Dexedrine Spansules (Oral)

Dextroamphetamine is used to treat attention-deficit hyperactivity disorder (ADHD) and narcolepsy (a sleep disorder). It is part of a group of medications called central nervous system (CNS) stimulants.

Dextroamphetamine helps treat ADHD by increasing attention and reducing restlessness in children and adults who are overactive, have trouble concentrating for long periods, or are easily distracted and impulsive. This medicine is used as part of a complete treatment plan that also includes social, educational, and psychological support.

This medicine is available only with a doctor's prescription.

It is very important for your doctor to check your or your child's progress at regular visits to ensure this medicine is working correctly. Blood tests may be needed to monitor for any unwanted effects.

Do not use this medicine if you are currently using or have used an MAO inhibitor (MAOI), including isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], or tranylcypromine [Parnate®], within the past 14 days.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while using this medicine.

This medicine may cause serious heart or blood vessel problems. This risk may be higher for patients with a family history of heart disease. Check with your doctor immediately if you or your child experience chest pain, trouble breathing, or fainting while taking this medicine.

You or your child will need to have your blood pressure and heart rate measured before starting this medicine and during its use. If you notice any change in blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.

This medicine may cause some people to feel an unrealistic sense of well-being or to feel dizzy, lightheaded, or less alert than usual. It may also cause blurred vision or other vision problems. Do not drive or do anything else that could be dangerous until you or your child know how this medicine affects you.

Check with your doctor immediately if blurred vision, difficulty reading, or any other change in vision occurs during or after treatment. Your doctor may want you or your child to have an eye exam by an ophthalmologist (eye doctor).

Tell your doctor right away if you or your family notice any unusual changes in behavior, such as increased aggression, hostility, agitation, irritability, or suicidal thoughts or behaviors. Also inform your doctor if you or your child have hallucinations or any unusual thoughts, especially if they are new or getting worse quickly.

If you or your child have been using this medicine for a long time and think you may have become mentally or physically dependent on it, consult your doctor. Some signs of dependence on dextroamphetamine include:

• A strong desire or need to continue taking the medicine.
• A need to increase the dose to get the same effects from the medicine.
• Withdrawal effects (for example, mental depression, nausea or vomiting, stomach cramps or pain, trembling, unusual tiredness or weakness) that occur after stopping the medicine.

Symptoms of an overdose include: aggression, agitation, anger, blurred vision, changes in consciousness, chest pain or discomfort, confusion, dark urine, diarrhea, dizziness, faintness, or lightheadedness when standing up suddenly, fast, pounding, or irregular heartbeat, fever, headache, inability to speak, loss of consciousness, muscle cramps, spasms, pains, or stiffness, nausea, nervousness, overactive reflexes, pain or discomfort in the arms, jaw, back, or neck, pale, clammy skin, palpitations, panic state, pounding in the ears, restlessness, seeing, hearing, or feeling things that are not there, seizures, shakiness in the legs, arms, hands, or feet, shivering, slow or fast heartbeat, slurred speech, sweating, uncontrolled excitement, temporary blindness, thirst, trembling or shaking of hands or feet, trouble breathing, unusual tiredness or weakness, vomiting, or weakness in one arm or leg. Call your doctor right away if you notice these symptoms.

This medicine may cause slow growth in children. If your child is taking this medicine, the doctor will need to monitor your child's height and weight to ensure proper growth.

This medicine may increase your risk of having seizures. This risk is higher in patients with a history of seizures or heart rhythm problems. Check with your doctor right away if this occurs.

This medicine may cause Raynaud's phenomenon, which affects blood circulation in the fingers or toes. Inform your doctor if you or your child experience tingling or pain, a cold feeling, paleness, or changes in skin color in the fingers or toes, especially when exposed to cold temperatures. Call your doctor immediately if you have unexplained sores or ulcers on your fingers or toes.

Check with your doctor right away if you or your child have anxiety, restlessness, a rapid heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

If you or your child will be taking this medicine in large doses for an extended period, do not stop taking it without first consulting your doctor. Your doctor may want you or your child to gradually reduce the amount taken before stopping it completely.

Before undergoing any medical tests, inform the medical doctor in charge that you or your child are taking this medicine. The results of some tests may be affected by this medicine.

Avoid using medications that increase stomach or urine alkalinity, including sodium bicarbonate, acetazolamide, and some thiazide diuretics (water pill).

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines, herbal (e.g., St. John's wort) or vitamin supplements, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.

