Clonidine Hydrochloride

Indications

Clonidine hydrochloride extended-release tablets are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications . Clonidine hydrochloride extended-release tablets are a centrally acting alpha 2 -adrenergic agonist indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to stimulant medications.

Dosage and administration (summary)

Start with one 0.1 mg tablet at bedtime for one week. Increase daily dosage in increments of 0.1 mg/day at weekly intervals until the desired response is achieved. Take twice a day, with either an equal or higher split dosage being given at bedtime, as depicted below Total Daily Dose Morning Dose Bedtime Dose 0.1 mg/day 0.1 mg 0.2 mg/day 0.1 mg 0.1 mg 0.3 mg/day 0.1 mg 0.2 mg 0.4 mg/day 0.2 mg 0.2 mg Do not crush, chew or break tablet before swallowing. Do not substitute for other clonidine products on a mg-per-mg basis, because of differing pharmacokinetic profiles. When discontinuing, taper the dose in decrements of no more than 0.1 mg every 3 to 7 days to avoid rebound hypertension.

Contraindications

Clonidine hydrochloride extended-release tablets are contraindicated in patients with a history of a hypersensitivity reaction to clonidine. Reactions have included generalized rash, urticaria, and angioedema . History of a hypersensitivity reaction to clonidine. Reactions have included generalized rash, urticaria, angioedema.

Warnings and precautions

Hypotension/bradycardia/syncope: Titrate slowly and monitor vital signs frequently in patients at risk for hypotension, heart block, bradycardia, syncope, cardiovascular disease, vascular disease, cerebrovascular disease or chronic renal failure. Measure heart rate and blood pressure prior to initiation of therapy, following dose increases, and periodically while on therapy. Avoid concomitant use of drugs with additive effects unless clinically indicated. Advise patients to avoid becoming dehydrated or overheated.

Storage and supply

Clonidine Hydrochloride Extended-Release Tablets, USP are supplied as follows: 0.1 mg — Each pink, round, unscored tablet debossed with on one side and 241 on the other side contains 0.1 mg of clonidine hydrochloride, USP. Tablets are supplied in bottles of 60 (NDC 0228-4241-06). Store at 20° to 25°C (68° to 77°F).

Source: Clonidine Hydrochloride (Clonidine Hydrochloride) — US FDA prescribing information, 2023-10-01, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.