DEXTROAMPHETAMINE SACCHARATE,
AMPHETAMINE ASPARTATE MONOHYDRATE,
DEXTROAMPHETAMINE SULFATE AND
AMPHETAMINE SULFATE TABLETS
CII
5 mg, 10 mg, 20 mg and 30 mg
(Mixed Salts of a Single-Entity Amphetamine Product)
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.
MISUSE OF AMPHETAMINE MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.
MISUSE OF AMPHETAMINE MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.
DESCRIPTION
Amphetamines are sympathomimetic amines. A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate monohydrate.
In addition, each tablet for oral administration contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch.
Colors: 5 mg and 10 mg tablets contain FD&C Blue #2 Aluminum Lake
20 mg and 30 mg tablets contain D&C Red #27 Aluminum Lake as a color additive
| EACH TABLET CONTAINS: | 5 mg | 10 mg | 20 mg | 30 mg |
| Dextroamphetamine | ||||
| Saccharate……………………………... | 1.25 mg | 2.5 mg | 5 mg | 7.5 mg |
| Amphetamine | ||||
| Aspartate Monohydrate ……...……….. | 1.25 mg | 2.5 mg | 5 mg | 7.5 mg |
| Dextroamphetamine | ||||
| Sulfate USP…………………………. | 1.25 mg | 2.5 mg | 5 mg | 7.5 mg |
| Amphetamine | ||||
| Sulfate USP………………………….... | 1.25 mg | 2.5 mg | 5 mg | 7.5 mg |
| Total amphetamine | ||||
| base equivalence ……………………… | 3.13 mg | 6.3 mg | 12.6 mg | 18.8 mg |
Colors: 5 mg and 10 mg tablets contain FD&C Blue #2 Aluminum Lake
20 mg and 30 mg tablets contain D&C Red #27 Aluminum Lake as a color additive
CLINICAL PHARMACOLOGY
Pharmacodynamics
Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The mode of therapeutic action in Attention Deficit Hyperactivity Disorder (ADHD) is not known. Amphetamines are thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.
Pharmacokinetics
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets contain d-amphetamine and l-amphetamine salts in the ratio of 3:1. Following administration of a single dose 10 or 30 mg of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets to healthy volunteers under fasted conditions, peak plasma concentrations occurred approximately 3 hours post-dose for both d-amphetamine and l-amphetamine. The mean elimination half-life (t1/2) for d-amphetamine was shorter than the t1/2 of the l-isomer (9.77-11 hours vs. 11.5-13.8 hours). The PK parameters (Cmax, AUC0-inf) of d-and l-amphetamine increased approximately three-fold from 10 mg to 30 mg indicating dose-proportional pharmacokinetics.
The effect of food on the bioavailability of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate has not been studied.
The effect of food on the bioavailability of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate has not been studied.
INDICATIONS AND USAGE
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.
Attention Deficit Hyperactivity Disorder (ADHD)
A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV®) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor ulener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; "on the go;" excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.
CONTRAINDICATIONS
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.)
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.)
WARNINGS
Serious Cardiovascular Events
Sudden Death and Pre-existing Structural Cardiac Abnormalities or Other Serious Heart Problems
Psychiatric Adverse Events
Long-Term Suppression of Growth
Careful follow-up of weight and height in children ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturaulic subgroups of newly methylphenidate-treated and non-medication treated children over 36 months (to the ages of 10 to 13 years), suggests that consistently medicated children (i.e., treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development. Published data are inadequate to determine whether chronic use of amphetamines may cause a similar suppression of growth, however, it is anticipated that they will likely have this effect as well. Therefore, growth should be monitored during treatment with stimulants, and patients who are not growing or gaining weight as expected may need to have their treatment interrupted.
Seizures
There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizure, in patients with prior EEG abnormalities in absence of seizures, and very rarely, in patients without a history of seizures and no prior EEG evidence of seizures. In the presence of seizures, the drug should be discontinued.
Visual Disturbance
Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.
PRECAUTIONS
Geriatric Use: Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets have not been studied in the geriatric population.
ADVERSE REACTIONS
DRUG ABUSE AND DEPENDENCE
Dextroamphetamine sulfate, amphetamine sulfate, amphetamine aspartate monohydrate, and dextroamphetamine saccharate are 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 higher than 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.
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 higher than 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.
OVERDOSAGE
Individual patient response to amphetamines varies widely. Toxic symptoms may occur idiosyncratically at low doses.
DOSAGE AND ADMINISTRATION
Regardless of indication, amphetamines should be administered at the lowest effective dosage and dosage should be individually adjusted according to the therapeutic needs and response of the patient. Late evening doses should be avoided because of the resulting insomnia.
HOW SUPPLIED
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets 5 mg, 10 mg, 20 mg, and 30 mg.
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets 5 mg: Blue, round, compressed tablets, debossed cor over 130 on one side and Quadrisect on the other side.
