at bedtime.

2.2Maintenance Dose Further increments of 0.09 mg once daily may be made at weekly intervals if necessary until the desired response is achieved. The therapeutic doses most commonly employed have ranged from 0.17 mg to 0.52 mg once daily. Clonidine extended-release tablets were studied at doses of 0.17 to 0.52 mg once daily. Doses higher than 0.52 mg per day were not evaluated and are not recommended.

2.3Patients Currently Using Clonidine Hydrochloride Immediate-Release Tablets The recommended dose of clonidine extended-release tablets for patients who are currently taking clonidine hydrochloride immediate-release tablets is provided in the table below. Clonidine Extended-Release Tablets Equivalent dose of Clonidine HCl Immediate-Release Tablets Initial Dose 0.17 mg once daily 0.1 mg twice daily Maintenance Dose Titration Increments 0.09 mg once daily 0.05 mg twice daily Common Doses Used for Blood Pressure Effect 0.17 mg once daily 0.1 mg twice daily 0.34 mg once daily 0.2 mg twice daily 0.52 mg once daily 0.3 mg twice daily

2.4Renal Impairment Adjust dosage according to the degree of impairment. In patients with end stage kidney disease on maintenance dialysis, start at 0.09 mg per day and up-titrate slowly to minimize dose related adverse events. Monitor patients carefully, especially for bradycardia, sedation and hypotension.

Only a minimal amount of clonidine is removed during routine hemodialysis. In patients with moderate to severe kidney impairment not undergoing dialysis, initiate clonidine at the same dose as for patients without renal impairment. Up-titrate slowly and monitor for dose-related adverse events.

💊 Dosage Forms and Strengths 24 words ▾

3 DOSAGE FORMS AND STRENGTHS 0.17 mg Extended-Release Tablets (clonidine base) 0.26 mg Extended-Release Tablets (clonidine base) Extended-Release Tablets: 0.17, 0.26 mg clonidine base

⛔ Contraindications 30 words ▾

4 CONTRAINDICATIONS Clonidine extended-release tablets should not be used in patients with known hypersensitivity to clonidine [ see Warnings and Precautions (5.2) ]. Known hypersensitivity to clonidine (rash, angioedema) (4)

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Patients should not discontinue therapy without consulting a physician. Dose reduction should be performed gradually over a 2- to 4-day period to avoid withdrawal symptomatology. Rare instances of hypertensive encephalopathy, cerebrovascular accidents and death have been reported after clonidine withdrawal.

( 5.1 ) Monitor closely and up-titrate slowly in patients with severe coronary insufficiency, conduction disturbances, recent myocardial infarction, cerebrovascular disease, or chronic renal failure. ( 5.2 ) Patients who engage in potentially hazardous activities, such as operating machinery or driving, should be advised of a possible sedative effect of clonidine. ( 5.2 ) In perioperative use, clonidine extended-release tablets may be administered up to 28 hours prior to surgery and resumed the following day.

( 5.3 )

5.1Withdrawal Instruct patients not to discontinue therapy without consulting their physician. Sudden cessation of clonidine treatment has resulted in symptoms such as nervousness, agitation, headache, and tremor accompanied or followed by a rapid rise in blood pressure and elevated catecholamine concentrations in the plasma. The likelihood of such reactions to discontinuation of clonidine therapy appears to be greater after administration of higher doses or continuation of concomitant beta-blocker treatment and special caution is therefore advised in these situations.

Rare instances of hypertensive encephalopathy, cerebrovascular accidents and death have been reported after clonidine withdrawal. When discontinuing therapy with clonidine extended-release tablets, reduce the dose gradually over 2 to 4 days to avoid withdrawal symptoms. An excessive rise in blood pressure following discontinuation of clonidine extended-release tablets can be reversed by administration of oral clonidine hydrochloride or by intravenous phentolamine.

If therapy is to be discontinued in patients receiving a beta-blocker and clonidine concurrently, the beta-blocker should be withdrawn several days before the gradual discontinuation of clonidine extended-release tablets. Because children commonly have gastrointestinal illnesses that lead to vomiting, they may be particularly susceptible to hypertensive episodes resulting from abrupt inability to take medication.

