Amphetamine Sulfate 10 mg Tablet, 100-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Central Nervous System Stimulant class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Amphetamine (Adzenys® ER, Adzenys® XR, Dyanavel® XR, Evekeo®, Evekeo® ODT, others) is used as part of a treatment program to control symptoms of attention deficit hyperactivity disorder (ADHD; more difficulty focusing, controlling actions, and remaining still or quiet than other people who are the same age) in adults and children. Amphetamine (Evekeo®, others) is also used to treat narcolepsy (a sleep disorder that causes excessive daytime sleepiness and sudden attacks of sleep). Amphetamine (Evekeo®, others) is also used for a limited period of time (a few weeks) along with a reduced calorie...
Read the full MedlinePlus article ↗- It depends on the specific product. Most amphetamine products — including Adzenys XR-ODT, Dyanavel XR, and the extended-release orally disintegrating tablets — are approved to trea...
- What conditions is amphetamine actually approved to treat?
- You can take most amphetamine products with or without food — it won't meaningfully change how much you absorb. That said, eating (especially a high-fat meal) can delay when it kic...
- Is it okay to take this with food, or does it have to be on an empty stomach?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Amphetamine Sulfate — tap one for details:
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 2S7830E561
Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
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UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
4 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.652 | $65.24 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Amphetamine Sulfate 10 mg 00406-1220-01 | SpecGx | 100 tablets | $0.409 | AA | FDA listed | save 37% |
| Amphetamine Sulfate 10 mg 00527-2525-37 | Lannett | 100 tablets | $0.427 | AA | Availability likely | save 35% |
| Amphetamine Sulfate 10 mg 43547-0458-10 | Solco | 100 tablets | $0.427 | AA | Availability likely | save 35% |
| Amphetamine sulfate 10 mg 43598-0898-01 | DR. | 100 tablets | $0.427 | AA | Availability likely | save 35% |
| Amphetamine Sulfate 10 mg 69238-1564-01 | Amneal | 100 tablets | $0.427 | AA | Availability likely | save 35% |
| Amphetamine Sulfate 10 mg 70010-0041-01 | Granules | 100 tablets | $0.427 | AA | Availability likely | save 35% |
| Amphetamine Sulfate 10 mgthis 52536-0059-10 | Wilshire | 100 tablets | $0.652 | AA | Discontinued | — |
| Evekeo 10 mg 24338-0026-03 | Azurity | 30 tablets | $7.690 | AA | Availability likely | +1079% |
| Amphetamine Sulfate 10 mg 13107-0260-01 | Aurolife | 100 tablets | — | AA | FDA listed | — |
| Amphetamine Sulfate 10 mg 42806-0030-01 | Epic | 100 tablets | — | AA | FDA listed | — |
| Amphetamine Sulfate 10 mg 63629-1114-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
| Amphetamine Sulfate 10 mg 63629-2078-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
| Amphetamine Sulfate 10 mg 63629-2498-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
| Amphetamine Sulfate 10 mg 71335-2990-01 | Bryant | 120 tablets | — | AA | FDA listed | — |
| Amphetamine Sulfate 10 mg 72162-1088-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
| Amphetamine Sulfate 10 mg 72162-1369-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
| Amphetamine Sulfate 10 mg 72162-1613-03 | Bryant | 30 tablets | — | AA | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
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Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 52536-0059-03 | 30 TABLET in 1 BOTTLE (52536-059-03) | $0.4270 / ea | $12.81 | 2021-01-07 | Active |
| 52536-0059-10 You're viewing this | 100 TABLET in 1 BOTTLE (52536-059-10) | $0.6524 / ea | $65.24 | 2018-03-29 | Discontinued by firm |
You're viewing the largest of 2 pack sizes for this product.
Per ea, this pack runs about 53% above the cheapest pack (30-count, $0.4270 vs $0.6524 NADAC).
Pack size FAQ
What quantity is in NDC 52536-0059-10?
What is the difference between NDC 52536-0059-10 and NDC 52536-0059-03?
