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Clonidine Hydrochloride .3 mg Tablet, 100-count — NDC 00228-2129-10 package photo

Clonidine Hydrochloride .3 mg Tablet, 100-count

by Actavis Pharma, Inc. · 100 TABLET in 1 BOTTLE (0228-2129-10)
NDC 00228-2129-10
🏷️ FDA NDC (as labeled) 0228-2129-10 billing pads the labeler segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 0228-2129-10
Product NDC 0228-2129
11-digit billing NDC 00228212910
NCPDP billing unit EA — each (per item)
RxCUI 884173, 884185, 884189
UNII W76I6XXF06
UPC 0302282128107, 0302282129104, 0302282127100
Application # ANDA070976
SPL Set ID a842ab83-3531-44dd-a8a8-64dd89e87026
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 1995-01-03
Route ORAL
Dosage form TABLET
Substance CLONIDINE HYDROCHLORIDE
GPI-14 36201010100315
GPI class cloNIDine HCl
GCN Seq No 000348
GCN 01392
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 0.3 MG TABLET
FDB brand name Clonidine 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 0228-2129-10 — a 4-4-2 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 labeler segment → 00228-2129-10. 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

LabelerActavis Pharma, Inc.
Application holderACTAVIS ELIZABETH LLC
FDA applicationANDA070976 (ANDA)
Labeler code00228
First marketedJan 1995
Product typeHuman Prescription Drug
Portfolio324 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 0.3 MG TABLET Ingredient Clonidine Hcl
📗 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 →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 orange
ShapeRound
ImprintR129
Size9 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 CQ3XH3DET6
    D&C Yellow No. 10 Aluminum Lake is a yellow colorant made by combining a dye with aluminum salts. It's used in medicines to add color for product identification and visual appeal.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • 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 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

