Gel for intestinal administration from white to white with a yellowish hue of color, homogeneous.
levodopa 20 mg
carbidopa (in the form of monohydrate) 5 mg
Excipients: carmellose sodium - 29.2 mg, water - up to 1 ml.
100 ml - bags (1) complete with connecting tubes - cassettes (7) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2015.
Duodopa В® is a gel containing a combination of active substances: levodopa and carbidopa monohydrate (4: 1 ratio), for prolonged intestinal administration to patients with severe Parkinson's disease with severe motor fluctuations and hyper / dyskinesia. Levodopa decarboxylates with the formation of dopamine in the brain, thereby reducing the severity of symptoms of Parkinson's disease. Carbidopa does not penetrate the BBB and inhibits the extra-cerebral decarboxylation of levodopa, which leads to an increase in the amount of delivery of levodopa to the brain and its transformation into dopamine. When monotherapy with levodopa to achieve the desired effect requires significantly more amount of the drug compared with the combined use of levodopa with carbidopa.
The intestinal administration of Duodopa В® reduces the severity of motor fluctuations and increases the duration of control periods of voluntary movements in patients with severe Parkinson's disease who have been treated with levodopa / aromatic L-amino acid decarboxylase inhibitor (tableted forms) for many years.Reduction of the severity of motor fluctuations and hyper / dyskinesias is due to the maintenance of a stable equilibrium concentration of levodopa in the plasma in the therapeutic range. Reducing the severity of motor fluctuations and hyper / dyskinesia is often achieved already during the first day of treatment.
Duodopa В® is administered via a probe placed directly into the duodenum or jejunum. Levodopa is rapidly and efficiently absorbed from the intestine through the amino acid transport system. Levodopa as part of Duodope В® has the same bioavailability as levodopa in the composition of levodopa / carbidopa preparations (tableted form 100/25 mg). Bioavailability of levodopa in the preparation of Duodope В® is comparable with the bioavailability of levodopa in the composition of levodopa / carbidopa preparations (in tableted form) and is 97%.
The Duodope В® preparation has significantly less individual plasma concentration fluctuations due to the fact that it is continuously introduced into the intestine and the rate of evacuation of the gastric contents does not affect the absorption rate. When using a high initial morning dose of Duodopa В®, the therapeutic concentration of levodopa in plasma is reached in 10-30 minutes.
Carbidopa (an inhibitor of decarboxylase aromatic L-amino acids), when used in combination with levodopa, increases bioavailability and reduces the clearance (Cl) of levodopa. Levodopa has a relatively small V d . The distribution coefficient between erythrocytes and blood plasma for levodopa is approximately equal to unity.Levodopa binds to blood plasma proteins slightly (about 10-30%). Levodopa penetrates the brain through a system of active transport of large neutral amino acids.
The degree of binding of carbidopa to plasma proteins is about 36%.
Metabolism and excretion
Levodopa is mainly excreted from the body through metabolism involving enzymes - decarboxylase of aromatic L-amino acids and catechol-O-methyl transferase.Other metabolic pathways are transamination and oxidation. Decarboxylation of levodopa to dopamine by decarboxylase of aromatic L-amino acids is the main pathway of enzymatic metabolism (when levodopa is used without enzyme inhibitors). When O-methylation of levodopa by catechol-O-methyl transferase is formed, 3-O-methyldopa. When levodopa is used with carbidopa T 1/2, levodopa is about 1.5 h.
Carbidopa is metabolized to two major metabolites (? -methyl-3-methyltoxy-4-hydroxyphenylpropionic acid and a-methyl-3,4-dihydroxyphenylpropionic acid). These two metabolites are mainly excreted through the kidneys unchanged or in the form of glgocuronide conjugates. Carbidopa in unchanged form is 30% of total urinary excretion. T 1/2 carbidopa is about 2 hours.
