Dextroamphetamine Sulfate 5 mg/5mL
dextroamphetamine sulfate · SOLUTION · Prasco Laboratories
Dextroamphetamine Sulfate is a solution containing dextroamphetamine sulfate at 5 mg/5mL, taken oral. Manufactured by Prasco Laboratories.
Key Facts
- Brand Name
- Dextroamphetamine Sulfate
- Generic Name
- dextroamphetamine sulfate
- NDC Code (Product)
66993-359- Manufacturer
- Prasco Laboratories
- Strength
- 5 mg/5mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule II (Controlled)
- Application #
- ANDA040776
- Marketing Start
- 05/15/2014
Recall History
Teva Pharmaceuticals USA
Some bottles may contain mixed strengths of the product.
Actavis Elizabeth LLC
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Actavis Elizabeth LLC
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Amerisource Health Services
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Amerisource Health Services
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Actavis Inc
Failed Dissolution Specifications
Amerisource Health Services
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Amerisource Health Services
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Granules Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications:
Azurity Pharmaceuticals, Inc.
Labeling: Label Mix-up
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Amphetamine Product) 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 listener; 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 fo…
Dosage & Administration
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. Attention Deficit Hyperactivity Disorder Not recommended for children under 3 years of age. In children 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 children 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. Prior to treating patients with DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE ANDAMPHETAMIN…
Warnings
WARNINGS Abuse, Misuse, and Addiction DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS has a high potential for abuse and misuse. which can lead to the development of a substance use disorder, including addiction. DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS can be diverted for non-medical use into illicit channels or distribution [see DRUG ABUSE and DEPENDENCE: Abuse]. Misuse and abuse of CNS stimulants, including DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS, can result in overdose and death [see OVERDOSAGE], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks and proper disposal of any unused drug. Advise patients to store amphetamine sulfate in a safe place, preferably locked, and in…
Contraindications
CONTAINDICATIONS In patients known to be hypersensitive to amphetamine, or other components of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products [see ADVERSE REACTIONS ]. Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis [see WARNINGS and DRUG INTERACTIONS ].
Drug Interactions
Drug Interactions MAO Inhibitors Concomitant use of MAOIs and CNS stimulants can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure. Do not administer DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS concomitantly or within 14 days after discontinuing MAOI [see CONTRAINDICATIONS and WARNINGS ]. Serotonergic Drugs The concomitant use of DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS and serotonergic drugs increases the risk of serotonin syndrome. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS initiation or dosage increase. If serotonin syndrome occurs, discontinue DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS and the concomitant serotonergic drug(s) [see WARNINGS and PRECAUTIONS ]. CYP2…
Adverse Reactions
ADVERSE REACTIONS Cardiovascular Palpitations, tachycardia, elevation of blood pressure, sudden death, myocardial infarction. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use. Central Nervous System Psychotic episodes at recommended doses, overstimulation, restlessness, irritability, euphoria, dyskinesia, dysphoria, depression, tremor, tics, aggression, anger, logorrhea, dermatillomania. Eye Disorders Vision blurred, mydriasis. Gastrointestinal Dryness of the mouth, unpleasant taste, diarrhea, constipation, intestinal ischemia and other gastrointestinal disturbances. Anorexia and weight loss may occur as undesirable effects. Allergic Urticaria, rash, hypersensitivity reactions including angioedema and anaphylaxis. Serious skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported. Endocrine Impotence, changes in libido, frequent or prolonged erections. Skin Alopecia. Musculoskeletal Rhabdomyolysis.
Frequently Asked Questions
What is Dextroamphetamine Sulfate used for?
Dextroamphetamine Sulfate contains dextroamphetamine sulfate. It is a solution taken oral. Consult your doctor for specific uses.
Is Dextroamphetamine Sulfate a controlled substance?
Yes, Dextroamphetamine Sulfate is classified as CII under the DEA Controlled Substances Act.
What is the generic name for Dextroamphetamine Sulfate?
The generic name for Dextroamphetamine Sulfate is dextroamphetamine sulfate. There are 9 other brand versions of dextroamphetamine sulfate.
What is the NDC code for Dextroamphetamine Sulfate 5 mg/5mL?
The NDC (National Drug Code) for Dextroamphetamine Sulfate 5 mg/5mL is 66993-359, listed by Prasco Laboratories.
Other Dextroamphetamine Sulfate Dosages
Other Dextroamphetamine Brands
See all →- DEXTROAMPHETAMINE SULFATE10 mg/172162-1234
- DEXTROAMPHETAMINE SULFATE5 mg/10406-8958
- Dextroamphetamine Sulfate Extended-Release5 mg/10406-8960
- Dextroamphetamine Sulfate Extended-Release15 mg/10406-8962
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate1.25 mg/10527-0790
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate7.5 mg/10527-0795
- Zenzedi10 mg/124338-853
- dextroamphetamine sulfate5 mg/145963-303
- MYDAYIS3.125 mg/154092-468
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)