Dextroamphetamine Oral Solution

• It is used to treat attention deficit problems with hyperactivity.
• It is used to treat narcolepsy.
• It may be given to you for other reasons. Talk with the doctor.

Use dextroamphetamine oral solution as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take this medicine early in the day to prevent sleep problems.
• Take with or without food.
• Avoid taking dextroamphetamine oral solution with fruit juice.
• Take this medicine at the same time of day.
• To gain the most benefit, do not miss doses.
• Measure liquid doses carefully. Use the measuring device that comes with dextroamphetamine oral solution. If there is none, ask the pharmacist for a device to measure this medicine.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Dry mouth.
• Not hungry.
• Not able to sleep.
• Hard stools (constipation).
• Loose stools (diarrhea).
• Headache.
• Weight loss.
• Upset stomach.
• Bad taste in your mouth.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

To report SUSPECTED ADVERSE REACTIONS, contact Avadel Generics, LLC at 1-855-206-7812, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Cardiovascular: Palpitations, tachycardia, elevation of blood pressure. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.

Central Nervous System: Psychotic episodes at recommended doses (rare), overstimulation, restlessness, dizziness, insomnia, euphoria, dyskinesia, dysphoria, tremor, headache, exacerbation of motor and phonic tics and Tourette’s syndrome.

Gastrointestinal: Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances. Anorexia and weight loss may occur as undesirable effects.

Allergic: Urticaria.

Endocrine: Impotence, changes in libido.

Musculoskeletal: Rhabdomyolysis.

Individual patient response to amphetamines varies widely. While toxic symptoms occasionally occur as an idiosyncrasy at doses as low as 2 mg, they are rare with doses of less than 15 mg; 30 mg can produce severe reactions, yet doses of 400 to 500 mg are not necessarily fatal.

In rats, the oral LD50 of dextroamphetamine sulfate is 96.8 mg/kg.

Manifestations of acute overdosage with amphetamines include restlessness, tremor, hyperreflexia, rhabdomyolysis, rapid respiration, hyperpyrexia, confusion, assaultiveness, hallucinations, panic states.

Fatigue and depression usually follow the central stimulation.

Cardiovascular effects include arrhythmias, hypertension or hypotension and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. Fatal poisoning is usually proceeded by convulsions and coma.

Treatment

Consult with a Certified Poison Control Center for up-to-date guidance and advice. Management of acute amphetamine intoxication is largely symptomatic and includes gastric lavage, administration of activated charcoal, administration of a cathartic, and sedation. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendation in this regard. Acidification of the urine increases amphetamine excretion, but is believed to increase risk of acute renal failure if myoglobinuria is present. If acute, severe hypertension complicates amphetamine overdosage, administration of intravenous phentolamine (Bedford Laboratories) has been suggested. However, a gradual drop in blood pressure will usually result when sufficient sedation has been achieved.

Chlorpromazine antagonizes the central stimulant effects of amphetamines and can be used to treat amphetamine intoxication.

Amphetamines should be administered at the lowest effective dosage and dosage should be individually adjusted. Late evening doses should be avoided because of the resulting insomnia.

Narcolepsy: Usual dose is 5 mg to 60 mg per day in divided doses, depending on the individual patient response.

Narcolepsy seldom occurs in children under 12 years of age; however, when it does, Dextroamphetamine Sulfate Oral Solution may be used. The suggested initial dose for patients aged 6 to 12 is 5 mg daily; daily dose may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. In patients 12 years of age and older, start with 10 mg daily; daily dosage may be raised in increments of 10 mg at weekly intervals until optimal response is obtained. If bothersome adverse reactions appear (e.g., insomnia or anorexia), dosage should be reduced. Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours.

Attention Deficit Disorder with Hyperactivity: Not recommended for pediatric patients under 3 years of age.

In pediatric patients from 3 to 5 years of age, start with 2.5 mg daily; daily dosage may be raised in increments of 2.5 mg at weekly intervals until optimal response is obtained.

In pediatric patients 6 years of age and older, start with 5 mg once or twice daily; daily dosage may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. Only in rare cases will it be necessary to exceed a total of 40 mg per day.

Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours.

Where possible, drug administration should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy.

Do not take this medicine with any of the following medications:

• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• other stimulant medicines for attention disorders, weight loss, or to stay awake

This medicine may also interact with the following medications:

• acetazolamide
• ammonium chloride
• ascorbic acid
• atomoxetine
• caffeine
• certain medicines for blood pressure, heart disease, irregular heart beat
• certain medicines for depression, anxiety, or psychotic disturbances
• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin
• cold or allergy medicines
• glutamic acid
• lithium
• medicines that increase blood pressure like dopamine, dobutamine, ephedrine, or norepinephrine
• meperidine
• methenamine; sodium acid phosphate
• narcotic medicines for pain
• sodium bicarbonate

Take this medicine by mouth. Follow the directions on the prescription label. Use a specially marked spoon or container to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 3 years for selected conditions, precautions do apply.

They need to know if you have any of these conditions:

• anxiety or panic attacks
• circulation problems in fingers and toes
• glaucoma
• hardening or blockages of the arteries or heart blood vessels
• heart disease or a heart defect
• high blood pressure
• history of a drug or alcohol abuse problem
• history of stroke
• kidney disease
• liver disease
• mental illness
• seizures
• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member
• thyroid disease
• Tourette's syndrome
• an unusual or allergic reaction to dextroamphetamine, other amphetamines, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Visit your doctor or health care professional for regular checks on your progress. This prescription requires that you follow special procedures with your doctor and pharmacy. You will need to have a new written prescription from your doctor every time you need a refill.

This medicine may affect your concentration, or hide signs of tiredness. Until you know how this medicine affects you, do not drive, ride a bicycle, use machinery, or do anything that needs mental alertness.

Tell your doctor or health care professional if this medicine loses its effects, or if you feel you need to take more than the prescribed amount. Do not change the dose without talking to your doctor or health care professional.

Decreased appetite is a common side effect when starting this medicine. Eating small, frequent meals or snacks can help. Talk to your doctor if you continue to have poor eating habits. Height and weight growth of a child taking this medicine will be monitored closely.

Do not take this medicine close to bedtime. It may prevent you from sleeping.

If you are going to need surgery, a MRI, CT scan, or other procedure, tell your doctor that you are taking this medicine. You may need to stop taking this medicine before the procedure.

Tell your doctor or healthcare professional right away if you notice unexplained wounds on your fingers and toes while taking this medicine. You should also tell your healthcare provider if you experience numbness or pain, changes in the skin color, or sensitivity to temperature in your fingers or toes.

Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.

This medicine may cause accidental overdose and death if taken by other adults, children, or pets. Mix any unused medicine with a substance like cat litter or coffee grounds. Then throw the medicine away in a sealed container like a sealed bag or a coffee can with a lid. Do not use the medicine after the expiration date.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light.