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Adzenys ER (Generic Amphetamine)

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WARNING

Amphetamine can lead to addiction. Never exceed the dosage, frequency, or duration of treatment recommended by your doctor. If you consume too much amphetamine, you can continue to feel the need to consume huge doses of the drug and might exhibit strange behavioural changes. If you see any of the following symptoms, you should contact your doctor right away. Sweating, dilated pupils, an unusually ecstatic mood, restlessness, irritability, trouble falling asleep or staying asleep, anger, aggression, anxiety, lack of appetite, loss of coordination, uncontrollable movement of a part of the body, flushed skin, vomiting, stomach ache; or preparing, attempting, or even just having the thought of hurting or killing oneself or someone else. Amphetamine abuse can potentially result in sudden cardiac death or significant heart issues.

Inform your doctor if you or any members of your family regularly use excessive amounts of alcohol, use street drugs, or abuse prescription pharmaceuticals. Most likely, your doctor won’t give you an amphetamine prescription.

If you have been using amphetamine excessively, do not quit taking it without first consulting your doctor. Your dose will likely be gradually reduced by your doctor, who will also closely watch you during this period. Depression and excessive exhaustion could set in. if you abruptly stop using amphetamine after abusing it excessively.

Avoid sharing, selling, or allowing others to use your medication. Amphetamine sales and distribution are illegal because they pose a risk to other people. Amphetamine should be kept in a secure location, preferably one that is secured, to prevent accidental or intentional theft. Count the remaining tablets or suspension (liquid) so you can determine if any are missing.

The patient information sheet (Medication Guide) from the manufacturer will be sent to you by your doctor or pharmacist when you start amphetamine treatment and each time you get a prescription refill. If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the Food and Drug Administration (FDA) website at http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm.

Why is this medication prescribed?

Adzenys ER, Adzenys XR, Dyanavel XR, Evekeo, Evekeo ODT, and other amphetamine-containing medications are used as part of a treatment programme to manage the signs and symptoms of attention deficit hyperactivity disorder (ADHD; more difficulty focusing, controlling actions, and remaining still or quiet than other people their age). ADHD affects both adults and children. Narcolepsy is also treated with amphetamine (Evekeo, among other brands) (a sleep disorder that causes excessive daytime sleepiness and sudden attacks of sleep). In obese persons who are unable to lose weight, amphetamine (Evekeo, among others) is also used for a brief (a few weeks) period of time in conjunction with a low-calorie diet and an exercise regimen. The drug amphetamine belongs to the group of drugs known as central nervous system stimulants. It functions by altering the concentrations of specific organic compounds in the brain.

How should this medicine be used?

The oral forms of amphetamine include immediate-release tablets (Evekeo), tablets that dissolve fast in the mouth (Evekeo ODT), extended-release (long-acting) tablets (Adzenys XR), and extended-release (long-acting) suspensions (Adzenys ER, Dyanavel XR). Usually taken once daily in the morning with or without meals, the extended-release suspension. The orally disintegrating tablet is typically taken with or without food and/or fluids once day in the morning. The oral disintegrating tablet for extended release is typically taken once daily in the morning with or without breakfast. The immediate-release pill is typically used one to three times day, 4 to 6 hours apart, with the first dose in the morning, for the treatment of ADHD or narcolepsy. The immediate-release tablet for weight loss is often given 30 to 60 minutes before meals. It is not advisable to take amphetamine in the late afternoon or evening because it may make it harder to fall or remain asleep. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Follow the amphetamine directions exactly.

Do not chew or crush the extended-release pills; instead, swallow them whole.

Avoid attempting to force the extended-release orally disintegrating tablet (Adzenys XR) or the orally disintegrating tablet (Evekeo ODT) through the blister pack foil. Instead, peel aside the foil wrapper with your dry hands. Take the tablet out right away, and put it in your mouth. The tablet can be ingested with saliva and will immediately dissolve. To ingest the tablet, no water is required.

Before each usage, thoroughly shake the extended-release suspension (Adzenys ER, Dyanavel XR) to combine the drug.

Adzenys ER, an extended-release suspension, should not be mixed with other beverages or added to meals.

It is crucial to precisely measure and take your dose of the extended-release suspension using an oral syringe (measuring device). If a device wasn’t offered, ask your pharmacist to provide one. After every usage, properly wash the oral syringe.