The relationship between pharmacokinetics and pharmacodynamics
The more stable the concentration of levodopa in plasma, the more stable the therapeutic effect. Because effective doses in the severe course of Parkinson's disease may be different, the dose should be selected individually, based on the clinical effect. When Duodopa В® was used, tolerance development was not observed with time.
- late stages of levodopa-sensitive Parkinson's disease with pronounced motor fluctuations and hyper / dyskinesias with insufficient effectiveness of other antiparkinsonian drugs.
The drug Duodope В® is a gel for long-term intestinal application. The gel should be injected directly into the lumen of the duodenum or the upper part of the jejunum via a permanent duodenal probe installed by percutaneous endoscopic gastrostomy and consisting of the external abdominal and internal enteral parts. If for any reason percutaneous endoscopic gastrostomy can not be performed, it is possible to perform gastroejunostomy under X-ray control. Surgical support for transabdominal access and dose adjustment should be carried out together with neurologists.
To determine the effectiveness during the selection of the dose of Duodopa В® in patients with Parkinson's disease before using a permanent probe, a temporary naso-natural probe can be used. The dose of the drug should be selected individually for each patient until an optimal clinical effect is achieved, which is the maximum elongation of periods of functional control over voluntary movements due to the maximum reduction in episodes of motor control disorders with bradykinesia and dyskinesia.
At the initial stage Duodop В® should be administered as a monotherapy. In the future, if necessary, you can simultaneously prescribe other drugs to treat Parkinson's disease. For the introduction of Duodope В® , only the special CADD В® -Legacy 1400 pump must be used. The instruction manual is supplied with the pump.
Treatment with Duodope В® using a permanent probe can be stopped at any time. To do this, you need to remove the probe and give the stoma at the site of its introduction to be tightened. Then it is necessary to continue treatment with the use of drugs (in oral dosage form), incl. containing levodopa / carbidopa.
Long-term administration of the total daily dose of Duodopa В® is divided into 3 periods: the morning bolus dose, the constant maintenance dose and additional bolus doses. In all cases, individual dose adjustment is necessary.
Morning dose: the morning bolus dose of Duodopa В® is administered within 10-30 minutes to quickly reach the therapeutic concentration. The morning dose of Duodope В® should be selected on the basis of the previous morning dose of Levodona by the patient. The total morning dose of Duodopa В® is usually 5-10 ml of gel, which corresponds to 100-200 mg of HCV. The total morning dose of Duodope В® should not exceed 15 ml of gel (300 mg of levodone). The morning dose of DuodopaВ® should be increased by 3 ml (the volume may vary depending on the probe used) gel to compensate for the dead volume of the probe. After the effective morning dose of Duodope В® has been established, no further dose adjustment is required.
Constant maintenance dose: a constant maintenance dose of Duodope В® is selected individually. It should be in the range of 1-10 ml / h (20-200 mg levodopa / h) and usually is 2-6 ml / h (40-120 mg levodopa / h). In special cases, a higher dose of Duodope В® may be needed. The maintenance dose of Duodope В® is adjusted in steps of 0.1 ml / h (2 mg levodopa / h). The dose of Duodope В® should be calculated on the basis of the previous dose of irradiated doses of the patient. After withdrawal of concomitant treatment, the dose of Duodope В® should be adjusted.
Additional bolus doses: an additional dose of Duodope В® should be selected individually, usually it is 0.5-2.0 ml. Additional bolus doses of Duodope В® are administered if necessary in the event of hypokinesia during the day. In rare cases, a higher dose of Duodope В® may be needed. If the need for additional bolus doses of Duodopa В® exceeds 5 times / day, then an increase in the maintenance dose of Duodope В® should be considered. After setting the initial dose of Duodopa В® for several weeks, small corrections of the morning bolus, supporting and additional bolus doses of Duodope В® should be done.
