Mirapex tab. of 1 mg No. 30

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Description

Tablets "Mirapex of ^®" are applied at the following indications:

treatment of signs and symptoms of idiopathic Parkinson's disease at adults as monotherapy (without levodopa) or in a combination with a levodopa during a course of the disease to late stages when the effect of a levodopa decreases or becomes unstable and arises fluctuation of therapeutic effect (phenomenon of "inclusion switching off");
symptomatic treatment of idiopathic restless legs syndrome from moderated to heavy degree at adults, doses are not higher than 0.75 mg.

Structure

Active ingredient - pramipeksol (one tablet supports a pramipeksol of dihydrochloride of monohydrate of 1 mg that corresponds to 0.7 mg of a pramipeksol).

Excipients: mannitol (E 421), starch corn, silicon dioxide colloidal anhydrous, povidone, magnesium stearate.

Contraindication

Hypersensitivity to a pramipeksol or to any other component of drug.

Route of administration

All information on dosing concerns a pramipeksol in the form of a pramipeksol of dihydrochloride.

Parkinson's disease

Daily dose is applied in 3 receptions by identical shares.

Initial treatment. As shown below, the dose of medicament needs to be increased gradually, from initial 0.375 mg in every day of 5-7 days. If at patients does not arise intolerable by-effects a dose it is necessary to titrate before achievement of the maximum therapeutic effect.

Scheme of increase in a dose of medicament "Mirapex of ^®":

1st week - 3x0.125 mg (the general daily dose - 0.375 mg);
2nd week - 3x0.25 mg (the general daily dose - 0.75 mg);
3rd week - 3x0.5 mg (the general daily dose - 1.5 mg).

In need of further increase in a dose a daily dose needs to be increased by 0.75 mg weekly to maximum which makes 4.5 mg a day. However it should be noted that the frequency of emergence of drowsiness increases at use of doses of 1.5 mg a day.

Maintenance therapy. The individual dose fluctuates from 0.375 mg to the maximum 4.5 mg a day. At increase in a dose during the main researches effect of treatment observed 1.5 mg since a daily dose. Further correction of a dose needs to be carried out on the basis of the clinical answer and considering emergence of side reactions.

during clinical trials about 5% of patients accepted doses less than 1.5 mg. At the progressing Parkinson's disease the dose higher than 1.5 mg a day can be useful to patients for whom reduction of a dose of a levodopa at combination therapy with a levodopa is planned. The levodopa dose decline in case of increase in a dose of medicament "is recommended to Mirapex of ^®" and at maintenance therapy depending on reaction of certain patients.

Termination of treatment. The sudden termination of dopaminergic therapy can lead to development of an antipsychotic malignant syndrome. A dose of a pramipeksol it is necessary to reduce according to the scheme 0.75 mg to a daily dose of 0.75 mg. After that the dose should be reduced to 0.375 mg a day.

Restless legs syndrome

Recommended initial dose of medicament "Mirapex of ^®" makes 0.125 mg in 2-3 hours prior to a dream once a day. For patients who need additional relief of symptoms it is possible to increase a dose each 4-7 days to the maximum 0.75 mg a day.

Scheme of increase in a dose of medicament "Mirapex of ^®":

first stage of titration: a single daily evening dose - 0.125 mg;
second stage of titration (in case of need): a single daily evening dose - 0.25 mg;
third stage of titration (in case of need): a single daily evening dose - 0.50 mg;
fourth stage of titration (in case of need): a single daily evening dose - 0.75 mg.

needs to estimate reaction of the patient to treatment after 3 months and to reconsider need of continuation of therapy. If treatment is interrupted more than for several days, it is necessary to begin with the dose stated above repeatedly.

treatment Termination. As the daily dose for treatment of restless legs syndrome does not exceed 0.75 mg, medicament "Mirapex of ^®" can be stopped without gradual dose decline. During 26 weeks placebo - controlled clinical trial it was observed resuming of symptoms of restless legs syndrome (strengthening of weight of symptoms in comparison with initial level) at 10% of patients (14 of 135 patients) after sudden phase-out of a pramipeksol. Such effect was observed for all doses.

