Ekselon tts Pak. 13.3mg 24h N30
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Active ingredients
Rivastigmine
Release form
TTC
Composition
Transdermal therapeutic system, composition (1 TTS): active substance: rivastigmine - 27 mg (content of rivastigmine in TTC - 13.3 mg / day, area 15 cm2) excipients: D, L-α-tocopherol - 0.09 mg; methyl methacrylate and butyl methacrylate copolymer - 18 mg; acrylic acid copolymer - 44.91 mg adhesive layer: silicone copolymer - 44.505 mg; Dimethicone (silicone oil 12.5 cSt) - 0.45 mg; D, L-α-tocopherol - 0.045 mg polymer films: PET substrate, 23 μm - 15 cm2; protective fluoropolymer PET film, 75 microns - 29.16 cm2
Pharmacological effect
anticholinesterase
Contraindications
- Hypersensitivity to rivastigmine, other carbamate derivatives or other components of the drug. - Exelon is contraindicated in patients with severely impaired liver function, since its use in this population has not been studied.
Dosage and administration
Transdermal. Treatment with the drug should be carried out only under the supervision of a physician who has experience in treating patients with dementia and under the supervision of caregivers. Patients and their caregivers should be instructed by competent medical staff about the features of the drug. The amount of contained and released rivastigmine depending on the dosage of TTC Excelon is presented in the table. h, mgTTS Exelon 4.6 mg / day 9 4,6TTC Exelon 9.5 mg / day 18 9.5TTC Exelon 13.3 mg / day 27 13.3Mently or moderately severe dementia of Alzheimer's type Now Ordering and selection of the recommended dose effective dose. Treatment with the drug should be started with the use of TTC Ekselon 4.6 mg / day 1 time per day. After 4 weeks of treatment at least, with good tolerance, the dose of the drug should be increased to the recommended effective dose by using TTC Ekselon 9.5 mg / day, which can apply as long as the therapeutic effect is maintained. Increasing the dose. For prolonged treatment in the presence of therapeutic efficacy in a patient, the use of TTC Exelon 9.5 mg / day is recommended. With good tolerability of the drug and at least after 6 months of treatment with TTC Exelon 9.5 mg / day, the attending physician may, if necessary, achieve an additional therapeutic effect, increase the dose to 13.3 mg / day in patients who, despite the use of TTC Exelon 9, 5 mg / day,there is a significant impairment of cognitive function (for example, deterioration of results on a short scale for assessing mental status) and / or deterioration in functional status (based on a subjective assessment of a physician). Severe Alzheimer's type dementia. Initial dose and selection of the recommended effective dose. Treatment with the drug should begin with the use of TTC Exelon 4.6 mg / day 1 time per day. The dose of the drug should be consistently increased first to 9.5 mg / day, and then to an effective dose of 13.3 mg / day. Each dose increase is possible only after 4 weeks of treatment with a minimum and with good tolerance of the previous dose. A dose of more than 13.3 mg / day does not give a significant advantage, but increases the frequency of side effects. Interruption of treatment It is necessary to regularly evaluate the clinical effect of therapy with Exelon TTC. In the absence of a clinical effect from therapy when using optimal doses of TTC Exelon, it is necessary to stop drug therapy. It is necessary to temporarily stop drug therapy in the event of adverse events (AE) on the part of the digestive system and / or deterioration of existing extrapyramidal symptoms (including tremor) to their permissions. If a break in the use of the drug was not more than 3 days, you can resume taking the drug in the same dose. In the case of a longer duration of the cancellation period, treatment should be resumed from the initial dose (TTC Ekselon 4.6 mg / day). Patients who have been treated with rivastigmine in the form of capsules or oral solution can proceed to treatment with TTC Ekselon as follows: - in patients who received oral therapy with rivastigmine at a dose of ≤6 mg / day, treatment should be started with TTC Exelon 4.6 mg / day; - in patients receiving oral therapy with rivastigmine at a stable and well-tolerated dose of 9 mg / day, treatment can be started immediately. for the use of TTC Ekselon 9.5 mg / day. But if oral therapy was not stable and well-tolerated, it is recommended to start the transition to the transdermal form with a dose of 4.6 mg / day; - in patients receiving oral therapy with rivastigmine at a dose of 12 mg / day, treatment can be started immediately with TTC Excelon 9 , 5 mg / day. After 4 weeks of treatment, at least with good tolerance, the dose of TTC Exelon 4.6 mg / day should be increased to the recommended effective dose by using TTC Exelon 9.5 mg / day. It is recommended to start treatment of TTC Exelon on the next day after applying p Latter oral dose rivastigmina.Osobye patsientovPatsienty groups weighing less than 50 kg.In patients with a body weight less than 50 kg, more frequent development of AE and withdrawal of therapy have been noted, therefore, with increasing doses in this group of patients, special caution should be taken, the dose should be carefully titrated and monitored for development of AE (for example, excessive nausea or vomiting), as well as the possibility of reducing the dose of the drug by using TTC Ekselon 4.6 mg / day in the case of the development of such AE. Particular caution should be taken when titrating the dose over the recommended effective dose of TTC Ekselon 9.5 mg / day. Violation of the liver. Correction of the dosing regimen TTC Exelon is not required. However, due to the increased exposure of rivastigmine observed when taking rivastigmine orally in patients with mild and moderately impaired liver function, it is recommended to carefully titrate the dose of rivastigmine in accordance with individual tolerance in patients of this category. Studying