In bottles of 100 tablets (NDC 64720-130-10)
In bottles of 500 tablets (NDC 64720-130-50)
In bottles of 1000 tablets (NDC 64720-130-11)
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets 10 mg: Blue, round, compressed tablets, debossed cor over 132 on one side and Quadrisect on the other side.
In bottles of 100 tablets (NDC 64720-132-10)
In bottles of 500 tablets (NDC 64720-132-50)
In bottles of 1000 tablets (NDC 64720-132-11)
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets 20 mg: Pink, round, compressed tablets, debossed cor over 135 on one side and Quadrisect on the other side.
In bottles of 100 tablets (NDC 64720-135-10)
In bottles of 500 tablets (NDC 64720-135-50)
In bottles of 1000 tablets (NDC 64720-135-11)
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets 30 mg: Pink, round, compressed tablets, debossed cor over 136 on one side and Quadrisect on the other side.
In bottles of 100 tablets (NDC 64720-136-10)
In bottles of 500 tablets (NDC 64720-136-50)
In bottles of 1000 tablets (NDC 64720-136-11)
Dispense in a tight, light-resistant container as defined in the USP.
Store at 20° - 25°C (68° - 77°F). (See USP Controlled Room Temperature).
Protect from moisture.
MF # 177-01
Rev. June 2007
Manufactured and Distributed by:
Corepharma LLC
Middlesex, NJ 08846
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets 5 mg: Blue, round, compressed tablets, debossed cor over 130 on one side and Quadrisect on the other side.
In bottles of 100 tablets (NDC 64720-130-10)
In bottles of 500 tablets (NDC 64720-130-50)
In bottles of 1000 tablets (NDC 64720-130-11)
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets 10 mg: Blue, round, compressed tablets, debossed cor over 132 on one side and Quadrisect on the other side.
In bottles of 100 tablets (NDC 64720-132-10)
In bottles of 500 tablets (NDC 64720-132-50)
In bottles of 1000 tablets (NDC 64720-132-11)
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets 20 mg: Pink, round, compressed tablets, debossed cor over 135 on one side and Quadrisect on the other side.
In bottles of 100 tablets (NDC 64720-135-10)
In bottles of 500 tablets (NDC 64720-135-50)
In bottles of 1000 tablets (NDC 64720-135-11)
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets 30 mg: Pink, round, compressed tablets, debossed cor over 136 on one side and Quadrisect on the other side.
In bottles of 100 tablets (NDC 64720-136-10)
In bottles of 500 tablets (NDC 64720-136-50)
In bottles of 1000 tablets (NDC 64720-136-11)
Dispense in a tight, light-resistant container as defined in the USP.
Store at 20° - 25°C (68° - 77°F). (See USP Controlled Room Temperature).
Protect from moisture.
MF # 177-01
Rev. June 2007
Manufactured and Distributed by:
Corepharma LLC
Middlesex, NJ 08846
Medication Guide for Dextroamphetamine Saccharte, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets CII
(DEX-troe-am-FET-uh-meen SACK-uh-rate/ am-FET-uh-meen ass-PAR-tate MAH-no-HIGH-drate/ DEX-troe-am-FET-uh-meen SULL-fate/ am-FET-uh-meen SULL-fate)
Read the Medication Guide that comes with Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Amphetamine Salts 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 Mixed Amphetamine Salts Tablets.
What are mixed amphetamine salts?
Mixed amphetamine salts are central nervous system stimulant prescription medicine. They are used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Mixed amphetamine salts may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
Mixed amphetamine salts should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.
Mixed amphetamine salts are also used in the treatment of a sleep disorder called narcolepsy.
Who should not take mixed amphetamine salts?
Mixed amphetamine salts should not be taken if you or your child:
Mixed amphetamine salts may not be right for you or your child. Before starting mixed amphetamine salts tell your or your child’s doctor about all health conditions (or a family history of) including:
Can Mixed Amphetamine Salts Tablets be taken with other medicines?
Tell your doctor about all of the medicines that you or child take including prescription and nonprescription medicines, vitamins, and herbal supplements.
Mixed amphetamine salts 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 mixed amphetamine salts.
Your doctor will decide whether mixed amphetamine salts can be taken with other medicines.
Especially tell your doctor if you or your child takes:
Do not start any new medicine while taking mixed amphetamine salts without talking to your doctor first.
How should Mixed Amphetamine Salts Tablets be taken?
See “What is the most important information I should know about mixed amphetamine salts?”for information on reported heart and mental problems.
Other serious side effects include:
Talk to your doctor if you or your child has side effects that are bothersome or do not give away.This is not a complete ul of possible side effects. Ask your doctor or pharmacist for more information.
How should I store Mixed Amphetamine Salts Tablets?
Medicines are sometimes prescribed for purpose other than those uled in a Medication Guide. Do not use mixed amphetamine salts for a condition for which it was not prescribed. Do not give mixed amphetamine salts to other people, even if they have the same condition. It may harm them and it against the law.
