Exelon capsules 1.5 mg, 28 pcs. (rivastigmin)

packing 28 pcs

Indications

- Mild to moderate Alzheimer's type dementia: probable Alzheimer's disease, Alzheimer's disease.

- Mild to moderate dementia in Parkinson's disease.

Contraindications

- Hypersensitivity to rivastigmine, other carbamate derivatives or other ingredients that make up the drug.

- Exelon is contraindicated in patients with severely impaired liver function, since its use in this population has not been studied.

Precautions:

- Exelon, like other cholinomimetic agents, it should be used with caution in patients with sinus node syndrome or conduction disturbances6 sino-arthrial block, atrioventricular block.

- Cholinergic stimulation can increase the secretion of hydrochloric acid in the stomach, lead to increased urinary tract obstruction and exacerbation of convulsive syndrome, therefore caution should be exercised when prescribing Exelon to patients predisposed to these conditions.

- Exelon, like other cholinomimetics, should be used with caution in patients with a history of bronchial asthma or obstructive airway diseases. Taking into account the pharmacodynamic properties of Exelon, it should not be prescribed simultaneously with other cholinomimetic drugs.

During the dose selection period, as with other cholinomimetics, adverse events were noted for a short period after increasing the dose. The severity of adverse events may decrease in response to a decrease in the dose of the drug. Otherwise, Exelon should be canceled.

Use in pregnancy and lactation

Experimental data showed that rivastigmine does not have teratogenic properties. However, the safety of Exelon during pregnancy in humans has not yet been established, therefore, the drug can be prescribed to pregnant women only in cases where the expected benefit of treatment exceeds the potential risk to the fetus.

It is not known whether Exelon passes into breast milk. Therefore, during the use of the drug should abandon breastfeeding.

Composition

1 capsule contains: Active substance: rivastigmine (in the form of hydrotartrate) 1.5 mg.

Excipients: magnesium stearate, methylhydroxypropyl cellulose (hypromellose), microcrystalline cellulose, anhydrous colloidal silicon dioxide, titanium dioxide (E 171), gelatin, yellow iron oxide (E 172), red iron oxide (E 172).

Dosage and administration of

Exelon should be taken orally 2 times a day, during breakfast and dinner.

When using the drug in patients who are especially sensitive to the effects of cholinergic drugs, treatment should begin with the use of the drug in a dose of 1 mg 2 times a day.

The initial recommended dose is 1.5 mg (0.75 ml of solution) 2 times a day. If after a minimum of two weeks of treatment there is good tolerance to this dose, it can be increased to 3.0 mg 2 times a day. In the case of good tolerance to the dose taken by the patient, its further increase is possible - up to 4. 5 mg 2 times a day and then up to 6 mg 2 times a day - with an interval of at least 2 weeks after each increase in dose.

Adverse events, namely nausea, vomiting, abdominal pain, loss of appetite or weight loss observed during treatment, may decrease after skipping one or more doses of the drug. If adverse events persist, the daily dose should be reduced to the previous dose well tolerated by the patient.

Maintenance dose is: from 1.5 mg to 6.0 mg 2 times a day. In order to achieve the best therapeutic effect, the dose should be kept at the maximum well tolerated level.

Maximum daily dose: 6.0 mg 2 times a day.

If the break in taking the drug was several days or more, treatment should be resumed with an initial dose to reduce the risk of resumption of adverse reactions (eg, severe vomiting). A gradual increase in dose is carried out stepwise, as described above. Exelon's equal doses, administered as capsules or as an oral solution, are interchangeable.

In patients with impaired renal or hepatic function, dosage adjustment of the drug is not required

Side effects

The overall incidence of adverse events with TTC Exelon therapy 9.5 / 24 h (50.5%) was lower compared with oral therapy using capsules in a daily dose of 3-12 mg (63. 3%) (for comparison, in the placebo group, this indicator was 46%).

The most frequent reaction from the digestive system. Nausea (7.2%) and vomiting (6.2%) were observed much less frequently with the use of TTC Exelon 9.5 mg / 24 h compared with capsules for oral administration, 23.1% and 17.0%, respectively (in the placebo group, the same indicators were 5.0% and 3.3% )

The frequency of adverse reactions in patients (291 people) with Alzheimer's type dementia who received TTC Exelon therapy (all dosages) was determined as follows: very often ( 1/10), often ( 1/100, less than 1/10) , infrequently ( 1/1000, less than 1/100), rarely ( 1/10 000, less than 1/1000), very rarely (less than 1/10 000), undesirable reactions are presented separately, the frequency of which is not precisely established.

Infectious and parasitic diseases: often urinary tract infections.

From the side of metabolism: often - anorexia.

