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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Adzenys Xr-odt
Generic Name
Amphetamine
Active Ingredient
AmphetamineCategory
Central Nervous System Stimulant [EPC]
Salt Form
Sulfate
Variants
6
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Adzenys Xr-odt, you must consult a qualified healthcare professional.
| 15.7 mg/1 | TABLET, ORALLY DISINTEGRATING | ORAL | 70165-025 |
| 9.4 mg/1 | TABLET, ORALLY DISINTEGRATING | ORAL | 70165-015 |
| 3.1 mg/1 | TABLET, ORALLY DISINTEGRATING | ORAL | 70165-005 |
Detailed information about Adzenys Xr-odt
Amphetamine is a potent central nervous system (CNS) stimulant and sympathomimetic amine. It is primarily indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy, working by increasing neurotransmitter activity in the brain.
Dosage for amphetamine must be highly individualized based on the patient's therapeutic response and tolerability. Healthcare providers typically follow the principle of 'start low and go slow.'
In patients with severe renal impairment (GFR 15 to <30 mL/min/1.73 m²), the maximum dose should not exceed 20 mg per day for certain extended-release formulations. For patients with end-stage renal disease (ESRD), use is generally not recommended as the drug is not significantly cleared by dialysis.
While the liver metabolizes amphetamine, specific dosage adjustment guidelines for hepatic impairment are not always provided in the standard labeling. However, healthcare providers will monitor patients with liver disease closely for signs of toxicity.
Clinical studies of amphetamine generally did not include sufficient numbers of subjects aged 65 and over. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function.
If you miss a dose, take it as soon as you remember, provided it is not late in the afternoon. Taking amphetamine late in the day can cause significant insomnia. If it is nearly evening, skip the missed dose and resume your regular schedule the next morning. Do not 'double up' to make up for a missed dose.
An overdose of amphetamine can be life-threatening. Signs of acute overdose include:
In the event of a suspected overdose, call 911 or your local emergency services immediately. Emergency treatment often involves gastric decontamination (if caught early), administration of activated charcoal, and supportive care to manage blood pressure and body temperature.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or stop the medication without medical guidance, as sudden discontinuation can lead to withdrawal symptoms.
Most patients taking amphetamine will experience some side effects, particularly during the first few weeks of treatment as the body adjusts to the stimulant. Common effects include:
Amphetamine is a potent medication that requires careful medical supervision. Before starting treatment, patients must undergo a thorough cardiovascular evaluation, including a blood pressure check and an assessment of family history for sudden death or ventricular arrhythmia. It is essential to disclose all pre-existing medical conditions, particularly heart defects, high blood pressure, or a history of substance abuse.
According to the FDA-approved prescribing information, Amphetamine has a high potential for abuse. Particular attention should be paid to the possibility of subjects obtaining amphetamines for non-therapeutic use or distribution to others, and the drugs should be prescribed or dispensed sparingly. Misuse of amphetamine may cause sudden death and serious cardiovascular adverse reactions. Long-term use can lead to clinically significant drug dependence.
Amphetamine is strictly contraindicated (must NEVER be used) in patients with the following conditions:
Amphetamine is classified as FDA Pregnancy Category C (under the older system). There are no adequate and well-controlled studies in pregnant women. Data from animal studies suggest that high doses of amphetamine can have embryotoxic and teratogenic 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. Amphetamine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Amphetamines are excreted in human milk. Because of the potential for serious adverse reactions in nursing infants (such as tachycardia, irritability, and poor weight gain), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Large doses of amphetamine might also interfere with milk production by suppressing prolactin levels.
Amphetamine is a primary treatment for ADHD in children. However, its use in children under age 3 is not recommended for ADHD. For narcolepsy, use in children under age 6 is generally not recommended. A major concern in pediatric use is the suppression of growth. Clinical data suggests that children taking stimulants may experience a temporary slowing in height and weight gain. Healthcare providers will track the child's growth on a standardized chart and may recommend 'drug holidays' during the summer or school breaks to allow for 'catch-up' growth.
Amphetamine is a non-catecholamine, sympathomimetic amine with CNS stimulant activity. Its primary molecular mechanism involves the promotion of neurotransmitter release from presynaptic nerve terminals. Specifically, it acts as a substrate for the Dopamine Transporter (DAT), Norepinephrine Transporter (NET), and Serotonin Transporter (SERT). Once inside the neuron, it acts as a competitive inhibitor of the Vesicular Monoamine Transporter 2 (VMAT2), causing the redistribution of neurotransmitters from synaptic vesicles into the cytosol. It also activates the Trace Amine-Associated Receptor 1 (TAAR1), which triggers signaling pathways that reverse the direction of the transporters, effectively pumping dopamine and norepinephrine out into the synapse.
