Mirapex (Pramipexole) - cost

Mirapex (Pramipexole)

Mirapex (Pramipexole) is a medication indicated for Parkinson’s disease (PD). It was developed by a German pharmaceutical company Boehringer Ingelheim. This medicine was approved by the FDA in 1997 and by the European Union (EU) in March 1998. Since that time, Mirapex has been successfully used in most countries of the world.

Mirapex is a prescription medication. It is used to treat the symptoms of Parkinson Disease and restless legs syndrome. Mirapex may be used alone or in combination with other medications.

Parkinson’s disease is a slowly developing pathology of the central nervous system. The main symptoms of this disease include movement disorders, muscle rigidity (increased tone), and tremors at rest. Restless legs syndrome is a neurological disorder, the name and manifestations of which may sound funny (the disease manifests itself in the need to move the legs in order to relieve discomfort in the lower extremities), but in fact this syndrome can greatly reduce the patient's quality of life.

Mirapex belongs to a class of antiparkinsonian agents and dopamine agonists. Its main active substance is called Pramipexole.

Mirapex reduces the lack of motor activity in Parkinson's disease by stimulating dopamine receptors in the striatum of the brain. The active substance of this drug inhibits the synthesis, release and metabolism of dopamine, due to which dopamine neurons are protected from degeneration that occurs in response to ischemia or methamphetamine neurotoxicity. The exact mechanism of action of the drug in the treatment of restless legs syndrome is currently not known, the pathophysiology of this syndrome itself. However, there is neuropharmacological evidence that the dopaminergic system is primarily involved in this process. Studies performed using PET show that moderate presynaptic dopaminergic dysfunction in the striatum may be involved in the pathogenesis of restless legs syndrome, which determines the effectiveness of Pramixepol in the treatment of this condition.

Pramipexole protects neurons from the neurotoxicity of Levodopa, a strong anti-Parkinsonian drug. It also reduces the secretion of prolactin (dose-dependently). A serious problem in the treatment of Parkinson's disease is that many drugs that work well at the initial stage of treatment cease to work over time, as the body develops tolerance to them. However, this does not apply to Pramipexole: even with long-term use (more than 3 years) of Pramipexole in patients with Parkinsons disease, there are no signs of a decrease in the effectiveness of the drug. When using Pramipexole in patients with restless leg syndrome for one year, the effectiveness of the drug is maintained as well.

Price

The cost for Mirapex oral tablets is around $120 for a supply of 30 tablets, depending on the pharmacy you decide visit. This refers to ordinary local US drugstores. This is quite an impressive amount, which hits the patients’ budget a lot, especially considering that in most cases long-term treatment is recommended. Mirapex is included in only a few health insurance programs in the US, and none of them fully cover the cost of this drug.

Fortunately, today generics come to the rescue for patients suffering from Parkinson’s disease. These are full-fledged taxes of the Mirapex brand drug, that is, they contain the same active ingredient Pramipexole in a similar dosage. Their only difference lies in a slightly different set of excipients, and also in the fact that they are sold under other names. Most often it is just Pramipexole or Pramipexole Generic. The main advantage of Mirapex generics is that they are available to consumers at much lower prices. By choosing Mirapex generic, the buyer can save up to 95% of the cost of the original drug! So, 30 tablets at a dosage of 0.5 mg are easy to find for a price of $ 3. At the same time, the lowest prices are traditionally offered by Indian manufacturers of generics. It is most convenient and most profitable to purchase their products in large international online pharmacies.

How To Use

Mirapex is taken orally, regardless of the meal, with water. The daily dose should be evenly divided into 3 doses.

The calculation of the required dosage is based on pramipexole dihydrochloride monohydrate.

In the symptomatic treatment of Parkinson’s disease, the initial daily dosage is 0.375 mg. It is increased every 5-7 days. A gradual increase in dosage is required to reduce the severity of side effects. Upon reaching the maximum therapeutic effect, you should stop modifying the dosage. The maximum daily dose is 4.5 mg.

With maintenance therapy, both at an early and late stage of the disease, the drug is effective, starting with a daily dose of 1.5 mg. However, it is not excluded that in some patients, doses above 1.5 mg per day may provide an additional therapeutic effect, especially at a late stage of the disease, when dose reduction of Levodopa, the drug most often taken for the treatment of Parkinson’s disease, is indicated.

With regard to the phase of discontinuation of treatment, exit from therapy should be gradual. The dose of Mirapex should be reduced by 0.75 mg per day until the daily dose reaches 0.75 mg. After that, the dose should be reduced by 0.375 mg per day.

With simultaneous therapy with Levodopa, it is recommended as the dose increases, as well as during maintenance therapy with Pramipexole, to reduce the dose of Levodopa. This is necessary to avoid excessive dopaminergic stimulation.

In clinical studies, only approximately 10% of patients report signs of worsening symptoms after abrupt discontinuation of treatment. This effect is manifested at any dosage.

