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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Titrate slowly and monitor vital packagw frequently. No embryotoxic or teratogenic effects were seen in rabbits administered oral clonidine hydrochloride during organogenesis at doses up to 3 times the MRHD.

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Immediate-release clonidine hydrochloride and KAPVAY have different pharmacokinetic characteristics; dose substitution on a milligram for milligram basis will result in differences in exposure.

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. Patients had been treated with a psychostimulant methylphenidate or amphetamine for four weeks with inadequate response. Percentage of Patients Reporting Event. The maximum placebo-subtracted mean change in diastolic blood pressure was Ask your pharmacist for a list of the ingredients.

Caution is warranted in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction e. In case of overdose, call the poison control helpline at Large overdoses may result in reversible cardiac conduction defects or dysrhythmias, apnea, coma and seizures.

Clonidine may help to control your condition but will not cure it. Symptoms of overdose may include the following: Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking KAPVAY until you talk with your doctor. Dosing should be initiated with one 0. Advise patients to avoid becoming dehydrated or overheated. Your doctor may prescribe a low-salt or low-sodium diet.

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The chemical name is 2- 2,6-dichlorophenylamino imidazoline hydrochloride.

kavay 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.

Your doctor will probably decrease your dose gradually over 2 to days for the regular tablet and 3 to 7 days for the extended-release tablet.

What side effects can this medication cause? Store it at room temperature and away from excess heat and moisture not in the bathroom. What should I know about storage and disposal of this medication?

This is more common when you first start taking clonidine. There was no effect on reproduction or sperm analysis in these males.

Signs and symptoms of overdose generally occur within 30 minutes to two hours after exposure. 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.

Do not stop taking clonidine without talking to your doctor. Dispense in a tight container. Talk to your doctor if you are pregnant or plan to become pregnant.

Do not drive a car or operate machinery until you know how this medication affects you. Titrate KAPVAY slowly and monitor vital signs frequently in patients with cardiac conduction abnormalities or patients concomitantly treated with other sympatholytic drugs. Titrate slowly and monitor vital signs frequently in patients at risk for hypotension, heart block, bradycardia, syncope, cardiovascular disease, vascular disease, cerebrovascular disease or chronic renal failure.

Advise patients that KAPVAY must be swallowed whole, never crushed, cut, or chewed, and may be taken with or without food. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment: Know the medicines that you take.

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Take clonidine at around the same times every day. The dose was maintained for a minimum of 2 weeks before being gradually tapered to 0. To relieve dry mouth caused by clonidine, chew gum or suck sugarless hard candy. For more information, ask your doctor or pharmacist.

Tell your doctor about all of the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. What other information should I know?

Kapvay | FULL Prescribing Information |

The dosage of KAPVAY must be adjusted according to the degree of impairment, and patients should be carefully monitored. Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. The following have been reported with other oral immediate release formulations of clonidine:. Juvenile Animal Data 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.

By stimulating alpha 2 -adrenergic receptors in the brain stem, clonidine reduces sympathetic outflow from packaeg central nervous system and decreases peripheral resistance, renal vascular resistance, heart rate, and blood pressure. 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.

KAPVAY taken with alcohol or medicines that cause sleepiness or dizziness may make your paclage or dizziness worse. If you become pregnant while taking clonidine, call your doctor.

Food had no effect on plasma concentrations, bioavailability, or elimination half-life.