Adhansia XR
- Generic Name: methylphenidate hydrochloride extended-release capsules
- Brand Name: Adhansia XR
Adhansia XR(Methylphenidate Hydrochloride Extended-release Capsules) side effects drug center
Adhansia XR Side Effects Center
What Is Adhansia XR?
Adhansia XR (methylphenidate hydrochloride) is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older. Adhansia XR is available in generic form.
What Are Side Effects of Adhansia XR?
Common side effects of Adhansia XR include:
- insomnia,
- dry mouth,
- decreased appetite, and
- weight loss
Dosage for Adhansia XR
The recommended starting dose of Adhansia XR for patients 6 years and older is 25 mg once daily in the morning. The dosage of Adhansia XR may be increased in increments of 10 to 15 mg at intervals of at least 5 days.
What Drugs, Substances, or Supplements Interact with Adhansia XR?
Adhansia XR may interact with monoamine oxidase inhibitors (MAOIs) and medications to treat excess stomach acid. Tell your doctor all medications and supplements you use.
Adhansia XR During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Adhansia XR; here is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Adhansia XR during pregnancy. Adhansia XR is believed to pass into breast milk but its effects on nursing infants are unknown. Consult your doctor before breastfeeding.
Additional Information
Our Adhansia XR (methylphenidate hydrochloride) Extended-Release 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.
Adhansia XR Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- signs of heart problems--chest pain, trouble breathing, feeling like you might pass out;
- signs of psychosis--hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia;
- signs of circulation problems--numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes; or
- penis erection that is painful or lasts 4 hours or longer (rare).
Methylphenidate can affect growth in children. Tell your doctor if your child is not growing at a normal rate.
Common side effects may include:
- excessive sweating;
- mood changes, feeling nervous or irritable, sleep problems (insomnia);
- fast heart rate, pounding heartbeats or fluttering in your chest, increased blood pressure;
- loss of appetite, weight loss;
- dry mouth, nausea, stomach pain; or
- headache.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Adhansia XR (Methylphenidate Hydrochloride Extended-release Capsules)
Adhansia XR Professional Information
SIDE EFFECTS
The following are discussed in more detail in other sections of the labeling:
- Known hypersensitivity to methylphenidate or other ingredients of ADHANSIA XR [see CONTRAINDICATIONS]
- Hypertensive crisis when used concomitantly with monoamine oxidase inhibitors [see CONTRAINDICATIONS and DRUG INTERACTIONS]
- Drug dependence [see BOXED WARNING, WARNINGS AND PRECAUTIONS, and Drug Abuse And Dependence]
- 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]
- Allergic Reactions FD&C Yellow No.5 [see WARNINGS AND PRECAUTIONS]
Clinical Trial 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 Children, Adolescents, And Adults with ADHD
Commonly reported (≥2% of the methylphenidate group and twice the rate of the placebo group) adverse reactions from placebo-controlled trials of methylphenidate products include: appetite decreased, weight decreased, nausea, abdominal pain, dyspepsia, dry mouth, vomiting, insomnia, anxiety, nervousness, restlessness, affect lability, agitation, irritability, dizziness, vertigo, tremor, blurred vision, blood pressure increased, heart rate increased, tachycardia, palpitations, hyperhidrosis, and pyrexia.
Clinical Trials Experience With ADHANSIA XR
ADHANSIA XR was studied in adults (18 to 72 years) and pediatric patients (6 to 17 years) who met Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria for ADHD.
The safety data for adults is based on three randomized, double-blind, placebo-controlled studies in doses of 25 mg to 100 mg per day. The safety data for pediatric patients (6 to 17 years) is based on two randomized, double-blind, placebo-controlled studies in doses of 25 mg to 85 mg per day.
The total number of patients exposed to ADHANSIA XR during 1 to 4-week long, controlled treatment periods is1168; this included 719 adult patients and 449 pediatric patients [156 (6 to 12 years); 293 (12 to 17 years)], from two clinical trials in adults, one in pediatric patients ages 12 to 17 years, and one in pediatric patients ages 6 to 12 years [see Clinical Studies].
Adverse Reactions Leading To Discontinuation Of Treatment
In controlled adult trials for Study 1, 3% of both of ADHANSIA XR-treated patients and placebo-treated patients discontinued due to adverse reactions. In an adult workplace environment study (Study 2), 10% of ADHANSIA XR-treated patients discontinued due to adverse reactions compared to 0% of placebo-treated patients. The following adverse reactions led to discontinuation at a frequency of 2% of ADHANSIA XR-treated patients: nausea, bronchitis, gastroenteritis viral, viral infection, blood pressure increased, and hypomania.
