Why is Methylphenidate prescribed?

The Daytrana patch provides a continuous release of medication. After the patch is applied, the medication flows through the skin and into the bloodstream. The patch is usually worn during the day for about 9 hours.

Most important fact about Methylphenidate

Tell the doctor if your child or a family member has any heart conditions, including structural abnormalities. Also, be sure to inform the doctor immediately if your child develops symptoms that suggest heart problems, such as chest pain or fainting.

How should you take Methylphenidate?

Apply Daytrana patches to a clean, dry area on the hip. Press and hold the patch firmly to the skin with the palm of your hand for 30 seconds. Alternate hips each day, and make sure there is no redness or areas of irritation where the patch is being applied.

Apply the patch in the morning, 2 hours before an effect is needed, and remove the patch after the child has worn it for 9 hours. If overstimulation or other side effects occur, check with your doctor. The patch may need to be removed earlier in the day.

• Storage instructions...
  Store at room temperature. Keep each patch in its original protective pouch until you are ready to apply it.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Methylphenidate.

• Side effects of Daytrana may include:
  Decreased appetite, inflammation of the nasal passages, irritation at site of application (such as redness or itching), nasal congestion, nausea, sadness/crying, sleeplessness, twitching, vomiting, weight loss

• Other side effects of methylphenidate may include:
  Allergic reactions, dizziness, drowsiness, fever, headache, increased blood pressure, nervousness, psychosis (abnormal thinking or hallucinations)

Why should Methylphenidate not be prescribed?

Daytrana should not be used if the child has:

• Anxiety, tension, or agitation, since methylphenidate may make these conditions worse.
• Allergies to methylphenidate or any other ingredients in Daytrana.
• Glaucoma, an eye disease.
• Motion or verbal tics, Tourette's syndrome, or a family history of Tourette's syndrome.

In addition, Daytrana should not be combined with antidepressants known as monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping an MAOI.

Special warnings about Methylphenidate

Do not apply heating pads or other external sources of heat to the patch. Also, avoid touching the sticky part of the patch.

Although rare, Daytrana could cause an allergic reaction. If you suspect the patch is causing skin irritation or a rash, contact your doctor.

Tell the doctor if your child develops blurred vision while taking Daytrana. This could be a sign of a serious problem.

Be sure to inform the doctor about your child's complete medical history, especially if the child has ever had any of the following: depression, bipolar disorder, aggressive behavior or hostility, heart problems, high blood pressure, vision problems, a history of alcohol or drug abuse, motion tics (such as repeated twitching) or verbal tics (such as repeated sounds or words), Tourette's syndrome, seizures, or abnormal brain waves as shown on an EEG. Also tell the doctor if your child has ever had hallucinations (such as hearing voices or seeing abnormal visions) or has been diagnosed with psychosis.

It's also important to tell the doctor if any of the child's family members has a heart condition, motion or verbal tics, or Tourette's syndrome.

Possible food and drug interactions when taking Methylphenidate

Before using Daytrana, tell the doctor about all prescription, over-the-counter, and herbal medications your child is taking. If Daytrana is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Daytrana with the following:

Antidepressants
Blood pressure medications
Blood-thinning drugs such as warfarin
Clonidine
Over-the-counter medications for colds, allergies, or a stuffy nose
Seizure medications

In addition, Daytrana should not be combined with antidepressants known as monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping an MAOI.

Special information if you are pregnant or breastfeeding

If your child is sexually active, pregnant, or breastfeeding, talk to your doctor about the effects of Daytrana. It is possible for methylphenidate to pass into breast milk.

Recommended dosage for Methylphenidate

CHILDREN 6 YEARS AND OLDER

The Daytrana patch should be applied to the skin once a day, generally for a 9-hour period. If side effects occur, the doctor may have your child wear the patch for a shorter period of time.

Overdosage

Any medication taken in excess can have serious consequences. Call your doctor immediately if your child uses more than the prescribed amount of Daytrana, or if you suspect your child may have symptoms of an overdose.

