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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 to 8. It is freely soluble in water, slightly soluble in alcohol and practically insoluble in ether.
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.
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 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.
This medication is also used to treat a certain sleeping disorder (narcolepsy) to help you stay awake during the day. It should not be used to treat tiredness or to hold off sleep in people who do not have a sleep disorder.
Amphetamine may also be used along with a doctor-approved, reduced-calorie diet to help significantly overweight (obese) people lose weight. It should only be used for a short time (a few weeks) in people who have not lost enough weight with other treatments (such as dieting, other drugs, group programs). It may work by decreasing your appetite.
How to use Evekeo
Read the Medication Guide provided by your pharmacist before you start using amphetamine 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 1 to 3 times a day. The first dose is usually taken when you wake up in the morning. If more doses are prescribed, take them as directed by your doctor, usually 4 to 6 hours apart.
If you are using this medication for weight loss, take it as directed by your doctor, usually 30 to 60 minutes before each meal.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day. Do not take this medication late in the evening because it may cause you to have trouble sleeping (insomnia).
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 (such as extreme tiredness, mental/mood changes such as agitation or 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.
Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.
Tell your doctor if your condition does not improve or if it worsens.
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 are inhibited by amphetamines.
Gastrointestinal alkalinizing agents (sodium bicarbonate, etc.) increase absorption of amphetamines. Urinary alkalinizing agents (acetazolamide, some thiazides) increase the concentration of the nonionized species of the amphetamine molecule, thereby decreasing urinary excretion. Both groups of agents increase blood levels and therefore potentiate the action of amphetamines.
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.
The concomitant use of Evekeo and CYP2D6 inhibitors may increase the exposure of Evekeo 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 Evekeo initiation and after a dosage increase. If serotonin syndrome occurs, discontinue Evekeo and the CYP2D6 inhibitor (. Examples of CYP2D6 Inhibitors include paroxetine and fluoxetine (also serotonergic drugs), quinidine, ritonavir.
The concomitant use of Evekeo 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 Evekeo initiation or dosage increase. If serotonin syndrome occurs, discontinue Evekeo and the concomitant serotonergic drug(s) Examples of serotonergic drugs include selective serotonin reuptake inhibitors (SSRI), serotonin norepinephrine reuptake inhibitors (SNRI), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John’s Wort.
MAOI antidepressants, as well as a metabolic of furazolidone, slow amphetamine metabolism. This slowing potentiates amphetamines, increasing their affect 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.
Amphetamines may counteract the sedative effect of antihistamines.
Amphetamines may antagonize the hypotensive effects of antihypertensives.
Chlorpromazine blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant effects of amphetamine, and can be used to treat amphetamine poisoning.
Amphetamines may delay intestinal absorption of ethosuximide.
Haloperidol blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant affects of amphetamines.
The antiobesity and stimulatory effects of amphetamines may be inhibited by lithium carbonate.
Amphetamines potentiate the analgesic effect of meperidine.
Urinary excretion of amphetamines is increased, and efficacy is reduced by acidifying agents used in methenamine therapy.
Amphetamines enhance the adrenergic effect of norepinephrine.
Amphetamines may delay intestinal absorption of Phenobarbital. Co- administration of phenobarbital may produce a synergistic anticonvulsant action.
Amphetamines may delay intestinal absorption of phenytoin; co- administration of phenytoin may produce a synergistic anticonvulsant action.
In cases of propoxyphene overdosage, amphetamine CNS stimulation is potentiated and fatal convulsions can occur.
Amphetamines inhibit the hypotensive effect of veratrum alkaloids.
Drug Abuse And Dependence
Evekeo 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 the 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 dermatosis, 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.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.
Amphetamine may be habit-forming. Never share amphetamine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.
If your doctor changes your brand, strength, or type of stimulant medicine, your dosage needs may change. Use only the brand of this medicine your doctor has prescribed.
Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).
