All Known Side Effects of Focalin XR

What is Focalin XR?

Focalin XR is an extended-release medicine, consisting of dexmethylphenidate, used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients older than 6 years.


 Important Information

  • Do not use Focalin XR if you have used a monoamine oxidase (MAO) inhibitor, which block the actions of monoamine oxidase enzymes such as phenelzine (Nardil) in the last two weeks. A dangerous drug interaction could happen, leading to serious side effects.
  • Before using this treatment, tell your physician if you have severe depression, seizures or epilepsy, high blood pressure, heart disease; a heart rhythm disorder, congestive heart failure, if you have recently had a heart attack, or if you have a history of mental illness or drug/alcohol addiction.
  • Some stimulants have caused sudden death in children and adolescents with serious heart problems or congenital heart defects. Before taking Focalin XR, tell your doctor if you have any type of heart problems.
  • Long term use of Focalin XR can slow a child’s growth. Inform your doctor or healthcare provider if the child using this medication is not growing or gaining weight properly.
  • Focalin XR uses may be habit-forming and should be used only by the person for whom it was prescribed and as indicated by the doctor. Keep the medication in a secure place where others cannot get to it.
  • And finally, keep track of the amount of medicine used from each new bottle. Focalin XR is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.


Side Effects of Focalin XR

The most common side effects of Focalin XR in clinical trials in children over six years old were upset stomach, decreased appetite, nausea, anxiety and headache. The most common Focalin XR side effects in clinical studies of adults were:

  • dry mouth,
  • dyspepsia,
  • feeling jittery,
  • dizziness,
  • headache,
  • anxiety and throat pain.

Other side effects Focalin XR (dexmethylphenidate) include:

  • vomiting,
  • sleeplessness,
  • nervousness, tics, increased blood pressure and psychosis (abnormal thinking or hallucinations).

Furthermore get emergency help if you have any of these signs of an allergic reaction:

  • hives,
  • fever,
  • difficult breathing,
  • swelling of your face, lips, tongue or throat.

Stop using Focalin XR (dexmethylphenidate) and call your doctor at once if you have any of these serious Focalin XR side effects:

  • Dangerous high blood pressure (severe headache, ringing in your ears, chest pain, numbness)
  • Seizure (convulsion)
  • Blurred uneven heart rate
  • Blurred vision or other visual changes
  • Unusual behavior, confusion or twitching or tics
  • Loss of appetite
  • Upset stomach
  • Feeling restless, anxious or jittery
  • Dependence: Abuse of Focalin XR can lead to dependence. Tell your physician if you have ever been dependent or abused on drugs or alcohol or if you are now abusing or dependent on alcohol or drugs.
  • Blurred Vision: Tell your doctor if you have blurred vision when taking Focalin XR. This could be a symptom of a serious problem.
  • Slower growth: Slower growth (weight gain and/or height) has been reported with long-term use of methylphenidate in children. Your physician will be carefully watching your weight and height. If you are not gaining weight or growing as your doctor expects, your doctor may stop your Focalin XR therapy. This is not a complete list of possible side effects of Focalin XR. Ask your doctor about other effects of Focalin XR. If you develop any Focalin XR side effects, talk to your doctor about any of these effects of Focalin XR.

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


Dosage of Focalin XR

Focalin XR is for oral administration once daily in the morning. Focalin XR may be taken as whole capsules or alternatively may be administered by sprinkling the capsule contents on a small amount of applesauce (see specific guides below). Focalin XR and/or their contents should not be crushed, chewed, or divided. The capsules may be carefully opened and the beads sprinkled over a spoonful of applesauce. The capsules of the drug should be consumed immediately in its entirety once open and not stored for future use.

i). Dosing recommendations

Dosage of Focalin XR should be individualized according to the needs and responses of the patients.

