Pramipexol ІC (pramipexole) tablets 0.25 mg. № 30

Description

Pramipexol IC Composition and form of release
active substance: pramipexole;
1 tablet contains pramipexole dihydrochloride monohydrate 0.25 mg (in terms of pramipexole 0.18 mg);
Excipients: mannitol (E 421), potato starch, povidone, colloidal anhydrous silica, magnesium stearate.
Produced in tablet form.

Pharmacological properties
Pramipexol IC is an antiparkinsonian drug. It is a non-ergotamine agonist of dopamine receptors. Highly selectively stimulates dopamine receptors (mainly D3-subtype) located in the striatum. Reduces the severity of movement disorders regardless of the stage of the disease. Weakens symptoms such as bradykinesia, rigidity, tremor, reduces the severity of motor fluctuations, dyskinesias. It also reduces the severity of neuropsychological disorders, depression.

Indications
Pramipexol ІC is used:

• with Parkinson’s disease;
• with idiopathic restless legs syndrome.

Contraindications
Contraindicated in case of intolerance to the components of the drug. It is not used in pediatrics.

Application during pregnancy and lactation
The category of action on the fetus according to USFDA – C.
Perhaps the appointment of Pramipexole IC if the expected drug effect outweighs the possible risk to the fetus.
Breastfeeding is stopped for the duration of treatment.

Method of administration and dosage
Pramipexol IC is used internally.
Standard dosage for Parkinson’s disease: the first week – 0.125 mg three times a day, the second week – 0.25 mg three times a day, the third week – 0.5 mg three times a day.
In case of insufficient clinical response, the daily dose is increased by 0.75 mg per week to a maximum of 4.5 mg / day.
Abrupt discontinuation of therapy can cause the development of neuroleptic malignant syndrome. Therefore, the therapy is stopped gradually – the dose is reduced by 0.75 mg until the dose of 0.75 mg is reached. Further, it is reduced to 0.375 mg / day.
The standard dosage for idiopathic restless legs syndrome is 0.125 mg once daily 2-3 hours before bedtime. The dose can be increased every 4-7 days, the maximum is 0.75 mg / day. You can stop treatment without a gradual dose reduction.

Overdose
Intoxication symptoms: vomiting / nausea, arterial hypotension, agitation
Treatment: induction of vomiting, gastric lavage, use of sorbents. In the presence of signs of CNS excitation, antipsychotics can be used. General support activities are being held.

Side effects:

• Neurological and mental disorders: asthenia, insomnia / drowsiness, hallucinations, ataxia, diplopia, confusion, amnesia, delirium, anxiety, dizziness, impaired thinking, dysphagia, akathisia, depression, dystonia, suicidal tendencies, extrapyramidal syndrome, hyposthesia, dyskinesia , myoclonus, hypokinesia, impaired coordination of movements, accommodation paralysis, neuroleptic malignant syndrome (autonomic lability, muscle rigidity, hyperthermia, impaired consciousness).
• Cardiovascular disorders: tachycardia, orthostatic hypotension, cardiac arrhythmia.
• Respiratory disorders: increased cough, shortness of breath, sinusitis, rhinitis, pharyngitis, flu-like syndrome.
• Gastrointestinal disorders: constipation, vomiting, dyspepsia, nausea, flatulence, dry mouth, diarrhea, anorexia.
• Musculoskeletal disorders: muscle hypertonicity, muscle twitching, cramps in the leg muscles, myasthenia gravis, bursitis, arthritis.
• Others: fever, sweating, peripheral edema, increased intraocular pressure, decreased libido, weight loss, impotence, frequent urination, urinary tract infections, increased CPK activity, manifestations of allergies, voice changes, conjunctivitis, hearing loss, pain syndrome, incl. h. pain in the abdomen, chest, neck, lumbosacral spine.

Storage conditions and periods
Store Pramipexol IC in its original packaging at temperatures up to +25 degrees. It is good for two years after production.