5.2General Precautions In patients who have developed localized contact sensitization to a clonidine transdermal system, substitution of oral clonidine therapy may be associated with the development of a generalized skin rash. In patients who develop an allergic reaction to a clonidine transdermal system, substitution of oral clonidine may also elicit an allergic reaction (including generalized rash, urticaria, or angioedema). Monitor carefully and up-titrate slowly in patients with severe coronary insufficiency, conduction disturbances, recent myocardial infarction, cerebrovascular disease, or chronic renal failure.

Patients who engage in potentially hazardous activities, such as operating machinery or driving, should be advised of a possible sedative effect of clonidine. The sedative effect may be increased by concomitant use of alcohol, barbiturates, or other sedating drugs.

5.3Perioperative Use Clonidine extended-release tablets may be administered up to 28 hours prior to surgery and resumed the following day. Blood pressure should be carefully monitored during surgery and additional measures to control blood pressure should be available if required.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in detail elsewhere in the labeling: Withdrawal [ see Warnings and Precautions (5.1) ] Allergic reactions [ see Warnings and Precautions (5.2) ] There is very little experience with clonidine extended-release tablets in controlled trials. Based on this limited experience, the adverse event profile appears similar with the immediate-release clonidine formulation. The most commonly expected adverse reactions are dry mouth, drowsiness, and dizziness.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Palmetto Pharmaceuticals, Inc. at 1-844-627-7696 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clonidine Extended-Release Tablets Clinical Trial Experience There is very limited experience with clonidine extended-release tablets in controlled trials. Based on this limited experience, the adverse event profile appears similar with to the immediate-release clonidine formulation.

6.2Experience with Immediate-Release Clonidine Most adverse reactions are mild and tend to diminish with continued therapy. The most frequent (which also appear to be dose-related) are dry mouth (approximately 40%); drowsiness (approximately 33%); dizziness (approximately 16%); constipation and sedation (approximately 10% each). The following less frequent adverse reactions have also been reported in patients receiving immediate-release clonidine, but in many cases patients were receiving concomitant medication and a causal relationship has not been established.

Body as a Whole: Fatigue, fever, headache, pallor, weakness, and withdrawal syndrome. Also reported were a weakly positive Coombs’ test and increased sensitivity to alcohol. Cardiovascular: Bradycardia, congestive heart failure, electrocardiographic abnormalities (i.e., sinus node arrest, junctional bradycardia, high degree AV block and arrhythmias), orthostatic symptoms, palpitations, Raynaud’s phenomenon, syncope, and tachycardia.

Cases of sinus bradycardia and atrioventricular block have been reported, both with and without the use of concomitant digitalis. Central Nervous System (CNS): Agitation, anxiety, delirium, delusional perception, hallucinations (including visual and auditory), insomnia, mental depression, nervousness, other behavioral changes, paresthesia, restlessness, sleep disorder, and vivid dreams or nightmares. Dermatological: Alopecia, angioneurotic edema, hives, pruritus, rash, and urticaria.

Gastrointestinal: Abdominal pain, anorexia, constipation, hepatitis, malaise, mild transient abnormalities in liver function tests, nausea, parotitis, pseudo-obstruction (including colonic pseudo-obstruction), salivary gland pain, and vomiting. Genitourinary: Decreased sexual activity, difficulty in micturition, erectile dysfunction, loss of libido, nocturia, and urinary retention. Hematologic: Thrombocytopenia.

Metabolic: Gynecomastia, transient elevation of blood glucose or serum creatine phosphokinase, and weight gain. Musculoskeletal: Leg cramps and muscle or joint pain. Oro-otolaryngeal: Dryness of the nasal mucosa.

Ophthalmological: Accommodation disorder, blurred vision, burning of the eyes, decreased lacrimation, and dryness of eyes.

🔄 Drug Interactions 217 words ▾

7 DRUG INTERACTIONS No drug interaction studies have been conducted with clonidine extended-release tablets. The following have been reported with other oral formulations of clonidine. Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs.

If a patient receiving clonidine hydrochloride is also taking tricyclic antidepressants, the hypotensive effect of clonidine may be reduced, necessitating an increase in the clonidine dose. Monitor heart rate in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction, e.g., digitalis, calcium channel blockers, and beta-blockers. Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concomitantly with diltiazem or verapamil.

Amitriptyline in combination with clonidine enhances the manifestation of corneal lesions in rats [ see Nonclinical Toxicology (13.2) ]. Alcohol: Based on in vitro studies, high concentration of alcohol may increase the rate of release of clonidine extended-release tablets. Sedating drugs: Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs.