Way of use - needs to take a pill orally, washing down with water, during meal or without it.

Pregnant

Influence on pregnancy and a lactation at the person was not investigated by

Feature of use

. "® " pregnant women can apply Mirapex of ^{only if the potential advantage exceeds potential risk for a fruit.
As treatment "Mirapex of ^®" suppresses prolactin secretion, reduction of a lactation is possible. Excretion of medicament "® " in breast milk was not studied by Mirapex of ^{at women. This medicine is not recommended to apply to women who nurse. If it is impossible to avoid use of medicament "Mirapex of ^®", feeding by a breast should be stopped.}
Children
Parkinson's disease. Safety and efficiency of medicament "® " for children (aged up to 18 years) are not established to Mirapex of ^{. sup does not have justification of a possibility of use of medicament "Mirapex of ^{® " to children in Parkinson's disease.}}
Restless legs syndrome. Use of medicament "® " is not recommended by Mirapex of ^{to children (aged up to 18 years) because of insufficiency of data on safety and efficiency.}
Turett's Syndrome. "Mirapex of ^®" should not be applied to children (aged up to 18 years) with Turett's syndrome because of a negative ratio advantage/risk to this disease.
Drivers
"Mirapex of ^®" can have considerable influence on ability to run motor transport or to work with mechanisms. Appearance of hallucinations or drowsiness is possible.
to Patients with drowsiness and/or episodes of sudden attack of drowsiness should abstain from driving and potentially dangerous activity when deterioration in attention increases risk of serious damage or death at use of medicament "Mirapex of ^®".
Overdose
Clinical experience of considerable overdose is absent. The expected side effects connected with a pharmakodinamichesky profile of dopamine agonist include nausea, vomiting, a hyperkinesia, hallucinations, excitement and arterial hypotension. Antidote at overdose by dopamine agonist is not established. In case of signs of excitement of the central nervous system it is possible to appoint neuroleptics. Treatment of patients with overdose can demand the general supporting measures together with gastric lavage, input of the fluid, use of activated carbon and control of the electrocardiogram.
Side effects Majority of side reactions is usually observed by
at the beginning of therapy, a considerable part them disappears even if therapy continues.
patients with Parkinson's disease at treatment pramipeksoly in comparison with placebo frequent side reactions (≥ 5%) had a nausea, dyskinesia, arterial hypotension, dizziness, drowsiness, insomnia, a constipation, hallucinations, a headache and fatigue. Frequency of emergence of drowsiness increased at use of doses of 1.5 mg a day. Dyskinesia was the most frequent side reaction at inclusion in combinations with a levodopa. Arterial hypotension can arise in an initiation of treatment, especially if pramipeksol it is titrated too quickly.
patients with restless legs syndrome at treatment pramipeksoly frequent side reactions (≥ 5%) had a nausea, a headache, dizziness and increased fatigue. Nausea and increased fatigue were more often observed at women (20.8% and 10.5% respectively) in comparison with men (6.7% and 7.3% respectively) at medicament treatment "Mirapex of ^®".
Storage conditions
to Store
at a temperature not above 25 °C, out of children's reach.
Expiration date - 3 years.}

Specifications

Characteristics
Active ingredients	Pramipeksol
Amount of active ingredient	1 mg
Applicant	Boehringer Ingelheim
Code of automatic telephone exchange	N04BC05 Pramipeksol
Interaction with food	It doesn't matter
Light sensitivity	Not sensitive
Market status	Original
Origin	Chemical
Prescription status	According to the prescription
Primary packing	blister
Producer	BOEHRINGER INGELCHEIM PHARM GMBH AND TO
Quantity in packing	30 tablets (3 blisters on 10 pieces)
Release form	tablets for internal use
Route of administration	Oral
Sign	Import
Storage temperature	from 5 °C to 30 °C
Trade name	Mirapex