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Azstarys

Azstarys is a brand-name prescription medication used for the treatment of attention-deficit hyperactivity disorder (ADHD) in patients aged 6 years and older. It is a combination drug that contains two active ingredients: serdexmethylphenidate and dexmethylphenidate. Serdexmethylphenidate is a prodrug, meaning it is converted in the body to the active stimulant dexmethylphenidate, which helps improve focus, attention, and impulse control in individuals with ADHD. Azstarys is designed to provide both an immediate and extended release of medication to offer symptom control throughout the day.


Drug Availability and Controlled Substance Status


Azstarys is available in capsule form, with varying strengths to accommodate different dosing needs. As a medication containing dexmethylphenidate, it is classified as a Schedule II controlled substance under the Controlled Substances Act, indicating a high potential for abuse and dependence. Therefore, it is available only by prescription and should be used under the strict guidance of a healthcare provider.


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Frequently Asked Questions

How long does it take for Azstarys to start working?
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Azstarys typically begins to work within 30 to 60 minutes after taking the medication. The effects are designed to last throughout the day due to its combination of immediate and extended-release components.

Can Azstarys be taken with food?
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Yes, Azstarys can be taken with or without food. If there are any gastrointestinal side effects, taking it with food might help to reduce these symptoms.

What should I do if I miss a dose of Azstarys?
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If you miss a dose, take it as soon as you remember. However, if it is late in the day, it is better to skip the missed dose to avoid potential insomnia. Do not take two doses at once to make up for a missed dose.

Is Azstarys safe to use during pregnancy?
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The safety of Azstarys during pregnancy has not been fully established. Pregnant women or those planning to become pregnant should consult their healthcare provider to discuss the potential risks and benefits of using Azstarys during pregnancy.

Can I drink alcohol while taking Azstarys?
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It is advisable to avoid alcohol while taking Azstarys, as alcohol can increase the risk of certain side effects such as dizziness, drowsiness, and increased heart rate. Discuss alcohol use with your healthcare provider to ensure it is safe in your specific case.

Can I take Azstarys if I'm allergic to stimulant medication?
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If you've experienced allergic reactions to stimulant medications or any ingredient in Azstarys, disclose this to your healthcare provider before starting the treatment.

Comprehensive Drug Guide

How Does Azstarys Work?

Azstarys works by increasing the levels of certain neurotransmitters in the brain, specifically dopamine and norepinephrine. These neurotransmitters play key roles in regulating attention, behavior, and emotional responses. The serdexmethylphenidate component of Azstarys is a prodrug that is gradually converted to dexmethylphenidate, providing sustained symptom control throughout the day. Dexmethylphenidate itself inhibits the reuptake of dopamine and norepinephrine, leading to increased concentrations of these neurotransmitters in the synaptic cleft, which improves communication between neurons and helps to alleviate ADHD symptoms.


What is Azstarys Used For?

Azstarys is FDA-approved for the treatment of attention-deficit hyperactivity disorder (ADHD) in children, adolescents, and adults aged 6 years and older. It is used as part of a comprehensive treatment plan that may include behavioral therapy and other interventions. The goal of Azstarys is to provide consistent symptom control throughout the day, helping patients manage their symptoms in both academic and social settings.

Common Dosages

Azstarys is available in several strengths, which include 26.1 mg/5.2 mg, 39.2 mg/7.8 mg, and 52.3 mg/10.4 mg of serdexmethylphenidate/dexmethylphenidate respectively. The starting dose is typically 39.2 mg/7.8 mg once daily in the morning. The dose may be adjusted based on the patient’s response and tolerability, with the maximum recommended dose being 52.3 mg/10.4 mg once daily.


Typical Dosing

FDA Approved Indications

The typical dosing of Azstarys is one capsule taken once daily in the morning. The capsule can be swallowed whole or opened, and the contents sprinkled on a small amount of applesauce or yogurt if swallowing capsules is difficult. It is important to take Azstarys at the same time each day, with or without food, to maintain consistent blood levels and symptom control.

Who Shouldn't Take Azstarys?

Azstarys is contraindicated in patients with known hypersensitivity to serdexmethylphenidate, dexmethylphenidate, or any of the other components of the medication. It should not be used in patients with significant cardiovascular disease, moderate to severe hypertension, hyperthyroidism, or in those who are currently taking or have recently taken monoamine oxidase inhibitors (MAOIs) within the last 14 days. Caution is advised in patients with a history of substance abuse, as Azstarys has a high potential for abuse and dependence.


Advice From The Pharmacist

Patients taking Azstarys should be advised to take the medication exactly as prescribed and not to share it with others, especially those with a history of substance abuse. It is important to monitor for any changes in behavior, mood, or mental health, especially during the initiation of treatment or dose adjustments. Patients should also be aware of the potential cardiovascular effects, such as increased heart rate and blood pressure, and should report any significant changes to their healthcare provider. Regular follow-up appointments are necessary to monitor the effectiveness of the medication and to make any necessary dosage adjustments.


Side Effects of Azstarys

Common Side Effects

Common side effects of Azstarys include decreased appetite, insomnia, stomach pain, headache, and nausea. Some patients may also experience anxiety, irritability, or weight loss.


Uncommon/Severe Side Effects

Serious side effects, though rare, can include cardiovascular events such as increased blood pressure, heart palpitations, and in rare cases, sudden death in patients with pre-existing heart conditions. Other serious side effects include the potential for psychiatric symptoms such as new or worsening aggression, hostility, or suicidal thoughts. Patients should contact their healthcare provider if they experience any severe or persistent side effects.

Risks and Warnings of Azstarys

Azstarys carries the risk of potential abuse and dependence, which is why it is classified as a Schedule II controlled substance. It should be used with caution in patients with a history of substance abuse or those with underlying psychiatric conditions, as it may exacerbate certain mental health symptoms. There is also a risk of cardiovascular side effects, particularly in patients with pre-existing heart conditions. Therefore, a thorough cardiovascular evaluation should be performed before initiating treatment, and ongoing monitoring is recommended.


Interactions with Azstarys

Common Drug Interactions

Azstarys may interact with other medications that affect the central nervous system, such as antidepressants, antipsychotics, and other stimulant medications. It can also interact with MAOIs, leading to potentially dangerous increases in blood pressure and other adverse effects. Patients should inform their healthcare provider of all medications and supplements they are taking to avoid potential interactions. Additionally, the use of alcohol should be discussed with the healthcare provider, as it can enhance certain side effects of the medication.


Alternatives to Azstarys

Alternative treatments for ADHD include other stimulant medications such as methylphenidate (Ritalin, Concerta) or amphetamine-based drugs (Adderall, Vyvanse). Non-stimulant alternatives include atomoxetine (Strattera), guanfacine (Intuniv), and clonidine (Kapvay). Behavioral therapies and lifestyle changes are also important components of ADHD management. The choice of alternative treatment will depend on the patient’s specific symptoms, medical history, and response to previous treatments.