Amphetamine Sulfate Uses

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What is Amphetamine Sulfate?

Amphetamine Sulfate is used to treat narcolepsy (sleep disorder). It is also used to treat attention-deficit hyperactivity disorder (ADHD). It belongs to the group of medicines called central nervous system (CNS) stimulants.

Amphetamine Sulfate is also used for weight reduction in obese patients.

Amphetamine Sulfate works in the treatment of ADHD by increasing attention and decreasing restlessness in children and adults who are overactive, cannot concentrate for very long, or are easily distracted and impulsive. Amphetamine Sulfate is used as part of a total treatment program that also includes social, educational, and psychological treatment.

Amphetamine Sulfate is available only with a doctor's prescription.

Amphetamine Sulfate indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Amphetamine Sulfate™ (Amphetamine Sulfate tablets, USP) is indicated for:

  1. Narcolepsy
  2. 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.
  3. Exogenous Obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs. The limited usefulness of amphetamines should be weighed against possible risks inherent in use of the drug, such as those described below.

How should I use Amphetamine Sulfate?

Use Amphetamine Sulfate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Amphetamine Sulfate comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Amphetamine Sulfate refilled.
  • Take Amphetamine Sulfate by mouth with or without food.
  • Take your doses of Amphetamine Sulfate 4 to 6 hours apart unless your doctor tells you otherwise.
  • Do not drink fruit juice at the same time that you take Amphetamine Sulfate. Certain fruit juices (eg, grapefruit, apple, orange) may decrease Amphetamine Sulfate's effectiveness.
  • Take Amphetamine Sulfate on a regular schedule to get the most benefit from it. Taking Amphetamine Sulfate at the same time each day will help you remember to take it.
  • If you miss a dose of Amphetamine Sulfate, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Amphetamine Sulfate.

Uses of Amphetamine Sulfate in details

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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This medication is used to treat attention deficit hyperactivity disorder - ADHD. It works by changing the amounts of certain natural substances in the brain. Amphetamine Sulfate belongs to a class of drugs known as stimulants. It can help increase your ability to pay attention, stay focused on an activity, and control behavior problems. It may also help you to organize your tasks and improve listening skills.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used to treat a certain sleeping disorder (narcolepsy). It should not be used to treat tiredness or to hold off sleep in people who do not have a sleep disorder.

How to use Amphetamine Sulfate

Read the Medication Guide provided by your pharmacist before you start taking Amphetamine Sulfate and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily in the morning. Taking this medication after noon may cause trouble sleeping (insomnia).

Keep the medication in the original package until you are ready to take a dose. Dry your hands before handling the medication. Peel back the foil layer of the blister pack to remove a tablet. Do not push the tablet through the foil because it may get damaged. Place the tablet on your tongue, allow it to dissolve, and swallow with your saliva. You do not need to take this medication with water or other liquid. Do not crush or chew the tablet.

The dosage is based on your medical condition and response to treatment. Your doctor may adjust your dose to find the dose that is best for you. Follow your doctor's instructions carefully.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

During treatment, your doctor may sometimes stop the medication for a short time to see if the medication is still needed.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (including severe tiredness, sleep problems, mental/mood changes such as depression) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.

When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.

Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.

Tell your doctor if your condition does not get better or if it gets worse.

Amphetamine Sulfate description

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Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. By mimicking the structures of the catecholamine neurotransmitters, noradrenaline and dopamine, amphetamines modulate monoamine release, reuptake, and signalling within the brain. Although "Amphetamine Sulfate" is used as a descriptor of its own structural class, Amphetamine Sulfate properly refers to a racemic free base composed of equal parts of its two optical antipodes: levo-Amphetamine Sulfate and dextro-Amphetamine Sulfate. Used in the past for the treatment of depression, stress, and for concentration improvement, it is currently available as a prescription drug for the treatment of attention hyperactivity disorder (ADHD), narcolepsy, and as an adjunct in the treatment of exogenous obesity. Amphetamine Sulfate is also available in a mixed salt/mixed enantiomer form (Adderall), where d-Amphetamine Sulfate and l-Amphetamine Sulfate are available in a ratio of 3:1. It is also available in a prodrug form as lisdexamfetamine.

