Nonmotor symptoms in Parkinson's disease: expanding the view of Parkinson's disease beyond a pure motor, pure dopaminergic problem. WARNING: Attach the cassette properly. Some patients with PD report wearing off or freezing that may affect their ability to perform as desired in sexual intercourse. DUOPA can pass into your milk and may harm your baby. At power up and at regular intervals thereafter, the motor circuit is checked to ensure that no power is being applied to the motor unless the motor is actually on. NOTE: The default setting for Reservoir Volume is Not in Use. Close the tubing clamp. Low blood pressure when you sit or stand up quickly. WARNING: Clamp the fluid path tubing and/or disconnect the tubing from the enteral access device before removing the medication cassette reservoir from the pump to prevent uncontrolled delivery of medication, which could compromise patient treatment. (If you do not wish to use the reservoir volume feature, scroll down to Not In Use located before 1 or after 9999.). What are the possible side effects of DUOPA? The Licensed Computer Program is supplied only in machine-readable object code form and is based upon Manufacturers proprietary confidential information. The keys on the keypad are described below. Merola A, Zibetti M, Angrisano S, Rizzi L, Lanotte M, Lopiano L. Comparison of subthalamic nucleus deep brain stimulation and Duodopa in the treatment of advanced Parkinson's disease. A small pump (CADD-Legacy 1400) is used to move DUOPA from the medication cassette through your PEG-J tube. Therefore, we believe it preferable to flush daily, which can serve as a check to ensure that medication is flowing properly and that the J portion of the tube is not kinked. The biomed functions are accessible only when the pump is stopped and in lock level 0 (LL0). During every pump activation, the software checks to see whether the motor completes one activation. The lock level must be changed to LL1 or LL2 to prevent the patient from having complete access to all programming and operating functions. This screen shows the total amount of medication delivered since the last time this value was cleared. Check tubing for clamps, kinks, or blockages. Refer to AbbVies full prescribing information for DUOPA (carbidopa and levodopa) enteral suspension for indications and usage, contraindications, warnings, precautions, and adverse reactions. At power up and at regular intervals thereafter, the program memory is tested by calculating a cyclic redundancy code (CRC) on the program and then comparing it with the CRC stored with the program. If a key is being pressed, stop pressing it. Get Label RSS Feed, Fully thaw DUOPA in the refrigerator prior to dispensing. If it is not possible to flush the tubes, contact your healthcare provider as your tube may be blocked. The DUOPA cassette can remain attached to the pump until the tubing is reconnected. Watchdog timer circuitry is provided to monitor the status of the microprocessor and disable the motor and enable the audible alarm if the microprocessor fails to function properly. If you do not wish to use the reservoir volume feature, scroll down to Not In Use (located before 1 and after 9999 in the range of values). Use only Smiths Medical accessories and replacement parts, as using other brands may adversely affect the operation of the pump. Some of these events have been reported more than one year after initiation of treatment. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. Martinez-Martin P, Reddy P, Katzenschlager R, Antonini A, Todorova A, Odin P, et al. The current morning dose value (or the default value of 0 ml) will appear UNLESS the morning dose is currently locked out (in which case the screen will not appear). within 25 seconds to confirm a change or the screen will revert to the previous setting. used to enter (save) a new value in the pumps memory when programming doses or pump settings or to clear values from record-keeping screens. Check the cassette latch on the side of the pump and make sure the line on the latch lines up with the arrow on the side of the pump. CAUTION: When the upstream occlusion sensor is turned off, the pump will not detect occlusions in the medication cassette reservoir. Merola A, Romagnolo A, Comi C, Rosso M, Artusi CA, Zibetti M, et al. Inclusion in an NLM database does not imply endorsement of, or agreement with, The AA batteries serve as the primary source of power, or as backup power when an ACadapter is in use. The decision to switch a patient to 24-h LCIG infusion is therefore highly patient specific. Yes it is slower to kick in. A broken or damaged seal will, therefore, be considered conclusive evidence that the pump has been misused and/or altered, which voids any and all warranties. Dose reductions may also be made only to