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home > drugs a-z list > ritalin (methylphenidate hcl) drug center > ritalin (methylphenidate hcl) drug - medication guide and patient information
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Ritalin
What is attention deficit hyperactivity disorder (ADHD)?
ADHD refers to a chronic biobehavioral disorder that initially manifests in childhood and is characterized by hyperactivity, impulsivity, and/or inattention. Not all of those affected by ADHD manifest all three behavioral categories. These symptoms can lead to difficulty in academic, emotional, and social functioning. The diagnosis is established by satisfying specific criteria and may be associated with other neurological, significant behavioral, and/or developmental/learning disabilities. Therapy may consider the use of medication, behavioral therapy, and adjustments in day-to-day lifestyle activities.
Studies in the United States indicates approximately 8%-10% of children satisfy diagnostic criteria for ADHD. ADHD is, therefore, one of the most common disorders of childhood. ADHD occurs two to four times more commonly in boys than girls (male to female ratio 4:1 for the predominant...
Ritalin
PATIENT INFORMATION
RITALIN®
(methylphenidate hydrochloride tablets, USP)
Read the Medication Guide that comes with RITALIN® (methylphenidate hcl) before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your or your child's treatment with RITALIN® (methylphenidate hcl) .
What is the most important information I should know about RITALIN® (methylphenidate hcl) ?
The following have been reported with use of methylphenidate hydrochloride and other stimulant medicines.
1. Heart-related problems:
- sudden death in patients who have heart problems or heart defects
- stroke and heart attack in adults
- increased blood pressure and heart rate
Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.
Your doctor should check you or your child carefully for heart problems before starting RITALIN® (methylphenidate hcl) .
Your doctor should check your or your child's blood pressure and heart rate regularly during treatment with RITALIN® (methylphenidate hcl) .
Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking RITALIN® (methylphenidate hcl) .
2. Mental (Psychiatric) problems:
All Patients
- new or worse behavior and thought problems
- new or worse bipolar illness
- new or worse aggressive behavior or hostility
Children and Teenagers
- new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms
Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.
Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking RITALIN® (methylphenidate hcl) , especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.
What Is RITALIN® (methylphenidate hcl) ?
RITALIN® (methylphenidate hcl) is a central nervous system stimulant prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). RITALIN® (methylphenidate hcl) may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
RITALIN® (methylphenidate hcl) should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.
RITALIN® (methylphenidate hcl) is also used in the treatment of a sleep disorder called narcolepsy.
RITALIN® (methylphenidate hcl) is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep RITALIN® (methylphenidate hcl) in a safe place to prevent misuse and abuse. Selling or giving away RITALIN® (methylphenidate hcl) may harm others, and is against the law.
Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.
Who should not take RITALIN® (methylphenidate hcl) ?
RITALIN® (methylphenidate hcl) should not be taken if you or your child:
- are very anxious, tense, or agitated
- have an eye problem called glaucoma
- have tics or Tourette's syndrome, or a family history of Tourette's syndrome. Tics are hard to control repeated movements or sounds.
- are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.
- are allergic to anything in RITALIN® (methylphenidate hcl) . See the end of this Medication Guide for a complete list of ingredients.
RITALIN® (methylphenidate hcl) should not be used in children less than 6 years old because it has not been studied in this age group.
RITALIN® (methylphenidate hcl) may not be right for you or your child. Before starting RITALIN® (methylphenidate hcl) tell your or your child's doctor about all health conditions (or a family history of) including:
- heart problems, heart defects, high blood pressure
- mental problems including psychosis, mania, bipolar illness, or depression
- tics or Tourette's syndrome
- seizures or have had an abnormal brain wave test (EEG)
Tell your doctor if you or your child is pregnant, planning to become pregnant, or breast-feeding.
Can RITALIN® (methylphenidate hcl) be taken with other medicines?
Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. RITALIN® (methylphenidate hcl) and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking RITALIN® (methylphenidate hcl) .
Your doctor will decide whether RITALIN® (methylphenidate hcl) can be taken with other medicines.
Especially tell your doctor if you or your child takes:
- anti-depression medicines including MAOIs
- seizure medicines
- blood thinner medicines
- blood pressure medicines
- cold or allergy medicines that contain decongestants
Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.
Do not start any new medicine while taking RITALIN® (methylphenidate hcl) without talking to your doctor first.
How should RITALIN® (methylphenidate hcl) be taken?
- Take RITALIN® (methylphenidate hcl) exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.