Table 1. Determination of the total daily dose of Duodopa В®
Morning dose Constant maintenance dose Additional bolus doses
Onset of treatment (day 1) The morning dose of Duodope В® should be calculated on the basis of the morning oral dose of levodopa / carbidopa (previously taken by the patient). The morning dose of DuodopeВ® is calculated taking into account the recommended conversion factor (Table 2. Dependence of the morning oral dose of levodopa / carbidopa and the morning dose of DuodopeВ®). The maintenance dose of DuodopeВ® is adjusted in steps of 0.1 ml / h (2 mg levodopa / h). Example of constant maintenance dose calculation Constant maintenance dose: (A mg) = total daily oral dose (previously taken by the patient) -the morning dose; A mg / 20 mg / ml = B ml; Calculation of the infusion rate for 16 h: In ml / 16 h = C ml / h C ml / h? 0.9 = D ml / h (infusion rate) Can be applied every hour. You should start with a dose of 1 ml.
Day 2 and the end of the dose titration period (titration is usually 4-7 days) The morning dose of Duodope В® can be adjusted based on the clinical effect of taking the previous morning dose. Maintain the infusion rate as on the previous day. The maintenance dose of Duodope В® is adjusted in steps of 0.1 ml / h (2 mg levodopa / h) Can be applied every hour. You should start with a dose of 1 ml.
The period of application of a stable total daily dose After the morning dose of Duodope В® was approved, no further dose change is required. Maintain the infusion rate as on the previous day. Can be used every 2 hours (if necessary). The dose is usually from 0.5 ml to 2 ml.
Table 2. Dependence of the morning oral dose of levodopa / carbidopa and the morning dose of Duodopa В®
Morning oral dose of levodopa / carbidopa Percentage of dose of Duodope В®
0-200 mg 80%
201-399 mg 70%
? 400 mg 60%
Use of Duodope В® at night
In the presence of medical indications, the administration of Duodope В® can be carried out at night.
Monitoring of treatment: a sudden deterioration in the response to treatment with recurrent motor fluctuations can serve as an indication that the distal part of the probe has moved from the duodenum / jejunum to the stomach. The probe is transferred back to the duodenum / jejunum by a conductor under fluoroscopy control.
Application in children and adolescents
The drug Duodopa В® is contraindicated for use in patients under the age of 18 years. Application in elderly patients
There is extensive experience with the use of levodopa / carbidopa in elderly patients. The dosage recommendations given above include an analysis of the clinical data obtained in this category of patients.
Application in renal / hepatic insufficiency
There is no data on the pharmacokinetics of carbidopa and levodopa in patients with hepatic or renal insufficiency. Determination of efficacy and dose selection of Duodope В® are based on achieving the optimal clinical effect in patients with Parkinson's disease, and there is no need to separately consider the effect of renal / hepatic insufficiency on the concentration of levodopa / carbidopa in blood plasma.
Interruption of treatment
If there is a need for a sharp dose reduction or the need to stop treatment with Duodope В® , careful monitoring of the patient should be made, especially if he receives antipsychotics.
If suspected to develop dementia or diagnose this and increase the risk of confusion, the maintenance of the pump should be provided by a specially trained personnel or guardian (for example, a close relative).
To use a drug cassette, it must be connected to a portable pump and a system connected to a nasoduodenal probe or a duodenal / neural probe in accordance with the instructions for use. Cassettes with the drug are intended for single use only and should not be used for more than 1 day (up to 16 hours), even if some amount of the drug remains. Do not use open cassettes again. At the end of the storage period, the gel may acquire a slightly yellowish color. This does not affect the concentration of the drug or the effectiveness of the treatment.
Adverse reactions, often observed with Duodopa В® :
- Adverse reactions associated with the use of the drug - dyskinesia, nausea;
- Adverse reactions associated with percutaneous endoscopic gastrostomy - pain in the abdomen, complications associated with the introduction of the probe, excessive formation of granulation tissue, reddening of the skin at the site of the stoma, suppuration of the postoperative wound, postoperative discharge, pain at the site of the stoma and reaction in place stoma installations.
