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Etkinia 0.5 Mg 30 Tablets ingredient Rasagiline
Please read this INSTRUCTIONS carefully before using this medicine, as it contains important information for you.
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Posology / administration frequency and duration
Rasagiline is administered orally, at a dose of 1 mg once a day, without levodopa treatment.
be taken with or without food.
Additional information on special populations Renal impairment: No
change in this dose is required for renal impairment.
Rasagil is contraindicated in patients with severe liver impairment (Child-Pugh score C). section 4.3). In patients with moderate hepatic impairment (Child-Pugh score B), the use of rasagiline should be avoided. Care should be taken when starting treatment with rasagiline in patients with mild liver disorder (Child-Pugh score A). Rasagiline should be discontinued in patients with mild hepatic impairment who progress to moderate hepatic impairment (see section 4.4).
Pediatric population: It
is not recommended to use rasagiline in this age group because there is not enough data on its reliability and efficacy.
ETKINIA® is contraindicated in the following cases;
In the case of hypersensitivity to any of the active substance or excipients (see section 6.1).
Other monoamine oxidase (MAO) inhibitors (including over-the-counter medical and natural products, including St. John's Wort) or concurrent treatment with petidine (see section 4.5). It should be at least 14 days between the discontinuation of rasagenin and initiation of MAO inhibitors or initiation of treatment with petidine.
Along with therasagiline, fluoxetine or fluvoxamine should be avoided (see section 4.5). At least five weeks must pass between the discontinuation of fluoxetine and the initiation of treatment with rasagenin. It should be at least 14 days between the discontinuation of rasagenin and the initiation of fluoxetine or fluvoxamine treatment.
It is not recommended to use rasagiline and dextromethorphan or sympathomimetics (eg nasal and oral decongestants with ephedrine or pseudoephedrine or cold medications) (see section 4.5).
The emergence of melanoma cases during the cynic enhancement program led to the idea that there may be a connection between melanoma cases and rasagenin. The collected data indicate that Parkinson's disease is not associated with a high risk of skin cancer (not just melanoma), rather than a particular drug. Any suspected skin lesions should be evaluated by a qualified physician.
interaction There are many known interactions between nonselective MAO inhibitors and other drugs and rasagenin.
Rasajilin should not be given in conjunction with other MAO inhibitors (including over-the-counter medical and natural products, including St. John Wort), as there may be a risk of nonselective MAO inhibition that may lead to hypertensive crises (see section 4.3).
Serious adverse effects have been reported in the simultaneous use of MAO inhibitors and petidine, including other selective MAO-B inhibitors. Simultaneous use of rasagiline and petidine is contraindicated (see section 4.3).
There have been reports of drug interaction in the simultaneous use of sympathomimetic drugs with MAO inhibitors. Due to the MAO inhibitory effect of rasagiline, it is not recommended to simultaneously administer rasacillin and sympathomimetics (eg, sympathomimetics in the content of nasal and oral decongestants with ephedrine or pseudoephedrine-containing medications) (see section 4.4).
There have been drug interaction notifications for the simultaneous use of dextromethorphan and non-selective MAO inhibitors. Due to the MAO inhibitory effect of rasagiline, simultaneous administration of rasagiline and dextromethorphan is not recommended (see section 4.4).
Concomitant use of rasagiline and fluoxetine or fluvoxamine should be avoided (see section 4.4).
In clinical studies, see section 4.8 for the simultaneous use of rasagenin and selective serotonin reuptake inhibitors (SSRTs) / selective serotoninorepinephrine reuptake inhibitors (SNRIs).
Serious adverse effects have been reported in the simultaneous use of selective serotonin reuptake inhibitors (SSRIs), selective serotonin-norepinephrine reuptake inhibitors (SNRTs), tricyclic, tetracyclic antidepressants, and MAO inhibitors. Due to the MAO inhibitory effect of rasagiline, antidepressants should be used with caution.
No clinically significant effect of levodopa treatment on rasagiline clearance was found in patients with Parkinson's disease receiving chronic levodopa therapy as adjuvant therapy.
