Азилект

Азилект – protivoparkinsonichesky drug; selective irreversible monoamine oxidase inhibitor of type B.

Form of release and structure

Азилект release in the form of tablets: almost white or white color, round, ploskotsilindrichesky, with a facet, on one party an engraving of "GIL 1" (on 10 pieces in blisters, on 1, 3 or 10 blisters in a cardboard pack).

Is a part of 1 tablet:

• Active agent: разагилин – 1 mg (мезилат a razagilina – 1,56 mg);
• Auxiliary components: talc – 4 mg; Mannitolum – 159,24 mg; colloid silicon dioxide – 1,2 mg; corn starch – 20 mg; stearic acid – 4 mg; prezhelatinizirovanny corn starch – 20 mg.

Indications to use

Азилект appoint at treatment of a disease of Parkinson (as monotherapy or along with levodopa drugs).

Contraindications

Absolute:

• Liver failure of average and heavy degree (the classes B and C on a scale of Chayld-Pyyu);
• The combined use with other monoamine oxidase inhibitors (including medicines and nutritional supplements with the maintenance of the St. John's Wort which is made a hole), pethidine. The interval between the end of therapy razagiliny and purpose of these drugs has to make not less than 14 days;
• Age up to 18 years (the profile of safety is absent);
• Hypersensitivity to drug components.

Relative (Azilekt appoint with care in the presence of the following diseases / states):

• Liver failure of easy degree (a class A on a scale of Chayld-Pyyu);
• The combined use with selective serotonin reuptake inhibitors (including fluoxetine, флувоксамин), selective serotonin reuptake inhibitors and noradrenaline, tetracyclic and tricyclic antidepressants, powerful inhibitors of an isoenzyme CYP1A2.

Before Azilekt's appointment pregnant women and the feeding women need to correlate advantage for mother to possible harm for health of the fruit/child (due to the lack of necessary data).

Route of administration and dosage

Азилект accept inside, regardless of meal.

Daily dose – 1 tablet (1 mg). Drug is used for monotherapy or as a part of complex treatment with a levodopa.

Performing long therapy is shown.

Side effects

The disturbances arising during Azilekt's reception can develop with various frequency: very often (≥1/10), it is frequent (≥1/100 to <1/10), infrequently (≥1/1000 to <1/100), is rare (≥1/10 000 to <1/1000), is very rare (<1/10 000).

Monotherapy:

• Immune system: often – allergic reactions;
• Nervous system: very often – a headache; infrequently – disturbance of cerebral circulation;
• Cardiovascular system: often – stenocardia; infrequently – a myocardial infarction;
• Alimentary system: often – abdominal distention;
• Respiratory system: often – rhinitis;
• Skeletal and muscular system: often – skeletal and muscular pain, neck pains, arthritis;
• Urinary system: often – desires to an urination;
• System of a hemopoiesis: often – a leukopenia;
• Parasitic and infectious diseases: often – flu;
• Hypodermic fabrics and skin: often - dermatitis; infrequently – vesicular and violent rash;
• The new growths (which are not specified, malignant and high-quality, including polyps and cysts): often – a carcinoma cutaneum;
• Metabolism and food: infrequently – a loss of appetite;
• Mental disturbances: often – a depression, hallucinations;
• Acoustic organ and labyrinth disturbances: often – вертиго;
• Organ of sight: often – conjunctivitis;
• Others: often – fever, an indisposition.

Use as auxiliary therapy:

• Cardiovascular system: infrequently – stenocardia; often – orthostatic hypotension;
• Nervous system: very often – dyskinesia; often – dystonia, a syndrome of a carpal tunnel, balance disturbance; infrequently – disturbance of cerebral circulation;
• Alimentary system: often – an abdominal pain, a lock, nausea and vomiting, dryness in a mouth;
• Skeletal and muscular system: often – an arthralgia, neck pain;
• Mental disturbances: often – hallucinations, dreadful dreams; infrequently – confusion of consciousness;
• The new growths (which are not specified, malignant and high-quality, including polyps and cysts): infrequently – a skin melanoma;
• Hypodermic fabrics and skin: often – rash;
• Food and metabolism: often – a loss of appetite;
• Others: often – weight reduction, falling.

At Parkinson's disease can be observed: confusion of consciousness and a hallucination (according to post-registration experience against the background of therapy razagiliny).

About development of the serious undesirable reactions arising at the combined use with selective serotonin reuptake inhibitors, selective serotonin reuptake inhibitors and noradrenaline, tetracyclic/tricyclic antidepressants and monoamine oxidase inhibitors it is well known. During post-registration researches there were messages on cases of development of a serotoninovy syndrome which was shown as agitation, confusion of consciousness, rigidity, fever and a myoclonia, at the patients who were at the same time accepting antidepressants/selective serotonin reuptake inhibitors and noradrenaline and разагилин.

During the post-registration period cases of increase in arterial pressure (including separate cases of hypertensive crises) at the patients using uncertain quantity of products rich with tyramine in a food allowance (cheeses, chocolate, etc.) were recorded, and also at use of an ophthalmologic vasoconstrictor тетрагидрозолин.

Special instructions

The patients receiving agonists of dopamine receptors and/or other dopaminomimetik have data on cases of impulsive frustration of the personality. The same frustration were observed in the post-registration period at Azilekt's reception in this connection during therapy it is necessary to watch a condition of patients. It is necessary to consider a possibility of development of such disturbances as increase in a libido, compulsive behavior, a game addiction, obsessions, hyper sexuality, impulsive behavior and compulsive requirements to get or buy.

The combined use with sympathomimetics, dextromethorphan or complex anti-cold medicines for intake or nasal use with the content of ephedrine or pseudoephedrine is not recommended.

At emergence of any pathological changes of skin it is necessary to see a doctor as Parkinson's disease or (according to other data) Azilekt can lead to development of a carcinoma cutaneum, in particular melanomas.

Such disturbances as hallucinations and confusion can be display of a disease or be side effects of Azilekt.

Considering probability of development of significant side reactions from the central nervous system, during therapy at control of motor transport and performance of potentially dangerous types of activity, it is necessary to be careful until patients do not make sure that Azilekt does not exert a negative impact on increase in concentration of attention and speed of psychomotor reactions.

Medicinal interaction

At the combined use of Azilekt with some drugs / substances the following effects can be observed:

• Pethidine: development of serious undesirable reactions (the combination is contraindicated);
• Other monoamine oxidase inhibitors (including medicines and nutritional supplements with the maintenance of the St. John's Wort which is made a hole): there is a high risk of developing of heavy hypertensive crisis (the combination is contraindicated);
• Fluoxetine or флувоксамин: probability of development of interaction (the combination is not recommended; it is necessary to observe an interval after cancellation of fluoxetine or a fluvoksamin – 5 weeks, after Azilekt's cancellation – 14 days);
• Dextromethorphan, sympathomimetic medicines: probability of development of interaction (the combination is not recommended);
• Powerful inhibitors of an isoenzyme CYP1A2: change of plasma concentration of a razagilin, smokers have a reduction (the combination demands care);
• Selective serotonin reuptake inhibitors, selective serotonin reuptake inhibitors and noradrenaline, tricyclic and tetracyclic antidepressants: development of serious undesirable reactions (the combination demands care);
• Entakapon: increase in clearance of a razagilin.

Terms and storage conditions

To store in the place, unavailable to children, at a temperature up to 25 °C.

Period of validity – 3 years.