Marketing

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.

Author: Faujas Nagami
Country: Sudan
Language: English (Spanish)
Genre: Art
Published (Last): 14 July 2018
Pages: 499
PDF File Size: 2.75 Mb
ePub File Size: 8.43 Mb
ISBN: 333-3-88519-351-1
Downloads: 44233
Price: Free* [*Free Regsitration Required]
Uploader: Mozilkree

If you become pregnant while taking clonidine, call your doctor. In adults with hypertension, sudden cessation of clonidine hydrochloride extended-release formulation treatment in the 0.

The mechanism of action of clonidine in ADHD is not known.

Clonidine is not ineert central nervous system stimulant. Your doctor should check your heart rate and blood pressure before starting treatment and regularly during treatment with KAPVAY. The cumulative proportion of patients with treatment failure over time during the double-blind phase is displayed in Figure 2. What side effects can this medication cause? Allergic Reactions Advise patients to discontinue KAPVAY and seek immediate medical attention if any signs or symptoms of a hypersensitivity reaction occur, such as generalized rash, urticaria, or angioedema [see Warnings and Precautions 5.

How should this medicine be used? The maximum placebo-subtracted mean change in diastolic blood pressure was You may need a different medicine.

The maximum placebo-subtracted mean change in heart rate was The following have been reported with other oral immediate release formulations of clonidine:.

Kapvay | FULL Prescribing Information |

The following is the structural formula:. Your doctor may ask you to check your pulse heart rate daily and will tell you how rapid it should be.

It is important to keep all medication out of sight and reach of children as many containers such as weekly pill minders and those for eye drops, creams, patches, and inhalers kapbay not child-resistant and young children can open them easily. When initiating treatment, provide dosage escalation instructions [see Dosage and Administration 2. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary.

  HC244 PDF

Clonidine: MedlinePlus Drug Information

The impact of renal impairment on the pharmacokinetics of clonidine in children has not been assessed. Percentage of Patients Reporting Event.

Talk to your doctor if you are pregnant or plan to become pregnant. Food had no effect on plasma concentrations, bioavailability, or elimination half-life. Clonidine may cause other side effects.

Doses should be taken twice a day, with either an equal or higher split dosage being given at bedtime inserg Table 1. Table 9 Treatment Failure: Juvenile Animal Data In studies in juvenile rats, clonidine hydrochloride alone or in combination with methylphenidate had an ,apvay on bone growth at clinically relevant doses and produced a slight delay in sexual maturation in males at 3 times the maximum recommended human dose MRHD for clonidine and methylphenidate.

May worsen sinus node dysfunction and atrioventricular AV block, especially in patients taking other sympatholytic drugs. Tell your doctor about all of the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Brand names of combination products. In case of overdose, call the poison control helpline at In animal embryofetal 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 dose MRHD.

Damage lapvay these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems.

The half-life increases up to 41 hours in patients with severe impairment of renal function. Instead, the best way to dispose of your medication is through a medicine take-back program. Call your doctor if you have any unusual problems while taking this medication. This is more common when you first start taking clonidine. Safety and efficacy in pediatric patients below the age of 6 years has not been established. Do not take a double dose to make up for a missed one.

  CSA A23.3-04 PDF

Take the missed dose as soon as you remember it. What other information should I know?

There was no evidence of genotoxicity in the Ames test for mutagenicity or mouse micronucleus test for clastogenicity. KAPVAY taken with alcohol or medicines that cause sleepiness or dizziness may make your sleepiness or dizziness worse.

PDR Search

Clonidine extended-release tablets may treat ADHD by affecting the part of the brain that controls paxkage and impulsivity. Take clonidine exactly as directed. In 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, advise patients to avoid becoming dehydrated or overheated.

Do not crush, chew, or break tablets because this will increase the rate of clonidine release.

Clonidine may cause side effects. They do not depict actual or relative size. Immediate-release clonidine hydrochloride and KAPVAY have different pharmacokinetic characteristics; dose substitution on a milligram for milligram basis will result in differences in exposure.

Following oral administration of an immediate release formulation, plasma clonidine concentration peaks in approximately 3 to 5 hours and the plasma half-life ranges from 12 to 16 hours. Follow these directions carefully. Brand names Brand names of combination products. Clonidine is also used in the treatment of dysmenorrhea severely painful cramps during menstrual periodhypertensive crisis a condition in which your blood pressure is very highTourette’s syndrome a condition characterized by the need to perform repeated motions or to kappvay sounds or words ,menopausal hot flashes, and alcohol and opiate narcotic withdrawal.

Your blood pressure should be checked regularly to determine your response to clonidine. Since only a minimal amount of clonidine is removed during routine hemodialysis, there pwckage no need to give supplemental KAPVAY following dialysis.

What special dietary instructions should I follow?

Back To Top