Amphetamine Sulfate dosage

Pre-Treatment Screening

Prior to treating patients with Amphetamine Sulfate, assess for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam).

Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy. Maintain careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and periodically re-evaluate the need for Amphetamine Sulfate use.

Dosing Considerations For All Patients

Amphetamine Sulfate may be taken with or without food. Individualize the dosage according to the therapeutic needs and response of the patient.

Amphetamine Sulfate should be taken as follows:

  • The tablet should remain in the blister pack until the patient is ready to take it.
  • The patient or caregiver should use dry hands to open the blister.
  • Tear along the perforation, bend the blister where indicated and peel back the blister’s labeled backing to take out the tablet. The tablet should not be pushed through the foil.
  • As soon as the blister is opened, the tablet should be removed and placed on the patient’s tongue.
  • The whole tablet should be placed on the tongue and allowed to disintegrate without chewing or crushing.
  • The tablet will disintegrate in saliva so that it can be swallowed.

Pediatric Patients

The recommended starting dosage is 6.3 mg once daily in the morning. Increase in increments of 3.1 mg or 6.3 mg at weekly intervals. The maximum recommended dose is 18.8 mg daily for patients 6 to 12 years, and 12.5 mg daily for patients 13 to 17 years.

Adults

The recommended dose is Amphetamine Sulfate 12.5 mg daily.

Switching From Other Amphetamine Sulfate Products

Patients taking ADDERALL XR may be switched to Amphetamine Sulfate at the equivalent dose taken once daily. Refer to Table 1 for equivalent doses of Amphetamine Sulfate and ADDERALL XR. ADDERALL XR (dextroamphetamine sulfate, dextroamphetamine saccharate, Amphetamine Sulfate aspartate monohydrate, and Amphetamine Sulfate extended-release capsules) is also referred to as mixed salts of a single-entity Amphetamine Sulfate product extended-release capsules (MAS ER).

Table 1: Equivalent Doses of Amphetamine Sulfate and ADDERALL XR (Mixed Salts of a Single-Entity Amphetamine Sulfate Product) Extended-Release Capsules

Amphetamine Sulfate 3.1 mg 6.3 mg 9.4 mg 12.5 mg 15.7 mg 18.8 mg
Amphetamine Sulfate extended-release orally disintegrating tablets
ADDERALL XR 5 mg 10 mg 15 mg 20 mg 25 mg 30 mg
Mixed salts of a single-entity Amphetamine Sulfate product extended-release capsules (MAS ER)

If switching from any other Amphetamine Sulfate products, discontinue that treatment, and titrate with Amphetamine Sulfate using the titration schedule.

Do not substitute for other Amphetamine Sulfate products on a milligram-per-milligram basis because of different Amphetamine Sulfate base compositions and differing pharmacokinetic profiles.

Dosage Modifications Due To Drug Interactions

Agents that alter urinary pH can impact urinary excretion and alter blood levels of Amphetamine Sulfate. Acidifying agents (e.g., ascorbic acid) decrease blood levels, while alkalinizing agents (e.g., sodium bicarbonate) increase blood levels. Adjust Amphetamine Sulfate dosage accordingly.

How supplied

Dosage Forms And Strengths

Amphetamine Sulfate 3.1 mg Amphetamine Sulfate Extended Release

Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A1 on one side)

Amphetamine Sulfate 6.3 mg Amphetamine Sulfate Extended Release

Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A2 on one side)

Amphetamine Sulfate 9.4 mg Amphetamine Sulfate Extended Release

Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A3 on one side)

Amphetamine Sulfate 12.5 mg Amphetamine Sulfate Extended Release

Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A4 on one side)

Amphetamine Sulfate 15.7 mg Amphetamine Sulfate Extended Release

Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A5 on one side)

Amphetamine Sulfate 18.8 mg Amphetamine Sulfate Extended Release

Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A6 on one side)