Most of these adverse reactions were recorded after percutaneous endoscopic gastrostomy and were observed during the first 28 days.
Adverse reactions associated with the use of the drug, percutaneous endoscopic gastrostomy and the use of a portable pump that arise after the start of prenarate application and are included, regardless of the cause of the occurrence, are combined with adverse reactions that occur during post-registration follow-up of DuodopВ®.
Adverse reactions that often occur when using levodopa / carbidopa are the result of the central action of dopamine. The severity of these reactions can usually be reduced by lowering the dose of levodopa. Adverse reactions are given below with frequency (very often? 1/10, often? 1/100, but <1/10; infrequently? 1/1000, but <1/100; rarely? 1/10000, but <1/1000 , very rarely <1/10000).
Data of clinical trials and post-registration period
Adverse reactions associated with the use of Duodope В® (excluding side reactions associated with percutaneous endoscopic gastrostomy and using a portable pump)
System of organs Frequency of occurrence Adverse reaction
Disturbances from the blood and lymphatic system Often Anemia
Infrequent leukopenia, thrombocytopenia
Immune system disorders Frequency unknown Anaphylactic reactions
Disorders from the gastrointestinal tract Very often Nausea, constipation
Often Vomiting, bloating, dyspepsia, flatulence, diarrhea, dry mouth, dysgeusia, dysphagia
Infrequently Hyper secretion of saliva
Rarely, Bruxism, discoloration of saliva, burning mouth syndrome, hiccough
Disorders from the metabolism and nutrition Very often Weight loss
Often Weight gain, increased concentrations of amino acids (elevated concentrations of methylmalonic acid), decreased appetite, vitamin B6 deficiency, vitamin B12 deficiency, hyperhomocysteinemia
Disorders from the kidneys and urinary tracts Often Urinary retention, involuntary urination
Disturbances from the musculoskeletal and connective tissue Often Muscular spasms, pain in the neck
Disorders from the nervous system Very often Dyskinesia, Parkinson's disease
Often Polineuropathy, dizziness, dystonia, the phenomenon of "on-off", paresthesia, fainting, headache, drowsiness, tremor, hypoesthesia
Infrequent Ataxia, cramps, gait disturbance
Disorders of the mind Very often Anxiety disorders, depression, insomnia
Often Unusual dreams, arousal, confusion, hallucinations, impulsive behavior, psychotic disorder, involuntary episodes of falling asleep, sleep disturbance
Infrequently completed suicide, dementia, confusion, a state of euphoria, anxiety, increased libido, nightmares, suicide attempt
Rare Abnormal thinking
Violations of the organ of sight is not often blepharospasm, diplopia, ocular ischemic neuropathy, blurred vision
Disorders of the respiratory system, chest cells and mediastinum often pain in the mouth and throat, shortness of breath, aspiration pneumonia
Infrequently pain in the chest, dysphonia
Rarely Abnormal breathing
Disorders with Torons skin and subcutaneous tissues often hyperhidrosis, contact dermatitis, peripheral edema, pruritus, rash
Infrequently alopecia, reddening of the skin, hives
Rarely Discoloration of sweat, malignant melanoma
Violations of the heart often Arrhythmia
Uncommon Feeling palpitations
Violations of the vessels is often Orthostatic tipoteiziya
of the decline in blood pressure, increased blood pressure
Laboratory and instrumental data of the increase concentration of homocysteine in the blood, reducing the concentration of vitamin B6 decrease the concentration of vitamin B12
General disorders and injection site often Fatigue, pain at the site of the stoma installation, asthenia
Uncommon Sense dis omforta
Injury, poisoning and manipulation complications very often Fall
analysis was conducted in patients who received the drug Duodopa В®or placebo gel through the jejunal probe after percutaneous endoscopic gastrostomy in order to ensure the identification of adverse reactions associated with percutaneous endoscopic gastrostomy and use of portable pumps in all studies, regardless of the study design (double-blind or open).