Your doctor will likely start you on a low dose of amphetamine and progressively increase your dosage every 4 to 7 days, depending on the prescription, if you or your child is taking it for ADHD. Periodically, your doctor could advise you to stop using amphetamine in order to determine whether you still require the drug. Pay close attention to these guidelines.

Your doctor will likely start you on a modest dose of amphetamine for narcolepsy and gradually raise your dose, not more frequently than once per week. Pay close attention to these guidelines.

One amphetamine product cannot be used in place of another because the drug in each product is absorbed by the body differently. Your doctor will recommend the dose that is most suitable for you if you are transitioning from one product to another.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking amphetamine,

  • Before ingesting amphetamine, disclose to your doctor and pharmacist if you are allergic to any medications, including benzphetamine, dextroamphetamine (Dexedrine, in Adderall), lisdexamfetamine (Vyvanse), and methamphetamine (Desoxyn), as well as other stimulant drugs. Consult the Medication Guide or your pharmacist for a list of the components.
  • Monoamine oxidase (MAO) inhibitors such as isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine should be mentioned to your doctor if you are currently taking any of these medications or have stopped taking them within the previous 14 days (Parnate). You should wait at least 14 days after stopping amphetamine use before starting an MAO inhibitor.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, and herbal supplements you are taking. Incorporate any of the following: buspirone, acetazolamide (Diamox), ammonium chloride, warfarin (Coumadin, Jantoven), ascorbic acid (Vitamin C), anticoagulants (‘blood thinners’) like aspirin, cimetidine (Tagamet), esomeprazole (Nexium), omeprazole (Prilosec, in Zegerid), and pantoprazole (Protonix), Antihistamines (medications for colds and allergies), chlorpromazine, some diuretics (‘water pills’), fentanyl (Actiq, Duragesic, Subsys, and others); guanethidine (Ismelin; no longer available in the United States); haloperidol (Haldol); blood pressure medications; lithium (Lithobid); methenamine salts (Hiprex, Urex); and medications for migraine; drugs for seizures like ethosuximide (Zarontin), phenobarbital, and phenytoin (Dilantin, Phenytek); narcotic painkillers like meperidine (Demerol) and propoxyphene (Darvon; no longer available in the United States); quinidine (in Nuedexta); reserpine; ritonavir (Norvir, in Kaletra); and selective serotonin Tramadol, sodium acid phosphate, sodium bicarbonate (Arm and Hammer Baking Soda, Soda Mint), or tricyclic antidepressants like desipramine (Norpramin) and protriptyline are examples of serotonin and norepinephrine reuptake inhibitors. Other examples include desvenlafaxine (Khedezla, Pristiq), duloxetine (Cymbalta), milnacip (Vivactil). Your doctor might need to adjust your medication doses or keep a close eye out for any negative side effects.
  • Inform your doctor about any nutritional supplements you are taking, such as glutamic acid, as well as herbal medications you are taking, especially St. John’s wort and tryptophan (L-glutamine).
  • If you experience intense emotions of worry, stress, or agitation, or if you have hyperthyroidism (a disease in which there is too much thyroid hormone in the body), let your doctor know. Most likely, your doctor will advise against using amphetamine.
  • Inform your doctor if anyone in your family has ever experienced a sudden death or has an abnormal heartbeat. Inform your physician if you have or have ever had a heart defect, arteriosclerosis (arterial hardening), coronary artery disease (a narrowing of the blood vessels supplying the heart), high blood pressure, an irregular heartbeat, cardiomyopathy (heart muscle thickening), heart or blood vessel disease, or any other heart issues. Your heart and blood vessels will be checked by your doctor during the examination. If you have a heart condition or there is a significant chance that you will develop a heart condition, your doctor will likely advise against using amphetamine.
  • Inform your doctor if you or anyone in your family is currently experiencing or has ever experienced depression, bipolar disorder (a condition characterised by mood swings between depressed and abnormally excited), mania, psychosis, motor tics, verbal tics, Tourette’s syndrome (a condition characterised by the need to perform repetitive motions or to repeat sounds or words), or has considered or attempted suicide. Also let your doctor know if you suffer from kidney illness, have ever had seizures, or have had an abnormal electroencephalogram (EEG; a test that gauges brain electrical activity).
  • If you are pregnant or want to become pregnant, let your doctor know. Call your doctor if you become pregnant while using amphetamine.
  • If you are using amphetamines, avoid breastfeeding.
  • Prior to understanding how this drug affects you, avoid using machinery or driving a car.
  • When using amphetamine, avoid drinking alcohol. Amphetamine side effects can be exacerbated by alcohol.
  • You should be aware that the usage of amphetamine for ADHD should be a part of a comprehensive treatment plan that may include involve counselling and specialised instruction. Ensure that you adhere to all recommendations from your therapist or doctor.
  • You should be aware that amphetamine can cause sudden death in children and teenagers, particularly in those with major heart conditions or heart defects. Adults taking this medication, particularly those with major cardiac issues or heart deformities, run the risk of experiencing sudden death, heart attacks, or stroke. If you or your child experiences any symptoms of heart issues while taking this drug, such as chest discomfort, breathlessness, or fainting, call your or your child’s doctor straight once.

