Drug Insights

Is Azstarys approved by the FDA?

10 July 2024
3 min read

Azstarys, a combination of dexmethylphenidate and serdexmethylphenidate, is a medication used to treat attention deficit hyperactivity disorder (ADHD) in both adults and children aged six and older. Azstarys was approved by the U.S. Food and Drug Administration (FDA) on March 2, 2021. This approval provided a new treatment option for those managing ADHD, addressing a significant need for effective medication in both children and adults.

Uses and Administration

Uses:

  • Azstarys is primarily used to treat ADHD in patients aged six years and older.

Administration:

  • The medication is taken orally, usually once daily in the morning, with or without food. The capsules should be swallowed whole. If swallowing is difficult, the capsule can be opened and the contents mixed with water or applesauce and consumed immediately.

Precautions and Considerations

Before Using Azstarys:

  • Allergies: Patients should not take Azstarys if they are allergic to dexmethylphenidate, serdexmethylphenidate, or any other methylphenidate-based medications.
  • Heart Conditions: Stimulants have been associated with stroke, heart attack, and sudden death in people with heart defects or high blood pressure. A thorough cardiac history is essential before starting this medication.
  • Mental Health: Azstarys can exacerbate or trigger new psychosis symptoms in individuals with a history of mental illness or bipolar disorder.
  • Substance Use: The medication has potential for habit formation. It should be used cautiously in individuals with a history of drug or alcohol abuse.

Potential Side Effects:

  • Serious Side Effects: Signs of heart problems (chest pain, difficulty breathing), psychosis (hallucinations, paranoia), circulation problems (numbness, cold extremities), and prolonged painful erections.
  • Common Side Effects: Loss of appetite, weight loss, stomach pain, nausea, vomiting, dizziness, increased heart rate, high blood pressure, mood changes, and insomnia.

Patients should report side effects to their healthcare provider or the FDA at 1-800-FDA-1088.

Interactions and Storage

Drug Interactions:

  • Azstarys can interact with various medications, including antidepressants and blood pressure drugs. Patients must inform their doctor about all medications they are currently taking.

Storage:

  • The medication should be stored at room temperature, away from moisture, heat, and light. It should be kept out of reach of children and securely stored to prevent misuse.

Dosage Information

Adult Dosage:

  • Initial dose: 39.2 mg/7.8 mg once a day
  • After one week: Increased to 52.3 mg/10.4 mg once a day
  • Maintenance dose: 52.3 mg/10.4 mg once a day
  • Maximum dose: 52.3 mg/10.4 mg per day

Pediatric Dosage (6-12 years):

  • Initial dose: 39.2 mg/7.8 mg once a day
  • Adjustments after one week based on response and tolerability: 26.1 mg/5.2 mg to 52.3 mg/10.4 mg once a day
  • Maximum dose: 52.3 mg/10.4 mg per day

Pediatric Dosage (13 years and older):

  • Initial dose: 39.2 mg/7.8 mg once a day in the morning
  • After one week: Increased to 52.3 mg/10.4 mg once a day
  • Maintenance dose: 52.3 mg/10.4 mg once a day
  • Maximum dose: 52.3 mg/10.4 mg per day

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