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FOCALIN
DEXMETHYLPHENIDATE - ORAL

Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

DEXMETHYLPHENIDATE - ORAL

(dex-meth-ill-FEN-eh-date)

COMMON BRAND NAME(S): Focalin

WARNING: 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. 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. 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.