DR. DOPING

Instructions

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Instructions / Instruction for use: Duodopa

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Dosage form: Intestinal gel

Active substance: Levodopa + Carbidopa*

Official current instruction

Last Modified: 12/05/2017

Dosage form

Gel for intestinal administration

Composition

100 g of gel contains:

Active substance:

Levodopa 2.00 g;

Carbidopa monohydrate 0.50 g.

Excipients:

Carmellose sodium 2.92 g,

Water 94.58 g.

In 1 ml of gel contains:

Active substance:

Levodopa 20.0 mg;

Carbidopa monohydrate 5.00 mg.

Excipients:

Carmellose sodium 29.2 mg,

Water up to 1 ml.

Description of dosage form

Homogeneous gel from white to white with a yellowish color of color.

Pharmacological group

The antiparkinsonian agent (dopamine precursor + decarboxylase peripheral inhibitor)

Pharmacodynamics

DuodopaŽ is a gel containing a combination of active substances: levodopa and carbidopa monohydrate (4: 1 ratio), for long-term intestinal administration to patients with severe Parkinson's disease with severe motor fl uctuations 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 blood-brain barrier 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 a significantly larger amount of the drug compared with the combined use of levodopa with carbidopa. The intestinal administration of DuodopaŽ reduces the severity of motor fluctuations and prolongs the duration of control periods of voluntary movements in patients with severe Parkinson's disease who received levodopa / decarboxylase inhibitor preparations of aromatic L-amino acids (tableted forms) for many beds. Reduced severity of motor fluctuations and hyper / dyskinesias is due to the maintenance of a stable equilibrium concentration of levodopa in plasma in the therapeutic range. Reducing the severity of motor fluctuations and hyper / dyskinesia is often achieved already during the first day of treatment.

Pharmacokinetics

Suction

DuodopaŽ 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 in the preparation of DuodopaŽ 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 DuodopaŽ is comparable with the bioavailability of levodopa in the composition of levodopa / carbidopa preparations (in tableted form) and is 97%.

The preparation Duodopa significantly less expressed individual fluctuations in plasma concentration due to the fact that it is constantly introduced into the intestine and the rate of evacuation of gastric contents does not affect the absorption rate. When using a high initial morning dose of DuodopaŽ, the therapeutic concentration of levodopa in plasma is reached in 10-30 minutes.

Distribution

Carbidopa (an inhibitor of decarboxylase aromatic L-amino acids), when used in combination with levodopa, increases bioavailability and reduces the clearance (C l) of levodopa. Levodopa has a relatively small volume of distribution (Vd). The distribution coefficient between erythrocytes and blood plasma for levodopa is approximately equal to one. 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 approximately 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 (with levodopa without enzyme inhibitors). When O-methylation of levodopa by catechol-O-methyl transferase, 3-O-methyldopa is formed. When levodopa is used with carbidopa, the elimination half-life (T 1/2) of levodopa is approximately 1.5 hours.

Carbidopa is metabolized to two major metabolites (α-methyl-3-methoxy-4-hydroxyphenylpropionic acid and α-methyl-3,4-dihydroxyphenylpropionic acid). These two metabolites are mainly excreted through the kidneys in unchanged form or in the form of glucuronide 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. Since the effective dose for severe Parkinson's disease may be different, the dose should be selected individually, based on the clinical effect. When Duodopa Ž was used, tolerance development was not observed with time.

Indications

The late stages of levodopa-sensitive Parkinson's disease with pronounced motor fluctuations and hyper / dyskinesias with insufficient effectiveness of other antiparkinsonian drugs.

Contraindications

ˇ Hypersensitivity to levodopa, carbidopa, or any auxiliary components of DuodopeŽ.

Closed-angle form of glaucoma.

Severe hepatic / renal failure.

Severe heart failure.

Severe heart rhythm disturbances.

ˇ Disturbance of cerebral circulation in an acute period.

ˇ Simultaneous administration with non-selective MAO inhibitors and selective MAO type A inhibitors. These preparations should be discontinued at least 2 weeks prior to the use of DuodopaŽ (with the exception of selective MAO-B inhibitors (eg selegiline hydrochloride)).

ˇ Conditions in which adrenomimetics are contraindicated, for example, pheochromocytoma, hyperthyroidism and Cushing's syndrome.

ˇ The period of breastfeeding.