The pharmacodynamic effects of amphetamine include increased systolic and diastolic blood pressure, weak bronchodilation, and respiratory stimulation. In the brain, the increase in catecholamines leads to increased alertness, decreased fatigue, and improved mood. At higher doses, it can cause significant euphoria and increased motor activity. Tolerance to the anorectic (appetite-suppressing) effects typically develops within a few weeks.
Common questions about Adzenys Xr-odt
Amphetamine is a central nervous system stimulant primarily used to treat Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. In patients with ADHD, it helps increase focus, reduce impulsivity, and manage hyperactivity by balancing neurotransmitters in the brain. For those with narcolepsy, it is used to promote wakefulness and reduce excessive daytime sleepiness. While it has been used historically for weight loss, this is now a very limited and short-term use due to the risk of addiction. It should only be used under the strict supervision of a healthcare professional as part of a comprehensive treatment plan.
The most common side effects of amphetamine include a significant decrease in appetite, difficulty falling asleep (insomnia), and dry mouth. Many patients also report experiencing a faster heart rate, headaches, and stomach pain, especially when first starting the medication. In children, weight loss and a temporary slowing of growth are also frequently observed. Most of these side effects are dose-dependent and may improve as the body adjusts to the medication. If these effects become severe or persistent, you should contact your healthcare provider to discuss a dose adjustment.
No, you should strictly avoid drinking alcohol while taking amphetamine. Alcohol can interact with the medication's delivery system, especially in extended-release formulations, causing the drug to be released into your bloodstream too quickly. Additionally, amphetamine is a stimulant that can mask the depressant effects of alcohol, making you feel less intoxicated than you actually are. This can lead to dangerous levels of alcohol consumption and increased cardiovascular strain. Combining the two also increases the risk of unpredictable psychological side effects like aggression or severe anxiety.
Amphetamine is generally not recommended during pregnancy unless the potential benefit clearly outweighs the risks to the fetus. Research suggests that infants born to mothers who use amphetamines may have an increased risk of premature birth, low birth weight, and withdrawal symptoms after birth. There is also limited evidence suggesting potential long-term behavioral effects on the child. If you are pregnant or planning to become pregnant, it is vital to discuss your ADHD or narcolepsy treatment with your doctor. They will help you weigh the risks of the medication against the risks of untreated symptoms during pregnancy.
The onset of action for amphetamine depends on the specific formulation you are taking. Immediate-release (IR) tablets typically begin to work within 30 to 60 minutes of ingestion, with peak effects occurring around 3 hours. Extended-release (ER) capsules take slightly longer to start but provide a steady release of medication over 8 to 12 hours. Most patients will notice an improvement in their focus or wakefulness on the very first day of treatment. However, it may take several weeks of dose adjustments with your doctor to find the 'sweet spot' where benefits are maximized and side effects are minimized.
Stopping amphetamine suddenly, especially after long-term use at high doses, can lead to a 'crash' or withdrawal syndrome. Symptoms of withdrawal include extreme fatigue, depression, irritability, vivid dreams, and increased appetite. To avoid these uncomfortable symptoms, healthcare providers usually recommend a gradual tapering of the dose. If you feel the medication is no longer working or you want to stop taking it, always consult your doctor first. They can provide a safe schedule to reduce your dose and monitor you for any mood changes during the process.
If you miss a dose of amphetamine, you should take it as soon as you remember, but only if it is still early in the day. Because amphetamine is a potent stimulant, taking a dose in the late afternoon or evening can cause significant insomnia. If it is already late in the day, it is usually best to skip the missed dose and wait until the following morning to take your next scheduled dose. Never take a double dose to make up for one that you missed, as this increases the risk of dangerous cardiovascular side effects and over-stimulation.
No, amphetamine is much more likely to cause weight loss rather than weight gain. As a stimulant, it significantly suppresses the appetite and increases the body's metabolic rate. Many patients find they have little interest in food while the medication is active in their system. For children, this weight loss is monitored closely by doctors to ensure it does not interfere with healthy development. If you are concerned about excessive weight loss, your doctor may suggest taking the medication after meals or incorporating high-calorie, nutritious snacks in the evening when the drug's effects wear off.