What NDC number is used to bill for this package of Amphetamine Sulfate 10 mg Tablet?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | ✓ Available |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: ABUSE, MISUSE, AND ADDICTION Amphetamines have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including amphetamine sulfate, 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 amphetamine sulfate, assess each patient’s risk for abuse, misuse, and addiction.
Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout amphetamine sulfate treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction (see WARNINGS and DRUG ABUSE AND DEPENDENCE ).
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Amphetamine Sulfate Tablets, USP, are indicated for: Narcolepsy 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 children with 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 the 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 not be warranted. Exogenous Obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patient's refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs. The limited usefulness of amphetamines (see CLINICAL PHARMACOLOGY ) should be weighed against possible risks inherent in use of the drug, such as those described below.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Regardless of indication, amphetamine should be administered at the lowest effective dosage and dosage should be individually adjusted. Late evening doses should be avoided because of resulting insomnia. Narcolepsy Usual dose is 5 to 60 milligrams 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, Amphetamine Sulfate Tablets 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 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 optimal response is obtained.
If bothersome adverse reactions appear (e.g., insomnia or anorexia) dosage should be reduced. Give the first dose on awakening; additional doses (5 or 10 mg) at intervals of 4 to 6 hours. Attention Deficit Disorder with Hyperactivity 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 or 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 milligrams per day.
With tablets give first dose on awakening; additional doses (1 to 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 Amphetamine Sulfate Tablets assess: for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) (see WARNINGS ). the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome (see WARNINGS ).
Exogenous Obesity Usual dosage is up to 30 mg daily, taken in divided doses of 5 to 10 mg, 30 to 60 minutes before meals. Not recommended for this use in children under 12 years of age.
⛔ Contraindications ▾
CONTRAINDICATIONS Known hypersensitivity to amphetamine products. During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result) (see WARNINGS ).
⚠️ Warnings ▾
WARNINGS Abuse, Misuse, and Addiction Amphetamines have a high potential for abuse and misuse. The use of amphetamines exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Amphetamine Sulfate can be diverted for non-medical use into illicit channels or distribution (see DRUG ABUSE and DEPENDENCE ).
Misuse and abuse of CNS stimulants, including amphetamines, 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 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 Tablets in a safe place, preferably locked, and instruct patients to not give Amphetamine Sulfate Tablets to anyone else. Throughout Amphetamine Sulfate treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction. Risks to Patients with Serious Cardiac Disease.
Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who are treated with CNS stimulants at the recommended ADHD dosages. Avoid Amphetamine Sulfate Tablets use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease. Increased Blood Pressure and Heart Rate CNS stimulants cause an increase in blood pressure (mean increase about 2 to 4 mm Hg) and heart rate (mean increase about 3 to 6 bpm).
Monitor all patients for potential tachycardia and hypertension. Psychiatric Adverse Reactions Exacerbation of Pre-Existing Psychosis CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder. Induction of a Manic Episode in Patients with Bipolar Disorder CNS stimulants may induce a manic or mixed episode in patients.
Prior to initiating Amphetamine Sulfate Tablets, screen patients for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, or depression). New Psychotic or Manic Symptoms CNS stimulants, at recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania. In a pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic or manic symptoms occurred in approximately 0.1% of CNS stimulant-treated patients, compared with 0% of placebo-treated patients.
If such symptoms occur, consider discontinuing Amphetamine Sulfate Tablets. Long-Term Suppression of Growth in Pediatric Patients CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Closely monitor growth (weight and height) in amphetamine sulfate-treated pediatric patients treated with CNS stimulants.
Pediatric patients not growing or gaining height or weight as expected may need to have their treatment interrupted (see PRECAUTIONS , PEDIATRIC USE ). Seizures There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizures, 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.
Peripheral Vasculopathy, including Raynaud’s phenomenon Stimulants, including Amphetamine Sulfate Tablets, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS: 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 verbal tics and Tourette’s syndrome.
