REQUIP MODUTAB PILLS PROLONGED 4MG

Indications

Parkinson's disease:

- monotherapy of early stages of the disease in patients who need dopaminergic therapy in order to delay the prescription of levodopa drugs;

- as part of combination therapy in patients receiving levodopa preparations, with the aim of increasing the effectiveness of levodopa, including controlling fluctuations ("on-off") and the effect of "end of dose" against the background of chronic levodopa therapy, as well as to reduce the daily dose of levodopa.

Dosing regimen

The drug is administered orally 1 time / day at the same time, regardless of the meal. pills are taken whole without chewing, without breaking.

It is recommended that individual selection of the dose in accordance with the effectiveness and tolerability of the drug.

A dose reduction is recommended if the patient is drowsy at any stage of the dose selection. With the development of other adverse reactions it is necessary to reduce the dose of the drug, followed by a gradual increase in dose.

It should be borne in mind the need for dose titration when skipping a dose (one or more).

Monotherapy

Start of treatment

The recommended initial dose of the drug Requip Modutab® is 2 mg 1 time per day for one week. Subsequently, the dose is increased by 2 mg at intervals of at least 1 week to 8 mg / day.

Maintenance dose

If, after the selection of the dose, the therapeutic effect is not sufficiently pronounced or is unstable, you can continue to increase the daily dose of the drug by 4 mg at intervals of 1–2 weeks (until the desired therapeutic effect is achieved). The dose can be changed depending on the therapeutic effect and increased to a maximum dose of 24 mg 1 time / day.

Combination therapy

When using the drug Requip Modutab® in doses used in monotherapy, in combination with levodopa preparations, the dose of levodopa can be gradually reduced (depending on the clinical effect). In clinical studies in patients who simultaneously receive Requip Modutab® in sustained release tablets, the dose of levodopa was gradually reduced by approximately 30%. In patients with a progressive form of the disease, taking Requip Modutab® in combination with levodopa preparations, dyskinesia may occur during the period of dose titration of ropinirole. Reducing the dose of levodopa drugs can lead to a reduction in these symptoms.

Cancel therapy. Requipup Modutab® (like other dopaminergic drugs) should be abolished, gradually reducing the daily dose for at least 1 week. If treatment was interrupted for 1 day or more, then when therapy is resumed, the need for dose titration should be considered.

Despite the possible decrease in clearance of the drug in patients aged 65 and over, the dose titration of ropinirole in this category of patients is carried out as usual.

Have patients with impaired renal mild and moderate severity (CC 30-50 ml / min) ropinirole clearance does not change, dose adjustment of ropinirole is not required.

For patients with end-stage renal failure on hemodialysis, The recommended starting dose of ropinirole is 2 mg 1 time / day. A subsequent increase in dose should be based on an assessment of tolerability and effectiveness. The maximum daily dose in patients on permanent hemodialysis is 18 mg. Administration of maintenance doses after hemodialysis is not required.

Adverse Effects

Determination of the frequency of adverse reactions: very often (≥1 / 10); often (≥1 / 100, <1/10); sometimes (≥1 / 1000, <1/100); rarely (≥1 / 10,000, <1/1000); very rarely (<1/10 000, including isolated cases).

Data from clinical studies in patients with Parkinson's disease

1 In patients with a progressive form of the disease, taking Requip Modutab, in combination with levodopa preparations, during the period of dose titration, the development of movement coordination is possible. It has been shown that withdrawal of levodopa preparations can lead to a reduction in these symptoms.

Post-marketing data

From the side of the central nervous system and peripheral nervous system: sometimes psychotic states (including delirium and delirium), perceptual disorders (including illusions, excluding hallucinations), increased impulsivity, increased libido, including hypersexuality, a pathological attraction to gambling; very rarely, marked drowsiness, episodes of sudden falling asleep (as with the use of other dopaminergic agents, these symptoms were very rarely recorded in patients with Parkinson's disease). With a decrease in dose or withdrawal of the drug, all the symptoms disappeared. In most cases, concomitant sedatives were used.

Since the cardiovascular system: often - orthostatic hypotension, decreased blood pressure.

Allergic reactions: very rarely - urticaria, angioedema, rash, itching.

Contraindications

- acute psychosis;

- abnormal liver function;

- severe renal dysfunction (CC less than 30 ml / min), which is not carried out regular hemodialysis;

- rare hereditary diseases: lactose intolerance, lactase deficiency, glucose or galactose absorption disorders;

- pregnancy;

- lactation;

- children's and teenage age up to 18 years;

- hypersensitivity to the drug.

WITH caution the drug should be used in patients with severe cardiovascular insufficiency. Ropinirol can be prescribed to patients with a history of psychotic disorders only in cases where the expected benefit from its use outweighs the potential risk.

