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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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Sedation and Somnolence Instruct patients to use caution when driving a car or operating hazardous machinery until they know how they will respond to treatment with KAPVAY.

Ask your pharmacist for a list of the ingredients. May worsen sinus node dysfunction and atrioventricular AV block, especially in patients taking other sympatholytic drugs.

Advise patients to avoid becoming dehydrated or overheated. Somnolence and sedation were commonly reported adverse reactions in clinical studies. Browse Drugs and Medicines. Generic alternatives may kspvay available. Mean concentration-time data from the 3 treatments are shown in Table 7 and Figure 1.

How should this medicine be used?

The formulation is designed to delay the absorption of active drug in order to decrease peak to trough plasma concentration differences. Clonidine pronounced as kloe’ ni deen.

Patients had been treated with a psychostimulant methylphenidate or amphetamine for four weeks with inadequate response. The sympatholytic action of clonidine may worsen sinus node dysfunction and atrioventricular AV block, especially in patients taking other sympatholytic drugs. The chemical name is 2- 2,6-dichlorophenylamino imidazoline hydrochloride.

Titrate slowly and monitor vital signs frequently.

In adults with hypertension, sudden cessation of clonidine hydrochloride extended-release formulation treatment in the 0. Clonidine extended-release tablets may treat ADHD by affecting the part of the brain that controls attention and impulsivity. Mean Baseline Score SD. Take the missed dose as soon as you remember it. When initiating treatment, provide dosage escalation instructions [see Dosage and Administration 2.

The dosage of KAPVAY must be adjusted according to the degree of impairment, and patients should be carefully monitored. KAPVAY taken with alcohol or medicines that cause sleepiness or dizziness may make your sleepiness or dizziness worse. Patients were pwckage assigned to one of two treatment groups: Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol.

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General information about the safe and effective use of KAPVAY Medicines are sometimes prescribed inserr purposes other than those listed in a Patient Information leaflet. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Instruct patients to use caution when driving a car or operating hazardous machinery until they know how they will respond to treatment with KAPVAY.

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Kapvsy doctor may prescribe a low-salt or low-sodium diet. The dose was maintained for a minimum of 2 weeks before being gradually tapered to 0. 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 rash.

Doses should be taken twice a day, with either an equal or higher split dosage being given at bedtime see Table 1. It may harm them. In patients who develop akpvay allergic reaction from clonidine transdermal system, substitution of oral KAPVAY may also elicit an allergic reaction including generalized rash, urticaria, or angioedema. Patients pacjage be inseft not to discontinue KAPVAY therapy without consulting their physician due to the potential risk of withdrawal effects.

The dose of KAPVAY, administered either as monotherapy or as adjunctive therapy to a psychostimulant, should be individualized according to the therapeutic needs and response of the patient. Before using KAPVAY with other centrally active depressants such as phenothiazines, barbiturates, or benzodiazepinesconsider the potential for additive sedative effects. Although studies of the effect of renal impairment and studies of clonidine excretion have not been performed with KAPVAY, results are likely to be similar to those of the immediate release formulation.

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Clonidine: MedlinePlus Drug Information

There was no drug effects on fertility or on other measures of sexual or neurobehavioral development. KAPVAY should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. What side effects can this medication cause? Call your doctor if you have any unusual problems while taking this medication.

This Patient Information leaflet does not take the place of talking to your doctor about your medical condition or treatment. What special dietary instructions should I follow?

Kapvay | FULL Prescribing Information |

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 Packafe Studies 14 ]. All patients were initiated at 0. Since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental KAPVAY following dialysis.

Do not let anyone else take your medication. Caution is warranted in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction e.

A total of 73 patients experienced treatment failure in the double-blind phase: Clonidine extended-release long-acting tablets Kapvay are used alone or in combination with other medications as part of a treatment program to control symptoms of attention deficit hyperactivity disorder ADHD; more difficulty focusing, controlling actions, and remaining still or quiet than other people who are oapvay same age in children.

There was no evidence of genotoxicity in the Ames test for mutagenicity or mouse micronucleus test for clastogenicity. Information is also available online at https: The maximum placebo-subtracted mean change in heart rate was The half-life increases up to 41 hours in patients with severe impairment of renal function.