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Kapvay

"Jan. 21, 2013 -- The number of children with ADHD is rising rapidly, according to a study of more than 840,000 California children.

While the research findings echo those of nationwide studies, the new study is stronger than some other stud"...

Kapvay

Kapvay

Kapvay Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Kapvay (clonidine hydrochloride) extended-release is a centrally acting alpha2-adrenergic agonist used to treat attention deficit hyperactivity disorder (ADHD). This medication is available in generic form. Common side effects include drowsiness, fatigue, upper respiratory tract infection, irritability, throat pain, insomnia, nightmares, emotional disorder, constipation, nasal congestion, increased body temperature, dry mouth, and ear pain.

The dose of Kapvay is individualized according to the needs and response of the patient. Dosing is initiated with one 0.1 mg tablet at bedtime, and the daily dosage is adjusted in increments of 0.1 mg/day at weekly intervals until the desired response is achieved. Kapvay may interact with alcohol, barbiturates or other sedating drugs, antidepressants, digitalis, calcium channel blockers, beta-blockers, other products containing clonidine, or antihypertensive drugs. Tell your doctor all medications and supplements you use. During pregnancy, Kapvay should be used only if prescribed. This drug passes into breast milk. Consult your doctor before breastfeeding.

Our Kapvay (clonidine hydrochloride) extended-release Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Kapvay FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trial Experience

Two KAPVAY ADHD clinical studies evaluated 256 patients who received active therapy, in one of the two placebo-controlled studies (Studies 1 and 2) with primary efficacy end-points at 5-weeks.

Study 1: Fixed-dose KAPVAY Monotherapy

Study 1 was a multi-center, randomized, double-blind, placebo-controlled study with primary efficacy endpoint at 5 weeks, of two fixed doses (0.2 mg/day or 0.4 mg/day) of KAPVAY in children and adolescents (6 to 17 years of age) who met DSM-IV criteria for ADHD hyperactive or combined inattentive/hyperactive subtypes.

Commonly observed adverse reactions (incidence of ≥ 2% in either active treatment group and greater than the rate on placebo) during the treatment period are listed in Table 2.

Table 2 : Common Adverse Reactions in the Fixed-Dose Monotherapy Trial- Treatment period (Study 1)

Preferred Term Percentage of Patients Reporting Event
KAPVAY 0.4 mg/day
N=78
KAPVAY 0.2 mg/day
N=76
Placebo
(N=76)
Somnolence* 31% 38% 5%
Headache 19% 29% 18%
Upper Abdominal Pain 13% 20% 17%
Fatigue† 13% 16% 1%
Upper Respiratory Tract Infection 6% 11% 4%
Irritability 6% 9% 3%
Throat Pain 6% 8% 3%
Nausea 8% 5% 4%
Nightmare 9% 3% 0
Dizziness 3% 7% 5%
Insomnia 6% 4% 1%
Emotional Disorder 5% 4% 1%
Constipation 6% 1% 0
Dry Mouth 5% 0 1%
Nasal Congestion 5% 3% 1%
Body Temperature Increased 1% 5% 3%
Gastrointestinal Viral 0% 7% 4%
Diarrhea 1% 4% 3%
Ear Pain 0 5% 1%
Nasopharyngitis 3% 3% 1%
Abnormal Sleep-Related Event 1% 3% 0
Aggression 1% 3% 1%
Asthma 1% 3% 1%
Bradycardia 4% 0 0
Enuresis 4% 0 0
Influenza like Illness 3% 1% 1%
Tearfulness 3% 1% 0
Thirst 3% 1% 0
Tremor 3% 1% 0
Epistaxis 0 3% 0
Lower Respiratory Tract Infection 0 3% 1%
Pollakiuria 0 3% 0
Sleep Terror 0 3% 0
* Somnolence includes the terms “somnolence” and “sedation”.
†Fatigue includes the terms “fatigue” and “lethargy”.

Commonly observed adverse reactions (incidence of ≥ 2% in either active treatment group and greater than the rate on placebo) during the taper period are listed in Table 3.

