Sifrol 0.25mg Boehringer treatment for Parkinson's disease (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Pramipexole dihydrochloride monohydrate

Ingredient

Composition information	Content
Pramipexole dihydrochloride monohydrate	0.25mg

Uses

Indications

Sifrol drug are indicated in the following cases:

Treat the signs and symptoms of the disease Parkinson idiopathic, the drug can be used for monomers (not with levodopa) or in combination with Levodopa, meaning it can be used during the treatment, until the late period when Levodopa has gradually lost the effect (Wear Off) or becomes unstable and appears the oscillation in the treatment effect [at the end of the dose or the oscillation. off)].

Pramipexol reduces the movement defects of Parkinson's patient by stimulating the dopamine receptors in the pattern. Animal studies have shown pramipexol inhibiting the synthesis, release and metabolism of dopamine.

Sifrol's action mechanism in the treatment of unknown vacuum syndrome. Neurological pharmacological evidence suggests that there is a major involvement of the dopaminergic system.

On the volunteer, a prolactin reduction depends on the recognized dose. It is observed that there is hypertension and heart rate in a clinical study on healthy volunteers, when the dose of Sifrol tablets releases slowly is faster than recommended (every 3 days) to the dose of 4.5mg of salt/day. Such effects are not observed in studies.

pharmacokinetics

Pramipexol is absorbed quickly and completely after drinking. Absolute bioavailability is greater than 90% and maximum concentration in plasma is achieved after 1 to 3 hours. Food does not affect the absorption level but reduces the absorption rate. Pramipexol has a linear dynamic and has little changes in plasma concentrations in patients.

In humans, pramipexol binds to protein at a very low rate (

Pramipexol is only metabolized in a few people.

Pramipexol is excreted mainly through the kidneys in non -metabolic form. About 90% of the drug is marked with 14C excretion through the kidneys, while less than 2% is found in the feces. The total clearance of Pramipexol is about 500 ml/min and the renal clearance is about 400 ml/min. The selling time varies from 8 o'clock in young people to 12 hours in the elderly.

Before taking Sifrol 0.25mg Boehringer treatment for Parkinson's disease (3 blisters x 10 tablets)

How to use

Sifrol medicine is used as follows:

Parkinson's disease: Should take medicine with water, can be used with food or not. The daily dose is divided evenly to drink 3 times a day.

Peaceful vacuum syndrome: Drugs are taken with water and can be taken with or not with food.

Dosage

Starting treatment

The dose increases gradually, the starting dose is 0.375 mg of salt daily, then increases the dose gradually every 5-7 days. If the patient does not experience uncomfortable side effects, gradually adjust the dose until the maximum treatment is achieved.

Sifrol dose increasing schedule week Dosage (Mg Salt) Total daily dosage (mg in salt form) 0.125 0.375 The daily dose adds 0.75 mg of salt to the maximum dose of 4.5mg of salt a day.

However, it should be noted that the drowsiness rate will increase when the dose is higher than 1.5 mg/day (see the "side effect" section).

Maintain treatment

Dosage for each patient should be in the range of 0.375 mg of salt to a maximum of 4.5 mg of salt daily. In the process of increasing the dose in three key studies, the efficiency achieved starting from 1.5 mg of salt. Additional dose adjustment should be based on clinical response and the appearance of adverse effects. In clinical studies, about 5% of patients are treated at lower doses of more than 1.5 mg of salt. In the treatment of Parkinson's disease, the dose higher than 1.5 mg of salt/day may be helpful for patients when planning to reduce Levodopa therapy. Levodopa dose reduction is recommended in both cases of increasing dose or maintenance treatment with Sifrol, depending on the reaction of each patient.

Stop treatment

Sudden stopping dopaminergic therapy can lead to malignant syndrome due to anti -psychotic drugs. Therefore, PramipExol should be reduced slowly at 0.75 mg of salt daily until the daily dose decreases to 0.75 mg of salt. After that, every day should reduce the dose of 0.375 mg of salt (see the "special and cautious note" section).

Dosage in patients with renal failure

Pramipexol elimination depends on the kidney function. Patients with creatinine clearance above 20 ml/minute do not need to reduce the dose

daily. Not studying the use of Sifrol in patients with dialysis or severe kidney failure.

Dosage in patients with liver failure

There is no need to adjust the dose in patients with liver failure because about 90% of the active ingredient is absorbed will be excreted through the kidneys. However, the effect of liver failure on pharmacokinetics of Sifrol has not been studied.

Peaceful vacuum syndrome

The pill is drinking with water and can be taken with or not with food.

Sifrol's recommended starting dose is 0.125 mg of salt and oral salt once a day, taking 2-3 hours before going to bed. For patients, they need to be reduced more symptoms, which can increase the dose every 4-7 days to a maximum of 0.75 mg of salt/day (as the table below).

