Dextroamphetamine Sulfate (Page 3 of 4)

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, 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

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

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 preceded 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 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.

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, dextroamphetamine sulfate 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 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.

HOW SUPPLIED

Dextroamphetamine Sulfate Tablets, USP are available as:

5 mg: Peach, round, flat-faced, beveled-edge, scored tablet. Debossed with “n” on the scored side and “870”on the other side. Available in bottles of:

30 NDC 40032-870-03

100 NDC 40032-870-01

1000 NDC 40032-870-10

10 mg: Pink, round, flat-faced, beveled-edge, scored tablet. Debossed with “n” on the scored side and “871” on the other side. Available in bottles of:

30 NDC 40032-871-03

100 NDC 40032-871-01

1000 NDC 40032-871-10

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Store at 20o to 25o C (68o to 77o F) [See USP Controlled Room Temperature].

KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN.

DEA Order Form Required.

Manufactured by:

Novel Laboratories, Inc.

Somerset, NJ 08873

PI8710000103

Rev. 04/2017

MEDICATION GUIDE

DEXTROAMPHETAMINE SULFATE (DEX-troe-am-FET-uh-meen SULL-fate) TABLETS USP, CII

Read the Medication Guide that comes with Dextroamphetamine Sulfate Tablets 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 you or your child’s treatment with Dextroamphetamine Sulfate Tablets.

What is the most important information I should know about Dextroamphetamine Sulfate Tablets?

The following have been reported with use of Dextroamphetamine Sulfate Tablets 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 Dextroamphetamine Sulfate Tablets.

Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with Dextroamphetamine Sulfate Tablets.

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 Dextroamphetamine Sulfate Tablets.

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 Dextroamphetamine Sulfate Tablets, 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 Dextroamphetamine Sulfate Tablets.

Dextroamphetamine Sulfate Tablets may not be right for you or your child. Before starting Dextroamphetamine Sulfate Tablets tell your or your child’s doctor about all health conditions (or a family history of) including:

  • circulation problems in fingers and toes.

What are Dextroamphetamine Sulfate Tablets?

Dextroamphetamine Sulfate Tablets are a central nervous system stimulant prescription medicine. It is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Dextroamphetamine Sulfate Tablets may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

Dextroamphetamine Sulfate Tablets should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

Dextroamphetamine Sulfate Tablets are also used in the treatment of a sleep disorder called narcolepsy.

Dextroamphetamine Sulfate is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Dextroamphetamine Sulfate Tablets in a safe place to prevent misuse and abuse. Selling or giving away Dextroamphetamine Sulfate Tablets may harm others, and is against the law.

Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.

Who should not take Dextroamphetamine Sulfate Tablets?

Dextroamphetamine Sulfate Tablets should not be taken if you or your child:

  • have heart disease or hardening of the arteries
  • have moderate to severe high blood pressure
  • have hyperthyroidism
  • have an eye problem called glaucoma
  • are very anxious, tense, or agitated
  • have a history of drug abuse
  • are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.
  • is sensitive to, allergic to, or had a reaction to other stimulant medicines

Dextroamphetamine Sulfate Tablets are not recommended for use in children less than 3 years old.

Dextroamphetamine Sulfate Tablets may not be right for you or your child. Before starting Dextroamphetamine Sulfate Tablets tell your or your child’s doctor about all health conditions (or a family history of) including:

  • heart problems, heart defects, high blood pressure
  • mental problems including psychosis, mania, bipolar illness, or depression
  • tics or Tourette’s syndrome
  • thyroid problems
  • seizures or have had an abnormal brain wave test (EEG)

Tell your doctor if you or your child is pregnant, planning to become pregnant, or breastfeeding.

Can Dextroamphetamine Sulfate Tablets be taken with other medicines?

Tell your doctor about all of the medicines that you or your child take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Dextroamphetamine Sulfate Tablets and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking Dextroamphetamine Sulfate Tablets.

Your doctor will decide whether Dextroamphetamine Sulfate Tablets can be taken with other medicines.

Especially tell your doctor if you or your child take:

• anti-depression medicines including MAOIs

• blood pressure medicines

• antacids

• seizure medicines

Know the medicines that you or your child take. Keep a list of your medicines with you to show your doctor and pharmacist.

Do not start any new medicine while taking Dextroamphetamine Sulfate Tablets without talking to your doctor first.

How should Dextroamphetamine Sulfate Tablets be taken?

  • Take Dextroamphetamine Sulfate Tablets exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.
  • Dextroamphetamine Sulfate Tablets are usually taken two or three times a day. The first dose is usually taken in the morning. One or two more doses may be taken during the day, 4 to 6 hours apart.
  • From time to time, your doctor may stop Dextroamphetamine Sulfate Tablets treatment for a while to check ADHD symptoms.
  • Your doctor may do regular checks of the blood, heart, and blood pressure while taking Dextroamphetamine Sulfate Tablets. Children should have their height and weight checked often while taking Dextroamphetamine Sulfate Tablets. Dextroamphetamine Sulfate Tablets treatment may be stopped if a problem is found during these check-ups.
  • If you or your child take too much Dextroamphetamine Sulfate Tablets or overdoses, call your doctor or poison control center right away, or get emergency treatment.

What are possible side effects of Dextroamphetamine Sulfate Tablets?

See “What is the most important information I should know about Dextroamphetamine Sulfate Tablets?” for information on reported heart and mental problems.

Other serious side effects include:

  • slowing of growth (height and weight) in children
  • seizures, mainly in patients with a history of seizures
  • eyesight changes or blurred vision
  • serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when medicines such as dextroamphetamine sulfate tablets are taken with certain other medicines. Symptoms of serotonin syndrome may include:
    • agitation, hallucinations, coma or other changes in mental status
    • problems controlling your movements or muscle twitching
    • fast heartbeat
    • high or low blood pressure
    • sweating or fever
    • nausea or vomiting
    • diarrhea
    • muscle stiffness or tightness

Common side effects include:

  • fast heart beat
  • decreased appetite
  • tremors
  • headache
  • trouble sleeping
  • dizziness
  • stomach upset
  • weight loss
  • dry mouth

Dextroamphetamine Sulfate Tablets may affect your or your child’s ability to drive or do other dangerous activities.

Talk to your doctor if you or your child have side effects that are bothersome or do not go away.

This is not a complete list of possible side effects. Ask your doctor or pharmacist for more information.

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

How should I store Dextroamphetamine Sulfate Tablets?

  • Store Dextroamphetamine Sulfate Tablets in a safe place at room temperature, 20° to 25°C (68° to 77°F).
  • Keep Dextroamphetamine Sulfate Tablets and all medicines out of the reach of children.

General information about Dextroamphetamine Sulfate Tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Dextroamphetamine Sulfate Tablets for a condition for which they were not prescribed. Do not give Dextroamphetamine Sulfate Tablets to other people, even if they have the same condition. It may harm them and it is against the law. This Medication Guide summarizes the most important information about Dextroamphetamine Sulfate Tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Dextroamphetamine Sulfate Tablets that was written for healthcare professionals.

What are the ingredients in Dextroamphetamine Sulfate Tablets?

Active Ingredient: dextroamphetamine sulfate

Inactive Ingredients

Colloidal Silicon Dioxide, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, and Povidone.

The 5 mg also contains D&C yellow no. 10, Iron oxide yellow and Iron oxide red.

The 10 mg also contains FD&C yellow no. 6 aluminium lake and FD&C red no. 40 aluminium lake.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured by:

Novel Laboratories, Inc.

Somerset, NJ 08873

PI8710000103

Rev. 04/2017

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