Below are adverse reactions associated with percutaneous endoscopic gastrostomy and using a portable pump.
Adverse reactions associated with percutaneous endoscopic gastrostomy and use of portable pumps
adverse reactions associated with percutaneous endoscopic gastrostomy and use of portable pump
organ system Incidence Adverse reaction
Disorders of the gastrointestinal tract is often pain in the abdomen
Often pneumoperitoneum, abdominal discomfort, peritonitis, pain in the upper abdomen
Infectious and parasitic diseases is often infection of surgical wounds
often Cellulitis at the site of the stoma installation, postoperative infection
Injury, poisoning and complications of manipulation is often pain at the site of the stoma installation, redness of the skin in the installation site of the stoma, reactions at the site of the stoma installation, postoperative discharge
often pain at the site of the stoma installation, post-operative bleeding complications related to a tired Coy gastrointestinal probe, postoperative discomfort, post-operative ileus, post-operative complications
Disorders of the skin and subcutaneous tissue Very often Excessive formation of granulation tissue
General disorders and at the injection site is often Difficulties with the introduction of the probe
of the probe offset, blockage of the probe
report frequent adverse reactions associated with the complication of the installation as a syunalnogo probe and probe noseejunal.
Adverse reactions in the application noseejunal probe: pain in the mouth and throat, abdominal distension, abdominal pain, abdominal discomfort, pain, throat irritation, gastrointestinal damage, esophageal bleeding, anxiety disorders, dysphagia, vomiting.
Adverse reactions with the use of jejunal probe: abdominal pain, abdominal discomfort, bloating, flatulence, pneumoperitoneum.
Other minor side effects that have been associated with the complication of the installation as a jejunal probe and noseejunal probe: abdominal discomfort, pain in the upper part of the stomach, duodenal ulcer, ulcer bleeding duodenal ulcer, erosive duodenitis, erosive gastritis, gastrointestinal bleeding, peritonitis, pievmoperitoneum, ulcers of the small intestine.
Probe displacement in the stomach cavity leads to a recurrence of motor fluctuations (due to irregular evacuation preparation Duodopa В® from the cavity stomach into the intestine). Moving the probe back into the duodenum is carried by a conductor under fluoroscopy.
The following deviations from laboratory values were reported in the treatment of levodopa / carbidopa, and therefore must be considered in the treatment of drug Duodopa В® : increase alkaline phosphatase activity, AST, ALT, LDH; increasing concentrations of blood urea nitrogen, bilirubin, blood glucose, creatinine, uric acid; Positive Coombs' test, and lowered values of hemoglobin and hematocrit. There have been reports about the content of leukocytes in urine, bacteria and blood.
Use of levodopa / carbidopa, and hence the drug Duodopa В®It can lead to lozhnopolozhitslnomu result of rapid tests for the detection of ketones in the urine; this reaction is not altered by boiling the urine. The use of glucose oxidase method for the investigation of the presence of glycosuria may give false negative results.
The following adverse reactions were observed at application dopaminergic drugs and can be observed when using the drug Duodopa В® :
- disorders of the blood and lymphatic system: agranulocytosis, hemolytic anemia;
- disorders of the nervous system: trismus, neuroleptic malignant syndrome;
- disorders of the organ of vision: Horner's syndrome, mydriasis, seizures, eye;
- disorders of the skin and subcutaneous tissue disorders: angioedema, Schonlein-Henoch purpura.