( 7 ) Tricyclic antidepressants: May reduce the hypotensive effect of clonidine, necessitating an increase in clonidine dose. ( 7 ) Drugs known to affect sinus node function or AV nodal conduction (e.g., digitalis, calcium channel blockers, beta-blockers): Additive effects such as bradycardia and AV block. ( 7 )

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy Category C ( 8.1 ) Clonidine is secreted in human milk. ( 8.2 ) Safety and effectiveness in children have not been established. ( 8.3 ) Renal impairment: Dose may need adjustment. ( 2.4 )

8.1Pregnancy Pregnancy Category C. Reproduction studies performed in rabbits at doses up to approximately 3 times the oral maximum recommended daily human dose (MRDHD) of clonidine hydrochloride produced no evidence of a teratogenic or embryotoxic potential in rabbits. In rats, however, doses as low as 1/3 the oral MRDHD (1/15 the MRDHD on a mg/m 2 basis) of clonidine were associated with increased resorptions in a study in which dams were treated continuously from 2 months prior to mating.

Increased resorptions were not associated with treatment at the same time or at higher dose levels (up to 3 times the oral MRDHD) when the dams were treated on gestation days 6 to 15. Increases in resorption were observed at much higher dose levels (40 times the oral MRDHD on a mg/kg basis; 4 to 8 times the MRDHD on a mg/m 2 basis) in mice and rats treated on gestation days 1 to 14 (lowest dose employed in the study was 500 mcg/kg). No adequate, well-controlled studies have been conducted in pregnant women.

Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

8.2Nursing Mothers Clonidine is secreted in human milk.

8.3Pediatric Use Safety and effectiveness in pediatric patients have not been established.

8.4Geriatric Use Elderly patients may benefit from a lower initial dose [ see Dosage and Administration (2) ].

8.5Patients with Renal Impairment The initial dosage should be based on the degree of impairment. Monitor patients carefully for hypotension and bradycardia, and titrate to higher doses cautiously. Only a minimal amount of clonidine is removed during routine hemodialysis.

🆘 Overdosage ~1 min read ▾

10 OVERDOSAGE Hypertension may develop early and may be followed by hypotension, bradycardia, respiratory depression, hypothermia, drowsiness, decreased or absent reflexes, weakness, irritability and miosis. The frequency of CNS depression may be higher in children than adults. Large overdoses may result in reversible cardiac conduction defects or dysrhythmias, apnea, coma, and seizures.

Signs and symptoms of overdose generally occur within 30 minutes to two hours after exposure. As little as 0.1 mg of clonidine has produced signs of toxicity in children. There is no specific antidote for clonidine overdosage.

Clonidine overdosage may result in the rapid development of CNS depression; therefore, induction of vomiting with ipecac syrup is not recommended. Gastric lavage may be indicated following recent and/or large ingestions. Administration of activated charcoal and/or a cathartic may be beneficial.

Supportive care may include atropine sulfate for bradycardia, intravenous fluids and/or vasopressor agents for hypotension and vasodilators for hypertension. Naloxone may be a useful adjunct for the management of clonidine-induced respiratory depression, hypotension and/or coma; blood pressure should be monitored since the administration of naloxone has occasionally resulted in paradoxical hypertension. Tolazoline administration has yielded inconsistent results and is not recommended as first-line therapy.

Dialysis is not likely to significantly enhance the elimination of clonidine. The largest overdose reported to date involved a 28-year old male who ingested 100 mg of clonidine hydrochloride powder. This patient developed hypertension followed by hypotension, bradycardia, apnea, hallucinations, semicoma, and premature ventricular contractions.

The patient fully recovered after intensive treatment. Plasma clonidine levels were 60 ng/mL after 1 hour, 190 ng/mL after 1.5 hours, 370 ng/mL after 2 hours, and 120 ng/mL after 5.5 and 6.5 hours. In mice and rats, the oral LD 50 of clonidine is 206 and 465 mg/kg, respectively.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Clonidine stimulates alpha-adrenoreceptors in the brain stem. This action results in reduced sympathetic outflow from the central nervous system and in decreases in peripheral resistance, renal vascular resistance, heart rate, and blood pressure. The patient’s maximum blood pressure decrease occurred within 6 to 8 hours.

