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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The half-life increases up to 41 hours in patients with severe impairment ihsert renal function. In adults with hypertension, sudden cessation of treatment with immediate-release clonidine has, in some cases, 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.

Ask your doctor or pharmacist for a list of these medicines, if you are not sure if your medicine is listed above. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

May reduce the hypotensive effect of clonidine.

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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. Just take the next dose at your regular time. Older adults should not usually use clonidine because it is not as safe as other medications that can be used to treat the same condition.

Patients were randomly assigned to one of the following three treatment groups: Especially tell your doctor if you take: 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.

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Other uses for this medicine What special precautions should I follow? Double-Blind Full Analysis Set. Since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental KAPVAY following dialysis. 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 are not child-resistant and young children can open them easily.

Brand names of combination products. This is more common when you first start taking clonidine.

Advise patients that KAPVAY must be swallowed whole, never crushed, cut, or chewed, and may be taken with or without food. Large overdoses may result in reversible cardiac nisert defects or dysrhythmias, apnea, coma and seizures. Do not take more or less of it or take it more often than prescribed by your doctor.

Clonidine: MedlinePlus Drug Information

What side effects can this medication cause? Ask your doctor or pharmacist to teach you how to take your pulse.

Dispense in a tight container. The inactive ingredients are sodium lauryl sulfate, lactose monohydrate, hypromellose typepartially pregelatinized starch, colloidal silicon dioxide, and magnesium stearate. The impact of renal impairment on the pharmacokinetics of clonidine in children has not been assessed. It is important for you 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.

Talk to your doctor if you are pregnant or plan to become pregnant.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. Measure heart rate and blood pressure prior to initiation of therapy, following dose increases, and periodically while on therapy.

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 ].

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Continue to take clonidine even if packsge feel well. High blood pressure is a common condition and when not treated, can cause damage to the brain, heart, blood vessels, kidneys and other parts of the body.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information. Somnolence and sedation were commonly reported insrrt reactions in clinical studies.

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

No embryotoxic or teratogenic effects were seen in rabbits administered oral clonidine hydrochloride during organogenesis at doses up to 3 times the MRHD. 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. The following serious adverse reactions are described in greater detail elsewhere in labeling:.

In addition to taking medication, making lifestyle changes will also help to control your blood pressure. 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 These doses are approximately 20, 25, and 15 times, respectively, the maximum recommended human dose MRHD of 0.

Safety and efficacy in pediatric patients below the age of 6 years has not been established. Table 9 Treatment Failure: Keep all appointments with your doctor. A total of 73 patients experienced treatment failure in the double-blind phase: Low blood pressure and low heart rate. There was no drug effects on fertility or on other measures of sexual or neurobehavioral development.