Table 3 : Common Adverse Reactions in the Fixed-Dose Monotherapy Trial- Taper period* (Study 1)

Preferred Term Percentage of Patients Reporting Event
KAPVAY 0.4 mg/day
N=78
KAPVAY 0.2 mg/day
N=76
Placebo
(N=76)
Abdominal Pain Upper 6% 0 3%
Headache 2% 5% 3%
Gastrointestinal Viral 5% 0 0
Somnolence 3% 2% 0
Heart Rate Increased 3% 0 0
Otitis Media Acute 0 3% 0
*Taper Period: 0.2 mg dose, week 8; 0.4 mg dose, weeks 6-8; Placebo dose, weeks 6-8

Study 2: Flexible-dose KAPVAY as Adjunctive Therapy to Psychostimulants

Study 2 was a multi-center, randomized, double-blind, placebo-controlled study, with primary efficacy endpoint at 5 weeks, of a flexible dose of KAPVAY as adjunctive therapy to a psychostimulant in children and adolescents (6 to 17 years) who met DSM-IV criteria for ADHD hyperactive or combined inattentive/hyperactive subtypes. KAPVAY was initiated at 0.1 mg/day and titrated up to 0.4 mg/day over a 3-week period. Most KAPVAY treated patients (75.5%) were escalated to the maximum dose of 0.4 mg/day.

Commonly observed adverse reactions (incidence of ≥ 2% in the treatment group and greater than the rate on placebo) during the treatment period are listed in Table 4.

Table 4 : Common Adverse Reactions in the Flexible-Dose Adjunctive to Stimulant Therapy Trial- Treatment Period (Study 2)

Preferred Term Percentage of Patients Reporting Event
KAPVAY+STM
(N=102)
PBO+STM
(N=96)
Somnolence* 19% 8%
Fatigue† 16% 4%
Abdominal Pain Upper 12% 7%
Nasal Congestion 6% 5%
Throat Pain 6% 3%
Decreased Appetite 5% 4%
Body Temperature Increased 4% 2%
Dizziness 4% 2%
Insomnia 4% 2%
Epistaxis 3% 0
Rhinorrhea 3% 0
Abdominal Pain 2% 1%
Anxiety 2% 0
Pain in Extremity 2% 0
* Somnolence includes the terms: “somnolence” and “sedation”.
†Fatigue includes the terms “fatigue” and “lethargy”.

Commonly observed adverse reactions (incidence of ≥ 2% in the treatment group and greater than the rate on placebo) during the taper period are listed in Table 5.

Table 5 : Common Adverse Reactions in the Flexible-Dose Adjunctive to Stimulant Therapy Trial- Taper Period* (Study 2)

Preferred Term Percentage of Patients Reporting Event
KAPVAY+STM
(N=102)
PBO+STM
(N=96)
Nasal Congestion 4% 2%
Headache 3% 1%
Irritability 3% 2%
Throat Pain 3% 1%
Gastroenteritis Viral 2% 0
Rash 2% 0
*Taper Period: weeks 6-8

Most common adverse reactions, defined as events that were reported in at least 5% of drug-treated patients and at least twice the rate as in placebo patients, during the treatment period were somnolence, fatigue, upper respiratory tract infection, irritability, throat pain, insomnia, nightmares, emotional disorder, constipation, nasal congestion, increased body temperature, dry mouth, and ear pain. The most common adverse reactions that were reported during the taper phase were upper abdominal pain and gastrointestinal virus.

Adverse Reactions Leading to Discontinuation

Thirteen percent (13%) of patients receiving KAPVAY discontinued from the pediatric monotherapy study due to adverse events, compared to 1% in the placebo group. The most common adverse reactions leading to discontinuation of KAPVAY monotherapy treated patients were from somnolence/sedation (5%) and fatigue (4%). Less common adverse reactions leading to discontinuation (occurring in approximately 1% of patients) included: formication, vomiting, prolonged QT, increased heart rate, and rash. In the pediatric adjunctive treatment to stimulants study, one patient discontinued from KAPVAY + stimulant group because of bradyphrenia.

Effects on Laboratory Tests, Vital Signs, and Electrocardiograms

KAPVAY treatment was not associated with any clinically important effects on any laboratory parameters in either of the placebo-controlled studies.

Mean decreases in blood pressure and heart rate were seen [see WARNINGS AND PRECAUTIONS].

There were no changes on ECGs to suggest a drug-related effect.

Postmarketing Experience

Hallucinations and atrioventricular (AV) block have been identified during post approval use of Kapvay. Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Read the entire FDA prescribing information for Kapvay (Clonidine Hydrochloride Extended-Release Tablets) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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