Gastrointestinal Dryness of the mouth, unpleasant taste, diarrhea, constipation, intestinal ischemia, and other gastrointestinal disturbances. Anorexia and weight loss may occur as undesirable effects when amphetamines are used for other than the anorectic effect. Allergic Urticaria Endocrine Impotence, changes in libido, and frequent or prolonged erections.
Musculoskeletal Rhabdomyolysis
🔄 Drug Interactions ▾
Drug Interactions MAO inhibitors - MAOI antidepressants, as well as a metabolic of furazolidone, slow amphetamine metabolism. This slowing potentiates amphetamines, increasing their effect on the release of norepinephrine and other monoamines from adrenergic nerve endings; this can cause headaches and other signs of hypertensive crisis. A variety of neurological toxic effects and malignant hyperpyrexia can occur, sometimes with fatal results.
Serotonergic Drugs- The concomitant use of 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 Amphetamine Sulfate Tablets initiation or dosage increase. If serotonin syndrome occurs, discontinue Amphetamine Sulfate Tablets and the concomitant serotonergic drug(s) (see WARNING and PRECAUTIONS ).
CYP2D6 Inhibitors - The concomitant use of Amphetamine Sulfate Tablets and CYP2D6 inhibitors may increase the exposure of Amphetamine Sulfate Tablets compared to the use of the drug alone and increase the risk of serotonin syndrome. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome particularly during Amphetamine Sulfate Tablets initiation and after a dosage increase. If serotonin syndrome occurs, discontinue Amphetamine Sulfate Tablets and the CYP2D6 inhibitor (see WARNING , OVERDOSAGE ).
Examples of CYP2D6 Inhibitors include paroxetine and fluoxetine (also serotonergic drugs), quinidine, ritonavir. Acidifying agents - Gastrointestinal acidifying agents (guanethidine, reserpine, glutamic acid HCl, ascorbic acid, fruit juices, etc.) lower absorption of amphetamines. Urinary acidifying agents (ammonium chloride, sodium acid phosphate, etc.) increase concentration of the ionized species of the amphetamine molecule, thereby increasing urinary excretion.
Both groups of agents lower blood levels and efficacy of amphetamines. Adrenergic blockers - Adrenergic blockers are inhibited by amphetamines. Alkalinizing agents - Gastrointestinal alkalinizing agents (sodium bicarbonate, etc.) increase absorption of amphetamines.
Urinary alkalinizing agents (acetazolamide, some thiazides) increase the concentration of the non-ionized species of the amphetamine molecule, thereby decreasing urinary excretion. Both groups of agents increase blood levels and therefore potentiate the action of amphetamines. Antidepressants tricyclic - Amphetamines may enhance the activity of tricyclic or sympathomimetic agents; d-amphetamine with desipramine or protriptyline and possibly other tricyclics cause striking and sustained increases in the concentration of d- amphetamine in the brain; cardiovascular effects can be potentiated.
Antihistamine s- Amphetamines may counteract the sedative effect of antihistamines. Antihypertensives - Amphetamines may antagonize the hypotensive effects of antihypertensives. Chlorpromazine - Chlorpromazine blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant effects of amphetamine, and can be used to treat amphetamine poisoning.
Ethosuximide - Amphetamines may delay intestinal absorption of ethosuximide. Haloperidol - Haloperidol blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant effects of amphetamines. Lithium carbonate - The antiobesity and stimulatory effects of amphetamines may be inhibited by lithium carbonate.
Meperidine - Amphetamines potentiate the analgesic effect of meperidine. Methenamine therapy - Urinary excretion of amphetamines is increased, and efficacy is reduced by acidifying agents used in methenamine therapy. Norepinephrine - Amphetamines enhance the adrenergic effect of norepinephrine.
