Yumex® (Jumex®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceSelegilineSelegiline
Dosage form: & nbsppills
Composition:
Active ingredient: selegiline hydrochloride - 5 mg.
Excipients: magnesium stearate, talc, povidone K-25 (polyvidone K-25), corn starch, lactose.

Description:
: white or almost white round flat tablets with engraved "JU" on one side and chamfered on both sides.

Pharmacotherapeutic group:antiparkinsonian means - MAO inhibitor
ATX: & nbsp

N.04.B.D   Inhibitors of monoamine oxidase type B

Pharmacodynamics:
Selegiline is an selective MAO-B inhibitor involved in the metabolism of dopamine and other catecholamines. It also inhibits the reuptake of dopamine at the level of presynaptic dopamine receptors, thereby increasing its concentration in the nuclei of the extrapyramidal system and other parts of the brain.
Selegilin potentiates and prolongs the action of levodopa in the treatment of parkinsonism.
Selegiline is not intended for use in patients with extrapyramidal symptoms not accompanied by a deficiency of dopamine (essential tremor, Huntington's chorea).

Pharmacokinetics:
When taken orally selegiline quickly and intensely absorbed.After ingestion of 10 mg of selegiline Stach, the unchanged drug in the plasma is 2.7 ± 2.2 ng / ml, T Stach - 0.5-2 h. The connection with plasma proteins is 94%. Seligiline is rapidly distributed and metabolized in the body. The main metabolites are L-methamphetamine, L-amphetamine and N-desmethylselegiline. The active substance and its metabolites penetrate well through the blood-brain barrier (BBB). Metabolites of selegiline
are mainly excreted in the urine (approximately 73% of the dose taken is excreted in the urine within 72 hours), about 15% - through the intestine.

Indications:
Parkinson's disease and symptomatic parkinsonism.
Selegiline can be used as a monotherapy in the early stages of Parkinson's disease with the purpose of delaying the appointment of levodopa (with or without the use of a peripheral inhibitor of decarboxylase (PID)), and can also be used in conjunction with levodopa (with or without FID).

Contraindications:
  • Hypersensitivity to selegiline.
  • Combination with serotonin reuptake inhibitors, tricyclic antidepressants, sympathomimetics and pethidine (meperidine), including up to 5 weeks after their withdrawal.
  • Extrapyramidal disorders not associated with dopamine deficiency (essential tremor, Huntington's chorea).
  • Pregnancy.
  • Breast-feeding.

Carefully:
in patients with peptic ulcer of the stomach and duodenum (including in the anamnesis), with lability of arterial pressure, tachycardia, severe angina, psychosis, dementia, tardive dyskinesia,
large-scale tremor, thyrotoxicosis, diffuse toxic goiter, pheochromocytoma, prostatic hyperplasia (with the presence of residual urine), angle-closure glaucoma, age 18 years (not enough experience in clinical use).
When combined with levodopa: open-angle glaucoma (chronic course), hepatic and / or renal insufficiency, melanoma (including in anamnesis), central nervous system depression, convulsive seizures, bronchial asthma, emphysema, myocardial infarction (incl. h. in the anamnesis, and also in a combination with atrial, nodular or ventricular arrhythmias).
It is recommended that care should be taken with regard to general anesthesia during surgical interventions in patients receiving MAO inhibitors.

Dosing and Administration:
The drug is administered orally at a dose of 5-10 mg per day, either with monotherapy or with levodopa or a combination of levodopa / PID. Tablets are not taken. chewing, squeezed a small amount of liquid.
Yumeks can be taken only once in the morning. If the daily dose is 10 mg, it is possible to divide it into two doses - in the morning and in the evening.
When combined with levodopa, the dose of levodopa can be reduced by an average of 30%.

Side effects:
With monotherapy, Humex is usually well tolerated.
Allergic reactions: skin rash, dyspnea, bronchospasm, photosensitivity. Gastrointestinal system: nausea, dry mouth, decreased appetite, constipation or diarrhea, dysphagia.
Cardiovascular system: orthostatic (postural) hypotension, rarely - increased blood pressure, arrhythmia.
Central nervous system: insomnia, dizziness, mood changes, fatigue, dyskinesias, rarely - psychoses.
Liver: increased activity of "liver" transaminases.
Urinary system: in some cases - urinary retention, rarely - painful urge to urinate, nocturia.
Other: headache, visual acuity, diplopia, sometimes - hair loss, excessive sweating, hypoglycemia.
When combined with levodopa.
Since Yumex potentiates the clinical effect of levodopa, side reactions of levodopa (agitation, hyperkinesis, abnormal movements, anxiety, confusion, hallucinations, postural hypotension, cardiac arrhythmias) may worsen with combined therapy (levodopa should always be given together with an inhibitor of peripheral decarboxylase). With combined therapy of selegeline with levodopa, a further reduction in the dose of levodopa (up to 30%) is possible.