6 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 eaPer package
Retail pharmacies payNADAC · weekly $0.040 $4.02 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.1820 $18.20 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.1038 $10.38 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.044 $0.038
▼ Down 4% over the last 24 months.
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 Hydrochloride .3 mgthis 00228-2129-10 Actavis 100 tablets $0.040 AB Availability likely —
clonidine hydrochloride .3 mg 29300-0137-01 Unichem 100 tablets $0.040 AB Availability likely —
Clonidine Hydrochloride .3 mg 43547-0567-10 Solco 100 tablets $0.040 AB Availability likely —
clonidine hydrochloride .3 mg 50268-0194-15 AvPAK 50 tablets $0.040 AB Availability likely —
Clonidine hydrochloride .3 mg 52817-0182-00 TruPharma, 1000 tablets $0.040 — Availability likely —
Clonidine Hydrochloride .3 mg 58657-0649-01 Method 100 tablets $0.040 AB Availability likely —
Clonidine Hydrochloride .3 mg 59651-0234-01 Aurobindo 100 tablets $0.040 AB Availability likely —
Clonidine Hydrochloride .3 mg 68001-0239-00 BluePoint 100 tablets $0.040 AB Availability likely —
clonidine hydrochloride .3 mg 43063-0924-30 PD-Rx 30 tablets — AB FDA listed —
Clonidine Hydrochloride .3 mg 43353-0316-09 Aphena 9000 tablets — AB FDA listed —
clonidine hydrochloride .3 mg 46708-0308-10 Alembic 100 tablets — AB FDA listed —
clonidine hydrochloride .3 mg 50090-1910-00 A-S 100 tablets — AB FDA listed —
clonidine hydrochloride .3 mg 51655-0339-25 Northwind 60 tablets — AB FDA listed —
Clonidine hydrochloride .3 mg 51655-0451-25 Northwind 60 tablets — — FDA listed —
clonidine hydrochloride .3 mg 62332-0056-10 Alembic 100 tablets — AB FDA listed —
Clonidine Hydrochloride .3 mg 63629-2318-01 Bryant 500 tablets — AB FDA listed —
Clonidine Hydrochloride .3 mg 63629-2319-01 Bryant 100 tablets — AB FDA listed —
clonidine hydrochloride .3 mg 66267-0464-90 NuCare 90 tablets — AB FDA listed —
clonidine hydrochloride .3 mg 68788-8163-01 Preferred 100 tablets — AB FDA listed —
clonidine hydrochloride .3 mg 70518-2203-01 REMEDYREPACK 30 tablets — AB FDA listed —
Clonidine Hydrochloride .3 mg 70518-4379-00 REMEDYREPACK 60 tablets — AB FDA listed —
clonidine hydrochloride .3 mg 71335-0915-01 Bryant 60 tablets — AB Discontinued —
Clonidine hydrochloride .3 mg 71335-1624-01 Bryant 60 tablets — — Discontinued —
Clonidine Hydrochloride .3 mg 71335-2889-01 Bryant 500 tablets — AB FDA listed —
Clonidine Hydrochloride .3 mg 71335-9682-01 Bryant 60 tablets — AB FDA listed —
Clonidine hydrochloride .3 mg 71610-0449-09 Aphena 9000 tablets — — FDA listed —
Clonidine Hydrochloride .3 mg 72162-1681-01 Bryant 100 tablets — AB FDA listed —
Clonidine Hydrochloride .3 mg 72162-2611-05 Bryant 500 tablets — AB FDA listed —
Clonidine hydrochloride .3 mg 76420-0286-01 Asclemed 100 tablets — — FDA listed —
clonidine hydrochloride .3 mg 87063-0183-01 ASCLEMED 100 tablets — AB FDA listed —
Clonidine Hydrochloride .3 mg 00615-2574-39 NCS 30 tablets — AB Discontinued —
clonidine hydrochloride .3 mg 67046-0646-03 Coupler 30 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
1995
On the market since
Jan 1995
📍
2026
Currently FDA-listed
31 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00228-2129-10, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
102.4K
Units reimbursed last 4 qtrs
4.7M
Gross reimbursed last 4 qtrs
$860.1K
Avg / prescription
$8.40
Avg / unit
$0.1820
Latest quarter Q4 2025
25.4KRx
Medicaid pays / ea
$0.1820
gross reimbursed
vs
NADAC / ea
$0.0402
acquisition cost
=
Spread
+$0.1418
+353% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
33% FFS 67% MCO
Fee-for-service · 34,137 Rx Managed care · 68,308 Rx
State Medicaid map
Alaska: 6,687 units · 912 per 100k residents AK Maine: 28,960 units · 2,076 per 100k residents ME Washington: 58,775 units · 752 per 100k residents WA Idaho: 21,835 units · 1,112 per 100k residents ID Montana: 20,513 units · 1,812 per 100k residents MT North Dakota: 9,852 units · 1,258 per 100k residents ND Minnesota: 49,646 units · 865 per 100k residents MN Wisconsin: 50,920 units · 862 per 100k residents WI Michigan: 143,621 units · 1,431 per 100k residents MI New York: 349,190 units · 1,784 per 100k residents NY Vermont: 4,516 units · 698 per 100k residents VT New Hampshire: 10,367 units · 739 per 100k residents NH Oregon: 53,082 units · 1,254 per 100k residents OR Nevada: 58,839 units · 1,842 per 100k residents NV Wyoming: 5,713 units · 978 per 100k residents WY South Dakota: 11,190 units · 1,218 per 100k residents SD Iowa: 28,829 units · 899 per 100k residents IA Illinois: 94,393 units · 752 per 100k residents IL Indiana: 54,484 units · 794 per 100k residents IN Ohio: 160,262 units · 1,360 per 100k residents OH Pennsylvania: 244,652 units · 1,888 per 100k residents PA New Jersey: 122,693 units · 1,321 per 100k residents NJ Massachusetts: 59,450 units · 849 per 100k residents MA California: 504,855 units · 1,296 per 100k residents CA Utah: 24,984 units · 731 per 100k residents UT Colorado: 44,001 units · 749 per 100k residents CO Nebraska: 22,904 units · 1,158 per 100k residents NE Missouri: 67,696 units · 1,093 per 100k residents MO Kentucky: 103,458 units · 2,286 per 100k residents KY West Virginia: 47,172 units · 2,665 per 100k residents WV Virginia: 70,926 units · 814 per 100k residents VA Maryland: 239,613 units · 3,877 per 100k residents MD Connecticut: 35,144 units · 972 per 100k residents CT Rhode Island: 9,430 units · 861 per 100k residents RI Arizona: 117,495 units · 1,581 per 100k residents AZ New Mexico: 12,594 units · 596 per 100k residents NM Kansas: 16,033 units · 545 per 100k residents KS Arkansas: 15,828 units · 516 per 100k residents AR Tennessee: 78,111 units · 1,096 per 100k residents TN North Carolina: 126,074 units · 1,164 per 100k residents NC South Carolina: 30,469 units · 567 per 100k residents SC Delaware: 8,407 units · 815 per 100k residents DE Oklahoma: 64,535 units · 1,592 per 100k residents OK Louisiana: 130,387 units · 2,851 per 100k residents LA Mississippi: 58,852 units · 2,002 per 100k residents MS Alabama: 79,410 units · 1,555 per 100k residents AL Georgia: 109,529 units · 993 per 100k residents GA D.C.: 16,168 units · 2,381 per 100k residents DC Hawaii: 11,052 units · 770 per 100k residents HI Texas: 322,928 units · 1,059 per 100k residents TX Florida: 676,391 units · 2,992 per 100k residents FL
Units reimbursed · per 100k residents
5163,877
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Maryland 3,877 /100k
2 Florida 2,992 /100k
3 Louisiana 2,851 /100k
4 West Virginia 2,665 /100k
5 D.C. 2,381 /100k
6 Kentucky 2,286 /100k
7 Maine 2,076 /100k
8 Mississippi 2,002 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00228-2129-10 You're viewing this 100 TABLET in 1 BOTTLE (0228-2129-10) 1995-01-03 Active

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 26 words ▾

INDICATIONS AND USAGE Clonidine hydrochloride tablets are indicated in the treatment of hypertension. Clonidine hydrochloride tablets may be employed alone or concomitantly with other antihypertensive agents.

