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| {{DrugProjectFormSinglePage
| | #redirect:[[Apomorphine]] |
| |authorTag={{AP}}
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| |genericName=Apomorphine hydrochloride
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| |aOrAn=a
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| |drugClass=[[non-ergoline dopamine agonist]]
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| |indicationType=treatment
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| |indication=advanced [[Parkinson's diseases]]
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| |adverseReactions=[[yawning]], [[drowsiness]]/[[somnolence]], [[dyskinesias]], [[dizziness]]/[[postural hypotension]], [[rhinorrhea]], [[nausea]] and/or [[vomiting]], [[hallucination]]/[[confusion]], and [[edema]]/[[swelling]] of extremities
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| |blackBoxWarningTitle=<b><span style="color:#FF0000;">TITLE</span></b>
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| |blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
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| |fdaLIADAdult=
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| =====Premedication and Concomitant Medication=====
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| APOKYN should be initiated with the use of a concomitant [[antiemetic]]. Oral] [[trimethobenzamide]] (300 mg three times a day) should be started 3 days prior to the initial dose of APOKYN and continued at least during the first two months of therapy. Based on reports of profound [[hypotension]] and [[loss of consciousness]] when apomorphine was administered with [[ondansetron]], the concomitant use of apomorphine with drugs of the [[5HT3 antagonist]]] class including [[antiemetics]] (for example, [[ondansetron]], [[granisetron]], [[dolasetron]], [[palonosetron]]) and alosetron are contraindicated.
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| =====Dosing Information=====
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| The recommended starting dose of APOKYN is 0.2 mL (2 mg). Titrate on the basis of effectiveness and tolerance, up to a maximum recommended dose of 0.6 mL (6 mg).
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| There is no evidence from controlled trials that doses greater than 0.6 mL (6 mg) gave an increased effect and therefore, individual doses above 0.6 mL (6 mg) are not recommended. The average frequency of dosing in the development program was 3 times per day. There is limited experience with single doses greater than 0.6 mL (6 mg), dosing more than 5 times per day and with total daily doses greater than 2 mL (20 mg).
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| Begin dosing when patients are in an "off" state. The initial dose should be a 0.2 mL (2 mg) test dose in a setting where medical personnel can closely monitor blood pressure and pulse. Both supine and standing blood pressure and pulse should be checked pre-dose and at 20 minutes, 40 minutes, and 60 minutes post-dose (and after 60 minutes, if there is significant hypotension at 60 minutes). Patients who develop clinically significant orthostatic hypotension in response to this test dose of APOKYN should not be considered candidates for treatment with APOKYN.
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| If the patient tolerates the 0.2 mL (2 mg) dose, and responds adequately, the starting dose should be 0.2 mL (2 mg), used on an as needed basis to treat recurring "off" episodes. If needed, the dose can be increased in 0.1 mL (1 mg) increments every few days on an outpatient basis.
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| The general principle guiding subsequent dosing (described in detail below) is to determine that the patient needs and can tolerate a higher test dose, 0.3 mL or 0.4 mL (3 mg or 4 mg, respectively) under close medical supervision. A trial of outpatient dosing may follow (periodically assessing both efficacy and tolerability), using a dose 0.1 mL (1 mg) lower than the tolerated test dose.
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| If the patient tolerates the 0.2 mL (2 mg) test dose but does not respond adequately, a dose of 0.4 mL (4 mg) may be administered under medical supervision, at least 2-hours after the initial test dose, at the next observed "off" period. If the patient tolerates and responds to a test dose of 0.4 mL (4 mg), the initial maintenance dose should be 0.3 mL (3 mg) used on an as needed basis to treat recurring "off" episodes as an outpatient. If needed, the dose can be increased in 0.1 mL (1 mg) increments every few days on an outpatient basis.
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| If the patient does not tolerate a test dose of 0.4 mL (4 mg), a test dose of 0.3 mL (3 mg) may be administered during a separate "off" period under medical supervision, at least 2-hours after the previous dose. If the patient tolerates the 0.3 mL (3 mg) test dose, the initial maintenance dose should be 0.2 mL (2 mg) used on an as needed basis to treat existing "off" episodes. If needed, and the 0.2 mL (2 mg) dose is tolerated, the dose can be increased to 0.3 mL (3 mg) after a few days. In such a patient, the dose should ordinarily not be increased to 0.4 mL (4 mg) on an out-patient basis.
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| |offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Apomorphine hydrochloride in adult patients.
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| |offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Apomorphine hydrochloride in adult patients.
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| |offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Apomorphine hydrochloride in pediatric patients.
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| |offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Apomorphine hydrochloride in pediatric patients.
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| |alcohol=Alcohol-Apomorphine hydrochloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
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| }}
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