Amphetamine has many potential drug interactions, some of which are very serious. It should never be taken with MAO inhibitors, and it must be used with caution alongside antidepressants like SSRIs or SNRIs due to the risk of serotonin syndrome. Even over-the-counter medications like antacids or Vitamin C can change how your body absorbs and clears amphetamine. Always provide your healthcare provider and pharmacist with a complete list of all medications, supplements, and herbal products you are taking. They will check for interactions and ensure that your combination of treatments is safe.
Yes, amphetamine is available in various generic forms, including amphetamine sulfate tablets and mixed amphetamine salts (the generic for Adderall). Generic versions are required by the FDA to have the same active ingredient, strength, dosage form, and route of administration as the brand-name drug. They must also prove bioequivalence, meaning they work in the body in the same way. Choosing a generic version can often significantly reduce the cost of treatment. Your pharmacist can help you determine which generic options are covered by your insurance plan and are equivalent to the brand prescribed by your doctor.
Other drugs with the same active ingredient (Amphetamine)
While rare, some side effects are medical emergencies. Stop taking the medication and contact your doctor or emergency services immediately if you experience:
Amphetamine carries an FDA Black Box Warning regarding its high potential for abuse and dependence.
Report any unusual symptoms to your healthcare provider. They may adjust your dose or suggest a 'drug holiday' (temporary break from the medication) to assess the ongoing need for treatment.
Patients on long-term amphetamine therapy require regular monitoring:
Amphetamine may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or vehicles. While it often improves focus, it can also cause dizziness or 'rebound' fatigue. Patients should be cautious until they know how the medication affects them.
Alcohol should be strictly avoided while taking amphetamine. Alcohol can change how the body absorbs and releases the medication, potentially leading to a rapid release of the drug (dose dumping). Furthermore, stimulants can mask the intoxicating effects of alcohol, increasing the risk of alcohol poisoning or dangerous behavior.
Do not stop taking amphetamine suddenly if you have been using it for a long period. Abrupt discontinuation can lead to a 'crash,' characterized by extreme fatigue, depression, irritability, and increased appetite. Your doctor will provide a tapering schedule to gradually reduce the dose.
> Important: Discuss all your medical conditions, including any history of glaucoma, hyperthyroidism, or severe anxiety, with your healthcare provider before starting Amphetamine.
For each major interaction, the management strategy usually involves either avoiding the combination, adjusting the dosage, or increasing the frequency of monitoring for adverse effects.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, including over-the-counter cold medicines that may contain decongestants.
In these cases, the healthcare provider will perform a careful risk-benefit analysis:
Patients who have had an allergic reaction to other stimulant medications, such as dextroamphetamine, methamphetamine, or lisdexamfetamine (Vyvanse), are likely to be cross-sensitive to amphetamine sulfate. Symptoms of an allergic reaction may include hives, rash, swelling of the face or throat, and difficulty breathing.
> Important: Your healthcare provider will evaluate your complete medical history, including your family's heart health and mental health history, before prescribing Amphetamine.
Elderly patients (aged 65 and older) may be more sensitive to the cardiovascular and central nervous system effects of amphetamine. There is an increased risk of hypertension, insomnia, and confusion in this population. Because elderly patients are more likely to have decreased renal function, the risk of toxic reactions to this drug may be greater. Dosage should be started at the lowest possible level.
As amphetamine is primarily excreted by the kidneys, patients with impaired renal function will have higher blood levels of the drug for longer periods. In patients with severe renal impairment (GFR 15 to 29), the maximum dose of certain extended-release products is reduced. Use is not recommended in patients with a GFR less than 15.
While specific dosing adjustments are not always defined, the liver's role in the oxidative deamination of amphetamine means that patients with severe hepatic impairment (Child-Pugh Class C) should be monitored closely for signs of over-stimulation.
> Important: Special populations require individualized medical assessment and more frequent follow-up appointments.
|---|---|
| Bioavailability | >75% (Rapidly absorbed) |
| Protein Binding | ~20% |
| Half-life | 10-13 hours (Adults), 7-11 hours (Children) |
| Tmax | 3 hours (Immediate-Release), 7-10 hours (Extended-Release) |
| Metabolism | Hepatic (CYP2D6) |
| Excretion | Renal (30-40% unchanged, pH dependent) |
Amphetamine is the parent compound of the 'Amphetamines' class. Related medications include Dextroamphetamine, Lisdexamfetamine, and Methamphetamine. It is distinct from the 'Methylphenidate' class, although both are considered CNS stimulants for the treatment of ADHD.