- hypersensitivity to levodopa, carbidopa, or any subsidiary components Duodopa drug В® ;
- zakrytougolpaya form of glaucoma;
- severe hepatic / renal failure;
- severe heart failure;
- severe heart rhythm disorders;
- cerebral circulation in the acute period;
- simultaneous with non-selective MAO inhibitors and selective inhibitors of MAO type A. necessary to stop the use of these drugs for at least 2 weeks before the start of the drug Duodopa В® (except MAO-B selective inhibitors (e.g., selegiline hydrochloride));
- a state in which the contra-agonists, e.g., pheochromocytoma, hyperthyroidism and Cushing's syndrome;
- the period of breastfeeding;
- Patients with suspected undiagnosed diseases or cutaneous melanoma in history (as levodopa can stimulate the development of malignant melanoma);
- Patients under the age of 18 years.
- severe cardiovascular or pulmonary disease;
- bronchial asthma;
- chronic open-angle glaucoma;
- kidney disease, hepatic or endocrine system;
- psychosis (current or history), and peptic ulcer disease or a history of convulsive disorder;
- co-administration with antipsychotics capable of blocking dopamine receptors (especially D2)
- co-administration with drugs able to induce orthostatic hypotension (e.g., ACE inhibitors, nitrates, diuretics, MAO inhibitors).
PREGNANCY AND LACTATION
Insufficient data on the use of levodopa / carbidopa in pregnant women. Data obtained in animal studies revealed malformations of the skeleton and internal organs of the fetus. Possible risk of human use is not known. In pregnancy, drug Duodopa В® can only be applied after careful assessment of the risk-benefit ratio when the benefits to the mother outweighs the potential risk to the fetus.
Levodopa is excreted in breast milk. There is evidence of suppression of milk production during treatment with levodopa. Carbidopa is excreted in breast milk in animals but is not known whether it is excreted in milk in humans. Impact of levodopa / carbidopa PA children is not known. During application of the drug DuodopaВ® breast-feeding should be discontinued.
APPLICATION FOR FUNCTIONS OF THE LIVER
Precautions apply to patients with kidney disease.
Apply to patients with severe renal impairment is contraindicated.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Precautions apply to patients with liver disease.
Use the drug in patients with severe hepatic impairment is contraindicated.
APPLICATION FOR CHILDREN
Use of the drug for children and podroskam under the age of 18 years is contraindicated.
Prior to the introduction of permanent nazoduodenalnogo probe must receive clinical benefit of the drug trial Duodopa В® introduction through a temporary nasojejunal probe.
Cautions and warnings given below relate levodopa, and therefore are applicable to the preparation Duodopa В® .
Preparation Duodopa В® is not recommended for the treatment of extrapyramidal reactions caused by other drugs.
In patients with previous myocardial infarction and atrial or ventricular arrhythmias is necessary to monitor the function of the heart, especially in the initial dose-titration period.
In all patients receiving treatment with Duodopa В®It is necessary to carry out careful monitoring for the development of mental changes, depression with suicidal tendencies, and other serious mental illnesses. Treatment of patients with psychosis, current or history, must be done with caution.
Caution should be prescribed the drug Duodopa В® conjunction with antipsychotics, capable of blocking dopamine receptors (especially D2) - may decrease antiparkinsonian effect or gain symptoms of the disease.
Treatment with Duodopa В® patients with chronic open-angle glaucoma should be done with caution provided control of intraocular pressure and the regular measurement.
Preparation Duodopa В® It may produce orthostatic hypotension, and the drug should be used with caution in patients taking other drugs causing orthostatic hypotension (e.g., ACE inhibitors, nitrates, diuretics, MAO inhibitors).
In sharp cancellation antiparkinsonian drugs can occur neyrolepticheksky malignant syndrome (ZNC) - a set of symptoms including muscle rigidity, fever, mental changes (e.g., agitation, confusion, to whom), as well as increase of CPK activity in plasma. In rare cases, within ZNC in patients with Parkinson's disease are observed rhabdomyolysis and severe psoriasis. In this regard, it is, with a sharp decrease in dose or repeal combination lsvodopy / carbidopa should be carefully observe the condition of the patient, especially if he takes antipsychotic.
