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Clonidine Hydrochloride .2 mg Tablet, 100-count — NDC 00904-7443-61 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Clonidine Hydrochloride .2 mg Tablet, 100-count — NDC 0904-7443-61 (Billing 00904-7443-61)

by Major Pharmaceuticals · 100 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK

This is a package of 100 tablets of Clonidine Hydrochloride .2 mg Tablet from Major Pharmaceuticals, marketed since Nov 2025 and currently FDA-listed; retail pharmacies pay about $0.0330 per tablet (NADAC). It is this product's only package size.

NDC 00904-7443-61
🏷️ FDA NDC (as labeled) 0904-7443-61 billing pads the labeler segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 20, 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0904-7443-61
Product NDC 0904-7443
11-digit billing NDC 00904744361
NCPDP billing unit EA — each (per item)
RxCUI 884173, 884185
UNII W76I6XXF06
Application # ANDA077901
SPL Set ID 8171776a-dd14-4dcc-8860-3c27d8ea9504
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 2025-11-21
Route ORAL
Dosage form TABLET
Substance CLONIDINE HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 000347
GCN 01391
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 0.2 MG TABLET
FDB brand name Clonidine Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 000347
  • GCN: 01391
  • HICL (First Databank): 000113
  • AHFS class code: 24:24.00.00
  • RxCUI (RxNorm): 884173
Why two NDCs? The FDA registers this code as 0904-7443-61 — 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 → 00904-7443-61. 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.

Clinical

Label name CLONIDINE HCL 0.2 MG TABLET Ingredient Clonidine Hcl
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Tablets, oral solutions, Nexiclon XR and patches lower high blood pressure. Certain extended-release products treat ADHD. The epidural injection is used...
  • No. Stopping suddenly can cause rebound high blood pressure, with headache, a racing heart, nervousness and anxiety. Your doctor will lower the dose gradually.
  • Sleepiness is common. Don't drive or use heavy equipment until you know how it affects you. Avoid alcohol, and ask me before combining it with other sedating medicines.
  • No. Extended-release clonidine tablets should be swallowed whole, not crushed, chewed or broken. They can be taken with or without food.
📖 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.

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 $0.033 $3.30 / 100 tablet
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.0688 $6.88 / 100 tablet
NADAC price history (per ea) — tap or hover for the price & month
Mar 2026 May 2026 Jul 2026 Sep 2026 $0.035 $0.032
▼ Down 5% over the last 7 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00904-7443-61 You're viewing this Main listing 100 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK 2025-11-21 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Clonidine Hydrochloride .2 mg 00228-2128-10 Actavis 100 tablets $0.033 AB Availability likely —
Clonidine Hydrochloride .2 mgthis 00904-7443-61 Major 100 tablets $0.033 AB Availability likely —
clonidine hydrochloride .2 mg 29300-0136-01 Unichem 100 tablets $0.033 AB Availability likely —
Clonidine Hydrochloride .2 mg 43547-0566-10 Solco 100 tablets $0.033 AB Availability likely —
clonidine hydrochloride .2 mg 50268-0193-15 AvPAK 50 tablets $0.033 AB Availability likely —
Clonidine hydrochloride .2 mg 52817-0181-00 TruPharma, 1000 tablets $0.033 — Availability likely —
Clonidine Hydrochloride .2 mg 58657-0648-01 Method 100 tablets $0.033 AB Availability likely —
Clonidine Hydrochloride .2 mg 59651-0233-01 Aurobindo 100 tablets $0.033 AB Availability likely —
Clonidine Hydrochloride .2 mg 60687-0124-01 American 100 tablets $0.033 AB Availability likely —
Clonidine Hydrochloride .2 mg 68001-0238-00 BluePoint 100 tablets $0.033 AB Availability likely —
Clonidine Hydrochloride .2 mg 00615-8272-30 NCS 30 tablets — AB Discontinued —
clonidine hydrochloride .2 mg 43063-0925-30 PD-Rx 30 tablets — AB FDA listed —
clonidine hydrochloride .2 mg 46708-0307-10 Alembic 100 tablets — AB FDA listed —
clonidine hydrochloride .2 mg 50090-1909-00 A-S 30 tablets — AB FDA listed —
Clonidine Hydrochloride .2 mg 51655-0362-26 Northwind 90 tablets — AB FDA listed —
Clonidine hydrochloride .2 mg 51655-0962-52 Northwind 30 tablets — — FDA listed —
Clonidine Hydrochloride .2 mg 55154-2577-00 Cardinal 10 tablets — AB FDA listed —
clonidine hydrochloride .2 mg 62332-0055-10 Alembic 100 tablets — AB FDA listed —
Clonidine Hydrochloride .2 mg 63629-2316-01 Bryant 500 tablets — AB FDA listed —
Clonidine Hydrochloride .2 mg 63629-2317-01 Bryant 100 tablets — AB FDA listed —
Clonidine Hydrochloride .2 mg 63629-9269-01 Bryant 1000 tablets — AB FDA listed —
Clonidine Hydrochloride .2 mg 67046-1000-03 Coupler 30 tablets — AB FDA listed —
Clonidine Hydrochloride .2 mg 67046-1552-03 Coupler 30 tablets — AB FDA listed —
clonidine hydrochloride .2 mg 68071-3016-06 NuCare 60 tablets — AB FDA listed —
clonidine hydrochloride .2 mg 68788-8080-03 Preferred 30 tablets — AB FDA listed —
clonidine hydrochloride .2 mg 70518-1060-01 REMEDYREPACK 50 tablets — AB FDA listed —
Clonidine Hydrochloride .2 mg 70518-3295-00 REMEDYREPACK 30 tablets — AB FDA listed —
Clonidine Hydrochloride .2 mg 70518-4357-00 REMEDYREPACK 30 tablets — AB FDA listed —
clonidine hydrochloride .2 mg 71205-0218-20 Proficient 20 tablets — AB FDA listed —
Clonidine hydrochloride .2 mg 71205-0829-30 Proficient 30 tablets — — FDA listed —
clonidine hydrochloride .2 mg 71335-1495-01 Bryant 30 tablets — AB Discontinued —
Clonidine Hydrochloride .2 mg 71335-2692-01 Bryant 30 tablets — AB FDA listed —
Clonidine hydrochloride .2 mg 71335-3028-01 Bryant 30 tablets — — FDA listed —
Clonidine Hydrochloride .2 mg 72162-1680-01 Bryant 100 tablets — AB FDA listed —
Clonidine Hydrochloride .2 mg 72162-2610-05 Bryant 500 tablets — AB FDA listed —
Clonidine hydrochloride .2 mg 76420-0285-01 Asclemed 100 tablets — — FDA listed —
clonidine hydrochloride .2 mg 87063-0182-01 ASCLEMED 100 tablets — AB FDA listed —
Clonidine Hydrochloride .2 mg 87441-0024-01 Unit 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

