Azstarys
- Generic Name: serdexmethylphenidate and dexmethylphenidate capsules
- Brand Name: Azstarys
Azstarys (Serdexmethylphenidate and Dexmethylphenidate Capsules) side effects drug center
- Related Drugs
- decreased appetite,
- insomnia,
- nausea,
- vomiting,
- heartburn/indigestion,
- abdominal pain,
- weight loss,
- anxiety,
- dizziness,
- irritability,
- mood changes,
- fast heart rate, and
- increased blood pressure
- monoamine oxidase inhibitors (MAOIs),
- antihypertensive drugs (such as potassium-sparing and thiazide diuretics, calcium channel blockers, angiotensin-converting-enzyme (ACE) inhibitors, angiotensin II receptor blockers [ARBs], beta blockers, and centrally acting alpha-2 receptor agonists),
- halogenated anesthetics, and
- risperidone
- Abuse and Dependence [see BOXED WARNING, WARNINGS AND PRECAUTIONS, and Drug Abuse And Dependence]
- Known hypersensitivity to methylphenidate or other ingredients of AZSTARYS [see CONTRAINDICATIONS]
- Hypertensive Crisis with Concomitant Use of Monoamine Oxidase Inhibitors [see CONTRAINDICATIONS]
- Serious Cardiovascular Reactions [see WARNINGS AND PRECAUTIONS]
- Blood Pressure and Heart Rate Increases [see WARNINGS AND PRECAUTIONS]
- Psychiatric Adverse Reactions [see WARNINGS AND PRECAUTIONS]
- Priapism [see WARNINGS AND PRECAUTIONS]
- Peripheral Vasculopathy, including Raynaud's Phenomenon [see WARNINGS AND PRECAUTIONS]
- Long-Term Suppression of Growth [see WARNINGS AND PRECAUTIONS]
What Is Azstarys?
Azstarys (serdexmethylphenidate and dexmethylphenidate) is a central nervous system (CNS) stimulant used to treat Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older.
What Are Side Effects of Azstarys?
Side effects of Azstarys include:
Dosage for Azstarys
The recommended starting dose of Azstarys for pediatric patients 6 to 12 years is 39.2 mg/7.8 mg orally once daily in the morning. The dosage may be increased to 52.3 mg/10.4 mg daily or decreased to 26.1 mg/5.2 mg daily after one week. The maximum recommended dosage is 52.3 mg/10.4 mg once daily. The recommended starting dose of Azstarys for adults and pediatric patients 13 to 17 years is 39.2 mg/7.8 mg orally once daily in the morning. Increase the dosage after one week to 52.3 mg/10.4 mg once daily.
Azstarys In Children
The safety and effectiveness of Azstarys have been established in pediatric patients ages 6 to 17 years of age for the treatment of ADHD.
The long-term efficacy of methylphenidate in pediatric patients has not been established.
The safety and effectiveness of Azstarys in pediatric patients less than 6 years have not been established.
What Drugs, Substances, or Supplements Interact with Azstarys?
Azstarys may interact with other medicines such as:
Tell your doctor all medications and supplements you use.
Azstarys During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Azstarys; there may be risks to the fetus associated with the use of CNS stimulants use during pregnancy. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including Azstarys, during pregnancy. It is unknown if Azstarys passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Azstarys (serdexmethylphenidate and dexmethylphenidate) Capsules, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Azstarys Professional Information
SIDE EFFECTS
The following are discussed in more detail in other sections of the labeling:
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Clinical Trials Experience With Other Methylphenidate Products In Pediatric Patients And Adults With ADHD
Commonly reported (≥ 5% of the methylphenidate group and at least twice the rate of the placebo group) adverse reactions from placebo-controlled trials of methylphenidate products include: decreased appetite, decreased weight, nausea, abdominal pain, dyspepsia, vomiting, insomnia, anxiety, affect lability, irritability, dizziness, increased blood pressure, and tachycardia.
Clinical Trials Experience With AZSTARYS In Pediatric Patients (6 to 12 years) With ADHD
Short-Term Study
A short-term study conducted in pediatric patients 6 to 12 years of age with ADHD was comprised of a 3-week, open-label, dose optimization phase in which all patients received AZSTARYS (n=155), followed by a 1-week, double-blind, controlled phase in which patients were randomized to continue AZSTARYS (n=74) or switch to placebo (n=76). Because of the study design, the reported adverse reaction rates cannot be used to predict the rates that may be expected in clinical practice.
Long-Term Study
A long-term, open-label safety study was conducted in pediatric patients 6 to 12 years of age with ADHD who either completed the short-term study or were de novo patients. This study was comprised of a 3-week dose optimization phase for patients not recently treated with AZSTARYS followed by a 12-month treatment phase for all patients during which 238 patients received openlabel AZSTARYS and had evaluable safety data. A total of 154 patients were treated for 12 months. Because of the open-label, uncontrolled design of this study, the reported adverse reaction rates cannot be assessed in terms of a causal relationship to AZSTARYS treatment.
To adjust for normal growth, z-scores were derived (measured in standard deviations [SD]); z- scores normalize for the natural growth of children and adolescents by comparisons to ageand sex-matched population standards. A z-score change less than 0.5 SD is considered not clinically significant.
In this study, the mean increase in weight from baseline to Month 12 was 3.4 kg among study completers. The mean change in z-score from baseline to Month 12 was -0.20, indicating a lower than expected increase in body weight compared to children of the same age and sex, on average. Most of the weight z-score decline occurred in the first 4 months of treatment.
