KAPVAY PACKAGE INSERT PDF

If you are a consumer or patient please visit this version. Extended-release tablets: 0. History of a hypersensitivity reaction to clonidine. Reactions have included generalized rash, urticaria, angioedema.

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If you are a consumer or patient please visit this version. Extended-release tablets: 0. History of a hypersensitivity reaction to clonidine. Reactions have included generalized rash, urticaria, angioedema. Swallow tablets whole. Do not crush, chew, or break tablets because this will increase the rate of clonidine release. Due to the lack of controlled clinical trial data and differing pharmacokinetic profiles, substitution of KAPVAY for other clonidine products on a mg-per-mg basis is not recommended [see Clinical Pharmacology 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.

Dosing should be initiated with one 0. Doses should be taken twice a day, with either an equal or higher split dosage being given at bedtime see Table 1. The 0. Reactions have included generalized rash, urticaria, and angioedema [see Adverse Reactions 6 ]. 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.

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. 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.

Somnolence and sedation were commonly reported adverse reactions in clinical studies. Before using KAPVAY with other centrally active depressants such as phenothiazines, barbiturates, or benzodiazepines , consider the potential for additive sedative effects.

Caution patients against operating heavy equipment or driving until they know how they respond to treatment with KAPVAY. Advise patients to avoid use with alcohol. In adults with hypertension, sudden cessation of clonidine hydrochloride extended-release formulation treatment in the 0. 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.

Patients should be instructed not to discontinue KAPVAY therapy without consulting their physician due to the potential risk of withdrawal effects. 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.

In patients who develop an allergic reaction from clonidine transdermal system, substitution of oral KAPVAY may also elicit an allergic reaction including generalized rash, urticaria, or angioedema. The sympatholytic action of clonidine may worsen sinus node dysfunction and atrioventricular AV block, especially in patients taking other sympatholytic drugs.

Titrate KAPVAY slowly and monitor vital signs frequently in patients with cardiac conduction abnormalities or patients concomitantly treated with other sympatholytic drugs. The following serious adverse reactions are described in greater detail elsewhere in labeling:. 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.

Study 1 CLON was a short-term, multi-center, randomized, double-blind, placebo-controlled study of two fixed doses 0. The most common adverse reactions that led to discontinuation were somnolence and fatigue. Adverse Reactions Leading to Discontinuation. 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 The maximum placebo-subtracted mean change in diastolic blood pressure was The maximum placebo-subtracted mean change in heart rate was 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.

These events exclude those already mentioned in 6. Psychiatric: hallucinations Cardiovascular: Q-T prolongation. The following have been reported with other oral immediate release formulations of clonidine:. Risk Summary Prolonged experience with clonidine in pregnant women over several decades, based on published literature, including controlled trials, a retrospective cohort study and case reports, have not identified a drug associated risk of major birth defects, miscarriage, and adverse maternal or fetal outcomes.

No developmental effects were seen in rabbits administered oral clonidine hydrochloride during organogenesis at doses up to 3 times the MRHD see Data. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U. Increased resorptions were not associated with treatment at the same or at higher dose levels up to 3 times the MRHD when treatment of the dams was restricted to gestation days Based on published lactation studies, clonidine hydrochloride is present in human milk at relative infant doses ranging from 4.

Although in most cases, there were no reported adverse effects in breastfed infants exposed to clonidine, there is one case report of sedation, hypotonia, and apnea in an infant exposed to clonidine through breast milk. If an infant is exposed to clonidine hydrochloride through breastmilk, monitor for symptoms of hypotension and bradycardia, such as sedation, lethargy, tachypnea and poor feeding see Clinical Considerations.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for KAPVAY and any potential adverse effects on the breastfed child from KAPVAY or from the underlying maternal condition. 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 ].

Safety and efficacy in pediatric patients below the age of 6 years has not been established. In studies in juvenile rats, clonidine hydrochloride alone or in combination with methylphenidate had an effect 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. There was no drug effects on fertility or on other measures of sexual or neurobehavioral development.

