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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Measure heart rate and blood pressure prior to initiation of therapy, following dose increases, and periodically while on therapy. The cumulative proportion of patients with treatment failure over time during the double-blind phase is displayed in Figure 2. This is more common when you first start taking clonidine. All these effects in male were not reversed at the end of a 4-week recovery period.
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 following serious adverse reactions are described in greater detail elsewhere in labeling:.
The dosage of KAPVAY must be adjusted according to the degree of impairment, and patients should be carefully monitored. Do not stop taking clonidine without talking to your doctor. 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: Immediate-release clonidine hydrochloride and KAPVAY have different pharmacokinetic characteristics; dose substitution on a milligram for milligram basis will result in differences in exposure.
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.
Talk to your doctor if you are pregnant or plan to become pregnant. 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.
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. There was no effect on reproduction or sperm analysis in these males. Instruct patients to use caution when driving a car or operating hazardous machinery until they know how they will respond to treatment with KAPVAY. It may harm them. Signs and symptoms of overdose generally occur within 30 minutes to two hours after exposure.
Double-Blind Full Analysis Set. Dispense in a tight container. Low blood pressure and low heart rate.
It is important for you to keep a written list of all of the prescription and nonprescription paxkage medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements.
Keep this medication in the container it came in, tightly closed, and out of reach of children. The extended-release tablet is usually taken once or twice a day with or without food. The maximum placebo-subtracted mean change in heart packags was Advise patients that KAPVAY must be swallowed whole, never crushed, cut, or chewed, and may be taken with or without food. Ask your pharmacist for a list of the ingredients. There was no drug effects on fertility or on other measures of sexual or neurobehavioral development.
Take clonidine at around the same times every day. Akpvay take the next dose at your regular time. This Patient Information leaflet does not take the place of talking to your doctor about your medical condition or treatment. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary.
Clonidine: MedlinePlus Drug Information
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.
Patients were randomly assigned to one of the following three treatment groups: Clonidine is not a central nervous system stimulant.
Do not crush, chew, or break tablets because this will increase the rate of clonidine release. Instead, the best way to dispose of your medication is through a medicine take-back program.
Clonidine may cause other side effects. The mechanism of action of clonidine in ADHD is not known. The study consisted of a week, open-label phase 4 weeks of dose optimization and 6 weeks of dose maintenancea week double-blind phase, and a 4-week taper-down and follow-up phase. Your blood pressure should be checked regularly to determine your response to clonidine.
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.
Safety and efficacy in pediatric patients below the age of 6 years has not been established.
Caution is warranted in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction e.
Why is this medication prescribed? Treatment Consult with a Certified Poison Control Center for up-to-date guidance and advice.
Do not let anyone else take your medication. History of a hypersensitivity reaction to clonidine.
In addition to taking medication, making lifestyle changes will also help to control your blood pressure. Clonidine may help to control your condition but will not cure it. 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 Pwckage and Precautions 5.