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clonidine hydrochloride .2 mg Tablet, 50-count

by AvPAK · 50 BLISTER PACK in 1 BOX (50268-193-15) / 1 TABLET in 1 BLISTER PACK (50268-193-11)

NDC 50268-0193-15

🏷️ FDA NDC (as labeled) 50268-193-15 billing pads the product 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 Dr. Brian Staiger, PharmD

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

🆔 Identity & classification

FDA NDC (as labeled) 50268-193-15

Product NDC 50268-193

11-digit billing NDC 50268019315

NCPDP billing unit EA — each (per item)

RxCUI 884173, 884185, 884189

UNII W76I6XXF06

Application # ANDA078895

SPL Set ID fcebe343-18ad-d4cd-e053-6294a90a72d5

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 2023-05-30

Route ORAL

Dosage form TABLET

Substance CLONIDINE HYDROCHLORIDE

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

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 50268-193-15 — 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 → 50268-0193-15. 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

LabelerAvPAK

Application holderUNICHEM LABORATORIES LTD

FDA applicationANDA078895 (ANDA)

Labeler code50268

First marketedMay 2023

Product typeHuman Prescription Drug

Portfolio346 products on file

🔎 All NDCs from AvPAK

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 0.2 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 →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Nutrient depletion considerations

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

COENZYME Q10 Insufficient Evidence

🧪 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

ImprintU;137

Size1 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 O7TSZ97GEP
A mineral compound that serves as a filler and binding agent in tablets and capsules. It adds bulk to the medicine and helps hold ingredients together during manufacturing.
UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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 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 ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
UNII 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.

8 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per ea	Per package
Retail pharmacies payNADAC · weekly	$0.032	$1.60 / 50 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	$3.44 / 50 tablet

NADAC price history (per ea) — tap or hover for the price & month

▼ Down 16% over the last 12 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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Clonidine Hydrochloride .2 mg 00228-2128-10	Actavis	100 tablets	$0.032	AB	Availability likely	—
Clonidine Hydrochloride .2 mg 00904-7443-61	Major	100 tablets	$0.032	AB	Availability likely	—
clonidine hydrochloride .2 mg 29300-0136-01	Unichem	100 tablets	$0.032	AB	Availability likely	—
Clonidine Hydrochloride .2 mg 43547-0566-10	Solco	100 tablets	$0.032	AB	Availability likely	—
clonidine hydrochloride .2 mgthis 50268-0193-15	AvPAK	50 tablets	$0.032	AB	Availability likely	—
Clonidine hydrochloride .2 mg 52817-0181-00	TruPharma,	1000 tablets	$0.032	—	Availability likely	—
Clonidine Hydrochloride .2 mg 58657-0648-01	Method	100 tablets	$0.032	AB	Availability likely	—
Clonidine Hydrochloride .2 mg 59651-0233-01	Aurobindo	100 tablets	$0.032	AB	Availability likely	—
Clonidine Hydrochloride .2 mg 60687-0124-01	American	100 tablets	$0.032	AB	Availability likely	—
Clonidine Hydrochloride .2 mg 68001-0238-00	BluePoint	100 tablets	$0.032	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

🏛️

2023

On the market since

May 2023

📍

2026

Currently FDA-listed

3 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.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
50268-0193-15 You're viewing this	50 BLISTER PACK in 1 BOX (50268-193-15) / 1 TABLET in 1 BLISTER PACK (50268-193-11)	2023-05-30	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 🤰 Pregnancy 🧒 Pediatric Use 🆘 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 ~2 min read ▾

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.

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.

⛔ 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 REACTIONS, contact AvKARE at 1-855-361-3993 or FDA at 1 800-FDA-1088 or www.fda.gov/medwatch.

🤰 Pregnancy 210 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 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 µg/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 acts 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 0 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 to 600 µg. 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 179 words ▾

HOW SUPPLIED Clonidine Hydrochloride Tablets, USP are supplied as: 0.1 mg White round shaped, biconvex, scored tablets, debossed with "U" and "135" on either side of breakline on one side and plain on other side. NDC 50268-192-15 (10 tablets per card, 5 cards per carton). 0.2 mg White rounded off oval shaped, biconvex tablets, with score line having "U" and "136" debossed across the score line on one side and plain on other side.