ii). Patients new to methylphenidate

The recommended starting dosage of Focalin XR for patients who are not currently taking dexmethylphenidate (Focalin XR) or racemic for patients or methylphenidate that are on stimulants other than methylphenidate, is 5 mg/day for pediatric patients as well as 10 mg/day for adult patients. Dosage may be shifted in 5 mg increments to a maximum of 20 mg/day for pediatric patients and in 10 mg increments to a maximum of 20 mg/day for adult patients. Generally, dosage shifts may proceed at approximately weekly intervals. The patient should be followed for a sufficient duration at a given dose to ensure that a maximal benefit has been achieved before a dose increase is considered.

iii). Patients currently using methylphenidate

For patients currently using methylphenidate, the recommended starting dosage of Focalin XR is half the total daily dose of racemic methylphenidate. Patients presently using Focalin (dexmethylphenidate) may be switched to the same daily dose of Focalin XR. The maximum acceptable dose is 20 mg/day for pediatric and adult patients.

iv). Maintenance/extended treatment

There is no body of evidence available from controlled trials to indicate how long the patient with ADHDshould be treated with Focalin XR. It is generally accepted, however, that pharmacological therapy of ADHD may be needed for extended periods. Nevertheless, the doctor who elects to use Focalin XR for extended periods in patients with ADHD should periodically re-evaluate the long-term usefulness of the drug for the individual patient with periods off medication to assess the patient’s functioning without pharmacotherapy. Improvement may be sustained when the medicine is either temporarily or permanently discontinued.

v). Dose reduction and discontinuation

If paradoxical aggravation of symptoms or other adverse events occur, the dosage of Focalin XR should be decreased, or, if necessary, the medicine should be discontinued. If improvement is not noticed after appropriate dosage adjustment over a 1-month period, the medicine should be discontinued.


Focalin XR Storage and Handling Conditions

Store the medicine in a closed container at room temperature, away from moisture, direct light heat. Avoid freezing this medicine and keep it out the reach of pets and children. Do not keep outdated medicine or medicine no longer needed. Furthermore, do not store in the bathroom. Do not flush Focalin XR down the toilet or pour them into a drain unless ordered to do so. Properly discard this product when it is expired or no longer needed. Discuss with your healthcare professional on how you should best dispose of any medicine you do not use.


Uses of Focalin XR

The uses of Focalin XR are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged six years and older. The effectiveness of Focalin XR uses, in such a situation was established in two placebo-controlled studies in patients meeting DSM (Diagnostic and Statistical Manual of Mental Disorders) -IV criteria for ADHD.

A diagnosis of ADHD; DSM-IV implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The signs must cause clinically significant impairment, e.g., in academic, or occupational functioning, social, and be found in two or more settings, e.g., home, school or work.  The symptoms must not be better evaluated for by another mental disorder. For the Inattentive Type, at most six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless errors, lack of sustained attention, poor listener, failure to monitor through on tasks, poor planning, avoids tasks requiring sustained easily distracted, loses things, mental effort, forgetful. For the Hyperactive-Impulsive Type, at least six of the following signs must have persisted for at least 6 months: leaving seat, fidgeting/squirming, inappropriate running/climbing, difficulty with simple activities, “on the go;” excessive talking, can’t wait turn, intrusive blurting answers. The Combined Types needs both inattentive and hyperactive-impulsive criteria to be met.

i). Special Diagnostic Considerations

This explains one of the uses of Focalin XR. The specific etiology of this syndrome is not known, and there is no one diagnostic test. Sufficient diagnosis requires the use not only of medical but of educational, social resources and special psychological. Learning may or may not be attacked. The diagnosis must be based upon a whole history and evaluation of the child and not solely on the presence of the required number of DSM-IV characteristics.

ii). Need for Comprehensive Treatment Program

This equally denotes one of the uses of Focalin XR as an integral part of a total treatment program for ADHD that may include other measures (educational, social psychological) for patients with this syndrome. Drug treatment may not be shown for all children with this syndrome. Stimulants are not meant for use in the child who exhibits symptoms secondary to environmental factors and/or other primary psychiatric complications, including psychosis. Precise educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are inadequate, the decision to prescribe stimulant treatment will depend upon the physician’s assessment of the chronicity and severity of the child’s symptoms.

iii). Long-Term Use

The effectiveness in the uses of Focalin XR for the long run, that is, for more than seven weeks, has not been systematically assessed in controlled trials. Therefore, the physician who electsFocalin XR uses for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.