Patients with suspicion of undiagnosed skin diseases or melanoma in the anamnesis (since levodopa can stimulate the development of malignant melanoma).

ˇ Patients under the age of 18 years.

Carefully

Severe cardiovascular or pulmonary diseases.

ˇ Bronchial asthma.

Chronic open-angle glaucoma.

ˇ Diseases of the kidneys, liver or endocrine system.

ˇ Psychoses (ongoing or in history), as well as peptic ulcer or a history of convulsive syndrome.

Joint reception with antipsychotics capable of blocking dopamine receptors (especially D2)

ˇ Joint use with drugs that can cause orthostatic hypotension (eg, ACE inhibitors, nitrates, diuretics, MAO inhibitors).

Application in pregnancy and breastfeeding

Pregnancy

There is insufficient data on the use of levodopa / carbidopa in pregnant women. The data obtained in animal studies revealed the developmental defects of the skeleton and internal organs of the fetus. Possible risk of use in humans is not known. In pregnancy, DuodopaŽ can only be used after a thorough assessment of the risk-benefit relationship, when the benefit to the mother exceeds the potential risk to the fetus.

Breastfeeding period

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 it is not known whether it is excreted in human milk. The effect of levodopa / carbidopa on children is not known. During the use of DuodopaŽ, breastfeeding should be discontinued.

Dosing and Administration

The drug Duodopa is a gel for long-term intestinal application. The gel should be injected with a portable pump 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 cannot 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 DuodopeŽ 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 the 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, DuodopaŽ should be given as a monotherapy. In the future, if necessary, you can simultaneously prescribe other drugs for the treatment of Parkinson's disease. For the administration of DuodopaŽ, only a special CA DDŽ-Legacy 1400 pump must be used. The instructions for use are supplied with the pump.

Treatment with DuodopaŽ 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 point of its introduction to be tightened. Then it is necessary to continue treatment with the use of drugs (in oral dosage form), including those containing levodopa / carbidopa.

Dose selection

Long-term administration of the total daily dose of DuodopaŽ 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 DuodopaŽ is administered within 10-30 minutes to quickly reach the therapeutic concentration. The morning dose of DuodopaŽ should be selected on the basis of the previous morning dose of levodopa by the patient. The total morning dose of DuodopaŽ is usually 5-10 ml of gel, which corresponds to 100-200 mg of levodopa. The total morning dose of DuodopaŽ should not exceed 15 ml of gel (300 mg of levodopa). The morning dose of DuodopaŽ 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 an effective morning dose of DuodopaŽ has been established, no further dose adjustment is required.

Permanent maintenance dose: a constant maintenance dose of DuodopeŽ 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 DuodopeŽ may be needed. The maintenance dose of DuodopeŽ is adjusted in increments of 0.1 ml / h (2 mg levodopa / h). The dose of DuodopeŽ should be calculated on the basis of the previous dose of levodopa administered by the patient. After withdrawal of concomitant treatment, the dose of DuodopeŽ should be adjusted.

Additional bolus doses: an additional dose of DuodopaŽ should be selected individually, usually 0.5-2.0 ml. Additional bolus doses of DuodopaŽ are administered if necessary in the event of hypokinesia during the day. In rare cases, a higher dose of DuodopaŽ may be needed. If the need for additional bolus doses of DuodopaŽ is more than 5 times a day, then an increase in the maintenance dose of DuodopaŽ should be considered. After setting the initial dose of DuodopaŽ for several weeks, small corrections of the morning bolus, supporting and additional bolus doses of DuodopaŽ should be done.

Table 1. Determination of the total daily dose of DuodopaŽ.