NDC 50268-193-15 (10 tablets per card, 5 cards per carton). 0.3 mg White rounded off oval shaped, biconvex tablets with score line having "U" and "137" debossed across the score line on one side and plain on other side. NDC 50268-194-15 (10 tablets per card, 5 cards per carton).

Dispensed in Unit Dose Package. For Institutional Use Only. Store at 20 o to 25 o C (68 o to 77 o F) [see USP Controlled Room Temperature].

Dispense in a tight, light-resistant container. Please address medical inquires to AvKARE at 1-855-361-3993, email [email protected]. Manufactured for: AvKARE Pulaski, TN 38478 Mfg.

Rev. 08/20 AV 02/23(P) AvPAK

📋 Description 102 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 colloidal silicon dioxide, corn starch, dibasic calcium phosphate, sodium starch glycolate, glycerin, lactose monohydrate, magnesium stearate, povidone.

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.

Chemical Structure

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

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

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

agitation: A state of feeling restless and upset and being unable to relax, sometimes with pacing or fidgeting.

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

alopecia: Loss of hair from the scalp or body.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

anorexia: Loss of appetite, or not feeling hungry (on a drug label this means reduced appetite, not the eating disorder).

antidote: A treatment that reverses or counteracts the effects of a specific medicine or poison.

anxiety: A feeling of worry, nervousness, or unease, sometimes along with a racing heart or restlessness.

apnea: A pause or temporary stop in breathing.

atrioventricular block: A slowing or blocking of the electrical signals traveling between the heart's upper and lower chambers, which can slow the heartbeat.

AV block: A slowing or blocking of the electrical signals traveling between the heart's upper and lower chambers, which can slow the heartbeat.

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

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

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

CNS depression: A slowing of brain and nervous-system activity that can cause drowsiness, slowed breathing, or reduced alertness.

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

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

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

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

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

edema: Swelling caused by extra fluid trapped in the body's tissues.

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

encephalopathy: Any condition that affects how the brain works, causing confusion, memory problems, or changes in alertness.

erectile dysfunction: Trouble getting or keeping an erection.

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

gynecomastia: Swelling or enlargement of breast tissue in males.

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

heart failure: A condition in which the heart cannot pump blood as well as it should, causing tiredness, breathlessness, and swelling.

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

hepatitis: Inflammation of the liver, which can be caused by infections, alcohol, or certain medicines.

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

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

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

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

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

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

irritability: Getting annoyed, frustrated, or angry more easily than usual.

liver function tests: Blood tests that check how well the liver is working and whether it is irritated or damaged.

maintenance dose: The regular ongoing dose taken to keep a steady, effective amount of medicine in the body over time.

malaise: A general feeling of being unwell, uneasy, or low on energy, without one clear symptom.

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

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

pallor: Unusual paleness of the skin.

palpitations: The feeling that your heart is racing, pounding, fluttering, or skipping beats.

paresthesia: A tingling, prickling, or "pins and needles" feeling in the skin, often in the hands or feet.

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

pregnancy category: An older letter rating (A, B, C, D, or X) once used to describe a medicine's possible risk during pregnancy.

pruritus: Itching of the skin.

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

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

restlessness: An inability to stay calm or still, with a constant feeling of needing to move.

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

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

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

teratogenic: Able to cause physical birth defects in a developing baby when a medicine is taken during pregnancy.

thrombocytopenia: A low level of platelets, the blood cells that help form clots, which can lead to easier bruising or bleeding.

tolerance: When the body gets used to a medicine over time, so a larger dose is needed to get the same effect.

tremor: Shaking or trembling of part of the body, such as the hands, that a person cannot control.

urinary retention: Being unable to empty the bladder fully or at all.

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

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

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

← 50268-0192-15 · AvPAK 50268-0194-15 · AvPAK →

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.

clonidine hydrochloride .2 mg Tablet, 50-count

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