From the nervous system: often - anxiety, depression, delirium, headache, fainting very rarely - extrapyramidal disorders frequency unknown - hallucinations.

From the cardiovascular system: infrequently - bradycardia, cerebrovascular accident.

From the digestive system: often - nausea, vomiting, diarrhea, dyspepsia, abdominal pain infrequently - stomach ulcer.

Dermatological reactions: often a rash.

On the part of the body as a whole and reactions at the site of TTC attachment: often - erythema, swelling and itching, irritation, inflammation at the site of application, increased fatigue, asthenia, fever, weight loss.

In clinical trials when using the drug in doses of more than 9.5 mg / 24 h, the following adverse reactions were noted much more often than in the TTC Exelon 9.5 mg / 24 h and placebo groups: dizziness, insomnia, agitation, decreased appetite, atrial fibrillation, heart failure ( possibly related to an increase in dose). The frequency of these adverse reactions during therapy with TTC Exelon 9.5 mg / 24 h was similar to that in the placebo group.

The following adverse reactions were observed only with capsule or Exelon oral solution and were not registered with TTC Exelon 9.5 mg / 24 h: dizziness (very often), agitation, drowsiness, general malaise, tremor, confusion, sweating (often), insomnia, occasional falls, increased liver activity (sometimes), convulsions, duodenal ulcer, angina pectoris, myocardial infarction (rare), arrhythmias (e.g. AV block, atrial fibrillation, tachycardia), increased blood pressure, pancreatitis, gastrointestinal bleeding, hallucinations (very rarely) in some cases - severe vomiting, leading to rupture of the esophagus (frequency unknown).

Dermatological reactions

When using TTC Exelon, the most frequently observed reddening of the skin (erythema) at the site of application, usually disappearing in most patients within 24 hours, in clinical trials with TTC Exelon 9.5 mg / 24 h, mild (21.8%), moderate (12.5%), severe (6.5%) redness of the skin, mild itching (11.9%), moderate (7.3%) and severe (5%) degree.

During therapy with TTC Exelon 9. 5 mg / 24 h, pruritus and erythema were observed in 1.7% and 1.1% of patients, respectively. Most skin reactions developed only in the area of ​​TTC application. When using TTC Exelon 9.5 mg / 24 h, discontinuation of drug treatment due to the development of dermatological reactions was noted in only 2.4% of cases.

Drug Interaction

Rivastigmine is metabolised mainly by hydrolysis with the participation of esterases. The metabolism of rivastigmine with the participation of major cytochrome P450 isoenzymes occurs to a minimum. Thus, pharmacokinetic interactions of rivastigmine with other drugs metabolized with the participation of these enzymes are unlikely.

In healthy volunteers, the pharmacokinetic interaction between rivastigmine and digoxin, warfarin, diazepam or fluoxetine was not detected. Warfarin-induced increase in prothrombin time at the appointment of rivastigmine did not change. With the concomitant use of rivastigmine and digoxin, no adverse effect on intracardiac conduction was noted.

Concurrent use of rivastigmine with commonly used drugs such as antacids, antiemetic agents, anti-diabetic agents, central antihypertensive agents, beta-blockers, calcium channel blockers, drugs that have positive inotropic, anti-hypertensive drugs benzodiazepines and antihistamines, was not accompanied by any changes in the kinetics of rivastigmine or an increased risk of clinically relevant adverse events. During anesthesia, rivastigmine, being a cholinesterase inhibitor, may potentiate the effects of depolarizing muscle relaxants (succinylcholine type muscle relaxants).



overdose Symptoms: In most cases, an accidental overdose of the drug was not accompanied by any clinical manifestations of virtually all patients continued with Exelon. At an overdose nausea, vomiting, diarrhea, the expressed increase in BP, hallucinations were noted. Given the vagotonic effect of cholinesterase inhibitors on heart rate (HR), bradycardia and / or syncope cannot be ruled out. In one case, 46 mg of the drug was taken after conservative cervical treatment for 24 hours, complete recovery was observed.

Treatment: As the plasma half-life of rivastigmine is about 1 hour and the duration of inhibition of acetylcholinesterase is about 9 hours, it is recommended not to use Exelon for the next 24 hours in cases of asymptomatic overdose. If overdose is accompanied by severe nausea and vomiting, the use of antiemetic agents should be considered. If other undesirable phenomena occur, appropriate symptomatic treatment is carried out if necessary. At significant overdose, atropine sulfate may be used, the initial dose of which is 0. 03 mg / kg intravenously, subsequent dosing depends on the clinical effect. The use of scopolamine as an antidote is not recommended.

Storage conditions

At a temperature not exceeding 30 ° C.

Expiration

5 years.

Deystvuyuschee substances

rivastigmin

Conditions of supply of pharmacies

Prescription

Dosage form

dosage form

capsules



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