Rivastigmine 1,5mg 28 capsules — Made in Finland — Free Delivery

(Rivastigmine 1,5mg)
Rivastigmine 1,5mg 28 capsules — Made in Finland — Free Delivery
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ORION PHARMA Brand: ORION PHARMA

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Description Rivastigmine 1,5mg 28 capsules — Made in Finland — Free Delivery

Indications

Symptomatic treatment of mild to moderate Alzheimer's dementia.
Symptomatic treatment of mild to moderate dementia in patients with idiopathic Parkinson's disease.

Application

Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of dementia in Alzheimer's disease or dementia due to Parkinson's disease. the diagnosis must be established in accordance with current guidelines. rivastigmine therapy should only be initiated if caregivers are available who can regularly monitor patients' intake of the preparation.
Rivastigmine is taken 2 times a day, morning and evening, with meals. Capsules should be swallowed whole.
The initial dose is 1.5 mg 2 times a day.
Dose titration: initial dose - 1.5 mg 2 times a day. If this dose is well tolerated after at least 2 weeks of treatment, it can be increased to 3 mg 2 times a day. A subsequent increase to 4.5 mg and then to 6 mg 2 times a day should be based on good tolerability of the current dose and is allowed no earlier than 2 weeks of treatment with this dose.
If adverse reactions occur (eg nausea, vomiting, abdominal pain or loss of appetite), weight loss or worsening of extrapyramidal symptoms (eg tremor) in patients with dementia due to Parkinson's disease, one or more doses may be omitted. If adverse reactions do not disappear, the daily dose should be temporarily reduced to the previous well-tolerated dose or treatment should be suspended.
Maintenance dose: An effective dose is 3–6 mg twice a day.
To achieve the maximum therapeutic effect, patients should use the maximum well-tolerated dose. The recommended maximum dose is 6 mg twice daily.
Maintenance treatment can be continued as long as it benefits the patient. Therefore, the clinical benefit of rivastigmine should be regularly assessed, especially in patients receiving the preparation at a dose of less than 3 mg 2 times a day. If after 3 months of treatment the severity of dementia symptoms has not changed for the better, treatment should be discontinued. In addition, it is necessary to consider the possibility of discontinuing treatment if signs of a therapeutic effect are no longer detected.
Individual response to rivastigmine cannot be predicted. However, the best effect of treatment was noted in patients with Parkinson's disease with moderately severe dementia. Similarly, the best effect was found in patients with Parkinson's disease with visual hallucinations.
Clinical studies lasting more than 6 months to study the therapeutic effect were not conducted.
Resumption of therapy. If treatment was interrupted for more than a few days, it should be restarted with a dose of 1.5 mg 2 times a day. The dose should then be titrated as described above.
Impaired kidney and liver function. Due to the increased effect of the preparation in mild to moderate renal and hepatic insufficiency, it is recommended to accurately select the dose by titration in accordance with individual tolerance.

Contraindications

Known hypersensitivity to rivastigmine, other carbamate derivatives or any of the excipients that make up the preparation, as well as in severe liver dysfunction, since the safety of the preparation has not been studied in this group of patients.

Side effects

Gastrointestinal disturbances occur most frequently, including nausea (38%) and vomiting (23%), especially during dose titration. Clinical studies have shown that women are more susceptible to gastrointestinal adverse reactions and weight loss than men.
The frequency of occurrence of adverse reactions has the following classification: very often (≥1 / 10); often (≥1/100, 1/10); infrequently (≥1/1000, 1/100); rarely (≥1/10,000 to 1/1000); very rarely (1/10,000); frequency unknown (cannot be determined from the available data).
In patients with dementia due to Alzheimer's disease, the following adverse reactions were noted during treatment with rivastigmine:
Infections and invasions: very rarely - urinary tract infections.
Mental disorders: often - agitation, confusion; infrequently - insomnia, depression; very rarely - hallucinations.
From the nervous system: very often - dizziness; often - headache, drowsiness, tremor; infrequently - syncope; rarely - convulsions; very rarely - extrapyramidal symptoms (including worsening of the course of Parkinson's disease).
From the side of the cardiovascular system: rarely - angina pectoris, arterial hypertension; very rarely - arrhythmias (including bradycardia, AV blockade, atrial fibrillation and tachycardia).
From the gastrointestinal tract: very often - nausea, vomiting, diarrhea; often - abdominal pain and dyspepsia; rarely - gastric and duodenal ulcer; very rarely - bleeding from the gastrointestinal tract, pancreatitis. Some cases of severe vomiting have been associated with esophageal rupture.
Metabolic and nutritional disorders: very often - anorexia.
From the hepatobiliary system: infrequently - an increase in liver function tests.
On the part of the skin and subcutaneous tissue: often - increased sweating; rarely - rash.
General disorders and reactions at the injection site: often - fatigue, asthenia, malaise; infrequently - an accidental fall.
Research results: often - weight loss.
In patients with dementia due to Parkinson's disease, the following adverse reactions were noted during treatment with rivastigmine.
Mental disorders: often - insomnia, anxiety, restlessness.
From the side of the central nervous system: very often - tremor; often - dizziness, drowsiness, headache, worsening of the course of Parkinson's disease, bradykinesia, dyskinesia; infrequently - dystonia.
From the side of the cardiovascular system: often - bradycardia; infrequently - atrial fibrillation, AV blockade.
From the gastrointestinal tract: very often - nausea, vomiting; often - diarrhea, loss of appetite, abdominal pain and dyspepsia, increased secretion of saliva.
On the part of the skin and subcutaneous tissue: often - increased sweating.
From the musculoskeletal system and connective tissue: often - muscle rigidity.
Metabolic and nutritional disorders: very often - anorexia, dehydration.
General disorders and reactions at the injection site: often - fatigue, asthenia; infrequently - gait disturbance.