Phenobarbital - Amphetamines may delay intestinal absorption of Phenobarbital. Co-administration of phenobarbital may produce a synergistic anticonvulsant action. Phenytoin - Amphetamines may delay intestinal absorption of phenytoin; co- admini…
🔄 Drug / Laboratory Test Interactions ▾
Drug/Laboratory Test interactions Amphetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening. Amphetamines may interfere with urinary steroid determinations.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects Dextroamphetamine sulfate has been shown to have embryotoxic and teratogenic effects when administered to A/Jax mice and C57BL mice in doses approximately 41 times the maximum human dose. Embryotoxic effects were not seen in New Zealand white rabbits given the drug in doses 7 times the human dose nor in rats given 12.5 times the maximum human dose. There are no adequate and well-controlled studies in pregnant women.
Amphetamine Sulfate Tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects Infants born to mothers dependent on amphetamines have an increased risk of premature delivery and low birth weight. Also, these infants may experience symptoms of withdrawal as demonstrated by dysphoria, including agitation, and significant lassitude.
🧒 Pediatric Use ▾
Pediatric Use Long-term effects of amphetamines in children have not been well established. Amphetamines are not recommended for use as anorectic agents in children under 12 years of age, or in children under 3 years of age with Attention Deficit Disorder with Hyperactivity described under INDICATIONS AND USAGE . Clinical experience suggests that in psychotic children, administration of amphetamines may exacerbate symptoms of behavior disturbance and thought disorder.
Data is inadequate to determine whether chronic administration of amphetamines may be associated with growth inhibition; therefore growth should be monitored during treatment. Drug Treatment is not indicated in all cases of Attention Deficit Disorder with Hyperactivity and should be considered only in light of the complete history and evaluation of the child. The decision to prescribe amphetamines should depend on the physician's assessment of the chronicity and severity of the child's symptoms and their appropriateness for his/her age.
Prescription should not depend solely on the presence of one or more of the behavioral characteristics. When these symptoms are associated with acute stress reactions, treatment with amphetamines is usually not indicated.
🆘 Overdosage ▾
OVERDOSAGE Clinical Effects of Overdose Overdose of CNS stimulants is characterized by the following sympathomimetic effects: Cardiovascular effects including tachyarrhythmias, and hypertension or hypotension. Vasospasm, myocardial infarction, or aortic dissection may precipitate sudden cardiac death. Takotsubo cardiomyopathy may develop.
CNS effects including psychomotor agitation, confusion, and hallucinations. Serotonin syndrome, seizures, cerebral vascular accidents, and coma may occur. Life-threatening hyperthermia (temperatures greater than 104°F) and rhabdomyolysis may develop.
Overdose Management Consider the possibility of multiple drug ingestion. D-amphetamine is not dialyzable. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY 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. Amphetamine, as the racemic form, differs from dextroamphetamine in a number of ways.
The l-isomer is more potent than the d-isomer in cardiovascular activity, but much less potent in causing CNS excitatory effects. The racemic mixture also is less effective as an appetite suppressant when compared to dextroamphetamine. There is neither specific evidence which clearly establishes the mechanism whereby amphetamines produce mental and behavioral effects in children, nor conclusive evidence regarding how those effects relate to the condition of the central nervous system.
Drugs in this class used in obesity are commonly known as "anorectics" or "anorexigenics." It has not been established, however, that the action of such drugs in treating obesity is primarily one of appetite suppression. Other central nervous system actions or metabolic effects may be involved, for example. Adult obese subjects instructed in dietary management and treated with "anorectic" drugs lose more weight on the average than these treated with placebo and diet, as determined in relatively short-term clinical trials.
The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. The rate of weight loss is greatest in the first weeks of therapy for both drug and placebo subjects and tends to decrease in succeeding weeks. The origins of the increased weight loss due to the various possible drug effects are not established.