In an adult laboratory classroom study (Study 5), 3.5% of ADHANSIA XR-treated patients discontinued due to adverse reactions during the open-label titration period. There were no discontinuations due to adverse reactions during the double-blind period of the study.
In a controlled trial (Study 3) in pediatric patients (12 to 17 years), 3% of ADHANSIA XR-treated patients discontinued due to adverse reactions compared to 0% of placebo-treated patients. The most frequent adverse reactions leading to discontinuation in at least 1% of ADHANSIA XR-treated patients and at a rate greater that placebo was irritability (1%). Two patients taking ADHANSIA XR 70 or 85 mg had delirium leading to discontinuation.
In a controlled trial (Study 4) in pediatric patients (6 to 12 years), 1% of ADHANSIA XR-treated patients discontinued due to adverse reactions compared to 0% of placebo-treated patients.
Adult Patients With ADHD
The most common adverse reactions (incidence of ≥5% and at least twice placebo) of ADHANSIA XR occurring in controlled trials in adults (Study 1) were insomnia, dry mouth, and decreased appetite.
Table 1 lists the adverse reactions that occurred ≥2% of adult patients and greater than placebo among ADHANSIA XR-treated adult patients in Study 1.
Table 1: Adverse Reactions Occurring in ≥ 2% of Adult Patients with ADHD on ADHANSIA XR and Greater than Patients Taking Placebo in a 4-week Clinical Trial (Study 1)
| Adverse Reaction N=375 |
ADHANSIA XR | All doses ADHANSIA XR (N=297) |
Placebo (N=78) |
|||
| 25 mg (N=77) |
45 mg (N=73) |
70 mg (N=73) |
100 mg (N=74) |
|||
| Initial Insomnia | 4% | 8% | 6% | 7% | 6% | 1% |
| Insomnia | 17% | 11% | 16% | 19% | 16% | 4% |
| Dry mouth | 8% | 8% | 7% | 14% | 9% | 4% |
| Nausea | 4% | 6% | 4% | 11% | 6% | 3% |
| Diarrhea | 1% | 3% | 7% | 5% | 4% | 1% |
| Decreased appetite | 4% | 7% | 15% | 19% | 11% | 3% |
| Feeling jittery | 1% | 3% | 8% | 4% | 4% | 1% |
| Weight decreased | 3% | 4% | 3% | 5% | 4% | 1% |
| Upper respiratory tract infection | 0% | 4% | 3% | 3% | 2% | 1% |
The most common adverse reactions (incidence of ≥5%) of ADHANSIA XR occurring in adults in the open-label dose-optimization period of Study 5 were headache, decreased appetite, insomnia, irritability, upper respiratory tract infection, dry mouth, nausea, anxiety, and fatigue.
Table 2 lists adverse reactions that occurred ≥2% of adult patients in the ADHANSIA XR-treated patients and greater than placebo-treated patients for the double-blind period of study 5.
Table 2: Adverse Reactions Occurring in ≥ 2% of Adult Patients with ADHD on ADHANSIA XR and Greater than Patients Taking Placebo in the Double-Blind Period (Study 5)
| Adverse Reaction N=239 |
ADHANSIA XR | All doses ADHANSIA XR (N=121) |
Placebo (N=118) |
||||||
| 25 mg (N=3) |
35 mg (N=4) |
45 mg (N=15) |
55 mg (N=31) |
70 mg (N=30) |
85 mg (N=22) |
100 mg (N=16) |
|||
| Headache | 0% | 0% | 7% | 0% | 3% | 5% | 13% | 4% | 3% |
| Fatigue | 0% | 0% | 0% | 3% | 3% | 9% | 0% | 3% | 1% |
| Insomnia* | 0% | 0% | 0% | 0% | 7% | 5% | 0% | 3% | 2% |
| Irritability | 0% | 0% | 0% | 0% | 0% | 9% | 0% | 2% | 0% |
| Nausea | 0% | 0% | 7% | 3% | 0% | 0% | 0% | 2% | 0% |
| Dysmenorrhea | 0% | 25% | 0% | 0% | 0% | 5% | 0% | 2% | 0% |
| * Includes insomnia, initial insomnia, and delayed sleep phase | |||||||||
Pediatric Patients (12 to 17 years) With ADHD
The most common (incidence ≥5% and at least twice placebo) adverse reactions reported in pediatric patients (12 to 17 years) were decreased appetite, insomnia, and weight decreased.
Table 3 lists the adverse reactions that occurred ≥2% of pediatric patients (12 to 17 years) and greater than placebo among ADHANSIA XR-treated pediatric patients (12 to 17 years).