To take the orally disintegrating tablet (Adzenys XR-ODT):
Remove a tablet from its blister pack only when you are ready to take the tablet. Use dry hands and take care not to damage a tablet while pushing it out of the blister.
Place the tablet in your mouth and allow it to dissolve, without chewing or swallowing it whole. Sip liquid if needed to help swallow the dissolved tablet.
While using this medicine, your doctor will need to check your progress at regular visits. Tell any doctor who treats you that you are using this medicine.
Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.
Keep track of your medicine. Amphetamine is a drug of abuse and you should be aware if anyone is using it improperly or without a prescription.
An overdose of amphetamine could be fatal.
Overdose symptoms may include restlessness, tremor, muscle twitches, rapid breathing, hostility, violence, panic, muscle pain or weakness, and dark colored urine. These symptoms may be followed by depression and tiredness. Overdose may also cause seizure or coma.
Take the missed dose as soon as you remember, but not late in the day. Skip the missed dose if it is almost evening. Do not take two doses at one time.
Before taking amphetamine, tell your doctor or pharmacist if you are allergic to it; or to other sympathomimetic drugs (such as dextroamphetamine or lisdexamfetamine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood circulation problems (such as Raynaud’s disease), high blood pressure, glaucoma, heart problems (including irregular heartbeat/rhythm, coronary artery disease, heart failure, cardiomyopathy, problems with the heart structure such as valve problems), mental/mood conditions (especially anxiety, tension, agitation), personal/family history of mental/mood disorders (such as bipolar disorder, depression, psychotic disorder, suicidal thoughts), personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), personal or family history of uncontrolled muscle movements (such as motor tics, Tourette’s syndrome), seizures, stroke, overactive thyroid (hyperthyroidism).
This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Children may be more sensitive to the side effects of this drug, especially weight loss. This medication may slow down a child’s growth. The doctor may recommend temporarily stopping the medication from time to time to reduce this risk. Monitor your child’s weight and height. Consult your doctor or pharmacist for more details.
Older adults may be more sensitive to the side effects of this drug, especially chest pain, trouble sleeping, or weight loss.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Infants born to mothers who are dependent on this medication may be born too soon (premature) and have low birth weight. They may also have withdrawal symptoms. Tell your doctor right away if you notice possible mood changes, agitation, or unusual tiredness in your newborn.
This medication passes into breast milk and may have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.
A number of side effects can occur when using Evekeo.
upset stomach, including diarrhea or constipation and vomiting
decreased appetite and weight loss
unpleasant taste in the mouth and a dry mouth
Serious side effects
Some more serious side effects can develop.
If the person who is using Evekeo experiences any of the following, they should call their doctor right away.
However, if the symptoms may be life-threatening, or if there appears to be a medical emergency, call 9-1-1.
Heart and cardiovascular problems
These can result in sudden death. They include stroke, heart attack, and increased blood pressure.
Cardiovascular problems may cause the following symptoms:
fingers or toes that feel numb, cool, or painful
fingers or toes that change color from pale, to blue, to red
unexplained wounds on the fingers or toes
They may also cause these serious symptoms, which signal a medical emergency and require urgent help:
weakness in one part or side of the body
pain in the chest, left arm, jaw, or between the shoulders
Call 9-1-1 if any of these occur.
Mental health problems
New unusual thoughts
Any worsening of symptoms, including newly occurring unusual thoughts, should be reported to the doctor.
These may include:
new behaviors or a worsening of unusual behaviors and thought problems
new or worsening symptoms of bipolar disorder
new or worsening aggressive behavior or hostility
If a person is in danger of harm, or if their life might be at risk, it is important to seek help at once.
Sometimes, new psychotic symptoms may appear in children and teenagers with psychiatric problems.
seeing things that are not real
believing things that are not true
new signs of being overexcited
Mild side effects may go away within a few days or a couple of weeks. Talk to your doctor or pharmacist if they are more severe or do not go away.
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