nexiclon xr
Nexiclon XR (Clonidine) is a central alpha-2 adrenergic agonist used to treat Attention Deficit Disorder with Hyperactivity, Diarrhea, Dysmenorrhea, Tourette Syndrome.
Clonidine · by Rosemont
Key facts
- Active ingredient
- Clonidine
- Drug class
- Central Alpha-2 Adrenergic Agonist
- Form
- Tablet, extended release
- Strength
- Clonidine EQ 0.17MG Base · Clonidine EQ 0.26MG Base
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Rosemont
- Half-life
- about 12 to 16 hours (how long it stays in your system)
- What the pharmacy pays
- ~$1.05 for 30 — not your price
- FDA application
- NDA022500
What is Nexiclon XR?
From the FDA label:Clonidine extended-release tablets are available for oral administration in two dose strengths: 0.17 mg and 0.26 mg. The 0.17 mg and 0.26 mg tablets are equivalent to 0.2 mg and 0.3 mg of immediate-release clonidine hydrochloride, respectively. Clonidine hydrochloride, a centrally active alpha-adrenergic agonist, is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2.6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula: C 9 H 9 C l2 N 3 ·HCl Mol. Wt. 266.56 Clonidine hydrochloride is an odorless, bitter, white crystalline substance soluble in water and alcohol. The inactive ingredients are: crospovidone, dental-type silica, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl acetate, povidone, sodium polystyrene sulfonate, triacetin. The 0.17 mg tablet also contains hypromellose, polyethylene glycol, and titanium dioxide. The 0.26 mg tablet also contains D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, fractionated coconut oil, maltodextrin, polydextrose, talc, and titanium dioxide. molecularstructure
How to use
The dose of clonidine extended-release tablets must be adjusted according to the patient's individual blood pressure response. The following is a general guide to its administration in adults. Initial dose: 0.17 mg once daily. Elderly patients may benefit from a lower initial dose. Initial dose is recommended to be administered at bedtime. ( 2.1 ) Maintenance dose: Further increments of 0.09 mg once daily may be made at weekly intervals if necessary until the desired response is achieved. The therapeutic doses most commonly employed have ranged from 0.17 mg to 0.52 mg once daily. ( 2.2 ) Patients with renal impairment: Up-titrate slowly (2.4) 2.1 Initial Dose Dosing with clonidine extended-release tablets should be initiated at 0.17 mg once daily. Elderly patients may benefit from a lower initial dose [ see Use in Specific Populations (8.4) ]. Initial dose is recommended to be administered at bedtime. 2.2 Maintenance Dose Further increments of 0.09 mg once daily may be made at weekly intervals if necessary until the desired response is achieved. The therapeutic doses most commonly employed have ranged from 0.17 mg to 0.52 mg once daily. Clonidine extended-release tablets were studied at doses of 0.17 to 0.52 mg once daily. Doses higher than 0.52 mg per day were not evaluated and are not recommended. 2.3 Patients Currently Using Clonidine Hydrochloride Immediate-Release Tablets…
Side effects
The following serious adverse reactions are discussed in detail elsewhere in the labeling: Withdrawal [ see Warnings and Precautions (5.1) ] Allergic reactions [ see Warnings and Precautions (5.2) ] There is very little experience with clonidine extended-release tablets in controlled trials. Based on this limited experience, the adverse event profile appears similar with the immediate-release clonidine formulation. The most commonly expected adverse reactions are dry mouth, drowsiness, and dizziness. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact TruPharma, LLC at 1-877-541-5504 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clonidine Extended-Release Tablets Clinical Trial Experience There is very limited experience with clonidine extended-release tablets in controlled trials. Based on this limited experience, the adverse event profile appears similar with to the immediate-release clonidine formulation. 6.2 Experience with Immediate-Release Clonidine Most adverse reactions are mild and tend to diminish with continued therapy. The most frequent (which also appear to be dose-related) are dry mouth (approximately 40%); drowsiness (approximately 33%); dizziness (approximately 16%); constipation and sedation (approximately 10% each). The following less frequent adverse reactions have also been reported in patients receiving immediate-release clonidine, but in many…
Warnings
Important safety information
Patients should not discontinue therapy without consulting a physician. Dose reduction should be performed gradually over a 2- to 4-day period to avoid withdrawal symptomatology. Rare instances of hypertensive encephalopathy, cerebrovascular accidents and death have been reported after clonidine withdrawal. ( 5.1 ) Monitor closely and up-titrate slowly in patients with severe coronary insufficiency, conduction disturbances, recent myocardial infarction, cerebrovascular disease, or chronic renal failure. ( 5.2 ) Patients who engage in potentially hazardous activities, such as operating machinery or driving, should be advised of a possible sedative effect of clonidine. ( 5.2 ) In perioperative use, clonidine extended-release tablets may be administered up to 28 hours prior to surgery and resumed the following day. ( 5.3 ) 5.1 Withdrawal Instruct patients not to discontinue therapy without consulting their physician. Sudden cessation of clonidine treatment has resulted in symptoms such as nervousness, agitation, headache, and tremor accompanied or followed by a rapid rise in blood pressure and elevated catecholamine concentrations in the plasma. The likelihood of such reactions to discontinuation of clonidine therapy appears to be greater after administration of higher doses or continuation of concomitant beta-blocker treatment and special caution is therefore advised in these situations. Rare instances of hypertensive encephalopathy, cerebrovascular accidents and death have been reported after clonidine withdrawal. When discontinuing therapy with clonidine extended-release tablets, reduce the dose gradually over 2 to 4 days to avoid withdrawal symptoms. An excessive rise in blood pressure following discontinuation of clonidine extended-release tablets can be reversed by administration of oral clonidine hydrochloride or by intravenous phentolamine. If therapy is to be discontinued in patients receiving a beta-blocker and clonidine concurrently, the beta-blocker should be withdrawn several days before the gradual discontinuation of clonidine extended-release tablets. Because children commonly have gastrointestinal illnesses that lead to vomiting, they may be particularly susceptible to hypertensive episodes resulting from abrupt inability to take medication. 5.2 General Precautions In patients who have developed localized contact sensitization to a clonidine transdermal system, substitution of oral clonidine therapy may be associated with the development of a generalized skin rash. In patients who develop an allergic reaction to a clonidine transdermal system, substitution of oral clonidine may also elicit an allergic reaction (including generalized rash, urticaria, or angioedema). Monitor carefully and up-titrate slowly in patients with severe coronary insufficiency, conduction disturbances, recent myocardial infarction, cerebrovascular disease, or chronic renal failure. Patients who engage in potentially hazardous activities, such as operating machinery or driving, should be advised of a possible sedative effect of clonidine. The sedative effect may be increased by concomitant use of alcohol, barbiturates, or other sedating drugs. 5.3 Perioperative Use Clonidine extended-release tablets may be administered up to 28 hours prior to surgery and resumed the following day. Blood pressure should be carefully monitored during surgery and additional measures to control blood pressure should be available if required.