Side Effects

When using the drug, side effects like abnormal dreams, temporary amnesia, behavioral disturbances (symptoms of impulsive and compulsive actions) such as compulsive overeating, obsessive desire to shop, hypersexuality and pathological craving for gambling are possible. There can be heart failure, confusion, constipation, delirium, dizziness, dyskinesia, shortness of breath, fatigue, hallucinations, headache, hiccups, hyperkinesia, hyperphagia, decreased blood pressure, impaired antidiuretic hormone secretion, insomnia, sexual desire disorders, nausea, paranoia, peripheral edema, pneumonia, itching, rash and other signs of hypersensitivity, anxiety, drowsiness, sudden falling asleep, fainting, visual disturbances, including diplopia, decreased visual acuity and clarity of perception, vomiting, weight loss, loss of appetite, weight gain.

Analysis of pooled data from placebo-controlled trials including a total of about two thousand patients taking Pramipexole and the same number of patients taking placebo, side effects were reported frequently in both groups. 63% of patients taking Pramipexole and 52% of patients taking placebo reported at least one adverse drug reaction. This proves that some side effects may have a psychological origin.

It should be noted that adverse drug reactions are observed only in less than 1% of patients treated with Pramipexole. Most of the side effects are mild to moderate, usually manifested early in therapy, and most tend to resolve even with continued therapy.

The most commonly reported side effects in patients with restless leg syndrome receiving Pramipexole include nausea, headache, dizziness and fatigue. The incidence of these side effects is approximately three times higher in women than in men.

Precautions

When prescribing Mirapex to patients with renal insufficiency, a dosage reduction is recommended.

Hallucinations and confusion are known side effects of dopamine agonist and Levodopa treatment. They are more commonly observed with Mirapex in combination with Levodopa in patients with advanced Parkinson’s disease than with monotherapy in patients with early Parkinson’s disease. Patients should be informed that hallucinations, predominantly visual and less often auditory, may develop in order to avoid panic attacks.

Patients and their caregivers should be aware that in connection with the treatment of patients with dopaminergic drugs, signs of abnormal behavior (symptoms of impulsive and compulsive actions) may occur, such as binge eating, compulsive shopping, hypersexuality, pathological craving for gambling and the desire to change places. In such cases, the decision to reduce the dose or gradually discontinue treatment should be considered. Co-administration of Pramipexole with antipsychotics should be avoided.

It is recommended to check vision at regular intervals or immediately after prescribing the drug in the presence of such disorders.

Care must be taken if the patient has severe cardiovascular diseases. Due to the risk of developing orthostatic hypotension during dopaminergic therapy, it is advised to control the level of blood pressure, especially at the beginning of treatment.

Patients should be warned about the possible sedative effect of the drug, including drowsiness and sudden falling asleep or feeling exhausted during daytime activities.

Some patients worry that Mirapex may have an oncogenic effect, because such rumors have been circulating on patient forums for some time. Meanwhile, although epidemiological studies show that patients with Parkinson’s disease have a higher risk of developing melanoma than the general population, there is no evidence that this increased risk is due to taking any drugs that are used in Parkinson’s disease.

There are reports that sometimes with the sudden cessation of therapy with dopaminergic drugs, including Mirapex, symptoms of neuroleptic malignant syndrome may occur. The possibility of visual hallucinations should be taken into account when deciding whether to drive a car or perform work that requires an increased speed of physical and mental reactions. Since drowsiness is a common adverse event with Mirapex, with potentially serious consequences, patients should not drive or operate machinery until they have sufficient experience with Mirapex to assess whether or not it adversely affects their mental or motor activity. With severe drowsiness, you should refuse to drive vehicles or perform precise work.

Interactions

Pramipexole, the active ingredient of Mirapex, binds to plasma proteins to a small extent (less than 20%) and undergoes biotransformation. Therefore, interactions with other drugs that affect plasma protein binding or excretion by biotransformation are unlikely.

Meanwhile, drugs that inhibit the active secretion of cationic drugs through the renal tubules (for example, cimetidine), or which are themselves excreted by active secretion through the renal tubules, may interact with pramipexole, resulting in a decrease in the clearance of one or both drugs. In the case of the simultaneous use of such drugs (one of the most commonly used is amantadine) and pramipexole, it is necessary to pay attention to such signs of excessive dopamine stimulation as dyskinesia, agitation or hallucinations. In such cases, it is necessary to reduce the dose or consider stopping taking one of the drugs.

Selegiline and Levodopa (two common antiparkinsonian drugs) do not affect the pharmacokinetics of Pramipexole. In turn, Pramipexole doesn’t affect the overall amount of absorption or elimination of Levodopa. When increasing the dose of pramipexole, a decrease in the dose of Levodopa is recommended, while the dose of other antiparkinsonian drugs must be maintained at a constant level.

Because of possible cumulative effects, patients should be advised to exercise caution when taking other sedative drugs or ethanol in combination with Mirapex, as well as when taking drugs that increase the concentration of pramipexole in plasma (for example, cimetidine) . The concomitant use of pramipexole with antipsychotics should also be avoided.

Overdose

In medical practice, cases of severe overdose of Mirapex are not described, however, the expected symptoms are characteristic of the pharmacodynamic profile of dopamine receptor agonists. These include nausea, vomiting, hyperkinesia, hallucinations, agitation, and decreased blood pressure.

There is no established antidote, so treatment for overdose is symptomatic. Recommended gastric lavage, dynamic observation. The effectiveness of hemodialysis has not been established. With signs of CNS excitation, neuroleptics may be prescribed.