In vitro metabolism studies showed that the main enzyme responsible for the metabolism of rasagiline was P4501A2 (CYP1A2). Co-administration of rasagiline and ciprofloxacin (an inhibitor of CYP1A2) increased the AUC of rasagiline by 83%. Co-administration of rasagenyl and theophylline (a substrate of CYPlA2) did not affect the pharmacokinetics of both products. Strong CYP1A2 inhibitors can alter the plasma levels of rasagiline and should therefore be administered with caution.
In smokers, there is a risk that rasagiline will decrease in plasma levels due to the induction of the metabolizing CYP1A2 enzyme.
In vitro studies, 1 ug / ml concentration of rasagiline (mean Cmax of 160 layer is equal to ~ after 1 mg multiple doses of rasagiline in Parkinson's patients 5.9-8.5 ng / ml) of cytochrome P450 isoenzymes (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4 and CYP4A). These results show that the therapeutic concentrations of rasagiline are not expected to cause a clinically significant interaction with the substrates of these enzymes.
Simultaneous administration of rasagiline and entacapone increased the oral clearance of rasagiline by 28%.
Pregnancy category is C.
Women with childbearing potential / contraception (Contraception)
Clinical data on the use of rasagiline in pregnancy are not available. Animal studies do not show direct or indirect adverse effects related to pregnancy, embryonal / fetal development, birth or postnatal development (see section JJ). The potential risk for humans is unknown.
benefits of drug therapy during pregnancy should be assessed against possible risks to the fetus.
ETKINIA® should not be used during pregnancy unless necessary.
According to experimental data, rasagiline inhibits prolactin release and can therefore inhibit breastfeeding. It is not known whether or not Rasajiline passes into human milk.
It should not be given during breastfeeding period.
Reproductive ability / Fertility
machinesand there are no studies on the effects on the ability to drive and use machines.
A total of 1361 patients in the Rasagiline clinical program were treated with rasagiline and 3076.4 patient years. In double-blind placebo-controlled trials, 529 patients were treated with 212 mg of rasagiline per day and 539 patients were treated with 213 patients years with placebo.
The following list contains adverse events reported with a higher incidence in placebo-controlled trials in patients who received rasagiline (rasagiline group n = 149, placebo group n = 151) per day.
Adverse effects with at least 2% difference compared to placebo are indicated in italics.
The incidence of adverse events (% of patients) for rasagiline and placebo was given in brackets, respectively.
Adverse effects are given according to the following frequency sequence:
Very common (> 1/10); common (> 1/100 to <1/10); uncommon (> 1/1000 to <1/100); sparse (> 1/10000 to <1/1000); Very rare (<1/10000)
Infection and infections
Common: influenza (4.7%, 0.7%)
Benign, malignant and unspecified neoplasms (including cysts and polyps)
Common: Skin carcinoma (1.3%, 0.7%)
Blood and lymphatic system disorders
: Leukopenia (1.3%, 0%)
Immune system disorders
Common: Alegiosis (1.3%, 0.7%)
Metabolism and nutritional disorders
Non-pervasive: Declining appetite (0.7%, 0%)
Difficulty: Depression (5.4%,% 2), hallucinations (1.3%, 0.7%)
Nervous system disorders
Very common: headache (14.1%, 11.9%)
Uncommon: cerebrovascular injury (0.7%, 0%)
Common: Conjunctivitis (2.7%,%) 0.7)
commonlydisorders:vertigo (2.7%, 1.3%)
common: Anjinapektoris (1.3%, 0%)
Uncommon: myocardial infarction (0.7% vs 0%)
Respiratory, thoracic and mediastinal disorders
commonly : Rhinitis (3.4%, 0%)
Common: Flatulans (1.3%, 0%)
Skin and subcutaneous tissue U disorders
: Dermatitis (2%, 0%)
Uncommon: Vesiculobullous rash (0.7%, 0%)
Musculoskeletal and connective tissue disorders
Common: Musculoskeletal pain (6.7%, 2.6%), neck pain (2.7%) (0%), arthritis (1.3%, 0.7%)
Kidney and urinary disorders
Common: Sudden urinary urgency (1.3%, 0.7%)
General disorders and conditions related to theof application
siteDifficulty: Fever (2.7%, 1.3%), malaise (%) 2, 0%)
the list below 1 mg rasagiline in patients receiving daily (rasagiline group n = 380, n placebo = 388) are included in a placebo controlled adverse effects reported higher incidence studies. The incidence of adverse effects (for% of the patient) in rasagiline and placebo was given in parentheses, respectively. Adverse effects with at least 2% difference compared to placebo are indicated in italics.
