Tell your doctor if you or your child is pregnant or planning to become pregnant. It is not known if Focalin will harm your unborn baby.
Take Focalin exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child. Focalin comes as a tablet and an extended-release capsule. The tablet is usually taken twice a day, at least 4 hours apart with or without food. The extended-release capsule is usually taken once daily in the morning. If taken without food, the extended-release capsule will start to work faster, but may be taken with or without food.
From time to time, your doctor may stop Focalin treatment for a while to check ADHD symptoms. Your doctor may do regular checks of the blood, heart, and blood pressure while taking Focalin. Children should have their height and weight checked often while taking Focalin. Focalin treatment may be stopped if a problem is found during these check-ups.
Focalin may not be right for you or your child. Before starting Focalin 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 breastfeeding.
Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements.
- Store Focalin in a safe place at room temperature, 59 to 86° F (15 to 30° C).
- Keep Focalin and all medicines out of the reach of children.
Focalin is a prescription medication used to treat attention deficit and hyperactivity disorder (ADHD).
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Active Ingredients:
Dexmethylphenidate hydrochloride
For more information on ADHD, the condition Focalin treats, go to :
1-800-Therapist ADHD Encyclopedia
It is important to keep a list of all medications you are currently taking. This should include all prescription, over the counter, and supplemental medications. This list should be kept with you at all times. Whenever you are beginning a new medication, be sure to consult your doctor and provide him or her with your list of medications.
For further information on Focalin speak with a pharmacist.
Common side effects include:
- Stomach ache
- Decreased appetite
- Nausea
- Fever
Serious side effects can include the following:
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 your or your child’s blood pressure and heart rate regularly during treatment with Focalin. 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 Focalin.
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 Focalin, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.
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
Focalin should be given cautiously to patients with a history of drug dependence or alcoholism.
Chronic, abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during drug withdrawal from abusive use since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.
The following have been reported with use of dexmethylphenidate hydrochloride (Focalin) 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 Focalin.
Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with Focalin.
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 Focalin.
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 Focalin, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.
Focalin 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 Focalin.
- Focalin should not be used in children less than 6 years old because it has not been studied in this age group.
- Focalin may not be right for you or your child.
Focalin is available as 2.5 mg, 5.0 mg, and 10.0 mg tablets.
Active Ingredient: dexmethylphenidate hydrochloride
Inactive Ingredients: pregelatinized starch, lactose monohydrate, sodium starch glycolate, microcrystalline cellulose, magnesium stearate, and FD&C Blue No.1 #5516 aluminum lake (2.5 mg tablets), D&C Yellow Lake #10 (5 mg tablets); the 10 mg tablet contains no dye.
Tell your doctor about all of the medicines that you or your child takes including prescription and nonprescription medicines, vitamins, and herbal supplements. Focalin 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 Focalin.
Your doctor will decide whether Focalin can be taken with other medicines.
Especially tell your doctor if you take:
- 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.
- Take Focalin exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.
- Take Focalin twice a day, at least 4 hours apart.
- Focalin can be taken with or without food.
- From time to time, your doctor may stop Focalin treatment for a while to check ADHD symptoms.
- Your doctor may do regular checks of the blood, heart, and blood pressure while taking Focalin. Children should have their height and weight checked often while taking Focalin. Focalin treatment may be stopped if a problem is found during these check-ups.
- If you or your child takes too much Focalin or overdoses, call your doctor or poison control center right away, or get emergency treatment.
Focalin is a central nervous system (CNS) stimulant prescription medicine. It is used for the treatment of attention deficit and hyperactivity disorder (ADHD). Focalin may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
Focalin should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.
Focalin is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Focalin in a safe place to prevent misuse and abuse. Selling or giving away Focalin 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.
Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Focalin there are no specific foods that you must exclude from your diet when receiving Focalin.
Tell your doctor if you or your child is breastfeeding. It is not known if Focalin is excreted in human breast milk or if it will harm your nursing baby.
Focalin 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 Focalin
Focalin should not be used in children less than 6 years old because it has not been studied in this age group.
Focalin may not be right for you or your child. Before starting Focalin 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.
DRUG DEPENDENCE:
Focalin should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic, abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during drug withdrawal from abusive use since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.
In case of overdose, seek medical attention.
Symptoms of overdose may include:
- Irregular heartbeat
- Sweating
- Vomiting
- Fever
- Seizures
- Unconsciousness
- Agitation
- Confusion
- Headache
The recommended starting dose of Focalin for patients who are not currently taking racemic methylphenidate, or for patients who are on stimulants other than methylphenidate, is 5 mg/day (2.5 mg twice daily).
Dosage may be adjusted in 2.5 to 5 mg increments to a maximum of 20 mg/day (10 mg twice daily). In general, dosage adjustments may proceed at approximately weekly intervals.
For patients currently using methylphenidate, the recommended starting dose of Focalin is half the dose of racemic methylphenidate. The maximum recommended dose is 20 mg/day (10 mg twice daily).
Focalin (dexmethylphenidate) is an oral medication used primarily to treat the symptoms of Attention Deficit Hyperactivity Disorder (ADHD) along with behavioral therapies and counseling. It is part of a a class of medications called norepinephrine-dopamine reuptake inhibitors (NDRI).
It is believed that a possible cause of ADHD is a low amount of the neurotransmitters norepinephrine and dopamine, among others. In the brain, the space between where two neurons meet to communicate is called a synapse, and the synapse is where norepinephrine, dopamine, and other neurotransmitters are used to communicate between neurons. In depression, people may not have enough norepinephrine and dopamine in their brain. Normally after a chemical message is sent between neurons, the neurotransmitters are reabsorbed by the sending neuron (presynaptic neuron).
A selective norepinephrine-dopamine reuptake inhibitor will bind to the presynaptic neuron and prevent it from absorbing the norepinephrine and dopamine, and leave the neurotransmitters active in the synapse, improving mood and anxiety symptoms. Focalin also acts as a releasing agent and therefore psychostimulant, meaning that in addition to preventing reuptake, it also causes the extra release of neurotransmitters.