Overdose:
Overdose does not have a specific clinical picture.
However, since selective MAO-B inhibition by selegiline is only achieved by taking the doses recommended for the treatment of Parkinson's disease (ie, 5-10 mg / day), the symptoms of overdose may be similar to the symptoms of an overdose of nonselective MAO inhibitors (central nervous and cardiac disorders the vascular system).
There is no specific antidote, treatment is symptomatic.

Interaction:
Contraindicated combinations.
Sympathomimetics:
In the treatment of Yumex, the use of sympathomimetics should be avoided because of the risk of increased blood pressure.
Pethidine:
The incompatibility between non-selective MAO inhibitors and pethidine is well known. Despite the fact that the mechanism of this interaction is still unknown, the combined use of a selective MAO inhibitor, UMEX, and pethidine or another opioid analgesic is contraindicated.
Inhibitors of serotonin reuptake:
Yumex should not be used in conjunction with fluoxetine, as excitation, hypertension, convulsions, ataxia, hallucinations and manic psychosis may develop, and fluoxetine Do not use within 14 days after the removal of UMEX. As fluoxetine has a very long half-life, after the abolition of fluoxetine and before the appointment of UMEX, at least 5 weeks must pass. Similar phenomena are described in patients who received UMEX and two other inhibitors of serotonin reuptake (sertraline and paroxetine). Since the mechanism of these reactions is not fully understood, it is recommended to avoid the combination of UMEX with serotonin reuptake inhibitors.
Tricyclic antidepressants: In some cases, the severe toxicity of the central nervous system (dizziness, tremor, seizures), sometimes accompanied by hypertension, hypotension, profuse sweating in patients using a combination of tricyclic antidepressants and UMEX. Since the mechanism of these reactions is not fully understood, it is recommended to avoid the joint use of UMEX with tricyclic antidepressants.
Not recommended combinations.
- MAO inhibitors:
The combined use of UMEX and MAO inhibitors can cause a significant drop in blood pressure.
Interaction with food:
Unlike traditional MAO inhibitors, which suppress both MAO-A and MAO-B enzymes, UMEX is a specific inhibitor of MAO-B.
When eating food containing tyramine, during treatment with Yumex in the recommended doses, the hypertensive effect is not described (that is, it does not cause the so-called "cheese-effect" effect).
Therefore, patients receiving UMEX can not adhere to a strict diet. However, in the case of combined use of UMEX and traditional MAO or MAO-A inhibitors, dietary restrictions are recommended (i.e.,Avoid food with a lot of tyramine, such as: ripe cheese and yeast products).
Other interactions:
Enhances the effects of levodopa, ethanol, drugs, depressing central nervous system, increases the risk of side effects of amantadine.

Special instructions:
Since UMEX® potentiates the action of levodopa, the side effects of levodopa can be exacerbated, especially when high doses of levodopa are used. In such cases, strict monitoring of the patients' condition is necessary. The use of Yumex® in the treatment of levodopa may cause involuntary movements and / or agitation in patients. These side effects disappear when the dose of levodopa decreases. With the simultaneous use of Yumex and levodopa, the dose of levodopa can be reduced by an average of 30%.
UMEX® should not be used in doses exceeding the recommended dosage (10 mg / day), as the drug loses selectivity for MAO-B, which increases the risk of developing hypertension.

Effect on the ability to drive transp. cf. and fur:
Studies to assess the effect of UMEX on the ability to drive a car and perform work associated with increased risk, were not conducted.
Nevertheless, one should refrain from engaging in potentially dangerous activities that require increased attention and speed of mental and motor reactions.
Form release / dosage:
Tablets 5 mg.

Packaging:
10 tablets per blister Al / Al.
For 5 blisters together with instructions for use in a cardboard box.

Storage conditions:
At a temperature of no higher than 30 ° C.
Keep out of the reach of children!
List B.

Shelf life:
3 years
Do not use the product after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription
Registration number:П N014146 / 01
Date of registration:26.12.2008
The owner of the registration certificate:HINOIN Pharmaceutical and Chemical Products Plant, ZAO HINOIN Pharmaceutical and Chemical Products Plant, ZAO Hungary
Manufacturer: & nbsp
Information update date: & nbsp15.09.2015
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