- Ritalin (methylphenidate hcl) is usually taken 2 to 3 times a day.
- Take RITALIN® (methylphenidate hcl) 30 to 45 minutes before a meal.
- From time to time, your doctor may stop RITALIN® (methylphenidate hcl) treatment for a while to check ADHD symptoms.
- Your doctor may do regular checks of the blood, heart, and blood pressure while taking RITALIN® (methylphenidate hcl) . Children should have their height and weight checked often while taking RITALIN® (methylphenidate hcl) . RITALIN® (methylphenidate hcl) treatment may be stopped if a problem is found during these check-ups.
- If you or your child takes too much RITALIN® (methylphenidate hcl) or overdoses, call your doctor or poison control center right away, or get emergency treatment.
What are possible side effects of RITALIN® (methylphenidate hcl) ?
See "What is the most important information I should know about RITALIN® (methylphenidate hcl) ?" for information on reported heart and mental problems.
Other serious side effects include:
- slowing of growth (height and weight) in children
- seizures, mainly in patients with a history of seizures
- eyesight changes or blurred vision
Common side effects include:
|
|
Talk to your doctor if you or your child has side effects that are bothersome or do not go away.
This is not a complete list of possible side effects. Ask your doctor or pharmacist for more information.
How should I store RITALIN® (methylphenidate hcl) ?
- Store RITALIN (methylphenidate hcl) in a safe place at room temperature, 59 to 86° F (15 to 30° C). Protect from light.
- Keep RITALIN® (methylphenidate hcl) and all medicines out of the reach of children.
General information about RITALIN® (methylphenidate hcl)
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use RITALIN® (methylphenidate hcl) for a condition for which it was not prescribed. Do not give RITALIN® (methylphenidate hcl) to other people, even if they have the same condition. It may harm them and it is against the law.
This Medication Guide summarizes the most important information about RITALIN® (methylphenidate hcl) . If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about RITALIN® (methylphenidate hcl) that was written for healthcare professionals. For more information about RITALIN® (methylphenidate hcl) call 1-888-669-6682.
What are the ingredients in RITALIN®?
Active Ingredient: methylphenidate HCL
Inactive Ingredients: D&C Yellow No. 10 (5-mg and 20-mg tablets), FD&C Green No.3 (10-mg tablets), lactose, magnesium stearate, polyethylene glycol, starch (5-mg and 10-mg tablets), sucrose, talc, and tragacanth (20-mg tablets).
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
RITALIN-SR®
(methylphenidate hydrochloride, USP) sustained-release tablets
Read the Medication Guide that comes with RITALIN (methylphenidate hcl) -SR® before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your or your child's treatment with RITALIN (methylphenidate hcl) -SR®.
What is the most important information I should know about RITALIN (methylphenidate hcl) -SR®?
The following have been reported with use of methylphenidate hydrochloride and other stimulant medicines.
1. Heart-related problems:
- sudden death in patients who have heart problems or heart defects
- stroke and heart attack in adults
- increased blood pressure and heart rate
Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.
Your doctor should check you or your child carefully for heart problems before starting RITALIN (methylphenidate hcl) -SR®.
Your doctor should check your or your child's blood pressure and heart rate regularly during treatment with RITALIN (methylphenidate hcl) -SR®.
Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking RITALIN (methylphenidate hcl) -SR®.
2. Mental (Psychiatric) problems:
All Patients
- new or worse behavior and thought problems
- new or worse bipolar illness
- new or worse aggressive behavior or hostility
Children and Teenagers
- new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms
Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.
Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking RITALIN (methylphenidate hcl) -SR®, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.
What Is RITALIN (methylphenidate hcl) -SR®?
RITALIN (methylphenidate hcl) -SR® is a central nervous system stimulant prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). RITALIN (methylphenidate hcl) -SR® may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
RITALIN (methylphenidate hcl) -SR® should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.
RITALIN (methylphenidate hcl) -SR® is also used in the treatment of a sleep disorder called narcolepsy.
RITALIN (methylphenidate hcl) -SR® is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep RITALIN (methylphenidate hcl) -SR® in a safe place to prevent misuse and abuse. Selling or giving away RITALIN (methylphenidate hcl) -SR® may harm others, and is against the law.
Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.
Who should not take RITALIN (methylphenidate hcl) -SR®?