the night-time dose, whereby night-time rates could be reduced by 5080% of daytime rates. If the Morning Dose on the preceding day was greater than 6 mL, increase the Morning Dose by 2 mL. The pumping action will stop automatically when 1 ml has been delivered. Because DUOPA is administered using a PEG-J or naso-jejunal tube, gastrointestinal complications can occur. The biomed functions are pump configurations that are less frequently changed. What is the most important information I should know about DUOPA? ), More about getting RSS News & Updates from DailyMed. Many patients express that they are no longer bothered by the idea of the pump/PEG-J port after several weeks. ST, VSCF, AM, MR, MJS, and NK participated in the organization and execution of the project, as well as drafting, critically reviewing, and approving the manuscript for submission. The gastric emptying rate does not influence the absorption of DUOPA since it is administered by continuous intestinal infusion. This medication comes in three dosages 10/100, 25/100 and 25/250. The open access fee was paid by AbbVie Inc. Sandeep Thakkar has received funding/grant support from Hoag Memorial Hospital Presbyterian as medical director for the Movement Disorders Program and honoraria for consultancy from Teva, AbbVie, Medtronic, Adamas, Amneal, and Neurocrine. Amedication cassette reservoir must be properly attached in order for the pump to run. Many patients with advanced PD also experience rigidity and gait imbalance at night, and we have found continuous infusion to reduce these symptoms. The extra dose frequency should be limited to one extra dose every 2 hours. If the alarm persists, close the cassette tube clamp and remove the pump from use. Press down on the pump, until the DUOPA cassette fits tightly against the pump (, Use a coin to twist the latch counterclockwise until the latch lines up straight with the arrow (, While holding the stomach tube steady, twist off the white cap on the end of the longer straight (green) connector, Connect the cassette tube to the end of the longer straight (green) connector. Do not store the pump with the medication cassette reservoir attached. The microprocessor must strobe the watchdog circuit at least once every second in order to prevent the watchdog from performing its reset function. around 3.10 the next . [30] reported that exacerbation of impulse control disorders was similar among patients treated with 16-h LCIG (two of 28 patients, 7%) and 24-h LCIG (one of 35 patients, 3%). Take one DUOPA cassette out of the carton and out of the refrigerator 20 minutes prior to use. We recommend scheduling a follow-up visit 12 weeks after switching to 24-h use to discuss dose adjustments, side effects, and any other patient concerns. A benefit of always changing the cassette at bedtime allows for five extra doses to be administered if needed, which may be helpful if symptoms of wearing off occur. If you are not changing the medication cassette reservoir but wish to prime the fluid path, you may follow the same procedure. WARNING: System delivery inaccuracies beyond the stated accuracy may occur as a result of back pressure or fluid resistance, which depends upon temperature, medication viscosity, catheter size, extension set tubing, and orientation of the pump system. 1) Remove the pump from the carrying bag (see Figure V). When you start the pump, programmed values will be automatically reviewed. If the stored and calculated CRCs do not match, the software will display a system fault screen, turn on a continuous two-tone audible alarm, and stop all medication delivery. If the upstream occlusion sensor is set to On and an occlusion in the medication cassette reservoir is detected, the upstream occlusion alarm will sound. 1. and M.R. Portable and mobile RF communications equipment should be used no closer to any part of the Pump, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. . Heart attack or other heart problems. The liquid crystal display (LCD) shows programming information and messages. If the medication cassette reservoir or the battery door is loose or damaged, do not use the pump. Development of peripheral neuropathies has been observed with levodopa treatment, with slightly higher prevalence of peripheral neuropathy observed among patients treated with LCIG vs oral levodopa (LCIG, 42.1%; oral levodopa, 30.2%), although a causal effect has not been established [44, 45]. Single-use cassettes containing 4.63 mg carbidopa (as 5 mg of the monohydrate) and 20 mg levodopa per mL of enteral suspension. If there was an inadequate clinical response within 1 hour of the Morning Dose on the preceding day, adjust the Morning Dose (excluding the 3 mL to fill the tube) as follows: If the patient experienced dyskinesias or DUOPA-related adverse reactions