Medicinal Products

DEPRENYL 5 mg

Generic Drug Therapeutic Class: Neurology-Psychiatry
active ingredients: Sélégiline
laboratory: Orion Corporation

Tablet breackable
Box of 100
All forms

Indication

Treatment of Parkinson's disease:

· 1) In monotherapy: at the beginning of the disease, selegiline makes it possible to postpone the use of the dopa therapy.

· 2) In combination with levodopa combined with a peripheral dopadecarboxylase inhibitor:

o selegiline strengthens the action of levodopa and thus allows a decrease in its dosage.

o At the "end of dose" fluctuation stage, selegiline prolongs the efficacy of dopa therapy.

Dosage DEPRENYL 5 mg Breakable tablet Box of 100

Adults and elderly subjects

The usual dosage, effective in Parkinson's disease, is 5 to 10 mg per day of selegiline hydrochloride:

· As monotherapy: start treatment at 10 mg / day

· In combination with levodopa: start treatment at 5 mg / day.

When selegiline is combined with levodopa it is possible to reduce the dose of levodopa. The decrease in levodopa should be progressive, depending on the clinical improvement of the patient and can be as high as 30% in 10% increments every 3 to 4 days.

Children and adolescents

Use not recommended.

Special populations

Hepatic insufficiency

There is no data on dose adjustment in patients with mild hepatic impairment.

Renal failure

There is no data on dose adjustment in patients with mild renal impairment.

Administration mode

Selegiline can be given either as a single dose in the morning or as two doses at breakfast and lunch.

Against indications

DEPRENYL is contraindicated in the following cases:

· Known hypersensitivity to selegiline or any of the constituents of the product,

· In patients with duodenal or gastric ulcer,

· In combination with anti- emetic neuroleptics (see section Interactions with other medicinal products and other forms of interaction ),

· In combination with pethidine or tramadol (see section Interactions with other medicinal products and other forms of interaction ),

· In combination with triptans metabolized by MAO (see section Interactions with other medicinal products and other forms of interaction ),

· In combination with bupropion (see section Interactions with other medicinal products and other forms of interaction ),

· In combination with selective monoamine oxidase-A inhibitors (see section Interactions with other medicinal products and other forms of interaction ),

· In combination with linezolid (see section Interactions with other medicinal products and other forms of interaction ).

When selegiline is prescribed in combination with levodopa, the contraindications for levodopa should be taken into account.

Deprenyl side effects

The frequencies of adverse reactions listed by MedDRA system-organ system are defined according to the following categories: very common (≥ 1/10), frequent (≥ 1/100 to <1/10), uncommon (≥ 1/1000 to <1/100), rare (≥ 1/10 000 to <1/1000), very rare (<1 / 10, 000) and not known.

Class organ

Frequency

Undesirable effect

Nervous system disorders

Frequent

Dizziness.

Headache.

Rare

Mild and transient sleep disorders.

Gastrointestinal disorders

Frequent

Nausea.

Rare

Dryness of the mouth.

Renal and urinary disorders

Not known frequency

Urinary retention.

Skin and subcutaneous tissue disorders

Rare

Skin reactions.

Heart conditions

Frequent

Bradycardia.

Rare

Supraventricular tachycardia.

Vascular disorders

Rare

Orthostatic hypotension.

investigations

Frequent

Slight increase in liver enzymes (ASAT, ALAT).

Psychiatric disorders

Rare

Mood disorders.

Not known frequency

Hypersexuality.

In combination with levodopa

When selegiline is combined with levodopa and since this product strengthens and prolongs the levels of dopa, effects have been reported which are in fact those of dopa therapy: headache, dyskinesia, hypotonia, nausea, vomiting, constipation, dryness mouth, anorexia, edema, dizziness, vertigo, fatigue, high blood pressure, anxiety, agitation, psychotic episodes with hallucinations and confusion, sleep disorders, pathological gambling (compulsive play), hypersexuality and increased libido, orthostatic hypotension, cardiac arrhythmias, bradycardia, angina pectoris, urination disorders, skin reactions, dyspnea, spasticity, leukopenia and thrombocytopenia.

Once the optimal dose of levodopa is determined, the adverse effects of this combination are usually less than those resulting from levodopa alone.

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