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ADHANSIA XR |
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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% |
* Includes insomnia, initial insomnia, and delayed sleep phase | |||||||||
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ADHANSIA XR |
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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% |
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ADHANSIA XR |
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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% |
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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 |
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Do not administer ADHANSIA XR concomitantly with MAOIs or within 14 days after discontinuing MAOI treatment. |
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selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue |
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May change the release, PK profiles and alter the pharmacodynamics of ADHANSIA XR. |
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Monitor patients for changes in clinical effect and use alternative therapy based on clinical response. |
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Omeprazole, esomeprazole, pantoprazole, famotidine, sodium bicarbonate |
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ADHANSIA XR may decrease the
effectiveness of drugs used to treat hypertension |
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Monitor blood pressure and adjust the dosage of the antihypertensive drug as needed. |
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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 |
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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). |
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Monitor for signs of EPS. |
n: number of subjects included in the primary efficacy
analysis set; SD: standard deviation; SE: standard error; LS Mean:
least-squares mean; CI: confidence interval, not adjusted for multiple
comparisons. a Difference (drug minus placebo) in least-squares mean change from baseline. * Doses that are statistically significantly different from placebo after adjusting for multiplicity. |
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Study 1 | 25 mg | 75 | 36.1 (8.1) | -11.6 (1.31) | -1.9 (-5.6, 1.7) |
45 mg* | 73 | 36.5 (7.2) | -16.8 (1.34) | -7.1 (-10.8, -3.4) | |
70 mg | 71 | 35.4 (7.4) | -12.0 (1.37) | -2.3 (-6.0, 1.4) | |
100 mg* | 72 | 37.0 (7.9) | -17.6 (1.39) | -7.9 (-11.6, -4.1) | |
Placebo | 77 | 35.7 (8.4) | -9.7 (1.32) | -- | |
Study 3 | 25 mg | 71 | 37.7 (8.7) | -12.8 (1.35) | -2.2 (-5.9, 1.6) |
45 mg* | 68 | 36.4 (8.5) | -16.0 (1.39) | -5.4 (-9.2, -1.6) | |
70 mg* | 72 | 35.9 (8.4) | -15.8 (1.35) | -5.2 (-9.0, -1.4) | |
85 mg | 70 | 37.8 (8.1) | -15.0 (1.39) | -4.4 (-8.2, -0.6) | |
Placebo | 71 | 37.3 (8.4) | -10.6 (1.35) | -- |
n: number of subjects in the primary efficacy analysis
set; SD: standard deviation; SE: standard error; LS Mean: least-squares
mean; CI: confidence interval, not adjusted for multiple comparisons. a Difference (drug minus placebo) in least-squares mean of post-dose scores. b In each treatment group, three subjects did not have a pre-dose score. Hence, the actual numbers of patients included in the primary analysis were 113 and 110 respectively. |
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Study 2 | Average PERMP-T | ADHANSIA XR | 45 | 225.1 (76.7) | 281.3 (4.33) | 26.80 (15.19, 38.41) |
Placebo | 45 | 235.7 (65.4) | 254.5 (4.63) | -- | ||
Study 5 | Average PERMP-T | ADHANSIA XR | 116b | 258.2 (89.2) | 302.9 (3.50) | 16.3 (7.6, 24.9) |
Placebo | 113b | 275.2 (105.8) | 286.6 (3.52) | – | ||
Study 4 | Average SKAMP-C | ADHANSIA XR | 74 | 14.4 (10.6) | 10.3 (0.74) | -8.6 (-10.6, -6.6) |
Placebo | 73 | 11.5 (7.1) | 18.9 (0.73) |
This Medication Guide has been approved by the U.S. Food and Drug Administration. | Revised 6/2021 |
ADHANSIA (ad han' see ah) XR® (methylphenidate hydrochloride) extended-release capsules, CII |
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ADHANSIA XR can cause serious side effects, including:
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ADHANSIA XR is a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years of age and older. ADHANSIA XR may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD. It is not known if ADHANSIA XR is safe and effective in children under 6 years of age. |
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ADHANSIA XR and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be changed during treatment with ADHANSIA XR. Your healthcare provider will decide whether ADHANSIA XR can be taken with other medicines. Know the medicines that you or your child take. Keep a list of the medicines with you to show your healthcare provider and pharmacist. |
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Avoid drinking alcohol during treatment with ADHANSIA XR. This may cause a faster release of the ADHANSIA XR medicine. |
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Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
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Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ADHANSIA XR for a condition for which it was not prescribed. Do not give ADHANSIA XR to other people, even if they have the same symptoms. It may harm them and it is against the law. You can ask your healthcare provider or pharmacist for information about ADHANSIA XR that was written for healthcare professionals. |
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To report SUSPECTED ADVERSE REACTIONS, contact Purdue Pharma L.P. at 1-888-726-7535 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. |