The package insert of the medicine Exelon

the package insert of the medicine is Exelon.

what For?

Treatment of patients with dementia, mild to moderately severe of the Alzheimer’s type, also known as probable Alzheimer’s disease or Alzheimer’s disease.

Contraindications

When should I not use?

The use of Exelon is contraindicated in patients with known hypersensitivity to rivastigmine, to other derivatives of the carbamate or to any component of the formula.

Dosage

How to use?

Exelon should be administered 2 times a day, with meals morning and evening. Initial Dose: 1.5 mg 2 times a day. Adjust dose: the recommended initial dose is 1.5 mg 2 times a day. If this dose is well tolerated after at least 2 weeks of treatment, the same can be increased to 3 mg 2 times a day. Increases subsequent to 4.5 mg and then 6 mg 2 times a day should also be based on good tolerability of the dose current and can be considered after a minimum of 2 weeks treatment at that dose level. If adverse effects are observed (for example nausea, vomiting, abdominal pain or loss of appetite) or weight loss during the treatment, these should be resolved with the omission of 1 or more doses. If adverse effects persist, the daily dose should be reduced to the previous dose that had a good tolerability. Maintenance Dose: 1.5 to 6 mg 2 times a day; to achieve the therapeutic benefit maximum, patients should be maintained on the dose well tolerated, the most high. Dose maximum recommended daily: 6 mg two times a day. Use in patients with renal or hepatic insufficiency: it is not necessary to perform adjustment of dose in patients with renal or hepatic insufficiency. Overdose: symptoms: most cases of overdose accidental has not been associated with any sign or clinical symptom, and almost all the patients involved continued the treatment with Exelon. In the cases in which they occurred symptoms, these included nausea, vomiting, and diarrhea. In most of these events, it was not necessary to the therapeutic intervention. Ingestion of 46 mg occurred in one case; following conservative treatment, the patient recovered completely in 24 hours. Treatment: as rivastigmine has a half-life in plasma of about 1 hour and duration of inhibition of the acetylcholinesterase of about 9 hours, it is recommended that, in cases of overdose asymptomatic, no dose of Exelon should be administered for the next 24 hours. In cases of overdose, accompanied by vomiting and nausea severe, the use of antiemetics should be considered. Symptomatic treatment for other adverse events should be performed, if necessary. In overdose severe, atropine may be used. It is recommended an initial dose i. v. of 0.03 mg/kg of sulphate of atropine, with subsequent doses based upon clinical response. It is not recommended the use of scopolamine as an antidote.

Side Effects

What are the evils that can cause me?

In general, adverse events are mild to moderate and are usually resolved without therapeutic intervention. The incidence and severity of adverse events are generally increased with higher doses. The incidence of the following adverse events was at least 2% higher than in patients who used Exelon compared to those who received placebo: increased sweating, malaise, weight loss, and tremor. Female patients were more susceptible to nausea, vomiting, loss of appetite and weight loss. Once that treatment with Exelon is not associated with changes in laboratory tests, including liver function tests, or ECG, you do not need a specific control of the same.

Warnings and Precautions

what should I know before using?

Exelon is not associated with cardiovascular adverse effects. However, as well as other colinomiméticos, care should be taken when using Exelon in patients with disease of the sinus node or heart arrhythmias serious. The stimulation cholinergic can cause increased secretion of gastric acid. Although the data from clinical studies have not demonstrated a significant increase in symptoms suggestive of states ulcer, caution is recommended when treating patients predisposed to these pathologies. Patients treated with Exelon showed no signs or respiratory symptoms such as new or exacerbation of pre-existing, including patients who had presented with respiratory illness or those who had displayed before. However, as other colinomiméticos, Exelon should be used with caution in such patients. There is no experience available in the treatment of patients with bronchial asthma acute. The colinomiméticos can exacerbate urinary obstruction and seizures. Although these effects have not been observed with Exelon, caution is recommended in these cases. – Pregnancy and lactation: the safety of Exelon in human pregnancy has not been established and the same should be used in pregnant women only if the potential benefit is greater than the possible risk to the fetus. It is not known if Exelon is excreted in human milk and, therefore, patients using Exelon should not breast-feed. Effects on ability to drive vehicles and operate machinery: there were no observed any impairments in motor function in patients treated with Exelon. However, the ability of patients with Alzheimer’s continue to driving a motor vehicle or operating complex machines should be routinely evaluated by the doctor. Drug interactions: rivastigmine is metabolised mainly through hydrolysis by estearases. A metabolism minimum occurs through most of the isozimas of cytochrome P450. In this way, are not anticipated drug pharmacokinetic with other drugs metabolized by these enzymes. No interactions were observed pharmacokinetic between Exelon and digoxin, warfarin, diazepam or fluoxetine in studies in healthy volunteers. The increase in prothrombin time induced by warfarin is not affected by administration of Exelon. Were not observed unfavorable effects on cardiac conduction after the concomitant administration of digoxin and Exelon. In patients with Alzheimer’s disease, the concomitant administration of Exelon with prescription drugs commonly, such as antacids, antiemetics, anti-diabetic, anti-hypertensive action central, beta-blockers, calcium channel blockers, drugs inotrópicas, antianginosos, nonsteroidal anti inflammatory drugs, oestrogens, analgesics, benzodiazepines and antihistamines, was not associated with changes in the kinetics of Exelon nor the increased risk of adverse effects clinically relevant. In view of its effects pharmacodynamic, Exelon should not be administered concomitantly with other drugs colinomiméticas and may interfere with the activity of medications anticholinergic. As an inhibitor of cholinesterase, Exelon can enhance the effects of muscle relaxers type succilcolina during anesthesia.