Focalin

DRUG DESCRIPTION

Focalin® (dexmethylphenidate hydrochloride) is the d-threo-enantiomer of racemic methylphenidate hydrochloride, which is a 50/50 mixture of the d-threo and l-threo-enantiomers. Focalin (dexmethylphenidate hydrochloride) is a central nervous system (CNS) stimulant, available in three tablet strengths. Each tablet contains dexmethylphenidate hydrochloride 2.5, 5, or 10 mg for oral administration. Dexmethylphenidate hydrochloride is methyl ?-phenyl-2-piperidineacetate hydrochloride, (R,R')-(+)-. Its empirical formula is C14H19NO2•HCl. Its molecular weight is 269.77 and its structural formula is

Focalin® (dexmethylphenidate hydrochloride) Structural Formula Illustration

Note: * = asymmetric carbon centers

Dexmethylphenidate hydrochloride is a white to off white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone.

Focalin (dexmethylphenidate hydrochloride) also contains the following inert 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.

What are the possible side effects of dexmethylphenidate (Focalin, Focalin XR)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

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

  • dangerously high blood pressure (severe headache, blurred vision, ringing in your ears, chest pain, numbness, seizure);
  • fast or uneven heart rate;
  • blurred vision or other visual changes;
  • unusual behavior,...

Read All Potential Side Effects and See Pictures of Focalin »

What are the precautions when taking dexmethylphenidate hydrochloride (Focalin)?

Before taking dexmethylphenidate, tell your doctor or pharmacist if you are allergic to it; or to methylphenidate; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe anxiety/tension, heart/blood vessel disease (e.g., irregular heartbeat/rhythm, coronary artery disease, angina, heart failure, cardiomyopathy), problems with heart structure (e.g., valve problems), history of heart attack or stroke, certain eye problem (glaucoma), personal or family history of uncontrolled muscle movements (motor tics,...

Read All Potential Precautions of Focalin »


Focalin Consumer (continued)

SIDE EFFECTS: Trouble sleeping, nausea, stomach pain, headache, nervousness, loss of appetite, or weight loss may occur. If any of these effects persist or worsen, notify your doctor.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: high fever, uncontrolled muscle movements (e.g., stiffness, twitching, shaking), mental/mood/behavior changes (e.g., agitation, aggression, mood swings, depression, hallucinations, abnormal thoughts/behavior), outbursts of words/sounds, severe sweating, swelling of the ankles/feet, extreme tiredness, blurred vision.

Seek immediate medical attention if any of these rare but very serious side effects occur: shortness of breath, easy bleeding/bruising, fainting, sudden vision changes, chest/jaw/left arm pain, severe headache, fast/irregular/pounding heartbeat, signs of infection (fever, persistent sore throat), seizures, weakness, slurred speech, confusion.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking dexmethylphenidate, tell your doctor or pharmacist if you are allergic to it; or to methylphenidate; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe anxiety/tension, heart/blood vessel disease (e.g., irregular heartbeat/rhythm, coronary artery disease, angina, heart failure, cardiomyopathy), problems with heart structure (e.g., valve problems), history of heart attack or stroke, certain eye problem (glaucoma), personal or family history of uncontrolled muscle movements (motor tics, Tourette's syndrome), seizures, certain mental/mood conditions (e.g., agitation, psychosis).

Tell your doctor your medical history, especially of: family history of sudden death/irregular heartbeat/rhythm, history of alcohol/drug abuse, heart problems (e.g., recent heart attack, heart failure, abnormal heartbeat), high blood pressure, family/personal history of mental/mood disorders (e.g., bipolar disorder, depression, psychotic disorder, suicidal thoughts), history of seizure disorders, overactive thyroid (hyperthyroidism).

This drug may cause blurred vision. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

Before having surgery, tell your doctor or dentist that you are taking this medication.

Caution is advised when using this drug in children because it may affect weight, growth rate, and final height. The doctor may recommend temporarily stopping the medication from time to time to reduce this risk. Monitor your child's weight and height and consult your doctor or pharmacist for more details.

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.


Focalin Patient Information Including Side Effects

Brand Names: Focalin, Focalin XR

Generic Name: dexmethylphenidate (Pronunciation: dex METH il FEN i date)

  • What is dexmethylphenidate (Focalin)?
  • What are the possible side effects of dexmethylphenidate (Focalin)?
  • What is the most important information I should know about dexmethylphenidate (Focalin)?
  • What should I discuss with my healthcare provider before taking dexmethylphenidate (Focalin)?
  • How should I take dexmethylphenidate (Focalin)?
  • What happens if I miss a dose (Focalin)?
  • What happens if I overdose (Focalin)?
  • What should I avoid while taking dexmethylphenidate (Focalin)?
  • What other drugs will affect dexmethylphenidate (Focalin)?
  • Where can I get more information?

What is dexmethylphenidate (Focalin)?

Dexmethylphenidate is a mild stimulant to the central nervous system (brain and nerves).

Dexmethylphenidate is used to treat attention deficit hyperactivity disorder (ADHD).

Dexmethylphenidate may also be used for other purposes not listed in this medication guide.

What are the possible side effects of dexmethylphenidate (Focalin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

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

  • dangerously high blood pressure (severe headache, blurred vision, ringing in your ears, chest pain, numbness, seizure);
  • fast or uneven heart rate;
  • blurred vision or other visual changes;
  • unusual behavior, confusion; or
  • twitching or tics.

Less serious side effects may include:

  • sleep problems (insomnia);
  • loss of appetite;
  • upset stomach;
  • feeling restless, anxious, or jittery;
  • dry mouth, sore throat; or
  • headache.

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

What is the most important information I should know about dexmethylphenidate (Focalin)?

Do not use dexmethylphenidate if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take dexmethylphenidate before the MAO inhibitor has cleared from your body.

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have severe depression or a history of mental illness, seizures or epilepsy, high blood pressure, a history of drug or alcohol addiction, congestive heart failure, or if you have recently had a heart attack.

Some stimulants have caused sudden death in children and adolescents with serious heart problems or congenital heart defects. Before taking dexmethylphenidate, tell your doctor if you have any type of heart problems.

Long-term use of dexmethylphenidate can slow a child's growth. Tell your doctor if the child using this medication is not growing or gaining weight properly.

Dexmethylphenidate may be habit-forming and should be used only by the person it was prescribed for. Dexmethylphenidate should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Keep track of how many pills have been used from each new bottle of this medicine. Dexmethylphenidate is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

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