within 1 hour of the Morning Dose on the preceding day, decrease the Morning Dose by 1 mL. The authors note that a high number of extra doses may be indicative of a too-low continuous dose, or that the patient overuses the extra dose button [31]. Updated The Pump uses RF energy only for its internal function. Benzalkonium chloride concentrate (0.13%), 10% solution of household bleach (one part household bleach to9partswater). Stocchi F, Coletti C, Bonassi S, Radicati FG, Vacca L. Early-morning OFF and levodopa dose failures in patients with Parkinson's disease attending a routine clinical appointment using Time-to-ON Questionnaire. It is designated chemically as (2S)-3-(3,4-dihydroxyphenyl)-2-hydrazino-2-methylpropanoic acid monohydrate. Standards used in Development of the Pump, The following are reference test methods applied to IEC/EN 60601-1-2. Start the pump, if necessary. A key beeps when pressed if it is operable in the current lock level. The effects of fluctuating plasma levodopa concentrations can be mitigated using continuous dopaminergic stimulation to maintain plasma levodopa concentrations within a therapeutic window [2, 3]. Absorption. This Instructions for Use provides information for the CADD-Legacy model 1400 pump only. Confusion, insomnia, and excessive dreaming may accompany hallucinations. (Refer to the beginning of the. Improper programming could compromise patient treatment. the contents by NLM or the National Institutes of Health. Before use, data associated with delivery and stored in NOVRAM is tested by calculating a CRC on the data and then comparing it with the CRC stored with the data. Paul, MN 55112 USATel: 1 800 258 5361 (USA)Tel: +1 614 210 7300www.smiths-medical.com. Do not use a pump that is damaged or is not functioning properly, as this could compromise patient treatment. Each DHIVY tablet has 3 functional scores with each segment Over time, additional changes may be necessary based on the patients clinical response and tolerability. In animal studies, carbidopa-levodopa has been shown to be developmentally toxic (including teratogenic effects) at clinically relevant doses (see Data). In a 12-week, active-controlled clinical trial (Study 1), a total of 71 patients with advanced Parkinsons disease were enrolled and had a PEG-J procedure. NOTE: If the desired morning dose amount does not appear in the display, program the desired morning dose amount as instructed in Section 2, Pump Setup and Programming. Do not stop taking your medicine unless ordered by your doctor. With PD progression, the therapeutic window needed to achieve optimal motor control narrows, giving the appearance of waning levodopa efficacy [1]. Certain information that is not intended for patients has been removed. Contact your healthcare provider if the alarm continues. Monitor patients who are taking these drugs. Do not store the pump for prolonged periods of time with the batteries installed. baseline, 10.5 (12.2); follow-up, 4.9 (2.5). Patients should be monitored for autonomic dysfunctions; symptoms when LCIG wears off overnight; changes in weight; fluctuations in plasma levels of Bvitamins, folate, and homocysteine; and changes in sleep patterns or worsening of hallucinations, delusions, and/or nightmares. The screen will show the value decreasing as the morning dose is delivered. Ask your healthcare provider or pharmacist if you have any questions. Use DUOPA before the expiration date printed on the cassette. CAUTION: Do not use rechargeable NiCd or nickel metal hydride (NiMH) batteries. Subject to the conditions of and upon compliance with this Limited Warranty, the Manufacturer will repair or replace at its option without charge (except for a minimal charge for postage and handling) any Pump (not including accessories) which is defective if a claim is made during such one-year period. NOTE: You may change the lock level at any time by stopping the pump and following the procedure below. Cassettes should be protected from light and kept in the carton prior to use. Confusion occurred in 8% of DUOPA-treated patients compared to 3% of patients treated with oral immediate-release carbidopa-levodopa, and psychotic disorder occurred in 5% of DUOPA-treated patients compared to 3% of patients treated with oral immediate-release carbidopa-levodopa. Do not use the pump if the battery door or tabs are damaged because the batteries will not be properly secured; this may result in loss of power and non-delivery of medication, which could compromise patient treatment. Meredith Rollins has received consultant compensation and honoraria from AbbVie. (Press and hold these keys to change values with increasing speed.). allows control according to a pre-planned schedule (e.g., increasing the rate by 0.1 mL/h every 2 or 4 weeks according to response). Treatment