KAPVAY PACKAGE INSERT PDF

Easy to read FDA package insert, drug facts, dosage and administration, and adverse effects for Kapvay (clonidine). Concordia Pharmaceuticals Inc.: KAPVAY (clonidine hydrochloride) extended- release is indicated for the treatment of attention deficit. The following text is taken verbatim from the Kapvay package insert: “The dose of Kapvay [ER clonidine], administered either as monotherapy or as adjunctive.

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Advise patients that KAPVAY must be swallowed whole, never crushed, cut, or chewed, and may be taken with or without food. It is important for insfrt to keep a written list of all of the prescription and nonprescription over-the-counter medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. Take clonidine at around the same times every day.

Your blood pressure should be checked regularly to determine your response to clonidine. They do not depict actual or relative size. Drugs that affect sinus node function or AV node conduction e.

The impact of renal impairment on the pharmacokinetics of clonidine in children has inseert been assessed.

Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. Advise patients to avoid use with alcohol. Avoid concomitant use of drugs with additive effects unless clinically indicated. Measure heart rate and blood pressure prior to initiation of therapy, following dose increases, and periodically while on therapy.

Titrate KAPVAY slowly in patients with a history of hypotension, and those with underlying conditions that may be worsened by hypotension and bradycardia; e. Use of KAPVAY in pediatric patients 6 to 17 years of age is supported by three adequate and well-controlled studies; a short-term, placebo-controlled monotherapy trial, a short-term adjunctive therapy trial and a longer-term randomized monotherapy trial [see Clinical Studies 14 ].

KAPVAY clonidine hydrochloride extended-release is a centrally acting alpha 2 -adrenergic agonist available as 0. Instead, the best way to dispose of your medication is through a medicine take-back program.

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Pakcage inactive ingredients are sodium lauryl sulfate, lactose monohydrate, hypromellose typepartially pregelatinized starch, colloidal silicon dioxide, and magnesium stearate.

These events exclude those already mentioned in 6. Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them.

If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment: Keep all appointments with your doctor. Patients were randomly assigned to one of the following three treatment groups: There was no evidence of genotoxicity in the Ames test for mutagenicity or mouse micronucleus test for clastogenicity. In patients who have developed localized contact sensitization to clonidine transdermal system, continuation of clonidine transdermal system or substitution of oral KAPVAY therapy may be associated with the development of a generalized skin kzpvay.

Caution is warranted in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction e. Reactions have included generalized rash, urticaria, and angioedema [see Adverse Reactions 6 ].

What should I do if I forget a dose? Monitor blood pressure and heart rate, and adjust dosages accordingly in patients treated concomitantly with antihypertensives or other drugs that can reduce blood pressure or heart rate or increase the risk of syncope. Advise patients who have a history of syncope or may have a condition that predisposes them to syncope, such as hypotension, orthostatic hypotension, bradycardia, or dehydration, to avoid becoming dehydrated or overheated [see Warnings and Precautions 5.

Clonidine may cause other side effects. Take twice a day, with either an equal or higher split dosage being given at bedtime, as depicted below 2. In animal packaeg studies, increased resorptions were seen in rats and mice administered oral clonidine hydrochloride from implantation through organogenesis at 10 and 5 times, respectively, the maximum recommended human nisert MRHD.

Make sure to follow all of your doctor’s and therapist’s instructions. Do not take a double dose to make up for a missed one. Generic alternatives may be available. Do not inseert a car or operate machinery until you know how this medication affects you. Immediate-release clonidine hydrochloride and KAPVAY have different pharmacokinetic characteristics; dose substitution on a milligram for milligram basis will result in differences in exposure.

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A total of 73 patients experienced treatment failure in the double-blind phase: These photos can be used only for identification by shape, color, and imprint.

Clonidine: MedlinePlus Drug Information

Clonidine is in a class packwge medications called centrally acting alpha-agonist hypotensive agents. Study 1 CLON was a short-term, multi-center, randomized, double-blind, placebo-controlled study of inset fixed doses 0. Effect on Blood Pressure and Heart Rate In patients that completed 5 weeks of treatment in a controlled, fixed-dose monotherapy study in pediatric patients, during the treatment period the maximum placebo-subtracted mean change in systolic blood pressure was When initiating treatment, provide dosage escalation instructions [see Dosage and Administration 2.

Before taking clonidine, tell your doctor and pharmacist if you are allergic to clonidine, any of its ingredients, clonidine patches, or any other medications.

Low blood pressure and low heart rate. Do not take two doses at the same time.

The frequency of CNS depression may be higher in children than adults. Clonidine concentrations in plasma increased with increases in dose over the dose range of 0.

Symptoms of overdose kapvzy include the following: Clonidine may help to control your condition but will not cure it. All these effects in male were not reversed at the end of a 4-week recovery period.

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However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Reactions have included generalized rash, urticaria, angioedema.

The incidence of “sedation-like” AEs somnolence and fatigue appeared to be independent of clonidine dose or concentration within the studied dose range in the titration study. Know the medicines that you take.