the use of TTC Exelone in patients with severely impaired liver function is not was carried out. Particular caution should be taken when titrating the dose in patients of this category. Patients with clinically significant liver dysfunction may experience more frequent development of dose-related adverse events, and therefore patients in this category should consider using TTC Exelon 4.6 mg / day as an initial and maximum dose. Impaired renal function. Correction of the dosing regimen TTC Exelon is not required. However, due to the increased exposure of rivastigmine, observed when taking rivastigmine orally in patients with impaired mild to moderate renal function, it is recommended to carefully titrate the dose of rivastigmine in accordance with individual tolerance in patients of this category. In patients with clinically significant impaired renal function, a more frequent development of dose-dependent adverse events may be noted, and therefore patients in this category should consider the possibility of using TTC Ekselon 4.6 mg / day as the initial and maximum dose. Children. The use of rivastigmine in children has not been studied, therefore, it is not recommended to prescribe the drug to children. Application instructions Attention! You can use only one TTS Exelon at a time.Each subsequent TTC Ekselon should be pasted only after removing the previous one. TTC Ekselon can not be cut or divided into parts, as well as damage in any way. It should be tightly pressed with the palm of TTC Ekselon in the place of attachment for at least 30 seconds. Place of attachment of TTC Ekselon: - TTC Ekselon is glued onto clean, dry, intact skin with minimal hairline; - do not use creams, lotions, oils, powder and other skin care products in the area of attachment of the drug to avoid peeling; - TTC Ekselon should not be glued to reddened, covered with rashes, irritated or damaged skin; - only one TTS Ekselon per day should be glued to only one of body bones: left or right shoulder, upper chest left or right (should not be glued to the breast area), upper back left or right, lower back left or right. Every 24 hours, you should delete the previous TTC Exelon before How to stick one new TTC Ekselon. In order to avoid skin irritation, each subsequent TTC Ekselon should be glued to another skin area (possible within the same anatomical region). For example, if TTC Ekselon was attached to the lumbar region on the right, then the next time it is necessary to place the system on the left. To minimize the risk of skin irritation, TTC on the same skin area can be glued only at 2 week intervals. How to attach TTC Ekselon: - carefully remove the previous TTC Ekselon; - remove the preparation from the sealed bag immediately before use by cutting or tearing the bag along the dotted line or groove; - carefully remove the protective film protecting the adhesive side of TTC E Xelon, without touching the surface; - immediately after removing the protective film, paste TTC Exelon on the skin of the upper or lower back, shoulder or chest; - after attaching the TTC to the skin, remove the upper protective layer on the other side of the TTC; - firmly press TTS Ekselon in the place of attachment for at least 30 s. It is necessary to make sure that the system fits snugly to the skin, especially along the edges; - if necessary, after sticking, it is recommended to write an attachment date (for example, day of the week) on the TTC with a thin ballpoint pen. a thin, opaque, plastic plaster for sticking on the skin. Do not remove TTC Excelon from the sealed bag and remove the previous TTC Excelon,if you do not plan to glue a new one. The drug should be used immediately after removing it from a sealed bag. Attaching TTC to different skin areas allows you to select the most comfortable areas of the body where the system will not come into contact with tight fitting clothes. How to remove TTC Ekselon: - should carefully bend one of the corners, slowly and carefully remove the TTS; - in the presence of residues of glue on the skin, slightly moisten this area with warm water and a mild soap solution or baby oil to remove any glue residues. Do not use alcohol or other liquid solvents (including nail polish remover); - Wash your hands thoroughly with soap and water after attaching or removing TTC Ekselon. In case of contact with eyes or red eyes after attaching or removing TTC Exelon, immediately rinse the eyes with plenty of water and, if symptoms persist, seek medical attention. How to dispose of used TTS Exelon: - bend the used TTS in half and connect the adhesive parts between - to put used TTC Ekselon in the package. The package of used TTC should be thrown out of the reach of children. After disposing of the drug, you should wash your hands with soap. Conditions for wearing TTC Ekselon (water procedures, prolonged stay near heat sources): - TTC Ekselon does not come unstuck during water procedures (shower, bath, pool). During water procedures it is necessary to make sure that the system fits snugly to the skin, especially along the edges; - Patients using TTC Exelon should not be near any external heat sources for a long time (excessive solar radiation, saunas, tanning beds). What to do if TTC Exelon peeled off: if TTC Ekselon peeled off, it must be replaced with a new TTS before the end of the day. The next day, you should attach the new TTS Ekselon as usual. If you use more than one TTC Ekselon at the same time: you should immediately remove all TTS from the skin and inform the attending physician about what happened. The patient may need medical attention. In some cases, overdose was observed nausea, vomiting, diarrhea, increased blood pressure, hallucinations. Bradycardia and / or syncope are also possible. If the patient has forgotten to paste the next TTC in the usual time, it should be glued immediately.The use of the next TTC is possible the next day at the usual time. Do not stick two TTS to compensate for the missed dose.