Table 3: Adverse Reactions Occurring in ≥ 2% of Pediatric Patients (12 to 17 years) with ADHD Taking ADHANSIA XR and Greater than Placebo in a 4-week Clinical Trial
| Adverse Reaction | ADHANSIA XR | All doses ADHANSIA XR (N=293) |
Placebo (N=74) |
|||
| 25 mg (N=73) |
45 mg (N=72) |
70 mg (N=76) |
85 mg (N=72) |
|||
| Decreased appetite | 7% | 19% | 28% | 26% | 20% | 0% |
| Insomnia | 4% | 0% | 9% | 13% | 6% | 1% |
| Initial Insomnia | 4% | 7% | 5% | 4% | 5% | 1% |
| Weight decreased | 1% | 3% | 8% | 13% | 7% | 0% |
| Abdominal pain upper | 5% | 1% | 5% | 4% | 4% | 1% |
| Nausea | 3% | 6% | 7% | 8% | 6% | 4% |
| Dizziness | 3% | 0% | 4% | 4% | 3% | 0% |
| Dry mouth | 1% | 0% | 5% | 4% | 3% | 1% |
| Vomiting | 1% | 1% | 3% | 6% | 3% | 0% |
Pediatric Patients (6 To 12 Years) With ADHD
Study 4, conducted in pediatric patients 6 to 12 years of age, was comprised of a 6-week open-label dose-optimization phase in which all patients received ADHANSIA XR (n=156; mean dose 48 mg), followed by a 1-week, double-blind controlled phase in which patients were randomized to continue ADHANSIA XR (n=75) or switch to placebo (n=73). During the open-label ADHANSIA XR treatment phase, adverse reactions reported in > 5% of patients included: decreased appetite (35%), upper abdominal pain (15%), affect lability (13%), nausea or vomiting (13%), weight decreased (12%), insomnia (10%), irritability (10%), headache (10%), and heart rate increased (5%). Because of the trial design (6-week open-label active treatment phase followed by a 1-week, randomized, double-blind, placebo-controlled withdrawal), the adverse reaction rates described in the double-blind phase are lower than expected in clinical practice. No difference occurred in the incidence of adverse reactions between ADHANSIA XR and placebo during the 1-week, double-blind, placebo-controlled treatment phase.
Post-marketing 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
Eye Disorders: diplopia, mydriasis, visual impairment
General Disorders: chest pain, chest discomfort, hyperpyrexia
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, rashes, eruptions, and
exanthemas
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
Nervous System Disorders: convulsion, grand mal convulsion, dyskinesia, serotonin syndrome in combination with serotonergic drugs
Psychiatric Disorders: disorientation, hallucination, hallucination auditory, hallucination visual, libido changes, logorrhea, mania
Skin and Subcutaneous Tissue Disorders: alopecia, erythema
Urogenital System: priapism
Vascular Disorders: Raynaud's phenomenon
DRUG INTERACTIONS
Clinically Important Drug Interactions
Table 3 presents clinically important drug interactions with ADHANSIA XR.
Table 3: Drugs Having Clinically Important Interactions with ADHANSIA XR
| Monoamine Oxidase Inhibitors (MAOI) | |
| Clinical Impact: | Concomitant use of MAOIs and CNS stimulants 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 ADHANSIA XR concomitantly with MAOIs or within 14 days after discontinuing MAOI treatment. |
| Examples: | selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue |
| Gastric pH Modulators | |
| Clinical Impact: | May change the release, PK profiles and alter the pharmacodynamics of ADHANSIA XR. |
| Intervention: | Monitor patients for changes in clinical effect and use alternative therapy based on clinical response. |
| Examples: | Omeprazole, esomeprazole, pantoprazole, famotidine, sodium bicarbonate |
| Antihypertensive Drugs | |
| Clinical Impact: | ADHANSIA XR 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 |
| 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). |
Drug Abuse And Dependence
Controlled Substance
ADHANSIA XR contains methylphenidate, a Schedule II controlled substance.
Abuse
CNS stimulants including ADHANSIA XR, 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. Abuse is characterized by impaired control over drug use, compulsive use, continued use despite harm, and craving.
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. Abusers of 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 CNS stimulants including ADHANSIA XR, 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 ADHANSIA XR use.
Dependence
ADHANSIA XR 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
ADHANSIA XR 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 Adhansia XR (Methylphenidate Hydrochloride Extended-release Capsules)
&Copy; Adhansia XR Patient Information is supplied by Cerner Multum, Inc. and Adhansia XR Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.