⏱️ Dosage and Administration 184 words ▾

DOSAGE AND ADMINISTRATION Adults: The dose of clonidine hydrochloride tablets must be adjusted according to the patient’s individual blood pressure response. The following is a general guide to its administration. Initial Dose: 0.1 mg tablet twice daily (morning and bedtime).

Elderly patients may benefit from a lower initial dose. Maintenance Dose: Further increments of 0.1 mg per day may be made at weekly intervals if necessary until the desired response is achieved. Taking the larger portion of the oral daily dose at bedtime may minimize transient adjustment effects of dry mouth and drowsiness.

The therapeutic doses most commonly employed have ranged from 0.2 mg to 0.6 mg per day given in divided doses. Studies have indicated that 2.4 mg is the maximum effective daily dose, but doses as high as this have rarely been employed. Renal Impairment: Patients with renal impairment may benefit from a lower initial dose.

Patients should be carefully monitored. Since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental clonidine following dialysis. For questions regarding this product, call Teva at 1-888-838-2872.

⛔ Contraindications 18 words ▾

CONTRAINDICATIONS Clonidine hydrochloride tablets should not be used in patients with known hypersensitivity to clonidine (see PRECAUTIONS ).

⚠️ Warnings 202 words ▾

WARNINGS Withdrawal: Patients should be instructed not to discontinue therapy without consulting their physician. Sudden cessation of clonidine treatment has, in some cases, 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 hydrochloride tablets, the physician should reduce the dose gradually over 2 to 4 days to avoid withdrawal symptomatology. An excessive rise in blood pressure following discontinuation of clonidine hydrochloride tablets therapy 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 hydrochloride 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.

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS Most adverse effects are mild and tend to diminish with continued therapy. The most frequent (which appear to be dose-related) are dry mouth, occurring in about 40 of 100 patients; drowsiness, about 33 in 100; dizziness, about 16 in 100; constipation and sedation, each about 10 in 100. The following less frequent adverse experiences have also been reported in patients receiving clonidine hydrochloride tablets, 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: 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. To report SUSPECTED ADVERSE EVENTS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch for voluntary reporting of adverse reactions.

🆘 Overdosage ~1 min read ▾

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 ▾

CLINICAL PHARMACOLOGY 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. Clonidine hydrochloride tablets act relatively rapidly.

The patient’s blood pressure declines within 30 to 60 minutes after an oral dose, the maximum decrease occurring within 2 to 4 hours. Renal blood flow and glomerular filtration rate remain essentially unchanged. Normal postural reflexes are intact; therefore, orthostatic symptoms are mild and infrequent.

Acute studies with clonidine hydrochloride in humans have demonstrated a moderate reduction (15% to 20%) of cardiac output in the supine position with no change in the peripheral resistance: at a 45 degree 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 reevaluation 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. Pharmacokinetics: The pharmacokinetics of clonidine is dose-proportional in the range of 100 mcg to 600 mcg. The absolute bioavailability of clonidine on oral administration is 70% to 80%.

Peak plasma clonidine levels are attained in approximately 1 to 3 hours. Following intravenous administration, clonidine displays biphasic disposition with a distribution half-life of about 20 minutes and an elimination half-life ranging from 12 to 16 hours. The half-life increases up to 41 hours in patients with severe impairment of renal function.

Clonidine crosses the placental barrier. It has been shown to cross the blood-brain barrier in rats. Following oral administration 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. Neither food nor the race of the patient influences the pharmacokinetics of clonidine. The antihypertensive effect is reached at plasma concentrations between about 0.2 and 2.0 ng/mL in patients with normal excretory function.

A further rise in the plasma levels will not enhance the antihypertensive effect.

📦 How Supplied / Storage and Handling 181 words ▾

HOW SUPPLIED Clonidine hydrochloride tablets, USP are supplied as follows: 0.1 mg - Each orange, round tablet imprinted with and 127 on one side and bisect on the other side contains 0.1 mg of clonidine hydrochloride, USP and is supplied in bottles of 100 (NDC 0228-2127-10) and 500 (NDC 0228-2127-50). 0.2 mg - Each orange, round tablet imprinted with on one side and 128 and bisect on the other side contains 0.2 mg of clonidine hydrochloride, USP and is supplied in bottles of 100 (NDC 0228-2128-10) and 500 (NDC 0228-2128-50).

0.3mg - Each orange, round tablet imprinted with on one side and 129 and bisect on the other side contains 0.3 mg of clonidine hydrochloride, USP and is supplied in bottles of 100 (NDC 0228-2129-10). Dispense in a tight, light-resistant container as defined in the USP. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Manufactured In Croatia By: Pliva Hrvatska d.o.o. Zagreb, Croatia Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. A 9/2022 0.1 mg image 0.2mg image 0.3mg image

📋 Description 114 words ▾

DESCRIPTION Clonidine hydrochloride, USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths: 0.1 mg, 0.2 mg, and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. The following inactive ingredients are contained in these products: corn starch, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake (Sunset Yellow Lake), lactose monohydrate, magnesium stearate, and sodium starch glycolate.

Clonidine hydrochloride, USP 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: Clonidine hydrochloride, USP is an odorless, bitter, white, crystalline substance soluble in water and alcohol.

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