Renal blood flow and glomerular filtration rate remain essentially unchanged. Normal postural reflexes are intact; therefore, orthostatic symptoms are mild and infrequent.

12.2Pharmacodynamics Clonidine extended-release tablets were was studied in an open-label crossover, force titration, partially randomized trial in patients with mild and moderate essential hypertension who were on two or fewer antihypertensive medications. The trial was designed to compare steady-state exposures between the Clonidine extended-release tablets and clonidine immediate-release tablets. There were up- and down-titration phases.

There was no washout period between phases or treatments. Studies with immediate-release clonidine hydrochloride have demonstrated a moderate reduction (15% to 20%) in cardiac output in the supine position with no change in the peripheral resistance. At a 45° tilt, there is a smaller reduction in cardiac output and a decrease of peripheral resistance.

During long-term therapy, cardiac output tends to return to control values, while peripheral resistance remains decreased. Slowing of the pulse rate has been observed in most patients given clonidine, but the drug does not alter normal hemodynamic response to exercise. Tolerance to the antihypertensive effect may develop in some patients, necessitating a re-evaluation of therapy.

Other studies in patients have provided evidence of a reduction in plasma renin activity and in the excretion of aldosterone and catecholamines. The exact relationship of these pharmacologic actions to the antihypertensive effect of clonidine has not been fully elucidated. Clonidine acutely stimulates growth hormone release in both children and adults, but does not produce a chronic elevation of growth hormone with long-term use.

12.3Pharmacokinetics Following single doses of clonidine extended-release tablets 0.17 mg, clonidine mean (S.D.) peak plasma concentrations of 0.49 (±0.09) ng/mL occurred at 7.8 (±1.7) hours. The plasma half-life of clonidine was 13.7 (±3.0) hours. There was no effect of food on the pharmacokinetic parameters.

A = Clonidine Extended-Release Tablets (0.17 mg QD) Fasted B = Clonidine IR Tablet (0.1 mg clonidine hydrochloride Q12h) Fasted C = Clonidine Extended-Release Tablets (0.17 mg QD) Fed In the multi-dose study, mild to moderate hypertensive patients were randomized to ER and BID IR clonidine formulations. The following plot shows the sitting blood pressure values for each treatment group at Day 22. The half-life may increase up to 41 hours in patients with severe impairment of renal function.

Following oral administration of clonidine about 40 to 60% of the absorbed dose is recovered in the urine as unchanged drug in 24 hours. About 50% of the absorbed dose is metabolized in the liver. figure1 figure2

📦 How Supplied / Storage and Handling 63 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Clonidine Extended-Release Tablets are scored, splitable, capsule-shaped coated tablets that are supplied in bottles of 30. Strength Color Markings NDC 0.17 mg White NP 2 68134-603-30 Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container with a child-resistant closure.

📋 Description 152 words ▾

11 DESCRIPTION Clonidine extended-release tablets are available for oral administration in two dose strengths: 0.17 mg and 0.26 mg. The 0.17 mg and 0.26 mg tablets are equivalent to 0.2 mg and 0.3 mg of immediate-release clonidine hydrochloride, respectively. Clonidine hydrochloride, a centrally active alpha-adrenergic agonist, is an imidazoline derivative and exists as a mesomeric compound.

The chemical name is 2-(2.6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula: C 9 H 9 C l2 N 3 ·HCl Mol. Wt.

266.56 Clonidine hydrochloride is an odorless, bitter, white crystalline substance soluble in water and alcohol. The inactive ingredients are: crospovidone, dental-type silica, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl acetate, povidone, sodium polystyrene sulfonate, triacetin. The 0.17 mg tablet also contains hypromellose, polyethylene glycol, and titanium dioxide.

The 0.26 mg tablet also contains D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, fractionated coconut oil, maltodextrin, polydextrose, talc, and titanium dioxide. molecularstructure

💬 Information for Patients 55 words ▾

17 PATIENT COUNSELING INFORMATION Caution patients against interruption of clonidine extended-release tablet therapy without their healthcare provider’s advice. Advise patients who engage in potentially hazardous activities, such as operating machinery or driving, of a possible sedative effect of clonidine. The sedative effect may be increased by concomitant use of alcohol, barbiturates, or other sedating drugs.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 68134-0403-16 · Palmetto 68135-0000-99 · BioMarin →
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.