with DUOPA is initiated in 3 steps [see Dosage and Administration (2.2)]: DUOPA has an extra dose function that can be used to manage acute Off symptoms that are not controlled by the Morning Dose and the Continuous Dose administered over 16 hours. The pump must be running with a cassette attached and in LL0 or LL1. There are other CADD-Legacy pump models available; review the rear label of the pump to ensure it is a CADD-Legacy 1400 pump before programming. If adjacent or stacked use is necessary, the user should verify normal operation of the pump in the configuration in which it is to be used. NOTE:Not in Use is the default setting for the reservoir volume. Two AA batteries fit into the battery compartment. Some hospitals use lock level 0, which allows for the dosage to be adjusted freely by patients or caregivers [31]. 2015 Smiths Medical. are experienced at any time during treatment, they should not drive or participate in potentially dangerous activities until they have contacted their physician. Labels, All Index Place the battery door over the battery compartment and slide the door closed. Further reductions in motor and NMS have been observed in some patients treated with LCIG around the clock. If authorized, the Pump must be properly and carefully packaged and returned to the Manufacturer, postage prepaid. 1) Remove the cassette clip (see Figure B): 2) Attach the DUOPA cassette to the pump (see Figure C): 3) Latch the DUOPA cassette into the pump: WARNING: Attach the DUOPA cassette correctly. Please refer to the full prescribing information for DUOPA (carbidopaand levodopa) enteral suspension for indications and usage, contraindications, warnings, precautions, and adverse reactions. NOTE: If you intend to run the pump in lock level 1 so the continuous rate can be varied, you should enter the maximum allowable rate while programming in lock level 0. Levodopa/carbidopa intestinal gel infusion and weight loss in Parkinson's disease. After transition to 24-h LCIG, nine patients reported reduced dyskinesia and two reported improved FOG [24]. Obtain a new, filled medication cassette reservoir. Because of the risk of exacerbating psychosis, patients with a major psychotic disorder should not be treated with DUOPA. Ifthe battery door becomes detached or loose, the batteries will not be properly secured; this could result in loss of power and non-delivery of medication, which could compromise patient treatment. Press. 1. Electromagnetic Emissions and Immunity Declarations. FOIA These symptoms can be addressed by reducing the continuous LCIG dose or by prescribing an atypical anti-psychotic medication, such as pimavanserin (not available in the European Union or Australia), clozapine, or quetiapine. Carbidopa is excreted in rat milk. Because of the limited evidence regarding 24-h LCIG infusion, the initiation of 24-h treatment should be decided individually, after weighing the potential benefits and drawbacks. Advise patients of the symptoms of the above listed complications and instruct them to contact their healthcare provider if they experience any of these symptoms [see Warnings and Precautions (5.1)]. The current lock level will appear. (current), carbidopa 4.63 MG / levodopa 20 MG in 1 mL Enteral Suspension, carbidopa 4.63 MG/ML / levodopa 20 MG/ML Oral Suspension, carbidopa 4.63 MG/ML (as carbidopa monohydrate 5 MG/ML) / levodopa 20 MG/ML Oral Suspension, carbidopa 4.63 MG/ML / L-DOPA 20 MG/ML Oral Suspension, Duopa 4.63 MG / 20 MG in 1 mL Enteral Suspension, carbidopa 4.63 MG/ML / levodopa 20 MG/ML Oral Suspension [Duopa], carbidopa 4.63 MG/ML / L-DOPA 20 MG/ML Oral Suspension [Duopa], Duopa (carbidopa 4.63 MG/ML (as carbidopa monohydrate 5 MG/ML) / levodopa 20 MG/ML) Enteral Suspension, The maximum recommended daily dose of DUOPA is 2000 mg of levodopa (i.e., one cassette per day) administered over 16 hours (, Prior to initiating DUOPA, convert patients from all forms of levodopa to oral immediate-release carbidopa-levodopa tablets (1:4 ratio) (, Titrate total daily dose based on clinical response for the patient (, Administer DUOPA into the jejunum through a percutaneous endoscopic gastrostomy with jejunal tube (PEG-J) with the CADD-Legacy 1400 portable infusion pump (, Gastrointestinal procedure-related complications may result in serious outcomes, such as need for surgery or death (, May cause falling asleep during activities of daily living (, Monitor patients for orthostatic hypotension, especially after starting DUOPA or increasing the dose (, Hallucinations/Psychosis/Confusion: May respond to dose reduction in levodopa (, Impulse Control Disorders: Consider dose reductions or stopping DUOPA (, Monitor patients for depression and suicidality (, Avoid sudden discontinuation or rapid dose reduction to reduce the risk of withdrawal-emergent hyperpyrexia and confusion (, May cause or exacerbate dyskinesia: Consider dose reduction (, Monitor patients for signs and symptoms of peripheral neuropathy (, Selective MAO-B inhibitors: May cause orthostatic hypotension (, Antihypertensive drugs: May cause symptomatic postural hypotension. These highlights do not include all the information needed to use DUOPA safely and effectively. and you will hear a short beep each time the pump goes through a delivery cycle. 