• Symptoms of Daytrana overdose may include:
  Agitation, confusion, convulsions, dry eyes, dry mouth, fever, flushing, hallucinations, headache, heart problems, muscle twitching, tremors

哌甲酯(methylphenidate)皮肤贴剂(Daytrana)治疗6~12岁小儿的注意力缺陷/多动障碍(ADHD),这是第一个治疗ADHD的非口服药。

FDA是根据两项研究做出上述决定的。一项Ⅱ期研究共纳入79例患儿;结果显示,哌甲酯贴剂可显著改善患儿的行为,提高数学运算能力。一项Ⅲ期研究(270例患儿)显示,用贴剂9个小时可显著减轻ADHD症状。

在两项研究的剂量优化期和双盲期,患儿对贴剂的耐受性都很好。该贴剂与哌甲酯的已知不良反应一致,通常为轻至中度,不停药也可消退。如出现不良反应应该缩短贴剂使用时间。不要给贴剂加热,加热可使哌甲酯释放增加,温度越高释放越多。

贴剂贴在髋部(两侧交替使用),每天1贴,2小时后起效,每天使用时间不要超过9小时。开始剂量为10 mg( 12.5 cm2),如果需要可每周增加一次剂量,从15 mg(18.75 cm2)到20 mg(25 cm2),最大剂量为30 mg(37.5 cm2)。

对哌甲酯或贴剂其他成分(例如丙烯酸和硅酮橡皮膏)过敏的患儿禁忌用贴剂;下述患儿亦不能用贴剂:有明显焦虑、紧张、激动、青光眼、抽搐、Tourette综合征或有上述疾病家族史者,以及正在用或最近用过单胺氧化酶抑制剂的患儿和有心脏结构异常的患儿.
      
研究发现，哌甲酯皮肤贴能提供稳定的血药浓度

美国的研究人员近期指出，与10mg哌甲酯每日三次的口服制剂相比，每日使用1次的20 cm2皮肤贴能提供更稳定的药物浓度。

佛罗里达的MarioGonzalez博士是在第36届美国临床药理学年会上公布这一结果的。他和他的同事们通过2项研究证实了哌甲酯皮肤贴的疗效。在研究1中，所有入组的12名年龄为8~12岁的儿童均经标准化心理学诊断标准明确注意力缺乏/多动症的诊断。在口服哌甲酯至少4周后，患儿随机进入皮肤贴治疗8小时/天和12小时/天治疗组，4天后恢复口服药物治疗3天。在研究2中，另12名来自一项双盲、对照、多剂量、三时段交叉药理研究的患儿在接受哌甲酯皮肤贴治疗后改为口服制剂治疗。在比较了多个相关因素后，研究人员指出，哌甲酯皮肤贴能提供稳定的血药浓度，且没有明显的不良反应。虽然研究1和研究2中分别有13种和36种不良反应，但不属于严重不良反应。

利他林(哌甲酯)贴剂治疗小儿多动症

美国俄亥俄州大学精神科专家称，采用利他林贴剂治疗小儿多动症是一门临床艺术。
 
小儿多动症(attention-deficit/hyperactivitydisorder，ADHD) 通常是是一种具有注意力不集中、易冲动和精力过剩等病状行为特点的综合病症，治疗药物包括苯丙胺、利他林等中枢兴奋剂。

为了避免频繁服药的麻烦，研究者设计了新药剂——利他林贴剂。但是，利他林贴剂比口服制剂在使用和管理时更加要求规范。临床医师计算用药剂量时，需要思考的是动态的药量（毫克/每小时），而不是固定药量（毫克/剂、毫克/天）。临床医师和患者可以通过两个途径控制药量：贴剂大小（控制毫克/每小时）和使用持续时间。这种新药剂对部分患者而言优于口服制剂，因为可以控制使用贴剂的时间达到个体化用药（早晨贴上，下午/晚上撕去）。患者在日常使用中要学会贴剂位置的选择、敷贴技巧、时间控制和皮肤护理等。

研究者说，医师很好地了解利他林贴剂的性能和注意事项，就能在治疗小儿多动症时发挥其优越性。

DAYTRANA PATCH 20MG 10
Generic Name: METHYLPHENIDATE
Class: X
Manufacture: SHIRE LLC
Strength: 20MG/9HR
Size: 10