Storage And Handling

Amphetamine Sulfate 3.1 mg Extended Release

Orally Disintegrating Tablet

: round, orange to light orange mottled (debossed A1 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-005-30

Amphetamine Sulfate 6.3 mg Extended Release

Orally Disintegrating Tablet

: round, orange to light orange mottled (debossed A2 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-010-30

Amphetamine Sulfate 9.4 mg Extended Release

Orally Disintegrating Tablet

: round, orange to light orange mottled (debossed A3 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-015-30

Amphetamine Sulfate 12.5 mg Extended Release

Orally Disintegrating Tablet

: round, orange to light orange mottled (debossed A4 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-020-30

Amphetamine Sulfate 15.7 mg Extended Release

Orally Disintegrating Tablet

: round, orange to light orange mottled (debossed A5 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-025-30

Amphetamine Sulfate 18.8 mg Extended Release

Orally Disintegrating Tablet

: round, orange to light orange mottled (debossed A6 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-030-30

Storage

Store at 20°C to 25° C (68°F to 77° F). Excursions permitted to 15-30° C (59-86° F)

Store Amphetamine Sulfate blister packages in the rigid, plastic travel case provided after removal from the carton. To obtain additional travel cases, patients and health care professionals can call Neos Therapeutics, Inc., at 1-XXX-XXX-XXXX.

Disposal

Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired Amphetamine Sulfate at authorized collection sites such as retail pharmacies, hospital or clinic pharmacies, and law enforcement locations. If no take-back program or authorized collector is available, mix Amphetamine Sulfate with an undesirable, nontoxic substance to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and discard Amphetamine Sulfate in the household trash.

Manufactured by: Neos Therapeutics, LP., Grand Prairie, TX 75050. Made in USA. Revised: Jan 2016

Amphetamine Sulfate interactions

See also:
What other drugs will affect Amphetamine Sulfate?

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Drugs Having Clinically Important Interactions With Amphetamines

Table 5: Drugs having clinically important interactions with amphetamines.

MAO Inhibitors (MAOI)
Clinical Impact MAOI antidepressants slow Amphetamine Sulfate metabolism, increasing amphetamines effect on the release of norepinephrine and other monoamines from adrenergic nerve endings causing headaches and other signs of hypertensive crisis. Toxic neurological effects and malignant hyperpyrexia can occur, sometimes with fatal results.
Intervention Do not administer Amphetamine Sulfate during or within 14 days following the administration of MAOI.
Examples selegiline, isocarboxazid, phenelzine, tranylcypromine
Alkalinizing Agents
Clinical Impact Increase blood levels and potentiate the action of Amphetamine Sulfate.
Intervention Co-administration of Amphetamine Sulfate and gastrointestinal alkalinizing agents should be avoided.
Examples Gastrointestinal alkalinizing agents (e.g., sodium bicarbonate).

Urinary alkalinizing agents (e.g., acetazolamide, some thiazides).

Acidifying Agents
Clinical Impact Lower blood levels and efficacy of amphetamines.
Intervention Increase dose based on clinical response.
Examples Gastrointestinal acidifying agents (e.g., guanethidine, reserpine, glutamic acid HCl, ascorbic acid).
Tricyclic Antidepressants
Clinical Impact May enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in the concentration of d-Amphetamine Sulfate in the brain; cardiovascular effects can be potentiated.
Intervention Monitor frequently and adjust or use alternative therapy based on clinical response.
Examples desipramine, protriptyline
Proton Pump Inhibitors
Clinical Impact Time to maximum concentration (Tmax) of Amphetamine Sulfate is increased compared to when administered alone.
Intervention Monitor patients for changes in clinical effect and adjust therapy based on clinical response.
Example omeprazole

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.

Drug Abuse And Dependence

Controlled Substance

Amphetamine Sulfate contains Amphetamine Sulfate, which is a Schedule II controlled substance in the U.S. Controlled Substance Act (CSA).

Abuse

Amphetamine Sulfate, is a CNS stimulant that contains Amphetamine Sulfate which has a high potential for abuse. Abuse is characterized by impaired control of drug use, compulsive use despite harm, and craving.