RITALIN (methylphenidate hcl) -SR® should not be taken if you or your child:
- are very anxious, tense, or agitated
- have an eye problem called glaucoma
- have tics or Tourette's syndrome, or a family history of Tourette's syndrome. Tics are hard to control repeated movements or sounds.
- are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.
- are allergic to anything in RITALIN (methylphenidate hcl) -SR®. See the end of this Medication Guide for a complete list of ingredients.
RITALIN (methylphenidate hcl) -SR® should not be used in children less than 6 years old because it has not been studied in this age group.
RITALIN (methylphenidate hcl) -SR® may not be right for you or your child. Before starting RITALIN (methylphenidate hcl) -SR® tell your or your child's doctor about all health conditions (or a family history of) including:
- heart problems, heart defects, high blood pressure
- mental problems including psychosis, mania, bipolar illness, or depression
- tics or Tourette's syndrome
- seizures or have had an abnormal brain wave test (EEG)
Tell your doctor if you or your child is pregnant, planning to become pregnant, or breast-feeding.
Can RITALIN (methylphenidate hcl) -SR® be taken with other medicines?
Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. RITALIN (methylphenidate hcl) -SR® and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking RITALIN (methylphenidate hcl) -SR®.
Your doctor will decide whether RITALIN (methylphenidate hcl) -SR® can be taken with other medicines.
Especially tell your doctor if you or your child takes:
- anti-depression medicines including MAOIs
- seizure medicines
- blood thinner medicines
- blood pressure medicines
- cold or allergy medicines that contain decongestants
Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.
Do not start any new medicine while taking RITALIN (methylphenidate hcl) -SR® without talking to your doctor first.
How should RITALIN (methylphenidate hcl) -SR® be taken?
- Take RITALEV-SR® exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.
- Take RITALIN (methylphenidate hcl) -SR® 30 to 45 minutes before a meal. The effect of a dose of RITALIN (methylphenidate hcl) -SR usually lasts about 8 hours.
- Do not chew or crush RITALEV-SR® tablets. Swallow RITALIN (methylphenidate hcl) -SR® tablets whole with water or other liquids. Tell your doctor if you or your child cannot swallow RITALIN (methylphenidate hcl) -SR® whole. A different medicine may need to be prescribed.
- From time to time, your doctor may stop RITALIN (methylphenidate hcl) -SR® treatment for a while to check ADHD symptoms.
- Your doctor may do regular checks of the blood, heart, and blood pressure while taking RITALIN (methylphenidate hcl) -SR®. Children should have their height and weight checked often while taking RITALIN (methylphenidate hcl) -SR®. RITALIN (methylphenidate hcl) -SR® treatment may be stopped if a problem is found during these check-ups.
- If you or your child takes too much RITALIN (methylphenidate hcl) -SR® or overdoses, call your doctor or poison control center right away, or get emergency treatment.
What are possible side effects of RITALIN (methylphenidate hcl) -SR®?
See "What is the most important information I should know about RITALEV-SR®?" for information on reported heart and mental problems.
Other serious side effects include:
- slowing of growth (height and weight) in children
- seizures, mainly in patients with a history of seizures
- eyesight changes or blurred vision
Common side effects include:
|
|
Talk to your doctor if you or your child has side effects that are bothersome or do not go away.
This is not a complete list of possible side effects. Ask your doctor or pharmacist for more information.
How should I store RITALIN (methylphenidate hcl) -SR®?
- Store RITALIN (methylphenidate hcl) -SR® in a safe place at room temperature, 59 to 86° F (15 to 30° C). Protect from moisture.
- Keep RITALIN (methylphenidate hcl) -SR® and all medicines out of the reach of children.
General information about RITALIN (methylphenidate hcl) -SR®
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use RITALIN (methylphenidate hcl) -SR® for a condition for which it was not prescribed. Do not give RITALIN (methylphenidate hcl) -SR® to other people, even if they have the same condition. It may harm them and it is against the law.
This Medication Guide summarizes the most important information about RITALIN (methylphenidate hcl) -SR®. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about RITALIN (methylphenidate hcl) -SR® that was written for healthcare professionals. For more information about RITALIN (methylphenidate hcl) -SR call 1-888-669-6682.
What are the ingredients in RITALIN-SR®?
Active Ingredient: methylphenidate HCL, USP
Inactive Ingredients: cellulose compounds, cetostearyl alcohol, lactose, magnesium stearate, mineral oil, povidone, titanium dioxide, and zein
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Last reviewed on RxList: 1/31/2011
This monograph has been modified to include the generic and brand name in many instances.
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