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AZSTARYS is a brand name for Serdexmethylphenidate. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE AZSTARYS is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older. Limitations of Use The use of AZSTARYS is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher…
Verbatim from this product's FDA label. Tap a section to expand.
8 mg orally once daily in the morning. 2 mg daily after one week. 4 mg once daily. 8 mg orally once daily in the morning. 4 mg once daily depending on response and tolerability. 2 ) Administer with or without food. 3 ) Swallow capsules whole or open and sprinkle onto applesauce or add to water.
3 ) To avoid substitution errors and overdosage, do not substitute for other methylphenidate products on a milligram-per-milligram basis. 2 )]. 10 )]. 8 mg dexmethylphenidate once daily in the morning. 2 mg dexmethylphenidate per day, depending on response and tolerability.
4 mg dexmethyphenidate once daily. 8 mg dexmethylphenidate once daily in the morning. 4 mg dexmethylphenidate per day, depending on response and tolerability. 4 mg dexmethylphenidate once daily. 3 )] . AZSTARYS capsules may be taken whole, or opened and the entire contents sprinkled into 50 mL of water or over 2 tablespoons of applesauce.
3 )] . 4 Switching from Other Methylphenidate Products If switching from other methylphenidate products, discontinue that treatment, and titrate with AZSTARYS using the titration schedule described above. 3 )] . 5 Dosage Reduction and Discontinuation If paradoxical aggravation of symptoms or other adverse reactions occur, reduce dosage or, if necessary, discontinue AZSTARYS.
If improvement is not observed after appropriate dosage adjustment over a one-month period, discontinue AZSTARYS.
10) ] Based on accumulated data from other methylphenidate products, the most common (>5% and twice the rate of placebo) adverse reactions are appetite decreased, insomnia, nausea, vomiting, dyspepsia, abdominal pain, weight decreased, anxiety, dizziness, irritability, affect lability, tachycardia, and blood pressure increased.
gov/medwatch. 1 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.
Adverse Reactions in Studies 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.
Adverse Reactions in Studies 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.
5 WARNINGS AND PRECAUTIONS Risks to Patients with Serious Cardiac Disease : Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac disease.
2) Increased Blood Pressure and Heart Rate : Monitor blood pressure and pulse. 3) Psychiatric Adverse Reactions : Prior to initiating AZSTARYS, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing AZSTARYS.
4) Priapism : If abnormally sustained or frequent and painful erections occur, patients should seek immediate medical attention. 5) Peripheral Vasculopathy, including Raynaud's Phenomenon : Careful observation for digital changes is necessary during AZSTARYS treatment with ADHD stimulants.
, rheumatology referral) may be appropriate for patients who develop signs or symptoms of peripheral vasculopathy. 6) Long-Term Suppression of Growth in Pediatric Patients : Monitor height and weight at appropriate intervals in pediatric patients.
, patients with significant hyperopia) should be evaluated by an ophthalmologist. 8) Increased Intraocular Pressure (IOP) and Glaucoma : Prescribe AZSTARYS to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk.
Closely monitor patients with a history of increased IOP or open angle glaucoma. 9) Motor and Verbal Tics, and Worsening of Tourette’s Syndrome: Before initiating AZSTARYS, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome.
Regularly monitor patients for the emergence or worsening of tics or Tourette’s syndrome. Discontinue treatment if clinically appropriate. 1 Abuse, Misuse, and Addiction AZSTARYS has a high potential for abuse and misuse. The use of AZSTARYS exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction.
4 CONTRAINDICATIONS AZSTARYS is contraindicated in patients: with known hypersensitivity to serdexmethylphenidate, methylphenidate, or other components of AZSTARYS. Bronchospasm, rash, and pruritus have been reported in patients who received AZSTARYS.
2 )] . 1 )] . Known hypersensitivity to serdexmethylphenidate, methylphenidate, or product components. ( 4 ) Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days. ( 4 )
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 open- label 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 age- and sex-matched population standards.
5 SD is considered not clinically significant. 4 kg among study completers. 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.
9 cm among completers. 21, indicating a lower than expected increase in height compared to pediatric patients of the same age and sex, on average. 2 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, increased intraocular pressure, 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, motor and verbal tics 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
2) ] . Misuse and abuse of CNS stimulants, including AZSTARYS, can result in overdose and death [see Overdosage ( 10 )], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.
Before prescribing AZSTARYS, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks and proper disposal of any unused drug. Advise patients to store AZSTARYS in a safe place, preferably locked, and instruct patients to not give AZSTARYS to anyone else.
Throughout AZSTARYS treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction. 2 Risks to Patients with Serious Cardiac Disease Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD dosage.
Avoid AZSTARYS use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease. 3 Increased Blood Pressure and Heart Rate CNS stimulants cause an increase in blood pressure (mean increase approximately 2 to 4 mmHg) and heart rate (mean increase approximately 3 to 6 beats per minute).
Some patients may have larger increases. Monitor all AZSTARYS-treated patients for hypertension and tachycardia. 4 Psychiatric Adverse Reactions Exacerbation of Pre-Existing Psychosis CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.
Induction of a Manic Episode in Patients with Bipolar Disorder CNS stimulants may induce a manic or mixed mood episode in patients. , comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, or depression).
, hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania. 1% of CNS stimulant-treated patients, compared to 0% of placebo-treated patients. If such symptoms occur, consider discontinuing AZSTARYS.
5 Priapism Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate use, in both adult and pediatric male patients. Although priapism was not reported with methylphenidate initiation, it developed after some time on methylphenidate, often subsequent to an increase in dosage.
Priapism also occurred during methylphenidate withdrawal (drug holidays or during discontinuation). AZSTARYS-treated patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.
6 Peripheral Vasculopathy, including Raynaud's Phenomenon CNS stimulants used to treat ADHD, including AZSTARYS, are associated with peripheral vasculopathy, including Raynaud's phenomenon. Signs and symptoms are usually intermittent and mild; however, sequelae have included digital ulceration and/or soft tissue breakdown.
Effects of peripheral vasculopathy, including Raynaud's phenomenon, were observed in post- marketing reports and at the therapeutic dosage of CNS stimulants in all age groups throughout the course of treatment. Signs and symptoms generally improved after dosage reduction or discontinuation of the CNS stimulant.
Careful observation for digital changes is necessary during AZSTARYS treatment. , rheumatology referral) may be appropriate for AZSTARYS-treated patients who develop signs or symptoms of peripheral vasculopathy. 4 )]. CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients.
1 )] . Closely monitor growth (weight and height) in AZSTARYS-treated pediatric patients. Pediatric patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted. 8 Acute Angle Closure Glaucoma There have been reports of angle closure glaucoma associated with methylphenidate treatment.
, patients with significant hyperopia) should be evaluated by an ophthalmologist. 2) ]. Prescribe AZSTARYS to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk.
Closely monitor AZSTARYS-treated patients with a history of abnormally increased IOP or open angle glaucoma. 10 Motor and Verbal Tics, and Worsening of Tourette’s Syndrome CNS stimulants, including methylphenidate, have been associated with the onset or exacerbation of motor and verbal tics.
2) ]. Before initiating AZSTARYS, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor AZSTARYS-treated patients for the emergence or worsening of tics or Tourette’s syndrome, and discontinue treatment if clinically appropriate.