Medicinal Products

AZILECT 1 mg

Generic Drug Therapeutic Class: Neurology-Psychiatry
Active ingredients: Rasagiline
laboratory: Teva Pharma Gmbh

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Box of 30
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Indication

AZILECT is indicated for the treatment of idiopathic Parkinson's disease monotherapy (without levodopa) or combination therapy (with levodopa) in patients with end-of-dose motor fluctuations.

Dosage AZILECT 1 mg Tablet Box of 30

Dosage
Rasagiline is administered orally at a dose of 1 mg once daily, with or without levodopa.

The drug can be taken during or outside meals.

Elderly: no dosage adjustment is necessary in the elderly.

Pediatric population: The use of AZILECT in children and adolescents is not recommended due to the lack of data on safety and efficacy.

Patients with hepatic impairment: Rasagiline is contraindicated in patients with severe hepatic impairment (see section 4.3 ). Its use should be avoided in patients with moderate hepatic impairment. Treatment with rasagiline should be initiated with caution in patients with mild hepatic impairment. In patients whose hepatic impairment progresses from a mild stage to a moderate stage, treatment with rasagiline should be discontinued (see Warnings and Precautions ).

Patients with renal impairment: No dose adjustment is necessary in patients with renal impairment.

Against indications

Hypersensitivity to the active substance or to any of the excipients (see section Composition ).

In combination with other monoamine oxidase (MAO) inhibitors (including non-prescription medicated and natural products such as St. John's wort) or pethidine (see section 4.5). interactions ). A free interval of at least 14 days should be maintained between discontinuation of rasagiline and initiation of treatment with MAO inhibitors or pethidine.

Rasagiline is contraindicated in patients with severe hepatic impairment.

Adverse effects Azilect

During the clinical development of rasagiline, a total of 1, 361 patients were treated with rasagiline, or 3, 076.4 patient-years. In placebo-controlled double-blind studies, 529 patients were treated with rasagiline at a dose of 1 mg per day (212 patient-years), and 539 patients received placebo (213 patient-years).

monotherapy

The list below includes adverse events that were reported with a higher incidence in patients receiving 1 mg / day of rasagiline in placebo-controlled studies (rasagiline-treated group n = 149, placebo-treated group). = 151). Adverse events observed with a difference greater than 2% greater than placebo are shown in italics. In parentheses is indicated the incidence of adverse effects (in percentage of patients) respectively with rasagiline versus placebo. Adverse reactions are classified according to their frequency using the following conventions: very common (≥ 1/10), common (≥ 1/100, <1/10), uncommon (≥ 1/1000, <1 / 100), rare (≥ 1/10 000, <1/1000), very rare (<1 / 10, 000).

Infections and infestations

Common: influenza-like illness (4.7% vs 0.7%)

Benign, malignant and unspecified tumors (including cysts and polyps)

Frequent: cutaneous carcinoma (1.3% vs. 0.7%)

Blood and lymphatic system disorders

Frequent: leukopenia (1.3% vs 0%)

Immune system disorders

Frequent: allergic reaction (1.3% vs 0.7%)

Metabolism and nutrition disorders

Uncommon: decreased appetite (0.7% vs. 0%)

Psychiatric disorders

Frequent: depression (5.4% vs. 2%), hallucinations (1.3% vs. 0.7%).

Nervous system disorders

Very common: headache (14.1% vs 11.9%)

Uncommon: stroke (0.7% vs. 0%)

Eye disorders

Common: conjunctivitis (2.7% vs. 0.7%)

Affections of the ear and labyrinth

Frequent: vertigo (2.7% vs 1.3%)

Heart conditions

Common: angina pectoris (1.3% vs 0%)

Uncommon: myocardial infarction (0.7% vs. 0%)

Respiratory, thoracic and mediastinal disorders

Common: rhinitis (3.4% vs. 0.7%)

Gastrointestinal disorders

Common: Flatulence (1.3% vs. 0%)

Skin and subcutaneous tissue disorders

Frequent: dermatitis (2.0% vs. 0%),

Uncommon: vesiculobullous rash (0.7% vs. 0%)

Musculoskeletal and systemic disorders

Frequent: musculoskeletal pain (6.7% vs. 2.6%), neck pain (2.7% vs. 0%), arthritis (1.3% vs. 0.7%)

