Apomorphine hydrochloride
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alberto Plate [2]
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Overview
Apomorphine hydrochloride is a non-ergoline dopamine agonist that is FDA approved for the treatment of advanced Parkinson's diseases. Common adverse reactions include yawning, drowsiness/somnolence, dyskinesias, dizziness/postural hypotension, rhinorrhea, nausea and/or vomiting, hallucination/confusion, and edema/swelling of extremities.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Premedication and Concomitant Medication
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.
Dosing Information
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). 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).
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.
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.
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.
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.
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.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Apomorphine hydrochloride in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Apomorphine hydrochloride in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Apomorphine hydrochloride FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Apomorphine hydrochloride in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Apomorphine hydrochloride in pediatric patients.
Contraindications
There is limited information regarding Apomorphine hydrochloride Contraindications in the drug label.
Warnings
There is limited information regarding Apomorphine hydrochloride Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Apomorphine hydrochloride Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Apomorphine hydrochloride Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Apomorphine hydrochloride Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Apomorphine hydrochloride in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Apomorphine hydrochloride in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Apomorphine hydrochloride during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Apomorphine hydrochloride in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Apomorphine hydrochloride in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Apomorphine hydrochloride in geriatric settings.
Gender
There is no FDA guidance on the use of Apomorphine hydrochloride with respect to specific gender populations.
Race
There is no FDA guidance on the use of Apomorphine hydrochloride with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Apomorphine hydrochloride in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Apomorphine hydrochloride in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Apomorphine hydrochloride in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Apomorphine hydrochloride in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Apomorphine hydrochloride Administration in the drug label.
Monitoring
There is limited information regarding Apomorphine hydrochloride Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Apomorphine hydrochloride and IV administrations.
Overdosage
There is limited information regarding Apomorphine hydrochloride overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Apomorphine hydrochloride Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Apomorphine hydrochloride Mechanism of Action in the drug label.
Structure
There is limited information regarding Apomorphine hydrochloride Structure in the drug label.
Pharmacodynamics
There is limited information regarding Apomorphine hydrochloride Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Apomorphine hydrochloride Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Apomorphine hydrochloride Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Apomorphine hydrochloride Clinical Studies in the drug label.
How Supplied
There is limited information regarding Apomorphine hydrochloride How Supplied in the drug label.
Storage
There is limited information regarding Apomorphine hydrochloride Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Apomorphine hydrochloride Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Apomorphine hydrochloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Apomorphine hydrochloride Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Apomorphine hydrochloride Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.