These doses are approximately 3 times the MRHD of 0. All these effects in male were not reversed at the end of a 4-week recovery period. These effects were accompanied by a decrease in body weight gain in treated animals during the treatment period but the effect was reversed at the end of the recovery period. There was no effect on reproduction or sperm analysis in these males.

The impact of renal impairment on the pharmacokinetics of clonidine in children has not been assessed. Monitor patients carefully for hypotension and bradycardia, and titrate to higher doses cautiously. Since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental KAPVAY following dialysis. Clonidine overdose: hypertension may develop early and may be followed by hypotension, bradycardia, respiratory depression, hypothermia, drowsiness, decreased or absent reflexes, weakness, irritability and miosis.

The frequency of CNS depression may be higher in children than adults. Large overdoses may result in reversible cardiac conduction defects or dysrhythmias, apnea, coma and seizures. Signs and symptoms of overdose generally occur within 30 minutes to two hours after exposure. Consult with a Certified Poison Control Center for up-to-date guidance and advice. KAPVAY clonidine hydrochloride extended-release is a centrally acting alpha 2 -adrenergic agonist available as 0.

Each 0. The inactive ingredients are sodium lauryl sulfate, lactose monohydrate, hypromellose type , partially pregelatinized starch, colloidal silicon dioxide, and magnesium stearate.

The formulation is designed to delay the absorption of active drug in order to decrease peak to trough plasma concentration differences. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2- 2,6-dichlorophenylamino imidazoline hydrochloride.

The following is the structural formula:. Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol. Clonidine stimulates alpha 2 -adrenergic receptors in the brain. Clonidine is not a central nervous system stimulant. The mechanism of action of clonidine in ADHD is not known. Clonidine is a known antihypertensive agent. By stimulating alpha 2 -adrenergic receptors in the brain stem, clonidine reduces sympathetic outflow from the central nervous system and decreases peripheral resistance, renal vascular resistance, heart rate, and blood pressure.

Single-dose Pharmacokinetics in Adults. 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. The half-life increases up to 41 hours in patients with severe impairment of renal function. 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.

The pharmacokinetic profile of KAPVAY administration was evaluated in an open-label, three-period, randomized, crossover study of 15 healthy adult subjects who received three single-dose regimens of clonidine: 0.

Treatments were separated by one-week washout periods. Mean concentration-time data from the 3 treatments are shown in Table 7 and Figure 1. Plasma clonidine concentrations in children and adolescents 0. Clonidine concentrations in plasma increased with increases in dose over the dose range of 0. 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.

These doses are approximately 20, 25, and 15 times, respectively, the maximum recommended human dose MRHD of 0. Mutagenesis There was no evidence of genotoxicity in the Ames test for mutagenicity or mouse micronucleus test for clastogenicity. Lower doses have not been adequately evaluated and a no adverse effect level could not be established.

Patients were maintained at their dose for a minimum of 2 weeks before being gradually tapered down to 0. Patients had been treated with a psychostimulant methylphenidate or amphetamine for four weeks with inadequate response.

The dose was maintained for a minimum of 2 weeks before being gradually tapered to 0. The study consisted of a week, open-label phase 4 weeks of dose optimization and 6 weeks of dose maintenance , a week double-blind phase, and a 4-week taper-down and follow-up phase. All patients were initiated at 0. A total of 73 patients experienced treatment failure in the double-blind phase: 31 patients

ANASTAZJA MEGRE PDF

NDC 59212-658 Kapvay

Swallow tablets whole. Do not crush, chew, or break tablets because this will increase the rate of clonidine release. Due to the lack of controlled clinical trial data and differing pharmacokinetic profiles, substitution of KAPVAY for other clonidine products on a mg-per-mg basis is not recommended [see Clinical Pharmacology 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. Dosing should be initiated with one 0.

DONLEAVY GINGERMAN PDF

Clonidine - Kapvay

The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes. The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient s of the product. The generic name of Kapvay is clonidine hydrochloride. The product's dosage form is tablet, extended release and is administered via oral form. Labeler Name: Concordia Pharmaceuticals Inc.

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