Morning dose Permanent maintenance dose: Additional bolus doses:
The beginning of treatment (day 1) The morning dose of DuodopaŽ should be calculated on the basis of the morning oral dose of levodopa / carbidopa (previously taken by the patient). The morning dose of DuodopaŽ is calculated taking into account the recommended conversion factor, (see Table 2. Dependence of the morning oral dose of levodopa / carbidopa and the morning dose of Duodopa Ž). The maintenance dose of Duodope Ž is adjusted in steps of 0.1 ml / h (2 mg levodopa / h). Can be applied every hour. Begin with a dose of 1 ml.
Day 2 and the end of the period of dose titration (titration is usually 4-7 days) The morning dose of DuodopaŽ can be adjusted based on the clinical effect of taking the previous morning dose. Example of constant maintenance dose calculation: Constant maintenance dose (A mg) = total daily oral dose (previously taken by the patient) - morning dose; Can be applied every hour. Begin with a dose of 1 ml.
The period of administration of a stable total daily dose After an effective morning dose of DuodopaŽ has been established, no further dose adjustment is required. A mg: 20 mg / ml = B ml; Can be used every 2 hours (if necessary).
Table 2. Dependence of the morning oral dose of levodopa / carbidopa and the morning dose of Duodopa Ž
Morning oral dose of levodopa / carbidopa Morning oral dose of levodopa / carbidopa
0-200 mg 80%
201-399 mg 70%
≥ 400 mg 60%
Use of DuodopaŽ at nightIf there is a medical indication, DuodopaŽ can be administered at night.

Monitoring of treatment: a sudden deterioration in 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 movement of the probe back into the duodenum / jejunum is carried out using a conductor under the control of fluoroscopy.

Application in children and adolescents

The drug DuodopaŽ 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 DuodopeŽ are based on achieving the optimal clinical effect in patients with Parkinson's disease, and it is not necessary to separately consider the effect of renal / hepatic insufficiency on the concentration of levodopa / carbidopa in blood plasma.

Interruption of treatment

If you need a sharp dose reduction or need to stop treatment with DuodopeŽ, careful monitoring of the patient should be made, especially if he receives antipsychotics.

If suspected development of dementia or the establishment of such a diagnosis and increased 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, you must attach it 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 of the drug remains. Do not use open cassettes again. At the end of the storage period, the gel may acquire a slight yellowish color. This does not affect the concentration of the drug or the effectiveness of treatment.

Side effects

Adverse reactions often observed with DuodopaŽ

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 in the place of installation of the stoma and reaction in the place of installation Stoma.

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 occur after the start of the drug and are included, regardless of the cause, combined with side reactions that occur during the post-registration observation of DuodopaŽ.

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 Duodopa Ž (excluding side reactions associated with percutaneous endoscopic gastrostomy and using a portable pump)
System of organs Frequency of occurrence Adverse Reactions
Violations of the blood and lymphatic system Often Anemia.
Infrequently Leukopenia, thrombocytopenia.
Immune system disorders Frequency unknown Anaphylactic reactions.
Disorders from the gastrointestinal tract Often Nausea, constipation.
Often Vomiting, bloating, dyspepsia, flatulence, diarrhea, dryness of the oral mucosa, dysgeusia, dysphagia.
Infrequently Hyper secretion of saliva, intestinal invagination.
Rarely Bruxism, discoloration of saliva, burning mouth syndrome, hiccough.
Disorders from the metabolism and nutrition Often Decreased body weight.
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 tract Often Urinary retention, involuntary urination.
Infrequently Chromaturia
Rarely Priapism.
Disturbances from musculoskeletal and connective tissue Often Muscle spasms, pain in the neck.
Disturbances from the nervous system Often Dyskinesia, Parkinson's disease
Often Polyneuropathy, dizziness, dystonia, the phenomenon of "on-off", paresthesia, fainting, headache, drowsiness, tremor, hypoesthesia.
Infrequently Ataxia, convulsions, gait disturbance.
Disorders of the psyche Often Anxiety disorders, depression, insomnia.
Often Unusual dreams, a state of arousal, confusion
Infrequently Consciousness, hallucinations, impulsive behavior, psychotic disorder, involuntary episodes of falling asleep, sleep disturbance.
Rarely Completed suicide, dementia, disorientation, a state of euphoria, a sense of fear, increased sexual desire, nightmares, suicide attempts.
Vision disorders Infrequently Pathological thinking.
Disturbances from the respiratory system, chest and mediastinal organs Often Blepharospasm, diplopia, ocular ischemic neuropathy, blurred vision, angle-closure glaucoma.
Infrequently Pain in the mouth and pharynx, shortness of breath, aspiration pneumonia.
Rarely Pain in the chest, dysphonia.
Disturbances from the skin and subcutaneous tissues Often Abnormal breathing.
Infrequently Hyperhidrosis, contact dermatitis, peripheral edema, pruritus, rash.
Rarely Alopecia, redness of the skin, hives.
Disorders from the heart Often Changing sweat color, malignant melanoma.
Infrequently Arrhythmia.
Vascular disorders Often Sensation of rapid heart rate.
Often Orthostatic hypotension.
Infrequently Reduction of blood pressure, increased blood pressure.
Laboratory and instrumental data Often Phlebitis.
Disturbances from the skin and subcutaneous tissues Often An increase in the concentration of homocysteine in the blood, a decrease in the concentration of vitamin B6, a decrease in the concentration of vitamin B12.
General disorders and disorders at the site of administration Often Hyperhidrosis, contact dermatitis, peripheral edema, pruritus, rash.
Infrequently Fatigue, pain in the place of installation of stoma, asthenia.
Trauma, intoxication and complications of manipulation Often Feeling of discomfort.
The analysis was performed in patients who received the DuodopaŽ preparation or placebo gel through an iminatal probe after percutaneous endoscopic gastrostomy to ensure that adverse reactions associated with percutaneous endoscopic gastrostomy and the use of a portable pump were detected in all studies, regardless of the design of the study (double-blind Or open).The following are side effects associated with percutaneous endoscopic gastrostomy and the use of a portable pump.
Adverse reactions associated with percutaneous endoscopic gastrostomy and the use of a portable pump
System of organs Frequency of occurrence Adverse Reactions
Disorders from the gastrointestinal tract Often Pain in the abdomen.
Often Pneumoperitoneum, unpleasant sensations in the abdomen, peritonitis, pain in the upper abdomen.
Infectious and parasitic diseases Often Infection of the postoperative wound.
Often Cellulite in the place of installation of stoma, postoperative infection.
Trauma, intoxication and complications of manipulation Often Pain in the site of the stoma installation, redness of the skin at the site of the stoma installation, reaction in the place of the stoma installation, postoperative discharge.
Often Pain at the site of stoma installation, postoperative bleeding, complications associated with the installation of the gastrointestinal probe, postoperative discomfort, postoperative intestinal obstruction, postoperative complications.
Disturbances from the skin and subcutaneous tissues Often Excess formation of granulation tissue.
General disorders and disorders at the site of administration Often Difficulties with the introduction of the probe.
Often Probe displacement, blockage of the probe.