Pregnanacy and breastfeeding

Contraindicated use during pregnancy and lactation (breastfeeding).

Application for violations of the liver

Contraindications: abnormal liver function.

Application for violations of kidney function

Have patients with impaired renal mild and moderate severity (CC 30-50 ml / min) ropinirole clearance does not change, dose adjustment of ropinirole is not required.

For patients with end-stage renal failure on hemodialysis, The recommended starting dose of ropinirole is 2 mg 1 time / day. A subsequent increase in dose should be warranted on the assessment of tolerability and effectiveness.The maximum daily dose in patients on permanent hemodialysis is 18 mg. Administration of maintenance doses after hemodialysis is not required.

Use in children

Contraindicated: children and adolescents up to 18 years.

Use in elderly patients

Despite the possible decrease in clearance of the drug in patients aged 65 and over, the dose titration of ropinirole in this category of patients is carried out as usual.

special instructions

Patients should be warned about the possible development of drowsiness or episodes of sudden sleep, sometimes not preceded by drowsiness. If such reactions occur, the possibility of discontinuing therapy should be considered.

It is recommended to monitor blood pressure due to the possibility of orthostatic hypotension.

In patients taking dopaminergic drugs, incl. ropinirole, craving disorders, including compulsive behaviors such as craving for gambling and hypersexuality, have been reported. According to the literature, similar side effects of therapy have been observed in patients with Parkinson's disease receiving high doses of dopaminergic drugs; other risk factors may be a history of compulsive behavior or the combined use of several dopaminergic drugs. In this case, consider the possibility of reducing the dose or cancellation of therapy.

Paradoxical deterioration in restless legs syndrome was noted with ropinirole therapy (earlier onset, increased intensity of manifestations, or progression of symptoms with previously untouched limbs involved), or ricochet syndrome in the early morning hours (symptom relapse in the early morning hours). With the appearance of these symptoms, it is necessary to revise the tactics of treatment with ropinirole, to clarify the dose up to the possible withdrawal of the drug.

Influence on ability to drive motor transport and control mechanisms

Patients should be warned of possible adverse reactions during ropinirole therapy.

Patients should be informed that there are very rare cases of episodes of sudden falling asleep without any prior or obvious signs of daytime sleepiness and cases of dizziness (sometimes pronounced).With the development of daytime sleepiness or episodes of falling asleep during the day, which requires active intervention, the patient must be warned about the need to abandon driving vehicles and other activities that require high concentration of attention and speed of psychomotor reactions.

Overdose

Symptoms: mainly due to dopaminergic action - nausea, vomiting, dizziness, drowsiness.

Treatment: use of dopamine antagonists, such as typical antipsychotics and Metoclopramide .

Drug interaction

Typical antipsychotics and other centrally acting dopamine antagonists, such as Sulpiride or metoclopramide, can reduce the effectiveness of ropinirole (concurrent administration should be avoided).

There was no marked pharmacokinetic interaction between ropinirole and levodopa or Domperidone, which would require dose adjustment of these drugs.

Ropinirol does not interact with other drugs that are often used to treat Parkinson's disease.

In patients with Parkinson's disease, who took both Digoxin, there was no interaction of digoxin with ropinirole, which would require dose adjustment.

Ropinirol is mainly metabolized by the CYP1A2 isoenzyme. Pharmacokinetic studies in patients with Parkinson's disease have shown that Ciprofloxacin increases Cmax and ropinirole AUC by about 60% and 84%, respectively. In this regard, in patients receiving ropinirol, its dose should be adjusted when prescribing and withdrawing drugs that inhibit the CYP1A2 isoenzyme, for example, ciprofloxacin, enoxacin or fluvoxamine.

A pharmacokinetic study of drug interactions in patients with Parkinson's disease between ropinirole and theophylline, a substrate of the CYP1A2 isoenzyme, showed that the pharmacokinetics of the drugs did not change. With the simultaneous use of ropinirole with other substrates of the isoenzyme CYP1A2, the pharmacokinetics of ropinirole does not change.

An increase in plasma ropinirole concentration was observed in patients receiving high doses of estrogen. In patients receiving hormone replacement therapy before starting treatment with ropinirole, treatment with ropinirole can be initiated as usual.However, in case of termination of hormone replacement therapy or the start of it during ropinirole therapy, dose adjustment may be required.

Information about the possibility of interaction of ropinirole and ethanol is not. As with other centrally acting drugs, patients should be warned about the need to refrain from taking alcohol during treatment with ropinirole.

It is known that nicotine induces a CYP1A2 isoenzyme, so if a patient starts or stops smoking during treatment with ropinirole, a dose adjustment may be required.

Terms and conditions of storage

The drug should be stored out of the reach of children, in its original packaging, at a temperature not exceeding 25 ° C.