ADZENYS XR-ODT Dosing and administration considerations for all patients
Adzenys XR-ODT may be taken with or without food. Individualize the dosage according to the therapeutic needs and response of the patient. Adzenys XR-ODT should be taken as follows:
- The tablet should remain in the blister pack until the patient is ready to take it.
- The patient or caregiver should use dry hands to open the blister.
- Tear along the perforation, bend the blister where indicated and peel back the blister’s labeled backing to take out the tablet. The tablet should not be pushed through the foil.
- As soon as the blister is opened, the tablet should be removed and placed on the patient’s tongue.
- The whole tablet should be placed on the tongue and allowed to disintegrate without chewing or crushing.
- The tablet will disintegrate in saliva so that it can be swallowed.
INSTRUCTIONS FOR OPENING BLISTER PACK
Do not push the tablet through the foil
Opening the Adzenys XR-ODT
This video can instruct your patients on the proper method for opening the Adzenys XR-ODT blister pack.
Prior to treating with Adzenys XR-ODT, assess your patients for:
- The presence of cardiac disease.
- The risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy.
Please see additional Important Safety Information below.
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- Known hypersensitivity to amphetamine or other ingredients in Adzenys XR-ODT or Adzenys ER. Angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products.
- Taking a monoamine oxidase inhibitor (MAOI), or have taken an MAOI within the past 14 days. Hypertensive crisis can occur.
- Serious Cardiovascular Reactions: Sudden death has been reported in association with CNS stimulant treatment at recommended doses in pediatric patients with structural cardiac abnormalities or other serious heart problems. In adults, sudden death, stroke, and myocardial infarction have been reported. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during either Adzenys XR-ODT or Adzenys ER treatment.
- Blood Pressure and Heart Rate Increases: CNS stimulants can cause an increase in blood pressure (mean increase about 2-4 mm Hg) and heart rate (mean increase about 3-6 bpm). Consider this before prescribing and monitor blood pressure and pulse.
- Psychiatric Adverse Reactions: CNS stimulants may cause psychotic or manic symptoms in patients with no prior history, or exacerbate symptoms of behavior disturbance and thought disorder in patients with pre-existing psychosis. Assess for bipolar disorder prior to treatment.
- Long-Term Suppression of Growth: Closely monitor weight and height in pediatric patients treated with either Adzenys XR-ODT or Adzenys ER. Treatment may need to be interrupted.
- Peripheral Vasculopathy, including Raynaud's Phenomenon: Signs and symptoms are usually intermittent and mild; very rare sequelae include digital ulceration and/or soft tissue breakdown. Careful observation for digital changes is necessary.
- Serotonin Syndrome: Increased risk may occur when amphetamines are co-administered with serotonergic agents (such as MAOIs, selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), or triptans), and during overdosage situations. If it occurs, discontinue either Adzenys XR-ODT or Adzenys ER and initiate supportive treatment.
- Potential for Overdose Due to Medication Errors: Substitution and dispensing errors with other amphetamine products could occur, leading to possible overdosage. Do not substitute for other amphetamine products on a milligram-per-milligram basis, because of different amphetamine base compositions and differing pharmacokinetic profiles.
- Potential for Intestinal Necrosis: Adzenys ER contains sodium polystyrene sulfonate (SPS) and sorbitol. There have been cases of intestinal necrosis, including some deaths, with the concomitant use of these ingredients in treating hyperkalemia with doses of SPS greater than 200 times the amount present in Adzenys ER. No absolute safe levels for the interaction of SPS and sorbitol have been established.
- Children (ages 6 - 12): loss of appetite, insomnia, abdominal pain, emotional lability, vomiting, nervousness, nausea, and fever.
- Adolescents (ages 13 - 17): loss of appetite, insomnia, abdominal pain, weight loss, and nervousness.
- Adults: dry mouth, loss of appetite, insomnia, headache, weight loss, nausea, anxiety, agitation, dizziness, tachycardia, diarrhea, asthenia, and urinary tract infections.
Based on animal data, may cause fetal harm. Amphetamines, such as Adzenys XR-ODT and Adzenys ER, can increase the risk of premature delivery, and infants born to amphetamine dependent mothers have an increased risk of low birth weight.
Breastfeeding is not recommended during treatment with Adzenys XR-ODT or Adzenys ER.
Adzenys XR-ODT and Adzenys ER are central nervous system (CNS) stimulants indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older.