Azstarys (serdexmethylphenidate/dexmethylphenidate) is a prescription medication primarily used to treat attention deficit hyperactivity disorder (ADHD) in adults and children aged 6 years and older. Like many medications, Azstarys can cause a range of side effects, with weight loss being one of the most frequently discussed. This article aims to provide a comprehensive overview of Azstarys, its uses, potential side effects, and specific considerations regarding weight loss.
What is Azstarys?
Azstarys is a brand-name oral capsule prescribed to treat ADHD in adults and certain children. The active ingredients in Azstarys are dexmethylphenidate and serdexmethylphenidate. It functions by increasing the levels of norepinephrine and dopamine in the body, preventing these chemicals from being reabsorbed by the nervous system. This mechanism helps improve focus, attention, and impulse control in individuals with ADHD.
Azstarys is available in several dosage forms:
- 26.1mg/5.2mg oral capsules
- 39.2mg/7.8mg oral capsules
- 52.3mg/10.4mg oral capsules
It is generally taken once in the morning, with or without food. For individuals who have difficulty swallowing capsules, the contents can be sprinkled onto 2 tablespoons of applesauce or dissolved in 50 mL of water and consumed immediately.
Common Side Effects of Azstarys
Like other medications, Azstarys can cause side effects. The most common side effects include:
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- Decreased appetite
- Trouble sleeping (insomnia)
- Nausea, vomiting, upset stomach, stomach pain
- Weight loss
- Anxiety
- Dizziness
- Irritability
- Mood swings
- Fast heartbeat
- High blood pressure
These side effects are generally dose-related. It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.
Weight Loss and Azstarys
Weight loss is a notable side effect of Azstarys. In clinical trials, decreased appetite and weight loss were commonly reported. Several factors may contribute to weight loss while taking Azstarys:
- Decreased Appetite: Azstarys can suppress appetite, leading to reduced food intake.
- Stimulant Effects: As a central nervous system (CNS) stimulant, Azstarys can increase metabolism and energy expenditure, potentially contributing to weight loss.
While some individuals may experience mild weight loss that stabilizes over time, others may find it more pronounced. In an open-label safety study, the mean increase in weight from baseline to Month 12 was 3.4 kg among study completers in pediatric patients aged 6 to 12 years. The mean change in z-score from baseline to Month 12 was -0.2, indicating a lower-than-expected increase in body weight, with most of the weight z-score decline occurring in the first 4 months of treatment.
Managing Decreased Appetite and Weight Loss
If you experience decreased appetite or weight loss while taking Azstarys, consider the following strategies:
- Eat Nutritious, High-Calorie Foods: Focus on nutrient-dense foods to ensure you're getting essential vitamins and minerals.
- Schedule Meals and Snacks: Set regular meal times, even if you don't feel hungry.
- Pair Protein and Carbohydrates: Combine protein with carbohydrates at meals and snacks, such as peanut butter with an apple or cheese and crackers.
- Use Fruit Smoothies: Incorporate healthy fats and vegetables into fruit smoothies for added calories and nutrients.
- Consult a Dietitian: Seek guidance from a registered dietitian for personalized meal planning.
- Take Azstarys After Breakfast: Make breakfast the highest-calorie meal of the day and take Azstarys afterward.
If weight loss becomes excessive or concerning, consult your healthcare provider. They may recommend adjusting the dosage, taking a break from the medication, or switching to a different treatment.
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Serious Side Effects of Azstarys
While less common, Azstarys can cause serious side effects that require immediate medical attention. These include:
- Severe Allergic Reactions
- Risk of Misuse and Addiction
- Heart Problems
- Increased Heart Rate and Blood Pressure
- Mental Problems
- Painful, Prolonged Erection (Priapism)
- Circulation Problems
- Slowed Growth in Children
- Glaucoma
- Tics
Risk of Misuse and Addiction
Azstarys carries a boxed warning, the most serious warning issued by the FDA, regarding the risk of misuse and addiction. As a CNS stimulant, Azstarys has a high potential for misuse, which can lead to overdose, addiction, and dependence.