There are reports of occurrence of pathological gambling, increased libido and hypersexuality, and the inability to control these phenomena, in patients with Parkinson's disease who Dofaminomimetiki therapy was carried out, including levodopa / carbidopa (Duodopa and drug В® ).
While the relationship of these phenomena using dopaminergic medications has not been proved, the abolition or reduction in dose of one or more dopaminergic agents caused cessation of these phenomena. Physicians should carry out the control of possible development of pathological gambling, increased libido and hypersexuality in patients with Parkinson's disease, taking medication Duodopa В® . Physicians should consider a dose reduction or withdrawal of the drug DuodopaВ®If the patient develops these phenomena.
When the need for general anesthesia treatment with Duodopa В® can continue as long. until the patient is allowed to take into the fluid and drugs. If necessary, the suspension of the drug therapy can be resumed at the same dose that will be allowed to drink liquids.
In order to avoid the development of dyskinesias in patients receiving levodopa dose Duodopa В® can be reduced.
During prolonged therapy with Duodopa В® recommended periodic assessment of liver function, kidney, hematopoietic and cardiovascular systems.
Preparation Duodopa В®It comprises hydrazine, carbidopa decay product that may have genotoxic and potentially oncogenic activity. The average daily dose Duodopa drug В® is 100 ml which corresponds to 2 g, 0.5 g of levodopa and carbidopa. The maximum daily dose is 200 ml. This corresponds to the intake of hydrazine in amounts up to an average of 4 mg / day; maximum - 8 mg / day. The clinical value falling in the body such amounts hydrazine HT known.
Previous surgery on upper abdomen may cause difficulties when installing or gastro- eyupostomy.
There are some reports of the probe clogging and / or blockage of the intestine with the formation of bezoar, requiring replacement of the probe and, in rare cases, surgery. Early symptoms of such conditions include abdominal pain, nausea and vomiting. In some cases, detected ulcers of the stomach and intestines. One bezoar formation risk factors can be use in food products with a high content of fibers (e.g., asparagus).
Inept handling of the patient's pump or probe may cause complications. In this case, the patient should help guardian (e.g., a nurse or a close relative).
Monitoring therapy: a sudden drop in efficiency with the occurrence of motor fluctuations of the drug may be indicative of movement of the distal part of the probe from the duodenum into the stomach. It is necessary to determine the location of the catheter using the X-ray examination and return it to the duodenum and under fluoroscopic guidance.
Sudden or gradual strengthening of bradykinesia may indicate an occlusion device for any reason, and requires study.
Epidemiological studies have shown that patients with Parkinson's disease have a higher risk of developing melanoma, compared with the population as a whole. It is unclear whether the associated increased risk of developing melanoma with Parkinson's disease or other factors, such as the use of drugs for the treatment of Parkinson's disease.
Thus, patients with drug application Duodopa В® should be monitored for melanoma regularly. Periodic inspections of the skin to be performed properly qualified (e.g., by dermatologists).
Complications were observed in clinical studies include: bezoar, intestinal obstruction, erosion / ulceration of the stoma, intestinal bleeding, intestinal ischemia, intestinal obstruction, intestinal perforation, pancreatitis, peritonitis, pievmoperitoneum and post-operative wound infection. Pain in the abdomen can be a symptom of one of the complications listed above. Some complications can lead to serious consequences, including requiring surgical intervention. Some complications can lead to death. Patients should notify their physician if they experience any of the above symptoms.
Impact on the ability to drive and other mechanisms
Levodopa / carbidopa may cause dizziness and orthostatic hypotension, somnolence and episodes of sudden sleep, so caution should be exercised when driving and the management of patients mechanisms. Patients receiving treatment with Duodopa В® , in which there is drowsiness and / or sudden sleep episodes, it is recommended to give up the car, or participate in the management of the actions, under which the impaired attention may expose them or others