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ADZENYS ER (amphetamine) extended-release oral suspension contains a 3 to 1 ratio of d-to l-amphetamine, a central nervous system stimulant.
The labeled strength reflects the amount of amphetamine in ADZENYS ER whereas the strengths of the mixed salts of a single-entity amphetamine products are in terms of the amount of amphetamine salts. Table 1 in Section 2.5 details the equivalent amounts of active ingredient in these products.
ADZENYS ER (amphetamine) Structural Formula Illustration,C9H13N MW 135.21
ADZENYS ER is an extended-release oral suspension containing approximately equal amounts of immediate-release and delayed-release amphetamine.
ADZENYS ER also contains the following inactive ingredients: purified water, sorbitol, propylene glycol, xanthan gum, natural orange flavor, methacrylic acid and methyl methacrylate copolymer, sodium polystyrene sulfonate, vegetable oil, triethyl citrate, methylparaben, citric acid, sucralose, propylparaben, orange color (FD&C Yellow No. 6), and polyethylene glycol.
Adzenys ER is a central nervous system stimulant that affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.
Adzenys ER is used to treat attention deficit hyperactivity disorder (ADHD).
The Evekeo brand of amphetamine is used to treat ADHD and also narcolepsy. Evekeo is sometimes used to treat obesity in people who have not lost weight with diets or other treatments.
Adzenys ER may also be used for purposes not listed in this medication guide.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (such as prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.
Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.
Some products have ingredients that could raise your heart rate or blood pressure. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products or diet aids).
The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/ “ecstasy,” St. John’s wort, certain antidepressants (including SSRIs such as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine), among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs.
Amphetamine is very similar to dextroamphetamine or lisdexamfetamine. Do not use medications containing dextroamphetamine or lisdexamfetamine while using amphetamine.
This medication may interfere with certain medical/lab tests (such as blood and urine steroid levels, brain scan for Parkinson’s disease), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.
DOSAGE AND ADMINISTRATION
Prior to treating patients with ADZENYS ER, 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 ADZENYS ER use
Dosing Considerations For All Patients
dminister ADZENYS ER orally once daily in the morning with or without food. The dose should be individualized according to the therapeutic needs and response of the patient.
Shake the bottle of ADZENYS ER before administering the dose. Do not add ADZENYS ER to food or mix ADZENYS ER with other liquids before consuming.
he recommended starting dose for patients 6 to 17 years of age is 6.3 mg (5 mL) once daily in the morning. Increase in increments of 3.1 mg (2.5 mL) or 6.3 mg (5 mL) at weekly intervals. The maximum dose is 18.8 mg (15 mL) daily for patients 6 to 12 years, and 12.5 mg (10 mL) daily for patients 13 to 17 years.
The recommended dose of ADZENYS ER for adults is 12.5 mg (10 mL) daily.
Switching From Other Amphetamine Products
Patients taking ADDERALL XR may be switched to ADZENYS ER at the equivalent dose taken once daily . Refer to Table 1 for equivalent doses of ADZENYS ER and ADDERALL XR. ADDERALL XR (dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate monohydrate, and amphetamine sulfate extended-release capsules) is also referred to as mixed salts of a single-entity amphetamine product extended-release capsules (MAS ER).
Do not substitute for other amphetamine products on a milligram-per-milligram basis because of different amphetamine salt 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. Acidifying agents (e.g., ascorbic acid) decrease blood levels, while alkalinizing agents (e.g., sodium bicarbonate) increase blood levels. Adjust ADZENYS ER dosage accordingly
Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other sympathomimetic drugs (such as lisdexamfetamine, dextroamphetamine); 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: high blood pressure, stroke, personal or family history of heart problems (such as irregular heartbeat, heart attack, heart failure, heart valve problem), blood circulation problems (such as Raynaud’s disease), glaucoma, personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), personal or family history of mental/mood disorders (such as bipolar disorder, depression, psychosis, suicidal thoughts), personal or family history of uncontrolled muscle movements (motor tics, Tourette’s syndrome), overactive thyroid (hyperthyroidism), seizures.
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. Avoid 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 (such as 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. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
DRUG SIDE EFFECTS
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.Call your doctor at once if you have:
signs of heart problems–chest pain, trouble breathing, feeling like you might pass out;
signs of psychosis–hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia;
signs of circulation problems–numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes;a seizure (convulsions),muscle twitches (tics); or changes in your vision.
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea
Adzenys ER can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.
Common side effects may include:
stomach pain, nausea, vomiting, diarrhea, constipation;loss of appetite, weight loss;
mood changes, feeling restless or nervous, sleep problems (insomnia);dry mouth, unusual or unpleasant taste in the mouth;
runny nose, nosebleeds;increased heart rate;
headache, dizziness;itching; or
impotence, sexual problems.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
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