DextroStat

DextroStat is used for:

Treating attention deficit disorder with hyperactivity in children. It is also used to treat a type of sleep disorder (narcolepsy). It may also be used for other conditions as determined by your doctor.

DextroStat is a central nervous system stimulant. Exactly how it works is not known. It affects certain chemicals in the brain, which may help to improve attention span and behavior.

Do NOT use DextroStat if:

• you are allergic to any ingredient in DextroStat or to similar medicines
• you have severe hardening of the arteries; active heart or blood vessel disease; moderate, severe, or uncontrolled high blood pressure; an overactive thyroid; glaucoma
• you have agitation, anxiety, or tension
• you take guanethidine
• you take or have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days
• you have a history of alcohol or other substance abuse

Contact your doctor or health care provider right away if any of these apply to you.

Before using DextroStat :

Some medical conditions may interact with DextroStat . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you or a family member have a history of mental or mood problems (eg, bipolar disorder, depression, psychosis), uncontrolled muscle movements (eg, tics), Tourette syndrome, or suicidal thoughts or attempts
• if you have a history of heart problems (eg, heart failure, heart rhythm problems, heart defect), high blood pressure, seizures, abnormal electorencephalogram (EEG) test, growth problems, thyroid problems, certain blood problems (eg, porphyria), hardening of the arteries, or blood vessel problems, or you have had a recent heart attack
• if you have a family history of sudden death or heart rhythm problems

Some MEDICINES MAY INTERACT with DextroStat . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Acetazolamide, propoxyphene, sodium bicarbonate, or thiazide diuretics (eg, hydrochlorothiazide) because they may increase the risk of DextroStat 's side effects
• Adrenergic blockers (eg, guanethidine), antihistamines (eg, diphenhydramine), ethosuximide, or medicine for high blood pressure because their effectiveness may be decreased by DextroStat
• Ammonium chloride, ascorbic acid (vitamin C), chlorpromazine, glutamic acid, haloperidol, lithium carbonate, methenamine, reserpine, or sodium acid phosphate because they may decrease DextroStat 's effectiveness
• Furazolidone or MAOIs (eg, phenelzine) because the risk of severe high blood pressure, fever, headache, and decreased heart rate may be increased
• Meperidine, norepinephrine, phenobarbital, phenytoin, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), sympathomimetics (eg, pseudoephedrine), or tricyclic antidepressants (eg, desipramine) because the risk of their side effects may be increased by DextroStat

This may not be a complete list of all interactions that may occur. Ask your health care provider if DextroStat may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use DextroStat :

Use DextroStat as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• DextroStat comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get DextroStat refilled.
• Take DextroStat by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Take your doses of DextroStat 4 to 6 hours apart, unless your doctor tells you otherwise.
• Do not drink fruit juice at the same time that you take DextroStat . Certain fruit juices (eg, grapefruit, apple, orange) may decrease DextroStat 's effectiveness.
• Take DextroStat on a regular schedule to get the most benefit from it. Taking DextroStat at the same time each day will help you remember to take it.
• If you miss a dose of DextroStat , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use DextroStat .

Important safety information:

• DextroStat may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use DextroStat with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Serious effects, including heart attack, stroke, and sudden death, have occurred with the use of stimulant medicines in patients with heart defects or other serious heart problems. If you have a heart defect or other serious heart problem, talk with your doctor about other therapies to treat your condition.
• DextroStat may cause sleeplessness. Do not take DextroStat near your bedtime unless your doctor tells you otherwise.
• Avoid large amounts of food or drink that have caffeine (eg, coffee, tea, cocoa, cola, chocolate). Caffeine may increase the side effects of DextroStat .
• Tell your doctor or dentist that you take DextroStat before you receive any medical or dental care, emergency care, or surgery.
• This product may contain tartrazine dye (FD&C Yellow No. 5). This may cause an allergic reaction in some patients. If you have ever had an allergic reaction to tartrazine, ask your pharmacist if your product has tartrazine in it.
• DextroStat may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking DextroStat .
• Lab tests, including blood pressure and heart rate, may be performed while you use DextroStat . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• DextroStat should not be used in CHILDREN younger than 3 years old; safety and effectiveness in these children have not been confirmed.
• DextroStat may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they take DextroStat .
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using DextroStat while you are pregnant. DextroStat is found in breast milk. Do not breast-feed while taking DextroStat .

Some people who use DextroStat for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you suddenly stop taking DextroStat , you may experience WITHDRAWAL symptoms. These may include severe fatigue and drowsiness.

Possible side effects of DextroStat :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; dry mouth; headache; loss of appetite; mild weight loss; nausea; restlessness; trouble sleeping; unpleasant taste; upset stomach.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; change in sexual ability or desire; chest pain or tightness; fainting; fast or irregular heartbeat; hallucinations; mental or mood changes (eg, aggression, hostility, new or worsening behavior or thought problems); numbness of an arm or leg; seizures; severe dizziness or headache; shortness of breath; significant weight loss; sudden vision changes; symptoms of stroke (eg, confusion, one-sided weakness, slurred speech); tremor; uncontrolled speech or muscle movements (eg, tics); unusual weakness or tiredness; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include aggressiveness; coma; confusion; fast breathing; fever; hallucinations; increased reflexes; irregular heartbeat; muscle pain; panic; seizures; severe dizziness, drowsiness, or fatigue; severe or persistent nausea, vomiting, or diarrhea; stomach pain or cramps; tremor.

Store DextroStat at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Keep in a tightly closed container. Do not store in the bathroom. Keep DextroStat out of the reach of children and away from pets.

General information:

• If you have any questions about DextroStat , please talk with your doctor, pharmacist, or other health care provider.
• DextroStat is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about DextroStat . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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