Pramipex (pramipexole) tablets 0.25 mg. №30

Description

Pramipex (pramipexole) tablets 0.25 mg. №30

Composition 

active substance: pramipexole;

1 tablet contains pramipexole dihydrochloride monohydrate 0.25 mg or 1.0 mg;

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

Medicinal form

Tablets.

The main physical and chemical properties:

• tablets of 0.25 mg – white or almost white, with a flat surface, round shape with a chamfer, with a cross on one side;
• tablets of 1.0 mg – white or almost white in color, with a flat surface, round shape with a chamfer, with a line on one side and marking “1” on the other.

Pharmacotherapeutic group

Dopaminergic drugs. Dopamine agonists.
ATX code N04B C05.

Pharmacological properties

It 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

Pramipex tablets 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 Ramipex, 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

Pramipex tablets 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 cessation 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.