11) Insert pump into the carrying bag (see Figure J). Furthermore, in our experience, caregivers of patients who have switched to 24-h LCIG administration have reported reduced burden of responsibility, greater happiness, improvements in their own quality of sleep, and reduced anxiety regarding the patient. Immediate- or extended-release formulations of dopamine agonists, such as the rotigotine patch, ropinirole, or pramipexole, may be prescribed to control night-time symptoms. 24-hour levodopa-carbidopa intestinal gel may reduce troublesome dyskinesia in advanced Parkinson's disease. Its empirical formula is C10H14N2O4H2O, and its structural formula is: The content of carbidopa in DUOPA is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.3. As a library, NLM provides access to scientific literature. Acceptance of the PEG-J port may initially be a barrier to implementing LCIG treatment. Alert patients to the potential sedating effects caused by DUOPA, including somnolence and the possibility of falling asleep while engaged in activities of daily living. It allows you to deliver a specified amount of medication, as a loading dose for example. Please refer to the prescribing information for DUOPA for dosage and administration information. Furthermore, in a single patient for whom 24-h LCIG infusion induced chronic inflammatory demyelinating polyneuropathy-like neuropathy, treatment with intravenous immunoglobulin resulted in long-term improvement in neuropathy symptoms, without needing to discontinue 24-h LCIG infusion [46]. Do not store the pump for prolonged periods of time with the batteries installed. NOTE: A morning dose cannot be started while an extra dose or another morning dose is in progress. For these patients, the latter strategy may need to be modified to accommodate patients usual schedule, or a different strategy may be implemented. In order to ensure controlled thawing of DUOPA, take the cartons containing the seven individual cassettes out of the transport box and separate the cartons from each other. Infusion of levodopa-carbidopa intestinal gel (LCIG; also designated carbidopa-levodopa enteral suspension) for 16 hours is a standard treatment for patients with advanced Parkinson's disease, and clinical observations suggest that 24-hour LCIG infusion may further reduce symptoms. Once no further adjustments are required to the DUOPA Morning Dose, Continuous Dose, or Extra Dose, this dosing regimen should be administered daily. Patients who have already experienced somnolence or an episode of sudden sleep onset should not participate in these activities while taking DUOPA. Proper Use Drug information provided by: Merative, Micromedex Take this medicine exactly as directed, and every time that you are supposed to take it. If the pump is dropped or hit, look at the pump for damage. It is designated chemically as (2S)-2-Amino-3-(3,4-dihydroxyphenyl) propanoic acid. For some patients (e.g., patients receiving a constant infusion rate per 24-h period), the morning dose can be eliminated. The reservoir volume value could be set higher than the capacity of the medication cassette reservoir. (2.3) -----DOSAGE FORMS AND STRENGTHS----- Tablets: Carbidopa and levodopa 25 mg/100 mg, functionally scored. FDA PI Print Save Carbidopa and Levodopa Prescribing Information Package insert / product label Dosage form: tablet, extended release Drug class: Dopaminergic antiparkinsonism agents Medically reviewed by Drugs.com. Although few studies have examined 24-hour LCIG infusion, available data indicate that certain patients may benefit from around-the-clock treatment. Files, All Mapping A Hungarian LCIG registry demonstrated that 12-month LCIG treatment reduced dyskinesia severity and disability and improved NMS, quality of life, and sleep [11]. Smiths Medical ASD, Inc. does not allow patient control of dosing. Additional adverse reactions that were co-reported with complication of naso-jejunal and PEG-J insertion included upper abdominal pain, duodenal ulcer, duodenal ulcer hemorrhage, erosive duodenitis, erosive gastritis, gastrointestinal hemorrhage, intussusception, peritonitis, post-operative abscess, and small intestine ulcer. Carbidopa inhibits the decarboxylation of peripheral levodopa, making more levodopa available for delivery to the brain. The Pump can only be