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美国FDA批准诺华制药公司的盐酸右哌甲酯（dexmethylphenidate HCl）控释胶囊（商品Focalin XR），用于治疗成人、青少年和儿童的注意力不集中/多动症（ADHD）。本品的批准是基于对320例诊断为ADHD的成人、青少年和儿童患者临床研究的有效性和安全性数据。 Focalin XR Dosage Form: GENERIC NAME: DEXMETHYLPHENIDATE - ORAL (dex-meth-ill-FEN-eh-date) BRAND NAME(S): FocalinWARNING: Dexmethylphenidate should be used cautiously by people who may be emotionally unstable or have a history of alcohol or drug abuse. Such patients may be more likely to increase their doses of this drug unnecessarily. Abuse of this medication may lead to abnormal behavior. If this medication must be stopped, it should be stopped gradually over time. Do not suddenly stop taking this medication because it may cause severe depression or hidden hyperactivity to occur. In some people, long-term monitoring may be required after this medication is stopped. USES: Dexmethylphenidate is used to treat Attention Deficit Hyperactivity Disorder (ADHD). It is chemically related to methylphenidate; another type of stimulant medication used to treat ADHD. OTHER USES: This drug may also be used for sleep disorders (e.g., narcolepsy) and mild depression. HOW TO USE: Take this medication by mouth usually twice daily either with or without food, or as directed by your doctor. Take the first dose of this medication in the morning and the second dose at least 4 hours later. Taking this medication later in the day may cause trouble sleeping (insomnia). The dosage is based on your medical condition and response to therapy. Your doctor may adjust your dose frequently (e.g., weekly) to find the dose that is best for you. Use this medication exactly as prescribed. Do not increase your dose, take it more frequently, or use it for a longer period of time than prescribed because this drug can be habit forming and increase your risk of side effects. When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well. Your doctor may recommend "drug holidays" where your medication is stopped temporarily and behavior is re-evaluated. SIDE EFFECTS: Trouble sleeping, nausea, diarrhea, upset stomach, dizziness, headache, nervousness, loss of appetite, dry mouth, or weight loss may occur. If any of these effects persist or worsen, notify your doctor. Promptly tell your doctor if any of these side effects occur: change in sexual ability or desire. Tell your doctor immediately if any of these serious side effects occur: stomach pain, fever, unusual weakness or tiredness, mental/mood changes. Tell your doctor immediately if any of these unlikely but serious side effects occur: unusually fast heartbeat, blurred vision, uncontrolled muscle movements (e.g., rigidity, tics, tremors), severe sweating, fever, chest pain, seizures. If you notice other effects not listed above, contact your doctor or pharmacist. PRECAUTIONS: This medication is not recommended for use if you have the following medical conditions: heart or blood vessel- related diseases (e.g., arteriosclerosis, cardiovascular disease), severe high blood pressure, over-active thyroid (hyperthyroidism), eye problems (e.g., glaucoma), emotional instability (e.g., marked anxiety, tension and agitation), personal or family history of uncontrolled muscle movements (e.g., tics, Tourette's syndrome), history of drug abuse. Tell your doctor your medical history, especially of: seizure disorders, other mental/mood problems (e.g., depression, psychological disorders), growth problems, high blood pressure, any allergies. This may make you dizzy and can affect your alertness. Use caution engaging in activities requiring alertness such as driving or using machinery. Though uncommon, depression itself can lead to thoughts or attempts of suicide. Tell your doctor immediately if you have any suicidal thoughts, or other mental/mood changes. Keep all medical appointments so your doctor can monitor your progress closely. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding. DRUG INTERACTIONS: Certain medications taken with this product could result in serious, even fatal, drug interactions. Avoid taking MAO inhibitors (e.g., furazolidone, linezolid, moclobemide, phenelzine, procarbazine, selegiline, isocarboxazid, tranylcypromine) within 2 weeks before or after treatment with this medication. Consult your doctor or pharmacist for additional information. Before using this medication, tell your doctor of all prescription and nonprescription medication you may use, especially: "blood thinners" (e.g., warfarin), antidepressants (e.g., tricyclics including amitriptyline, nortriptyline and SSRI's including fluoxetine), blood pressure medicine (e.g., beta blockers, clonidine, guanethidine), anti-seizure medicine (e.g., phenobarbital, phenytoin, primidone), other stimulant medications (e.g., amphetamines). Check the labels on all your medicines (e.g., cough-and-cold products, diet aids) because they may contain ingredients that could increase your heart rate or blood pressure. Ask your pharmacist about the safe use of these products. Avoid drinking large amounts of beverages containing caffeine (e.g., coffee, tea, colas). Caffeine can increase the side effects of this medication. Do not start or stop any medicine without doctor or pharmacist approval. OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: vomiting, severe mental/mood changes, confusion, severe or persistent headache, sweating, severe restlessness, fast breathing, dilated eyes/pupils, seizures. NOTES: Do not share this medication with others. Laboratory and/or medical tests (e.g., blood pressure, blood counts) may be performed to monitor your progress. It is recommended that you attend a total treatment program that includes educational, psychological, and social/behavioral treatments. MISSED DOSE: If you miss a dose, use it as soon as you remember in the morning hours. If it is later in the day or near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up. STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Focalin XR Dosage The recommended starting Focalin XR dose for people who have never taken methylphenidate is 5 mg once daily for children and 10 mg once daily for adults. For people who have taken methylphenidate before, the recommended starting Focalin XR dosage is half the total daily dose of methylphenidate taken before. If necessary, the dosage can be increased on a weekly basis. Your age and other drugs you may be taking are among the factors that can affect Focalin XR dosing. An Overview of Focalin XR Dosage The dosage of Focalin XR® (dexmethylphenidate extended-release) your healthcare provider prescribes will vary depending on a number of factors, including:
As always, do not adjust your Focalin XR dosage unless your healthcare provider specifically instructs you to do so.
Focalin XR Dosage for ADHD
People who are new to methylphenidate products (such as Concerta®, Ritalin®, Metadate®, or Methylin®) should start with Focalin XR 5 mg once daily for children and Focalin XR 10 mg once daily for adults.
People who have been on methylphenidate before should start at half the total daily dose of methylphenidate taken before. For people switching from Focalin tablets to Focalin XR, the total dose per day should be the same. The maximum recommended dose of Focalin XR is 20 mg per day.
The Focalin XR dose may be increased at weekly intervals, if necessary.
General Focalin XR Dosage Information
Some considerations for people taking Focalin XR include:
美国FDA 批准30分钟起效的Focalin(R) XR缓释胶囊 美国FDA已经批准30分钟起效的盐酸右哌甲酯缓释胶囊（dexmethylphenidate HCl；Focalin XR）用于注意缺陷与多动障碍（ADHD）患者的治疗，因本品可在一天的清晨（即儿童患者准备上学这段重要时间内）给多动症儿童患者及其家长带来益处。 新标签的修改得益于临床研究结果。最近的一项临床研究共纳入86例6～12岁的ADHD 患儿。研究结果表明患者在服用本品30分钟以后与安慰剂相比：在注意力、举止及学术生产力（academic productivity）等方面都得到明显改善。ADHD大约影响到6%的美国儿童，其症状为注意力不集中、多动、且易冲动，这些症状影响了儿童在校期间学习能力及其行为表现。 |