Who should not take Nexiclon XR
Clonidine extended-release tablets should not be used in patients with known hypersensitivity to clonidine [ see Warnings and Precautions (5.2) ]. Known hypersensitivity to clonidine (rash, angioedema) (4)
Overdose — what happens if you take too much
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…
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
No drug interaction studies have been conducted with clonidine extended-release tablets. The following have been reported with other oral formulations of clonidine. Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs. If a patient receiving clonidine hydrochloride is also taking tricyclic antidepressants, the hypotensive effect of clonidine may be reduced, necessitating an increase in the clonidine dose. Monitor heart rate in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction, e.g., digitalis, calcium channel blockers, and beta-blockers. Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concomitantly with diltiazem or verapamil. Amitriptyline in combination with clonidine enhances the manifestation of corneal lesions in rats [ see Nonclinical Toxicology (13.2) ]. Alcohol: Based on in vitro studies, high concentration of alcohol may increase the rate of release of clonidine extended-release tablets. Sedating drugs: Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs. ( 7 ) Tricyclic antidepressants: May reduce the hypotensive effect of clonidine, necessitating an increase in clonidine dose. ( 7 ) Drugs known to affect sinus node function or AV nodal conduction (e.g., digitalis, calcium channel blockers, beta-blockers): Additive effects such as bradycardia and AV block. ( 7 )
How long does Clonidine stay in your body?
The elimination half-life of clonidine is about 12 to 16 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. The half-life gets much longer when the kidneys are not working well — up to about 41 hours in people with severe kidney impairment.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: Clonidine Hydrochloride Tablets, USP (DailyMed).
Drug class
How this class works, per Clonidine - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
- attention deficit disorder with hyperactivity
- diarrhea
- dysmenorrhea
- tourette syndrome
- glaucoma
- hypertension
See how Nexiclon XR ranks — best-rated central alpha-2 adrenergic agonist for:
Dosage forms
Tablet, extended release
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
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Frequently asked questions
- What does Nexiclon XR treat?
- Nexiclon XR (Clonidine) may be used to treat attention deficit disorder with hyperactivity, diarrhea, dysmenorrhea, tourette syndrome, glaucoma, hypertension, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Nexiclon XR work?
- Nexiclon XR is a central alpha-2 adrenergic agonist. These drugs activate alpha-2 receptors in the brainstem, which tells the nervous system to send out less norepinephrine and reduce sympathetic (fight-or-flight) signaling to the body. With less of this stimulation, blood vessels relax and heart rate slows, lowering blood pressure.
- How much does Nexiclon XR cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $1.05 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Nexiclon XR?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Nexiclon XR. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Nexiclon XR?
- Nexiclon XR is marketed by Rosemont. You can see Rosemont's full profile, rating, and other products on pharmaranks.
- Is Nexiclon XR a brand-name or generic drug?
- Nexiclon XR is a brand-name product with the active ingredient Clonidine.
- Is Nexiclon XR available over the counter?
- No. Nexiclon XR is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Nexiclon XR come in?
- Nexiclon XR is currently marketed as tablet, extended release, per the FDA's National Drug Code Directory.
- What class of drug is Nexiclon XR?
- Nexiclon XR is classified as central alpha-2 adrenergic agonist, per the FDA's Established Pharmacologic Class.
- Is Nexiclon XR FDA-registered?
- Nexiclon XR is on record with the U.S. FDA under application number NDA022500. You can verify this on its official FDA label.
- Is Nexiclon XR safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Nexiclon XR. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Nexiclon XR?
- Nexiclon XR's side effects are taken directly from its FDA label. From the label: The following serious adverse reactions are discussed in detail elsewhere in the labeling: Withdrawal [ see Warnings and Precautions (5.1) ] Allergic reactions [ see Warnings and Precautions (5.2) ] There is very little experience with clonidine extended-release tablets in controlled trials.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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