Signs and symptoms of Amphetamine Sulfate abuse may include increased heart rate, respiratory rate, blood pressure, and/or sweating, dilated pupils, hyperactivity, restlessness, insomnia, decreased appetite, loss of coordination, tremors, flushed skin, vomiting, and/or abdominal pain. Anxiety, psychosis, hostility, aggression, suicidal or homicidal ideation have also been observed. Abusers of amphetamines may use other unapproved routes of administration which can result in overdose and death.

To reduce the abuse of Amphetamine Sulfate, assess the risk of abuse prior to prescribing. After prescribing, keep careful prescription records, educate patients and their families about abuse and proper storage and disposal of CNS stimulants, monitor for signs of abuse while on therapy, and re-evaluate the need for Amphetamine Sulfate use.

Dependence

Tolerance

Tolerance (a state of adaptation in which exposure to a drug results in a reduction of the drug’s desired and/or undesired effects over time) may occur during the chronic therapy of CNS stimulants including Amphetamine Sulfate.

Dependence

Physical dependence (which is manifested by a withdrawal syndrome produced by abrupt cessation, rapid dose reduction, or administration of an antagonist) may occur in patients treated with CNS stimulants including Amphetamine Sulfate. Withdrawal symptoms after abrupt cessation following prolonged high dosage administration of CNS stimulants include dysphoric mood; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation.

Amphetamine Sulfate side effects

See also:
What are the possible side effects of Amphetamine Sulfate?

Applies to Amphetamine Sulfate: oral tablet

In addition to its needed effects, some unwanted effects may be caused by Amphetamine Sulfate. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking Amphetamine Sulfate:

Rare

  • Seeing, hearing, or feeling things that are not there
  • severe mental changes
Incidence not known:
  • Blurred vision
  • dizziness
  • false or unusual sense of well-being
  • fast, irregular, pounding, or racing heartbeat or pulse
  • headache
  • nervousness
  • pounding in the ears
  • restlessness
  • shakiness in the legs, arms, hands, or feet
  • slow or fast heartbeat
  • trouble sleeping
  • twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
  • uncontrolled vocal outbursts or tics (uncontrolled repeated body movements)

If any of the following symptoms of overdose occur while taking Amphetamine Sulfate, get emergency help immediately:

Symptoms of overdose:

  • Abdominal or stomach cramps
  • confusion
  • dark-colored urine
  • diarrhea
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fainting
  • fever
  • muscle cramps or spasms
  • muscle pain or stiffness
  • nausea
  • seizures
  • sweating
  • unusual tiredness or weakness
  • vomiting

Minor Side Effects

Some of the side effects that can occur with Amphetamine Sulfate may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Incidence not known:

  • Decreased interest in sexual intercourse
  • difficulty having a bowel movement (stool)
  • dry mouth
  • hives or welts, itching, or skin rash
  • inability to have or keep an erection
  • loss in sexual ability, desire, drive, or performance
  • loss of appetite
  • redness of the skin
  • unpleasant taste
  • weight loss

Amphetamine Sulfate contraindications

See also:
What is the most important information I should know about Amphetamine Sulfate?

Hypersensitivity to Amphetamine Sulfate or any component of the formulation, anaphylactic reactions and angioedema have been reported; use during or within 14 days following MAO inhibitor (including linezolid or intravenous methylene blue).

Amphetamine Sulfate immediate-release tablet: Additional contraindications: Hypersensitivity or idiosyncrasy to Amphetamine Sulfate, other sympathomimetic amines, or any component of the formulation; advanced arteriosclerosis; symptomatic cardiovascular disease; moderate to severe hypertension; hyperthyroidism; agitated states; history of drug abuse; use during or within 14 days following MAO inhibitor.

Documentation of allergenic cross-reactivity for amphetamines is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Active ingredient matches for Amphetamine Sulfate:

Amphetamine sulfate


References

  1. DailyMed. "AMPHETAMINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. PubChem. "AMPHETAMINE". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "AMPHETAMINE". http://www.drugbank.ca/drugs/DB00182 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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