Clonidine

IR clonidine hydrochloride tablets, Qlonilik IR oral solution, Nexiclon XR tablets and the selected weekly transdermal system are labeled for hypertension, alone or with other antihypertensives. These labels do not establish ADHD indications. This reference covers these products plus the two ADHD formulations below; epidural clonidine and unreviewed compounded preparations require separate specialist/product references.

The selected clonidine-HCl ER tablets treat ADHD as monotherapy or as an adjunct to stimulants, with established pediatric efficacy/safety at age 6–17. Onyda XR is labeled for ADHD monotherapy or adjunctive CNS-stimulant therapy in pediatric patients age ≥6. Do not transfer either indication to a patch, Qlonilik or Nexiclon XR.

Adult IR tablets and Qlonilik begin at 0.1 mg twice daily, morning and bedtime. Increase total daily dose by 0.1 mg at weekly intervals according to blood pressure; commonly used totals are 0.2–0.6 mg/day in divided doses. Labels describe 2.4 mg/day as a rarely used maximum, not a routine target. Older or renally impaired patients may need lower starts. Qlonilik is 0.05 mg/mL: a 0.1-mg dose is 2 mL. Use a calibrated oral device, with or without food.

Start 0.1 mg at bedtime. Increase daily total by 0.1 mg at weekly intervals to response, maximum recommended 0.4 mg/day. At totals ≥0.2 mg, split morning/bedtime doses with an equal or larger bedtime dose. Swallow whole; never crush, chew or break. Take with or without food. This ER tablet is not automatically substitutable for other clonidine products.

Start 0.1 mg once nightly, with or without food; increase by 0.1 mg at weekly intervals up to 0.4 mg once nightly. Concentration is 0.1 mg/mL, so these doses are 1–4 mL. Gently shake up and down for at least 10 seconds, avoiding foam; use the supplied adapter and oral dispenser. Switching from another clonidine product requires the labeled discontinuation/titration plan, not equal-milligram substitution; the prescriber must also manage withdrawal risk.

This product expresses strength as clonidine BASE. Begin 0.17 mg once daily at bedtime; titrate by 0.09 mg weekly. Common doses are 0.17–0.52 mg once daily; >0.52 mg was not evaluated and is not recommended. Its label maps IR clonidine-HCl 0.1 mg twice daily to Nexiclon 0.17 mg daily, 0.2 mg twice daily to 0.34 mg daily, and 0.3 mg twice daily to 0.52 mg daily. Use its scored, splittable tablets as labeled, rather than importing the ADHD ER tablet’s prohibition. For maintenance dialysis, the label starts 0.09 mg/day with slow titration; moderate/severe nondialysis impairment uses the usual start with slow titration and close monitoring.

Start the 0.1-mg/day system, applying one patch every 7 days to hairless intact upper outer arm or chest skin; rotate sites. Reassess after 1–2 weeks before adding a 0.1-mg/day system or using a larger strength. Above two 0.3-mg/day systems usually adds no efficacy. Effect may not begin for 2–3 days, so the prescriber must gradually reduce prior therapy and may temporarily continue it; a patch is not rapid rescue treatment. The adhesive cover has no drug and is placed over a loosening patch.

Never stop clonidine abruptly. ADHD ER tablets and Onyda: reduce daily total by no more than 0.1 mg every 3–7 days; for a missed dose skip it, resume the schedule and do not exceed the prescribed total in 24 hours. IR/Qlonilik/Nexiclon/patch labels describe gradual reduction over 2–4 days; individual clinical circumstances may need a longer supervised plan. When stopping clonidine with a beta blocker, these hypertension labels direct withdrawing the beta blocker several days before the clonidine taper—coordinate both changes with the prescriber. Vomiting that prevents doses needs prompt advice.

Known hypersensitivity to clonidine is the formal contraindication in these selected labels; components and formulation-specific allergy history must also be reviewed. Bradycardia, renal impairment and conduction disease are important precautions requiring assessment, rather than a universal formal contraindication in every product label.

These six selected U.S. labels contain no boxed warning. Their withdrawal, hypotension, bradycardia, sedation and allergy warnings remain clinically important.

Dry mouth, sedation/drowsiness, dizziness, constipation and fatigue are reported; patch-site irritation/contact dermatitis is formulation-specific. Excess exposure may initially raise blood pressure and then cause hypotension, bradycardia, respiratory depression, coma or seizures. Suspected poisoning, including a child’s exposure to a used patch, requires immediate emergency/poison-center assessment; remove an exposed patch. Care is supportive with airway and cardiovascular monitoring, and dialysis removes little clonidine. Do not induce vomiting.

Alcohol, benzodiazepines and other CNS depressants can add sedation; ADHD labels advise avoiding alcohol. Other antihypertensives add hypotension, while digoxin, beta blockers and verapamil/diltiazem can add bradycardia or AV block. Monitor pressure, pulse and symptoms. Qlonilik and ADHD ER interaction tables specifically advise avoiding CNS depressants and drugs affecting sinus/AV-node function; older IR/patch/Nexiclon labels emphasize caution/monitoring. Do not turn these differences into permission for an unsupervised combination.