This Medication Guide summarizes the most important information about mixed amphetamine salts. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about mixed amphetamine salts that was written for healthcare professionals. For more information, you may also contact Corepharma (the maker of Mixed Amphetamine Salts) at 1-800-850-2719.
What are the ingredients in Mixed Amphetamines Salts Tablets?
Active Ingredients:dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate USP, and amphetamine sulfate USP.
Inactive Ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch.
Colors: Mixed Amphetamine Salts Tablets 5 mg and 10 mg contain FD&C Blue #2 Aluminum Lake
Mixed Amphetamine Salts Tablets 20 mg and 30 mg contain D&C Red #27 Aluminum Lake as a color additive.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
MF# 593-01
Rev. June 2007
| What is the most important information I should know about mixed amphetamine salts? The following have been reported with use of mixed amphetamine salts and other stimulant medicines. 1. Heart –related problems:
Your doctor should check you or your child carefully for heart problems before starting mixed amphetamine salts. Your doctor should check you or your child’s blood pressure and heart rate regularly during treatment with mixed amphetamine salts. 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 Mixed Amphetamine Salts Tablets. 2. Mental (Psychiatric) problems: All Patients
Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking Mixed Amphetamine Salts Tablets, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious. |
Mixed amphetamine salts are central nervous system stimulant prescription medicine. They are used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Mixed amphetamine salts may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
Mixed amphetamine salts should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.
Mixed amphetamine salts are also used in the treatment of a sleep disorder called narcolepsy.
| Mixed amphetamine salts are a federally controlled substance (CII) because they can be abused or lead to dependence. Keep Mixed Amphetamine Salts Tablets in a safe place to prevent misuse and abuse. Selling or giving away Mixed Amphetamine Salts 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. |
Mixed amphetamine salts 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
Mixed amphetamine salts may not be right for you or your child. Before starting mixed amphetamine salts 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)
Can Mixed Amphetamine Salts Tablets be taken with other medicines?
Tell your doctor about all of the medicines that you or child take including prescription and nonprescription medicines, vitamins, and herbal supplements.
Mixed amphetamine salts 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 mixed amphetamine salts.
Your doctor will decide whether mixed amphetamine salts can be taken with other medicines.
Especially tell your doctor if you or your child takes:
- anti-depression medicines including MAOIs
- seizure medicines
- blood thinner medicines
- blood pressure medicines
- stomach acid medicines
- cold or allergy medicines that contain decongestants
Do not start any new medicine while taking mixed amphetamine salts without talking to your doctor first.
How should Mixed Amphetamine Salts Tablets be taken?
- Take Mixed Amphetamine Salts Tablets exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.
- Mixed Amphetamine Salts Tablets are usually taken two to three times a day. The first dose is usually taken when you first wake in the morning. One or two more doses may be taken during the day, 4 to 6 hours apart.
- Mixed Amphetamine Salts Tablets can be taken with or without food.
- From time to time, your doctor may stop mixed amphetamine salts treatment for a while to check ADHD symptoms.
- Your doctor may do regular checks of the blood, heart, and blood pressure while taking mixed amphetamine salts. Children should have their height and weight checked often while taking mixed amphetamine salts. Mixed amphetamine salt treatment may be stopped if a problem is found during these check-ups.
- If you or your child takes too much mixed amphetamine salt or overdoses, call your doctor or poison control center right away, or get emergency treatment.
See “What is the most important information I should know about mixed amphetamine salts?”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
- headache
- stomach ache
- trouble sleeping
- decreased appetite
- nervousness
- dizziness
Talk to your doctor if you or your child has side effects that are bothersome or do not give away.This is not a complete ul of possible side effects. Ask your doctor or pharmacist for more information.
How should I store Mixed Amphetamine Salts Tablets?
- Store in a safe place at 20° - 25° C (68° - 77° F). (See USP Controlled Room Temperature).
- Protect from moisture.
- Keep Mixed Amphetamine Salt Tablets and all medicines out of the reach of children.
Medicines are sometimes prescribed for purpose other than those uled in a Medication Guide. Do not use mixed amphetamine salts for a condition for which it was not prescribed. Do not give mixed amphetamine salts to other people, even if they have the same condition. It may harm them and it against the law.
This Medication Guide summarizes the most important information about mixed amphetamine salts. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about mixed amphetamine salts that was written for healthcare professionals. For more information, you may also contact Corepharma (the maker of Mixed Amphetamine Salts) at 1-800-850-2719.
What are the ingredients in Mixed Amphetamines Salts Tablets?
Active Ingredients:dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate USP, and amphetamine sulfate USP.
Inactive Ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch.
Colors: Mixed Amphetamine Salts Tablets 5 mg and 10 mg contain FD&C Blue #2 Aluminum Lake
Mixed Amphetamine Salts Tablets 20 mg and 30 mg contain D&C Red #27 Aluminum Lake as a color additive.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
MF# 593-01
Rev. June 2007