There were reports of frequent adverse reactions associated with the complication of the installation of both the imanal probe and the naso-natural probe.

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, pneumoperitoneum, ulcer of the small intestine.

probe displacement in the stomach cavity leads to a recurrence of motor fluctuations (due to irregular evacuation of the cavity preparation DuodopaŽ stomach into the intestine). The probe is transferred back to the duodenum by means of a conductor under the control of fluoroscopy.

Laboratory indicators

The following deviations from laboratory values were reported in the treatment of levodopa / carbidopa, and therefore must be considered in the treatment of drug DuodopaŽ: increased activity of alkaline phosphatase, aspartate aminotransferase, alanine transaminase, lactate dehydrogenase; Increased blood urea nitrogen concentrations, bilirubin, blood glucose, creatinine, uric acid; Positive Coombs test result and reduced blood hemoglobin and hematocrit. There were reports of urine in the urine of leukocytes, bacteria and blood.

Use of levodopa / carbidopa, and hence the drug DuodopaŽ can lead to false positive results rapid tests for the detection of ketones in the urine; This reaction does not change when urine is boiled.

The use of glucose oxidase methods to investigate the presence of glucosuria can give false-negative results.

The following adverse reactions were observed with dopaminergic drugs and may be observed with Duodopa Ž

Violations from the blood and lymphatic system:

Agranulocytosis, hemolytic anemia.

Disturbances from the nervous system:

Trism, malignant neuroleptic syndrome.

Disorders from the side of the organ of vision:

Bernard-Horner's syndrome, mydriasis, cramp of the eye.

Disturbances from the skin and subcutaneous tissues:

Angioneuroticeski swelling, purpura Shenlaine-Genocha.

Overdose

Treatment of acute overdose of the preparation DuodopeŽ basically coincides with the treatment of acute overdose of levodopa. Nevertheless, in this situation, pyridoxine is ineffective. Regular ECG should be performed in connection with the danger of developing cardiac arrhythmias; If necessary, appropriate antiarrhythmic therapy is prescribed. It should be remembered about the possibility of drug interaction with other drugs that the patient was taking. Dialysis with an overdose of the drug has hitherto been applied, so its effectiveness is unknown.