🏛️
2025
On the market since
Nov 2025
📍
2026
Currently FDA-listed
1 year 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.

What it looks like

Color White / Orange
ShapeOval
Imprint25;42;V
Size8 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.

Manufacturer & labeler

LabelerMajor Pharmaceuticals
Application holderPRINSTON PHARMACEUTICAL INC
FDA applicationANDA077901 (ANDA)
Labeler code00904
First marketedNov 2025
Product typeHuman Prescription Drug
Portfolio630 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 28 words ▾

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

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION Adults The dose of clonidine hydrochloride tablets, USP 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.

Adults The dose of clonidine hydrochloride tablets, USP 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.

⛔ Contraindications 19 words ▾

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

⚠️ Warnings ~2 min read ▾

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.

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 REACTIONS, contact Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 176 words ▾

Drug Interactions 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. If a patient receiving clonidine is also taking neuroleptics, orthostatic regulation disturbances (e.g., orthostatic hypotension, dizziness, fatigue) may be induced or exacerbated.

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 Toxicology ).

Based on observations in patients in a state of alcoholic delirium it has been suggested that high intravenous doses of clonidine may increase the arrhythmogenic potential (QT-prolongation, ventricular fibrillation) of high intravenous doses of haloperidol. Causal relationship and relevance for clonidine oral tablets have not been established.

🤰 Pregnancy 209 words ▾

Pregnancy Teratogenic Effects: 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 tablets, USP produced no evidence of a teratogenic or embryotoxic potential in rabbits. In rats, however, doses as low as ⅓ 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.

Clonidine crosses the placental barrier (see CLINICAL PHARMACOLOGY, Pharmacokinetics ). Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 21 words ▾

Pediatric Use Safety and effectiveness in pediatric patients have not been established in adequate and well-controlled trials (see WARNINGS, Withdrawal ).

🆘 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° 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. Pharmacokinetics The pharmacokinetics of clonidine is dose-proportional in the range of 100 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 129 words ▾

HOW SUPPLIED Clonidine Hydrochloride Tablets, USP are available as: 0.1 mg: white, oval, scored, convex, debossed "25" bisect "41" on one side and debossed "V" on the reverse side, supplied as follows: • Cartons of 100 tablets (10 tablets each blister pack x 10), NDC 0904-7442-61 0.2 mg: orange, oval, scored, convex, debossed "25" bisect "42" on one side and debossed "V" on the reverse side, supplied as follows: • Cartons of 100 tablets (10 tablets each blister pack x 10), NDC 0904-7443-61 WARNING: These Unit Dose packages are not child resistant and are Intended for Institutional Use Only.

Keep this and all drugs out of the reach of children. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.

📦 Storage and Handling 19 words ▾

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.

📋 Description 174 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 inactive ingredients are dibasic calcium phosphate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate.

The clonidine hydrochloride tablets 0.2 mg and 0.3 mg also contains FD&C Yellow #6 aluminum lake. Clonidine hydrochloride 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 is an odorless, bitter, white, crystalline substance soluble in water and alcohol. This is an image of the structural formula for clonidine hydrochloride.