Tricyclic antidepressants may counteract the blood-pressure effect; monitor and adjust under supervision. Antipsychotics can worsen orthostatic symptoms. Review concurrent beta blockers before any clonidine withdrawal. Onyda labeling also reports faster drug release with high alcohol concentrations in vitro; this supports avoiding alcohol, not a quantified safe drinking threshold.

Modern ER/Onyda/Qlonilik labels report that decades of human experience have not identified a drug-associated major-birth-defect or miscarriage risk, while older hypertension labels use more limited “clearly needed” wording; neither proves absence of risk. Clonidine enters human milk. Monitor a breastfed infant for sedation, lethargy, poor feeding or breathing abnormalities suggesting bradycardia/hypotension; a case of hypotonia/apnea is reported. Balance maternal need and feeding benefits with the clinician; do not abruptly stop during pregnancy.

ADHD ER tablet efficacy/safety is established at 6–17 years; Onyda’s indication is pediatric age ≥6, with its supporting evidence described at 6–17. Safety/effectiveness below age 6 is unestablished. Selected hypertension products do not establish pediatric safety/effectiveness. Older hypertension patients may benefit from a lower initial dose and close assessment for falls, sedation and slow pulse.

Renal impairment prolongs clonidine half-life and can require a lower start or slower titration; ADHD pediatric renal pharmacokinetics were not assessed. Follow the Nexiclon-specific dialysis/nondialysis directions above, and monitor pressure/pulse closely for every formulation. Routine hemodialysis removes too little to require supplemental clonidine after dialysis. These labels do not establish one numerical hepatic adjustment algorithm; individualize rather than inventing a reduction.

Clonidine reduces sympathetic outflow from the central nervous system, lowering peripheral resistance, heart rate and blood pressure. The mechanism of benefit in ADHD is not established by the ER/Onyda labels. Do not infer that every clonidine formulation has the same therapeutic indication.

IR plasma half-life is about 12–16 hours and may reach about 41 hours in severe renal impairment; substantial unchanged drug is excreted in urine. ER tablets and Onyda have distinct peak/trough profiles and are not automatic equal-milligram replacements. Weekly patches deliver drug continuously, reach therapeutic levels over 2–3 days and decline slowly after removal; removal does not instantly end exposure.

Measure blood pressure and heart rate before initiation, after increases and periodically. Assess syncope, conduction disease, renal function, interacting drugs, sedation and ADHD or hypertension response. With a patch, inspect adhesion and skin reactions and ask about loss of pressure control. Arrange a product-specific surgical plan: IR/Qlonilik may continue close to surgery, Nexiclon has different timing, and patches generally continue; the treating team should use the exact label.

Do not stop, double doses or switch formulation on your own. Avoid driving until sedation is understood and avoid alcohol as directed. Seek care for fainting, unusually slow pulse, severe headache/chest symptoms after missed doses, breathing difficulty or generalized allergy. Contact the prescriber if vomiting prevents doses or supply will run out. Keep new and used patches away from children and pets; the cover is not a replacement drug patch.

Alembic IR 0.1 mg is a light-tan scored oval L167 tablet (NDC 62332-054-30, 30 tablets). Qlonilik 0.05 mg/mL is clear/colorless raspberry solution (NDC 46287-085-04, 120 mL). Onyda is beige/tan viscous 0.1 mg/mL suspension (NDC 24478-148-04, 60 mL kit). Selected Mylan 0.1-mg/day patch carton contains four systems plus covers (NDC 0378-0871-99); each system contains 2.52 mg total clonidine, not an oral 2.52-mg dose.

IR HCl tablets: 0.1/0.2/0.3 mg; Qlonilik IR solution: 0.05 mg/mL. Selected ADHD ER tablet: 0.1 mg, pink round unscored, marked 241 on one face; Onyda ER suspension: 0.1 mg/mL. Nexiclon section 3 lists 0.17/0.26 mg BASE, while the selected current section 16 supplies 0.17-mg white scored NP 2 tablets (NDC 71511-503-30); verify package availability rather than assuming every listed strength is supplied. Weekly patches deliver 0.1/0.2/0.3 mg per day for 7 days.

IR tablets: 25°C, excursions 15–30°C, tight/light-resistant container. ER tablets and Nexiclon: 20–25°C, excursions 15–30°C, tight/light-resistant container. Qlonilik: 20–25°C, excursions 15–30°C, original container; discard 60 days after opening. Onyda: same temperature range, protected from light in its original bottle with supplied device; discard 30/60-mL bottles 30 days after opening, but 120-mL bottles after 60 days. Mylan patches: 20–25°C. Fold a used patch adhesive sides together and discard securely away from children.