Interaction

Care should be taken when using DuodopaŽ and the following drugs at the same time:

Antihypertensive drugs

When using a combination of levodopa and an aromatic L-amino acid decarboxylase inhibitor, postural hypotension developed in patients who are already taking antihypertensive drugs. You may need to adjust the dose of an antihypertensive drug.

Antidepressants

There are rare reports of such adverse reactions as an increase in blood pressure and dyskinesia that occurred with the combined use of tricyclic antidepressants and levodopa / carbidopa preparations.

Anticholinergic drugs

Anticholinergic drugs can reduce the severity of tremor when combined with levodopa, but their combined use can enhance pathological involuntary movements. Anticholinergic drugs can reduce the severity of the effects of levodopa due to a slowdown in absorption. You may need to adjust the dose of DuodopaŽ.

Inhibitors of catechol-O-methyltransferase (tolcapone, entacapone)

The combined use of COMT inhibitors (catechol-O-methyltransferase) and DuodopaŽ can increase the bioavailability of levodopa. You may need to adjust the dose of DuodopaŽ.

Preparations of iron

15, the gastrointestinal tract of levodopa can form chelate complexes with iron, which leads to a decrease in the absorption of levodopa.

Other medications

Dopamine receptor antagonists (some antipsychotics, such as phenothiazines, butyrophenones and risperidone, and antiemetics such as metoclopramide), benzodiazepines, isoniazid, phenytoin and papaverine may decrease the effectiveness of levodopa treatment. Patients taking these drugs with DuodopeŽ. Need careful monitoring for loss of therapeutic effectiveness.

It is possible to use DuodopaŽ together with the recommended dose of MAO inhibitor. But only selective inhibitor MAO type B (eg selegiline hydrochloride). The combined use of selegiline and levodopa / carbidopa can lead to severe orthostatic hypotension.

Amantadine has a synergistic effect with levodopa and may increase the severity of adverse reactions associated with this use. You may need to adjust the dose of DuodopaŽ.

Sympathomimetics may increase the severity of cardiovascular side effects associated with levodopa.

Due to the fact that levodopa competes with some amino acids for transport mechanisms, absorption of levodopa can worsen in patients whose diet is rich in proteins.

The effect of antacids on the bioavailability of DuodopaŽ has not been studied.

Special instructions

Before the introduction of a permanent nasode-duodenal probe, it is necessary to obtain positive clinical results of the trial application of DuodopaŽ with the introduction through a temporary naso-natural probe.

The warnings and cautions below are for levodopa, and therefore apply to DuodopaŽ. The drug DuodopaŽ is not recommended for the treatment of extrapyramidal reactions caused by other drugs.

In patients with a history of myocardial infarction and an atrial or ventricular arrhythmia, it is necessary to monitor cardiac function, especially in the initial period of dose selection.

In all patients receiving DuodopeŽ treatment, careful monitoring should be carried out for the development of mental changes, depression with suicidal tendencies and other severe mental illnesses. Treatment of patients with psychoses, ongoing or in history, should be done with caution.

It is necessary to carefully prescribe Duodopa Ž together with antipsychotics that can block dopamine receptors (especially D2) - possibly reducing the antiparkinsonian effect or increasing the symptoms of the disease.

Treatment Duodopa Ž patients with chronic open-angle glaucoma should be carried out with caution, provided that the monitoring of intraocular pressure and its regular measurement.

The drug DuodopaŽ can cause orthostatic hypotension, therefore the drug should be administered with caution to patients taking other medications that cause orthostatic hypotension (eg, ACE inhibitors, nitrates, diuretics, MAO inhibitors).

With a sharp cancellation of antiparkinsonian drugs, malignant neuroleptic syndrome (CNS) can be observed - a complex of symptoms including muscle rigidity, fever, mental changes (eg, agitation, confusion, coma), and increased activity of creatine phosphokinase in plasma. In rare cases within the ZNS patients with Parkinson's disease are observed rhabdomyolysis and severe dyskinesia. In this regard, with a sharp reduction in dose or withdrawal of a combination of levodopa / carbidopa, it is necessary to carefully monitor the patient's condition, especially if he takes antipsychotics.

There are reports of cases of gambling, increased sex drive and hypersexuality, and inability to monitor these phenomena in patients with Parkinson's disease who have been treated with dopaminomimetics, including levodopa / carbidopa preparations (and DuodopaŽ).