Clonidine hydrochloride 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 is an odorless, bitter, white, crystalline substance soluble in water and alcohol. This is an image of the structural formula for clonidine hydrochloride.

💬 Information for Patients 89 words ▾

Information for Patients Patients should be cautioned against interruption of clonidine hydrochloride tablets therapy without their physician's advice. Since patients may experience a possible sedative effect, dizziness, or accommodation disorder with use of clonidine, caution patients about engaging in activities such as driving a vehicle or operating appliances or machinery. Also, inform patients that this sedative effect may be increased by concomitant use of alcohol, barbiturates, or other sedating drugs.

Patients who wear contact lenses should be cautioned that treatment with clonidine hydrochloride tablets may cause dryness of eyes.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General In patients who have developed localized contact sensitization to clonidine transdermal system, continuation of clonidine transdermal system or substitution of oral clonidine hydrochloride therapy may be associated with the development of a generalized skin rash. In patients who develop an allergic reaction to clonidine transdermal system, substitution of oral clonidine hydrochloride may also elicit an allergic reaction (including generalized rash, urticaria, or angioedema). The sympatholytic action of clonidine may worsen sinus node dysfunction and atrioventricular (AV) block, especially in patients taking other sympatholytic drugs.

There are post-marketing reports of patients with conduction abnormalities and/or taking other sympatholytic drugs who developed severe bradycardia requiring IV atropine, IV isoproterenol and temporary cardiac pacing while taking clonidine. In hypertension caused by pheochromocytoma, no therapeutic effect of clonidine hydrochloride tablets can be expected. Perioperative Use Administration of clonidine hydrochloride tablets, USP should be continued to within four hours of surgery and resumed as soon as possible thereafter.

Blood pressure should be carefully monitored during surgery and additional measures to control blood pressure should be available if required. Information for Patients Patients should be cautioned against interruption of clonidine hydrochloride tablets therapy without their physician's advice. Since patients may experience a possible sedative effect, dizziness, or accommodation disorder with use of clonidine, caution patients about engaging in activities such as driving a vehicle or operating appliances or machinery.

Also, inform patients that this sedative effect may be increased by concomitant use of alcohol, barbiturates, or other sedating drugs. Patients who wear contact lenses should be cautioned that treatment with clonidine hydrochloride tablets may cause dryness of eyes. Drug Interactions 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. If a patient receiving clonidine is also taking neuroleptics, orthostatic regulation disturbances (e.g., orthostatic hypotension, dizziness, fatigue) may be induced or exacerbated. 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 Toxicology ). Based on observations in patients in a state of alcoholic delirium it has been suggested that high intravenous doses of clonidine may increase the arrhythmogenic potential (QT-prolongation, ventricular fibrillation) of high intravenous doses of haloperidol.

Causal relationship and relevance for clonidine oral tablets have not been established. Toxicology In several studies with oral clonidine hydrochloride, a dose-dependent increase in the incidence and severity of spontaneous retinal degeneration was seen in albino rats treated for six months or longer. Tissue distribution studies in dogs and monkeys showed a concentration of clonidine in the choroid.

In view of the retinal degeneration seen in rats, eye examinations were performed during clinical trials in 908 patients before, and periodically after, the start of clonidine therapy. In 353 of these 908 patients, the eye examinations were carried out over periods of 24 months or longer. Except for some dryness of the eyes, no drug-related abnormal ophthalmological findings w… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 24 words ▾

Nursing Mothers As clonidine hydrochloride is excreted in human milk, caution should be exercised when clonidine hydrochloride tablets are administered to a nursing woman.

🧬 Pharmacokinetics 174 words ▾

Pharmacokinetics The pharmacokinetics of clonidine is dose-proportional in the range of 100 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.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 129 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Chronic dietary administration of clonidine was not carcinogenic to rats (132 weeks) or mice (78 weeks) dosed, respectively, at up to 46 or 70 times the maximum recommended daily human dose as mg/kg (9 or 6 times the MRDHD on a mg/m 2 basis). There was no evidence of genotoxicity in the Ames test for mutagenicity or mouse micronucleus test for clastogenicity. Fertility of male or female rats was unaffected by clonidine doses as high as 150 mcg/kg (approximately 3 times MRDHD).

In a separate experiment, fertility of female rats appeared to be affected at dose levels of 500 to 2000 mcg/kg (10 to 40 times the oral MRDHD on a mg/kg basis; 2 to 8 times the MRDHD on a mg/m 2 basis).

📄 Package Label / Principal Display Panel 48 words ▾

Package/Label Display Panel MAJOR® NDC 0904-7442-61 Unit Dose Clonidine Hydrochloride Tablets, USP 0.1 mg 100 TABLETS (10 x 10) Rx only 0.1mg carton label

Package/Label Display Panel MAJOR® NDC 0904-7443-61 Unit Dose Clonidine Hydrochloride Tablets, USP 0.2 mg 100 TABLETS (10 x 10) Rx only 0.2mg carton label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00904-7442-61 · Major 00904-7444-61 · Major →
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.