special instructions

The frequency and severity of adverse reactions usually increase with increasing dose. if treatment is interrupted for more than a few days, it should be resumed at a dose of 1.5 mg 2 times a day to reduce the likelihood of adverse reactions (for example, vomiting).
Dose titration: Adverse reactions (eg, hypertension and hallucinations in patients with dementia due to Alzheimer's disease, and worsening of extrapyramidal symptoms, especially tremor, in patients with dementia due to Parkinson's disease) were noted shortly after dose increase. They may decrease after dose reduction. In other cases, the preparation was discontinued.
Gastrointestinal disorders, such as nausea and vomiting, are detected, in particular, at the beginning of treatment and with increasing doses. Adverse reactions occur more often in women. In Alzheimer's disease, weight loss is possible. Weight loss in these patients is associated with the use of cholinesterase inhibitors, including rivastigmine. During therapy, it is necessary to monitor the patient's body weight.
In severe vomiting associated with treatment with rivastigmine, an appropriate dose adjustment is recommended. Some cases of severe vomiting have been associated with esophageal rupture. Especially often such phenomena were noted after increasing the dose or using rivastigmine in high doses.
As with other cholinomimetics, caution should be exercised when prescribing rivastigmine to patients with sick sinus syndrome or conduction disorders (sinus node block, atrioventricular node block).
Like other cholinergic substances, rivastigmine may increase gastric acid secretion. Care must be taken when prescribing the preparation to patients with an active gastric or duodenal ulcer or a predisposition to these conditions.
Cholinesterase inhibitors should be used with caution in patients with asthma or a history of obstructive pulmonary disease.
Cholinomimetics may induce or exacerbate urinary tract obstruction and convulsions. Care must be taken when treating patients with a predisposition to these nosologies.
The use of rivastigmine in patients with severe dementia due to Alzheimer's or Parkinson's disease, other types of dementia, or other types of memory impairment (eg, age-related cognitive decline) has not been studied.
Like other cholinomimetics, rivastigmine can exacerbate or induce extrapyramidal symptoms. In patients with dementia due to Parkinson's disease, there have been cases of deterioration (including bradykinesia, dyskinesia, gait disturbances) and an increase in the frequency of tremor. In some cases, because of these events, it was necessary to stop rivastigmine therapy (namely: the frequency of preparation withdrawal due to tremor was 1.7% in the rivastigmine group and 0% in the placebo group). Clinical monitoring of these events is recommended.
Use during pregnancy and lactation
Pregnancy. There are no clinical data on the use of rivastigmine during pregnancy. Studies in rats and rabbits have shown no undesirable effect on the ability to fertilize and the development of the embryo and fetus, except at doses that are toxic to females. During peri- and postnatal studies in rats, an increase in the gestation period was found. Rivastigmine should not be used in pregnant women unless absolutely necessary.
Breastfeeding period. In animals, the penetration of rivastigmine into breast milk has been established. It is not known whether rivastigmine is excreted in human breast milk. Therefore, women receiving rivastigmine should not breastfeed.
Children. Rivastigmine is not indicated for use in children.
The ability to influence the reaction rate when driving vehicles or working with other mechanisms
Alzheimer's disease can lead to a gradual deterioration in the ability to drive and use machines. In addition, rivastigmine may cause dizziness and drowsiness, especially at the beginning of treatment and when the dose is increased. Therefore, the ability of patients with dementia receiving rivastigmine to drive vehicles or operate complex machinery should be periodically assessed by the attending physician.

Interactions

As a cholinesterase inhibitor, rivastigmine may enhance the effects of muscle relaxants such as succinylcholine during anesthesia.
Due to pharmacodynamic effects, rivastigmine should not be co-administered with other cholinomimetics; it may also interact with anticholinergic preparations.
Pharmacokinetic interactions between rivastigmine and digoxin, warfarin, diazepam or fluoxetine have not been identified during studies in healthy volunteers. Rivastigmine does not affect the increase in prothrombin time under the action of warfarin. With the simultaneous use of digoxin and rivastigmine, no undesirable effect on cardiac conduction was detected.
Based on metabolism, metabolic interactions are unlikely, although rivastigmine may inhibit the metabolism of other preparations mediated by butyrylcholinesterase.

Overdose

Symptoms: Most cases of overdose were not accompanied by any clinical signs or symptoms, and almost all patients continued treatment with rivastigmine. Symptoms associated with overdose were nausea, vomiting, diarrhea, hypertension, and hallucinations. due to the known vagotonic effect of cholinesterase inhibitors on heart rate, bradycardia and/or syncope are also possible. in one of the cases, 46 mg of the preparation was taken orally; after conservative treatment, the patient fully recovered within 24 hours.
Treatment: Since the half-life of rivastigmine in plasma is about 1 hour and the duration of acetylcholinesterase inhibition is about 9 hours, in cases of asymptomatic overdose, it is not recommended to take the next dose of rivastigmine within 24 hours. In case of overdose with nausea and vomiting, the use of antiemetics should be considered . In the event of other adverse events, symptomatic therapy should be used.
In case of severe overdose, atropine can be used. An initial dose of atropine sulfate of 0.03 mg/kg is recommended, followed by an increase depending on clinical signs. The use of scopolamine as an antidote is not recommended.

Storage conditions

At a temperature not higher than 25 ° C.

Tags: Rivastigmine

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