Sifrol dose schedule mg)

1 0.125 essential. If the treatment is interrupted for a few days, it is necessary to start adjusting the dose as the table above.

Stop treatment

No need to reduce the dose from before stopping sifrol due to daily dose of daily treatment of uneasy vacuum syndrome does not exceed 0.75 mg of salt. In a clinical study with a 26 -week placebo, the reverse phenomenon of uneasy vacuum syndrome (severe symptoms compared to the original) were observed in 10% of patients (14 of 135) after suddenly stop using Pramipexol. This effect is recorded similarly at all doses.

Dosage in patients with renal failure

Pramipexol elimination depends on the kidney function. Patients with creatinine clearance above 20 ml/minute do not need to reduce daily dose. Not studying the use of Sifrol in patients with dialysis or severe kidney failure.

Dosage in patients with liver failure

There is no need to reduce the dose in patients with liver failure, as about 90% of the active ingredient has absorbed through the kidneys.

Dosage in children and teenagers

It is recommended not to use Sifrol for children and teenagers under 18 years of age because there is not enough data on the safety and effectiveness of the drug for this group.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose? The adverse events that may be encountered are manifestations related to the pharmacological properties of dopamine, including nausea, vomiting, hyperactivity, hallucinations, agitation and hypotension.

There is no antidote for dopamine overdose. If there are signs of central nerve stimulation, sedative can be used. Overdose management by general support measures such as gastric lavage, infusion, active carbon and electrocardiography.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Sifrol 0.25 you may experience unwanted effects (ADR).

When using Sifrol may experience the following side effects:

Abnormal behavior (reflecting the manifestations of impulse control disorders and coercive pulse actors) such as insatiable eating, compulsive shopping, increased sexual activity and pathological gambling; Abnormal dreams, forgetting, heart failure , confusion, constipation, delusion, illusion, dizziness, dysfunction, shortness of breath, fatigue, hallucinations, headache, hiccups, hyperactivity, eating a lot, lower blood pressure , anti -anti -resistant hormones are not adequate, insomnia, sexual disorders, nausea, paranoia) Pneumonia, itching, rash and other hypersensitivity reactions; restlessness, drowsiness, sudden falling, fainting, vision impairment includes double view, blurred vision and vision, vomiting, weight loss including reducing appetite, weight gain.

Based on gross analysis from clinical studies with a placebo, including 1,923 patients using Sifrol and 1,354 patients with placebo, side effects of the drug recorded in both groups. There are 63% of patients using Sifrol and 52% of patients using placebo said at least one side effect.

Common side effects (≥ 5%) are reported in Parkinson patients using Sifrol more than the placebo group, vomiting, dynamic, hypotension, dizziness, drowsiness, insomnia, constipation, hallucinations, headaches and fatigue. The new rate of drowsiness increases when the dose is 1.5 mg/day (see the "dose and usage" section). The common side effect when used in combination with Levodopa is dynamic. Hypotension can occur at the beginning of treatment, especially when increasing the dose of Sifrol Quick.

The most common side effect (≥ 5%) is reported in patients with unifrol vacuum syndrome including vomiting, headache , dizziness and fatigue. Vomiting and fatigue are often reported in female patients with Sifrol treatment (20.8% and 10.5% respectively) compared to men (equivalent to 6.7% and 7.3%).

Table 1 and Table 2 show the frequency of side effects from clinical clinical studies in Parkinson patients and restless vacuum syndrome. The side effects presented in these tables are the side effects that appear with a ratio of over 1% in patients using Sifrol and appear more (statistically significant) in patients using sifrol compared to placebo, or clinical significance events. However, most of the side effects are often mild to medium and often appear in the early stages of the treatment process and most disappear even when continuing treatment.

Table 1: Very common side effects (≥ 1/10)

Agency system

Side effects

pramipexole
n = 1923 (%)

dizziness

15.5

12,9

vomit

17,2

Hypotension

12.6

Agency system

Side effects

pramipexole
n = 1923 (%)

Mental disorders

abnormal dreams

3.5

3.0

6.6

insomnia 8.2

drowsy

8.6

headache

6.5

Constipation

5.5

tired

6,1

1.9

See the "Special and Cautable Note" section.

Sifrol is also associated with sexual desire disorders (up (0.1%) or decrease (0.4%).

Parkers treatment patients with dopamine bronze drugs, including Sifrol, especially in high doses, have recorded symptoms of pathological gambling, increased sexual desire and sexual activity, often recovered when reducing the dose or stopping treatment.

In clinical studies and after -sales data, heart failure reports in patients treated with PramipExol. In an epidemiological study, using Pramipexol is associated with an increase in the risk of heart failure compared to patients who do not use PramipExol. It has not yet been proven to have a causal relationship between pramipexol and heart failure.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Sifrol 0.25 contraindicated in the following cases:

Hypersensitivity to pramipexol or any component of the product.