Renal and urinary disorders

Common: urgency (1.3% vs. 0.7%)

General disorders and administration site conditions

Frequent: fever (2.7% vs 1.3%), malaise (2% vs 0%)

In association

The list below includes adverse events that were reported with a higher incidence in patients receiving 1 mg / day of rasagiline in placebo-controlled studies (rasagiline-treated group n = 380, placebo-treated group). = 388). In parentheses is indicated the incidence of adverse effects (in percentage of patients) respectively with rasagiline and placebo. Adverse events observed with a difference of at least 2% greater than placebo are shown in italics. Adverse reactions are classified according to their frequency using the following conventions: very common (≥ 1/10), common (≥ 1/100, <1/10), uncommon (≥ 1/1000, <1 / 100), rare (≥ 1/10 000, <1/1000), very rare (<1 / 10, 000).

Benign, malignant and unspecified tumors (including cysts and polyps)

Uncommon: Cutaneous melanoma (0.5% vs 0.3%)

Metabolism and nutrition disorders

Frequent: decreased appetite (2.4% vs. 0.8%)

Psychiatric disorders

Frequent: hallucinations (2.9% vs. 2.1%), abnormal dreams (2.1% vs. 0.8%) Uncommon: confusion (0.8% vs. 0.5%)

Nervous system disorders

Very common: dyskinesia (10.5% vs 6.2%)

Common: Dystonia (2.4% vs. 0.8%), Carpal Tunnel Syndrome (1.3% vs. 0%), Impaired Balance (1.6% vs. 0.3%)

Uncommon: stroke (0.5% vs. 0.3%)

Heart conditions

Uncommon: angina (0.5% vs. 0%),

Vascular disorders

Common: orthostatic hypotension (3.9% vs 0.8%)

Gastrointestinal disorders

Common: abdominal pain (4.2% vs. 1.3%), constipation (4.2% vs. 2.1%), nausea and vomiting (8.4% vs. 6.2%), dry mouth (3, 4% vs 1.8%)

Skin and subcutaneous tissue disorders

Common: rash (1.1% vs 0.3%)

Musculoskeletal and systemic disorders

Common: arthralgia (2.4% vs. 2.1%), neck pain (1.3% vs. 0.5%).

investigations

Frequent: weight loss (4.5% vs. 1.5%)

Injury, poisoning and procedural complications

Frequent: falls (4.7% vs. 3.4%)

Parkinson's disease is associated with symptoms such as hallucinations and confusion. During postmarketing surveillance, these symptoms were also observed in patients with Parkinson's disease treated with rasagiline. Known serious adverse reactions have been reported with concomitant use of SSRIs, SNRIs, tricyclic or tetracyclic antidepressants with MAO inhibitors. Since marketing, cases of serotonin syndrome associated with agitation, confusions, rigidity, fever and myoclonus have been reported in patients treated with antidepressants / SNRIs in combination with rasagiline.

In clinical trials of rasagiline concomitant use of fluoxetine or fluvoxamine and rasagiline was not permitted, but the following antidepressants were permitted at the recommended dosages: amitriptyline ≤ 50 mg / day, trazodone ≤ 100 mg / day, citalopram ≤ 20 mg / day, sertraline ≤ 100 mg / day, and paroxetine ≤ 30 mg / day. No cases of serotonin syndrome have been reported during the clinical development of rasagiline in which 115 and 141 patients were exposed concomitantly with rasagiline and tricyclics or rasagiline and SSRI / SNRIs, respectively.

Since marketing, cases of increased blood pressure have been reported in patients treated with rasagiline, including rare cases of hypertensive crisis associated with the ingestion of an unknown amount of tyramine-rich foods.

Cases of drug interactions have been reported with the concomitant administration of sympathomimetic drugs and MAO inhibitors.
Since its marketing, a case of elevation of blood pressure has been reported in a patient treated with the ophthalmic vasoconstrictor ttrytrolin hydrochloride with rasagiline.

Impulse control disorders

Symptoms such as: gambling gambling, increased libido, hypersexuality, compulsive shopping or spending, binge eating, and eating compulsions may occur in patients treated with dopamine agonists and / or other dopaminergic therapies. Similar disorders including compulsive disorders, obsessive thoughts and impulsive behavior have been reported after the marketing of rasagiline (see Warnings and Precautions section).

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