What special dietary instructions should I follow?

If you plan to consume fruit juice while taking this medication, consult your doctor.

What should I do if I forget a dose?

If you miss a dosage, take it as soon as you recall. If the next dose is soon due, skip the missed one and carry on with your regular dosing plan. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

There may be negative effects from amphetamine. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Mouth ache
  • Nausea
  • Diarrhea
  • Constipation
  • Unappealing flavour
  • Stomach pain
  • Loss of weight
  • A bleeding nose
  • Headache
  • Teeth clenching or grinding when sleeping
  • Anxiety
  • Alterations in sex desire or capacity
  • Unpleasant menstruation
  • Urination that causes pain or burning

Some adverse effects can be very harmful. Call your doctor right away if you have any of the following symptoms or any of those mentioned in the IMPORTANT WARNING section and stop taking amphetamine:

  • Dizziness
  • Arm or leg weakness or numbness
  • Verbal or motor tics
  • Believing incorrect information
  • Feeling unusually wary about other people
  • Hallucinating (seeing things or hearing sounds and voices that do not exist)
  • Mania (frenzied or overly exuberant emotion) (frenzied or abnormally excited mood)
  • Agitation, sweating excessively, confusion, rapid heartbeat, shivering, extremely rigid or twitching muscles, loss of coordination, nausea, vomiting, or diarrhoea
  • Seizures
  • Eyesight alterations or blurry vision
    Skin that is stinging or peeling
  • Rash
  • Hives
  • Itching
  • Face, throat, tongue, lips, or eye swelling
  • Breathing or swallowing challenges
  • In the fingers or toes, numbness, discomfort, or sensitivity to temperature
  • Pale skin that turns blue or red in the fingers or toes
  • Unidentified cuts on the fingers or toes

In particular, children and teenagers with major heart conditions or heart defects are at risk for sudden death when using amphetamine. Adults who already have major cardiac issues or heart defects may also experience sudden death, heart attacks, or stroke as a result of this medicine. If you or your child has chest pain, breathlessness, or fainting while taking this medication, contact your doctor straight away. The dangers of using this drug should be discussed with your doctor.

Amphetamine may inhibit children’s weight gain or growth. The physician for your child will keep a close eye on their development. If you are worried about your child’s weight gain or growth while taking this medicine, talk to your child’s doctor. Discuss the dangers of giving your child amphetamine with their doctor.

Other negative effects of amphetamine are possible. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Blister packages for orally disintegrating tablets should be kept in the plastic sleeves that are provided. After removing them from the carton, store the blister packages of extended-release orally disintegrating tablets in the firm plastic travel case. Store it away from light, excessive heat, and moisture at room temperature (not in the bathroom).

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medicines website at http://goo.gl/c4Rm4p for additional information.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Overdose signs could include the following:

  • Restlessness
  • Confusion
  • Aggressive attitude
  • Bodily tremors in a particular area
  • Weakness or fatigue
  • Depression
  • Rapid or erratic heartbeat
  • Nausea
  • Vomiting
  • Diarrhea
  • Stomach pain
  • Seizures
  • Coma (loss of consciousness for a period of time)

What other information should I know?

Keep all of your doctor’s appointments. Your doctor may prescribe specific tests to assess your blood pressure and the way your body reacts to amphetamine.

Inform the lab staff and your doctor that you are taking amphetamines prior to any laboratory test.

This medication cannot be renewed. In order to prevent running out of medication, make sure you plan regular doctor’s appointments.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Adzenys ER®
  • Adzenys XR®
  • Dyanavel XR®
  • Evekeo®
  • Evekeo® ODT
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