In deciding to use a medicine, you and your doctor need to weigh the risks of taking it against the benefits it may provide. Here are some important points to consider for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies have not been done to determine how age affects the use of dextroamphetamine tablets for treating attention-deficit hyperactivity disorder in children younger than 3 years. Safety and effectiveness have not been proven for this age group.

Dexedrine® Spansule® is not suggested for treating attention-deficit hyperactivity disorder in children younger than 6 years.

Geriatric

There is no information available on how age affects the use of dextroamphetamine in older patients.

Breast Feeding

Studies in breastfeeding women have shown harmful effects on infants. You should either be prescribed an alternative to this medication or stop breastfeeding while using this medicine.

Interactions with Medicines

While some medicines should never be taken together, others can be used together with caution. In such cases, your doctor may need to adjust the dose or take other precautions. It is very important for your healthcare provider to know if you are taking any of the medicines listed below. The following interactions are significant but not necessarily a complete list.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide to avoid using this medication or adjust your other medicines.

• Furazolidone
• Iproniazid
• Isocarboxazid
• Linezolid
• Methylene Blue
• Moclobemide
• Nialamide
• Ozanimod
• Phenelzine
• Procarbazine
• Rasagiline
• Safinamide
• Selegiline
• Sibutramine
• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both are prescribed, your doctor may change the dose or how often you take one or both of the medicines.

• Abiraterone Acetate
• Acetazolamide
• Alfentanil
• Almotriptan
• Aluminum
• Amifampridine
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Anileridine
• Benzhydrocodone
• Benzthiazide
• Brompheniramine
• Buprenorphine
• Bupropion
• Buspirone
• Butorphanol
• Calcium Carbonate
• Carbamazepine
• Chlorothiazide
• Chlorpheniramine
• Cimetidine
• Cinacalcet
• Citalopram
• Clobazam
• Clomipramine
• Cobicistat
• Cocaine
• Codeine
• Cyclobenzaprine
• Desipramine
• Desvenlafaxine
• Dexlansoprazole
• Dextromethorphan
• Diazoxide
• Dibenzepin
• Difenoxin
• Dihydrocodeine
• Dihydroxyaluminum Aminoacetate
• Diphenoxylate
• Dolasetron
• Donepezil
• Doxepin
• Duloxetine
• Eletriptan
• Escitalopram
• Esomeprazole
• Ethylmorphine
• Fenfluramine
• Fentanyl
• Fluoxetine
• Fluvoxamine
• Frovatriptan
• Gepirone
• Granisetron
• Hydrochlorothiazide
• Hydrocodone
• Hydroflumethiazide
• Hydromorphone
• Hydroxytryptophan
• Imipramine
• Iobenguane I 131
• Ketobemidone
• Lansoprazole
• Lasmiditan
• Levomilnacipran
• Levorphanol
• Lithium
• Lofepramine
• Lorcaserin
• Magaldrate
• Magnesium Carbonate
• Melitracen
• Meperidine
• Metaxalone
• Methadone
• Milnacipran
• Mirabegron
• Mirtazapine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Naratriptan
• Nefazodone
• Nicomorphine
• Nortriptyline
• Omeprazole
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Oxycodone
• Oxymorphone
• Palonosetron
• Pantoprazole
• Papaveretum
• Paregoric
• Paroxetine
• Pentazocine
• Piritramide
• Polythiazide
• Protriptyline
• Quinidine
• Quinine
• Rabeprazole
• Remifentanil
• Ritonavir
• Rizatriptan
• Rolapitant
• Sertraline
• Sodium Bicarbonate
• St John's Wort
• Sufentanil
• Sumatriptan
• Tapentadol
• Terbinafine
• Tianeptine
• Tilidine
• Tramadol
• Trazodone
• Trichlormethiazide
• Trimipramine
• Tryptophan
• Venlafaxine
• Vilazodone
• Vortioxetine
• Xipamide
• Ziprasidone
• Zolmitriptan

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Be sure to tell your doctor about any other medical issues, especially:

• Agitation, severe or
• Anxiety, severe or
• Arteriosclerosis (hardening of the arteries), severe or
• Drug abuse, history of or
• Glaucoma or
• Heart attack, recent or
• Heart failure or
• Heart or blood vessel disease (e.g., cardiomyopathy, coronary artery disease) or
• Heart rhythm problems (e.g., arrhythmia, ventricular arrhythmia), or family history of or
• Hypertension (high blood pressure), moderate to severe or
• Hyperthyroidism (overactive thyroid) or
• Stroke, history of or
• Tension, severe—Should not be used in patients with these conditions.

