DEXEDRINE SPANSULE (Page 3 of 5)

ADVERSE REACTIONS

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, intestinal ischemia, and other gastrointestinal disturbances. Anorexia and weight loss may occur as undesirable effects.

Allergic

Urticaria.

Endocrine

Impotence, changes in libido, frequent or prolonged erections.

Musculoskeletal

Rhabdomyolysis.

Skin and Subcutaneous Tissue Disorders

Alopecia.

To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG ABUSE AND DEPENDENCE

Dextroamphetamine sulfate is a Schedule II controlled substance.
Amphetamines have been extensively abused. Tolerance, extreme psychological dependence and severe social disability have occurred. There are reports of patients who have increased the dosage to many times that recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with amphetamines include severe dermatoses, marked insomnia, irritability, hyperactivity, and personality changes. The most severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia. This is rare with oral amphetamines.

OVERDOSAGE

Manifestations of amphetamine overdose include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states, hyperpyrexia and rhabdomyolysis. Fatigue and depression usually follow the central nervous system stimulation. Serotonin syndrome has also been reported. Cardiovascular effects include arrhythmias, hypertension or hypotension and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. Fatal poisoning is usually preceded by convulsions and coma.

Treatment
Consult with a Certified Poison Control Center for up to date guidance and advice.

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.

Since much of the SPANSULE capsule medication is coated for gradual release, therapy directed at reversing the effects of the ingested drug and at supporting the patient should be continued for as long as overdosage symptoms remain. Saline cathartics are useful for hastening the evacuation of pellets that have not already released medication.

DOSAGE AND ADMINISTRATION

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 children under 12 years of age; however, when it does, DEXEDRINE 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 an 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.

SPANSULE capsules may be used for once-a-day dosage wherever appropriate.

Attention Deficit Disorder with Hyperactivity

The SPANSULE capsule formulation is not recommended for pediatric patients younger than 6 years of age.

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. SPANSULE capsules may be used for once-a-day dosage wherever appropriate.

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

HOW SUPPLIED

DEXEDRINE SPANSULE capsules
Each capsule, with brown cap and natural body, contains dextroamphetamine sulfate.
The 5-mg capsule is imprinted in white with IX and 5 mg on the brown cap and is imprinted in white with 673 and 5 mg on the natural body.
The 10-mg capsule is imprinted in white with IX and 10 mg on the brown cap and is imprinted in white with 674 and 10 mg on the natural body.
The 15-mg capsule is imprinted in white with IX and 15 mg on the brown cap and is imprinted in white with 675 and 15 mg on the natural body.
5 mg 90s: NDC 64896-673-10
10 mg 90s: NDC 64896-674-10
15 mg 90s: NDC 64896-675-10
Store at controlled room temperature between 20° to 25°C (68° to 77°F) [see USP].
Dispense in a tight, light-resistant container.
Manufactured by:
Catalent Pharma Solutions
Winchester, KY 40391
Distributed by:
Amneal Specialty, a division of
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807
Rev. 01-2022-01
For additional copies of the printed medication guide, please visit www.amneal.com or contact us at 1-877-835-5472.

MEDICATION GUIDE

DEXEDRINE®
(dextroamphetamine sulfate) SPANSULE® sustained-release capsules, CII
Read the Medication Guide that comes with DEXEDRINE before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your or your child’s treatment with DEXEDRINE.

What is the most important information I should know about DEXEDRINE?
The following have been reported with use of DEXEDRINE and other stimulant medicines.

1. Heart-related problems:

  • Sudden death in patients who have heart problems or heart defects
  • Stroke and heart attack in adults
  • Increased blood pressure and heart rate

Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.
Your doctor should check you or your child carefully for heart problems before starting DEXEDRINE.
Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with DEXEDRINE.

Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking DEXEDRINE.

2. Mental (Psychiatric) problems:

All Patients

  • new or worse behavior and thought problems
  • new or worse bipolar illness
  • new or worse aggressive behavior or hostility

Children and Teenagers

  • new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms

Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.

Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking DEXEDRINE, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

3. Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud’s phenomenon]:

  • fingers or toes may feel numb, cool, painful
  • fingers or toes may change color from pale, to blue, to red

Tell your doctor if you have or your child has numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes.

Call your doctor right away if you have or your child has any signs of unexplained wounds appearing on fingers or toes while taking DEXEDRINE.

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