Prescription Drug Information: Dextroamphetamine Sulfate (Page 3 of 4)

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 extended-release 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, dextroamphetamine sulfate extended-release capsules 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. Extended-release capsules may be used for once-a-day dosage wherever appropriate.

Attention Deficit Disorder with Hyperactivity

The extended-release 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.

Dextroamphetamine sulfate extended-release 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

Dextroamphetamine sulfate extended-release capsules are available as:

5 mg: Hard gelatin capsules with a brown opaque cap imprinted with black ink “N” and brown opaque body imprinted with black ink “943”, packaged as follows:

NDC 68382-943-01 Bottles of 100 Capsules

10 mg: Hard gelatin capsules with a brown opaque cap imprinted with black ink “N” and white opaque body imprinted with black ink “944”, packaged as follows:

NDC 68382-944-01 Bottles of 100 Capsules

15 mg: Hard gelatin capsules with a brown opaque cap imprinted with black ink “N” and white opaque body imprinted with black ink “945”, packaged as follows:

NDC 68382-945-01 Bottles of 100 Capsules

Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Protect from light.

Manufactured By:

Nesher Pharmaceuticals USA LLC

St. Louis, MO 63044

Distributed by:

Zydus Pharmaceuticals USA Inc.

Pennington, NJ 08534

P10281-4 01/2019

For additional copies of the printed patient information/medication guide, please visit wwww.zydus.com or call 1-877-993-8779.

INFORMATION FOR PATIENTS

MEDICATION GUIDE

Dextroamphetamine Sulfate (dex” troe am fet’ a meen sul’ fate) Extended-Release Capsules

CII

Rx Only

Read the Medication Guide that comes with dextroamphetamine sulfate extended-release capsules 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 dextroamphetamine sulfate extended-release capsules.

What is the most important information I should know about dextroamphetamine sulfate extended release capsules ? The following have been reported with use of dextroamphetamine sulfate extended release capsules and other stimulant medicines . 1.Heartrelated 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 extended-release capsules.Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with dextroamphetamine sulfate extended-release capsules.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 extended release capsules . 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 extended release capsules , 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 redTell 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 extended release capsules .

What are dextroamphetamine sulfate extended-release capsules?

Dextroamphetamine sulfate extended-release capsules are a central nervous system stimulant prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD).

Dextroamphetamine sulfate extended-release capsules may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

Dextroamphetamine sulfate extended-release capsules should be used as a part of a total treatment program for ADHD that may include counseling or other therapies. Dextroamphetamine sulfate extended-release capsules are also used in the treatment of a sleep disorder called narcolepsy.

Dextroamphetamine extended release capsules are a federally controlled substance ( CII ) because it can be abused or lead to dependence . Keep dextroamphetamine sulfate extended release capsules in a safe place to prevent misuse and abuse . Selling or giving away dextroamphetamine sulfate extended release capsules 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 extended-release capsules?

Dextroamphetamine sulfate extended-release capsules 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 antidepression medicine called a monoamine oxidase inhibitor or MAOI.
  • Is sensitive to, allergic to, or had a reaction to other stimulant medicines

Dextroamphetamine sulfate extended-release capsules are not recommended for use in children younger than 6 years old.

Dextroamphetamine sulfate extended-release capsules may not be right for you or your child. Before starting dextroamphetamine sulfate extended-release capsules tell you 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)
  • Circulation problems in fingers and toes

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

Can dextroamphetamine sulfate extended-release capsules be taken with other medicines?

Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. Dextroamphetamine sulfate extended-release capsules 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 extended-release capsules.

Your doctor will decide whether dextroamphetamine sulfate extended-release capsules can be taken with other medicines.

Especially tell your doctor if you or your child takes:

  • Anti-depression medicines including MAOIs
  • Blood pressure medicines
  • Antacids
  • Seizure medicines

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

Do not start any new medicine while taking dextroamphetamine sulfate extended-release capsules without talking to your doctor first.

How should dextroamphetamine sulfate extended-release capsules be taken?

  • Take dextroamphetamine sulfate extended-release capsules exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.
  • Dextroamphetamine sulfate extended-release capsules come as a capsule.
  • Dextroamphetamine sulfate extended-release capsules are usually taken once a day in the morning. Dextroamphetamine sulfate extended-release capsules are an extended release capsule. It releases medicine into your body throughout the day.
  • From time to time, your doctor may stop treatment with dextroamphetamine sulfate extended-release capsules for a while to check ADHD symptoms.
  • Your doctor may do regular checks of the blood, heart, and blood pressure while taking dextroamphetamine sulfate extended-release capsules. Children should have their height and weight checked often while taking dextroamphetamine sulfate extended-release capsules. Treatment with dextroamphetamine sulfate extended-release capsules may be stopped if a problem is found during these check-ups.
  • If you or your child takes too much dextroamphetamine sulfate extended-release capsules or overdoses, call your doctor or poison control center right away, or get emergency treatment

What are possible side effects of dextroamphetamine sulfate extended-release capsules?

See What is the most important information I should know about dextroamphetamine sulfate extended-release capsules?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

Common side effects include:

  • Fast heart beat
  • Decreased appetite
  • Tremors
  • Headache
  • Trouble sleeping
  • Dizziness
  • Stomach upset
  • Weight loss
  • Dry mouth

Dextroamphetamine sulfate extended-release capsules may affect your or your child’s ability to drive or do other dangerous activities.

Talk to your doctor if you or your child has 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 extended-release capsules?

  • Store dextroamphetamine sulfate extended-release capsules in a safe place at room temperature, 68° to 77°F (20° to 25°C). Protect from light.
  • Keep dextroamphetamine sulfate extended-release capsules and all medicines out of the reach of children.

General information about dextroamphetamine sulfate extended-release capsules

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use dextroamphetamine sulfate extended-release capsules for a condition for which it was not prescribed. Do not give dextroamphetamine sulfate extended-release capsules 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 extended-release capsules. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about dextroamphetamine sulfate extended-release capsules that was written for healthcare professionals. For more information about dextroamphetamine sulfate extended-release capsules, please contact Zydus Pharmaceuticals USA, Inc. at 1-877-993-8779 or visit www.zydus.com.

What are the ingredients in dextroamphetamine sulfate extended-release capsules?

Active Ingredient: Dextroamphetamine sulfate

Inactive Ingredients:

Inactive ingredients common to all strengths are dibutyl sebacate, ethylcellulose, oleic acid, povidone, silicon dioxide, starch, sucrose, and talc. Inactive ingredients common to all capsules are D&C Yellow 10, FD&C Blue 1, FD&C Red 40, gelatin, sodium lauryl sulfate and titanium dioxide. Each capsule is printed with black ink, which includes black iron oxide, potassium hydroxide, propylene glycol, and shellac.

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

Manufactured by:

Nesher Pharmaceuticals USA) LLC

St. Louis, MO 63044

Distributed by:

Zydus Pharmaceuticals USA Inc.

Pennington, NJ 08534

P10281-4

01/2019

For additional copies of the printed patient information/medication guide, please visit www.zydus.com or call 1-877-993-8779.

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