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A better life – for both of them
Research into Parkinson’s disease is making progress towards
more effective treatment methods.
Solvay Pharmaceuticals supports this research and actively
contributes to its success. Our aim is to help improve the
everyday life for patients with Parkinson’s disease.
And when Parkinson’s disease patients enjoy a better life,
so do those close to them.
Duodopa
®
contains 1 ml contains 20 mg levodopa and 5 mg carbidopa monohydrate.100 ml contain 2000 mg levodopa and 500 mg carbidopa monohydrate. Pharmaceutical form: intestinal
gel. Therapeutic indications: Treatment of advanced levodopa-responsive Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia when available combinations of Parkinson
medicinal products have not given satisfactory results. Posology and method of administration: the gel should be administered with a portable pump directly into the duodenum or upper
jejunum by a permanent tube via percutaneous endoscopic gastrostomy with an outer transabdominal tube and an inner intestinal tube. A temporary nasoduodenal tube is recommended to
find out if the patient responds favourably to this method of treatment. Dosage: the total dose/day of Duodopa is composed of three individually adjusted doses: the morning bolus dose, the
continuous maintenance dose and extra bolus doses. Morning dose: The morning bolus dose is administered by the pump to rapidly achieve the therapeutic dose level (within 10-30 minutes).
The total morning dose should not exceed 15 ml (300 mg levodopa). Continuous maintenance dose: The maintenance dose is adjustable in steps of 2 mg/hour (0.1 ml/hour). The continuous
maintenance dose is adjusted individually. It should be kept within a range of 1-10 ml/hour (20-200 mg levodopa/hour). Extra bolus doses: To be given as required if the patient becomes
hypokinetic during the day. The extra dose should be adjusted individually. Treatment must monitored. Contraindications: hypersensitivity to levodopa, carbidopa or any of the excipients;
severe liver and renal insufficiency; severe heart failure; severe cardiac arrhythmia; acute stroke. Special warnings and precautions for use: Duodopa should be administered with caution to
patients with severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease, or history of peptic ulcer disease or of convulsions. In patients with a history
of myocardial infarction who have residual atrial nodal or ventricular arrhythmias, cardiac function should be monitored with particular care during the period of initial dosage adjustments.
All patients treated with Duodopa should be monitored carefully.. Patients with past or current psychosis and chronic wide-angle glaucome can be treated with caution. Levodopa has been
associated with somnolence and episodes of sudden sleep onset in patients with Parkinson’s disease and caution should therefore be exercised when driving and operating machines. Previous
surgery in the upper part of the abdomen may lead to difficulty in performing gastrostomy or jejunostomy. Interaction with other medicinal products and other forms of interaction: Caution
is needed in concomitant administration of Duodopa with the following medicinal products: antihypertensives, antidepressants, anticholinergics, COMT ihibitors, some antipsychotics and
benzodiazepines. Duodopa can be taken concomitantly with the recommended dose of an MAO inhibitor, which is selective for MAO type B (for instance selegiline-HC1). Concomitant use
of selegiline and levodopa-carbidopa has been associated with serious orthostatic hypotension. Amantadine has a synergic effect with levodopa and may increase levodopa related adverse
events. Sympathicomimetics may increase cardiovascular adverse events related to levodopa. Levodopa forms a chelate with iron in the gastrointestinal tract leading to reduced absorption of
levodopa. As levodopa is competitive with certain amino acids, the absorption of levodopa can be disturbed in patients who are on a protein rich diet. The effect of administration of antacids
and Duodopa on the bioavailability of levodopa has not been studied. Pregnancy: Duodopa should not be used during pregnancy unless the benefits for the mother outweigh the possible risks
to the foetus. Lactation: Levodopa is excreted in the breast milk. It is unknown whether carbidopa is excreted in human breast milk. Duodopa should not be used during breast-feeding. Effects
on ability to drive and use machines: Caution should be exercised when driving or using machines. Undesirable effects: Undesirable effects that occur frequently with levodopa/carbidopa are
those due to the central neuropharmacological activity of dopamine. These reactions can usually be diminished by levodopa dosage reduction. The device: Complications with the devices may
occur, e.g. connector leakage and dislocation of the intestinal tube. Dislocation of the intestinal tube backwards into the stomach leads to reappearance of motor fluctuations. In general, reloca-
tion of the tube can be done using a guide-wire to steer the tube into the duodenum under fluoroscopy. Occlusion, kinks, or knots of the intestinal tube lead to high pressure signals from the
pump. Occlusions are usually remedied by flushing the tube with tap water; kinking, knotting, or a tube displacement may need readjustment of the tubing. The stoma usually heals without
complications. However, abdominal pain, infection and leakage of gastric fluid may occur shortly after surgery; it is rarely a problem long-term. Reported complications include wound infection
(the most common complication) and peritonitis. Local infections around the stoma are usually treated conservatively with a disinfectant. Overdose: Most prominent clinical symptoms of an
overdose with levodopa/ carbidopa are dystonia and dyskinesia. Blepharospasm can be an early sign of overdose. The treatment of an acute overdose of Duodopa is in general the same as that
of an acute overdose of levodopa. Electrocardiographic monitoring should be used and the patient observed carefully for the development of cardiac arrhythmias; if necessary an appropriate
antiarrhythmic therapy should be given. The possibility that the patient took other medicinal products together with Duodopa should be taken into consideration. To date experiences with
dialysis have not been reported, therefore its value in the treatment of overdose is unknown. Shelf life: 15 weeks. Special precautions for storage: store in a refrigerator (2ºC-8°C).Keep the
cassette in the outer carton in order to protect from light. The marketing holder of the product is Solvay Pharmaceuticals. For further information consult
www.solvaypharmaceuticals.com
1
Nyholm D. et al. Duodenal levodopa infusion monotherapy versus oral
polypharmacy in advanced Parkinson’s disease. Neurology 2005; 64: 216-223.
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