DEXTROAMPHETAMINE SULFATE TABLETS, USP
5 mg and 10 mg

CII

Rx only

AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE AND MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NON-THERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUGS SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY.

Dextroamphetamine sulfate is the dextro isomer of the compound d,l-amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha-methylphenethylamine, and is present in all forms of Dextroamphetamine Sulfate Tablets, USP as the neutral sulfate. It has the chemical formula of (C₉H₁₃N)₂• H₂SO₄ and a molecular weight of 368.49.

Structural Formula:

Each tablet, for oral administration, contains dextroamphetamine sulfate USP, 5 mg or 10 mg. Each tablet also contains the following inactive ingredients: Microcrystalline Cellulose, Povidone, Silicon Dioxide, and Stearic Acid.

Amphetamines are non-catecholamine, sympathomimetic amines with CNS stimulant activity. Peripheral actions include elevations of systolic and diastolic blood pressures and weak bronchodilator and respiratory stimulant action.

There is neither specific evidence which clearly establishes the mechanism whereby amphetamines produce mental and behavioral effects in children, nor conclusive evidence regarding how these effects relate to the condition of the central nervous system.

Dextroamphetamine sulfate tablets are indicated:

• In Narcolepsy
• In Attention Deficit Disorder with Hyperactivity, as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.

Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma.

Agitated states.

Patients with a history of drug abuse.

During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result).

• Amphetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening.
• Amphetamines may interfere with urinary steroid determinations.

Dextroamphetamine sulfate tablets 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.

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.

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.

Each Dextroamphetamine Sulfate Tablet, USP (5 mg) contains dextroamphetamine sulfate 5 mg. It is available as triangle shaped, white to off white tablet debossed with a number “5” and a bisect on one side and an “M” in a box on the other.

•  Bottles of 100 ........................NDC 0406-8958-01

Each Dextroamphetamine Sulfate Tablet, USP (10 mg) contains dextroamphetamine sulfate 10 mg. It is available as diamond shaped, white to off white tablet debossed with a number “10” and a partial quadrisect on one side and an “M” in a box on the other.

•  Bottles of 100 ........................NDC 0406-8959-01

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

Dispense in well-closed containers with a child-resistant closure as defined in the USP.

DEA Order Form Required.

Mallinckrodt Inc.
St. Louis, Missouri 63134, U.S.A.

tyco

Healthcare

Mallinckrodt

Rev 030907

CII

Dextroamphetamine Sulfate Tablets USP

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 your or your child's treatment with dextroamphetamine sulfate tablets.

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.

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 antidepression 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
• liver or kidney problems
• 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 nonprescription 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 takes:

• antidepression medicines including MAOIs
• blood pressure medicines
• antacids
• seizure medicines

Know the medicines that you or your child takes. Keep a ul 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 awhile 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 tablet treatment may be stopped if a problem is found during these check-ups.
• If you or your child takes 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

Common side effects include:

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 has side effects that are bothersome or do not go away.

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

How should I store Dextroamphetamine Sulfate Tablets?

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

General information about Dextroamphetamine Sulfate Tablets

Medicines are sometimes prescribed for purposes other than those uled in a Medication Guide. Do not use dextroamphetamine sulfate tablets for a condition for which it was 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, or you can visit www.Mallinckrodt.com or call 1-888-744-1414, option 2, then 1 between the hours of 7 am and 5 pm CST.

What are the ingredients in Dextroamphetamine Sulfate Tablets?

Active Ingredient: dextroamphetamine sulfate USP

Inactive Ingredients: Microcrystalline Cellulose, Povidone, Silicon Dioxide, and Stearic Acid.

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

Mallinckrodt Inc.

St. Louis, Missouri 63134, U.S.A.

tyco
Healthcare

Mallinckrodt

Rev 030907