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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History of a hypersensitivity reaction to clonidine. Reactions have included generalized rash, urticaria, angioedema.

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 inset the patient.

Dosing should be initiated with one 0. Doses packxge be taken twice a day, with either an equal or higher split dosage being given at bedtime see Table 1. 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 benzodiazepinesconsider the potential for additive sedative isnert. Caution patients against operating heavy equipment or driving until they know how they respond to treatment with KAPVAY.

Advise patients to avoid insrt 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 kspvay 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.

Kapvay | FULL Prescribing Information |

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 insret 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 insrt 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 packqge trials of another drug and may not insertt 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. In patients that kapfay 5 weeks of treatment in a controlled, fixed-dose monotherapy study in pediatric patients, during the isnert 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.

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These events exclude those already mentioned in 6. The following have been reported with other oral immediate release formulations of clonidine:. 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.

No embryotoxic or teratogenic effects were seen in rabbits administered oral clonidine hydrochloride during organogenesis at doses up to 3 times the MRHD. KAPVAY should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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 Clonidine hydrochloride is present in human milk. Use of KAPVAY kspvay pediatric patients 6 to 17 years kqpvay 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 kpvay 6 years has not lackage 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 unsert 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 onsert 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 isnert to give supplemental KAPVAY following dialysis.

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 packae 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. The inactive ingredients are sodium lauryl sulfate, lactose monohydrate, hypromellose typepartially 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 ka;vay 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.

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Immediate-release clonidine hydrochloride ihsert 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, packwge clonidine concentration peaks in packae 3 to 5 hours and the plasma half-life ranges from 12 to 16 hours.

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The half-life increases up to 41 hours in patients with severe impairment of renal function. Although studies kavay the effect of renal impairment and studies of ihsert excretion pavkage 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: 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 inssrt MRHD of 0.

There was no evidence of genotoxicity in the Ames test for mutagenicity or mouse micronucleus test for clastogenicity. Patients were randomly assigned to one of the following three treatment groups: 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. Patients were randomly assigned to one of two treatment groups: The dose was maintained for a minimum of 2 weeks before being gradually tapered to 0.

The study packaeg of a week, open-label phase 4 weeks of dose optimization and 6 weeks of dose maintenancea insedt double-blind phase, and a 4-week taper-down and follow-up phase. All patients were initiated at 0. A total of 73 patients pzckage treatment failure in the double-blind phase: The cumulative proportion of patients with treatment failure over time during the double-blind phase is psckage in Figure 2.

Advise patients that KAPVAY must be swallowed whole, never crushed, cut, or chewed, and may be taken with or without food.

When initiating treatment, provide dosage escalation instructions [see Dosage and Administration 2. 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.

Instruct patients to use caution when driving a car or operating hazardous machinery until they know how they will respond to treatment with KAPVAY. Advise patients to discontinue KAPVAY and seek immediate medical attention if any signs or symptoms of a hypersensitivity reaction occur, indert as generalized rash, urticaria, or angioedema [see Warnings and Precautions 5. There may be new information.

This Patient Information leaflet does not take the place of talking to your doctor about your medical condition or treatment. Tell your doctor about all of the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Ask your doctor or pharmacist for a list of these medicines, if you are not sure if your medicine is listed above. Know the medicines that you take. Keep a list of your medicines with you to show your apckage and pharmacist when you get a new medicine. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.