The mean increase in height from baseline to Month 12 was 4.9 cm among completers. Using the same z-score analysis for height, the mean change in z-score from baseline to Month 12 was - 0.21, indicating a lower than expected increase in height compared to pediatric patients of the same age and sex, on average.
Postmarketing Experience
The following adverse reactions have been identified during post approval use of methylphenidate products. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These adverse reactions are as follows:
Blood and Lymphatic System Disorders: pancytopenia, thrombocytopenia, thrombocytopenic purpura
Cardiac Disorders: angina pectoris, bradycardia, extrasystole, supraventricular tachycardia, ventricular extrasystole, palpitations, increased heart rate
Eye Disorders: diplopia, mydriasis, visual impairment, blurred vision
General Disorders: chest pain, chest discomfort, hyperpyrexia
Gastrointestinal Disorders: dry mouth
Hepatobiliary disorders: hepatocellular injury, acute hepatic failure
Immune System Disorders: hypersensitivity reactions such as angioedema, anaphylactic reactions, auricular swelling, bullous conditions, exfoliative conditions, urticarias, pruritus NEC, rashes, eruptions, and exanthemas NEC
Investigations: alkaline phosphatase increased, bilirubin increased, hepatic enzyme increased, platelet count decreased, white blood cell count abnormal
Musculoskeletal, Connective Tissue and Bone Disorders: arthralgia, myalgia, muscle twitching, rhabdomyolysis, muscle cramps
Nervous System: convulsion, grand mal convulsion, dyskinesia, serotonin syndrome in combination with serotonergic drugs, nervousness, headache, tremor, drowsiness, vertigo
Psychiatric Disorders: disorientation, libido changes, hallucination, hallucination auditory, hallucination visual, logorrhea, mania, restlessness, agitation
Skin and Subcutaneous Tissue Disorders: alopecia, erythema, hyperhidrosis
Urogenital System: priapism
Vascular Disorders: Raynaud's phenomenon
DRUG INTERACTIONS
Clinically Important Interactions With AZSTARYS
Table 1 presents clinically important drug interactions with AZSTARYS.
Table 1: Clinically Important Drug Interactions with AZSTARYS
| Monoamine Oxidase Inhibitors (MAOIs) | |
| Clinical Impact: | Concomitant use of MAOIs and CNS stimulants, including AZSTARYS, can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure [see CONTRAINDICATIONS]. |
| Intervention: | Do not administer AZSTARYS concomitantly with MAOIs or within 14 days after discontinuing MAOI treatment [see CONTRAINDICATIONS]. |
| Examples: | Selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue |
| Antihypertensive Drugs | |
| Clinical Impact | AZSTARYS may decrease the effectiveness of drugs used to treat hypertension [see WARNINGS AND PRECAUTIONS]. |
| Intervention | Monitor blood pressure and adjust the dosage of the antihypertensive drug, as needed. |
| Examples | Potassium-sparing and thiazide diuretics, calcium channel blockers, angiotensin-converting-enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), beta blockers, centrally acting alpha-2 receptor agonists. |
| Halogenated Anesthetics | |
| Clinical Impact | Concomitant use of halogenated anesthetics and AZSTARYS may increase the risk of sudden blood pressure and heart rate increase during surgery. |
| Intervention | Avoid use of AZSTARYS in patients being treated with anesthetics on the day of surgery. |
| Examples | Halothane, isoflurane, enflurane, desflurane, sevoflurane. |
| Risperidone | |
| Clinical Impact | Combined use of methylphenidate with risperidone when there is a change, whether an increase or decrease, in dosage of either or both medications, may increase the risk of extrapyramidal symptoms (EPS). |
| Intervention | Monitor for signs of EPS. |
Drug Abuse And Dependence
Controlled Substance
AZSTARYS contains dexmethylphenidate hydrochloride, a Schedule II controlled substance, and serdexmethylphenidate. (Controlled substance schedule of serdexmethylphenidate to be determined after review by the Drug Enforcement Administration.)
Abuse
CNS stimulants including AZSTARYS, other methylphenidate-containing products, and amphetamines have a high potential for abuse. Abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Both abuse and misuse may lead to addiction, and some individuals may develop addiction even when taking AZSTARYS as prescribed.
Signs and symptoms of CNS stimulant abuse include increased heart rate, respiratory rate, blood pressure, and/or sweating, dilated pupils, hyperactivity, restlessness, insomnia, decreased appetite, loss of coordination, tremors, flushed skin, vomiting, and/or abdominal pain. Anxiety, psychosis, hostility, aggression, suicidal or homicidal ideation have also been observed. Individuals who abuse CNS stimulants may chew, snort, inject, or use other unapproved routes of administration which can result in overdose and death [see OVERDOSAGE].
To reduce the abuse of AZSTARYS, assess the risk of abuse prior to prescribing. After prescribing, keep careful prescription records, educate patients and their families about abuse and on proper storage and disposal of CNS stimulants, monitor for signs of abuse while on therapy, and re-evaluate the need for AZSTARYS use.
Dependence
Physical Dependence
AZSTARYS may produce physical dependence from continued therapy. Physical dependence is a state of adaptation manifested by a withdrawal syndrome produced by abrupt cessation, rapid dose reduction, or administration of an antagonist. Withdrawal symptoms after abrupt cessation following prolonged high-dosage administration of CNS stimulants include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation.
Tolerance
AZSTARYS may produce tolerance from continued therapy. Tolerance is a state of adaptation in which exposure to a drug results in a reduction of the drug's desired and/or undesired effects over time.
Read the entire FDA prescribing information for Azstarys (Serdexmethylphenidate and Dexmethylphenidate Capsules)