The amount of weight loss associated with the use of an "anorectic" drug varies from trial to trial, and the increased weight loss appears to be related in part to variables other than the drug prescribed, such as the physician-investigator, the population treated, and the diet prescribed. Studies do not permit conclusions as to the relative importance of the drug and nondrug factors on weight loss. The natural history of obesity is measured in years, whereas the studies cited are restricted to few weeks duration; thus, the total impact of drug-induced weight loss over that of diet alone must be considered clinically limited.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Amphetamine Sulfate Tablets, USP, are supplied as follows: 5 mg: White, round tablet, debossed “EVK” on one side, and “5” with a score on the other side in: Bottles of 30 tablets, NDC 52536-057-03 10 mg: Blue, round tablet, debossed “EVK” on one side, and “10” with double scores on the other side in: Bottles of 30 tablets, NDC 52536-059-03 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a well-closed container, as defined in the USP. Manufactured for: Wilshire Pharmaceuticals, Inc.
Atlanta, GA 30328 AMAG-PI-03 Rev. 11/2023
📋 Description ▾
DESCRIPTION Amphetamine Sulfate is a sympathomimetic amino of the amphetamine group. It is a white, odorless crystalline powder. It has a slightly bitter taste.
Its solutions are acid to litmus, having a pH of 5.0 to 6.0. It is freely soluble in water and slightly soluble in alcohol. Each tablet, for oral administration contains 5 mg or 10 mg of amphetamine sulfate.
Each tablet also contains the following inactive ingredients: crospovidone, silicified microcrystalline cellulose and stearic acid. The 10 mg tablet also contains FD&C Blue #1. Structural Formula: C 18 H 28 N 2 SO 4 MW 368.49 structure
💬 Medication Guide ▾
MEDICATION GUIDE Amphetamine Sulfate Tablets, USP CII (am fet' a meen sul' fate) What is the most important information I should know about Amphetamine Sulfate Tablets? Amphetamine Sulfate Tablets may cause serious side effects, including: • Abuse, misuse, and addiction. Amphetamine Sulfate Tablets have a high chance for abuse and misuse and may lead to substance use problems, including addiction.
Misuse and abuse of Amphetamine Sulfate Tablets, other amphetamine-containing medicines, and methylphenidate, can lead to overdose and death. The risk of overdose and death is increased with higher doses of Amphetamine Sulfate Tablets or when they are used in ways that are not approved, such as snorting or injection. o Your healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before starting treatment with Amphetamine Sulfate Tablets and will monitor you or your child during treatment. o Amphetamine Sulfate Tablets may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. o Do not give Amphetamine Sulfate Tablets to anyone else.
See “What are Amphetamine Sulfate Tablets?” for more information. o Keep Amphetamine Sulfate Tablets in a safe place and properly dispose of unused medicine. See “How should I store Amphetamine Sulfate Tablets?” for more information. o Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs. • Risks for people with serious heart disease. Sudden death has happened in people who have heart defects or other serious heart disease.
Your healthcare provider should check you or your child carefully for heart problems before starting Amphetamine Sulfate Tablets. Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects. Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with Amphetamine Sulfate Tablets. • Increased blood pressure and heart rate.
Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with Amphetamine Sulfate Tablets. • Mental (psychiatric) problems, including: o new or worse behavior and thought problems. o new or worse bipolar illness. o new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms. Tell your healthcare provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.
Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems during treatment with Amphetamine Sulfate Tablets, especially hearing voices, seeing or believing things that are not real, or new manic symptoms. What are Amphetamine Sulfate Tablets? Amphetamine Sulfate Tablets are a central nervous system (CNS) stimulant prescription medicines used for the treatment of: • a sleep disorder called narcolepsy. • Attention Deficit Hyperactivity Disorder (ADHD).
Amphetamine Sulfate Tablets may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD. • exogenous obesity. Amphetamine Sulfate Tablets may be used as part of a short term (a few weeks) weight reduction program for obesity in people who have not responded to other treatment. Amphetamine Sulfate Tablets are not for use in children with ADHD under 3 years of age.
It is not known if Amphetamine Sulfate Tablets are safe and effective in children with exogenous obesity under 12 years of age. Amphetamine Sulfate Tablets are a federally controlled substance (CII) because they contain amphetamine that can be a target for people who abuse prescription medicines or street drugs. Keep Amphetamine Sulfate Tablets in a safe place to protect them f…