Over dosage of Focalin XR

i). Signs and symptoms

Signs and symptoms of excess methylphenidate overdose, resulting principally from overstimulation of the CNS (central nervous system) and from excessive sympathomimetic effects, may include the following: vomiting, agitation, tremors, hyperreflexia, muscle twitching, convulsions (may be followed by coma), euphoria, confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia, tachycardia, palpitations, cardiac arrhythmias, hypertension, mydriasis, and dryness of mucous membranes.


Treatment for Focalin XR Overdose

i). Recommended Treatment

As with the management of all overdose, the possibility of multiple drug ingestion should be considered. When treating an overdose, practitioners should bear in mind that there is a prolonged release of dexmethylphenidate from Focalin XR extended-release capsules. Treatment consists of appropriate supportive measures. The patient must be safe against self-injury and against external stimuli that would aggravate overstimulation already present. Gastric contents may be sent by gastric lavage as indicated. Before operating gastric lavage, control agitation and seizures if found and protect the airway. Other measures to detoxify the gut consist of administration of activated charcoal and a cathartic. Intensive care must be offered to maintain adequate circulation and respiratory exchange; external cooling procedures may be required for hyperpyrexia. Efficacy of peritoneal dialysis for Focalin overdose has not been established.

Most importantly, if you miss a dose, take it immediately as you remember. But if it is near bedtime or the time of the next dose, leave the missed dose out and resume your usual dosing schedule. Never double the dose in an attempt to catch up.


Focalin XR Use in specific populations

Pregnancy Category C

In studies conducted in rats and rabbits, dexmethylphenidate was taken orally at doses of up to 20and 100 mg/kg/day, respectively, during the time of organogenesis. No proof of teratogenic activity was found in either the rat or rabbit study; however, retarded fetal skeletal ossification was observed at the highest dose level in rats. When dexmethylphenidate was given to rats throughout pregnancy and lactation at doses of up to 20 mg/kg/day, post weaning body weight gain was reduced in male offspring, but no other effects on postnatal growth were noticed. At the highest doses tried, plasma levels of dexmethylphenidate in pregnant rats and rabbits were approximately 5 and 1 times, precisely, those in adults dosed with 20 mg/day. Sufficient and well-controlled studies in pregnant women have not been carried out, thus, Focalin XR should be applied during pregnancy only if the potential benefit justifies the potential risk to the fetus.

ii). Nursing Mothers

It is not known whether dexmethylphenidate is excreted in human milk. Because several drugs are excreted in human milk, attention should be exercised if Focalin XR is taken by a nursing woman.

iii). Pediatric Use

The safety and efficacy of Focalin XR in children under 6 years old have not been set up. Long-term effects of Focalin in children have not been well established. In a study conducted in young rats, racemic methylphenidate was taken orally at doses of up to 100 mg/kg/day for 9 weeks, beginning early in the postnatal period (Postnatal Day 7) and continuing through sexual maturity (Postnatal Week 10). When these animals were researched as adults (Postnatal Weeks 13-14), reduced spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day (approximately 6 times the maximum recommended human dose [MRHD] of racemic methylphenidate on a mg/m2 basis) or greater, and a shortage in the acquisition of a specific learning task was seen in females exposed to the highest dose (12 times the racemic MRHD on a mg/m2 basis).

iv). Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other drugs. Also inform your health care professional if you have any other types of allergies, such as to preservatives, or animals, dyes, foods. For non-ordered products, read the label or package components carefully.

v). Geriatric

Concise studies on the relationship of age to the effects of dexmethylphenidate have not been performed in the geriatric population.

vi). Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential merits against the potential risks before taking this medication while breastfeeding.


