Dextroamphetamine sulfate tablets are indicated in Narcolepsy and Attention Deficit Disorder with Hyperactivity as an integral part of a total treatment program that typically includes other remedial measures.
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.
Endocrine: Impotence, changes in libido.
Dextroamphetamine sulfate tablets are 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.
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.
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, DextroStat® (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 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.
DextroStat® (dextroamphetamine sulfate) Tablets are available as follows:
5 mg Yellow, Round, Scored Tablet debossed “RP” on one side and “51″ on the other side.
NDC #: 54092-448-01 for 100s
10 mg Yellow, Round, Double-Scored tablet debossed “RP” on one side and “52″ on the other side.
NDC #: 54092-452-01 for 100s
Dispense in a tight container as defined in the USP.
Store at 25° C (77° F) excursions 15-30° C (59-86° F). [See USP Controlled Room Temperature]
DEA Order Form Required.
Pharmacist: Medication Guide to be dispensed to patients.
Shire US Inc.
725 Chesterbrook Blvd.
Wayne, PA 19087
Made in USA
©2007, Shire US Inc.
448 0107 005
Rev. 10/07 005344
Read the Medication Guide that comes with DEXTROSTAT® 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 DEXTROSTAT®.
|What is the most important information I should know about DEXTROSTAT®? |
The following have been reported with use of DEXTROSTAT® 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 DEXTROSTAT®.
Your doctor should check you or your child’s blood pressure and heart rate regularly during treatment with DEXTROSTAT®
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 DEXTROSTAT®.
2. Mental (Psychiatric) problems:
• 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 has any new or worsening mental symptoms or problems while taking DEXTROSTAT®, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.
What Is DEXTROSTAT®?
DEXTROSTAT® is a central nervous system stimulant prescription medicine. It is used for the treatment of Attention Deficit Hyperactivity Disorder(ADHD). DEXTROSTAT® may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
DEXTROSTAT® should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.
DEXTROSTAT® is also used in the treatment of a sleep disorder called narcolepsy.
|DEXTROSTAT® is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep DEXTROSTAT® in a safe place to prevent misuse and abuse. Selling or giving away DEXTROSTAT® 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 DEXTROSTAT®?
DEXTROSTAT® 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
DEXTROSTAT® is not recommended for use in children less than 3 years old.
DEXTROSTAT® may not be right for you or your child. Before starting DEXTROSTAT® 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 DEXTROSTAT® be taken with other medicines?
Tell your doctor about all of the medicines that you or your child takes including prescription and non-prescription medicines, vitamins, and herbal supplements. DEXTROSTAT® 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 DEXTROSTAT®.
Your doctor will decide whether DEXTROSTAT® can be taken with other medicines.
Especially tell your doctor if you or your child takes:
• Anti-depression medicines including MAOIs
• Blood pressure medicines
• 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 DEXTROSTAT® without talking to your doctor first.
How should DEXTROSTAT® be taken?
• Take DEXTROSTAT® exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.
• DEXTROSTAT® tablets are usually taken two to 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 DEXTROSTAT® treatment for a while to check ADHD symptoms.
• Your doctor may do regular checks of the blood, heart, and blood pressure while taking DEXTROSTAT®. Children should have their height and weight checked often while taking DEXTROSTAT®. DEXTROSTAT® treatment may be stopped if a problem is found during these check-ups.
If you or your child takes too much DEXTROSTAT® or overdoses, call your doctor or poison control center right away, or get emergency treatment.
What are possible side effects of DEXTROSTAT®?
See “What is the most important information I should know about DEXTROSTAT®?” 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
• Trouble sleeping
• Stomach upset
• Dry mouth
• Decreased appetite
• Weight loss
DEXTROSTAT® may affect you 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.
How should I store DEXTROSTAT®?
• Store DEXTROSTAT® Tablets in a safe place at room temperature, 59 to 86° F (15 to 30° C).
• Keep DEXTROSTAT® and all medicines out of the reach of children.
General information about DEXTROSTAT®
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use DEXTROSTAT® for a condition for which it was not prescribed. Do not give DEXTROSTAT® 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 DEXTROSTAT®. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about DEXTROSTAT® that was written for healthcare professionals. For more information about DEXTROSTAT®, you may also contact Shire Pharmaceuticals (the maker of DEXTROSTAT®) at 1-800-828-2088 or visit the website at http://www.shire.com
What are the ingredients in DEXTROSTAT®?
Active Ingredients: dextroamphetamine sulphate
Inactive Ingredients: acacia, corn starch, lactose monohydrate, magnesium stearate, sucrose. 10 mg tablet contains sodium starch glycolate. 5 mg and 10 mg tablets contain FD&C Yellow #5 (tartrazine).
Manufactured for Shire US Inc., Wayne, PA 19087.
©2007 Shire US Inc.
448 0110 002 005343
This Medication Guide has been approved by the U.S. Food and Drug Administration.
| DEXTROSTAT |
dextroamphetamine sulfate tablet
| DEXTROSTAT |
dextroamphetamine sulfate tablet
|Labeler — Shire US Inc.|
Revised: 07/2008 Shire US Inc.