Precautions when using

kidney failure

When prescribing Sifrol for Parkinson patients with renal failure, the dose should be reduced as instructed in the "Dosage and usage" section.

Illusion and abnormal behavior

The illusion is the known side effect of Dopamine and Levodopa. Patients need to be notified that the illusion may occur (mostly virtual market).

Patients and caregivers should identify abnormal behaviors (reflecting the symptoms of impulse control disorders and coercive acts such as bingge early, compulsive shopping, increased sexual activity and pathological gambling that have been reported in patients treated with dopaminergic drugs. Should consider reducing the dose/stopped drugs slowly.

movement disorders

In Parkinson patients with progression, when treatment combined with Levodopa, dysplasia may encounter when starting the standard Sifrol dose. If this happens, levodopa dose should be reduced.

Solving suddenly and drowsiness

Sifrol is involved in drowsiness and sudden drowsiness, especially in Parkinson's patient. There is rarely falling off in daily activities that in some cases of unknown or no warning signs. Patients need to be notified and carefully advised when driving or operating machinery when treated with Sifrol. Patients who have manifested drowsiness and/or falling asleep need to limit driving or operating machinery. Moreover, it is necessary to consider reducing the dose or may stop treatment. Due to the combination effect, it should be recommended if the patient uses sedatives or alcohol with pramipexol (see the item "affects the ability to drive and operate machinery" and the "Side effects").

Halfy and delirium

Should check periodically to detect the impellance and delirium in the patient. Patients and caregivers should be noted that the impellance and delusion may occur in patients treated with PramipExol. Can consider reducing the dose/stop slowly if these symptoms start.

Patients with mental disorders

Should only treat dopamine bronze drugs for patients with mental disorders if the benefits are higher than the risk.

Eyes

Need to check the eye periodically or when there is an abnormal vision.

posture hypotension

Be careful in case of severe cardiovascular disease. Blood pressure monitoring should be monitored, especially when starting to treat, because the general risk is hypotension posture related to dopaminergic therapy.

muscle disorders

Stop treatment in Parkinson's patient

Symptoms that suggest malignant syndrome caused by psychotic drugs are also recorded when the dopaminergic therapy suddenly stops dopaminergic therapy (see the "dose and usage" section).

Increase the expression of uneasy vacuum syndrome

Literature reports show that the treatment of dopaminergic dopaminergic syndrome may cause this syndrome. The increased phenomenon is shown by the onset of symptoms earlier in the evening (or even in the afternoon), there are many symptoms and symptoms spread to other limbs. Increased phenomenon is specialized in a clinical study with a 26 -week control. Time analysis until there is an increase in the Kaplan-Meier method that shows no significant differences between the group using Pramipexol (n = 152) and the placebo group (n = 149).

The ability to drive and operate machinery

Sifrol has a great impact on the ability to drive and operate machinery. Illusion or drowsiness may occur. Patients using Sifrol have drowsiness and/or fall asleep, which should be notified to stop driving or participate in activities that if lacking alertness can cause serious injuries or death for themselves or others (for example, when operating machinery) until solving drowsiness and falling asleep (see "special note and cautious", "interaction" and "side effects").

Pregnancy

Effects on pregnant and lactating women have not been studied in humans. PramipExol does not have a monster on rats and rabbits but has toxicity on mouse embryos when using toxic doses for mother mouse.

Do not use Sifrol during pregnancy unless it is really necessary, that is, only treatment if the benefits are higher than the risk to the fetus.

Breastfeeding period

Because Sifrol inhibits prolactin secretion on humans, can inhibit milk secretion.

Sifrol excretion in breast milk has not been studied in humans. On the mouse concentration of active ingredient is higher than the radiation in milk in plasma.

Because there is no human data, Sifrol should not be used during breastfeeding.

However, if the use of the drug is inevitable, should stop breastfeeding.

Drug interaction

Pramipexol is associated with plasma proteins with very low rate (

Although interacting with cholinergic anti -cholinergic drugs has not been studied, because cholinergic drugs are eliminated by biological transformation, the ability to interact is very low. There is no pharmacokinetic interaction with Selegilin and Levodopa.

cimetidine reduces the kidney clearance of pramipexol by about 34%, perhaps due to inhibition of the transportation system of positive ions in the renal tubules. Therefore, inhibitors inhibit the active excretion through the kidneys or are eliminated through this road, such as cimetidine and amantadin, which can interact with pramipexol resulting in reducing one or both medication clearance. Need to consider reducing the dose of pramipexol when these drugs are used with Sifrol.

When using Sifrol with Levodopa, Levodopa is required and keeps the dose of other Parkinson's medications while increasing the sifrol dose.

Due to the possibility of a combination effect, be careful for patients when using pramipexol simultaneously with other sedatives or alcohol.

Should avoid simultaneous use of anti -psychotic drugs with pramipexol (see the section "Special and cautious note"), for example, antagonistic effects may occur.

Storage

Storage below 30 ° C.

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