Dexedrine Tablets

Amphetamines are excreted in human milk. Mothers taking amphetamines should be advised to refrain from nursing.

Long-term effects of amphetamines in pediatric patients have not been well established. Amphetamines are not recommended for use in pediatric patients under 3 years of age with Attention Deficit Disorder with Hyperactivity described under  INDICATIONS AND USAGE.

Clinical experience suggests that in psychotic pediatric patients, administration of amphetamines may exacerbate symptoms of behavior disturbance and thought disorder.

Amphetamines have been reported to exacerbate motor and phonic tics and Tourette's syndrome. Therefore, clinical evaluation for tics and Tourette's syndrome in pediatric patients and their families should precede use of stimulant medications.

Data are inadequate to determine whether chronic administration of amphetamines may be associated with growth inhibition; therefore, growth should be monitored during treatment.

Drug treatment is not indicated in all cases of Attention Deficit Disorder with Hyperactivity and should be considered only in light of the complete history and evaluation of the pediatric patient. The decision to prescribe amphetamines should depend on the physician's assessment of the chronicity and severity of the pediatric patient's symptoms and their appropriateness for his/her age. Prescription should not depend solely on the presence of one or more of the behavioral characteristics.

When these symptoms are associated with acute stress reactions, treatment with amphetamines is usually not indicated.

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 to 60 mg per day in divided doses, depending on the individual patient response.

Narcolepsy seldom occurs in pediatric patients under 12 years of age; however, when it does, Dexedrine Tablets 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 an 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, by tablet; 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.

DEXEDRINE (dextroamphetamine sulfate, USP) TABLETS, 5 mg, 100 Tablets

Applies to dextroamphetamine: oral capsule extended release, oral solution, oral tablet

Along with its needed effects, dextroamphetamine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

• Agitation
• delusions
• seeing, hearing, or feeling things that are not there

• Blurred vision
• chest discomfort or pain
• difficulty breathing
• dizziness
• faintness
• false or unusual sense of well-being
• fast, pounding, or irregular heartbeat or pulse
• headache
• pounding in the ears
• shakiness in the legs, arms, hands, or feet
• 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

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

• Change in consciousness
• dark-colored urine
• diarrhea
• discouragement
• feeling sad or empty
• fever
• irritability
• lack of appetite
• loss of consciousness
• loss of interest or pleasure
• mood or mental changes
• muscle cramps or spasms
• muscle pain or stiffness
• nausea
• panic state
• physical attempt to injure
• rapid breathing
• seizures
• stomach cramps
• sweating
• trouble concentrating
• violent actions
• vomiting

Some side effects of dextroamphetamine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may 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:

• Bad, unusual, or unpleasant (after) taste
• change in taste
• constipation
• 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

Data not available.

Data not available.

Narcolepsy Patients: Reduce dosage if bothersome adverse reactions (e.g., insomnia, anorexia) appear.

Administration Advice:
-Avoid late evening doses because of the potential for insomnia.
-Administer this drug at the lowest effective dosage, and individually adjust dosage.
-Take tablet doses at the same times on each day preferably with or immediately after meals.

Storage Requirements:
-Store this drug between 20 to 25 degrees Celsius (68 to 77 Fahrenheit) and dispense in a tight, light-resistant container.

General:
-Individual patient response to amphetamines varies widely: toxic symptoms can occur at doses as low as 2 mg but 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.
-Overdosage: Management is largely symptomatic and may include gastric lavage, activated charcoal, a cathartic, and sedation; insufficient data is available to recommend the use of hemodialysis or peritoneal dialysis.

Monitoring:
-Cardiovascular: Blood pressure, heart rate, changes in fingers and toes
-General: Signs of abuse/dependence
-Musculoskeletal: Growth (height, weight, appetite)
-Psychiatric: New or worsening psychiatric disorders, including aggressive behavior/hostility, depression, psychosis, mania, and suicidal thoughts or behavior

Patient Advice:
-Avoid driving and other potentially dangerous activities such as operating machinery until you know how this drug affects you.
-Contact your healthcare provider if you experience any of the following on your fingers or toes during treatment: unexplained wounds, new numbness, pain, skin color change, or temperature sensitivity.