• Bipolar disorder (manic-depressive illness), or a family history of or
• Blood vessel problems (e.g., Raynaud disease) or
• Depression, or a family history of or
• Hypertension (high blood pressure), mild or
• Psychosis (mental illness), history of or
• Seizures, history of or
• Thyroid problems or
• Tourette's syndrome, or family history of—Use with caution. May make these conditions worse.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, you may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

• Agitation
• Delusions
• Seeing, hearing, or feeling things that are not there

Incidence not known

• Blurred vision
• Chest discomfort or pain
• Constipation
• Diarrhea
• Difficulty breathing
• Dizziness
• Faintness
• False or unusual sense of well-being
• Fast, pounding, or irregular heartbeat or pulse
• Headache
• Nausea
• Pounding in the ears
• Shakiness in the legs, arms, hands, or feet
• Stomach pain
• Swelling of the feet or lower legs
• Trembling or shaking of the hands or feet
• Twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
• Unable to sleep
• Uncontrolled vocal outbursts and/or tics (uncontrolled repeated body movements)
• Unusual tiredness or weakness
• Vomiting

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Aggressive
• Agitation
• Angry
• Blurred vision
• Change in consciousness
• Chest pain or discomfort
• Confusion
• Dark urine
• Diarrhea
• Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• Fainting
• Fast breathing
• Fast, slow, or irregular heartbeat
• Fever
• Headache
• Inability to speak
• Loss of consciousness
• Muscle cramps, spasms, pain, or stiffness
• Nausea
• Nervousness
• Overactive reflexes
• Pain or discomfort in the arms, jaw, back, or neck
• Pale, clammy skin
• Palpitations
• Pounding in the ears
• Restlessness
• Seeing, hearing, or feeling things that are not there
• Seizures
• Shivering
• Slow or fast heartbeat
• Slurred speech
• Stomach cramps
• Sweating
• Talking or acting with excitement you cannot control
• Temporary blindness
• Thirst
• Tremor
• Trouble breathing
• Unusual tiredness or weakness
• Vomiting
• Weakness in the arm or leg on one side of the body, sudden and severe

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Bad, unusual, or unpleasant (after) taste
• Change in taste
• Decreased interest in sexual intercourse
• Dry mouth
• Hives or welts, itching, or skin rash
• Inability to have or keep an erection
• Indigestion
• Loss in sexual ability, desire, drive, or performance
• Passing of gas
• Redness of the skin
• Weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Dexedrine
• Dexedrine Spansules
• Dextrostat
• Liquadd
• ProCentra
• Zenzedi

Available Dosage Forms:

• Tablet
• Capsule, Extended Release
• Solution

Therapeutic Class: CNS Stimulant

Chemical Class: Amphetamine (class)

Take this medicine only as directed by your doctor. Do not take more or less of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming (causing mental or physical dependence). If you or your child feel that the medicine is not working properly after you have taken it for several weeks, check with your doctor first and do not increase the dose.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If you or your child use the tablet form of this medicine, and you take it 2 or 3 times a day. Take the first dose in the morning. The other doses may be taken during the day with 4 to 6 hours between doses.

It is best to take the sustained-release capsule in the morning. Taking this medicine in the afternoon or evening could make it harder for you to fall asleep.

Swallow the sustained-release capsule whole. Do not crush, break, or chew it.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For attention-deficit hyperactivity disorder (ADHD): For oral dosage form (sustained-release capsules): Adults and children 6 years of age and older—At first, 5 milligrams (mg) 1 or 2 times a day. Your doctor may adjust your dose as needed. Children younger than 6 years of age—Use is not recommended. For oral dosage form (tablets): Adults and children 6 years of age and older—At first, 5 milligrams (mg) 1 or 2 times a day. Your doctor may adjust your dose as needed. Children 3 to 5 years of age—At first, 2.5 mg once a day. Your doctor may adjust your dose as needed. Children younger than 3 years of age—Use and dose must be determined by your doctor.
• For narcolepsy:For oral dosage forms (sustained-release capsules or tablets): Adults and children 12 years of age and older—At first, 10 milligrams (mg) once a day. Your doctor may adjust your dose as needed. Children 6 to 12 years of age—At first, 5 mg once a day. Your doctor may adjust your dose as needed. Children younger than 6 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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