used under the supervision of medical personnel whose skill and judgment determine the suitability of the Pump for any particular medical treatment. In our experience, we have found that patients may benefit from 24-hour infusion when reductions in nocturnal symptoms and improvements to quality of sleep are needed. Nyholm D, Jansson R, Willows T, Remahl IN. Finally, when reducing patient and caregiver burden is desired, 24-h LCIG administration may be useful, as it lessens the need for caregivers to assist with tasks such as toileting and medication administration. DUOPA is dispensed from medication cassette reservoirs that are specifically designed to be connected to the CADD-Legacy 1400 pump. Doses are usually taken 4 to 8 hours apart while . The addition of carbidopa to levodopa reduces the peripheral effects (e.g., nausea and vomiting) due to decarboxylation of levodopa; however, carbidopa does not decrease the adverse reactions due to the central effects of levodopa. To program a morning dose the pump must be running and a medication cassette reservoir must be attached. Your healthcare provider programs your prescription into the CADD-Legacy 1400 pump. In the controlled trial, the average number of titration days required to establish a stable Morning and Continuous Dose was 5 days. Burack M, Aldred J, Zadikoff C, Vanagunas A, Klos K, Bilir B, et al. 1265 Grey Fox RoadSt. No agent, representative, or employee of the Manufacturer has authority to bind the Manufacturer to any representation or warranty, expressed or implied. Stopping the pump stops delivery. M.J.S. Mains power quality should be that of a typical commercial or hospital environment. again to fill the fluid path. Do not permit patients to have access to this manual, as the information contained would allow the patient complete access to all programming and operating functions. 2. Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). The following solutions may be used to clean the pump and accessories, unless otherwise specified: Routinely clean the battery contacts, possibly as part of the preventative maintenance cycle, to remove buildup of foreign material on the contacts. Convert the oral levodopa dose from milligrams to milliliters by multiplying the oral dose by 0.8 and dividing by 20 mg/mL. DUOPA should not be given to children (younger than 18 years). Karlsborg M, Korbo L, Regeur L, Glad A. Duodopa pump treatment in patients with advanced Parkinson's disease. When the pump calculates that 5 ml remain in the medication cassette reservoir, beeps sound and ResVol Low appears on the main screen. Install new batteries to silence the alarm. WARNING: Do not use the Prime button. The Pump is intended for use in the electromagnetic environment specified below. NOTE: You will not be able to adjust the continuous rate, extra dose, or morning dose beyond the value originally programmed in LL0. A symptom complex that resembles neuroleptic malignant syndrome (characterized by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability), with no other obvious etiology, has been reported in association with rapid dose reduction, withdrawal of, or changes in dopaminergic therapy. This value will be programmed into the pump as the continuous rate. When power up is complete, 6 beeps will sound, and the pump will be stopped on the main screen. Baseline, 15 patients; follow-up, 7 patients. Do not store the pump at temperatures below -20C (-4F) or above 60C (140F). WARNING: Programming the pump at a delivery rate other than what is prescribed will cause over- or under-delivery of medication, which could compromise patient treatment. If the prescription does not call for a continuous rate, enter zero. If adjacent or stacked use is necessary, the user should verify normal operation of the pump in the configuration in which it is to be used. The life of the batteries is dependent on the amount of medication delivered, delivery rate, battery age, and the temperature. Other patients have reported improved sexual performance owing to increased muscle strength. If the alarm persists, close the tubing clamp and remove the pump from use. Notice to the Manufacturer must include date of purchase, model and serial number, and a description of the claimed defect in sufficient detail to allow the Manufacturer to determine and facilitate any repairs which may be necessary. Ultimately, the dose required to control symptoms, and hence the number of cassettes needed over the 24-h period, is patient specific. Port may initially be a barrier to implementing LCIG treatment over the 24-h period, is specific! Prime the fluid path, you may change the lock level at any time by the! The main screen in motor and NMS have been reported more than one year after of... 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