Although the association of these phenomena with the use of dopaminergic has not been proven, the abolition or reduction of the dose of one or more dopaminergic drugs caused the cessation of these phenomena. Physicians should monitor the possible development of gambling, increased sex drive and hypersexuality in patients with Parkinson's disease who are taking DuodopaŽ. Doctors should consider reducing the dose or withdrawal of DuodopaŽ if the patient develops these phenomena.

If general anesthesia is required, treatment with DuodopaŽ can continue until the patient is allowed to take liquids and medications. If it is necessary to temporarily stop the therapy, the drug intake can be resumed at the same dose, when it will be allowed to take the liquid.

To avoid the development of dyskinesias against the background of taking levodopa, the dose of DuodopaŽ can be reduced.

During prolonged therapy with DuodopaŽ, periodic assessment of liver, kidney, hematopoietic and cardiovascular systems is recommended.

DuodopaŽ contains hydrazine, a carbidopa degradation product that can have genotoxicity and potentially oncogenic activity. The average daily dose of DuodopaŽ is 100 ml, which corresponds to 2 g of levodopa and 0.5 g of carbidopa. The maximum daily dose is 200 ml. This corresponds to the intake of hydrazine in amounts reaching, on average, 4 mg per day; A maximum of 8 mg per day. The clinical significance of ingesting such amounts of hydrazine is not known.

Previous surgical intervention on the upper abdomen may cause difficulties in the installation of gastro- or ejnostomy.

There are separate reports of cases of occlusion of the probe and / or blockage of the intestine with the formation of bezoar, requiring replacement of the probe and, in rare cases, surgical intervention. Early symptoms of such conditions include abdominal pain, nausea and vomiting. In some cases ulcers of the stomach and intestines were found. One of the risk factors for the formation of bezoar can be eating foods with a high fiber content (for example, asparagus).

Inadvertent treatment of the patient with a pump or probe can cause the development of complications. In this case, the patient should be assisted by a guardian (for example, a nurse or a close relative).

Monitoring therapy: a sudden decrease in the effectiveness of the drug with the occurrence of motor fluctuations may indicate the movement of the distal part of the probe from the duodenum to the stomach. It is necessary to determine the location of the catheter by X-ray examination and return it to the duodenum under the radiological control.

A sudden or gradual increase in bradykinesia may indicate blockage of the device for any reason and requires examination.

Epidemiological studies have shown that patients with Parkinson's disease have a higher risk of developing melanoma compared to the population as a whole. It is unclear whether the increased risk of developing melanoma is associated with Parkinson's disease or other factors, such as the use of drugs to treat Parkinson's disease. Thus, patients with DuodopeŽ should monitor melanoma development on a regular basis. Periodic examinations of the skin should be carried out properly by qualified specialists (for example, dermatologists).

Complications observed in clinical trials include: bezoar, intestinal obstruction, erosion / ulcer stoma, intestinal bleeding, intestinal ischemia, intestinal obstruction, intestinal perforation, intestinal invagination, pancreatitis, peritonitis, pneumoperitoneum and postoperative 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 those 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 can cause dizziness and orthostatic hypotension, drowsiness and sudden falling asleep, so patients should be careful when driving and controlling the mechanisms. Patients treated with DuodopaŽ, who are drowsy and / or have a sudden falling asleep, are advised not to drive or participate in activities in which impaired attention may expose them or others to the risk of serious injury or death (eg, management of mechanisms ) until. While these adverse reactions will cease.

Release form

Gel for intestinal administration, 20 mg / ml + 5 mg / ml.

For 100 ml of gel in a bag of PVC with a PVC connecting tube attached to it; The bag with the embedded tube sealed and placed in a solid cassette of transparent gray plastic, the connecting tube is passed through the hole in the top cover of the cassette (side) and fixed with special clips along the top cover of the cassette. The connecting tube is provided with a clip, a female Luer connection and a screwed protective cap. In addition, a red label with a warning "WARNING: NOT for intravenous connection" in several languages can be attached to the tube.

A label is attached to the cassette.

For 7 cassettes, the connecting tubes upwards together with the instruction for use are placed in a cardboard pack.

Storage conditions

At a temperature of 2 ° C to 8 ° C in a dark place.

Keep out of the reach of children.

Shelf life

15 weeks.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies

On prescription.

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