Pronoran

Pronoran – a stimulator of dopaminergic transfer to the central nervous system, protivoparkinsonichesky drug.

Form of release and structure

Dosage form – tablets with controlled release, coated: biconvex, round, red color, existence of separate impregnations, insignificant heterogeneity of degree of glossiness and coloring is allowed (in blisters on 15 or 30 pieces, in a pack the cardboard respectively 2 or 1 blister).

Active agent: piribedit, in 1 tablet – 50 mg.

Auxiliary components: povidone, talc, magnesium stearate.

Structure of a cover: povidone, polysorbate 80, karmelloza of sodium, silicon dioxide colloid, talc, sucrose, white beeswax, titanium dioxide, Natrii hydrocarbonas, dye crimson (Ponso 4R).

Indications to use

• Parkinson's disease (especially at the forms which are followed by a tremor) (as monodrug or as a part of complex therapy (in a combination with a levodopa) at initial and later stages of a disease);
• Auxiliary symptomatic therapy of the alternating lameness owing to obliterating diseases of arteries of the lower extremities (the II stage according to Fontaine-Lerish's classification);
• Auxiliary symptomatic treatment of chronic disturbances of cognitive function and neurosensory deficit in the course of aging (including dysmnesias and attention);
• Symptomatic therapy of ophthalmologic diseases of an ischemic origin, including narrowing of a field of vision, decrease in visual acuity, contrast decrease of flowers.

Contraindications

Absolute:

• Acute myocardial infarction;
• Collapse;
• Intolerance of fructose, galactose or glucose, deficit of a sukrozoizomaltaza;
• Simultaneous use of neuroleptics (except for clozapine);
• Age up to 18 years;
• Period of pregnancy and lactation;
• Hypersensitivity to any component which is a part of drug.

Route of administration and dosage

Pronoran it is necessary to accept inside after meal: to swallow of tablets entirely and to wash down with a half of a glass of water.

At Parkinson's disease appoint:

• Monotherapy: on 150-250 mg a day in 3 receptions, at use of the highest daily dose it is recommended to accept 100 mg in the morning, 100 mg in the afternoon and 50 mg in the evening;
• Combination therapy (with a levodopa): on 50 mg 3 times a day.

In all other cases appoint 50 mg of 1 times a day. Increase in a daily dose up to 100 mg – on 50 mg 2 times a day is in some cases possible.

At selection of a dose its titration – gradual increase by 50 mg is recommended each 2 weeks.

Side effects

Side effects are connected preferential with dopaminergic activity of a piribedil, have dozozavisimy and moderate character, arise more often in an initiation of treatment, pass after drug withdrawal.

Classification of side effects: often (≥1/100, <1/10), infrequently (≥1/1000, <1/100).

Possible undesirable reactions:

• From the alimentary system: often – insignificant gastrointestinal symptoms (a meteorism, nausea, vomiting);
• From the central nervous system: often – excitement, confusion of consciousness, dizziness, hallucinations, drowsiness (in rare instances – in the afternoon days, up to sudden backfilling);
• From cardiovascular system: infrequently – orthostatic hypotension with lability of arterial pressure / loss by a consciousness/indisposition, arterial hypotension;
• Allergic reactions.

At patients with Parkinson's disease piribedit the libido, hyper sexuality, a compulsive overeating, tendency to gamblings, desire to shop can cause strengthening.

Special instructions

Pronoran is generally applied at elderly patients. Considering their age, it is necessary to remember risk of falling because of sudden backfilling, arterial hypotension or confusion of consciousness.

Patients with a disease of Parkinson and their trustees need to be warned about probability of emergence of symptoms of disorder of behavior (strengthening of a libido, hyper sexuality, desire to shop, etc.) during treatment. In case of similar frustration it is necessary to see a doctor who will consider a question of need of a dose decline or gradual drug withdrawal.

Some patients (especially with Parkinson's disease) during reception of a piribedil sometimes sharply have a condition of strong drowsiness up to sudden backfilling. And though this phenomenon is observed seldom or never, patients should be warned about possible risks. For the same reason during treatment it is recommended to refrain from the driving and performance of work demanding high degree of attention.

Medicinal interaction

Between protivoparkinsonichesky drugs (including Pronoran) and neuroleptics (except for clozapine) mutual antagonism therefore such combinations are contraindicated is noted.

Patients with the extrapyramidal syndrome which arose owing to use of neuroleptics should appoint anticholinergic drugs and it is not necessary to appoint dopaminergic protivoparkinsonichesky means since neuroleptics block dopaminergic receptors.

Dopaminergic protivoparkinsonichesky drugs can strengthen or cause psychotic frustration. If to patients who receive piribedit, purpose of neuroleptics is required, it is necessary to stop at first Pronoran's reception, gradually reducing a dose up to full cancellation (sudden cancellation can lead to development of a malignant antipsychotic syndrome).

In need of simultaneous use of antiemetic drugs it is necessary to appoint those which do not cause extrapyramidal symptoms.

Due to the mutual antagonism simultaneous use of a tetrabenazin is not recommended.

During treatment it is forbidden to take alcohol.

With care it is necessary to use at the same time any other drugs possessing sedative action.

Terms and storage conditions

Special storage conditions are not required. To protect from children.

Period of validity – 3 years.