Warnings and Precautions

i). Sudden death and preexisting structural cardiac abnormalities or other serious heart problems

Children and Adolescents: Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Although some serious heart difficulties alone carry an increased risk of sudden death, stimulant products actually should not be used in children or adolescents with known serious structural cardiac abnormalities, serious heart rhythm abnormalities, or other intense cardiac problems cardiomyopathy, that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.

Adults: Sudden death, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Even though the role of stimulants in these adult cases is also not known, adults have a greater possibility than children of having serious structural cardiac abnormalities, coronary artery disease, or other intense cardiac difficulties cardiomyopathy, serious heart rhythm abnormalities. Adults with these abnormalities should also generally not be treated with stimulant drugs.

ii). Hypertension and other cardiovascular conditions

Stimulant medications cause a modest increase in average blood pressure (about 2-4 mmHg) and average heart rate (about 3-6 bpm), and individuals may have higher increases. Meanwhile the mean changes alone would not be expected to have short-term consequences; all patients should be followed up for larger changes in heart rate and blood pressure. Care is shown in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate, e.g., especially people with preexisting hypertension, recent myocardial infarction, or ventricular arrhythmia, and heart problem.

iii). Assessing cardiovascular status in patients being treated with stimulant medications

Children, adolescents, or adults who are being considered for treatment with stimulant medications should have a careful history (including assessment for a family history of sudden death or ventricular arrhythmia) and physical exam to assess for the presence of cardiac disease, and should obtain further cardiac evaluation if findings suggest such disease (e.g., echocardiogram and electrocardiogram). Patients who develop signs such as unexplained syncope, or other signs suggestive of cardiac disease, exertional chest pain, during stimulant treatment should undergo a prompt cardiac evaluation.

iv). Preexisting psychosis

Administration of stimulants may aggravate symptoms of behavior disturbance and thought disorder in patients with a preexisting psychotic disorder.

v). Bipolar illness

Particular care should be taken in using stimulants to treat ADHD in patients with comorbid bipolar disorder because of concern for possible induction of a mixed/manic episode in such patients. Prior to initiating therapy with a stimulant, patients with comorbid depressive signs should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, alongside a family history of suicide.

vi). Aggression

Aggressive behavior or hostility is often observed in children and adolescents with ADHD, and has been reported in clinical tests and the post marketing experience of some medications indicated for the treatment of ADHD. Although there is no systematic prove that stimulants cause aggressive behavior or hostility, patients beginning therapy for ADHD should be monitored for the appearance of or worsening of aggressive behavior or hostility.

vii). Emergence of new psychotic or manic symptoms

Treatment emergent psychotic or manic symptoms, e.g., delusional thinking, or mania in children and adolescents and hallucinations, without a prior history of psychotic illness or mania can be caused by stimulants at usual doses. If such symptoms happen, attention should be given to a possible causal role of the stimulant, and discontinuation of therapy may be appropriate. In a pooled analysis of several short-term, placebo-controlled studies, such signs occurred in about 0.1% (4 patients with events out of 3,482 dished out to methylphenidate or amphetamine for several weeks at usual doses) of stimulant-treated patients compared to 0 in placebo-treated patients.

viii). Seizures

There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizures, in patients with related EEG abnormalities in absence of seizures, and, very few, in patients without a history of seizures and no prior EEG evidence of seizures. In the presence of seizures, the medicine should be discontinued.

Other areas on warnings and precautions of Focalin XR include: priapism, peripheral vasculopathy, including raynaud’s phenomenon, visual disturbance, use in children under six years of age, and hematologic monitoring.

A disclaimer: It should be noted that this article serves as a guide only and therefore should not in any wise be used as a replacement to Doctor’s prescriptions.

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