Adverse effects are given according to the following frequency sequences:
Very common (> 1/10); common (> 1/100 to <1/10); uncommon (> 1/1000 to <1/100); sparse (> 1/10000 to <1/1000); very rare (<1/10000)
Benign, malignant and unspecified neoplasms
Non-pervasive: Skin melanoma (0.5%, 0.3%)
Metabolism and nutritional disorders
Common: Declining appetite (2.4%, 0.8%)
Common: Hallucinations (%) 2.9, 2.1%), abnormal dreams (2.1%, 0.8%)
Uncommon: Confusion (0.8%, 0.5%)
Nervous system disorders
Very common: Dyskinesia (10.5%, 6.2%)
Common: Dystonia (2.4%, 0.8%) carpal tunnel syndrome (1.3%, 0%), balance disorder
Uncommon: cerebrovascular damage (0.5%, 0.3%)
Uncommon:angina pectoris (0.5%, 0%)
Common : Postural hypotension (3.9%, 0.8%)
Common: Karm pain (4.2%, 1.3%), constipation (4.2%, 2.1%), nausea and vomiting (8.4%, 6.2%), dry mouth (3.4%, 1.8%)
Skin and subcutaneous disorders
Common: Rash (1.1%, 0.3%)
Musculoskeletal and connective disorders
Diffuse: Arthralgia (2.4%, 2.1%), neck pain (1.3%, 0.5%)
Common: Weight loss (4.5%, 1.5%)
Injury and intoxication
Width: Falling (4.7%, 3.4%)
Parkinson's disease shows hallucinations and confusion symptoms. In post-marketing experience, these symptoms were also observed in patients with Parkinson's who were treated with rasacillin.
It is known that serious adverse effects occur in the simultaneous use of selective serotonin reuptake inhibitors (SSRTs), selective serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic, tetracyclic antidepressants and MAO inhibitors. In the post-marketing period, serotonin syndromes associated with agitation, confusion, rigidity, pyrexia and myoclonus have been reported in patients who received antidepressant / SNRI treatment simultaneously with rasagiline.
In clinical trials with rasagiline, the use of fluoxetine or fluvoxamine in combination with rasagiline is not permitted, but the following antidepressants and doses have been allowed for use in the clinical trials of rasacillin: amitriptyline <50 mg / day, trazodone <100 mg / day, citalopram <20 mg / day , sertraline <100 mg / day and paroxetine <30 mg / day. There were no cases of seratonin syndrome in the clinical program of rasagiline in which 115 patients were exposed to rasagiline and tricyclines simultaneously and 141 patients were exposed to rasagiline and SSRTs / SNRTs.
In the post-marketing period, increased blood pressure, including rare cases of hypertensive crises associated with the ingestion of unknown quantities of tiramine-rich foods, has been reported in patients using rasagiline.
There have been reports of drug interaction in the simultaneous use of sympathomimetic drugs with MAO inhibitors.
Overdosage: Symptoms reported after overdosage in doses ranging from 3 mg to 100 mg of rasagiline; dysphoria, hypomania, hypertensive crisis and serotonin syndrome.
Overdose can be attributed to significant inhibition of MAO-A and MAO-B. In a single dose study, healthy volunteers received 20 mg per day and 10 mg daily for healthy volunteers in a ten-day study. Adverse effects are mild or moderate and do not depend on rasagiline therapy. In a dose titration study in patients treated with chronic levodopa and treated with 10 mg rasacillin per day, there were reports of undesirable cardiovascular side effects (including hypertension and postural hypotension) after discontinuation of therapy. These symptoms may be similar to those observed with non-selective MAO inhibitors.
There is no specific antidote. In case of overdose, patients should be monitored and appropriate symptomatic and supportive treatment should be initiated.
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