Symptoms of Overdose:
- Confusion
- High blood pressure
- Increased heart rate
- Tremors
- Anxiety
- Hallucinations
- Vomiting
What You Can Do:
- Take Azstarys only as prescribed.
- Do not share Azstarys with anyone else.
- Inform your doctor immediately if you experience any symptoms of overdose.
- Consult your doctor before stopping Azstarys treatment to safely manage any withdrawal symptoms.
Heart Problems
Azstarys can increase the risk of death in people with serious heart problems. Before starting Azstarys, inform your healthcare provider if you have a history of heart problems, heart disease, or heart defects.
Symptoms of a Serious Heart Problem:
- Chest pain
- Shortness of breath
- Fainting
- Irregular heartbeat
- Increased heart rate
What You Can Do:
- Seek immediate medical attention if you experience any symptoms of a heart problem.
- Inform your doctor of any existing heart conditions before starting Azstarys.
Allergic Reaction
Although not reported in clinical trials, allergic reactions to Azstarys have been reported post-approval.
Symptoms of an Allergic Reaction:
- Skin rash
- Itching
- Flushing
- Swelling of the skin, mouth, tongue, or throat
- Difficulty breathing
What You Can Do:
- For mild symptoms, contact your doctor immediately.
- For severe symptoms, call 911 or your local emergency number.
Precautions Before Using Azstarys
Before starting Azstarys, discuss your medical history and current medications with your healthcare provider. Particular attention should be given to the following conditions:
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- Abuse and Misuse
- Heart Problems
- Mental Conditions
- Circulation Problems
- Eye Problems
- Tics
- Surgery
- Pregnancy
- Breastfeeding
Drug Interactions
Azstarys should not be taken with certain medications, including:
- Monoamine oxidase inhibitors (MAOIs)
- Blood pressure medicines
- Anesthetics
- Risperidone
Always inform your healthcare provider of all prescription, over-the-counter medications, vitamins, and supplements you are taking.
Azstarys vs. Other ADHD Medications
Azstarys is often compared to other ADHD medications like Vyvanse (lisdexamfetamine dimesylate) and Adderall (amphetamine/dextroamphetamine). All three are CNS stimulants and share similar side effects, including:
- Insomnia
- Weight loss
- Decreased appetite
- Anxiety
- Abdominal pain
- Nausea or vomiting
However, the specific ingredients differ, and Azstarys and Vyvanse may have a lower risk of misuse and addiction compared to Adderall due to their prodrug properties.
Azstarys Dosing and Administration
Azstarys is available in three different doses, and the appropriate dose varies based on age and individual sensitivity to the medication. It is generally recommended to start with the middle dose and adjust as needed based on response.
Dosing Guidelines:
- Ages 6-12: 26.1 mg/5.2 mg, 39.2 mg/7.8 mg, or 52.3 mg/10.4 mg
- Ages 13 and older: 39.2 mg/7.8 mg or 52.3 mg/10.4 mg
Administration Tips:
- Take the capsule whole or sprinkle the contents onto applesauce or dissolve in water.
- Consume the entire solution immediately.
- Avoid dosing in the afternoon to prevent insomnia.
- Side effects are generally dose-related.
Azstarys and Growth in Children
Children taking Azstarys may experience slowed growth, resulting in lower weight and shorter height than average for their age. Your healthcare provider may monitor your child’s height and weight during treatment and adjust the treatment plan if necessary. It is important to note that most studies indicate that parental height is the primary determinant of a child’s final height, and most children taking stimulants eventually reach their expected height, albeit at a slower pace.
Alcohol and Azstarys
While there are no known interactions between alcohol and Azstarys, alcohol can cause similar side effects such as dizziness, nausea, headache, and vomiting. Combining alcohol with Azstarys may worsen these side effects and potentially increase the risk of misusing Azstarys.